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BIOTECHNOLOGY

INDUSTRY REPORT

SUBMITTED BY

TUSHAR PAREEK

MBA BIOTECHNOLOGY

PUMBA

BIOTECHNOLOGY INDUSTRY REPORT Page 1


CONTENTS

Topic Page No.


Industry Overview 3
Biopharmaceutical Sector 11
Bioagricultre Sector 27
Bioindustrial Sector 56
Bioservices Sector 76
Biosupplier Sector 101
Bioinformatics Sector 121
SWOT and Conclusion 132
References 136

BIOTECHNOLOGY INDUSTRY REPORT Page 2


BIOTECHNOLOGY INDUSTRY OVERVIEW
BIOTECHNOLOGY is an umbrella term that covers a wide spectrum of scientific applications used
in many sectors. It must be seen in the context of a large number of other disciplines and technologies
such as systems biology, synthetic biology, bioinformatics and nanotechnology, whose convergence
will drive new products and technologies in the future. It has been described as a classic example of
‗disruptive technology‘, similar to the steam engine, electricity or information technology. Disruptive
technologies are often initially resisted because their potential is not recognized, even as large
pharmaceutical companies initially dismissed biotechnology in the beginning. The global
biotechnology industry is now at the beginning of a technology curve whose upside potential appears
limitless. Governments around the world are embracing biotechnology as the next driver of
innovation and economic growth. Biotechnology is already beginning to usher in complex, rapidly
emerging and far-reaching new changes in several areas, particularly food and nutrition security,
healthcare and environmental sustainability. It has at the same time sparked-off a number of
controversies. These range from seeking an optimal balance between rewarding innovation and
ensuring the broadest possible access to the benefits of biotechnology, ethical issues related to
‗modifying life‘ and ‗playing God‘, as well as concerns related to environment and health safety.
Society at large has to learn to grapple with these through effective and transparent application of
science-based processes to address these vexing issues. In addition, generation of employment,
creation of intellectual wealth, expansion of entrepreneurial opportunities and augmenting industrial
growth are a few compelling factors that warrant a focused approach for this sector.

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The 21st century is witnessing the dawn of biotechnology which is expected to surpass
Information Technology as the new engine of the global economy. Its products will be more
important than the fire the wheel or the car and will generate more knowledge in a short
period of time than history's collective wisdom. Biotechnology is expected to alter healthcare
agriculture commercial and industrial products. It is predicted that by the middle of the 21st
century all companies will become Biotech companies in some form or the other. A key
driver and enabler of this emerging technology is bioinformatics. The biotech industry
developed only within the last twenty-five years. Conventional techniques of producing
biotechnology products such as using traditional microbiological fermentation evolved with
the development of modern technologies. Modern biotechnology entails the use of cell fusion
techniques bio-informatics (use of information technology for documenting bio-diversity and
studying DNA structures) genetic engineering structure based molecular design and
recombinant DNA technology (insertion of foreign gene) and hybridoma technology (fusing
and multiplying cells).

Over the last two decades, world biotechnology has been dominated by the US and Japan.
US-based life sciences companies generate a lion‘s share of over US$ 500 billion in
revenues, followed by Japan. Biotechnology industry continues to grow rapidly, with over
6000 companies engaged in activities related to discovery, consumables and equipment and
the number is increasing at 6% annually. It is noteworthy that in spite of much larger R&D
investments in the pharmaceutical sector, more and more approvals granted by the US FDA
are for bio-drugs.

INDIA & BIOTECHNOLOGY OVERVIEW


The Indian biotech sector is in a unique crossroads. On one hand it is forced to meet the
internal and more public-cantered healthcare objectives of reaching out the right medication
or treatment to the needy and on the other hand it is forced to remain competitive in the
international markets.

India which has earned a name worldwide as the most prefered location for global
information technology outsourcing and software services firms, is gradually making a mark
in another high-tech sector- Biotechnology. The large pool of scientific talent available at a
reasonable cost, a wealth of R & D institutions, a rich and varied bio-diversity, a flourishing
pharmaceutical industry, strong IT skills and an English speaking population have all placed
India favorably in the global market. This sunrise sector which has seen which has seen the
entry of many new players both Indian and International, is poised to take the country to the
big league with investment flowing in from all corners. India has an enormous potential in
becoming a leading player in the global biotechnology industry. The Indian biotech sector
stands 4th in terms of volume and 13th in terms of value. The sector is one of the fastest
growing knowledge-based sectors in India and experts predict that biotechnology is going to
play a key role in shaping India's rapidly developing economy. The country has traditionally
done well in pharmaceutical and drug industry. As a derivative of thepharmaceutical industry
the Biotechnology sector took shape over the last decade with many entrapreneurs making
substantial investment in it. India is ranked among the top-12 biotech destinations in the

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world and is the third biggest in the Asia-Pacific region in terms of the number of biotech
companies according to a report by the Confederation of Indian Industry (CII) and the
consultancy firm KPMG. India is also gaining importance as a clinical trial destination. The
global clinical research outsourcing market is projected to touch US$ 23 billion by 2011, with
consultancy firm, KPMG, estimating that India will corner 15 per cent of this in two years.
Also, according to a joint study by FICCI and (E&Y) Ernst and Young, the industry-
sponsored Phase II, Phase III clinical trial study sites in India have grown by 116 per cent
over the last 15 months, with the country moving from rank 18 to 12 across the 60 most
active countries. India participates in 7 per cent of the global Phase III trials and 3.2 per cent
in the Phase II trials with industry-sponsored trials.India has been a recent entrant into the
elite 6 countries group who have successfully decoded the human genome indigenously, the
others being the US, UK, China, Canada and South Korea. India houses about 380 biotech
companies, of which 198 are in Karnataka with 191 in Bangalore alone. Clinical data
management, drug discovery and low-cost production manufacturing are some advantages
that Indian companies enjoy against their global counterparts. Nearly 40 percent of the
biotech companies operate in the biopharma sector, followed by the bioservices (21 percent),
bioagri (19 percent), bioinformatics (14 percent) and lastly the bioindustrial sector (5
percent). Discovery research is leading to new molecules in place of generics. Pre-clinical
development and presence of large animal facilities is set to attract investments in biopharma
and bio-agritech segments. The challenges before the sector are about securing private and
public funding despite risk aversion among VCs (venture capital funds). The industry is
lobbying for the need to improve the regulatory infrastructure, bio-manufacturing standards,
clinical development capabilities, R&D collaborations with US/European Union firms and
acceptance of Indian clinical data by the US Food and Drug Administration and the European
Agency for Evaluation of Medicinal Products of Europe. A number of far reaching changes
are taking place to facilitate growth in the biotech sector further. India is becoming one of the
most favored destinations for collaborative R&D, bioinformatics, contract research and
manufacturing and clinical research as a result of growing compliance with internationally
harmonized standards such as Good Laboratory Practices (GLP), current Good
Manufacturing Practice (cGMP) and Good Clinical Practices (GCP). A well-defined
regulatory framework, along with an emerging stringent IPR regime is also contributing to
this trend.

The Indian Biotechnology Industry can be classified into five different segments, Bio-Pharmaceutical,
Bio-Agriculture, Bio-Services, Bio- Industrial & Bio- informatics with each concentrating on a
particular area.

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Bio pharma: deals with the production of vaccines, therapeutics and diagnostics, while the end
products of the biotech industry find two different kinds of buyers, the first type include private
hospitals, governments; patients and the second type include industries like pharmaceutical.

Agri-biotech: deals with hybrid seeds and transgenic crops, bio pesticides and bio fertilizers.

Bio informatics: deals with creation and maintenance of extensive electronic databases on various
biological systems.

Bioservices: market deals with clinical trial, contract research and manufacturing activities.

Bio Industrial: industry deals with enzyme manufacturing and marketing companies and these
enzymes are used in detergent, textile, food, leather, paper and pharmaceutical industry.

At present there are more than 350 biotech companies in India providing employment for over 20,000
scientists. Most of the companies are located in the six major cities of Delhi, Mumbai, Pune, Chennai,
Bangalore, Hyderabad and Ahmadabad. The leading companies in India are Biocon, Serum Institute
of India(in the biopharma space),Mahyco Monsanto, Rasi seeds(in the agribio tech field),Strand
Genomics, GVK Biosciences (in the bioinformatics arena),Syngene and Quintiles in the (in bio
services).

Each sector plays an important role in the growth and development of the Industry. Biopharmaceutical
sector has been the largest contributor to the industries growth with a value contribution of US $ 1.32
billion accounting for a 69.73% contribution in 2006-07 to value contribution of US $ 1.96 billion
accounting to 60% contribution in 2009-2010.

The Indian Biotechnology industry was growing at an astounding 34% growth rate till 2006 and it
was during this period that it was expected to cross the US $ 5billion mark by 2010, but then the
2007-08 recession hit the biotechnology industry growth rate and it came down to 18% in 2008-09

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and in 2009-10 the industry grew by 17% and reported a revenue of US $ 3 billion. Even though the
growth rate has slowed down but the industry is recovering from the recession hangover at a good
pace and is expected to reach $ 12 billion by 2017.

The biopharma sector contributed nearly three-fifth to the industry's revenues at US$ 1.9 billion, a rise
of 12 per cent, followed by bioservices at US$ 573 million and bioagri at US$ 420.4 million in the
year 2009-10. The remaining revenue came from the bioindustrials US$ 122.5 million and
bioinformatics US$ 50.2 million segments.

The Indian biotech industry can be broken down in to three clusters Western Cluster, Southern Cluster
and Northern cluster. The Western Biocluster emerged as the biggest contributor to India‘s
Biotech sector revenues followed by the Southern Biocluster contributing US $ 1.23 billion.
Western India continued to dominate India‘s biotech industry with 46% share in the overall
revenues of US $ 1.47 billion from 137 companies in the region. The Northern Biocluster
contributed just about one-seventh of the revenues at US $ 451 million.

West is home to top Bioagri companies such as Monsanto, Mahyco and Ajeet Seeds and
MNCs like GlaxoSmithKline, Roche, Aventis Pharma, Wyeth, Quintiles. Four of India‘s top
10 services companies (CROs) are also based out of West, including the No 1 CRO in the
Indian industry – Quintiles India (Rs 375 crore).

India‘s National Capital Region (NCR), home to the Top 3 companies, Panacea (Rs. 703
crore), Jubilant (Rs. 249 crore) and Eli Lily (Rs. 187 crore), contributed 56% of the revenues
from North. This cluster is better known for its research institutes and of course, government
bodies. Of the three large companies in the North, Panacea is the only one that grew at
17.86%, a growth rate higher than the industry growth rate.

South continues to remain India‘s largest Biotech cluster in terms of the number of
companies adding 9 new biotech companies, highest in the country during the year. The
region has 172 biotech companies which posted revenues of Rs 5537.68 crore during the year
making up 39% of the overall revenues. Eastern India does not add any significant revenues
to the country‘s overall BioTech pie.

Key Biotech clusters in India


Bangalore, in Karnataka is the Biotech capital for India. India houses 380 biotech companies
of which a majority of 198 are in Karnataka and 191 in Bangalore alone. Bangalore and
Karnataka jointly contribute 27% to the revenue of the sector. The other key clusters include
Mumbai and Ahmedabad in the West (Maharashtra and Gujarat respectively), Hyderabad
(Andhra Pradesh) in the South and the area in and around New Delhi in the North. The
Western belt houses companies that are large pharmaceuticals with a prominent
manufacturing and R&D base, who have active interest in pursuing the manufacture of
biogenerics. Hyderabad has several vaccine manufacturers and other large biotech companies
involved in research. The regions in and around New Delhi house several key research
centres and univerisites that are involved in research.

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Karnataka –Bangalore
Biotechnology, post the ICT success, has emerged as a recent rapidly expanding sector in
Bangalore. The city accounts for over 50% of the 380 biotech companies in India. The city
has revenue of over $550 for 2008-2009 which is over 20% of the total biotech revenue for
the country. Bangalore is the country‘s largest cluster, the city boasts of 198 biotech firms.
Biocon, the nation‘s leading biotech company is headquartered in Bangalore. Some of the
key life science companies to look out for in Bangalore include: Advinus Therapeutics, Astra
Zeneca, Aurigene Discovery services, Biocon India, Jubilant Biosys, Metahelix Life
Sciences, Strand Life Sciences, Strides Arcolab and Xcyton Diagnostics Government of
Karnataka is investing Rs. 5,500 crore in Bangalore Helix Biotech park which is spread over
106 acres at the Electronics City, off Hosur Road in Bangalore. Bangalore can boast of good
Universities like the Indian Institute of Science, JNCASR, NCBS, and University of
Agricultural Sciences. ABLE the Trade association for Biotech Industry is headquartered at
Bangalore. Bangalore has opportunities in Contract Research Space and lot of potential in the
Stem Cell area.

Andhra Pradesh - Hyderabad


Biotechnology is an important industry in Andhra Pradesh. There is a high concentration of
biotech companies producing recombinant therapeutics for human consumption. It also has
the second largest recombinant DNA therapeutic production facility in the world, which is
also being used by multi-national companies to produce their own recombinant products.
Andhra Pradesh is called ―Bulk drug Capital of India‖. Andhra Pradesh has a dominant
position in the bulk drugs and pharmaceutical sector with Hyderabad accounting for nearly
one third of India's total bulk drug production. Hyderabad has witnessed infrastructural
development in the biotech domain wherein the Knowledge Park, the Biotech Park, Genome
Valley and other projects have come up giving the city an advantage over others. Hyderabad
is also a house for research and development Centres like Centre for Cellular and Molecular
Biology (CCMB), Indian Institute of Chemical Technology (IICT), International Crop
Research Institute for Semi-arid Tropics (ICRISAT),Central Food Technology Research
Institute (CFTRI) and Institute for Life sciences centre is based out of Hyderabad and have
32 laboratories and 12 research centres. (ILSC) The Government of Andhra Pradesh offers
opportunities in Therapeutics, Diagnostics, Industrial Biotechnology, Inputs to the industry
(hardware suppliers - Instrumentation and Chemicals), and Agricultural Biotechnology in the
biotech space.

TamilNadu - Chennai Tamilnadu is the first state to have introduced a separate Bio Tech
policy. Tamil Nadu presents an attractive market for medical biotechnology products as it
accounts for about 11% of the pharmaceutical market in the country. The Government of
Tamil Nadu has also announced the establishment of Biotechnology Enterprise Zones (Bio-
Valleys) along the lines of Silicon Valley to exploit the bioresources of the State. Chennai has
some of the top pharma companies like Orchid Pharma, Shasun Pharma and Bafna
Pharmaceuticals and few Biotech companies like ABL Biotech and Proalgen Biotech. Tamil
Nadu also has reasearch centres like Centre for Biotechnology, Anna University Centre for
Plant Molecular Biology, Tamil Nadu Agricultural University, Coimbatore, and Centre for
Research in Medical Entomology, Madurai, Department of Biotechnology, School of
Bioengineering, SRM University, Rajiv Gandhi Centre for Biotechnology, School of
Biotechnology, Madurai Kamaraj University, School of Chemical and Biotechnology –
Sastra University. Tamil Nadu has opportunities in the area of Stemcell Research and
Nanotechnology.

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Western Region Maharashtra The state accounts for 40 per cent of the country'
pharmaceuticals output. It has strong research capabilities and accounts for over 30 per cent
of country‗s patents. It has a presence of reputed companies focusing on the biotech sector
including Wockhardt, Nicholas Piramal, Cipla and Lupin, among others and state is setting
up biotech parks at Hinjewadi, near Pune. Major opportunities have emerged in the
pharmaceutical sector, primarily in the areas of contract research, contract manufacturing and
clinical trials. State boasts of Low costs, strong manufacturing base, well developed
laboratory and R&D infrastructure, a strong resource pool. The backward linkage with the
well-developed chemicals and petrochemicals sector is an added advantage.

Gujarat: Gujarat accounts for 28 per cent of national pharmaceutical production (2006-
2007). First state to manufacture APIs and finished dosage forms. It is a home to 902
allopathic manufacturing units and 2,122 contract manufacturing units. Gujarat accounts for
exports worth US$ 1.4 billion (2006-2007). It has number of clinical research organisations
in India and over 100 companies with WHO-compliant manufacturing units, academic and
research institutions providing over 4,600 technically-skilled man power per annum. India‘s
largest biotech park of 700 acres is being developed at Savli, Vadodara. Key players are
Zydus Cadila, Torrent Pharma, Sun Pharma, Intas Pharma, Alembic, Dishman Pharma.
Mumbai is home to the two major pharmaceutical associations including Indian Drug
Manufacturers Association (IDMA) and organisation of Pharmaceutical Producers of India
(OPPI).

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THE TOPPERS OF THE INDIAN BIOTECH INDUSTRY
The top Indian biotech companies contribute a lot to the overall biotech sector of the country.
The top 30 companies contribute more than 50% of the total revenue of the industry

The top ten biotech companies by revenue for the year 2009-10 are as follows.

Revenue Rank Company 2009-10 % Change over


2010 2008-09
(Revenue (Revenue in
in
Million US $)
Million
US $ )

1 Biocon 262.2 202.74 29.34

2 Serum 188.8 247.55 -23.70


Institute of
India

3 Panacea 156.2 132.69 17.76


Biotech

4 Nuziveedu 105.9 99.9 6.07


Seeds

5 Reliance Life 100


Sciences

6 Quintiles 83.3

7 Rasi Seeds 79.7 83.4 -4.48

8 NovoNordisk 76 73.3 3.64

9 Shantha 74.2 54.8 35.32


Biotech

10 Mahyco 69.3 46.9 47.78

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BIOPHARMACEUTICAL SECTOR
Biopharmaceuticals are complex macromolecules derived from recombinant DNA
technology, cell fusion, or processes involving genetic manipulation. They include
recombinant proteins, genetically engineered vaccines; therapeutic monoclonal antibodies;
and nucleic acid based therapeutics (i.e. DNA based drugs), including gene therapy vectors.
Unlike orally delivered small molecule drugs that underpin the traditional pharmaceutical
industry, biopharmaceuticals are usually administered by subcutaneous, intravenous, or
intramuscular injection.

BIOPHARMACEUTICAL MARKET OVERVIEW


The biopharmaceutical market has come a long way since 1982 when the first
biopharmaceutical product, recombinant human insulin, was launched. Over 130 such
products are currently being marketed around the world including thirteen blockbuster drugs.
The global market for biopharmaceuticals, currently valued at US$48 billion, has been
growing at an impressive CAGR of 19% over the previous five years. With over one third of
all pipe-line products in active development are biopharmaceuticals, this segment is set to
continue outperforming the total pharmaceutical market and could easily reach US$100
billion by the end of the decade.

Under mounting economic pressures to increase their outputs, pharmaceutical manufacturers


have embraced biopharmaceuticals as a means to maintain flow in their drying pipelines.
Bringing a biopharmaceutical, however, represents a very risky proposition and out of every
ten drugs that enter the clinical phases, only three manage to gain market approval. But the
industry‘s US$ 92 Billion figures and double digit growth rates in the last five years are a
testimonial to the fact that the ones that finally do get approval represent goldmines for
investors. Although factors such as biosimilar entry and cost containment in the developed
markets are likely to restrain the growth of this market in the coming years, it is expected that
the high potency and ability of biopharmaceuticals to attack targets beyond the reach of
traditional small molecule drugs gives the industry a huge scope for future growth. A rich late
stage pipeline and the growth of emerging markets are also expected to be major drivers for
growth in the next five years. The global biopharmaceutical market is estimated to reach
level of sales figures worth more than US$ 167 Billion by 2015.

The development of bio-pharmaceutical industry is in sync with the development of


biotechnology. The technology was quickly applied to new drug development on, and has
achieved great success. Many countries in the world are involved in the development of bio-
pharmaceutical industry, a huge market, but the main focus is in the countries like United
States, Japan and Europe.

AMERICA: Birthplace of modern biotechnology and also the first application of this
technology, the United States in the development of bio-pharmaceutical industry lead the
world. The United States currently has more than 1000 biotechnology companies,
biotechnology market capitalization more than 400 billion dollars, US spends over 50 billion

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U.S. dollars in research funding each year. Amgen, Biogen Idec, Genentech, Genzyme, Life
Technologies, and Monsanto are among the major U.S. biotechnology companies in the USA.
US biopharmaceutical market has annual revenue of about $70 Billion USD according to a
Research and Markets report. U.S. has successfully developed more than 30 important drugs.
These drugs are widely used in cancer, diabetes, hepatitis and other diseases treatment.

EUROPE: European Bio-pharmaceuticals market is behind U.S. overall, but is developing


rapidly. Progress of countries like Britain, France, Germany, Russia and other countries in
the developed Europe have been impressive, in the production of biological medicines.

JAPAN: Japan's pharmaceutical industry is also developing rapidly. The country is also
focusing on bio-and nanotechnology, Information technology, disease-related genes and the
resulting protein structure, in order to develop "genetic drugs" as the goal to promote the
biotechnology industry in Japan. Currently, Japan already has 65% of the biotechnology
company engaged in biomedical research; Japanese company's technical strength has been
among the highest in the world.

ASIA PACIFIC: Asia-Pacific countries other than Japan are also developing rapidly in the
field of biopharmaceuticals; especially Australia, China and India, these countries continue to
attract investment in their Biopharmaceutical market.

GLOBAL BIOPHARMACEUTICAL HIGHLIGHT:


Biopharmaceuticals enjoy a higher approval success rate compared to traditional
small molecule drugs. They, however, require higher investments and take longer
development times. Biopharmaceuticals are significantly more expensive than
traditional medications, with the annual cost of therapy of some biopharmaceuticals
touching more than a hundred thousand dollars a year. The cost of these drugs,
however, is expected to be closely scrutinized by payers in the coming years.
Recombinant Proteins represented the biggest biopharmaceutical class in 2009-10,
accounting for more than 65% of the total global biopharmaceutical sales. Growth in
this class is expected to be low in most of the developed markets as a result of
biosimilar entry and increasing cost containment measures.
Monoclonal Antibodies are expected to be the biggest drivers of the
biopharmaceutical market in the next five years. Driven by a rich late stage pipeline
and a strong uptake from both developed and emerging market, Monoclonal
Antibodies are expected to be worth more than US$ 79 Billion by 2015.
Imarc expects the top eight markets (US, Germany, Japan, France, Italy, Spain, UK
and Canada) to account for around 79% of the total global biopharmaceutical sales by
2015. This represents a decline of 4% over their 2009 share.
The market share of emerging markets (Brazil, Russia, India, China, Mexico, Turkey
and South Korea) is likely to increase from less than 5% in 2009 to more than 8% by
2015.

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TOP COMPANIES IN THE GLOBAL MARKET:

Top 10 Biopharmaceutical Companies as per revenues - 2009:

01 Roche/Genentech $36,017

02 Amgen $14,642

03 Novo Nordisk $9,566

04 Merck Serono $7,454

05 Baxter BioScience $5,573

06 Biogen Idec $4,247

07 Genzyme $3,562

08 CSL Ltd.* $3,211

09 Allergan $1,310

10 Alexion Pharma $387

Based on 2009 biopharma revenues.*


Note: In all Top Company profiles, dollar amounts are in millions.

* CSL's financial year ran from July 1, 2008 to June 30, 2009

COMPANY PROFILE IN DETAIL:

ROCHE/GENENTECH:

Headquartered in Basel, Switzerland, Roche is one of the world‘s leading research-focused


healthcare groups in the fields of pharmaceuticals and diagnostics. As the world‘s biggest
biotech company and an innovator of products and services for the early detection,
prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of
fronts to improving people‘s health and quality of life. Roche is the world leader in in-vitro
diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is
also active in other major therapeutic areas such as autoimmune diseases, inflammatory and
metabolic disorders and diseases of the central nervous system. In 2010 sales by the
Pharmaceuticals Division totaled 37 billion Swiss francs, and the Diagnostics Division posted
sales of 10.4 billion francs. Roche has R&D agreements and strategic alliances with

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numerous partners, including majority ownership interests in Genentech and Chugai, and
invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about
80, 000 people. With Roche‘s acquisition of Genentech, which closed in April 2009, Roche
supplanted Amgen and moved into the top rank of global biopharma companies.

AMGEN:

Amgen Inc. is an international biotechnology company headquartered in Thousand Oaks,


California. Located in the Conejo Valley Amgen is among the biggest of the biotech
companies. The company uses cellular biology and medicinal chemistry to target cancers,
kidney ailments, inflammatory disorders, and metabolic diseases. Anti-anemia drugs Epogen
and Aranesp account for more than one-third of its sales. Enbrel, another leading drug, treats
rheumatoid arthritis and is one of the best-selling drugs in this multi-billion-dollar market.
The company has a healthy drug pipeline, as well as marketing alliances with Japanese
brewer and drugmaker Kirin, Johnson & Johnson, and other pharmaceutical companies.
Amgen sells its products primarily through wholesale distributors in North America and
Europe. Although Amgen was supplanted as the world‘s biggest biopharma company; the
company got the U.S. and EU approval of Prolia (a.k.a. denosumab), its semi-annual
postmenopausal osteoporosis treatment. Analysts project $1 billion in sales in its first full
year, and $3 billion in annual sales by 2013.

NOVO NORDISK:

Headquartered in Denmark, Novo Nordisk employs approximately 30,000 employees in 76


countries, and markets its products in 179 countries. Novo Nordisk manufactures and markets
pharmaceutical products and services. It is one of the world‘s leading companies in
diabetes care; Novo Nordisk pursues research into pulmonary delivery systems. Novo
Nordisk also commands large sectors of the markets in haemostatic management, growth
hormone therapy and hormone replacement therapy. It controls nearly a quarter of the world
market in diabetes care. Novo Nordisk has continued its dominance in the diabetes market; as
its human insulin sales diminish, its modern insulin products are tearing it up, rising 18% to
$4 billion in revenues.

MERCK

Merck & Co., Inc. (Merck) is a global health care company. Merck delivers health solutions
through its prescription medicines, vaccines, biologic therapies, animal health, and consumer
care products, which it markets directly through its joint ventures. The Company‘s operations
are principally managed on a products basis. Merck‘s operates in four segments: the
Pharmaceutical, Animal Health, Consumer Care and Alliances segments. The Pharmaceutical
segment includes human health pharmaceutical and vaccine products marketed either directly
by the Company or through joint ventures. Human health pharmaceutical products consist of
therapeutic and preventive agents, sold by prescription, for the treatment of human disorders.

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The Company sells these human health pharmaceutical products primarily to drug
wholesalers and retailers, hospitals, government agencies and managed health care providers,
such as health maintenance organizations, pharmacy benefit managers and other institutions.
Vaccine products consist of preventative pediatric, adolescent and adult vaccines, primarily
administered at physician offices. Additionally, the Company has consumer health care
operations that develop, manufacture and market Over-the-Counter (OTC), foot care and sun
care products, which are sold through wholesale and retail drug, food chain and mass
merchandiser outlets in the United States and Canada.

BAXTER:
Baxter International Inc., is an American health care company with headquarters in Deerfield,
Illinois. The company primarily focuses on products to treat hemophilia, kidney disease,
immune disorders and other chronic and acute medical conditions. The company has sales of
$12.3 billion, across three manufacturing divisions (BioScience, producing blood plasma
proteins; Medication Delivery producing intravenous therapy products and liquids; and Renal
producing equipment for dialysis and the treatment of kidney disorders). The company is also
involved in the production of a vaccine for the H1N1 influenza. Baxter‘s BioScience
revenues were up 5% to $5.6 billion in 2009.

BIOGEN IDEC:

Biogen Idec, Inc. is a biotechnology company specializing in drugs for neurological


disorders, autoimmune disorders and cancer. The company was formed in 2003 by the
merger of Cambridge, Massachusetts-based Biogen Inc. and San Diego, California-based
IDEC. Biogen, one of the oldest biotechnology companies. Biogen Idec is headquartered in
Weston, Massachusetts. Biogen Idec serves customers in more than 90 countries. Total
revenues of Biogen Idec in 2010 were $4.7 billion, an increase of 8% versus 2009.

GENZYME:

Genzyme Corporation is an American biotechnology company based in Cambridge,


Massachusetts. Genzyme is the world‘s third-largest biotechnology company, employing
more than 11,000 people around the world. The company has a presence in approximately 40
countries, including 17 manufacturing facilities and 9 genetic-testing laboratories, its
products are sold in 90 countries. Genzyme‘s 2009-10 revenue was $4,516 million.

CSL:

CSL Limited is an Australia-based manufacturer of medical products. With major facilities in


Australia, Germany, Switzerland and the US, CSL has over 10,000 employees working in 27
countries. Its products include various blood plasma derivatives, vaccines, antivenin, and cell

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culture reagents used in various medical and genetic researches and manufacturing
applications. CSL‗s vaccine for Swine Flu was approved in September 2009 for use in
Australia by people aged 10 and over. The revenue of CSL for 2009-10 was $4456 million.

ALLERGAN:

Allergen Inc. is a global specialty pharmaceutical company. Their product ranges include
ophthalmic pharmaceuticals, dermatology products, and neurological products.

The company‘s most notable neurologic product is Botox, used around the world to treat a
variety of debilitating disorders associated with muscle over activity and also well-known—
under the trade names Botox Cosmetic and Vistabel—for the treatment of facial lines. It‘s
most important manufacturing plants are in Waco, Texas; Westport, Ireland; and San Jose,
Costa Rica.

ALEXION PHARMACEUTICALS:

Alexion Pharmaceuticals, Inc., a biopharmaceutical company, engages in the discovery,


development, and commercialization of biologic therapeutic products in the United States,
Europe, Latin America, Japan, and the Asia Pacific. It focuses on products for severe and
life-threatening disease states, including hematologic, kidney, and neurologic diseases;
transplant rejection; cancer; and autoimmune disorders. The company was founded in 1992
and is headquartered in Cheshire, Connecticut.

INDIAN BIOPHARMACEUTICAL INDUSTRY:


The Biopharma sector makes for a huge part of the Indian biotechnology industry—$1.9
billion in 2009-2010 to be precise, accounting for 60% of the $3 billion revenues of the
biotech industry as a whole. Vaccines are of largest share among biopharma products with
60% contribution. With world class R&D facilities and cost cutting capabilities India is
attracting contract research outsourcing projects which is an add-on to the biopharma sector
growth .The world has understood the value of India as R&D hotspot and they simply cannot
lose the opportunity of being in India.

According to a study undertaken by research firm RNCOS; the biopharmaceuticals industry


in India will grow at a CAGR of about 13% between 2010-2011 and 2012-2013. The
biopharmaceutical sector accounts for 65% of the total industry‘s revenue. Domestic firms
dominate this sector, accounting for fourteen of the top twenty firms. The biopharma sector is
comprised of 200 companies involved mainly in the production of vaccines, therapeutic
drugs, animal biologicals, statins and diagnostics. Vaccine production is the most profitable,
with five of the top ten companies in the biopharma segment dealing primarily in vaccines.
Vaccines account for approximately 60% of total biopharma products. India has a handful of

BIOTECHNOLOGY INDUSTRY REPORT Page 16


dedicated biopharma companies which manufacture monoclonal antibodies (MAbs) which
primarily include cancer drugs, insulin, growth hormones, and cell culture to produce
vaccines. India is one of the largest producers of traditional vaccines in the world comprising
mainly of paediatric vaccines such as Anti Rabies Vaccine, Oral Polio Vaccine, and Hepatitis
B Vaccine.

Vaccines

Vaccines had the largest pie in biopharma with an estimated sale of Rs 2,180 crore over last
year's figure of Rs 2,000 crore. The vaccine segment, human as well as animal
vaccines accounted for approximately 60 percent of the total Biopharma market. Total
estimated sales from the human vaccine business stood at Rs 1,750 crore over the 2008-2009
figure of Rs 1,550 crore. Domestic sales of human vaccines have just crossed Rs 1,000 crore.
In FY 2008-2009 this figure stood at Rs 900 crore. Export sales are estimated to have
generated Rs 750 crore, as compared to Rs 650 crore in FY 2008-09. Animal Vaccines
registered a marginal decline with sales of Rs 430 crore over last year's figure of Rs 450
crore. In animal vaccines, poultry vaccines clocked Rs 220 crore, cattle and sheep vaccines
registered Rs 210 crore. The vaccine market will continue to drive the growth of the
biopharma segment growing in the range of 10-13 percent in the next 5 years. The factors
that will drive this include education and awareness about disease prevention, increase in
disposable income and participation by government.

