Managerial Economics Report

Origin of the report

This report titled as Future Challenges to the Growth of Pharmaceutical Industry of Bangladesh has been prepared for Dr. A. K. M. Saiful Majid, Course Instructor, Managerial Economics as the partial requirement of the course.

Broadly the objective of the study is to focus on the future challenges to Objectives: Broad and specific the growth of pharmaceutical industry of Bangladesh. Specific objectives are: To present the overall growth situation of pharmaceutical industry of Bangladesh. To identify the existing problems in pharmaceutical industry of Bangladesh. To explore the prospects of this sector. To show the trend of pharmaceutical industry. To suggest some policy guidelines for resolving these problems and to cope with the new regime of globalization

An exploratory research will be conducted to get an insight into the factors Methodology responsible to the growth along with the future obstacles for the growth of this sector. Primary data was collected via interviewing executives of ten major pharmaceutical companies of Bangladesh. A semi-structured interview schedule will be used to collect data from the officials. A checklist has been used while interviewing to ensure collecting all required data. Secondary data was used for the purpose of the study. Secondary data and information were collected from the existing literature in the field of both local and international pharmaceutical area. It used synthesized Future Challenges to the growth of the Pharmaceutical Industry of Bangladesh

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information collected from several recognized journals, magazines, newspapers and websites of both local and international pharmaceutical companies and various published and unpublished research materials on the subject. Collected data are analyzed on the basis of the objective of the study. While interpreting the findings, apart from using these sources the writer also incorporated his observations and experiences to better explain the crucial issues through the writing process. This paper discussed the relevant issues and analyzed the current market situation based on recent phenomenon.

Lack of available previous research works in this area for designing the Limitations of the report study. Time and cost is also a considerable limitation. The category of the product of the pharmaceutical organization was not same. So it was difficult to compare among their performance.

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1.

Introduction

Pharmaceuticals industry is the core of healthcare sector of Bangladesh. Being part of healthcare sector, its performance is related to demographic variables like population growth as well as economic growth and healthcare policy. In our country, with improving demographic characteristics, recent economic growth and favorable policy, the industry has seen good growth. The history of Pharmaceuticals industry dates back to 1950s. Over the years, The industry has gone through some significant changes. After liberation in 1971, the industry was largely dominated by MNCs, and the country was very much import dependent. In 1982, through the formulation of national drug policy, and drug control ordinance, a defined guideline for the development of the industry was created. By then, 75% of the market was dominated by the MNCs, whereas the rest were shared by some 133 local firms. Since then, the local firms have established a stronger foothold, and the country has become from an import dependent to an active exporter of pharmaceuticals products. At present, top 5 MNCs have approximately 9.05% of the market share and 97% of total local demand is met through local production.

2.

Pharmaceutical Industry Structure

The industry has some distinct features compared to other countries. First, Branded Generic Industry Mainly Finished Formulation Products R&D activity is virtually nil in Bangladesh pharmaceutical industry it is a branded generic market. At present, there is approximately 258 manufacturers, with approximately 8000 branded generics in Bangladesh pharmaceuticals market. Companies basically manufacture finished formulation by assembling known generic and patented (in some cases) Future Challenges to the growth of the Pharmaceutical Industry of Bangladesh

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product combination. Some firms have been engaged in producing APIs, the core of pharmaceutical products, but these productions are limited to synthesis stage (final stage) only. The global pharmaceutical industry is expected to grow to USD 1.3tn by 2020. The Bangladeshi market, though currently small from a global perspective, is growing rapidly at an average rate of 12%. Bangladesh has the largest pharmaceutical industry among the Least Developed Countries (LDC). The TRIPS agreement has given it an advantage as an LDC to legally reverse-engineer patented products and sell in the local market. India has been subjected to patent protection in 2005. This places Bangladesh at an advantage in the generics market until 2016.

3.

Key players in the Industry

Due to the branded generic nature of products, companies are usually able to charge a premium price, while enjoy stable position. As a result, the top performing companies in the industry are relatively consistent over the years, often along with their respective market position. The market leader is Square pharmaceuticals, which have enjoyed the top position since 1985. At present, it has a 19.18% market share. The next player is Incepta, followed by Beximco, Opsonin, Eskayef and others. The top 10 firms are almost the same over the years, often with little change in order.

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Key facts of the Sector With a USD 600mn industry and an average annual growth rate of 12%, the Bangladeshi pharmaceutical industry is the biggest (in volume) amongst all the LDCs. Primarily a generics industry producing about 8,000 different brands which meet 97% of the domestic demand. Local companies enjoy 86% market share. Of the 245 registered pharmaceuticals, the top ten players account for 65% market share. According to the WTO TRIPS agreement, LDCs are exempted from Patent Protection until 2016 allowing legal reverse engineering and sale of patented products. This provides a unique opportunity for Bangladesh over India and China, who are under the patent regime. Bangladesh has made significant progress in the export market. Between 2003 and 2010 pharmaceutical exports increased to about 85 countries from 51 and quadrupled in value from USD 7.9mn to USD 32.74mn. Future Challenges to the growth of the Pharmaceutical Industry of Bangladesh

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Since many companies have acquired international certifications like USFDA, UKMHRA and TGA, Bangladesh can penetrate into regulated and unregulated markets. With the demise of reverse-engineering in India and China, Possibility of being the R&D hub in South Asia Bangladesh is in a position to emerge as one of the regional R&D centers for Pharmaceutical Research. Bangladesh provides a strong platform for off-shoring/outsourcing generic bulk and formulation drugs due to a cheap labor force and established infrastructure. Through the establishment of modern technical facilities, the industry can emerge as a regional hub for pre-clinical testing and clinical trials. Establishment of adequate reverse engineering and API

manufacturing facilities provide a substantial market for import substitution as currently 80% of the APIs are imported. Local manufacture of vaccines and injectables will enable Bangladesh to become self-sufficient in the production of formulations. The Patent exemption through TRIPS and the government endorsement as a thrust sector have presented a perfect platform for the industry to launch itself into the global arena.

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5.

Features of the Industry

Export growth Over the last few years the Bangladeshi pharma industry has seen a significant increase in exports. At present Bangladesh exports to over 65 countries around the world, the majority of which are LDCs. Export destinations include Japan, Canada, Italy, Korea, Saudi Arabia, Malaysia, the UK and the USA. Patent exemption In 2002, the Doha Declaration of TRIPs was adopted. LDCs were exempted from Pharmaceutical Patent Protection until Year 2016. This means that Bangladesh can legally reverse-engineer patented products and sell them in the local market as well as export to other LDCs. The TRIPS agreement can be used to ensure access to innovation, invention and affordability of pharmaceutical products and processes by developing nations. Regulatory environment The local drug ordinance established in 1982 was designed in a manner to protect the local players. One clause states that if Price Regulations exists 4 or more local companies manufacture a certain drug, no MNC can import that drug. The TRIPS agreement along with the national drug policy gives the local companies in the generics market a significant advantage. Strong manufacturing base Among the LDCs Bangladesh is the only country which is almost 100% dependent on drugs produced locally. Bangladesh also has the largest market size among the LDCs giving Bangladesh a strong manufacturing base. Only 49 LDCs, including Growth in exports to LDCs till TRIPS implementation Bangladesh, are able to export their patented drugs. Other countries, including India and China will not be able to export their patented drugs, as the facility will be reserved for LDCs until 2016. No license fees Due to its LDC status and the fact that Bangladesh has no patent protection for pharmaceutical products, no license fees are payable Future Challenges to the growth of the Pharmaceutical Industry of Bangladesh

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for manufacturing and for export to other LDCs. License fees would be applicable for export to any non-LDC where the patent holder has registered his patent. No such fee has to be paid, either because the patent is not filed or because it is not enforced. Low logistics costs According to the World Banks Doing Business report, Low transportation and handling cost inland transportation and handling costs are very competitive in Bangladesh at USD 150 per standard cargo compared to USD 404 in India, USD 520 in Tanzania and USD 600 in Ethiopia. Low-cost energy Fuel and energy is highly subsidized in Bangladesh, making prices very competitive. But the current scenario is changing. Competitive labor force Bangladesh is internationally very competitive in Cheap labor available terms of labor cost. Labor cost may account for up to 50% of the overall manufacturing cost for APIs. Since Bangladeshi manufacturers are not fully backward integrated, they can capture only part of this competitive advantage. Export regulations & prospects Currently, there are no restrictions on the export of pharmaceuticals. The countrys existing Export and Import Policy is followed. According to the new three-year Export Policy for FY07 to FY09 pharmaceutical products were included in the list of thrust sectors. Outbound passengers will be able to carry USD200 worth of products with them abroad. The allowable limit for pharmaceutical samples export is USD10,000. The government has plans to introduce a policy to boost export of pharmaceuticals in the near future. Import license of raw materials are issued to all manufacturers which allow them to import from most parts of the world.

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S O

W T

6. 6.1

Industry SWOT Analysis Strengths There is a large population base in Bangladesh for the pharmaceutical sector. The use of allopathic medicine is increasing with increase in number of qualified medical practitioners (MBBS doctors) and health facilities. Bangladesh has the necessary technical experts (pharmacists, chemists, microbiologists etc.) who are capable of producing high quality medicine and have the necessary knowledge to comply with the latest guidelines for good manufacturing practice (GMP). The top local companies are already exporting their formulation products and have the necessary technology and capacity to produce world standard products.