Major Investments:
Investments, along with outsourcing activities and exports, are key drivers for growth in the
biotech sector. According to data released by the Department of Industrial Policy and
Promotion (DIPP), the drugs and pharmaceuticals sector has attracted foreign direct
investment (FDI) worth US$ 1.82 billion between April 2000 and September 2010.

Some of the major investments in the sector are as follows:

Swiss Pharma company Lonza AG, plans to invest around US$ 55.33 million through its
Indian subsidiary in a phased manner in Genome Valley project, Hyderabad, said Stefan
Borgas, CEO, Lonza.

Biotechnology major Biocon plans to invest around US$ 64 million - US$ 107 million over
the next three years to set up plants that would supply generic biotechnology drugs to Europe
and the United States, said Murali Krishnan K N, President-Group Finance, Biocon.

The Defense Research and Development Organization (DRDO), which caters primarily to the
armed forces, plans to spend US$ 63.5 million to upgrade and custom-make its existing line
of biotech products for civilian use.

BIOTECHNOLOGY INDUSTRY REPORT Page 17


The Export vs Domestic Scenario
Biotech Industry Exports vs. Domestic 2009-10

% share % share
Segment Exports Domestic Total
Exports Domestic

Biopharma 4767.66 4061.34 8829 54 46

BioServices 2507.05 131.95 2639 95 5

BioAgri 58.08 1877.92 1936 3 97

BioIndustrial 124.08 439.92 564 22 78

BioInformatics 73.92 157.08 231 32 68

Total 7530.79 6668.21 14199 53.04 46.96

All figures in Rs. Crore unless indicated otherwise

Growth in India is primarily export-driven.

Export sales of Indian biopharmaceutical products are currently rising at an annual rate of
47%, while domestic sales of Indian biopharmaceutical products have gone up only 4–5% per
annum for each of the past two years. The above data makes it clear that the Indian
Biopharmaceutical sector is an export driven sector

The Indian Biopharma Toppers


The top ten Indian Biopharmaceutical companies based on revenue are as follows

Revenue Company 2009-10 2008-09 (Revenue % Change


Rank 2010 (Revenue in in Million $) Over 2008-09
Million $)

1 Biocon 262.2 202.74 29.34

2 Serum Institute of 188.8 247.55 -23.70


India

3 Panacea Biotech 156.2 132.69 17.76

4 Reliance Life 100 - -


Sciences

BIOTECHNOLOGY INDUSTRY REPORT Page 18


5 NovoNordisk 76 73.3 3.64

6 Shantha Biotech 74.2 54.8 35.32

7 Indian 60.4 51.4 17.89


Immunologicals

8 Bharat Biotech 60.3 53.5 12.7

9 Eli Lilly 41.5 36.4 13.85

10 Bharat Serums 38.8 31.1 25

* BioSpectrum estimates

Biocon:
Biocon is India's leading integrated biotechnology enterprise focused on the development of
biopharmaceuticals. Since its inception Biocon has evolved from an enzyme manufacturing
company to a fully integrated biopharmaceutical enterprise, focused on healthcare. Biocon
has successfully forayed into drug discovery and development. It has developed innovative
and effective bio molecules in diabetology, oncology, cardiology and other therapeutic
segments. Biocon delivers products and solutions to partners and customers in over 50
countries.

Major Achievements of Biocon:

First Indian company to manufacture and export enzymes to USA and Europe.

First Indian Biotech Company to receive US funding for proprietary technologies.

First Indian company to be approved by US FDA for the manufacture of lovastatin, a


cholesterol-lowering molecule.

First company worldwide to develop human insulin on a Pichia expression system.

India's largest producer and exporter of enzymes.

Second Indian company to cross the $ 1 billion mark on the day of listing.

Launched India's first cancer drug BIOMAb EGFR

Serum Institute of India:


Serum Institute of India limited is the largest vaccine and immunobiological manufacturing
company and is at par with world class manufacturing facility. Serum Institute is recognized

BIOTECHNOLOGY INDUSTRY REPORT Page 19


as a reliable source of High Quality vaccines and biologicals. Products have been supplied to
International Health Agencies like the WHO, UNICEF, PAHO and also to more than 140
countries across the globe. Serum Institute aims at total indigenization to make India achieve
self-sufficiency in life-saving drugs.

Panacea Biotec:

Panacea Biotec is a research based Health Management Company involved in research,


manufacturing and marketing of branded pharmaceutical formulations, vaccines and natural
products. The product portfolio includes highly innovative prescription products in important
therapeutic areas like pain management, diabetes & cardiovascular management, renal
disease management, osteoporosis management, anti-tubercular, gastro-intestinal care
products and vaccines. The flagship brands of the company- Willgo for pain management;
Glizid & Glizid-M for diabetes; Panimun Bioral & Mycept for kidney transplant occupy
leadership positions in their therapeutic segments. The vaccines portfolio consists of oral
polio vaccines (type I and type III), Enivac-HB (Hepatitis B vaccine), Enivac-HB Safsy,
Ecovac-4 (DTwP+Hep B), Easyfour (DTwP+Hib), Easyfive (DTwP+Hep B+Hib). Vaccines
in the offing are- Anthrax, Dengue, Japanese encephalitis and several others. Panacea Biotec
has earned the distinction of being a WHO pre-qualified supplier of oral polio and Hepatitis-
B vaccines and are in the process of obtaining similar pre-qualifications for other vaccines.
Panacea Biotec is contributing in disease prevention and reducing the child mortality.

Reliance Life Sciences:


Reliance Life Sciences Pvt., Ltd. operates as a research, biotechnology, and life sciences
organization. The company participates in the domains of medical, plant, and industrial
biotechnology opportunities that relate to biopharmaceuticals, molecular diagnostics and
genetics, cell-based therapies, plant tissue culture, plant metabolic engineering, Biofuels,
biopolymers, bio chemicals, contract manufacturing, and clinical research services. It has
facilities in Navi Mumbai and Bangalore, India. The company was incorporated in 2001 and
is based in Navi Mumbai, India. Reliance Life Sciences Pvt., Ltd. operates as a subsidiary of
Reliance Industries, Ltd.

NovoNordisk:
Novo Nordisk is a global healthcare company with 87 years of innovation and leadership in
diabetes care. The company also has leading positions within hemophilia care, growth
hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and
markets pharmaceutical products and services that make a significant difference to patients,
the medical profession and society. With headquarters in Denmark, Novo Nordisk employs
more than 29,000 employees in 81 countries, and markets its products in 179 countries.

BIOTECHNOLOGY INDUSTRY REPORT Page 20


Shantha Biotech:

A pioneer in the field of biotechnology, Shantha Biotech is the first Indian company to
develop, manufacture and market a recombinant human healthcare product in India. Shantha
Biotech is currently focusing its R&D efforts in the development of generic biologicals, novel
therapeutic antibodies, proteins and vaccines. Shantha conducts exploratory research in the
fields of Oncology, Infectious Diseases and Platform technologies. Shantha Biotech produced
the first Indian Hepatitis-B vaccine to be pre-qualified by WHO, Geneva, for supplying to
UN agencies globally SHANVAC-B. Today, Shantha caters to major international markets
including Asia-Pacific, Africa, CIS and Latin America in addition to supra nations like
UNICEF and PAHO.

Indian Immunologicals:

The National Dairy Development Board (NDDB) set up Indian Immunologicals Ltd. (IIL) in
1982 with the objective of making Foot and Mouth Disease (FMD) vaccine available to
farmers at an affordable price. The technology for FMD vaccine manufacture was obtained
from M/s. Wellcome Foundation Limited, United Kingdom. The plant in Hyderabad today
has a capacity to make 80 million trivalent doses of FMD vaccine. Following the successful
introduction of Foot &Mouth Disease Vaccine-Raksha, IIL launched the tissue culture
vaccine "Raksharab" in 1989. This was the first Indian tissue culture vaccine in the market.
Subsequently IIL has developed many biologicals through its own R&D efforts and launched
several vaccines in the Indian market at affordable prices. IIL is today the fifth largest animal
health player in the Indian market and the market leader in veterinary biologicals in India. It
operates one of the largest plants in the world for veterinary vaccines and is WHO-GMP and
ISO-9001 certified. IIL exports its products to several countries and exports contributed
substantially to the company's turnover. IIL operates a facility in Ooty to manufacture the
Vero cell culture rabies vaccine for use in human beings.

Bharat Biotech:

Bharat Biotech International Limited (BBIL/Bharat Biotech), Hyderabad, India, is a


multidimensional biotechnology company specializing in product-oriented research,
development and manufacturing of vaccines and biotherapeutics. Bharat Biotech, established
in the year 1996 by Dr. Krishna M. Ella & Mrs. Suchitra K. Ella as the Founder Directors,
is engaged in developing next-generation vaccines and bio-therapeutics through innovative
and collaborative research. BBIL's state-of-the-art manufacturing plant is the largest of its
kind in Asia-Pacific. The first bio-pharma facility in the country to be audited and approved
by Korean Food & Drugs Administration (KFDA), it sprawls over a picturesque campus at
Genome Valley, Hyderabad. Built with an investment of over INR 1000 million, the facility's
Manufacturing, Control Procedures and Protocols, conform to the stringent standards laid
down by internationally recognized institutions such as USFDA, UKMCA and WHO.

BIOTECHNOLOGY INDUSTRY REPORT Page 21


Eli Lilly:
Founded in 1876 by Eli Lilly, they are now the 10th largest pharmaceutical company in the
world. They have steadfastly remained independent, but not isolated. Across the globe, Lilly
has developed productive alliances and partnerships that advance their capacity to develop
innovative medicines at lower costs. The Company manufactures and distributes its products
through facilities in the United States, Puerto Rico, and 17 other countries. Its products are
sold in approximately 125 countries. The Company‘s products include neuroscience products,
endocrinology products, oncology products, cardiovascular products, animal health products
and other pharmaceuticals.

Bharat Serums:
Since inception in 1971, BSV develops, manufacture and market specialized biological,
pharmaceutical and biotechnology products.Today, BSV is one of the fast growing Indian
bio-pharmaceutical companies. The product portfolio comprises of a wide range of products
such as plasma derivatives, monoclonals, hormones, equine antitoxins and serums,
antifungals, anaesthetics, cardiovascular and diagnostic products.BSV is managed by an
experianced Board of Directors, who are assisted by a team of dedicated and qualified
professionals drawn from various disciplines. The management team comprises of qualified
doctors, professionals and postgraduates having rich experience and expertise in their
respective fields.

MERGERS AND ACQUISITIONS IN THE INDIAN


BIOPHARMACEUTICAL SECTOR:
Indian market in 2009-10 has seen rise of inbound deals both in volume as well as value.
Inbound deals in India are either due to geographical expansion or through the CRAMS side.
Indian Companies were involved in a total of 356 merger and acquisition deals.

Mergers and Acquisitions by Indian Biopharmaceutical Companies

In the Indian pharmaceutical market there are a number of companies that have entered into
merger and acquisition agreements in the context of the global market scenario. In 2009 there
have been a number of small scale out bound deals but the one deal that stands out as the
blockbuster is the Dr. Reddy‘s Labs acquisition of Beta Pharma a $ 560mn deal which was ap
art of Dr. Reddy‘s Labs inorganic growth strategy. Other deals worth mentioning are as
follows

In the recent times –

Nicholas Piramal has taken the ownership of 17% of Biosyntech that is a major
pharmaceutical packing organization in Canada.

Torrent has got the ownership of Heumann Pharma, a general drug making company and,
formerly, a subsidiary of Pfizer.

Matrix has acquired Docpharma, a major pharmaceutical company of Belgium.

BIOTECHNOLOGY INDUSTRY REPORT Page 22


Sun Pharmaceutical Industries is set to make acquisitions in pharmaceutical companies in the
US and has set aside $450 million to execute these plans.

In Bengaluru, Strides Arcolab has aimed at acquiring 70 percent in a pharmaceutical facility


in Italy that is worth $10 million.

Opportunities for Pharmaceutical Companies

There are a number of opportunities for the major pharmaceutical products and services
providers in the Indian pharmaceutical sector as the price controls have been relaxed and
there have been significant changes in the medicinal requirements of the Indians. The
manufacturing base in India is also strong enough to support the major international
pharmaceutical companies from the performance perspective.

This may be said as the Indian pharmaceutical market is varied as well as economical. It is
expected that in the coming years the Indian pharmaceutical companies would be executing
more mergers and acquisitions. It is expected that the regulated pharmaceutical markets in the
United States and Europe would be the main areas of operation.

In the recent years the Indian pharmaceutical companies have been venturing into mergers
and acquisitions so that they can gain access to the big names of the international
pharmaceutical scenario.

Mergers and Acquisitions of Indian companies


Year Indian Company Foreign Country Deal size ( $
taken over Player millions)

DEC 10 PARAS PHARMA RECKITT UK 726


BENCKISER

MAY 10 PIRAMAL ABBOT Inc US 3720


HEALTHCARE

DEC 09 ORCHID CHEM HOSPIRA US 400

JULY 08 SHANTHA SANOFI FRANCE 783


BIOTECH AVENTIS

JUNE 08 RANBAXY LAB DAIICHI JAPAN 4600


SANKYO

AUGUST 06 MATRIX LAB MYLAN Inc US 736

The market is set to grow and double by 2015. Higher spending on healthcare, increasing
middle class incomes, and rising penetration in rural areas will help spur growth in the
domestic market. This is also the reason why increasingly global Pharma player are looking

BIOTECHNOLOGY INDUSTRY REPORT Page 23


at the inorganic route to build a presence in India. According to Mr. Ajay G. Piramal
(Chairman Piramal Healthare) ―Companies across the global are excited about the growth
opportunity in India and the potential to scale up the Indian business models in other
emerging markets. The motivation behind the acquisition is growth and not cost optimization.
Hence they are looking for companies with strong brand and processes.‖

Promoters are asking for higher and higher valuations, and some of them have even realized
their aspiration. In fact there are only getting better with each deal, with a substantial upward
trend in purchase prices - the Daiichi Sankyo transaction was done at 4 times sales, the $783
million Sanofi- Shantha acquisition at 8 times sales while Abott bought Piramal at 9 times
sales .

Patterns of Mergers and Acquisitions in Pharmaceutical Sector

One of the major features of the mergers and acquisitions in the pharmaceutical sector of the
Asia-Pacific region has been the integration of the local pharmaceutical companies. This has
happened especially in India and China. Acquisition has made it convenient for a number of
companies to do business in various pharmaceutical markets.

FUTURE OF BIOPHARMA INDUSTRY:


The pharmaceutical industry comprises establishments primarily engaged in manufacturing
drugs, medicines and related products for human or animal use. Nowadays,
Biopharmaceutical corporations are facing serious inefficiencies in their drug discovery
process. The initial data from the late-stage clinical trials on Biocon‘s oral insulin drug IN-
105 for diabetes did not meet the desired results. In the final-stage trials being conducted in
India, IN-105 failed to comply with its target of lowering HbA1c levels, or haemoglobin
count in patients with type 2 diabetes. These kinds of setbacks can be discouraging to the
industry and other players would be sceptical to enter into a huge budget R&D project.

The biopharma companies are expecting to cut down the drug discovery time line by half and
achieve double-digit growth rates by exploiting the ‗Blockbuster‘ drug/therapy strategy.
Unfortunately Biopharma companies have not been able to fulfil those expectations. The
average time line for a new drug candidate to be on the market is still around 16 to 20 yrs.
Drug discovery is a long journey fraught with risks as well as painstaking research and
testing. Thus, companies are willing to invest in any process that could accelerate the drug
development. The industry is a classic winner-takes-all example as the first-mover with a new
drug usually gets over 75% of the market.

Given that situation, there is no doubt that in biopharma corporations‘ new operating
structures enabling collaborative relationships and cost-effective management are needed.

Global Market
The global market for Biopharmaceuticals is projected to reach US$182.5 billion by 2015,
registering a CAGR of 12.4% during the period 2006-2015. Intense research efforts made

BIOTECHNOLOGY INDUSTRY REPORT Page 24


biopharmaceuticals the most successful products in various therapeutic areas such as
Neurology, Infectious Diseases, Cardiovascular, Oncology etc. Undoubtedly, all the major
pharmaceuticals are, now, engaged in doing research for new biopharmaceutical active
ingredients. Biopharma active ingredients are containing in about 50% of the newly approved
drugs. The future of biopharmaceuticals is to be projected bright as the market share is
growing gradually. In terms of market revenue, out of total pharma market the
biopharmaceutical products accounted for about 10% in 2006 and are projected to account for
about 15% 2015. Biopharmaceutical products analyzed in this study comprise Monoclonal
Antibodies, Biotech Vaccines, Erythropoietin, Granulocyte-Colony Stimulating Factor,
Recombinant Human Insulin, Interferon, Human Growth Hormones and Other. India‘s new
Free Trade Agreement with Japan to be in force from April 2011 has increased expectations
of this industry. Thus a new market will developed to compete for the pharma and the
biopharma companies.

Patent Scenario
With the advent of globalization, more Indian biopharma companies started looking at the
western markets in general and the US market in particular as their target for expansion. This
has led to the need for the companies to seek patent protection for their inventions in those
countries besides making a foothold there. The whole perspective of Indian
biopharmaceutical companies changed when the accession of India to WTO brought
obligations to implement the agreement on Trade Related Aspects of Intellectual Property
Rights (TRIPS). For the industry, the critical issue was the (re-) introduction of the product
patent regime and the limitations that this change has imposed on its ability to produce
technologies through reverse engineering.

Considering the biopharma patent scenario in India, the US patent holdings of Indian
companies have been very less. Only 57 Indian biopharma companies have US patents.
Altogether 19 biotech and 425 pharma patents are held by these companies. The pharma and
biotech patents have been obtained since 1990 and 2001 respectively. These patents protect
both the processes and products. The largest number of patents protects pharma inventions.
This reflects the importance of this industry in present scenario.

The number of biotech patents is 19 as compared to 425 pharma patents, which is 20-fold
greater. The interesting fact about the patents granted to Indian biopharma sector is that the
pharma patents are granted to biotech companies whereas the biotech patents have been
granted to companies with pharma background. For example, two-third of the patents granted
to Biocon, are categorized as pharma. Similarly, in case of Reddy U S Therapeutics, there are
three biotech patents. Although the biotech numbers have increased in the past few years, a
consistent year on year increase is not visible yet.

Patents vs. companies


It has been found that out of 424 companies investigated for pharma patents; only 53 have US
patent holdings. That amounts to less than 15 percent of the total home grown Indian

BIOTECHNOLOGY INDUSTRY REPORT Page 25


companies. Although the number of patents held are lesser, but the companies indicated a
certain improvement of the capabilities of the biotech and pharma industries. The pharma
sector got first two patents in 1990. Then the number of pharma patents between 1990 and
1995 were only eight. After that, there was tremendous increase in the patent holding of the
Indian pharma companies and 67 patents were awarded in 2007 whereas the biotech sector
registered the first patent in 2001.

The future beckons


The companies looking forward to the new greener pastures abroad will definitely look for
the protection of their products on foreign shores. So, with the increased R&D collaborations
and expanding bases, there will be a surge in the number of US and western country held
patents. As of now, generic biologicals or biosimilars doesn't have a single patent to its credit.
The lack of patents pertaining to biosimilars is due to the lack of a clear regulatory pathway
for such molecules in the US at present. Major Biologics worth $10 billion come off patent in
2009 and there are proposals before US senate to bring in the biosimilars into the US market.
Therefore, the only key that seems to break open this deadlock is innovation. The expression
systems and bio manufacturing processes are expected to have a major share in future
patents. Also, with more and more companies focusing on R&D ventures outside India, the
change in the scenario is likely to happen in the coming years. Therefore, the Indian biotech
companies venturing out for opportunities in western markets are expected to get armed with
lots of new US patents in coming years.

BIOTECHNOLOGY INDUSTRY REPORT Page 26


BIOAGRICULTURE

INDUSTRY OVERVIEW
Agriculture continues to be a fundamental instrument for sustainable development and
poverty reduction in India. India resides in its villages and according to the 2001 census 72.2
per cent of the people are in rural areas. The agriculture sector contributes only about 18 per
cent of the total Gross Domestic Product (GDP). Indian agriculture has made rapid strides
from food shortages and imports to self-sufficiency and exports. It has moved from
subsistence farming to intensive and technology led cultivation. Agriculture is at the core of
socio economic development of the country. Growth of other sectors and overall economy
depends on performance of agriculture to a considerable extent. Not only it is a source of
livelihood and food security for a large population of India, but also has a special significance
for low income, poor and vulnerable sections. However, several constraints such as
preponderance of small and marginal holdings accounting for about 82 per cent of total
holdings, imperfect market conditions and lack of backward and forward linkages have
contributed to the stagnation of the sector.

While more specifically the BioAgri sector has come of age in India. In 2004-05, Rasi Seeds
became the second company in India to make commercially available Bt cotton. With the
entry of Rasi, the entire Bt cotton seeds business changed. The release of RCH 2 Bt in 2004
by Rasi has created greater confidence in the farmers about Bt technology. The farmers have
understood that they get maximum benefit using hybrids with Bt technology and there is huge
demand.

Agriculture in India, the pre-eminent sector of the economy, is the source of livelihood of
almost two thirds of the workforce in the country. The contribution of agriculture and allied
activities to India's economic growth in recent years has been no less significant than that of
industry and services. The importance of agriculture to the country is best summed up by this
statement: "If agriculture survives, India survives".

Agri biotech is the third largest contributor to Indian biotech industry in FY 2009-2010 with a
total segment turnover of Rs 1,936 crore, accounting for almost 14.6 percent of the total
biotech revenues. Registering a growth of 37 percent over last year, BioAgri emerged the
industry's fastest growing segment. India is the fourth largest country in the world with
almost 8.4 million hectares of area under Bt cotton.

INDIAN BIOAGRICULTURE MARKET

BioAgri is the third largest contributor to Indian biotech industry in FY 2009-2010 with a
total segment turnover of US$ 427.86 million (Rs 1,936 crore), accounting for almost 14

BIOTECHNOLOGY INDUSTRY REPORT Page 27


percent of the total biotech revenues. Registering a growth of 37 percent over last year
BioAgri emerged as industry‘s fastest growing segment.

The BioAgri market, consisting of Bt cotton in the seeds category and bio pesticides and bio
fertilizers, with a total share of 6 percent was Rs 110 crore. The Hybrid seeds were estimated
at about Rs 180 crores. India is the fourth largest country in the world with almost 8.4 million
hectares of area under Bt cotton. The number of companies selling Bt cotton seeds in India
has increased dramatically over the last eight years since the first commercialization in 2002.
Today, there are over 30 companies marketing Bt cotton seeds in the country. Nuziveedu
Seeds is the largest seller with 25 percent of the market share. Rasi Seeds is close second with
19 percent market share of Bt cotton seeds. Other significant players include Ajeet Seeds.
Bio-Agri is sub categorized into three categories they are as follows

1] Tissue Culture

Plant tissue culture is a technique through which cells tissues, organs and even the whole
plant can be grown in the laboratory according to one's will throughout the year without
seasonal constraint. It is a rapid method of multiplication and thus saves time, money and
space. Within very small area large number of plants can be grown. This method is especially
important for propagation of plants in which natural propagation is difficult due to absence of
viable seeds/propagules. Thus, it is a very powerful tool for propagation and conservation of
plants in general and that of rare and endangered species in particular.

The major consumers of tissue culture plants (TCPs) are the State Agriculture Department,
Agri Export Zones (AEZs), sugar industry and private farmers. The paper industry, medicinal
plant industry and State Forest Departments are using TCPs in a limited scale. Nowadays,
PTC is used on various types of fruits, flowers, medicinal plants and even trees.

Here are some examples:

Fruits: Banana, pineapple, strawberry


Cash crops: Sugarcane, potato
Spices: Turmeric, ginger, vanilla, large cardamom, small cardamom
Medicinal plants: Aloe vera, geranium, stevia, patchouli, neem

Ornamentals: Gerbera, carnation, anthurium, lily, syngonium, cymbidium


Woody plants (trees): Teak, bamboo, eucalyptus, populous

BIOTECHNOLOGY INDUSTRY REPORT Page 28


Market scenario- For the tissue cultured plants in India

Crop 2003-04 2004-05 2005-06 2006-07 2007-08

Volume Value Volume Value Volume Value Volume Value Volume Value

Banana 21613 1945 27537 2478 35808 3223 47470 4272 64060 5765

Pineapple 4618 693 5080 762 5588 838 6147 922 6761 1014

Grapes 926 232 975 244 1026 257 1080 270 1137 284

Sugarcane 14791 592 16271 651 18709 748 22449 898 28055 1122

Potato 6 10 22 43 83

Turmeric 634 44 698 49 767 54 844 59 929 65

Vanilla 1000 70 1245 87 1123 79 1123 79 1123 79

Large 2000 140 2000 140 2000 140 2000 140 2000 140

Cardamom

Small 200 18 300 27 400 36 500 45 600 54

Cardamom

Ginger 401 28 441 31 484 34 533 37 586 41

Medicinal 2100 105 11510 576 11741 587 11995 600 12275 614

and

aromatic

plants

Ornamentals 20290 3044 18120 2718 18944 2842 19973 2996 21172 3176

Trees 3000 750 3380 845 3824 956 4342 1086 4951 1238

Total 71579 7660 87567 8607 100436 9793 118499 11404 143731 13592

(Volume in thousand nos., Value in Rs. Lakhs)

BIOTECHNOLOGY INDUSTRY REPORT Page 29


Benefits of Plant Tissue Culture
Rapid multiplication of plants
Limited requirement of mother plants
Uniformities of properties among the planting material
Disease – free planting material
Increased productivity
Non dependence on environmental conditions

India has a production capacity of 300 million plants per annum, of which around 70 percent
is actually produced by conservative measures; the market size is estimated to be more than
Rs 200 crore with an annual growth of 20 percent. Indian laboratories and companies
currently cater mostly to international markets. However, with increasing awareness about
the advantages of tissue culture raised plants, such as improvement in yield and quality; there
is a noticeable increase in the domestic consumption as well. The major domestic consumers
of tissue culture raised plants include the State Agriculture Department, agri-export zones
(AEZs), Spice Board, the sugar industry and private farmers. Apart from this, the paper
industry, medicinal plant industry and state forest departments also constitute this market.

2). Bio-fertilizers & Bio-pesticides


Bio-fertilizers - Biologically active products or microbial inoculants of bacteria, algae and
fungi either separately or in combination, which may enhance the availability of nutrients for
the benefit of plants are called biofertilizers. They also include organic fertilizers like
manures which are converted to a readily available form due to interaction of microorganisms
or their association with plants. Biofertilizer is a substance which contains living
microorganisms which, when applied to seed, plant surfaces, or soil, colonizes the
rhizosphere or the interior of the plant and promotes growth by increasing the supply or
availability of primary nutrients to the host plant. Some companies involved in production of
biofertilizers are- Pro G Agro Private Limited, Vizien Organics, Bio Organic Industries,
Vardhaman Fertilizers, ADS Agrotech Private Limited, Aksh Bio-Fertilizer, Multimol Micro
Fertilizer Industries etc.

Bio-pesticides- The Biopesticide market is growing very rapidly. This share is grow to about
4.2% by 2010 while the market value is estimated to reach more than US$ 1 billion However,
the overall growth rate of biopesticides is estimated to be about 10% per annum for the next 5
years.

Region wise, North America consumes the largest share (40%) of the global biopesticide
production followed by Europe and Oceanic countries accounting for 20% each.

BIOTECHNOLOGY INDUSTRY REPORT Page 30


Trend of global pesticide vis-à-vis biopesticide market

Indian scenario-
Organic cultivation (crops) in India is estimated at 100K hectare; Current supply stands at
approx. 3160 metric ton while estimated demand is approx.1 metric ton. Bio-fertilizer
increases yield by 8-24% to make agriculture a viable proposition. Indian bio-fertilizer and
bio-pesticides industry estimated at approx. $20M in 2008-2009; growing at a CAGR of
approx. 3% and expected to grow at a CAGR of 10%-15% till 2012. Phosphate-solubilising
micro-organisms market witnessed the most growth among bio fertilizers. Leading players
include Biotech International, Excel, and Multiplex. Many research universities and institutes
pursuing research in bio-fertilizers, for example, University of Hyderabad, National Research
Centre for Plant Biotechnology etc.

3] New crop development


Genetically modified plants are plants whose DNA is modified using genetic engineering
techniques. In most cases the aim is to introduce a new trait to the plant which does not occur
naturally in this species.

Market scenario
Global-

Global value of the biotech seed market alone was valued at US$11.2 billion in 2010 with
commercial biotech maize, soybean grain and cotton valued at ~US$150 billion for 2010.

BIOTECHNOLOGY INDUSTRY REPORT Page 31


In 2010, the global market value of biotech crops, estimated by Cropnosis, was US$11.2
billion, (up from US$10.6 billion in 2009); this represents 22% of the US$51.8 billion global
crop protection market in 2010, and 33% of the US$34 billion commercial seed market. The
estimated global farm-scale revenues of the harvested commercial ―end product‖, (the biotech
grain and other harvested products) is much greater than the value of the biotech seed alone
(US$11.2 billion) – extrapolating from 2008 data, biotech crop harvested products would be
valued at approximately US$150 billion globally in 2010, and projected to increase at up to
10 - 15% annually.

Indian Scenario-

The Indian Government had promulgated the Rules for dealing with Genetically Modified
Organisms (GMOs) in 1989

In India BT cotton launched in 2002

Indian Bio-Crop Industry estimated at approx $462 per hectare in 2008-2009; growing at a
CAGR of approx 8%.
India is the 4th largest adopter of Biotech crop in the world, outpacing Canada.
Bt crop accounts for approx 3% of total crop harvesting area.
Approx 97% of untapped market representing huge opportunity.
Bt crops improves yield by 31%.
Target for Bt crop seed replacement rate set from 20% to 35% in the ongoing 11th five year
plan

Sr. No. Crop Organization Transgene

1 Birnjal IARI( new Delhi), MAHYCO(Mumbai), Cry1Aa, Cry1Aabc,


Cry1Ac,
Sungro Seeds Research ltd.(Delhi)

2 Cabbage Nunherms India Pvt.Ltd. Cry1Ba, Cry1Ca

3 Castor Directorate of Oil seed Research Ltd.( Cry1Aa, Cry1Ec


Hydrabad)

4 Cauliflower Sungro Seeds Research ltd.(Delhi), Cry1Ac

Nunherms India Pvt.Ltd. Cry1Ba, Cry1Ca

5 Corn Monsanto India Ltd.(Mumbai) Cry1Ab

6 Groundnut ICRISAT (Hydrabad) Chitinase gene from rice

7 Okra MAHYCO(Mumbai) Cry1Ac, Cry2Ab

BIOTECHNOLOGY INDUSTRY REPORT Page 32


8 Potato Central Potato Research Institute(Shimla) RB gene derived from
Solanum bulbocastanum

9 Rice MAHYCO(Mumbai), Cry1Ac, Cry2Ab

Tamil Nadu Agriculture University, Rice Chitinase or tobacco


osmotin gene

10 Tomato MAHYCO(Mumbai), IARI Pusa (New Antisense replicase gene


Delhi) of tobacco leaf curl virus,
cry2Ab

Positive Impacts of GM crops


For the development of improved food materials, GM has the following advantages over
traditional selective breeding:

Allows a much wider selection of traits for improvement: e.g. not only pest, disease and
herbicide resistance (as achieved to date in plants) but also potentially drought resistance,
improved nutritional content and improved sensory properties

It is faster and lower in cost


Desired change can be achieved in very few generations
Allows greater precision in selecting characteristics
Reduces risk of random occurrence of undesirable traits.

These advantages could, in turn, lead to a number of potential benefits, especially in the
longer term, for the consumer, industry, agriculture and the environment:

Improved agricultural performance (yields) with less labour input and less cost input.
Benefits to the soil of ―notill‖ farming practice. Reduced usage of pesticides and herbicides
Ability to grow crops in previously inhospitable environments (e.g. via increased ability of
plants to grow in conditions of drought, soil salinity, extremes of temperature, consequences
of global warming, etc.). Improved processing characteristics leading to reduced waste and
lower food costs to the consumer. Prevention of loss of species to endemic disease (e.g. the
Cavendish dessert banana which is subject to two fungal diseases that have struck Africa,
South America and Asia, but could be reprieved by GM development of a disease resistant
version).

BIOTECHNOLOGY INDUSTRY REPORT Page 33


Negative Impacts of GM crops
There are following unintended impacts on environment, health, markets

1] Environment:

Unintended environmental impacts include harming no target and/or beneficial species in the
case of crops with engineered insecticidal properties, as well as the development of new
strains of resistant pests. Additionally there is concern that pollen from genetically
engineered herbicide resistant crops could reach wild, weedy relatives of the crop and create
so called

superweeds. This is of particular concern in the U.S. with crops such as canola and squash.

2] Health:

At present, there is no evidence to suggest that GM foods are unsafe. However, there are no
absolute guarantees, either. Unintended health impacts from GMOs concern allergens,
antibiotic resistance, decreased nutrients, and toxins.

Allergens Because protein sequences are changed with the addition of new genetic material,
there is concern that the engineered or modified organism could produce known or unknown
allergens. A recent National Research Council committee report on GMOs recommended the
development of improved methods for identifying potential allergens, "specifically focusing
on new tests relevant to the human immune system and on more reliable animal models."
Antibiotic resistance Plant genetic engineers have frequently attached genes they are trying
to insert to antibiotic resistance genes. This allows them to readily select the plants that
acquire the new genes by treating them with the antibiotic. Sometimes these genes remain in
the transgenic crop that has lead critics to charge that the antibiotic resistance genes could
spread to pathogens in the body and render antibiotics less effective. However, several panels
of antibiotic resistance experts have concluded that the risk is miniscule.
Decreased nutrients Because the DNA of genetically engineered plants is altered, there is
concern that some GMOs could have decreased levels of important nutrients, as DNA is the
code for the production of nutrients. However, it must be noted that nutritional differences
also have been documented with traditionally bred crops.
Introduced toxins Residual toxins resulting from introduced genes of the bacteria Bacillus
thuringiensis in so called Bt crops are unlikely to harm humans. This is because the toxin
produced by the bacteria is highly specific to certain types of insects. Prior to its inclusion in
GE/GM crops, Bt has been used as a biological insecticide, causing no adverse effects in
humans consuming treated crops.
Naturally occurring toxins There is concern that genetic engineering could inadvertently
increase naturally occurring plant toxins. However, traditional plant breeding also can result
in higher levels of plant toxins.

BIOTECHNOLOGY INDUSTRY REPORT Page 34


4] Bio-diesel

Bio-fuels in India are still in their infancy - about 66 million gallons of ethanol is utilized
in10 Indian states. Domestic and foreign collaborations are expected to boost India‘s bio-
diesel production to 1 million tons per year in the next 2-3 years. India has developed high-
yielding varieties of jatropha seeds. Government has been testing bio-diesel in public
transport locomotives and buses. Commercial bio-diesel production units have been set up by
Southern Online Biotechnologies and Natural Bioenergy Ltd. Bio-diesel companies have
collaborations with companies in the US and Europe. National biofuel policy of India is to
realize 20% blending of petrol and diesel with green-fuels by 2017. Ethanol and Biodiesel
blending requirements estimated to be approx 3.3 metric ton and approx. 17 metric ton by
2016 respectively.

KEY FACTS
Agriculture biotech grew at 37% in FY 2009-10.

 Approx 60% of Bioagri revenue owned by top 3 players.


 Approx 96% of total revenues from Indian domestic market.
 Approx 8% of bioagri market owned by Bio-pesticides and Bio-fertilizers
 Bt cotton driving bioagri growth with approx. 81% of total cotton area in India. Has
enabled an increase in farmers‘ income by $2B in 2007 alone

It accounts for 14.6 per cent of the country's gross domestic product (GDP) in 2009-10, and
10.23 per cent (provisional) of the total exports. The sector provided employment to 55 per
cent of the work force (about 50% for males and about 68% for females) is still in agriculture.

The total geographical area of India is 328.7 million hectares of which 140.3 million hectares
is net sown area, while 193.7 million hectares is the gross cropped area, according to the
Annual Report 2009-10 of the Ministry of Agriculture. India's agriculture and allied sector
grew by 3.8 per cent in the first six months of the current fiscal (2010-11), against one per
cent in the year-ago period on the back of better Kharif crop output. According to the GDP
data released by the Central Statistical Organisation (CSO) on November 30, 2010, the
country's farm sector grew by 2.5 per cent and 4.4 per cent each in the first two quarters of
the current fiscal, against 1.9 per cent and 0.9 per cent, respectively, in the same period last
year.

The segment will grow at an average of 26% in the next 5 years. Capital investment in
agriculture has increased from US$ 1.2 billion in 2007-08 to US$ 3.26 billion in 2010-11
(inclusive of State Plan Scheme Rashtriya Krishi Vikas Yojana), as per a Ministry of
Agriculture press release dated August 3, 2010. The total geographical area of India is 328.7
million hectares of which 140.3 million hectares is net sown area, while 193.7 million
hectares is the gross cropped area, according to the Annual Report 2009-10 of the Ministry of
Agriculture.

BIOTECHNOLOGY INDUSTRY REPORT Page 35


Production :
India is the largest producer of coconuts, mangoes, bananas, milk and dairy products, cashew
nuts, pulses, ginger, turmeric and black pepper. It is also the second largest producer of rice,
wheat, sugar, cotton, fruits and vegetables. As per the Centre for Monitoring Indian Economy
(CMIE) farm output will grow by 10 per cent to 114 million tonnes (MT) in the 2010 Kharif
season, while Rabi season is expected to report a 2 per cent increase at 116.6 MT. Oilseeds
production is expected to rise by 11.1 per cent during the season to 18.1 per cent, sugarcane
to notch up by 15.6 per cent to 321 MT and cotton to grow by 12.4 per cent to 26.9 million
bales compared to 23.9 million bales in the last season. The agency pegs the overall food
grain output growth up by 5.3 per cent to 229.7 MT. Major agricultural crops, including food
grain, oilseeds, cotton, sugarcane, and fruits and vegetables, are projected to grow by 7.2 per
cent in 2010-11, while production of non-food crops as a whole is projected to grow by 9.7
per cent in the year. There are over 30 companies marketing Bt cotton seeds in India.

Policy and regulatory framework

The various ministries within the Government of India and other agencies responsible for the
development of the agricultural sector include.

 Ministry of Food Processing Industries.

 Department of Agriculture & Cooperation (National Horticulture Board)

 Department of Animal Husbandry, Dairying and Fisheries

 Ministry of Commerce and Industry (commodity boards for rubber, coffee, tea and
spices)

 National Dairy Development Board (NDDB)

FDI Policy
100 per cent FDI is allowed under the automatic route in floriculture, horticulture,
development of seeds, cultivation of vegetables and mushrooms under uncontrolled conditions
and services related to the agriculture and allied sectors.

100 per cent FDI is allowed in the tea sector, including tea plantations, under the government
route, subject to the following conditions:

Compulsory divestment of 26 per cent equity of the company in favour of an Indian


partner/the public with in a period of 5 years.

Prior approval of the state government, in the event of any future land use change.

BIOTECHNOLOGY INDUSTRY REPORT Page 36


TOP GLOBAL COMPANIES FROM VARIOUS BIOAGRICULTURE
SECTORS

1] FLORIGENE

Florigene is a biotechnology company based in Melbourne, Australia, which is principally


involved in the application of in-house genetic modification techniques to develop novel
color expressions in a range of commercial plants.

Florigene has a subsidiary division in the Netherlands and other production operations around
the world.

History

Florigene has long been associated with genetic engineering floriculture. Founded as Calgene
Pacific Ltd in 1986 with institutional backing from Amcor, CP Ventures Ltd and the Japan-
Australia Venture Capital Fund, it was one of Australia's first biotechnology companies.

In 1991, Florigene's research team announced that it had isolated the gene responsible for the
expression of the color blue in petunias, beating out rivals around the globe by a matter of
weeks. This breakthrough paved the way for the acquisition of Dutch rival, Florigene, in
1993. Calgene assumed Florigene's corporate name in 1994 to capitalise on that firm's
international reputation. Since then, Florigene has developed naturally long-life and disease
resistant carnations, new morphologies of gerberas and natural color modifications of the
three main cut flowers - roses, carnations and chrysanthemums, which it exports throughout
the Americas, Europe, the UK and Asia.

Ownership

In 2003, Japanese brewing giant and long term partner Suntory acquired 98.5% equity in
Florigene from Nufarm.

Development and Potential

The significance of Florigene's technology is the brand potential of its novel flower varieties -
a blue rose is a marketer's dream. In 2004, after 20 years and $45 million worth of exhaustive
research and prolific patenting, Florigene and Suntory scientists announced to the world the
development of the first rose in the pipeline to a true blue rose. It is expected to be
commercialized in the coming years.

Products

Florigene - Moon Carnations are an exquisite range of unique carnation varieties. The color
of these flowers is absolutely novel for carnation, and offers the floral industry new uses for
carnation. Always excellent in vase life, carnation can now be a sensational centre piece or
bouquet.

BIOTECHNOLOGY INDUSTRY REPORT Page 37


Countries of operation

Australia, Canada, United Arab Emirates, Germany, Holland, Japan, Sweden, United
Kingdom, USA, Russia

Revenues:

(Value in Billion USD)

Year 2010 2009 2008 2007 2006


Revenue 107.8 115.1 119 88.3 75.2
Gross Profit 26.6 24.9 23.1 18.7 15.9

2] BAYER CROP SCIENCES

History:

Bayer AG was founded in Barmen (today a part of Wuppertal), Germany in 1863


by Friedrich Bayer and his partner, Johann Friedrich Weskott. In order to separate operational
and strategic managements, Bayer AG was reorganized into a holding company in December
2003. The group's core businesses were transformed into limited companies, each controlled
by Bayer AG. These companies are: Bayer Crop Science AG; Bayer HealthCare AG; Bayer
Material Science AG and Bayer Chemicals AG, and the three service limited companies
Bayer Technology Services GmbH, Bayer Business Services GmbH and Bayer Industry
Services GmbH & Co. OHG.

Bayer Crop Sciences has products in crop protection and non-agricultural pest control. It also
has activities in seeds and plant traits. In 2002 Bayer AG acquired Aventis Crop Science and
fused it with their own agrochemicals division (Bayer Pflanzenschutz or "Crop Protection")
to form Bayer Crop Science. The company is now one of the world's leading
innovative crop science companies in the areas of crop protection (i.e. pesticides), non-
agricultural pest control, seeds and plant-biotechnology. In addition to conventional
agrochemical business it is involved in genetic engineering of food. The Belgian biotech
company Plant Genetic Systems, became part of the company by the acquisition of Aventis
Crop Science. Also in 2002, Bayer AG acquired the Dutch seed company Nunhems. Bayer
Crop Science is involved in a joint project with Archer Daniels Midland
Company and Daimler AG to develop jatropha as a biofuel.

Products:

In Bayer‘s Bio Science Business Unit growth would be seen in their core crops - canola,
cotton, rice and vegetables. Bayer is also expanding the business to soy and wheat and is
exploring solutions for corn and sugarcane as well. Crop seeds with enhanced yield and
quality properties for the benefit of agriculture, food and fibre manufacturers, consumers and
the environment are developed by Bayer Crop Sciences. Bayer employs modern breeding

BIOTECHNOLOGY INDUSTRY REPORT Page 38


methods including plant biotechnology for this. Bayer‘s work is focused on improving the
plant properties, for example their optimized performance under the most varied of
environmental conditions. Bayer therefore creates sustainable, plant-based solutions for
agriculture.

Countries of Operations:

Germany - headquarters of the holding company as well as the subsidiary companies Bayer
Crop Science,

Revenues:

(**Values in $ Billions)

Year 2010 2009 2008 2007

Revenue 50.64 44.98 47.51 67.47

Gross 25.95 23.14 23.14 23.76


Profit

3] DOW AGROSCIENCES
Agricultural sciences- Dow AgroSciences provides 7% of sales of the entire DOW group,
and is responsible for a range of insecticides (such as Lorsban), herbicides and fungicides.
Genetically modified plant seeds are also an important, growing area. Dow AgroSciences
sells seeds commercially under the following brands: Mycogen (grain corn, silage corn,
sunflowers, alfalfa, and sorghum), Atlas (soybean), PhytoGen (cotton) and Hyland Seeds in
Canada (corn, soybean, alfalfa, navy beans and wheat).

Countries of Operation:

Asia- Pacific, Europe, Latin America, North America

Revenues: (Value in Million USD)

Year 2010 2009 2008 2007 2006

Revenue 53,674 44,875 57,361 53,375 49,124

Gross Profit 7,894 5,727 5,448 7,073 7,598

BIOTECHNOLOGY INDUSTRY REPORT Page 39


4] MONSANTO
The Monsanto Company is U.S.based multinational agricultural.biotechnology corporation.
It is the world's leading producer of the herbicide glyphosate, marketed as "Roundup".
Monsanto is also the leading producer of genetically engineered (GE) seed. It provides the
technology in 90% of the world's genetically engineered seeds. It is headquartered in Creve
Coeur, Missouri. Agracetus, owned by Monsanto, exclusively produces Roundup
Ready soybean seed for the commercial market. In 2005, it finalized purchase of Seminis Inc,
making it the world's largest conventional seed company.

Monsanto scientists became the first to genetically modify a plant cell in 1982. Five
years later, Monsanto conducted the first field tests of genetically engineered crops.

Products:

Monsanto offers farmers a wide range of corn, soybean, cotton, wheat, canola, sorghum and
sugar cane seeds. We use our elite seed genetics and cutting-edge traits and technologies to
create products that meet farmers‘ wants and needs. These products are offered through
various brands – each of which provides farmers around the world with the solutions that best
fit their farms.

Countries of Operation:

North/ Central America, South America, Europe, Middle East, Asia Pacific, Africa

Revenues: (Values in Million U.S $)

Year 2010 2009 2008 2007 2006

Revenue 10,502 11,724 11,365 8,349 7,065

Gross 5,086 6,762 6,177 4,230 3,443


Profit

5] SYNGENTA

Syngenta is a large global Swiss agribusiness company which notably


markets seeds and pesticides. Syngenta is involved in biotechnology and genomic research.
The company is a leader in crop protection and ranks third in total sales in the commercial
agricultural seeds market. Sales in 2008 were approximately US$ 11.6 billion. Syngenta
employs over 24,000 people in over 90 countries. Syngenta is listed on both the Swiss stock
exchange and in New York.

BIOTECHNOLOGY INDUSTRY REPORT Page 40


History:

Based in Basel, Switzerland, Syngenta was formed in 2000 by the merger


of Novartis Agribusiness and Zeneca Agrochemicals. Its roots are considerably older. In
2004, Syngenta Seeds purchased the North American corn and soybean business of Advanta,
as well as Garst and Golden Harvest. In 2005, Syngenta opposed a Swiss ban on genetically
engineered organisms. In 2007, Syngenta's Canadian division was named one of Canada's
Top 100 Employers, as published in Maclean's magazine, one of only a handful of
agribusiness firms to receive this honour.

Products:

Syngenta has eight primary product lines. The company develops markets and sells products
worldwide.

Pesticides: Selective Herbicides, Non-selective Herbicides, Fungicides, Insecticides,


Professional Products

Seeds: Field Crops, Vegetables, Flowers

Countries of Operations: Switzerland, USA, UK, France, China, Brazil, India, Singapore

Revenue: (Values in Million U.S $)

Year 2010 2009 2008 2007

Revenue 11,641 10,992 11,624 9,240

Gross Profit 5,775 5,420 5,918 4,571

TOP INDIAN COMPANIES IN BIOAGRICULTURE SECTOR


Top 10 Agri Companies by Revenue (2009-10)

Sr. Company 2009-10 (Revenue in 2008-09 % Change


no. Rs Cr) (Revenue in Over 2008-09
Rs Cr)

1 Nuziveedu Seeds 476.86 449.58 6.07

2 Rasi Seeds 358.78 375.59 -4.48

3 Mahyco 312 211.12 47.78

4 Monsanto* 255 345.00 -26.09

BIOTECHNOLOGY INDUSTRY REPORT Page 41


5 Krishidhan Seeds 133.23 63.25 110.64

6 Ankur Seeds 109.5 80.35 36.28

7 Ajeet Seeds* 103 - -

8 Nath Seeds 85 48.50 75.26

9 JK Agrigenetics* 35 26.00 34.62

10 Bayer CropScience* 22.5 - -

Revenues of Indian Bioagriculture companies (in Cr Rupees) for the period 2009-2010.

1] AJEET SEEDS
History:

Ajeet Seeds Ltd established in 1986, when the Green Revolution was progressing, Ajeet
seeds participated and shared its role in this. This company is formed by a son of farmer and
industrialist Shri Padmakarrao Mulay, keeping in mind to avail best quality seeds at
reasonable rates to farming community. With the humble beginning the company started
production and marketing of public bred hybrids & varieties. Simultaneously ‗Research wing

BIOTECHNOLOGY INDUSTRY REPORT Page 42


established‘ under leadership of veteran agri-scientist and experienced professor, Dr.
Thombre.

Products:

Cereals and crops: jowar, bajra, maize, paddy, wheat, gram, pegion pea, green gram, black
gram,

Fibre and oil crops: cotton, sunflower, mustard.

Vegetable crops: hybrids of okra (bhendi), tomato, chilli, brinjal, bottle gourd and ridge
gourd. Seeds of bitter gourd, cowpea and clusterbean.

Competencies:

Plant Tissue Culture: Mass propagation, Development of novel hybrids and isogenies lines.

Molecular Biology: Gene prospecting, development of DNA based molecular markers,


development of transgenic.

Infrastructure:

State of Art plant tissue culture facility, green houses. Molecular biology facilities for gene
isolation. Diagnostic facilities for all Immunology based and PCR based assays.

Glimpse of current research:

In vitro regeneration of select vegetable crops – A prerequisite to any molecular


intervention is the development of a robust in vitro regeneration and transformation system.
Company has been actively engaged in this area and particularly focused on vegetable and
fruit corps.

Banana Development: The company is involved in vitro propagation of banana on a


commercial scale. Banana breeding is handicapped by the fact that banana is triploid and
sterile. Hence, there is need to develop alternatives. The Plant Biotechnology Centre has
embarked upon a programme of in vitro chemical mutagenesis of banana to develop novel
genotypes with enhanced agronomical characteristics.

Oil Seed Crops: Soybean is of importance both as an oil seed and as a pulse. The crop is,
however, confounded by two major problems, the presence of the antineutrient trypsin
inhibitor in the seed and pod shattering. The plant Biotechnology Centre endeavours to
address both these problems.

Molecular Biology Engineering Resistance to Biotic Stress: Almost all the vegetable crops
grown in tropical climate are invaded by fungal and viral pathogens at one or the other stage
of their life cycle. The Plant Biotechnology Centre is actively involved in the development of
transgenic expressing anti fungal peptides for resistance to fungal pathogens.

BIOTECHNOLOGY INDUSTRY REPORT Page 43


ATGC Division: Company has established a separate division by name atgc. Scientist works
to develop robust diagnostic kits, virus indexing kits, molecular diagnostics kits and services
for Indian biotechnology.

DNA Finger Printing: We use DNA finger printing on a regular basis to validate
transformation events. In recent times we are also concentrating on the development of use of
DNA finger printing for MAS breeding programme. The commercial services are available
for SSR microsatellite based DNA fingerprinting.

Development of Diagnostic Tools: Embarked upon the development of DNA and protein
based diagnostic tools and kits for pest and virus disease indexing.

ELISA Kits for Rapid Test: Immunology based ELISA test kits are available for Bt
diagnosis of –

Cry 1 Ac (Bollgard) gene

Cry 1 Ab / AC (Fusion Bt) gene

Cry 2 Ab (Bollgard-II) gene

Cry 1 EC gene

PCR Kits for Rapid Test: PCR kits are available for –

35S promoter.

SSU promoter.

OCS terminator.

SSU terminator.

Cotton SSR micro satellite based DNA finger printing.

Okra SSR micro satellite based DNA finger printing.

2] JK AGRIGENETICS:
The company has two business segments namely 'Seeds, Allied Products & Services' and
'Investments'. JK Agri Genetics has reported a sales turnover of Rs 5.30 crore and a net loss
of Rs 7.82 crore for the quarter ended Dec '10. For the quarter ended Dec 2009 the sales
turnover was Rs 7.72 crore and net loss was Rs 4.22 crore.

BIOTECHNOLOGY INDUSTRY REPORT Page 44


Products:

Seeds

Field crops: cotton, bajra, jowar, paddy, castor, mustard, redgram, soyabean, maize,
sunflower, wheat.

Vegetables: tomato, bhendi, chilli, bottle gourd, Watermelon, radish, cabbage, sweet corn,
cucumber, coriander.

Current year (2009-2010)

During the year under review, the Company achieved a turnover of Rs.123.77 Crores with
Operating Profit of Rs. 15.71 Crores and the Profit before Tax of Rs. 10.99 Crores. The sales
turnover increased by 20% over the same period of the previous year. The sale of Cotton,
Maize, and Vegetables & Rice increased while the area under cultivation of Jowar shrunk.
The profitability improved due to increased sales, as well as overall better operational
efficiencies. The Company has launched several new hybrid vegetables which have been
well received by the market. During the year the company also launched number of new Bt.
Cotton hybrids which have started finding good acceptance in the market. Even though some
of these products have been introduced this year these are likely to be major growth drivers of
sales and profitability over the next few years.

Research and development

The Company has intensified its research efforts in developing differentiated superior
products for the major segments in mandate crops. Accordingly, promising products are fast
tracked so as to select the best products whilst ascertaining the performance and stability at
several locations under varying agro climatic conditions. Simultaneously, production is taken
up so as to scale up the volumes rapidly. Various biotech tools are being applied for
introgressing the biotech traits within shortest span of time to bring down the product
development cycle time. The company has widened its collaborative network with national
and international Institutions as well as global agri-biotech companies to source out the latest
technologies/ traits. The company has already started reaping the benefits of this strategy.
Several Bt. cotton hybrids with stacked gene technology were launched during the year. In
addition, several superior virus tolerant hybrids in Tomato and Bhendi were launched.
Similar focused efforts are going on in the other crops which will start showing the results in
the next year or two, to take your company to play significant role in the market.

BIOTECHNOLOGY INDUSTRY REPORT Page 45


(Rs. in Lakhs)

Quarter ended Quarter ended Year ended


30.12.2010 30.12.2009 30.09.2010
Research & 284.51 252.49 1,116.36
Development
Expenses
Segment 631.68 11,590.27
Revenue: 529.71
Seeds, Allied
Products &
Services

Capital 5,229.43 5,984.46 7,665.80


Employed
Seeds, Allied
Products &
Services

Finished products: Sep 2010 (in Rs. Cr.)

Product Name Sales Sales


Quantity Value

Seeds 614.81 105.78

3] NATH BIOGENE (I) LTD.


Company Profile

A Pioneer Indigenous Seed Company established 30 years ago, it is one of the most
experienced seed companies in India. It has strong all India marketing network & brands. It
has strong research & testing facilities all over the country. Also, it has competitive range of
pipeline products in major field and vegetable crops.

Nath-Biogenes (I) Ltd, independently and jointly with the Global Transgenes Ltd(Sister
Concern), have been investing in one of the most intensive product development R & D
programs in the country, using Conventional Breeding Systems as well as GM Technologies.

BIOTECHNOLOGY INDUSTRY REPORT Page 46


R and D Pipeline products:

Nath seeds have a very strong product pipeline consisting of:

COTTON:

BAJRA: - NBH-1999

SORGHUM

MAIZE: CHILLIES: OKRA TOMATO

NMZ-02 NCH-748 NBO-443 HTM-1144

NMZ-03 NCH-791 NBO-595 HTM-1222

NCH-886
NMZ-1001
NCH-861

NMZ-1002

4] RASI SEEDS:
History: Rasi Seeds was envisioned by Mr.M.Ramasami, and was initiated in the year 1973
in Attur located in Salem District, India. Rasi Seeds has made rapid advances from seed
production and supply ventures to a commendable position in Research and Development
(R&D) Having excelled in the Research and Development in cotton seeds, it went on to
expand into a multi-crop, multi-location quality research movement and has proved beneficial
to the farming community.

Present: The Company, already well known for its leadership in Bt Cotton is now operating
its vegetable seed business under ‗HyVeg‖ brand. Rasi Group also explores the new trends in
the industry like the corporate and contract farming, which will provide a win-win solution to
Corporate/Farmer, Spinner, Ginner and Seed Company.

R & D:

Rasi Seeds is the 2nd company to obtain regulatory approval for its popular RCH 2 Bt. Well-
maintained Research Farm of 140 acres and about 55000 Sq.Ft. contained Green House. State
of art fibre testing lab (HVI). Well equipped seed testing laboratory. Separate dehumidified
cold storage facility for Germplasm and Breeding lines. A modern high throughput biotech

BIOTECHNOLOGY INDUSTRY REPORT Page 47


facility for molecular breeding, transgenic crops production and testing Over 20 million acres
have been covered by our own cotton hybrids. Insect rearing and leaf bio assay facility for
assisting biotechnological research products. RCH 2 is one among the very few proprietary
Research Hybrids that has been notified by the Government of India.

Services Offered-

 Contract farming is the best effort they take to fulfill our dream of creating a unique
organization with BREEDING TO BRANDING in house and consultations to large
corporates involved in farming are an end-to-end solution which is also unique.
 R&D assistance to required corporate.
 Technical services for contract farming.
 Identifying, producing and supplying of high quality seeds to marketing companies
 Marketing agro based products and inputs
 Conducting multilocational trials/testing of hybrids on contract.
 The cotton hybrids RCH2, RCH 20, RCH 134 and RCH 138 were among the top
ranking hybrids evaluated in the All India Co-ordinated Cotton Improvement Project
 Development of 1405 hybrids of diverse characteristics
 Testing centers in various zones for multi-location trials to evaluate hybrids for
suitability
 R&D is capable of Breeding intra Hirsutum (H X H), intra Barbadense (B x B) and
inter specific (H X B) hybrids and hybrids with high ginning percentage

5] DUPONT INDIA
It is a subsidiary of US-based $26.1 billion E. I. du Pont de Nemours and Company, a 208 -
years old Science and Technology company. DuPont is a global supplier of products and
services in a variety of industries from transportation and construction to agriculture and
energy

History: DuPont India is a wholly-owned subsidiary of E. I. du Pont de Nemours and


Company. DuPont association with India started in 1802 when the first shipment of raw
materials for black powder to be used in explosives was imported by India from the U.S.

Present: Pioneer Hi-Bred International, a subsidiary of DuPont, is the world's leading


developer and supplier of advanced plant genetics for farmers, livestock producers and grain
and oilseed processors. In 2007, Pioneer entered into an agreement to work with a new seed-
conditioning facility in Medchal, on the outskirts of Hyderabad. This new facility is owned
and operated by Prasad Seeds. The new plant offers much-needed drying and conditioning
capacity for substantial increase in production to accommodate the farmers' growing demand
for seeds. The facility also has the ability to dry hybrid rice seed and condition, treat and
package rice, corn and pearl millet seed.

R&D: The center will support research and development activities in crop and industrial
biotechnology for global markets. Research teams will work together with local farmers and

BIOTECHNOLOGY INDUSTRY REPORT Page 48


regional institutions like ICRISAT and Osmania University to develop resources for food,
materials and energy markets. The biotech center will be the first center in the world to have
patent analysts working with Research and Development staff. The technical investment
made by DuPont was $1.7 billion, out of which $1.4 billion was on research and
development. The material research center and the engineering center opened in the summer
of 2008.

6] KF BIOPLANTS
KF Bioplants is India‘s premier producer and exporter in the high-technology field of plant
tissue culture. The Company was established as a joint venture between Kumar Gen Tech &
Tissue Culture Company (KGTC) and Florist de Kwakel b.v., Holland.

Infrastructure

The process begins at the in-vitro stage, and for this purpose, KF Bioplants has a massive
90,000 sq. ft. state-of-art laboratory in Pune. There are separate initiation rooms to safeguard
the quarantine status of the main facility. Rigorous procedures ensure that our contamination
rate is well below the world average. Our 22 growth rooms can store over 10 million plants at
any given time. Highly qualified personnel handle every stage of the process. KF Bioplants
employs over 425 lab technicians to ensure constant production and quality management. For
post in-vitro production, our facilities in Pune have over 4 hectares of completely controlled
greenhouses provided with cooling, heating, benches and energy screens. Finally, KF
Bioplants has world-class grading & packing facilities handling plants for safe, assured
export to the far corners of the world. Plants are sent to customers in agar, ex-agar or fully
hardened, depending on their requirements.

Products

Gerbera
Carnation
Lilium
Zantedeschia
Phalaenopsis
Gypsophila
Pot Plants
Strawberry

7] KRISHIDHAN
Krishidhan Seeds Limited is a pioneer & dynamic agricultural biotech company delivering
high quality seeds for the Indian seeds market. Krishidhan is a research-based organization.
Its R&D activities and research stations are recognized by the Department of Scientific and
Industrial Research (DSIR), Govt. of India. The company is actively involved in research,

BIOTECHNOLOGY INDUSTRY REPORT Page 49


production, processing, packing, and marketing of high quality seeds of Cotton, Cereals,
Pulses, Oil seeds and Vegetables. Recently, it has incorporated a separate legal entity as
Krishidhan Vegetable Seeds India Pvt. Ltd (KVSIPL), a company dedicated exclusively for
vegetable seeds business. Krishidhan is one amongst the first three sub-licensees of M.M.B.
India Ltd., which has commercialized Bollgard (BG-I) & Bollgard-II (BG-II) cotton hybrids
in India. With products ranging from Cotton, Cereals, Pulses, Oil seeds, Vegetables, it
command significant market share in Indian commercial seeds. Not only seeds, it also take
care of needs of farmers related to Fertilizers and Nutrients.

RECENT HAPPENINGS
In March 2010, Bharti Walmart Private Limited, the joint venture between Bharti Enterprises
and Walmart Stores Inc, launched the sustainable agricultural programme in Punjab. The
programme provides sanitation and energy-efficient solutions through community toilets and
bio-gas plants that impact the yield and quality of the farm produce. Key domestic deal in
2010: The largest deal in the sector was the acquisition of Agro Dutch Industries Ltd by Penta
Homes Pvt. Ltd., Vishwa Calibre Builders Pvt Ltd, and a private investor for US$ 85.4 million
(INR 3.9 billion).

In March 2010, the Mauritius-based private equity fund, India Agri Business Fund, agreed to
invest US$ 10 million (INR 460 million) in The Global Green Company Limited, the foods
division of the Avantha Group.

In July 2007, Cadbury India Ltd and the Tamil Nadu Horticulture Department entered an
agreement to promote cocoa farming. The five-year agreement aims to bring 50,000 acres
under cocoa farming, which would provide coconut farmers an additional income of US$ 17.4
million (INR 80 million) a year.

In August 2006, Reliance Retail entered an agreement with the Punjab government for
agricultural and retail projects entailing an initial investment of US$ 108.7 million (INR 5.0
billion). The company plans to set up rural hubs for procurement of vegetables, fruits, pulses
and other farm produces.

In 2003, Mahindra Shubhlabh Services Ltd, a subsidiary of Mahindra & Mahindra Ltd, and
Punjab Agro Food grains Corporation, entered an agreement to divert about 100,000 acres of
land from paddy (rice) to maize under contract farming.

Vibha Seeds Group, specializing inprivate crop genetics and plant breeding researches, has
invested ~$43M to setup a multi-crop seed processing facility inA.P.

Bayer CropScience AG, a subsidiary of Germanybased global crop sciences major Bayer AG
and GVK Biosciences Private Limited (GVK Bio) of Hyderabad have entered into a research
cooperation agreementin the area of early discovery chemistry.

BIOTECHNOLOGY INDUSTRY REPORT Page 50


Key –state wise contract farming initiatives by private sector

Sr. State Crop Company/corporate Area/Hectors


No.

1 Maharashtra Soyabean Tinna Oils and Chemicals 134,800

2 Madhya Wheat Hindustan Lever Ltd 15,000


Pradesh

3 Punjab Rice (Basmati) Satnam Overseas, DD 14,700


Intenational Inc, Amira
Foods India Ltd

4 Punjab Rice (Basmati), PepsiCo India Ltd ~6,000


Groundnut,
Potato,tomato ,chilli

5 Karnataka Marigold & Caprica Chili AVT Natural Products Ltd 4,000

6 Punjab Rice (Basmati), Maize Maize Satnam Overseas 4,000

7 Punjab Barley United Breweries Ltd. 2,270

Investment

Total investment in the agriculture and allied sectors in 2008–09 amounted to US$ 28.87
billion (INR 1,386 billion), of which the private sector accounted for 82 per cent (US$ 23.78
billion).

Cumulative FDI inflows

Period: April 2000 to September 2010

Sector Amount (US$ million)

Agricultural services 1,540.5

Food-processing industries 1,102.0

Fermentation industries 787.72

Vegetable oils and vanaspati 185.69

Agricultural machinery 150.3

BIOTECHNOLOGY INDUSTRY REPORT Page 51


Fertilisers 121.27

Tea and coffee 94.57

Sugar 41.7

Total 4,023.8

Biodiesel

The National Biofuel policy was approved by the Union Cabinet on 11 September, 2008.
Biofuels is in its infancy, with only about 66 million gallons of ethanol utilised in Ten Indian
States. Domestic and foreign collaborations are expected to boost India‘s biodiesel production
to one million tonnes per year in the next two to three years. India has developed high-yielding
varieties of Jatropha seeds. The government has been testing bio-diesel in public transport
locomotives and buses. Commercial bio-diesel production units have been set up by Southern
Online Biotechnologies and Naturol Bioenergy Ltd.

Developments in National Biodiesel Mission.

Date Action Comments

April, 2003 Demonstration phase 2003 to 2007: Ministry Public & private sector, state
of Rural Development appointed as nodal government, research institutions
ministry to cover 400,000 hectares under (Indian and foreign) involved in
jatropha cultivation. This phase also proposed the program achieved varying
nursery development, establishment of seed degrees of success.
procurement and establishment centres,
installation of trans-esterification plants,
blending and marketing of bio-diesel.

October, MoPNG announced bio-diesel purchase policy Cost of bio-diesel production


2005 in which Oil Marketing Companies (OMC) higher (20 to 50 percent) than
would purchase bio-diesel across 20 procure- purchase price. No sale of bio-
ment centres across the country to blend with diesel.
high speed diesel w.e.f January 2006. Purchase
price set at Rs 26.5 per liter

2008 Self Sustaining Execution phase 2008 to 2012: Lack of large scale plantations,
Targeted to produce sufficient biodiesel for 20 seed collection and extraction
percent blending by end of XIth (2008-12) five infrastructure, buy-back arrange-
year plan ments, capacity and confidence
building measures among
farmers impeded the progress of
this phase.

BIOTECHNOLOGY INDUSTRY REPORT Page 52


FUTURE OF THE SECTOR
Projected growth rate and demand for various food commodities towards 2011-12

Commodity Growth Rate

Food grains 2.21

Milk and Milk products 3.18

Meat 4.65

Eggs 4.62

Fish 4.58

Oilseeds 2.94

Vegetables 2.51

Fresh fruits 3.46

Sugar and Gur 1.88

Source: Report of the Steering Committee on Agriculture and Allied Sectors for Formulation
of the 11th Five Year Plan, Planning Commission

New technology

Though modern harvesters and planters will do a better job than their predecessors, the
combine of today still cuts, threshes, and separates grain in essentially the same way it has
always been done. However, technology is changing the way that humans operate the
machines, as computer monitoring systems, GPS locators, and self-steer programs allow the
most advanced tractors and implements to be more precise and less wasteful in the use of
fuel, seed, or fertilizer. In the foreseeable future, some agricultural machines will be capable
of driving themselves, using GPS maps and electronic sensors to become agricultural robots.
Even more esoteric are the new areas of nanotechnology and genetic engineering, where
submicroscopic devices and biological processes may be used as machines to perform
agricultural tasks.

Business wise Growth- The marketing sector suffers from long and fragmented supply
chains resulting in high waste and low efficiency. Within this sector, horticulture and
floriculture is especially sensitive to handling and transport infrastructure and evidence shows
that these costs are particularly high in India. A recent study found that the farm gate price of
horticultural products is less than 15% of the price at the importing destination. This means
improvement in production conditions and decreases in production cost will have minor
impacts on prices and shares in world markets. The major impact will come from addressing
the cost build-up from the farm gate to the world markets. Its f.o.b. prices are in most cases,

BIOTECHNOLOGY INDUSTRY REPORT Page 53


well below, international prices. Therefore, if export opportunities are tapped, domestic
demand will not be a constraint to the growth of this sector.

The major public investments in marketing have to do with modernization of existing


markets, creation of new markets, supply chain infrastructure at airports and ports, and the
development and implementation of standards relating to agricultural practices and food
safety.

Road Ahead

The country's demand for horticulture products is expected to grow by over 20 per cent to
touch 360 MT in 2020-21, according to a study conducted by the Horticulture Society of
India. The report said that rising income will create more demand for horticultural products,
which will further push the production of such crops in India.

The horticulture sector encompasses a wide range of commodities, including fruits,


vegetables, potatoes, tuber crops, and ornamentals, medicinal and aromatic crops.

The Indian organic product market, currently pegged at US$ 322.41 million, is expected to
reach US$ 2.15 billion in the next five years, as per Mukesh Gupta, President International
Competence Centre for Organic Agriculture.

BIOTECHNOLOGY INDUSTRY REPORT Page 54


Opportunities

Demand side growth alone with government The Indian population is projected to reach
initiatives expected to help India to become approximately 1.6 billion in 2050, thereby creating
a leading agro country. a huge domestic demand for agricultural products.

According to the Organisation for Economic Co-


operation and Development- Food and Agri- culture
Organization, India is estimated to account for 12.1 per
cent and 21.8 per cent of the world‘s wheat and rice
production, respectively by 2015.

From 2021 demand will outstrip supply for cereals, ,


pulses, edible oil and sugar. India need a pluses
revolution in order to meet the demand.

Agricultural inputs expected to grow due to With the production levels expected to grow, agricultural
increased production levels. input such as fertilizers, farm equipment and machinery,
irrigation facilities , institutional credit, and research and
development, are expected to be driven towards the
higher target

Private sector involvement expected to Private equity players have invested US$ 300 million in
boost Indian agriculture further food processing & agri based companies during Jan-June
2010.

Indian agriculture is in a state of crisis, both from the economic and ecological points of
view. India has to shift from viewing food security at the aggregate level to ensuring
nutrition-security at the level of each individual. This will call for concurrent attention being
paid to availability, access and absorption. In India there is still a gross mismatch between
production and post-harvest technologies. This results in the spoilage of food grains and
missed opportunities for value addition and agro-processing. The use of agricultural biomass
is generally wasteful and does not lead to the creation of jobs or income. Unless attention is
paid to soil health care and enhancement, water conservation and efficient use, adoption of
climate resilient technologies, timely supply of needed inputs at affordable prices, credit and
insurance and producer-oriented marketing, a higher growth rate in agriculture cannot be
realized.

BIOTECHNOLOGY INDUSTRY REPORT Page 55


BIOINDUSTRIAL SECTOR
OVERVIEW

Bio industrial sector or Industrial biotechnology, also known as white or even environmental
biotechnology, is the modern use and application of biotechnology for the sustainable
production of industrially useful products like bio chemicals, biomaterials and Biofuels from
renewable resources, using living cells and/or their enzymes. This results generally in cleaner
processes with minimum waste generation and energy use. Enzymes which constitute a major
segment of this sector, are used in industrial processing of starch, distilleries, alcohol, textile
& garments, leather processing as well as for supplementing healthcare products. Current
practice in industrial biotechnology demonstrates that the social (People), Environmental
(Planet) and economic (Profit) benefits of bio-based processes go hand in hand. Substantial
reductions of 17-65% greenhouse gas emissions could potentially account for up to 20% of
the global Kyoto target.

Industrial biotechnology can be differentiated from pharmaceutical (red) biotechnology or


agricultural (green) biotechnology. ―Red‖ biotechnology is confined to the healthcare sector,
whereas ―green‖ biotechnology is applied to the agro-food sector. Industrial biotechnology is
mainly based on fermentation technology and biocatalysis. In a contained environment,
genetically modified or non-GM micro-organisms (e.g. yeast, fungi and bacteria) or cell lines
from animal or human origin are cultivated in closed bioreactors to produce a variety of
goods. Likewise enzymes, which are derived from these microorganisms, are applied to
catalyze a conversion in order to generate the desired products. Activities and opportunities in
this field are rapidly growing due to recent breakthroughs in genomics, molecular genetics,
metabolic engineering, and catalysis.

The
Industrial
Biotechnolo
gy Value
Chain

The Industrial Biotechnology Value Chain.

The above figure shows the industrial biotechnology value chain. Raw materials, including
crops and organic by products from agricultural sources and households, are converted into

BIOTECHNOLOGY INDUSTRY REPORT Page 56


sugars, which can be readily converted by tailor-made microorganisms into the desired
products. Typical products include enzymes, vitamins, flavours and fine chemicals such as
chiral building blocks for the pharmaceutical industry. Traditionally, The Netherlands has a
strong foothold in this value chain, given the presence of many important and international
players in the agribusiness, food and chemical industry.

Subsectors in the Bio Industrial Sector


The Textile Sector
Mankind and the environment benefit daily from industrial biotechnology without being
aware of it, for example while doing a load of laundry. Enzymes have been used in detergents
since the 1960s and since then have helped to reduce the amount of detergent released into
the environment as well as decreasing the energy needed to do laundry. In fact detergent
enzymes represent one of the largest and most successful applications of modern Industrial
Biotechnology. In addition to making clothes cleaner, one of the main environmental
advantages of cold water enzymes is that clothes can be washed at a lower temperature.
Washing machines are one of the biggest consumers of household electricity, and 80% of the
electricity for washing Laundry is used to heat the water. With the new generation of cold
water enzymes, washing temperatures can be reduced from 40°C to 30°C, without sacrificing
cleanliness, and saving 30% of the electricity used on the laundry. This one small step has not
only had an impact on electricity bills but has also significantly reduced CO 2 emissions.
Studies show that CO2 emissions can be reduced by 100 g per wash by washing at 30°C
rather than 40°C. Enzymes partly replace other, often less desirable, chemicals in detergents
and contribute to reducing both the duration of the washing cycle and water consumption.
Enzymes are biodegradable, do not present risks to aquatic life, and so minimize the
environmental impact of detergents. Use of enzymes in laundering process leads to reduction
of eco-toxic substances by 5% to 60% depending on the product.

Textile bleaching is usually done using hydrogen peroxide followed by at least two rinses in
hot water (80-95°C). With the use of an enzyme that degrades residual peroxide during the
second post-bleach rinse, water heated to 30-40°C can be used and less energy is needed.
Another application of enzymes in the textile industry is in the treatment of cotton fibres.
Traditionally, before cotton can be dyed, it goes through numerous processes including a
series of chemical treatments and rinsing in water. With a biotechnology process, it is
possible to reduce the use of chemicals and therefore the amount of water needed to rinse the
fibres by as much as 30-50%. Compared to the traditional chemical process, the enzymatic
process reduces the pH (acidity) from 14 to 9 (7 = pH neutral) and temperature from 95°C to
55°C, meaning that there are important energy savings. Also, the rinse water required is
reduced by half, which in combination with the energy savings makes the process cheaper.
Finally, fibre strength and softness are improved and, because the process is milder on the
cotton, a higher yield is achieved.

BIOTECHNOLOGY INDUSTRY REPORT Page 57


Plastics production
Plastics in general are important materials contributing significantly to environmental
protection: due to their tailor-made properties (e.g. light weight, excellent insulation ability,
tuneable properties for optimum food protection, etc.) they reduce already energy use by 26%
and greenhouse gas emissions (GHG) by 56% across a variety of applications compared to
alternatives. Besides crude oil, natural gas and coal, biomass is an additional raw material
source for plastics. Today, biotech processes allow for the production of bio-based plastics
from renewable resources. Even though today bio-based plastics make up only a small
portion of all plastics produced, they contribute to a reduction of dependency on fossil fuel in
some specific sectors. In many cases, the production of bio-based polymers has a great
potential to reduce greenhouse gases. By using biotechnology processes to produce plastics,
less energy may be expended, few resources are consumed and global greenhouse gas (GHG)
emissions are reduced. Depending on the type of bio-plastic, bio-based polymers may
contribute up to a 50% decrease in terms of energy consumption and up to 67% savings of
CO2 emissions during the production process. In the future, industry expects that less energy
will be needed and GHG emissions will fall as the production processes are optimized and
new feedstock and cheaper energy sources become available.

Pulp and paper production and bleaching


GHG emissions reduction in pulp bleaching

Converting wood into paper is an energy, water and chemical intensive process. The
conventional chemical process requires boiling wood chips at around 160°C before bleaching
the pulp with chlorine dioxide. With the application of biotechnology processes, it is now
possible to reduce the amount of chlorine chemicals by 10-15% and to cut the energy used
during the bleaching process by 40% which means lower emissions during power generation.

Chemicals industry
Biotechnology can be used to produce various bulk and fine chemicals that are currently
produced from fossil fuel based feedstock. Bio-based substances can also act as building
blocks for many other materials provided that they are cost competitive. Since 1990, most
chemical processes have been replaced by fermentation. Producers now use yeasts or fungi in
a single integrated biological process. The move to bio processing for production of vitamin
B2 resulted in a 40% cost reduction and in a drastic reduction of wastes and pollutants.

The energy used in the chemical and the biotechnological processes is about equal: chemical
synthesis uses more steam (energy) which comes from fossil fuels, but fermentation involves
more electricity. However, compared to chemical synthesis, fermentation has reduced the use
of non-renewable resources by 80%, volatile organic compounds by 50% and emissions to
water by 66% while the residuals (34%) are inorganic salt and biomass.

Car engines are not the only way to reduce fuel consumption & the impact of vehicles on the
environment. Tyres can play a crucial role: out of every five full tanks of fuel, one is

BIOTECHNOLOGY INDUSTRY REPORT Page 58


consumed by tyre friction on the road. To reduce the energy consumed by the tyres hitting the
road, a technology was developed using corn starch as a polymer filer that reinforces the
tyre‘s compounds & optimizes their properties. Traditional chemical compounds such as
silica & carbon black can be replaced with a renewable & environmentally-friendly additive.

Tyres made using this technology weigh less than traditional tyres & have a 20% reduction to
rolling resistance. Combined, these two advantages have shown a decrease in fuel
consumption of up-to 5 % in tests. Moreover, this new technology decreases CO 2 emissions
by 7,7g/km (0,2g/km in the production process of the filter & 7,5g/km as a result of lower
rolling resistance).

Bio-fuels
Several studies have been published on the eco-efficiency of biofuels, reporting CO2 savings
with the present biofuel technologies between 20 and 80% (depending on the feedstock and
conversion process) compared with using conventional petrol. And it is estimated that this
can increase to 90% and higher for second generation biofuels such as cellulosic ethanol.
Further innovation in the biofuel supply chain, such as high energy feedstock, less fuel
intensive cultivation of crops and low carbon conversion processes could help to achieve
further CO2 savings as well as a more sustainable use of biomass.

Food industry
Enzymes have been used in food manufacturing for hundreds of years, mainly based on
fermentation by micro-organisms. The last 10 years in particular has seen an increase in new

BIOTECHNOLOGY INDUSTRY REPORT Page 59


enzyme applications in food. Before that, the dominant new enzyme innovations were aimed
at the production of high fructose syrups from corn starch. Today, novel enzyme applications
are also being implemented in baking, fruit and vegetable processing, brewing, wine-making,
processing of vegetable oils, cheese manufacturing, and meat- and fish-processing. There are
different drivers for the use of enzyme technology in the food industry. Enzyme technology
can improve the quality of the food product, for instance, by making juice products that are
more cloud-stable (that stays clear and does not precipitate particles from the pulp) or by
reducing the content of unsaturated fat in fat spreads. The technology can further reduce
processing costs by reducing chemical and energy use and processing time. Finally many
enzymes applications in the food industry are advantageous mainly due to their impact on
processing conditions in food manufacturing plants, where enzyme use may result in savings
of energy and chemicals.

Tanning and leather industry


Enzymes have been used in the tanning industry for centuries because they are efficient in
degrading protein and fat. In early times, the enzymes were derived from animal excrement
and later on from the pancreases of cattle. Today, the enzymes are almost entirely produced
by microbial fermentation. Soaking enzymes reduce the required soaking time, the surfactant
(a molecule that lowers surface tension, e. g. increasing its wetting properties or assisting the
formulation of emulsified liquids) and soda requirements during the tanning process.
Reduced soaking time leads to electricity savings in turning the drum where the hides rest.

Enzymes that remove hair during the tanning process reduce the sulphide requirements for
the process. Comparison of conventional and enzyme-assisted bovine soaking and de-
hairing/liming processes indicates that the application of enzymes in the tanning industry is
justified by considerable energy savings and considerable reductions in the processes‘

BIOTECHNOLOGY INDUSTRY REPORT Page 60


contribution to global warming. Assuming that the environmental improvements by
switching from conventional to enzyme-assisted soaking and de-hairing/liming are applicable
worldwide, the global saving potential is in the order of 8 million GJ of energy & 0.7 million
tonnes of CO2 per year.

Dye industry
Enzymes can help to reduce the potential environmental impact of dyes; bioprocesses to
produce bio-based colorants have been developed and recently patented as an alternative to
traditional chemical synthesis. While the creation of chemical-based dyes requires
temperature up to 70-90°C in harsh conditions, the enzymatic synthesis of these colorants can
be obtained at ambient temperature, under mild conditions. A life cycle analysis24 has shown
that on an industrial scale, enzymatic processes could help to reduce CO2 emissions and
toxicity towards the environment.

INDIAN SCENARIO OF BIOINDUSTRIAL SECTOR:


The Bio Industrial market mainly comprising industrial enzymes is estimated to be Rs 564crore in the
year 2009-10 as against Rs 478crore in 2008-09. The Sector is mainly dominated by Enzymes which
constitute around 60% of the market; rest of the market is shared by Bio fuels, Chemicals etc. The
segments revenue percent share was 3.95% in 2009-2010 as compared to 3.94% in 2008-2009.

The segment grew 16 percent in FY 2009-10. Though the overall enzyme consumption figures of
India are comparatively low with respect to other countries and 60-70 percent of domestic demand is
imported, the segment on an average has been growing over 15 percent in the last five years.

In India, the industrial enzyme consumption is predominantly in the detergents market (40 percent),
followed by the starch market (25 percent). The other important segments are food and feed, textiles,

BIOTECHNOLOGY INDUSTRY REPORT Page 61


leather, pulp and paper. In recent years, enzymes have found numerous applications in the food,
pharmaceutical, diagnostic and chemical processing industries. The trend for their application in
almost every sector is on increase.

Bio Industrial sector will grow over 15% for next 5 years. The leading players in this segment include
Novozymes which has over 50 percent market share followed by Advanced Enzyme Technologies
holding 25-30 percent market share. Other important players are Maps, Genecor, Lumis and Kerry
Biosciences. Besides, a new entrant Anthem Cellutions, a part of Anthem Biosciences group has
gained significant market share over a short period of time.

Apart from focusing on the local market, companies like Advanced Enzyme Technologies are looking
at other markets such as China. Considering the potential opportunity in the other markets Advanced
Enzyme has registered good growth in its export sales. The Indian companies are reporting a good
growth; a lot of R&D is happening in these companies and new applications are being explored.
Indian companies are looking at technologies from Europe, China and Australia. However, with
respect to global enzyme industry India still needs to do a lot of catching up.

BIO FUELS:

The Indian Bio fuel market has been consistently witnessing growth and developments for
past few years. The Government of India is injecting huge amount of money and resources
into the development of this sector in an attempt to reduce dependency on imported oil. High
volatile oil prices and production levels have further enlightened the need for continuous
developments of this sector.

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According to a research report "Emerging Biofuel Market in India", the Indian ethanol
consumption is projected to grow at a CAGR of around 4% during 2009-2018. Besides, the
trend of high consumption will not be limited to ethanol but biodiesel will also register strong
upsurge in consumption in coming years. Thanks to fluctuating oil prices in the international
market and continuously increasing oil import, the Indian bio fuel sector is expected to see
robust growth in coming years. Currently, ethanol dominates the Indian bio fuel sector, but
biodiesel will soon join the commercial stream as the phase one of pilot projects has already
been completed. Being at the initial stage, but with huge potential in terms of production, the
Indian bio fuel industry will prove to be a good option for bio fuel producers.

Industrial biotechnology can address emerging challenges resulting from global population
growth. Bio-based technologies can expand economic opportunities in rural areas while
reducing the burden on the environment. Bio-based technologies are an evolution, not a
revolution Modern uses of biotechnology, including industrial biotechnology, are just starting
and there are vast opportunities to use these tools in new and valuable ways. The world‘s
population will surpass 7 billion later this year and 9 billion by 2050, meaning 150,000 new
people in the world every day and an increasing need for energy. Industrial biotechnology
can provide additional sources of energy and help reduce dependence on fossil fuels.
We recognize that the future of industrial biotechnology will be based on collaborative
partnerships and no one company or country can go it alone given the complexities involved.

That is why companies like DuPont are actively engaged in global partnerships on bio fuels
technologies that produce energy from farm wastes and fuels with unique performance
properties and are delivering products from renewable feed stocks that are enabling
everything from clothing, carpets, car parts and cosmetics to airplane de-icing fluids. To
succeed in world markets, new bio-materials cannot be simple substitutions. They must result
in innovations that are more environmentally sustainable with cost parity and performance
superior to petrochemical-based equivalents. Various DuPont science-powered innovations
will yield products with fuller renewable and recyclable content, and the use of non-food feed
stocks for larger volume technologies. Biotechnology has a great impact on rural
development where renewable feed stocks are abundant. Industry is now increasing its
emphasis on bio fuels and other chemicals i.e. apart from enzymes the industry is trying to
increase its base area from one product dominated to multiproduct line so that the risk
associated with a single product line is reduced and growth prospects are also increased. In
future the share of Bio fuels and chemicals would also become very significant in this sector.

TOP COMPANIES IN INDIAN MARKET

ENZYMES

Novozymes, India:
Novozymes is the largest supplier of industrial enzymes and microorganisms in India,
catering to requirements in the detergent, food, feed, textile, leather, oils & fats, beverage
alcohol, and biofuel industries. The Company‘s enzymes and microorganisms save energy
and raw materials while reducing waste. The result is higher productivity, lower costs, and a

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better environment. Novozymes has over 700 products used in 130 countries. Novozymes
has 5,200+ employees working in research, production and sales. The development,
production, distribution, and sale of enzymes form the major part of Novozymes business,
currently accounting for 94% of sales.

Biocon:
Biocon was founded on November 29, 1978 as a joint venture between Biocon Biochemicals
Ltd. of Ireland and an Indian entrepreneur, Kiran Mazumdar Shaw. In 1979, Biocon became
the first Indian company to manufacture and export enzymes to USA and Europe. Biocon is
India's largest producer and exporter of enzymes. It manufactures and markets a broad range
of industrial enzymes, food additives and process aids. Biocon is the first enzyme company
globally to receive the ISO 9001 accreditation. Enzymes manufactured by Biocon are:
Amylases, Amyloglucosidases, Cellulases, Catalase, Lipases, Glucanases, Hemicellulases,
Phytases, Proteases, and Pectinases.

Rossari Biotech Limited:

Recognized one of the industry's premier enzyme & specialty chemicals specialist, The
Company is in the manufacture of Textile, Spinfinish, Coning Oils, Sewing Thread
Lubricants and Knitting Oil, Construction Chemicals, Laundry Chemicals, Animal Health
Care and Nutrition, Pharmaceuticals Products. Manufacturing facility is spread over l0
acres of lush greenery at Village Naroli, Silvassa near Vapi.

Advanced Enzymes Technologies Ltd:

With a history spanning more than half a century, Advanced Enzymes Technologies Ltd
(Advanced Enzymes) has emerged as a worldwide leader in the production of plant,
microbial and animal-based enzymes. In 1957, founder, Mr. L.C. Rathi, pioneered the
extraction of papain, an enzyme complex derived from papaya fruit and widely used for
pharmaceutical and medical purposes. Advanced is the largest manufacturer of Enzymes in
the Indian Sub-Continent.Advanced Enzymes is one of the few manufacturers in the world
that produces a full-spectrum of enzymes derived from all four natural origins: plant, fungal,
bacterial and animal. They also manufacture probiotics, especially Bacillus coagulans and
Saccharomyces boulardii. Their state-of-the-art ISO 9001:2008 certified manufacturing
facilities utilize the most advanced, surface and submerged fermentation technologies
available. Extensive research advances have led to the development of more than 400 unique
enzyme products, making Advanced Enzymes a major value provider to Healthcare and
Processing industries worldwide. With the strength of 42+ enzymes today, Advanced
Enzymes through its technical enzyme experts is able to create value, and provide solutions,
to its clients in 37+ countries globally. Advanced Enzymes operates in four key verticals:
Human Healthcare, Animal Healthcare, Food Processing and Industrial Processing. For each
of these verticals they have created subsidiaries which focus exclusively on delivering
solutions to the industries that operate within that vertical. Advanced Vital Enzymes Ltd
(Advenza) is the human healthcare vertical, while Advanced Bio-Agro Tech Ltd (Bio-Agro)

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focuses on Animal Healthcare. Advanced BioPro Solutions Ltd (BioPro) focuses on the Food
Processing vertical while Advanced EnzyTech Solutions Ltd (EnzyTech) focuses on the
Industrial Processing vertical. Also they have created Advanced Enzyme Far East Ltd. (Far
East) to cater specifically to the large and growing Chinese market. Enzytech, a subsidiary of
Advanced Enzymes, caters solely to the industrial processing vertical consisting of: Textile
Processing, Pulp & Paper Processing and Leather Processing industries. Launched in 2008,
Enzytech is responsible for developing, manufacturing and marketing enzyme based
solutions for these industries. Having developed a dedicated research & development facility,
Enzytech's goal is to innovate, patent and provide sustainable solutions to the major industrial
hubs of Indian sub-continent.

Zytex:
Zytex was established in 1996 starting with textile enzymes; that is how the name Zytex was
coined. Zytex has a world-class R & D research lab & application support lab, which is
approved by DSIR (Department of Science and Industrial Research), Govt. of India. Since the
last decade Zytex has been the leader in India in the textile enzyme business. In 2007, they
made a strategic technical collaboration with Giovanni Bozzetto, Italy, the leading European
textile auxiliaries‘ manufacturer since 1919. Zytex research is based on fermentation
technology and with prime focus on nutraceuticals and cosmoceuticals. Zytex has established
a new manufacturing facility at Savli Biotech Park, Baroda where it will produce products,
which will be sold to Nutraceuticals. Today Zytex products are sold for Nutraceutical,
Cosmetics, Textile, Ethanol, Animal Feed and Baking industry.

BIOFUELS

BIODIESEL TECHNOLOGIES:
Biodiesel Technologies is headquartered in Kolkata. It was conceived in 2002 in response to
the serious environmental and health hazards arising out of the various polluting emissions
casing our environment. The feedstock used is organic in character which produces Biodiesel
as per the ASTM, EN and BIS Standards. Since the operation of the first Biodiesel processing
Plant in Hyderabad, Biodiesel Technologies has built a strong reputation as a leading pioneer
in the manufacturing, fabricating and assembling Biodiesel Processing Plants.

MISSION BIOFUELS INDIA PVT LTD:


Mission Biofuels India Private Limited ("MBIPL") is situated in Bhubneshwar Orissa it is a
subsidiary of Mission NewEnergy Limited was established in March 2007 for the upstream
Jatropha Curcas Feedstock Business and wind energy projects. Mission Biofuels India Private
Limited is involved in a large scale cultivation of Jatropha Curcas as well as nurseries and
procurement centres in several states of India. The company produces Jatropha oil for
production of sustainable biodiesel. Mission Biofuels has a strong network of field
professionals in 6 states of India and agreements in place with micro farming groups and
world class research groups. The company also has Partnerships with the leading Jatropha

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research centre - The Energy Resources Institute (TERI), to implement optimum planting
cultivation technologies and ensure highest yields are achieved .

PRAJ INDUSTRIES:
Praj is a global Indian company that offers innovative solutions and adds value in bio-
ethanol, alcohol, brewery plants, process equipment and water and wastewater treatment
systems for customers, worldwide. Praj is a knowledge based company with expertise and
experience in Bioprocesses and engineering. Praj addresses the entire value chain for
processing of alcohol/ethanol as well as beer production, right from feedstock handling to
fermentation, distillation and waste water treatment and re-utilization. The solutions are end-
to-end and comprehensive. Praj also offers water & wastewater treatment solutions for
various applications with a focus on recycle, reuse, reduce and recover. Praj has over 450
references in more than 60 countries across 5 continents with its own offices in Bangkok
(Thailand), Johannesburg (South Africa) and Sharjah (UAE), apart from India. Praj is also
present in USA, The Netherlands, Brazil, Colombia and Guatemala.

TOP COMPANIES IN GLOBAL MARKET

Enzymes

Novozymes:

The company operates in industrial enzymes, microorganisms, and biopharmaceutical


ingredients. Their biological solutions are used in the production of numerous products such
as biofuels, detergents, food, and animal feed. In 2009, they achieved revenue of US $
1635.11 million based on a large portfolio of products and services worldwide. Their
business consists of two segments: Enzyme Business and BioBusiness. Around 14% of their
revenue is spent on research and development, and they currently hold more than 6,000
patents. The number of employees globally is over 5,200. The development, production, and
distribution of enzymes are a major part of the business, currently accounting for 94% of
sales. With a 47% share of the global enzyme market in 2009, they retained the position as
the world leader in enzymes. The enzyme market is divided into four main areas:
Detergent enzymes (32%), Technical enzymes (31%), Food Enzymes (21%), Feed
Enzymes (8%), Microorganisms (5%), Biopharmaceuticals ingredients (3%). 2009
showed a strong earnings development.

Genencor ( A Danisco division):

Genencor discovers, develops, manufactures, and delivers eco-friendly, efficient enzyme


product solutions for the agricultural processing, cleaning and textiles, food and feed,
consumer, and industrial markets. It also develops innovative advancements for the biofuels,
biodefense, and bio safety industries. Genencor is a recognized leader in protein and pathway
engineering. Genencor, Danisco‘s industrial biotech division, posted revenue of US $
881.237 million in the year 2009-10. The division showed broad-based growth in all major
product segments and all key geographies. Throughout the year, growth was particularly
strong in enzymes for Bioethanol production and animal nutrition, and strengthened product
offering and positions in many fields including detergent and food enzymes.

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Biofuels
Coskata:

Coskata is a biology-based renewable energy company whose low-cost platform technology


allows for the production of fuels and chemicals from a variety of input material (including
biomass, agricultural and municipal wastes, and other carbonaceous material). Using
proprietary microorganisms and patented bioreactor designs, they are ready today to produce
FlexEthanol™, or feedstock flexible ethanol, to fuel energy security, economic growth, and
environmental sustainability. Coskata is commercializing a proprietary process and related
technologies for the conversion of a wide variety of input materials into ethanol.

Sapphire Energy:

It is a privately held company founded in May 2007. Its headquarters and primary lab are in
San Diego, California; Engineering and project management, Orange County, California;
Research and Development Facility, Las Cruces, New Mexico; Integrated Algal Bio-
Refinery, Columbus, New Mexico.

Virent Energy Systems:


Virent is commercializing an innovative advanced biofuel technology that catalytically
transforms a wide range of soluble plant sugars into hydrocarbon molecules like those
produced at a petroleum refinery. Virent‘s renewable hydrocarbons can be blended
seamlessly to make gasoline, jet fuel, and diesel. Virent made its ground-breaking discoveries
in 2006 and is rapidly advancing its innovative Bio Forming technology platform for the
production of high performance, environmentally superior biofuels. Virent and its
collaborator, Royal Dutch Shell, recently started production at the world‘s first bio gasoline
demonstration plant. The plant proves the ability to scale Virent‘s technology platform to
commercial production volumes. Virent has received significant commercial interest and

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counts Cargill, Shell, and Honda among its leading investors. The company has entered into
key strategic industrial collaborations, including with Royal Dutch Shell for the development
and commercialization of bio gasoline and diesel production from plant sugars.

POET, LLC:

It is a privately held company. POET is a leader in biorefining through its efficient, vertically
integrated approach to production. Today, POET has a network of 27 plants in seven states.
POET provides turnkey development, design, engineering, construction, management and
marketing for the plant network. The 27 POET Biorefineries are owned by various investors
most of whom purchased shares in the biorefineries in a private offering. Almost all of the
biorefineries are organized as limited liability companies. Project LIBERTY is POET's large-
scale cellulosic ethanol plant. The Iowa-based company plans on using corn waste -- cobs,
husks, and leaves -- as feedstock for the ethanol plant. The plant is expected to begin
commercial operations in 2012, and POET plans on producing 3.5 billion gallons of
cellulosic ethanol by 2022.

Range Fuels:

Range Fuels is a privately held company funded primarily by greentech venture capital
companies, including Khosla Ventures, LLC, arguably the top venture firm in the U.S.
focusing on alternative, clean energy systems. Range Fuels is one of six companies selected
by the United States Department of Energy (DOE) for financial support in building
commercial cellulosic ethanol plants and is the first to break ground.

World Enzymes Market


Enzyme demand worldwide will reach $7 billion by 2013. Continued strong demand for
specialty enzymes, as well as above average growth in the animal feed and ethanol
production markets, will drive growth. Growth in specialty enzymes, nucleases and
polymerases, along with various other enzyme types, will outpace the more industrially
concentrated lipases, carbohydrases and proteases. From a regional perspective, the
developed economies of North America and Western Europe will achieve healthy gains,
while the fastest growth will continue to come from the more rapidly developing economies
of the Asia/Pacific and Africa/ Mideast regions, as well as Latin America and Eastern
Europe. World enzyme demand grew at a nearly double-digit pace from 2003 to 2008, helped
in large part by the rapid increase in world energy prices (which made enzyme-related
processes and products more cost effective, and facilitated the legislation of a rapid expansion
of the fuel ethanol market, particularly in the United States) and the successful launch of
several enzyme-containing pharmaceuticals. With the world in a global economic downturn
in 2009, however, the market for enzymes has become much more challenging, and growth
will moderate significantly going forward. Pharmaceutical and biocatalyst enzymes will lead
the growth of the global enzyme industry. Through 2013 world enzyme demand is expected
to achieve average annual gains of 6.3 percent per year, led by pharmaceutical and biocatalyst
enzymes. Diagnostics enzyme demand will also fair well due to expanded access to medical
care in developing countries, and the drive to achieve nearly universal health care in the

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United States. With pharmaceutical companies having difficulty bringing new small-
molecule drugs to market, biotechnology will continue to gain in importance, helping to
sustain demand for research and biotechnology enzymes.

Among the industrial enzyme markets, animal feed and ethanol production will both achieve
above average advances, while the food and beverage market will grow at a healthy pace.
Animal feed enzymes will achieve their fastest growth in developing markets where rising
per capita incomes will continue to increase demand for meat in the local diets. However,
demand for ethanol production enzymes will slow from the torrid pace of 2003 to 2008 as
countries re-evaluate the use of food-derived raw materials for ethanol production. While the
development of second generation biofuels derived from cellulosic raw materials will help
sustain demand growth, a variety of processes -- including some that do not use enzymes - -
will be employed, restraining advances. Food and beverage enzyme demand growth will
moderate to a below average pace through 2013, reflecting the challenging environment in
North America and Western Europe. Similarly, growth in the cleaning product and other
industrial markets will also be below average.

Global Scenario:
Nowadays, multinational firms dominate the bio industrial market. For example, Monsanto,
Dupont, Syngenta, Novartis, Basf, Pioneer and so forth have jumped into the industry much
earlier than others, absolutely controlling the global market. As for the recently popular
genetically modified seeds, companies from the United States, Switzerland and Germany
account for 96% of the global market. The global market for industrial enzymes is estimated
at $3.3 billion in 2010. This market is expected to reach $4.4 billion by 2015, a compound
annual growth rate (CAGR) of 6% over the 5-year forecast period. Detergents (37%), textiles
(12%), starch (11%), baking (8%) and animal feed (6%) are the main industries, which use
about 75% of industrially, produced enzymes. Technical enzymes are valued at just over $1
billion in 2010. This sector will increase at a 6.6% compound annual growth rate (CAGR) to
reach $1.5 billion in 2015. The highest sales of technical enzymes occurred in the leather
market, followed by the bio ethanol market. The food and beverage enzymes segment is
expected to reach about $1.3 billion by 2015, from a value of $975 million in 2010, rising at a
compound annual growth rate (CAGR) of 5.1%. Within the food and beverage enzymes
segment, the milk and dairy market had the highest sales, with $401.8 million in 2009.

Merger and Acquisitions in Bioindustrial Sector


Start-ups/SMEs have four different growth strategies along the two dimensions
established/new markets and established/new technologies: internal R&D, R&D co-
operations, joint ventures as well as mergers and acquisitions (M&A).

The growth strategies all have their specific advantages and disadvantages, but currently,
most industrial biotech companies only use a very limited set of these strategies. The
preferred strategy is organic growth based on internal R&D for established markets and
technologies. Especially start-ups/SMEs use this strategy to move from a service-oriented to

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an IP-oriented business model. This originates from the fact that start-ups/SMEs maintain
very good relationships with universities and research institutions and can rapidly access the
latest research results. However, since start-ups/SMEs have to carry the entire costs of R&D
activities, the number and size of projects is limited.

An option for established companies to access new technologies involves R&D co-operations
with specialized biotech start-ups/SMEs. This growth strategy has often been used in the past
and nearly all industrial biotech companies have such co-operations (e.g. R&D co-operations
of BASF, DSM, Henkel and others with Brain as example from the chemical industry and co-
operations of Shell with Codexis or Total with Gevo in the area of biofuels). They are of
special importance for industrial biotechnology as this ensures the technology transfer of
research results from universities and research institutions to established companies. In
contrast, R&D co-operations between start-ups to realize synergies on the technological as
well as the market side are rare, because of strong competition between start-up companies
for co-operation projects with established companies.

Joint ventures to open new markets are rather seldom in the area of industrial biotechnology
and mainly used to obtain access to emerging markets like China and India. With increasing
maturity of the industrial biotech sector such partnerships will grow in importance and
synergistic risk/reward sharing deal structures will begin to appear. Start-ups/SMEs avoid a
time and cost consuming development of new markets, while the market oriented partner is
able to incorporate innovative and state-of-the-art technologies into their own product
portfolio. Another growth strategy with increasing importance are M&A transactions
between established companies and start-ups/SMEs (e.g. the sale of Biopract by DSM) or
between SMEs (e.g. acquisition of Jlich Fine Chemicals through Codexis).

Followings are some important deals in Bioindustry:

Novozymes

Novozyme is working with leading distributors like Millipore/Celliance and SAFC


Biosciences that specialize in supplying solutions to the biopharmaceutical industry. This will
help to ensure that the products have the best possible access to the pharmaceutical market.

Novozymes Delta Ltd.

In July 2006 Novozymes acquired UK Company Delta Biotechnology Ltd (now Novozymes
Delta Ltd) from the sanofi-aventis group. The Nottingham-based company generated sales of
around DKK 100 million in 2006 and has around 100 employees. The acquisition has brought
additional know-how and technology in the market for recombinant human serum albumin
(rHSA). Novozymes Delta‘s most important product is Recombumin ®, an FDA-approved
rHSA product. Its uses include extending the shelf-life of vaccines. As well as several other
rHSA projects, Novozymes Delta has a development project in recombinant transferrin, a
protein which is particularly good at transporting iron. The acquisition has also given

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Novozymes a technology called albufuse™, which can extend a medicine‘s action by fusing it
with albumin, and significant expertise in the production of proteins in yeast cells.

Novozymes Gropep Ltd.

In December 2006 Novozymes acquired Australian listed company GroPep Ltd (now
Novozymes GroPep Ltd). The Adelaide-based company generated sales of around DKK 70
million in the 2005/06 financial year and has around 80 employees. Its most important
product is an insulin-like growth factor (IGF) analogue. Novozymes GroPep Ltd also markets
a number of other recombinant cell culture ingredients for the biopharmaceutical industry and
has a specialist sales organisation which works with the big distributors on marketing these
ingredients to the biopharmaceutical industry. The company has various pharmaceutical
projects under development.

Advanced Enzyme Ltd.

Mumbai-based Advanced Enzyme Technologies Ltd (AETL), the country‘s second largest
natural enzyme manufacturers, set up base in China by acquiring minority stake in two
Chinese technology companies. AETL has earmarked an investment of Rs 10 crore for the
acquisition and has equity collaboration with the Japanese enzyme major-Higuchi. The
company is eyeing China not only market expansion but technology exchange as well,
according to C L Rathi, managing director of AETL. ―China has a well developed enzyme
market and we are scouting for ideal partners to leverage our capabilities both in terms of
market potential as well as technology exchange. However, it is very early to reveal the
details of the investment,‖ he said. The Rs 100 crore company has its research centre and
manufacturing facilities in India and plans to set up three new manufacturing plants in the
country. Rathi said that the additional manufacturing facilities are coming up at Indore in
Punjab, Jalna and Vasinj in Maharshtra. AETL had set up a research centre and a production
plant in US recently

DuPont

On 10 January 2011, American chemical company DuPont had announced that they will
acquire Danisco, a Danish food ingredients and enzymes producer for US$5.8 billion. The
deal is seen by many analysts as a way for DuPont to enter the niche market of chemical food
additives, which has long been dominated by their smaller rival International Flavors and
Fragrances Inc. It is also expected that the deal will see increasing cooperation between the
two firms in the field of technology for advanced bioethanol. The acquisition of Danisco will
be the largest by DuPont since it bought modified seed-maker Pioneer Hi-Bred International
Inc. for US$7.7 billion in 1999. Analysts estimate that during the past year there has been
US$84.8 billion worth of chemical -company takeovers in the past year, with an average
premium on shares of 26%.

Nalco Chemical Company

Nalco Chemical Company is the largest manufacturer and marketer of water treatment and
process chemicals and services in the world. Nalco Chemical Company announced it has
acquired the pulp and paper enzyme business of Ciba Specialty Chemicals Inc., formerly

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known as Ciba-Geigy Ltd., Basel, Switzerland. Nalco will gain worldwide exclusive rights to
this advanced enzyme technology which together with the Company's polymer technology is
used in paper mills to enhance fiber quality and water drainage during the papermaking
process. In addition, Nalco has entered into an exclusive, long-term supply and joint research
agreement with Genencor International, Inc., of Rochester, N.Y., a joint venture company
held by Eastman Chemical Company of Kingsport, Tenn., and Cultor Ltd., of Finland.
Genencor is the sole supplier of these enzyme products for Ciba Specialty Chemicals. The
agreement includes Nalco's exclusive right to use Genencor's pulp and paper enzyme
applications laboratory in Finland to further advance research and development in this area.
The lab will also provide customer support and research. Genencor is the second largest
manufacturer of industrial enzymes in the world. Nalco expects to further advance this
enzyme technology and expand its use to pulp and paper mill customers throughout the
Pacific region, Europe, Latin America and North America. "This new enzyme technology
will greatly enhance what we can offer our customers and allow us to extend our competitive
edge in this dynamic and growing market," said Peter Dabringhausen, Group Vice President
and President of Nalco's Process Chemicals division. Since May 1996, Nalco has completed
acquisitions which total nearly $100 million and add to its core water, wastewater treatment
and process chemicals capabilities.

Codexis

On February 22, 2005 Codexis, Inc., a privately held biosciences company announced it has
acquired Germany's Julich Fine Chemicals GmbH (JFC), a leading supplier of specialty
enzymes (biocatalysts) for organic synthesis and chiral building blocks to pharmaceutical and
chemical companies worldwide. The acquisition has made a positive cash contribution to
Codexis in its first full year of operations. Additional financial terms were not disclosed. JFC
is one of Europe's leading providers of products and services for the biocatalytic production
of chiral pharmaceutical intermediates. JFC will operate as an independent, wholly owned
subsidiary of Codexis. JFC offers a wide range of off-the-shelf specialty enzymes and chiral
intermediates useful in pharmaceutical development. JFC will be an outlet for several of
Codexis' proprietary enzymes, while Codexis will continue to focus on using its Molecular
Breeding(TM) directed molecular evolution technology to provide proprietary, customized
solutions directly to leading pharmaceutical companies worldwide."The acquisition of JFC is
part of Coedix strategic expansion into international markets, in particular Europe. We
believe it will accelerate adoption of Codexis' biocatalytic approach to pharmaceutical
process research and manufacturing, an area historically dominated by synthetic organic
chemistry," said Alan Shaw, Ph.D., President and Chief Executive Officer of Codexis.

Future prospect for Industrial Biotechnology (Bioindustry)

The world is facing many serious challenges. A fast-growing human population and the
consequent growing demand for food, energy and water are the most serious. In addition,
anthropogenic climatic change is a severe threat to mankind and requires that we significantly
reduce our current greenhouse gas (GHG) emissions to avoid detrimental consequences for
the globe. Only the use of new technologies will allow us to bridge the gap between

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economic growth and environmental sustainability in the long run. Over the course of many
multi-stakeholder discussions driven by the Chemicals Industry Community at the World
Economic Forum in 2008 and 2009, industrial biorefineries (bioindustry) were identified as
one potential solution that may help mitigate the threat of climate change and the seemingly
boundless demand for energy, fuels, chemicals and materials. Biorefineries are facilities that
convert biomass – biological materials from living or recently living organisms – into fuels,
energy, chemicals and materials (and feed). To date, the industry is still in a nascent state,
with most second-generation biorefineries plants (using cellulosic material) only expected to
be ready for large-scale commercial production in a few years. The landscape of active
players is rather scattered and fragmented with many relatively small technology players, but
there is an ever increasing number of large players starting to invest. Two of the main
industry drivers, in addition to energy security and environmental concerns, are mandates and
policies. Fuel regulations, such as the Low-carbon Fuel Standard introduced in California in
2007, are examples of potential industry drivers. The Standard requires fuel providers to
reduce GHG emissions of the fuel they sell, to achieve a 10% reduction in the carbon
intensity of transport fuels by 2020. Additionally, the Renewable Fuel Standard introduced in
the US in the same year sets an emissions threshold that includes direct and indirect
emissions from land use changes. Regardless of these legislation-based regional differences
in the status quo of industrial commercialization, generally the markets for bio-based
products are expected to grow very strongly globally over the next few years due to four
underlying, irreversible trends. First, the economics of fossil-based products are deteriorating
since conventional crude oil resources are getting scarce. Second is the growing need for
national energy security and geopolitical security. Third, public pressure for environmental
sustainability is increasing due to an increasing environmental awareness. Last, but not least,
rapid demographic growth will drive demand supported by rising economic aspirations of
developing countries. These fundamental trends triggered a vast interest in bio-based
products and placed them high on the strategic agenda of most players in a variety of
industries. In agriculture, for example, new economic opportunities will emerge from the
rising demand for biomass. In the chemicals industry, bio-based innovative products outside
the conventional petroleum-based product family trees will confer an advantage to players
who manage to find the right molecules and insert them into existing or new value chains. In
the automotive and aviation industries, corporations are looking at bio fuel as an important
means to reduce the GHG emissions of their fleets to comply with regional or national
regulations, while utilities are making high investments in the expansion of their renewable
power generation assets, with biomass coming third after solar and wind investments.

Future Challenges

Despite the great relevance of bio-based products for many industries, experts still see
numerous technical, strategic and commercial challenges that need to be overcome before
any large-scale commercialization of the industry can succeed. Most importantly,
biorefineries will have to employ the best possible technologies (for fermentation,
gasification and chemical conversion, and also for pre-treatment and storage) to ensure that
bio-based products break even. This will require the concerted action of many non-traditional
partners – such as grain processors, chemical companies, and technology players – to cover
all aspects of the complex biomass value chain, from feedstock production to end-user
distribution. Another significant challenge is to establish the necessary infrastructure (supply
chain and distribution infrastructure) and raise the high capital costs required. The latter are
typically beyond the financial reach of individual private companies, and may therefore
require public funding. In the United States, a recent report from Sandia showed that the US

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can produce 90 billion gallons of bio fuels to replace oil (total use today is around 110 billion
gallons). With improvements in mileage, that means that US could run solely on bio fuel in
2030-2050. The limitation is not the supply of biomass but, rather, a complete infrastructure
built around oil, expected low oil prices at least between now and 2020 and a lack of political
decisions. To overcome these challenges, various stakeholders need to play different roles in
the industrialization process of biorefineries systems. Governments interested in supporting
biorefineries for reasons of environmental protection and energy security should make
significant investments in R&D, supply chain and distribution infrastructure as well as
conversion capacity, while carefully regulating the implementation process to ensure food
security and avoid land-use change. Companies highly exposed to fossil feedstock and fuels
will need to develop petroleum-replacement strategies to manage their risk, and explore the
new business opportunities created by innovative conversion technologies and novel
molecular outputs. Retail and business consumers need to be better educated about the
benefits of bio-based products both from an environmental sustainability and business
opportunity perspective. Finally, NGOs and public authorities must be involved from an early
stage to ensure development of the industry in a manner compatible with the highest
environmental and social standards. Without the latter, broad public acceptance and the
adoption of bio-based products will be hard to accomplish.

Industrial biotechnology takes the biotech tools developed to fight disease and cure illness
and applies them to the greatest challenges in industrial manufacturing, chemical synthesis,
and renewable energy production. Industrial biotechnology has not gained the recognition it
deserves, but the years ahead will see more acknowledgement of its strength. The future
major thrust area will be fuel and energy, pollution control and enzymes and products derived
from petroleum oil/crude. This area includes polymers such as plastics.

There are two important reasons for increased impetus on bioindustry: first of all, it is a
possible substitute for petroleum/ fossil fuel-based economy: Secondly, it is safe and
environment friendly. The status of bioindustry is limited since, until now, the importance of
biotechnology was mostly attributed to the pharmaceutical segment and, latterly, the
agriculture sector. Industries benefiting from biotechnology include textiles, chemicals,
pollution prevention / bioremediation, pulp and paper and metals. An important development
occurring is the replacing of hydrocarbon-based materials with renewable resources. These
resources are based on both plant and microbes and the estimates suggest that, by 2015, this
will affect the chemical industry to the tune of USD160 billion. This enormous potential
could surpass the revenue generated from the pharmaceutical and agricultural sectors.

The technologies applied in bioindustry are no different to those benefiting healthcare and
agriculture. These technologies include recombinant DNA, genomics, proteomics, gene
shuffling and high-throughput screening and advanced fermentation. An advantage of
biotechnological processes is their ability to occur at normal temperature and pressure in
more neutral conditions. This leads to fewer air emissions and therefore a reduction in plant
pollution. This means that, although bioindustrial processes require significant energy levels,
the economies favor these processes when we consider the following facts:

• Higher energy requirements can be met by generating indigenous energy at the plant using
biomass.
• The elimination/reduction of many pollution-controlling processes resulting in cost

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reduction. Similarly the bioremediation sector is showing potential. Earlier approaches (using
microbes for cleaning) are increasing in scope. These days companies experiment with
genetic modification of microbes to produce better microbial species for bioremediation. In
the industrial arena, scientists are combining nanotechnology with biotechnology (bio-
nanotechnology). The research that takes place with the combination of these two advanced
sciences varies from creating smart machines to using DNA as a storage device

Collection and delivery of agricultural residues will require substantial investment in supply
infrastructure, including new planting and one-pass harvest equipment, an enhanced rail
freight network, and greater adoption of no-till cropping. Farmers can expect to recover much
of their necessary investment through residue sales - a 1,000-acre farm could expect to
recover additional costs in as little as 2 years - but government support is also needed to
speed development.

New markets that commoditize the environmental benefits of no-till farming could provide
even greater incentive for farmers to convert to no-till cropping with residue collection. New
mandatory greenhouse gas limits in California and the Northeast could help farmers earn $10
per acre or more from the sale of carbon credits.

Processing just 30 percent of U.S. corn Stover into bio fuels would reduce net U.S.
greenhouse gas emissions by 90 to 150 million metric tons of carbon dioxide equivalent
annually, enough to, Offset the CO2 emissions of 10 typical 1,000-megawatt coal-fired
power plants. More than offset recent annual growth in emissions from all sectors of the U.S.
economy.

A recent study from the University of Tennessee ("25% Renewable Energy for the United
States by 2025: Agricultural and Economic Impacts", Nov. 2006) found that:

 Producing 25% of America's energy from agricultural resources would generate in


excess of $700 billion annually in economic activity, create 5.1 million jobs, and add
$180 billion to net farm income by 2025
 Improved market prices for corn and other feedstock crops will produce an estimated
cumulative savings in government farm payments of $15 billion.

An analysis by the Natural Resources Defense Council found that an investment of $1 billion
in R&D and demonstration should cut the cost of producing cellulosic ethanol in half by
2015, saving consumers $20 billion per year in fuel costs by 2050 ("Growing Energy",
NRDC 2004).

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BIOSERVICES SECTOR
The bioservices sector contributes a total of 22% to Indian Biotech sector and it widely
consists of:

 Clinical research
 Contract manufacturing
 Contract research
 Consultancy

With increasing pressures on R&D cost containment across the global pharmaceutical
industry, there is an increased focus on reducing the cost of clinical development, which
accounts for two-thirds of the development costs. This is in addition to the pressure of
accelerating the pace of the entire process of drug development. These challenges have led to
a paradigm shift in the approach of major pharmaceutical companies.

Clinical Research: The process of drug discovery and development takes 14.2 years
(average) and costs $802 million. Clinical trials are the most significant direct costs related to
drug discovery and development. The cost attached is about $282 million and takes about
seven years to complete. These place significant strains on a company‘s resources and
management time and hence significant amounts of these activities are being outsourced.

Besides contract research and manufacturing, India is also emerging as a global hub for
clinical trials. India is being projected to grow in this field on account of adequate patient
population having a wide spectrum of diseases, from common to the rarest, qualified medical
professionals, good communication network and IT capabilities.

Quintiles, Specialty Ranbaxy, Siro Clinpharm, Eli Lilly, Clingene International (a subsidiary
of the Biocon India Group), Lotus labs, Clintec International, Pfizer, Novo Nordisk, Lambda
Therapeutic Labs, Novartis, etc. are some of the companies conducting clinical trials in India.

Contract research: Outsourcing has become the mantra of the industry and contract research
has evolved into a huge market. India is in a unique position to tap this new business
opportunity because of three factors—a large pool of qualified English speaking
professionals, India‘s traditional strength in the pharma business and the cost-effectiveness.

And there are organizations doing contract research and trials for other companies
(independent CRO) like Quintiles Spectral, SIRO Clinpharm and Syngene. Aurigene,
Shantha Biotechnics and Chembiotech. Syngene International, a Biocon Group company, set
up in 1994 was India‘s first integrated CRO in the area of drug discovery

Contract research is very innovative, capital intensive, involving lots of R&D. Further, the
field is not process but product-driven and cannot be operated on a large scale.

Contract manufacturing: Contract manufacturing has become a big industry as India offers
a strong manufacturing base at competitive costs, supported by a well-developed engineering
base and an abundance of scientific talent. Eli Lilly, Bharat Biotech and Shreya Biotech are
some of the important contract manufacturing companies.

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The Indian CRO market is currently growing at 20 percent per annum and has excellent
growth opportunities. Market trends indicate that the CRO market is going to experience
rapid growth in the coming years and will become an indispensable part of the drug
development process. The potential is huge and the opportunities exist at every level. As on
date, clinical research is still a sunrise industry in India and contributes just 0.7 percent to the
global clinical research industry but this scenario is soon expected to change.By the year
2011 India would contribute 20 percent to the global clinical research industry revenues.

Clinical Research
Clinical research is a branch of medical science that determines the safety and effectiveness
of medications, devices, diagnostic products and treatment regimens intended for human use.
These may be used for prevention, treatment, diagnosis or for relieving symptoms of a
disease.

The term clinical research refers to the entire biography of a drug from its inception in the lab
to its introduction to the consumer market and beyond. Once the promising candidate or the
molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where
different aspects of the drug (including its efficacy and toxicity) are studied.

These human studies are conducted in four phases in research subjects that give consent to
participate in the clinical trials.

Phase 1 trials: mainly targeted to identify the safety, tolerability and the mechanism of
action of drug. Studied drug investigated in minor number of healthy volunteers.

Phase 2 trials: Goal is to identify appropriate dosage and minimize safety risk for future
research subjects. Trial requires more than 100 patients to demonstrate the relevant results.

Phase 3 trials: Done to study the effectiveness of the studied drug in a variety of
demographic and socioeconomic subjects with variants of disease under study. A comparison
is usually made with standard drug available in the market. More than 1000 subjects are
exposed to the studied drug. Post this stage a New Drug Application (NDA) is filed with the
FDA

Phase 4 trials: Aim is to further characterize the safety of the drug through the identification
of unknown adverse reactions and to potentially research new therapeutic indications.

Further trials: Clinical research continues throughout the lifetime of the drug to include post
marketing surveillance where a periodic 'progress report' is submitted to the regulatory
authorities once every 2 years after the drug is released into the market, and
pharmacovigilance where the safety of marketed drugs, biologics or medical devices are
monitored. The focus of clinical research is wide enough to include important items such as
data management, medical writing, regulatory consultation, and biostatistics.

Clinical trials is the most expensive stage of the drug development chain and India possess
resources that would allow the country to offer clinical research services at very competitive
cost. The international biopharmaceutical sector finds India‘s pool of highly skilled doctors,

BIOTECHNOLOGY INDUSTRY REPORT Page 77


trained medical personnel, investigators, and the support research infrastructure to be highly
attractive and as a result, large numbers of international companies are now viewing India as
a potential centre of knowledge, skills and resources, and are hoping to derive expertise-
based synergies from Indian partners. The foundations for clinical research clearly exist in
India, and the regulatory agency, having issued the Indian GCP guidelines in December 2001
and the Schedule Y in January 2005 (requirements and guidelines for conducting a Clinical
Trial in India), is determined, under the leadership of the new Drug Controller General of
India (DCGI), to enhance the operations of the agency and deliver timely, robust, and quality
medical advice and decisions. In addition, the Indian Council of Medical Research (ICMR)
issued the Ethical Guidelines for Biomedical Research on Human Subjects in 2000 and works
with the DCGI to improve the processes and procedures for clinical research and
development in India.

Global Market
The market for clinical trial services has been expanding rapidly, with impressive revenue
growth and expansion of the sector in recent years. Ageing populations, increasing
prevalence of chronic diseases, growing demand for improved therapies and high growth of
the pharmaceutical and biotechnology markets worldwide are driving the clinical trials sector
and market. The globalization of development programs and the increasing complexity of
trials – with regulatory developments – are heightening the need for larger trials and greater
numbers of trials. Many pharma companies are outsourcing clinical trials to gain cost
savings/efficiencies, greater flexibility and specialist expertise. The emerging clinical trial
destinations, including CEE countries, India and China, are achieving double-digit growth.
Pharmaceutical and biotechnology companies in the US spent approximately $59 billion on
R&D, which equates to roughly 18% of their sales. A significant portion of R&D budgets are
used for the outsourcing services offered by the CRO industry, approximately $15 billion.
This figure is expected to grow at 15% over the next seven years and should increase further
with the broadening of the spectrum of services outsourced to cover the entire value chain. As
outsourced services in developing countries such as China and India move up the value chain
to cover phase 1 and 2 trials, the total contracts value may go up to $20 billion. Further,
certain therapeutic areas within pharmaceutical development are slated for an even greater
growth curve, namely the oncology class, expected to see continued growth of upwards of
21% over the next few years due to the large target market, strong unmet medical need, and
overwhelming number of drugs currently in development (667 for cancer vs. 252 for CNS
disorders, 206 for cardiovascular disorders, and 186 for infections). There are over 1,100
companies in the world. It is a very fragmented industry with the top 10 controlling 56.1% of
the market.

The Indian Market


Over the past decade, there has been a perceptible change from scepticism to acceptance in
how India is viewed for clinical trials; many consider it a core region for global plans. As a
result, many global pharmaceutical players including Pfizer, Novartis, and Roche etc. have

BIOTECHNOLOGY INDUSTRY REPORT Page 78


expanded their existing clinical research investment and infrastructure in India. Clinical trials
generated an estimated $70 million in revenues for Indian companies in this sector, and the
number was predicted to grow to $200 million in 2015. Early pharmaceutical pioneers in
India faced a daunting task in operating in a regulatory and ethics environment that was
overtly unfriendly for quality clinical trials. To make matters worse there was a dearth of
experienced investigators and clinical research professionals. However, with patience and
persistence, these organizations and their supporters brought about a change in the quality of
research professionals, increased awareness of good clinical practice (GCP) compliance, and
made efforts to improve ethical aspects of clinical trial operations

Regulations
The Central Ethics Committee on Human Research (CECHR) of the Indian Council of
Medical Research (ICMR), New Delhi, issued Ethical Guidelines for Biomedical Research
on Human Subjects in 2000.
Subsequently in 2001, a central expert committee was set up by the Central Drugs Standard
Control Organization (CDSCO) to develop Indian GCP guidelines in line with the latest
WHO, ICH, FDA, and MHRA guidelines. A continuation of this regulatory revolution has
been revision of Schedule Y.
Schedule Y deals with regulations relating to clinical trial requirements for the import,
manufacture, and of obtaining marketing approval for a new drug in India. The procedure for
applying for marketing approval depends on the status of the new drug. When the revised
Schedule Y fully comes into force, it will confirm India‘s image as a reliable clinical research
destination.

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Top global clinical research companies
In the international scene there are several clinical research companies that are making their
mark.

Dar Pharma: Mexican company which offers services (clinical trials as well as research), for
development of the new products.

Euromedex: manufactures medicines for human as well as veterinian use, health products
and medical equipment.

Gastroenterology research consultants. This organisation is totally integrated, clinical


centre comprising of nine board certified professionals in Gastroenterology as well as in
internal remedies.

Matrix contract limited is also a leading service CRO having abundance experience in
paper-based project (research projects) and e-process development in clinics.

Rostrum is also known for designing as well as delivering training for different
pharmaceuticals companies.

Cetero Research is an industry leading CRO in clinical pharmacology, bio analytical, and
specialty Phase II-IV services.

Rules-Based Medicine (RBM) is a CLIA-certified biomarker testing laboratory specializing


in cost-effective, high-quality multiplexing services.

Diteba is a research and testing laboratory that provides GMP analytical services and GLP
bioanalytical services to the pharmaceutical, biotechnology and natural health products
industries.

PRA International conducts clinical trials in more than 75 countries across 6 continents and
provides services through all phases of clinical development.

Pacific BioLabs: offers testing and research support services in the medical device,
pharm/biopharm, and other industries.

Indian Clinical research companies


Clinigene
Established in the year 2000 as a Biocon subsidiary, Clinigene became India's first CAP
(College of American Pathologists) accredited Central Laboratory. Clinigene's services now
span a broad spectrum of activities including human pharmacology, bio analytical research,

BIOTECHNOLOGY INDUSTRY REPORT Page 80


central laboratory, clinical operations, medical writing, medical monitoring, safety
management, pharmacovigilance, clinical data management & biostatistics and regulatory
services supporting early-phase through late-phase clinical development programs. Clinigene
has extensive working knowledge of a wide range of products such as biologics,
biotechnology products, vaccines, devices and small molecules. Clinigene has, in a short span
of time, earned a reputation for maintaining internationally benchmarked standards in clinical
research.

Jubilant Clinsys

Jubilant Clinsys, Inc., a Jubilant Life Sciences company, is a therapeutically focused clinical
research organization headquartered in Bedminster, New Jersey. It provides pharmaceutical,
biotechnology and medical device companies with a broad range of clinical research services
in support of Phase I-IV drug and device development, including project management,
clinical monitoring, scientific and medical support, investigator and patient recruitment, site
management, biostatistics, data management, drug safety, quality assurance, regulatory
affairs, and medical writing. Clinsys has expertise in a wide range of highly specialized
therapeutic areas, including oncology, cardiovascular, central nervous system, dermatology,
respiratory and allergy/immunology. The company has operations in Bedminster, New
Jersey; Raleigh, North Carolina; Ottawa, Ontario Canada; Düsseldorf, Germany; and Noida
and Bangalore, India.

Kendle India

Kendle International Inc. is a leading global clinical research organization providing the full
range of early- to late-stage clinical development services for the world's biopharmaceutical
industry. Kendle focuses is on innovative solutions that reduce cycle times for the customers
and accelerate the delivery of life-enhancing products to market for the benefit of patients
worldwide. As one of the world‘s largest global providers of Phase I-IV services, it offers
experience spanning more than 100 countries, along with industry-leading patient access and
retention capabilities and broad therapeutic expertise.

Other companies worth mentioning are.

Ace Biomed Private Limited


Actimus Biosciences Private Limited
Bharat Biotech International Limited
BioArc Research Solutions
Bioserve Clinical Research Private Limited
Cadila Pharmaceuticals Limited
Chembiotek Research International
Lupin Limited
Johnson and Johnson
Manipal Acunova
Lambda Therapeutic Research Limited
Novartis and Novo Nordisk India Private Ltd.

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Future of clinical research
India is clearly on course to become a major centre for clinical trials, and is routinely
considered by international sponsors for their global trials. The involvement of regulatory
agencies, such as the FDA, should be seen as a beneficial step to ensure that the clinical trials
environment evolves in an appropriate fashion and that standards used to protect patients in
other markets are also applied in India. Although companies face continuing pressure to
reduce clinical development timelines and costs, it is important that these factors do not
encourage staff to let standards slip in particular markets. It is in the pharmaceutical
industry‘s interest to fully engage with Indian patients in their work. Patient participation is
essential if future drugs are to be developed successfully in India. If the public have
confidence in the industry, then rapid patient recruitment will be enhanced.

Ensuring ethical evolution - With so much attention focused on the financial aspects of the
clinical trials market in India, it is important that issues such as ethics do not take second
place. There have been occasional allegations that poor and illiterate patients in India are
being used, often unknowingly, by some CROs in India as ―human guinea pigs‖ to test new
drugs. This, of course, is unacceptable and the industry must send a clear message to its staff
about the high standards it expects for the conduct of clinical trials. All those involved in
drug development must ensure that they adhere to international and local regulations in order
to protect patients. Sponsors must verify, and not just assume, that investigators completely
understand and respect ICH–GCP, the consent process and the need for documentation of the
consent process, and the ethics process. There should also be a formal training of clinical
trials staff so that the required standards can be upheld.

CONTRACT MANUFACTURING
“Businesses today thrive by focusing on what they do best and leaving the rest to others.”
Contract manufacturing seems to fit neatly into this practice. In addition to allowing
companies to focus on core competencies, contract manufacturers offer numerous other
advantages over in-house manufacturing, including lower costs, flexibility, access to external
expertise and reduced capital. In most cases, the manufacturer will also handle the ordering
and shipment processes for the client. As a result, the client does not have to maintain
manufacturing facilities, purchase raw materials, or hire labour in order to produce the
finished goods. In manufacturing, much of the cost competitiveness comes from the
manufacturing process yield. This yield can be increased through an accurate control and
handling of the manufacturing equipment, careful selection of materials and their proper
handling on the product line. The general concept of contract manufacturing is not limited to
the production of goods. Services such as telecommunications, Internet access, and cellular
services can also be supplied by a central vendor and private branded for other customers who
wish to sell those services. Doing so allows the customer to establish a buy rate from the
vendor, and then resell the services at a profit to their own client base.

Contract manufacturing is a process that established a working agreement


between two companies. As part of the agreement, one company will custom
produce parts or other materials on behalf of their client.
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In order to secure contract manufacturing jobs, the contract manufacturer usually initiates
discussions with the potential client. The task is to convince the prospective customer that the
manufacturer can use their facilities to produce quality goods that will meet or exceed the
expectations of the customer. At the same time, the manufacturer will demonstrate how the
overall unit cost of production to the customer will be less than any current production
strategies in use, thus increasing the amount of profit that will be earned from each unit sold.

The success of contract manufacturing depends on the mutual understanding between the
contract manufacturer and the customers. The former must know how to service the latter,
and must make clear his requirements (to the customer) in advance. The relationship depends
on mutual trust, and hence the communication between the two parties must remain open.
This will help both the sides to understand the requirements of maintaining the partnership.

History/Trend
Contract manufacturing became popular in many industries during the 1990s as a way to
counter rising costs and to reinvestment. The pharmaceutical industry has been slow to adopt
this practice because of its absolute need for secrecy.

With the onset of global economic recession, several countries in the developed world began
scouting for ways to minimize expenditure on drugs. Resultantly, pharmaceutical companies
were compelled to seek ways of minimizing cost of drugs, which in turn forced them to
evaluate opportunities for manufacturing outsourcing. Despite tough times faced by
companies in the pharmaceutical contract manufacturing industry during the recession,
overall market maintained a positive growth posting only a moderate slowdown in growth.
However, a drop in venture capital funding due to the recession has compelled many
pharmaceutical and biotechnology companies to cut down on spending, affecting the fortunes
of contract manufacturers worldwide. As a result, several projects were kept on hold and new
project starts were delayed, cascading the impact of the pharmaceutical industry to the
outsourcing industry as well.

Global pharma industry has been witnessing drastic changes such as increasing competition
in generic markets, declining research and development (R&D) productivity, shrinking
average patent life, and mounting governmental pressure to reduce drug prices. Further, the
drug development process is known to extend over a period ranging from 8 to 15 years, and
the cost of bringing out a single new molecule into the market is more than US$800 million.
With limited new blockbuster drugs, the decisive factors for growth and sustainability are
faster new drug development and cost containment. When the drug gets regulatory approval,
Pharma companies will require large quantities of product supplies for marketing and
distribution. Given the considerable timelines of drug development, it is not only difficult to
project a company's manufacturing needs but also challenging to procure extensive capital
requirements. As a result, Pharmaceutical Contract Manufacturing (PCM) outsourcing
emerged to bail out Pharma companies from these manufacturing uncertainties. Initially, it
gained popularity in the US and Western Europe. Over the years, PCM outsourcing shifted its
base to low-cost nations. Today, manufacturing capacity constraints are only one of the
reasons for outsourcing. Pharmaceutical manufacturing entails sophisticated technology
(cGMP synthesis and scale up, impurity profiling, lyophilization) and strict regulatory
compliance (good manufacturing practices - GMP). Outsourcing such activities to Contract

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Manufacturing Organizations (CMOs) enables a Pharma company to expedite its R&D, and
thus realize the potential revenues. Moreover, CMOs are increasingly offering a wide range
of value-added services, which make PCMO an indispensable opportunity to Pharma
companies.

Winning Factors in Contract Manufacturing


Product Quality: Perhaps the most important thing in contract manufacturing is to produce
high-quality products.
Delivery Schedule: As All Contract manufacturer demand that their products be delivered
within contractual time frames. Maintaining a Consistent and strict delivery schedule
involves close planning of the entire production.
Cost Competitiveness: By assisting pharmaceutical companies with approval procedures, by
evaluating the safety, efficacy and quality of new medicines prior to authorization and by
constantly monitoring them once they are on the market.
CM/Customers Relationship: In CM, mutual trust plays a crucial role, Hence Customer
relations is important
Managing the Manufacturing Shop Floor: In manufacturing, obtaining a better yield
through controlling the process, process optimization, understanding and implementing new
technologies, and providing training and motivation to the production floor personnel is
important to deliver high end results.

Win- Win situation to a contract manufacturing arrangement

For the manufacturer

There is the guarantee of steady work. Having contracts in place that commit to certain levels
of production for one, two and even five year periods makes it much easier to forecast the
future financial stability of the company

For the client

There is no need to purchase or rent production facilities, buy equipment, purchase raw
materials, or hire and train employees to produce the goods. There are also no headaches
from dealing with employees who fail to report to work, equipment that breaks down, or any
of the other minor details that any manufacturing company must face daily. All the client has
to do is generate sales, forward orders to the manufacturer, and keep accurate records of all
income and expenses associated with the business venture.

Global Scenario
Global Pharmaceutical Contract Manufacturing Market to Reach US$40.7 Billion by 2015,
the pharmaceutical contract manufacturing market is expected to grow at a CAGR of around
12% during 2010-2012.

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The US represents the largest regional market for Pharmaceutical Contract Manufacturing
worldwide. Europe trails behind the US. However, future growth in the market is expected to
emanate from developing regions, such as Asia-Pacific. Japanese market for Pharmaceutical
Contract Manufacturing alone is projected to register a compounded annual growth rate of
12.8% in 1 year.

Countries like India, Brazil, Ukraine, Mexico, China and Singapore have been emerging as
the key destination for contract manufacturing. Several factors like low cost of manufacturing
and highly developed infrastructure have boosted growth in the contract manufacturing
industry. It has been observed that pharmaceutical companies are increasingly adopting the
concept of ‘virtual pharma’, wherein they retain the marketing rights while outsourcing all
manufacturing activities and related processes. This allows companies to deliver goods at a
faster rate than an internal plant would allow.

Global Manufacturing Outsourcing pie

The global market for pharmaceutical contract manufacturing witnessed robust growth in
recent years, and the future continues to hold tremendous prospects for the industry.

Some Global Players


Nycomed Abbott, US B. Braun OEM, Germany

Wockhardt, UK Laboratoria Smeets, Belgium DPT Laboratories, US

IDT Biologika GmbH, Symyx, US Vetter Pharma International,


Germany Germany

BIOTECHNOLOGY INDUSTRY REPORT Page 85


Indian Scenario
With an increase in the number of off-patent drugs available, the competition, both domestic
and MNCs, are tapping custom manufacturing outsourcing in a big way. India is the fastest
growing custom manufacturing outsourcing (CMO) destination with a growth rate of 43
percent, which is thrice the global market rate. India, currently the third largest active
pharmaceutical ingredient (API) player after China and Italy, is expected to be the second
largest after China by 2010. API exports from India were to the tune of $3.75 billion and are
expected to reach $12.75 billion by 2012.

Contract manufacturing market size

The Indian contract manufacturing segment is expected to reach up to $1 billion in 2011.

Factors that have led to the establishment of several CMOs in India and Reasons for high
growth in this sector:

This is driven by its ability to create a differentiating cost value proposition powered by its
lower manufacturing costs, as the cost of secondary manufacturing in India is around 13%-
15% of the cost in the US, the UK and Germany
 Skilled manpower- India has more than four times the total drug manufacturing staff
than the US and more than 12 times that in the UK
 Strong technical capabilities- The existence of more than 80 US FDA approved
manufacturing facilities makes India the only country outside the US to have the
highest FDA-certified manufacturing facilities.
 Reliability of suppliers
 Improvements in IP policy are in line with world standards, and are factors that have
led to the establishment of several CMOs in India.

Indian Companies
Ranbaxy Dr Reddy's Divi's Laboratories Zydus Cadila
Laboratories

Cipla Alkem Dishman Alembic

Piramal Lupin Shasun Chemicals Torrent Pharma


Healthcare

Sun Pharma Aristo Jubilant Organosys IndocoRemedies

BIOTECHNOLOGY INDUSTRY REPORT Page 86


Contract Manufacturing in India – A backgrounder

API costs account for around 30 per cent of the total cost of a generic drug. This does
not impact patented products as much as cost competitive generic medications. The price of a
generic formulation is highly dependent upon the cost of APIs and companies attempt to
determine firms, which can provide APIs with stable costs. This has resulted in a growing
demand for contract manufacturers who produce pre-determined products at prices fixed in
advance.

The contract manufacturing market comprises of bulk drugs as well as formulations.


However, the bulk drug contract manufacturing contributes to 77 per cent of the total
contract manufacturing market. India has emerged as one of the prime destinations for
contract manufacturing due to its low cost and high efficient manufacturing processes

India has a cost advantage unrivalled by many countries, while offering state-of-the-art
manufacturing facilities.

The US Senate has approved the Healthcare Bill, which entails expanding the insurance
coverage to citizens either employed with smaller companies or unemployed. It is estimated
that around 3.2Cr US citizens would now receive additional healthcare access. This
development augurs well for Indian CMO industry

India Contract Manufacturing Pie

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Indian CMO – Strengths
Cost advantage: Indian companies are able to reduce the upfront capital cost of setting up a
project by 25-50 percent due to access to locally fabricated equipment and high quality local
technology/engineering skills. This benefit can be passed on to customers. Labor cost in India
is typically in the range of 10-15 percent of similar costs in the US.
Resource: India has the world's second biggest pool of English speakers and a strong system
of higher education 115,000 scientists with Masters degrees and 12,000 with PhDs every year
Regulatory & FDA: India has recorded 1,671 DMF filings, China shows a tally of 520, the
second largest number of DMF filings after India
Market Economics: The industry received investments worth Rs 21.4 bn in the form of FDI
between April 2007 and April 2009. Out of 36 countries that contributed to FDI in India, 5
countries, led by Mauritius (56.4%), Singapore (11.2%), USA (5.8%), UAE (4.7%) and
Canada (4.0%), accounted for over 82% of FDI in drugs and pharmaceuticals. According to
the Ministry of Commerce and Industry, domestic investment in the industry is estimated at
Rs 31.34 bn.

Indian CMO – Weakness


Quality practices & compliance

Recently major bulk drug companies of India have come under FDA scanner Examples:
Ranbaxy's Paonta Sahib & Manesar Mfg unit were under the FDA scan & 30 drugs banned in
US. Sun Pharma's Carcao Mfg. unit (Detroit) - was the victim of FDA rage. Cipla has been
questioned for deviation from US FDA Mfg. process

Logistics
Logistics and distribution has been Outsourcing companies‘ most perceived risk area. The
market size of Indian pharmaceutical logistics has been growing at an average annual growth
rate of four percent Latent information asymmetry; loss of logistics innovative capacity;
hidden costs; dependence on the third party logistics (3PL) providers; loss of control over the
3PL providers.

Recent Contract Manufacturing News


Global consolidation hits Indian contract drug manufacturing companies

Mergers & acquisitions in the global pharmaceutical industry that have led to reduction in
outsourced research work have hit Indian contract drug manufacturing and research services
or CRAMS companies. The impact is being felt by both large firms such as Jubilant Life
Sciences as also mid-sized firms such as Dishman Pharmaceuticals and Shasun
Pharmaceuticals. Analysts say global consolidation poses a challenge for Indian CRAMS
firm‘s revenues for the future.

BIOTECHNOLOGY INDUSTRY REPORT Page 88


The impact is visible in the financial performance of CRAMS firms:

Ahmedabad-based Dishman Pharmaceuticals & Chemicals faced a loss of Rs. 33 crore.


Another large CRAMS company Shasun Pharmaceuticals that also has bulk drug business
saw consolidated loss increase almost fivefold to 9.7 crore for the third quarter.
The country's largest CRAMs firm Jubilant Life Sciences saw its revenues from its research
services drop almost by a third shrinking its profit more than half to 44 crore for the third
quarter.

Future of Indian Contract Manufacturing


Indian CMO – Opportunities
Early Mover Advantage

Estimated USD 103 bn worth of global generic drugs are at the risk of losing their patents by
2012 India is significantly ahead in chemistry services such as analogue preparation,
analytical chemistry and structural drug design, which will provide the country with ample
avenues in the field of contract manufacturing approved facilities and 200 cGMP
manufacturing facilities

TRIPS agreement
The introduction of the new patent regime in India from January 2005 has boosted the
confidence of multinational companies looking to outsource the manufacturing of branded
drugs with the protection of intellectual property rights (IPRs). Amendment to Schedule Y to
allow parallel phase clinical trails

Government Subsidy
15 per cent capital subsidy for manufacturing facility investment and equipment projects.
SEZ – Pharmaceutical exclusive setups : Vizag and Himachal Pradesh

Domestic Market
The growing domestic market with TRIPS agreement in place presents opportunity for direct
investments of Pharma MNCs in India

Indian CMO – Threats


China and India together account for 7% of world pharmaceutical industry in value terms
with revenues of US$28 billion.FDI in pharmaceutical sector in China is more than 20 times
than in Indian sector 18 of world top 20 companies have setup their manufacturing and R&D
facilities in China China competing as bulk drug-sourcing base for MNC‘s and global
generic majors, by developing patent non-infringing processes for drugs on which the patent
is set to expire

BIOTECHNOLOGY INDUSTRY REPORT Page 89


Contract Manufacturing: Leading Players, Global Moves
Adding capacities and capabilities
Partnerships: For example: Ranbaxy – Eli Lilly, Lupin –Cynamid, Cadila –Byk Gulden,
Aurobindo – Pfizer, Dr. Reddy‘s – GSK Plc, Strides Arcolabs – Pfizer, Claris Lifescience –
Pfizer
Mergers and acquisitions: For example: Dr Reddy's Laboratories (DRL) acquired
betapharm from Germany for €480 million.

CONTRACT RESEARCH ORGANIZATIONS


A contract research organization (CRO) is a service organization that provides support to
the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical
research services (for both drugs and medical devices). CROs range from large, international
full service organizations to small, niche specialty groups and can offer their clients the
experience of moving a new drug or device from its conception to FDA marketing approval
without the drug sponsor having to maintain a staff for these services. In the Code of Federal
Regulations (CFR), the U.S. Food and Drug Administration regulations state that a CRO is "a
person [i.e., a legal person, which may be a corporation] that assumes, as an independent
contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a
protocol, selection or monitoring of investigations, evaluation of reports, and preparation of
materials to be submitted to the Food and Drug Administration."

Global Market Scenario


Despite cutbacks caused by a drop in early-stage research, a new report finds that the global
CRO market is poised to grow 14 percent per year over the next three years. That would
make contract research a $35 billion industry by 2013. The pharmaceutical and biotech
industries are facing cost containment and regulatory pressures, which drive R&D
outsourcing across the globe. Additionally, drug makers also have to jump over higher
regulatory hurdles, which have increased the complexity of clinical research. This, the
Business Insight report claims, will lead to the CRO industry's growth as drug companies
choose to outsource expensive and difficult research projects. Of the 1,100-plus CRO
companies the top 10 players only accounted for 56.1 percent of the global market (Quintiles
is the largest, with a market share of almost 17 percent). That means many smaller and mid-
sized contractors could be buyout or merger bait.

BIOTECHNOLOGY INDUSTRY REPORT Page 90


Strategies used by CROs to increase the market share

Top Companies in Global Market


Rank Company Revenue in 2009-10
2009

1 Quintiles $ 2.5 bn

2 Covance $ 1.8 bn

3 Pharmaceutical Product Development (PPD) $ 1.4 bn

4 Charles River Laboratories (CRL) $ 1.2 bn

5 Parexel $ 930 mn

6 ICON $ 887 mn

7 Kendle $ 590 mn

8 Pharmanet $ 470 mn

9 PRA International $ 410 mn

10 Aptuit $ 370 mn

Indian Market Scenario


Contract Research activities for global Clinical Research Industry is becoming one of the
major contributors in booming Indian economy. The Top 10 CROs make up 60 percent of the
total segment revenue of Rs 2,639 crore. The segment is growing on account of the growing
requirements of the multinational companies that are looking at India as an outsourcing
destination with high-skill, low cost advantage. Besides, due to business model evolutions
driven by market forces, even the domestic companies are outsourcing various portions of the
drug discovery chain. With India offering 10-year tax concessions on revenue to local

BIOTECHNOLOGY INDUSTRY REPORT Page 91


companies making Research & Development (R&D) investments, a substantial increase in
R&D activities of both multinational and domestic biopharmaceutical companies is
inevitable. Clinical Research spending in India will increase by more than 30% annually
through 2010. Following are the factors which determine India to become a preferred
destination for contract research activities:

• Cost effectiveness (economical manpower, shorter timelines etc.).

• Large and diverse patient pool.

• World class medical infrastructures.

• Familiarity with western medical facilities.

• Succeeding with latest trends.

• Technical Support.

• Data Credibility.

• English speaking qualified professionals.

• Central lab facilities (Internationally, Nationally accredited).

• ICH/GCP guidelines implementation.

The cost of trials in India may be just 20-60 percent of the cost in western countries. At
present, about 20-30 percent of the clinical development activity is outsourced to developing
countries like India. Indian clinical trials market is expected to grow at a CAGR of nearly
36% between 2006 and 2011 to register revenues worth US$ 546 Million in future. India by
2011 will be conducting more than 15% of the total global clinical trials.

BIOTECHNOLOGY INDUSTRY REPORT Page 92


Top Companies in Indian Market
Rank Company 2009-10
2010 (Revenue $
Million)

1 Quintiles India 83.3

2 Syngene International 56

3 Jubilant Organosys 55.4

4 Siro Clinpharm 33.3

5 Lambda Therapeutic 32.2

Research

6 Veeda Clinpharm 24.4

7 Ecron Acunova 21.5

8 Vimta Labs 19.6

9 Anthem Biosciences 11.7

10 Max Neeman 8.8


International

Quintiles India
Quintiles helps pharmaceutical, biotechnology and medical device companies develop and
market innovative therapies. It is the largest pharmaceutical contract research organization
(CRO) in the world. As the global pioneer in pharmaceutical services, Quintiles helps deliver
new drugs and cures for the world‘s most challenging diseases. For more than 25 years,
Quintiles has built its work on scientific rigor, therapeutic expertise and unparalleled service.
With offices in more than 50 countries, Quintiles is positioned to accelerate new therapies to
market — ensuring a higher level of healthcare for the people all over the world. Quintiles
has helped develop or commercialize all of the top 30 best-selling drugs. Quintiles is the only
fully integrated bio and pharmaceutical services provider offering clinical, commercial,
consulting and capital solutions. It has 22,000 employees in 60 countries that have helped to
develop or commercialize all of the top 30 best-selling drugs.

BIOTECHNOLOGY INDUSTRY REPORT Page 93


Syngene International
Established in 1994, in Bangaluru Syngene was India‘s first Contract Research Organization
(CRO). Over the past 16 years, Syngene has successfully partnered with the leading players
in global pharmaceutical, biotechnology, chemical and agrochemical industries across a wide
range of discovery and development programs. Syngene is an internationally reputed
contract research and manufacturing organisation with multidisciplinary skills in chemistry
and biology services. From early stage discovery and process development through to cGMP
manufacturing, Syngene provides customised services to pharmaceutical and biotechnology
majors, on a strong platform of confidentiality and intellectual property protection.

Siro Clinpharm
SIRO Clinpharm is a leading full service Clinical Research Organization that specializes in
providing solutions to the twin challenges of speed and cost in clinical drug development.
SIRO Clinpharm is among one of the leading global Clinical Research Organizations
(CROs), offering full scope services, conducting clinical trials in the pharmaceutical,
biotechnology and medical devices sectors in compliance with international standards. The
company has offices in India, USA, Israel and in Europe at Germany, Romania, Estonia,
Greece, Czech Republic and Spain.

Recent Happenings
Due to the tremendous growth shown by this sector, many new global companies have been
born. Also recently many mergers and acquisitions have taken place. Some of them are as
follows:

SIRO Clinpharm having presence in India, Western & Central Eastern Europe, and
US has now entered into an alliance with DreamCIS Inc., a leading CRO based out of
Seoul in South Korea. The company has also signed an agreement with Virginia
Contract Research Organization (VCRO), a Taiwan-based CRO to offer a range of
services to Taiwan companies. And, it is not just Asia Pacific market that the
company is looking at. SIRO is expanding operations in the developed markets like
USA and Europe as well. It has entered an alliance with Advanced Clinical Trial
Solutions, Flemington, NJ, USA

Syngene International, a subsidiary of Biocon Group, has partnered with Sapient


Discovery, a US-based biotechnology company. Both the companies intend to provide
a highly integrated platform for structure-based drug discovery. It also signed a pact
with another US company, Endo Pharma, to jointly discover and develop novel
biological drug molecules to fight cancer.

BIOTECHNOLOGY INDUSTRY REPORT Page 94


Bangalore-based Ecron Acunova has tied-up with a Japanese CRO and expects this
alliance to trigger a trend and set off 40-50 clinical trials between India and Japan in
the next two-to-three years. Japan is the second biggest pharma market after the US.
This apart, the Indo-German clinical research major with its established presence in
India and Europe is scouting for more market share in clinical research in these
countries and other parts of the globe.

Veeda Clinical Research, which has completed five years of existence in January
2010, has opened its office in South East Asia by signing a collaborative agreement
with the Malaysian Ministry Health to open a Phase I and Early Clinical Development
Unit in the Ampang Hospital in Kuala Lumpur.

Future of CROs
Firstly, it is unlikely that the drug development industry and process will change in any
radical fashion within the next three to five years. CROs must be mindful of these technology
advances and be prepared to mine the benefits of proven approaches. And this must be done
without either destroying the CRO‘s current infrastructure or mortgaging its future by
investing in any and all related technologies. One approach to ensure that clients have access
to the latest discovery and development technologies is to weave together a number of world-
class providers of different technologies under one service offering. Secondly, CROs must
get the ‗service‘ aspect of their business right. They have proven that they can deliver a
quality product, now they must convince the client (through actions, not words) that they can
do it consistently. Consistency in the CRO industry service starts with the staff. This means
that they must focus on developing an environment that allows staff to develop personally
and professionally, reducing the high turnover that has plagued particularly the clinical
research side of the business. Clients will reward such consistency with increased loyalty and,
ultimately, a willingness to develop closer, deeper and more strategic relationships.

Lastly, once they address the ‗service‘ issue mentioned above, CROs need to find ways to
develop and solidify more strategic (ie, deep and long-lasting) relationships with sponsors
(notably Pharma). In order to accomplish this they will have to engage senior executives
within Pharma and Biotech. These are the people who have the appropriate holistic view of
the R&D process within their respective companies and understand the value/benefits that a
more strategic, broad-based approach to outsourcing can bring – particularly to a company
that is vertically integrated. If sponsors feel comfortable that their chosen strategic CRO
partner is capable of delivering on its promise of performance – routinely and consistently –
they will invest the time required to define, negotiate and develop a close strategic
relationship.

Having made significant strides in the areas of quality and scientific expertise, CROs have
legitimately established themselves as a) alternatives to Pharma‘s internal resources, and b)
expert drug development resources for Biotech that have (rightfully so) little internal

BIOTECHNOLOGY INDUSTRY REPORT Page 95


infrastructure. Pressure on the Pharma and Biotech industries to control R&D costs while
improving the yield of new, approvable drugs points to an even greater reliance on
outsourcing. Overall, industry growth rates should remain strong. However, those CROs that
embrace their role as ‗service providers‘ and take concrete steps to improve the consistency
of the delivery of their service will be in the best position to forge stronger and more strategic
ties with their sponsors – and capture a greater share of the industry‘s growth. Success
moving forward will not be measured by how many services a CRO can deliver, but by how
well it delivers the services it offers and by how well these services can be integrated across
the continuum of drug discovery and development needs of its clients.

CROs provide services that form the pharmaceutical R&D value chain, including drug
discovery, product development and formulation, pre-clinical and clinical trial management
spanning phase I–IV. The share of CROs in the industry‘s research operations is 27%. Indian
CROs provide substantial global capacity to drug developers with full-service and specialised
CROs taking the biggest pieces of the pie. The present CRO market size is estimated at $10
billion and growing, with revenue increasing at an annual rate of 14-16%. An extensive
evaluation of the current scenario and incorporating the necessary improvisation has become
the need of the hour for making the Indian CRO sector emerge as a forerunner amongst the
highly competitive global CRO market. India has to cross the critical path with proactive risk
management approach in this world of innovations and new technology. India with its
strength will be able to outweigh inherent weakness. The opportunities are appealing and
attractive and the threats are manageable. Thus, Indian industry can carve out a niche for
itself in the global market place. Then the time is not far when India will be CRO
superpower.

BIOTECHNOLOGY INDUSTRY REPORT Page 96


CONSULTANCY
Services play a crucial role in our economy by contributing around 50% of the GDP. Among
services, consultancy profession assumes significance as a catalyst of change in the ever
expanding industrial and infrastructure scenario. Consultants help in optimizing use of
resources to enhance efficiency and overall returns from a project. Consulting is a diversified
industry that encompasses diverse trades, disciplines, services and straddles almost all the
sectors of economic activity. Consultants provide key inputs from conceptualization,
planning to implementation stages. The growth of this industry is closely linked to economic
performance and development Indian consulting industry has been in existence for some time
and has matured over a period. In last few decades, the development of consulting profession
in India has been quite significant. A large number of consultants offer a multiplicity of
consulting services in various sectors such as agriculture and rural development,
construction, manufacturing, social development, tourism, transportation, urban
development, and water supply & sanitation. Indian consultants are gaining recognition
globally for their technical prowess and capabilities.

The number of consulting firms has increased manifolds in a short span of time. It has
resulted in large number of Consulting Organization, Consultants / Domain Experts available
in India offering consulting services in almost all sectors of economic growth. With a view to
identify the key capabilities and expertise of the Indian Consulting industry and also make it
available to prospective clients both within and outside India, it is felt that a comprehensive
database of Consultancy organizations and Consultants/ Domain experts in India need to be
developed. Department of Scientific and Industrial Research (DSIR), Ministry of Science and
Technology, Govt. of India has taken initiative to prepare Industry Specific Sectoral National
Online Database of Consultants and Consultancy organizations
and has commissioned this assignment to Consultancy Development Centre (CDC), an
autonomous institution of DSIR.

Global Scenario
Global Consulting Industry Revenues (including HR, IT, strategy, operations management &
business advisory services) reached US$ 345 billion in 2010

Global Consultancies
McKinsey & Company

McKinsey is a privately held leading management consulting firm with over 80 offices
around the globe. McKinsey specializes in delivering thoughtful solutions to challenging
strategic and operational problems. The company has approximately 15,600 employees and
booked revenue in 2009 of US $6.60 Billion. McKinsey groups its practices into seven main
areas: business technology, corporate finance, marketing and sales, operations, organization,
risk, and strategy. McKinsey serves clients in numerous industry sectors, from automotive to
high tech to telecommunications

BIOTECHNOLOGY INDUSTRY REPORT Page 97


Bain & Company
Bain and Company is a global privately held management consulting company. Bain focuses
on consulting aimed at increasing efficiency, creation of value and determination of strategy.
The firm gets involved in a wide variety of corporate issues including marketing,
performance and information technology. Bain is heavily involved in mergers and
acquisitions, private equity investments and transformation plans. Bain has over 4,000
employees. Bain is also affiliated with Bain Capital, an elite private equity firm, with a record
for outstanding large investments.

Booz Allen Hamilton (not present in India)


Founded in 1914, Booz & Company is the oldest management consulting firm still in
business and the first to use the term ―management consultant". Booz is a top-tier provider of
consulting services in both the public and private sectors around the world. Booz has 3200
employees. The company has 57 offices in 33 countries. In 2008, Booz & Co separated its
operations from its U.S. Government consulting business, which retains the name Booz Allen
Hamilton.

Boston Consulting Group


The Boston Consulting Group (BCG) is a privately held management consulting company
founded in 1968 by Bruce Henderson. The company looks for insightful innovation solutions
to corporate problems. They focus on driving tangible results while making their clients more
capable. BCG has approximately 6,000 employees. BCG has more than 65 offices around the
globe.

Ernst & Young


Ernst & Young is a global leader in assurance, tax, transaction and advisory services.
Worldwide, the 141,000 people are united by the company‘s shared values and an
unwavering commitment to quality.

Deloitte
Deloitte Consulting is the consulting arm of Deloitte & Touche. Deloitte Consulting has 15,000
professionals in 33 countries and serves more than one-third of the companies in the Global Fortune®
500. Deloitte provides strategic and operational management consulting, tax advisory and financial
advisory services to many of the world's largest companies. Managing consulting practice areas
include human capital, technology/systems integration, and strategy and operations management. The
consulting practice focuses on nine industry groups: aviation and transport services; consumer
business; energy and resources; financial services; life sciences and health care; manufacturing; the
public sector; real estate; and technology, media, and communications.

KPMG
KPMG operates as an international network of member firms offering audit, tax and advisory
services. The company works closely with its clients, helping them to mitigate risks and grasp
opportunities.

BIOTECHNOLOGY INDUSTRY REPORT Page 98


Accenture
Accenture is a global management consulting, technology services and outsourcing company.
Combining unparalleled experience, comprehensive capabilities across all industries and
business functions, and extensive research on the world's most successful companies,
Accenture collaborates with clients to help them become high-performance businesses and
governments.

PwC
PwC is one of the world‘s largest providers of assurance, tax, and business consulting
services. They believe that the best outcomes are achieved through close collaboration with
the clients and the many stakeholder communities. 161,000 PwC people in 154 countries
work hard to build strong relationships with others and understand the issues and aspirations
that drive them.

IBM Global Services


IBM integrates hardware, software, business consulting and IT services into business
solutions to meet the goals. IBM also has strong alliances with partners to deliver business
solutions.

Asia Pacific Scenario


APAC- Asia Pacific consulting generated $33.5 billion as revenues in 2008 and is expected
to reach $ 39.2 billion by 2012. The consulting industry overall is growing at a CAGR of
4.1% since 2001. India contributed to 5.4% of the total revenues in Asia Pacific as compared
to Japan which contributes 67.2%. Corporate strategy, Outsourcing Services, Human
Resource Management and Operations Management have been some of the prominent
business divisions in the consulting market in the Asia Pacific Region.

Indian Scenario
India's Outsourcing & Consulting Industry Revenues contributed to US$ 47 billion in the
year 2009. The rising opportunities and growing consultancy spectrum as a result of high
demand, consulting industry in India is well poised to grow at CAGR of about 30% to carry
forward its size to over Rs. 22,000 crores as against current size of nearly Rs. 16,500 crores.
It also holds that the consultancy opportunities for domestic project managers would enhance
engagements and occupation, numbering over 3.5 lakhs in next three years in nearly 9500 to
11000 consultancy firms in the field of projects management including turned key projects,
engineering, designing, financing & auditing consultancy, besides consultancies in medical
services, travel & hospitality. Currently, approximately 7000 consultancy firms are in
operations in major cities like Delhi, Bangalore, Hyderabad, Chennai, Cochin, Ahmedabad,
Mumbai, Pune, Chandigarh and even Dehradun.

BIOTECHNOLOGY INDUSTRY REPORT Page 99


Distribution of consultancies in the Indian Metros

The future prospects for consultancies particularly in project consultancy on turned key basis
are emerging to be more exciting as India is one of the largest economies in the world with its
strategic location giving access to vast domestic and South Asian market. The presence of
skilled manpower and professional managers are available at competitive cost as India‘s
manufacturing sectors providing ample opportunities for assimilation of consultancy in
variety of sectors. Other than economies of scale, the other countries that are looking for
Indian consultancy firms to provide them innovative ways for projects execution in the field
textile and garments, energy, geology & mining, agriculture, rural development,
transportation and tourism. In case of Indonesia, Uganda and Ethiopia, the most sought after
consultancy areas from India oil & gas, education, infrastructure, IT enabled services,
mining, water management, telecommunications, construction & health, information
technology, agriculture & petrochemicals and transportation, besides power.

BIOTECHNOLOGY INDUSTRY REPORT Page 100


BIOSUPPLIERS
INDUSTRY OVERVIEW

2.1 Indian Scenario Of Biosupplier Industry


One of the main components that sustains the life sciences businesses globally are the
Biosuppliers that make components of everyday use at labs and manufacturing units. A
growing life science business, increased investment and pro active government have made
Biosuppliers take notice of the potential of Asian countries. This has, in turn, led to the
growth of a massive Biosupplier industry. This has also led to a huge windfall in terms of
investments in R&D and expansion. Top Biosupplier companies such as Pall Life Sciences,
Shimadzu, Millipore, Agilent Technologies, GE Healthcare, Thermofisher, Waters, BioTek
and Sartorius have already started business in the Asian region to meet the increasing
demands and they are investing huge amounts in building own facilities in the region.

The recession has affected Biosuppliers significantly. In FY 2009-10 they were hit hard with
the industry growth sliding to 7.5 percent, even though the overall scenario remains positive.
The overall supplier industry revenues stood at $ 865.11million as against $ 804.6 million in
2008-09. The downward trend of 2008-09, when the industry growth slipped to 16 percent
from earlier levels of 40 percent, continued in 2009-10 on account of number of MNCs
reporting flat or negative growth. However, the home-grown companies have done well-
posting healthy double digit growth. Waters India is the top biosupplier in country with a
growth of 21 percent. Top 20 bio supplier companies contributed 70 percent of the overall
supplier revenues of $ 865.11 million while the Top 20 Principals contributed about 60
percent of the revenues. Home-grown suppliers have seen stable year-on-year growth,.
Companies like Spinco Biotech, Imperial Life Sciences, and DSS Imagetech are worth a
mention. Backed by strong teams and a good strategy these have managed to grow in double
digits.

Biosupplier Industry registered 7.5% growth with a revenue of $ 865.11 million.Top 20


companies contributed 70% of this revenue. A number of MNCs reported flat or negative
growth. Fastest growing companies tally was led by small distributors. Most of the domestic
companies grew at healthy double digitsIndian

Bio Suppliers- The Challenges faced


Bio-suppliers provide the critical ingredients for Biotech research. Bio-Suppliers are under
constant pressure from their customers to offer better quality materials, at competitive pricing
and to provide for a more flexible ordering system. The challenges faced by this segment
include:

Ensure that customers make use of their products to the optimal extent, by packaging
experiment design and data analysis tool.

BIOTECHNOLOGY INDUSTRY REPORT Page 101


Offer flexible and customized order fulfilment to customers who have varied needs driven by
usage of disparate high throughout and combination of technologies

Continuous introduction of new products that meet the ever increasing high quality and low
price demands of customers while having to beat well entrenched & ―industry standard‖
competition.

2.2 Indian Biosupplier industry- Revenue and Growth Rate for 2002-10

BIOTECHNOLOGY INDUSTRY REPORT Page 102


From above two graphs we can see that though the industry is growing each year, the rate of
the growth has slowed down during last few years. The industry registered only 16 percent
growth in 2008-09, compared to last year's 30 percent growth. The Bio suppliers were hit
primarily as the Indian biotech sector deferred some of their infrastructure investments owing
to the recessionary trends. The rate of growth in Asia for most of the companies was also
slow compared to that in 2007-08 and the growth there was around 6 percent mark for most
companies considering the foreign currency movement.

Company % Share in Total


Revenue(2010)
19.72%
29.74% 70.15%

47.75%

Total Revenue= $ 865.11 million


Top 20 Companies Top 10 Companies
Top 5 Companies Top 3 Companies

BIOTECHNOLOGY INDUSTRY REPORT Page 103


►Top 3 companies make up 28 percent of the total Top 20 revenues of $ 606.66 million

►Top 10 companies contribute 68 percent of the Top 20 revenue

►8 of the fastest growing supplier companies were between $ 11.11 million- $ 17.77 million
in revenues

Region % Share in Total


Revenue(2010)

West North
25% 31%
South
44%

Total Revenue = $ 865.11 million


►Top 10 companies from the North contributed 26 percent to the overall revenues.
►Top 10 companies from the South contributed 35 percent to the overall revenues.
►Top 10 companies from the West contributed 21 percent to the overall revenues.

MAJOR GLOBAL AND INDIAN BIOSUPPLIERS


3.1 Top 20 Global Biosuppliers

The table given below shows the top 20 global Bio suppliers along with their
revenues from 2005 to 2010.
Rank Company 2005-06 2006-07 2007-08 2008-09 2009-10 %
2009 Change
($ ($ ($ ($ ($ 2009-
millions) millions) millions) millions) millions) 10

1 Waters India 40.8 47.33 58.6 74 58.2 -21.43

2 Agilent 30.8 43.1 61.5 - 56.6 -


Technologies

3 Thermo 38.2 54.6 70 41.1 46.6 13.03


Fisher

BIOTECHNOLOGY INDUSTRY REPORT Page 104


Scientific

4 BD 25.1 29.5 39.5 51.5 40 -22.41

5 Millipore 20.2 30.2 38.4 35.5 39.3 10.43


India

6 Invitrogen - - - - 33.3 -
Bioservices
India

7 Shimadzu 21.3 24.4 28.4 34.2 31.3 -8.44


Analytical
(India)

8 GE 10.8 13.5 17.7 26.6 26.6 0.00


Healthcare

9 Sigma - - - - 22.2 -
Aldrich India

10 Merck - - - - 21.5 -

3.2 Major Global Companies


WATERS US:

Waters Corporation, founded in 1958 by James L. Waters and headquartered in Milford,


Massachusetts, U.S.A., is the world's leading supplier of ultra performance liquid
chromatography, high performance liquid chromatography, mass spectrometry, thermal
analysis and rheology instrumentation and consumables. Around the world, Waters products
are used by pharmaceutical, biotechnology, industrial, university, and government research &
development, quality assurance, and environmental testing laboratories. For these customers,
they provide technology that gives scientists fundamental data on the composition of natural
products and synthetic chemical mixtures and the physical properties of materials. An
independent company since 1994, Waters and its subsidiaries employ 4,500+ persons around
the world each with an average of 10 years service with the company. The company is
Operating in 27 countries, including 11 manufacturing facilities, with products available in
more than 50 countries.Exports account for nearly two-thirds of Waters' sales while the
company's largest single market is the pharmaceutical industry. Waters is a member of the
Standard and Poors 500 Index.

Its main product areas are-

 Chromatography Consumables & Columns


 Analytical & Preparative Columns

BIOTECHNOLOGY INDUSTRY REPORT Page 105


 Sample Preparation Products
 Bio Separation Products and Columns
 SFC Columns
 Sample Vials & Plates
 GPC & GFC Columns and Standards

AGILENT TECHNOLOGIES

As the world's premier measurement company, Agilent offers the broadest range of
innovative measurement solutions in the industry. The company's three businesses --
Chemical Analysis, Life Sciences and Electronic Measurement -- provide customers with
products and services that make a real difference in the lives of people everywhere. Agilent is
committed to providing innovative measurement solutions that enable its customers and
partners to deliver the products and services that make a measurable difference in the lives of
people everywhere. The company has 18,500 employees and serves customers in more than
100 countries. Agilent had net revenues of $5.4 billion in fiscal year 2010.

Market Leadership

Agilent holds many product and market leadership positions, including being first worldwide
in overall test and measurement products, as well as in gas chromatographs and liquid
chromatography/mass spectrometry.

Within life sciences, their solutions are focused in the following markets:

Pharmaceutical Companies Contract Research Organizations

Biotechnology Companies Contract Marketing Organizations

Academic and Government Laboratories

Within chemical analysis, Agilent focuses on the following markets:

Energy & Fuels Forensics

Environmental Bioagriculture

Food Safety Homeland Security

Product areas

Gas Chromatography ICP-MS

Liquid Chromatography Magnetic resonance

Mass Spectrometry Reagents

BIOTECHNOLOGY INDUSTRY REPORT Page 106


Microarrays Capillary Electrophoresis

Sequencing Target Enrichment Lab Automation

Microfluidics Software and Informatics

Consumables and Services Vacuum Technology

Thermo Fischer Scientific


Thermo Fisher Scientific is the world leader in serving science. The company enables its
customers to make the world healthier, cleaner and safer by providing analytical instruments,
equipment, reagents and consumables, software and services for research, analysis, discovery
and diagnostics. With annual sales of more than $11 billion, Thermo Fisher Scientific has
approximately 37,000 employees and serves more than 350,000 customers in pharmaceutical
and biotech companies, hospitals and clinical diagnostic labs, universities, research
institutions and government agencies, as well as environmental, industrial quality and process
control settings.
The company delivers the industry‘s broadest selection of analytical instruments, equipment,
consumables and laboratory supplies. Its growing portfolio of products includes innovative
technologies for mass spectrometry, elemental analysis, molecular spectroscopy, sample
preparation, informatics, fine and high-purity chemistry production, cell culture, RNA
interference analysis and immunodiagnostic testing, as well as air and water quality
monitoring and process control.

Markets Served

Thermo Fisher Scientific offers a complete and integrated portfolio of solutions and services
for laboratory research and analysis, healthcare and clinical science and manufacturing and
the field.

A. Laboratory Research and Analysis

Thermo Fisher Scientific serves the pharmaceutical, biotechnology, academic, government


and other research and industrial laboratory markets. Its products and integrated solutions are
used by pharmaceutical companies for drug discovery and development, by biotechnology
companies and universities for life science research to discover new cures and preventions for
disease and in laboratories focused on elemental analysis of liquids and solids. This includes-
Analytical instrumentation

 Lab equipment

 Research consumables

 Fine and high-purity chemistry

BIOTECHNOLOGY INDUSTRY REPORT Page 107


 Propriety protein, nucleic acid, cell biology and cell-culture

 Software and Laboratory Information Management Systems

B. Healthcare and Clinical Science

Thermo Fisher Scientific healthcare solutions include a full range of supplies for hospitals,
clinical laboratories, reference laboratories and physician‘s offices. Its clinical diagnostic
products and services are used by healthcare facilities and independent laboratories to analyze
patient samples, such as blood. It includes-Clinical testing systems and supplies Diagnostic
products and services Clinical trial support services

C. Manufacturing and the Field

Thermo Fisher Scientific provides products, solutions and services for process control and
optimization and for environmental monitoring, safety and security. Offerings include a
complete range of fixed and portable instruments for detecting radiation, explosives and
chemicals and instrumentation used in manufacturing to ensure quality control through
precise monitoring, measurement and analysis. It includes-Process instruments
Environmental analysis instrumentation Security and detection devices.

Brands
Thermo Fisher Scientific is the world leader in serving science supporting customers through
two premier brands - Thermo Scientific and Fisher Scientific - along with a family of
specialty product brands.

Thermo Scientific

The Thermo Scientific brand encompasses a complete range of high-end analytical


instruments as well as laboratory equipment, software, services, consumables and reagents to
enable integrated laboratory workflow solutions.

Fisher Scientific

Fisher Scientific is our premier customer channel and services brand providing a complete
portfolio of laboratory equipment, chemicals, supplies and services used in healthcare,
scientific research, safety and education through the most convenient purchasing options
from a single purchase to a supply chain solution

Becton-Dickinson

BD is a leading global medical technology company that develops, manufactures and sells
medical devices, instrument systems and reagents. BD is focused on improving drug delivery,
enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing

BIOTECHNOLOGY INDUSTRY REPORT Page 108


research, discovery and production of new drugs and vaccines. Founded in 1897 and
headquartered in Franklin Lakes, New Jersey, BD employs approximately 29,000 associates
in more than 50 countries throughout the world. The Company serves healthcare institutions,
life science researchers, clinical laboratories, the pharmaceutical industry and the general
public.BD Worldwide fetched revenues around US $ 7.37 billion in 2010.

BD Worldwide segments:

A.BD MEDICAL:

This segment deals with the supply of Medical Surgical Systems, Anaesthesia Products,
Infusion Therapy Products, Injection Products, Sharps Disposal Products, and Diabetes Care
Pharmaceutical Systems like:

 Needles and syringes


 Intravenous catheters
 Safety-engineered and auto-disable devices
 Prefillable drug delivery systems
 Prefilled IV flush syringes
 Insulin syringes and pen needles
 Regional anesthesia needles and trays
 Sharps disposal containers

B.BD DIAGNOSTICS:

BD Diagnostics deals in Diagnostic Systems and Preanalytical Systems like:

 Integrated systems for specimen collection


 Safety-engineered blood collection products and systems
 Automated blood culturing systems
 Molecular testing systems for sexually transmitted diseases and HAIs
 Microorganism identification and drug susceptibility systems
 Liquid-based cytology systems for cervical cancer screening
 Rapid diagnostic assays
 Plated media

C.BD BIOSCIENCES:

The Biosciences Division deals with Cell Analysis and Discovery Lab ware products some of
which are:

 Fluorescence-activated cell sorters and analyzers


 Monoclonal antibodies and kits for cell analysis
 Reagent systems for life science research
 Cell imaging systems

BIOTECHNOLOGY INDUSTRY REPORT Page 109


 Laboratory products for tissue culture and fluid handling
 Cell culture media and supplements for biopharmaceutical manufacturing

The revenues generated by each segment were US $ 3.796 billion, US $ 2.319 billion and US
$ 1.257 billion respectively.

Millipore

As scientists and engineers pioneering new cures to mankind's most challenging health
issues, they relied more on Millipore as a trusted partner who for more than 50 years has
supported them with a continuum of cutting edge tools, technologies and application
solutions to ensure success in research, development and production. Merck Millipore is part
of the Merck Group, a company with 40,000 employees in 64 countries that was generating
total revenues of US $ 11.11 billion in 2009. Merck Millipore, a division of Merck Group,
offers solutions that enable scientists to conduct life science research easily, efficiently and
economically. With a range of more than 40,000 products, Merck Millipore is one of the top
three suppliers of tools to the life science industry. The division comprises three business
units: Bioscience, Lab Solutions and Process Solutions.

A.Biosciences:

The Bioscience business unit is focused on helping customers in the pharmaceutical and
biotechnology industries, as well as academia, understand complete biological systems and
identify new therapeutic targets. It provides an increasing number of tools and services to
support researchers seeking to understand complex biological systems. The products help to
advance life science research in a wide variety of areas ranging from neuroscience, infectious
disease, oncology, and metabolic disorders to stem cells, cell signalling, nuclear function, and
chromatin biology. Bioscience products and services simplify the work flow for researchers,
offering consolidated and validated solutions.

B. Lab Solutions:

The Lab Solutions business unit supplies products for research, analytical and clinical
laboratories in a wide variety of industries. The company is one of the leading suppliers of
laboratory chemicals, lab water equipment and consumables. For inorganic chemistry, they
offer reagents of high purity such as salts, acids, caustics, volumetric solutions, buffers,
reference materials for instrumental analysis and products for inorganic trace analysis. For
organic chemistry, they supply a full range of basic products for synthesis; including building
blocks, reagents and solvents most commonly used in organic synthesis from laboratory scale
to bulk production. As a leading supplier of chromatography products, Merck Millipore is
also advancing the development of analytical separation technologies. The product focus is
on analytical high performance liquid chromatography (HPLC) and innovations to the
monolithic Chromolith® HPLC columns for ultrafast separations.

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C. Process Solutions:

The Process Solutions business unit supplies products used by pharmaceutical and
biotechnology companies to develop and manufacture biopharmaceutical drugs safely and
efficiently. Millipore provides fully integrated solutions to biopharmaceutical customers and
an attractive range of development and regulatory services to biopharmaceutical
manufacturers.

Invitrogen Scientific

Invitrogen Corporation is a large, multinational biotechnology company headquartered in


Carlsbad, California. In November 2008, a merger between Applied Bio systems and
Invitrogen was finalized. The new company is called Life Technologies. Invitrogen
Corporation develops, manufactures, and markets more than 10,000 products for customers
involved in life sciences research and the commercial manufacture of genetically engineered
products. The company‘s research kits are used to simplify and improve gene cloning, gene
expression, and gene analysis. Invitrogen also is involved in cell structure activities, which
provides customers with the material to grow cells in the laboratory and to produce
pharmaceutical and other materials made by cultured cells.

Key products and technologies include

 Dynabeads magnetic separation technology,

 GIBCO cell culture media and reagents,

 SuperScript reverse transcriptase,

 Platinum Taq polymerase

 TOPO cloning and expression products

 Novex protein electrophoresis products

 Numerous fluorescent reagents such as Qdot nanocrystals and Alexa Fluor and SYBR
dyes.

Invitrogen currently offers more than 25,000 products and services to support research in
cellular analysis, genomics, proteomics, and drug discovery, and has sought to leverage their
extensive technology portfolio to address research problems in developing fields, including
biodefense and environmental diagnostics, bioinformatics, epigenetics, and stem cell
research.

BIOTECHNOLOGY INDUSTRY REPORT Page 111


The popular brands of Invitrogen are as follows:

1. Ambion: RNA sample preparation

2. Dynal: magnetic beads for separation

3. Gateway- for cloning and protein expression

4. Gibco: Cell culture media

5. Lipofectamine- transfection reagents

6. Molecular probes- fluorescent dyes and probes

7. Novex-protein separation and blotting

8. SuperScript- Cdna synthesis reagents

9. TaqMan- Real time PCR kit

10. TOPO- PCR cloning kits

3.3 Top 10 Indian Biosuppliers


Top 10 Indian Bio supplier companies and their revenues from 2005-2010 are given below.

Rank Company 2005-06 2006-07 2007-08 2008-09 2009-10 %


2009 Change
($ ($ ($ ($ ($
2009-10
millions millions millions millions millions
) ) ) )
)

1 Spinco Biotech 30.6 34.6 46.6 50 55.5 11.40

2 Imperial Life 5.3 8.6 19.5 22.6 24.8 9.67


Sciences

3 RFCL 3.7 4.8 7.5 20.4 20.6 1.11

4 Genetix Biotech 8.8 11.3 15.5 17.7 20 12.50


Asia

5 DSS Imagetech 9.1 12 15.1 17.3 19.5 12.05

6 Toshvin — — — 16.6 18.8 12.12


Analytical

BIOTECHNOLOGY INDUSTRY REPORT Page 112


7 Nishotech — — — — 15.5 —

8 Towa Optics — 8.8 10.2 12.4 13.7 11.43

9 Advanced — — 8.2 10 12.4 24.44


Microdevices

10 HiMedia 26.6 33.3 40 — 10 —


Laboratories*

The pie diagram above shows the percent share of top 10 Indian bio supplier companies in
total revenue generate in year 2009-10

BIOTECHNOLOGY INDUSTRY REPORT Page 113


Major Indian Companies:

SPINCO BIOTECH PVT.LTD

It is ranked No. 1 Bio-suppliers in India with a proven track record of 29 years in Analytical
& Life Science Instrumentation. The revenue of Spinco Biotech during the financial year
2009-10 was US $ 55.7 million, and the percentage change was 11.40. Spinco has been able
to cross many milestones like maximum number of HPLC in India, highest capacity
lyophiliser in India, largest field support team with more than 28 branches. Headquartered in
Chennai, and has more than 28 branches spanning north, south, east and west of India.

Some of the major product line includes:

 Chromatography-
 Mass Spectrometry
 Life Science
 Lab Products
 Chemistry and Consumables

IMPERIAL LIFESCIENCES PVT. LTD.

Imperial has grown by leaps and bounds since inception in 1992 and the growth has been
consistent and well defined through these years. The revenue of Imperial Life sciences Pvt.
Ltd. during the financial year 2009-10 was US $ 25.07 million, and the percentage change
was 9.67. Its key customers include companies in the biopharma, biotech, agriculture,
veterinary sciences segment along with universities, medical colleges, drug discovery labs,
clinical trial and contract research facilities and research institutes.

 Automated Liquid Handling


 Benchtop Instruments
 Microarray Scanner
 Reagents & Consumables
 Bioanalyzer
 Lab chip Systems

RANBAXY FINE CHEMICALS LIMITED

Ranbaxy Fine Chemicals Limited is owned by ICICI Venture Funds Management Company
Limited, and is managed by a highly dynamic group of professionals which accounts for
approx. US $ 533.3 million business group. The revenue of RFCL during the financial year
2009-10 was US $ 20.71 million and the percentage change was 1.11. RFCL is soon going to
launch new reagents - JSB Stain-I & JSB Stain-II. It is headquartered at Delhi, and has
branch offices in Hyderabad, Bangalore, Ahmadabad, Mohali, Mumbai, Ghaziabad, Indore,
Kolkata, Pune, and Chennai. Recently Avantor has completed acquisition of RFCL Limited.

BIOTECHNOLOGY INDUSTRY REPORT Page 114


Avantor and New Mountain Capital will provide RFCL with significant financial and
strategic resources to support their growth initiatives

It has four different SBUs as follows

 ‗Rankem‘ dealing in total scientific laboratory solutions;


 ‗Ventex‘ dealing with next generation veterinary solution for livestock, poultry and
pets;
 ‗Diagnova‘ dealing with in vitro diagnostics; and
 ‗Neosynth‘ which deals with custom synthesis

GENETIX BIOTECH ASIA

Genetix Asia is a retailer & Supplier of pharmaceuticals, health care, herbal, diagnostic
products, animal care products, finished pharmaceutical products, perfume, herb, skincare,
medical devices, bio pharmaceuticals, etc. The revenue of Genetix Biotech Asia during the
financial year 2009-10 was US $ 20 million, and the percentage change was 12.50. Genetix is
a world leader for supply of Kits, Reagents, Laboratory Plasticware and Filterware for use
within Molecular Biology, Genomics, Proteomics, Immunology and Cell Culture. It is
headquartered at Delhi, with branch offices at Chandigarh, Lucknow, Bhopal, Kolkata,
Mumbai, Pune, Hyderabad, Bangalore, Chennai.

The product range of Genetix Biotech Asia includes:

 Diagnostic
 Medical devices
 Laboratory products
 Molecular diagnostics
 Filtration Products
 Molecular Biology / Industrial Enzymes
 PCR Machine

DSS IMAGETECH

With the capital of $ 995,268 (Rs 4.5 crore) and 25 employees, the DSS IMAGETECH
engages into the manufacturing and sales of research reagents and kits. DSS Imagetech is
based on providing cutting edge technology solutions to Researchers and Clinicians in the
field of Life Sciences including Genetics, ART, Drug Discovery, Biotechnology etc. Products
and application areas include microscopy, image analysis software/systems, Genetic
workstation, ICSI workstation, DNA probes, Thermal Cyclers, Micro Array Readers etc. The
revenue of DSS Imagetech during the financial year 2009-10 was US $ 19.5 million, and the
percentage change was 12.05. Headquartered at New Delhi, with branch offices in Bangalore,
Chandigarh, Chennai, Hyderabad, Mumbai, Kolkata, Pune, Trivandaram,

BIOTECHNOLOGY INDUSTRY REPORT Page 115


The areas it caters to are:

 Microscopy
 Image analysis software / systems,
 Genetic workstation,
 ICSI workstation,
 DNA probes,
 Micro array readers,

TOSHVIN ANALYTICAL

It is the sixth largest company in biosuppliers and its revenue generation for year 2009-10
was US $ 18.9 million. Toshvin Analytical Pvt. Ltd. is one of the leading companies in India
in the field of analytical and laboratory instrumentation. Since 1948, Toshvin has been at the
forefront of bringing the latest, most sophisticated range of instruments to Indian companies
from leading manufacturers around the world. Its products range from analytical instrument,
water purification system, Chromatography Accessories to Consumables. It has a partnership
with Shimadzu Japan Company since from 1970. They offer the following range of product
like

 Laboratory Instruments
 Testing and Inspection
 Balances and Scales
 Life Science Lab Instruments
 Medical Systems and Equipment
 Industrial Equipment

NISHOTECH

Nishotech is well known in the Pharma, Food Processing and Biotech world for its Sterile
Process Piping Systems. With its vast experience in executing prestigious projects and a
highly skilled workforce, it uses latest techniques particularly in orbital welding technology
to integrate pipe work installation and end results are checked using Boroscopy with still /
video rendering. It also has partnership with Novasep process SAS. Novasep Process SAS
primarily concentrates on purification needs of pharmaceutical, food, cosmetic, agrochemical
and specialty chemical industries; using industrial processes. Novasep Process offers
solutions for producing pure products, from process development to optimization, from the
supply of laboratory purification equipment to the delivery of industrial turn-key purification
plants. Through synergies with Novasep Synthesis, Novasep Process technologies enable
straightforward and cost efficient global synthesis of new molecules, while helping to reduce
time to market. Novasep Process‘ core technologies are Chromatography, Crystallization, Ion
exchange, Membranes, Evaporation. DrM is a technology partner for Nishotech system for
their patented candle filtration design. There are over 1500 Filters in operation worldwide and
about 80 new systems are put in place every year; most of them in the chemical industry but
also in petrochemical, pharmaceutical, food and industrial waste water applications.

BIOTECHNOLOGY INDUSTRY REPORT Page 116


The clients of Nishotech are Cipla, Claris, Intas Biopharma, Biocon, Emcure, Dr.Reddy‘s,
Ipca, Pfizer, Torrent and many more.

TOWA OPTICS

Towa Optics (I) Pvt. Ltd. is the authorized distributor of many reputable international
companies such as NIKON (Japan), Andor (UK) , Linkam (UK), Thermo Fischer Scientific (
USA & UK), Genikon (Italy) and Spectro Inc (USA). It manufactures various instruments
and equipment like Biological Microscopes, Imaging Systems, Cooled/UnCooled Scientific
Cameras, Semi-Conductor Inspection Equipment, Controlled Environment Equipment,
Histopathology /Cytology Products etc. It is a dedicated company in the field of Bio
science/Industrial and now expanded its activities into analytical products. With ten dedicated
offices, in different cities of India Towa provides the most prompt attention to the customers
for sales and service.

HIMEDIA LABORATORIES

Hi- Media Laboratories was founded in 1973 as a small, regional manufacturer of prepared
culture media. Over the past 28 years, it has added many diverse products, moving into a
current position as a full-service supplier for several disciplines in the laboratory. Its catalog
now includes microbial identification systems, quality control organisms, stains, reagents,
dehydrated culture media, prepared media and diagnostic test kits, including EIA test kits and
slide agglutination kits. It also encourages inquiries for products not listed in the catalog. It is
a leading manufacturer of products for microbiology, parasitological, immunology, serology
and virology. Their customers include clinical, industrial, research and academic laboratories
around the world.

Its range of products include

 Dehydrated Culture Media


 Animal Tissue Culture Media
 Plant Tissue Culture Media Bacteriological
 Differentiation Aids
 Antimicrobial Sensitivity Single Discs 50 discs
 Antimicrobial Sensitivity Octo Discs 10 discs

Standardized Chemicals & Ingredients Various Fields of HiMedia product applications and
company's customers:

Academic Fields: Research Institutes and Education Institutes including Veterinary and
Medical Colleges.

Public Health Care: Water supply, Waste water disposal, Pollution control, Hospitals and
Clinical Laboratories.

BIOTECHNOLOGY INDUSTRY REPORT Page 117


Industries:

 Pharmaceutical & Cosmetics

 Vaccine, Toxin and Antibiotics

 Food and Dairy Products

 Agriculture such as Biofertilizers and

 Hotels, Catering and Flight Kitchens Biopesticides

RECENT HAPPENINGS- MERGERS AND ACQUISITIONS


Acquisitions are common in the life-science tools sector as large companies seek to fill gaps
in their product portfolios and broaden geographical reach by buying-out smaller peers. An
acquisition is the purchase of one company by another company. The combination of two or
more organizations is a merger.

Agilent Technologies acquired Varian Inc for $1.5 billion


Transformational transaction establishes Agilent‘s position as a leading provider of analytical
instrumentation to the applied and life sciences markets. Varian had annual revenue of $1
billion in its fiscal year 2008 in a product portfolio that includes lab instrumentation and
consumables. Transaction expanded Agilent product and application breadth in industrial and
life sciences markets; establishes entry into nuclear magnetic resonance (NMR), imaging and
vacuum technology markets. Price reflects a premium of approximately 35% to Varian
shareholders. The acquisition broadened Agilent‘s applications and solutions offerings in Life
Sciences, Environmental, and Energy and Materials. It also expanded Agilent‘s product
portfolio into atomic and molecular spectroscopy; establishes a leading position in NMR,
imaging and vacuum technologies; and strengthens its consumables portfolio.

Merck-Millipore merger-A $2.9 billion.


The Merck-Millipore deal is an important step in the transformation of Merck as it adds a
high-growth business that is not vulnerable to patent expiry.

Crux of the deal

1. Merck acquired all outstanding Millipore shares for $107 per share in cash, creating a
world-class partner for the life science sector.

2. Agreed transaction is valued at approximately $7.2 billion.

3. Combination created a $2.9 billion partner for the life sciences sector and transform Merck
Chemicals.

BIOTECHNOLOGY INDUSTRY REPORT Page 118


4. Combined business has significant scale in high-growth bioresearch and bioproduction
segments.

Together, Millipore and Merck created a $2.9 billion world-class partner for the life sciences
sector, achieving significant scale in high-margin specialty products with an attractive growth
profile.

4.3 Danaher will acquire Beckman Coulter for $6.8 Billion


Danaher Corporation, in February of this year, announced that it has entered into a definitive
merger agreement with Beckman Coulter, Inc. Danaher will acquire Beckman Coulter by
making a cash tender offer to acquire all of the outstanding shares of common stock of
Beckman Coulter at a purchase price of $83.50 per share, for a total enterprise value of
approximately $6.8 billion, including debt assumed and net of cash acquired.

With annual revenues of approximately $3.7 billion, Beckman Coulter develops,


manufactures and markets products that simplify, automate and innovate complex biomedical
testing. Its diagnostic systems are found in hospitals and other clinical settings around the
world and produce information used by physicians to diagnose disease, make treatment
decisions and monitor patients. Scientists use its life science research instruments to study
complex biological problems including causes of disease and potential new therapies or
drugs. Beckman Coulter would become part of Danaher‘s Life Sciences & Diagnostics
segment, joining Danaher‘s Leica, AB Sciex, Radiometer and Molecular Devices businesses.

Danaher is a diversified technology leader that designs, manufactures, and markets


innovative products and services to professional, medical, industrial, and commercial
customers. Its portfolio of premier brands is among the most highly recognized in each of the
markets they serve. Driven by a foundation provided by the Danaher Business System, its
48,000 associates serve customers in more than 125 countries and generated $13.2 billion of
revenue in 2010.

BIO SUPPLY MANAGEMENT ALLIANCE

The Bio Supply Management Alliance has launched an industry initiative to meet the risk
management challenges in the emerging global market.

About the Bio Supply Management Alliance

The Bio Supply Management Alliance was born of the need to create a worldwide
community of operations and supply chain management leaders and professionals in the
biotechnology industry. Based in the San Francisco Bay Area, home to more than 600 biotech

BIOTECHNOLOGY INDUSTRY REPORT Page 119


firms, the Alliance provides a forum for collaboration, learning and best practice sharing of
practitioners, executives and thought leaders in these uniquely demanding industry sectors.
Founders Tim Salaver and Devendra Mishra have forged relationships with key industry
leaders and defined initiatives with a vision to create process, people, and policy
improvements in this vital sector. The Bio Supply Management Alliance supports B2B
networking, continuous learning and career improvement of bio supply management
professionals.

BIOTECHNOLOGY INDUSTRY REPORT Page 120


Bioinformatics Sector
Introduction
Bioinformatics is the application of statistics and computer science to the field of molecular
biology. The primary goal of bioinformatics is to increase the understanding of biological
processes. What sets it apart from other approaches, however, is its focus on developing and
applying computationally intensive techniques (e.g., pattern recognition, data mining,
machine learning algorithms, and visualization) to achieve this goal. Major research efforts in
the field include sequence alignment, gene finding, genome assembly, drug design, drug
discovery, protein structure alignment, protein structure prediction, prediction of gene
expression and protein-protein interactions, genome-wide association studies and the
modelling of evolution.

The major research areas of bioinformatics are Sequence analysis, Genome Annotation,
computational evolutionary biology, analysis of gene expression, analysis of regulation,
analysis of protein expression, analysis of mutation in cancer, comparative genomics,
Modelling Biological systems, high throughput image analysis, structural bioinformatics
approaches etc.

Bioinformatics involves the application of computer technology for analysis and management
of biological data. The computers are used to collect, analyze, store and merge the biological
data. The aim of bioinformatics is to collect the wealth of biological information and use it to
improve the living standards of human beings. Bioinformatics is applied in various fields like
human health, environment, agriculture, biotechnology and energy to advance the biomedical
research and development. It is used in the field of molecular medicine to produce the
customized medicines for the prevention or cure of the disease. Bioinformatics is today
rapidly growing field all over the world. Therefore one can start a career in Bioinformatics
and find employment opportunities in biotechnology, biomedical and pharmaceutical
sciences, in industries, hospitals and research institutions.

The scope of bioinformatics is in areas like database design and maintenance, sequence
assembly, proteomics, clinical pharmacologist, sequence analysis, informatics developer and
bio-analytics. Excellent job opportunities are available in Biotech and Pharmaceutical
companies in India. Indian companies like Wipro, Reliance, Satyam, TCS and companies like
Accelrys and IBM Life Sciences Pubgene, Silicon Genetics and Tessella offer good
employments to the bioinformatics candidates. Due to increasing demand of bioinformatics
candidates, a career in bioinformatics offer good prospects.

The Bioinformatics tools are the software programs for the saving, retrieving and analysis of
Biological data and extracting the information from them.

Factors that must be taken into consideration when designing these tools are:

The end user (the biologist) may not be a frequent user of computer technology and thus it
should be very user friendly.

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These software tools must be made available over the internet given the global distribution of
the scientific research community.

The Bioinformatics Tools may be categorized into following categories:

 Homology and Similarity Tools

 Protein Function Analysis

 Structural Analysis

 Sequence Analysis

Homology and Similarity Tools:

The term homology implies a common evolutionary relationship between two traits -whether
they are DNA sequences or bristle patterns on a fly's nose. Homologous sequences are
sequences that are related by divergence from a common ancestor. Thus the degree of
similarity between two sequences can be measured while their homology is a case of being
either true of false. This set of tools can be used to identify similarities between novel query
sequences of unknown structure and function and database sequences whose structure and
function have been elucidated.

Protein Function Analysis


Function Analysis is Identification and mapping of all functional elements (both coding and
non-coding) in a genome. This group of programs allow you to compare your protein
sequence to the secondary (or derived) protein databases that contain information on motifs,
signatures and protein domains. Highly significant hits against these different pattern
databases allow you to approximate the biochemical function of your query protein.

Structural Analysis
These sets of tools allow you to compare structures with the known structure databases. The
function of a protein is more directly a consequence of its structure rather than its sequence
with structural homologs tending to share functions. The determination of a protein's 2D/3D
structure is crucial in the study of its function.

Sequence Analysis
This set of tools allows you to carry out further, more detailed analysis on your query
sequence including evolutionary analysis, identification of mutations, hydropathy regions,
CpG islands and compositional biases. The identification of these and other biological
properties are all clues that aid the search to elucidate the specific function of your sequence.

BIOTECHNOLOGY INDUSTRY REPORT Page 122


Bioinformatics Tools
BLAST:
The Basic Local Alignment Search Tool (BLAST) for comparing gene and protein sequences
against others in public databases now comes in several types including PSI-BLAST, PHI-
BLAST, and BLAST 2 sequences. Specialized BLASTs are also available for human,
microbial, malaria, and other genomes, as well as for vector contamination,
immunoglobulins, and tentative human consensus sequences.

FASTA
A database search tool used to compare a nucleotide or peptide sequence to a sequence
database. The program is based on the rapid sequence algorithm described by Lipman and
Pearson. It was the first widely used algorithm for database similarity searching. The program
looks for optimal local alignments by scanning the sequence for small matches called
"words". Initially, the scores of segments in which there are multiple word hits are calculated
("init1"). Later the scores of several segments may be summed to generate an "initn" score.
An optimized alignment that includes gaps is shown in the output as "opt". The sensitivity
and speed of the search are inversely related and controlled by the "k-tup" variable which
specifies the size of a "word".

EMBOSS
EMBOSS (The European Molecular Biology Open Software Suite) is a new, free open source
software analysis package specially developed for the needs of the molecular biology user
community. Within EMBOSS you will find around 100 programs (applications) for sequence
alignment, database searching with sequence patterns, protein motif identification and
domain analysis, nucleotide sequence pattern analysis, codon usage analysis for small
genomes, and much more.

Clustalw
ClustalW is a general purpose multiple sequence alignment program for DNA or proteins. It
produces biologically meaningful multiple sequence alignments of divergent sequences,
calculates the best match for the selected sequences, and lines them up so that the identities,
similarities and differences can be seen.

RasMol
It is a powerful research tool to display the structure of DNA, proteins, and smaller
molecules. Protein Explorer, a derivative of RasMol, is an easier to use program.

Application Programs
JAVA in Bioinformatics:

Due to Platform independence nature of Java, it is emerging as a key player in


bioinformatics. Physiome Sciences' computer-based biological simulation technologies and
Bioinformatics Solutions' PatternHunter are two examples of the growing adoption of Java in
bioinformatics.

BIOTECHNOLOGY INDUSTRY REPORT Page 123


Perl in Bioinformatics:

Perl is also being used in the processing of biological data. One example of perl project is
BioPerl project.

Bioinformatics Projects:
BioJava: The Bio-Java Project is providing the Java tool for the processing of data in Java

BioPerl: The BioPerl project many modules for biological data processing.

BioXML: A part of the BioPerl project, this is a resource to gather XML documentation,
DTDs and XML aware tools for biology in one location.

Industry overview
The industry comprises of players in areas such as contract research and development (R and
D) services, clinical and proof of concept clinical investigation, clinical trials, contract
research, bio-engineering, stem cell research, contract manufacturing, bioinformatics and
drug development. We are also witnessing activity in the field of research and development
in biotechnology with companies like Ranbaxy, Dr Reddy‘s Laboratories and Nicholas
Piramal have been working on licensed molecules, clinical trials of drugs already formulated,
and bioprospecting from Ayurveda, which is India‘ s traditional medicine. The Indian
software companies have come up with the software tools to capture, manage and analyse the
voluminous amount of genetic data. India‘s skilled but low cost manpower is the reason why
MNCs are sending their genomic and proteomic data to India for analysis. A key advantage
of India is the availability of skilled but low cost manpower. Unlike IT, bioinformatics
requires a highly skilled work force with knowledge of IT, molecular biology, protein
separation chemistry, instrument control, data acquisition and data analysis tools. India is on
the verge of taking the global leadership in genomic studies. Analysis shows that pure cost
benefits for biotech companies will drive the bioinformatics industry in the country. Slated as
the next big opportunity for India in the global arena after the success of IT Services,
Bioinformatics and Life Science research is gaining attention from government, industry and
the academia. In today‘s fast paced scientific innovations, Bioinformatics plays a very crucial
role in the areas of contemporary biomedical research. With the introduction of
Bioinformatics, the focus of the pharmaceutical companies has shifted from the trial and error
process of drug discovery to a rational structure based drug design. India has several ethnic
populations that are valuable in providing information about disease predisposition and
susceptibility, which in turn will help in drug discovery. Many eminent research and
development institutes are in the process of developing a database of genetic profiles among
diverse Indian population in terms of ethnicity, demographics and ancestral roots. However,
as there is lack of records and data management capabilities, the biotech and pharma
companies need tremendous software support. With computers biological problems that can
be addressed are in the areas of DNA / Protein sequence characterization, Protein Structure

BIOTECHNOLOGY INDUSTRY REPORT Page 124


Predictions, Protein Interaction Prediction, i.e., Drug Discovery and Pathway Modeling. The
need for the hour is High Performance Computing Infrastructure by development of new
advanced software and optimization of existing software.

History of the sector


The start of bioinformatics sector was from the time George Mendel experimented with cross
fertilization. He carefully recorded the data and analyzed the data. Mendel illustrated that the
inheritance of traits could be more easily explained if it was controlled by factors passed
down from generation to generation.

The understanding of genetics has advanced remarkably in the last thirty years. In 1972, Paul
berg made the first recombinant DNA molecule using ligase. In that same year, Stanley
Cohen, Annie Chang and Herbert Boyer produced the first recombinant DNA organism. In
1973, two important things happened in the field of genomics. The advancement of
computing in 1960-70s resulted in the basic methodology of bioinformatics. However, it is
the 1990s when the INTERNET arrived when the full fledged bioinformatics field was born.

Bioinformatics Network
India was one of the first countries in the world to establish a nationwide bioinformatics
network. The Department of Biotechnology (DBT) initiated a program on bioinformatics in
1986. The Biotechnology Information System Network (BTIS), a division of DBT, now
connects 57 key research centers, covering the entire country. More than 100 databases for
biotechnology have been developed. Two databases, namely one that covers data regarding
biotechnology research on coconuts and another that contains the complete genome of the
white spota syndrome of shrimp, have been released for public use. In addition, several major
international databases with applications for genomics and proteomics have been established
under the National Jai Vigyan Mission. BTIS also has decided to establish five advanced
research and training centers. These Centers of Excellence (COE) in Bioinformatics
undertake advanced research in bioinformatics, provide PhD and postdoctoral training,
develop new solutions to support the Indian Bioinformatics industry and its academic
institutions in India, help in solving complex biological problems, and retain required high-
end manpower.

BIOTECHNOLOGY INDUSTRY REPORT Page 125


TOP INDIAN COMPANIES IN BIOINOFORMATIC SECTOR
The Indian BioInformatics segment grew at 5%. Domestic market contributed to 68% of
BioInformatics revenue. The top two Indian companies in the Bioinformatics sector are

RANK COMPANY 2009-10 2008-09 Percentage


Revenue in Revenue in Change over
Million USD Million USD 2008-09

1 Ocimum 9.2 10.5 -12.97


Biosolutions

2 Strand Life 7.7 7.7 0.0


Sciences

Company Profile
Ocimum Biosolutions

Ocimum Biosolutions is a leading integrated global genomics company providing GLP-


compliant microarray services, comprehensive genomic reference databases, life science lab
information management solutions and essential research consumables. Ocimum‘s services
span across key priority areas including Biopharmaceutical, Diagnostics, Agriculture, and
Food & Nutrition. Diverse research and development efforts in such key areas have benefited
from our unique range of integrated services. Ocimum provides multi-platform GLP-
compliant gene expression, SNP genotyping and other Microarray based services. It also
provides full biorepository and genomic services support for the Genetic Alliance, which is
an umbrella organization representing ~600 genetic advocacy groups. Besides providing the
physical infrastructure for storing thousands of biological samples, we provide services to
assist sample accrual, IRB approvals, CRO training, sample collection, clinical data capture
and management. Ocimum has created the world‘s largest commercial gene expression
databases – BioExpress® and ToxExpress®,

Strand Life Sciences


Strand Life Sciences – Pioneers in Discovery Research Informatics, is a premier life science
informatics innovation company. Strand leverages its core strengths and intellectual property
in data mining, predictive modelling, bioinformatics, and computational chemistry to develop
products and solutions for drug discovery. Five of the top ten pharmaceutical companies,
three of the top six biotechnology companies, and numerous academic institutions across the
globe, are part of Strand's customer profile. Using its award-winning application
development platform, AVADIS®, Strand has built innovative products that enable cutting-
edge analysis, relationship building, modelling and accurate predicting, and building and

BIOTECHNOLOGY INDUSTRY REPORT Page 126


deploying of systems biology models. Strand products are very user-friendly and adept at
dealing with complexity. They help users conduct virtual experiments and use the results in
an intuitive manner

Products

GeneSpring GX : It is a cutting-edge analysis tool for gene expression, genotyping, exon and
tiling microarrays. It has a database of over 1.5 million biological interactions extracted by
the powerful Natural Language Processing (NLP) - based text mining engine developed by
Strand. GeneSpring is developed on Strand's AVADIS platform and marketed worldwide by
Agilent Technologies, USA.

Sarchitect: It is meant for Quantitative Structure Activity Relationship (QSAR) studies


and modeling of ADME / Tox properties. Sarchitect allows model builders to build best
possible models of their data and equally importantly, monitor and improve the models over a
period of usage. It allows users of the models to optimize complex multi-dimensional
ADME/Tox properties of molecules while retaining their biological activity. The Sarchitect
platform empowers computational and medicinal chemists, modelers, DMPK scientists and
other users with: QSAR modeling and deployment platform. Powerful algorithms, interactive
views, single click model building, intuitive workflows for chemists and customized
scripting.

BioLego: It is an interactive modelling and simulation platform built on Strand's award


winning AVADIS® technology. It has following features

 Transparent and comprehensive knowledge-base

 Handling Complexity

 Reliable solvers

 Large scale data handling and sharing

 BioLego helps in

 Building Own Models

 Accessing, modifying and customizing dynamic systems models built at Strand

 Generating and/or Testing Hypothesis in silico

 Visualizing, Storing, Retrieving and Comparing Results

WebChemistry: It is Strand's proprietary web-based analysis and reporting tool to explore


and learn about compounds, their structures and properties. WebChemistry enables medicinal
chemists and DMPK Scientists to carry out HTS, Lead generation and Lead optimization
activities more efficiently, while enabling Research IT to deploy these functions easily and
integrate them seamlessly.

BIOTECHNOLOGY INDUSTRY REPORT Page 127


Global Scenario
Growth Rate and Market Size

The product lines, software tools and other biometric applications were projected at an annual
market growth of 15.8% or US $3 billion for the year 2010. As it stands the bioinformatics
market is at stability where 20% of the applications discovered are based on genomics and
proteomics, which boosts growth of bioinformatics tools. A greater number of R&D centers
across the world are seeking a common base for transfer of data, information and knowledge
to enable an informatics-based decision support system. Given the said market structure there
is an emerging need to develop breakthrough drugs while shortening the discovery time and
costs. There is also need for forming mergers and partnerships of companies both at local and
international levels. Leading biotech firms like Compugen, DoubleTwist have come forward
with novel drug programs. Interestingly, India and South East Asian countries have
comparative advantage in terms of cheap labor, which can offer database solutions and
genome research for biotech companies globally.

Future of the Bioinformatics Sector (Global)


The global market for bioinformatics is forecast to reach US$5.0 billion by the year 2015.
Key factors driving market growth are:-

 Substantial development in the area of genomics


 Increasing application of genomics in R&D processes
 Availability of huge genomic information
 Continuing demand for new drugs

Bioinformatics, one of the most vibrant industries in the current scenario, is at the forefront of
the biotech revolution. The market is projected to transform into a major industry within the
next few years. Driving the revolution is genomics, a set of advanced tools designed for large
data acquisition and analysis. New tools are not only pushing the development of drug
discovery, but also fundamentally changing the nature of biological research. The success of
Human Genome Project and breakthrough technologies in drug discovery initiatives spells
significant investment opportunities for the industry. As new players enter the market, and
existing companies grow in size and revenue, competition in the bioinformatics industry is
likely to intensify significantly.

Globally, pharmaceutical companies are increasingly seeking help from biotechnology to


alleviate concerns related to increasing number of blockbuster drugs going off-patent, narrow
product pipelines, and high drug development costs. Bioinformatics can be applied in every
stage of the R&D processes in biotechnology as well as the pharmaceutical sectors. The
emergence of genomics and its ever-growing application in the research and development
processes have created soaring amount of data, creating significant opportunities for
bioinformatics. Data management tools based on bioinformatics have helped companies in
easing the task of R&D analysis, thereby enhancing their productivity by way of identifying
new biomarkers for toxicity and drug efficacy, diagnostic biomarkers as well as new drug

BIOTECHNOLOGY INDUSTRY REPORT Page 128


targets. Bioinformatics help utilization of the gene and protein data and construct interactive
models that aid in identifying disease pathways and effects of compounds.

Going forwards, the penetration of genomics in drug discovery is expected to increase


further, which bodes tremendous market prospects for bioinformatics. In addition, more and
more spending is expected to be made in research and development from pharmaceutical
companies, of which a major chunk is expected to end up in the area of bioinformatics.
Bioinformatics is a multifaceted market, characterized by a host of licensing and research and
development collaborations. Worldwide bioinformatics market is primarily concentrated in
the United States and Europe. The industry represents one of the fastest growing fields
offering economic opportunities in various areas.

The US represents the largest regional market for bioinformatics worldwide, followed by
Europe, as stated by the new market research report on Bioinformatics. However, Asia-
Pacific is projected to record the fastest growth over the analysis period. Japanese market is
projected to post a CAGR of 13.5% during the analysis period. Segment wise, Biocontent
represents the largest product segment in the global bioinformatics market. Bioinformatics
Software represents the fastest growing product segment. Demand for Bioinformatics
hardware is projected to rise by 9.5% during the analysis period. The global bioinformatics
industry is highly fragmented, with several companies offering only specific services and a
very few companies delivering comprehensive solutions for their clients‘ R&D needs. Large-
scale presence of smaller companies and high fragmentation is due to lower entry barriers and
existence of large IT companies in the sector.

Major players include

 3rd Millennium Inc


 Accelrys, Inc.,
 Affymetrix
 Agilent Technologies
 BioWisdom Ltd
 Celera Group
 Gene Logic
 IBM Life Sciences
 Life Technologies Corporation
 Rosetta Inpharmatics.

Bioinformatics in India

Bioinformatics will be a potential star in bioscience field in the coming years after
considering the factors like bio-diversity, human resources, infrastructure facilities and
government initiatives. It has been reported that the pharmaceutical firms and research
institutes in India are looking forward for cost-effective, high-quality research development,

Bioinformatics has emerged out of the inputs from several different areas such as biology,
biochemistry, biophysics, molecular biology, biostatics, and computer science. Specially
designed algorithms and organized databases is the core of all informatics operations. The
requirements for such an activity make heavy and high level demands on both the hardware
and software capabilities.

BIOTECHNOLOGY INDUSTRY REPORT Page 129


The Bioinformatics revenue change (in Rs. Crore) over the recent years can be seen in the
following table:-

Segment 2007-08 2008-09 2009-10 % change % change


over 2007- over 2008-
08 09
Bioinformatics 190 220 231 16 5

Current Market Status

Bioinformatics is one of the fastest-expanding fields in India's biotechnology sector today.


There are over 200 companies in Bangalore, Hyderabad, Pune, Chennai, and Delhi that are in
some way involved in bioinformatics. Large IT organizations such as Intel, IBM, and Wipro
are also getting into this sector in India. Just as important, over 300 college-level institutes
across India now offer degrees in biotechnology, bioinformatics, and biological sciences.
These facilities are educating millions of students annually. This educational base is creating
a solid future for India's bioinformatics industry. Although a fast expanding Sector the
smallest segment of the Industry, BioInformatics which has just about 2 percent segment
share in the overall industry, has been sluggish in FY 2009-10. It registered a 5 percent
growth over 2008-09, clocking Rs 231 crore in revenues last year as compared to Rs 220
crore in FY 2008-09, when it recorded a growth of 16 percent

Segregation of companies according to region:


Region No. of Bioinformatics %Share of Sector in the
Companies Regions
NORTH 5 12%
SOUTH 32 78%
WEST 4 10%

South based companies generate almost 55 percent of the total CRO business in the country.
The biggest of number of Bioinformatics companies headquartered in a region is the South as
it accounts for 77 percent share of the total number of companies in the country. Northen
region accounted for 15 percent share of the total base. This field has generated such high
revenues mainly because it is home to almost all the top diagnostics companies.
Bioinformatics applications in drug discovery and development are expected to reduce the
annual cost of developing a new drug by 33%, and the time for drug discovery by 30%.
The pure-play BioInformatics companies in India include Strand Genomics, Ocimum
Biosolutions, SysArris, CytoGenomics and Molecular Connections. These companies have
come out with products that cater mainly to the needs of the pharmaceutical and
biotechnology companies. Most of these companies are small and medium enterprises based
at locations such as Bangalore, Hyderabad, and Pune. Much of this growth is because of the
linkages between IT and biotechnology. India's software engineers are established around the
globe. This breadth of expertise is, in turn, creating an engine for global biopharmaceutical
growth. In fact, because of India's global presence in bioinformatics, Indian scientists and

BIOTECHNOLOGY INDUSTRY REPORT Page 130


bioinformatics professionals are in high demand. Today, the country's talented software
engineers are establishing themselves as more than just inexpensive. As a result, salary
differentials today are shrinking quickly. Engineers in India today command salaries of
around half of those in the US.

INDIA'S ADVANTAGES
The core R&D strength in Indian biotechnology is its relatively well-educated and trained
labor force, with a strong base of English-speaking scientists who are well versed in
mathematics, physics, and chemistry. Thus, the country has the scientific skills that
encompass capabilities for handling all aspects of biological information acquisition,
processing, analysis, and interpretation. India's well-known software skills are, of course,
another key advantage in global bioinformatics.

ON THE CONTRARY
Venture capital and other funding sources are still needed, though. This may require
concurrent support from government agencies, in the form of building infrastructure and
funding of small- and medium-sized entrepreneurs. Foreign companies can offer knowledge
Indian companies may lack, so partnering will likely become an important element in this
segment's growth, as Indian companies increasingly recognize that expertise in
bioinformatics is not enough without expertise in areas such as lead generation, toxicology
studies, regulatory affairs, and patenting.

BIOTECHNOLOGY INDUSTRY REPORT Page 131


SWOT ANALYSIS AND CONCLUSION: BIOTECHNOLOGY INDIAN INDUSTRY

The importance of India in the field of Biotechnology is manifold. In addition to generating


trained manpower and a knowledge base, India is proving to be an ideal setting for
manufacturing activities and high-level biotechnology research programmes. With the
initiatives taken by the government, Indian Biotechnology is poised for a tremendous growth.

Government Initiatives

In recognition of the need of training and education for generating interdisciplinary human
resource relevant to biotechnology, the Government of India and UNESCO, have taken a
joint decision to establish the Regional Centre for research, training and education in
biotechnology under the auspices of UNESCO. The UNESCO Regional Centre for
Biotechnology is scheduled to come up in Faridabad, Haryana by the end of 2010. Further,
the Department of Biotechnology (DBT), Government of India, has also decided to set up a
unique Health Biotech Science Cluster (HBSC) at Faridabad. Moreover, the government will
fast forward the process of setting up a National Biotechnology Regulatory Authority, to
stimulate public and private investment in biotechnology. Besides the central government
initiatives, individual states are also doing their bit to promote the biotechnology industry.
Karnataka takes the lead and the state's revised biotech policy offers many fiscal incentives
and concession to prospective investors in the industry. According to the Mr. B S
Yeddurappa, Chief Minister of Karnataka, a bio-venture fund with a seed capital of US$ 10
million will be set up to incubate start-ups by young entrepreneurs. Moreover, the state
government is setting up 10 biotech finishing schools in association with the industry and
academia to create a steady talent pool. Sector specific biotech parks are expected to be set up
at Mysore, Mangalore, Dharwad and Bidar in north Karnataka. Similarly, a bio-cluster will
be set up in the Bangalore Biotech Park on a public-private partnership mode.

Incentives for investing in Indian Biotech Sector

 DBT provides a single window processing mechanism for all mega Biotechnology
projects involving FDI of $ 22 million or more under the FIIA with its Fast Track
Committee (FTC)

 150% weighted tax deduction on R&D expenditure

 3 year excise duty waiver on patented products

 100% rebate on own R&D expenditure

 125% rebate if research in contracted to public funded R&D institutes

 Joint R&D projects provided special fiscal benefits

BIOTECHNOLOGY INDUSTRY REPORT Page 132


MAJOR STENGTHS OF INDIA

AVAILABILTY OF SKILLED MANPOWER

 India has the largest English speaking population after US

 Sciences and Engineering streams produce 3 million graduated, 700,000 post


graduates and 1500 PhDs every year

 Manpower costs much lower as compared to other nation

HIGHEST QUALITY STANDARDS IN MANUFACTURING

 Outside the US, India has the highest number of FDA approvals in the world

 World class facilities for manufacturing that comply with GLPs, cGMPs and GCP
standards

 Well recognized for low-cost fermentation technology and generics biologicals

GENETIC PROFILE OF INDIAN POPULATION

 Clinical trials can be outsourced to India as the Indian population has the similar
genetic profile as the US and European population, due to joint Aryan descent.

NEW BUSINESS MODELS:

COLABORATIVE R&D: Indian companies partnering with foreign players to enter into
collaborative R&D efforts as an initial step towards focusing on R&D.

NEW REVENUE STREAMS: Revenues from patent licensing and litigation can redefine
existing business models completely and shift them to a higher value generation plan.

EMERGING BUSINESS OPPORTUNITIES: India will become a highly lucrative option


for contract research once stronger IP protection legistation

CAPTURING THE INDIAN: Indian companies can introduce entry barriers foreign players
in the Indian market by using IP to protect their own innovation.

BIOTECHNOLOGY INDUSTRY REPORT Page 133


STRENGTH WEAKNESS

TRAINED MANPOWER AND KNOWLEDGE MISSING LINK BETWEEN RESEARCH


BASE AND COMMERCIALIZATION

LACK OF VENTURE CAPITAL

GOOD NETWORK OF RELATIVELY LOW R&D EXPENDITURE


BY THE INDUSTRY
RESEARCH LABORATORIES
DOUBTSABOUT INDIAN PRODUCTS TO
MEET INTERNATIONAL QUALITY
RICH BIODIVERSITY ADMINISTRATION OF RESOURCES
SUPPORTING BIOTECH RESERACH
AND DEVELOPMENT
WELL DEVELOPED BASE

INDUSTRIES (PHARMACEUTICAL AND


SEEDS)

EXTENSIVE CLINICAL TRIALS AND


RESEARCH

ACCESS TO VAST AND DIVERSE DISEASE


POPULATION

BIOTECHNOLOGY INDUSTRY REPORT Page 134


OPPORTUNITY THREAT

THE LARGE INDIAN MARKET CAN BE DANGER OF ANTIBIOTECH


CAPTURED BY GAINING PROPER IP PROPAGANDA GAINING GROUND
PROTECTION`
IPR POLICIES
THERE WILL EMERGE NEW REVENUE
STREAMS FROM PATENT LICENSING BRAIN DRAIN
ANDLITIGATION ENHANCED LEVEL OF POLITICS IN THE
STRONG IP PROTECTION INCREASES SYSTEM
THE LUCRATIVNESS OF INDIA AS A
CLINICAL RESERACH DESTINATION

ACCLERATED GROWTH OF BIOTECH


INDUSTRY

INCREASED OPPORTUNITY FOR


ENTRAPRENURIAL ACTIVITY

BIOTECHNOLOGY INDUSTRY REPORT Page 135


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