6.2

Weaknesses Although Bangladesh manufactures 95% of the necessary formulation drugs it is heavily dependent on imported raw materials for their production. The economy of the country is not strong enough to support the drug manufacturing industry to the extent that bulk drug manufacturing can begin based on the local demand only. Compared to China and India, Bangladesh pharmaceutical industry operates in a much smaller internal market with an even weaker economy.

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6.3

Opportunities From 2005 onwards Bangladesh being a member of LDC will be allowed to produce cheap copies of patented drugs and their raw

Due to TRIPS relaxation, LDCs can produce drugs without patent or license cost up to 2016

materials. If the government extends necessary support to the industry it has the potential to become a very big export as it will be able to export both API and formulation products to all the LDC countries and off patented formulation products to developing and develop countries. As Indian and Chinese companies will not be able to produce

LDCs have sought an extension of TRIPS relaxation up to 2021

patented active ingredients but they have the necessary technology and expertise in reverse engineering and chemical synthesis they are more interested in cooperation with Bangladesh after 2005. The government has decided to set up an API park in Chittagong with the facility to house 20 plants and investment worth TK. 20 billion is expected.

6.4

Threats In the post 2016 scenario Bangladesh may end up not having the necessary raw materials and may have to buy raw materials from

Post TRIPS threats No Price control Impeded market access Increased competition Cost pressure

the innovator company at a much higher price. The current regulations require that all manufacturing facilities comply with World Health Organization (WHO) GMP requirements. The small industries of the country are still lagging behind and in the post 2016 scenario find it very difficult to survive.

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The implementation of TRIPS agreement is very likely to result in the rise in production cost of medicine and their distribution which may adversely affect the local industry. Big multinationals may come and take major market due to their economies of scale, superior technology and product patent. Cheap and substandard drugs especially from neighboring countries may enter the market illegally and destabilize the market. The present regulation does not allow companies to advertise their OTC drugs in the mass media whereas these are allowed in neighboring countries already creating a market for those products.

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7.

Growth Expectation

For a strong API base, R&D Activities, formulation and market are three primary concerns. Whereas our industry does not have R&D activities, we have a good domestic formulation industry and a moderate size domestic market. Alongside, we have trained local human resources to support development in the industry. With the govt. proposed utility and ETP benefits, and present regulatory structure, it is possible for Bangladesh to develop a good base in formulation of API and formulations for generic products. Alongside, due to growth factors such as low manufacturing labor cost,
Growth Scenario 2011-2016 Local Market = 15% Export Market = 10% Overall Growth = 14.8%

availability of relevant manufacturing technology and entrepreneurial assertiveness, the domestic market is to become a major emerging market. Change in affordability, strength of continuous investment, rapid spread of urbanization and education will result in high growth of the industry in the coming years. Being a part of healthcare sector, growth of pharmaceuticals industry is related to several economic variables. And at present, Bangladesh has a quite good outlook on its demographics. GDP growth has been roaming around 6% over last few years. Within 2001-11, average population growth is 1.58%, with the growth rate declining at 1.68% per year. Life expectancy at birth has increased at 0.89% annually, along with poverty level reducing 1.68% each year. Most importantly, healthcare expenditure per capita grew by a 8.7% per year, and private healthcare expenditure grew by 3.16% annually, demonstrating a growing propensity among people for healthcare expenditure. With a consistent GDP growth rate around 6%, expected population growth rate 1.55%, Health expenditure per capita growing at an average rate of 8.7% and continued pattern of increased life expectancy and Future Challenges to the growth of the Pharmaceutical Industry of Bangladesh

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poverty reduction, an expected growth of 15% can be expected for period up to 2016 for the local market. In the export market, growth (presently 9.4%) is expected to stay at an
Growth Scenario 2016-2021 If TRIPS benefit is extended, Expected Growth = 10.1% If TRIPS benefit is not extended, Expected Growth = 8.5%

average of 10% up to 2016, as TRIPS relaxation prevails, and present effort towards improving international reach continues. Further, if the present expectations materialize, the API industry can provide another growth opportunity in the export market. Exports presently amount to 5.93% of total size (local + Export) of pharmaceutical market on average. However, exports may contribute more in industry growth in coming periods. Overall, an growth of 14.8% can be expected from our pharmaceuticals industry up to 2016. After 2016, growth pace would depend on whether TRIPS relaxation is extended or not. If extended, the industry can expect another period of good growth, with more growth coming from exports. However, total growth will be lower than 2011-2016, due to industry size effect, saturation in many product classes locally and rising competition. Therefore, assuming a GDP growth of 5%, alignment of private expenditure on healthcare with GDP, and a stable life expectancy level, 10.1% growth can be expected. And If not extended, export growth would certainly fall (assumed growth to be 2%), while domestic industry would reach saturation and will depend on demographic variables. In that case, a growth rate of 8.5% can be expected.

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8.

Investment Opportunities

APIs to produce patented drugs. As countries like India, China and Brazil are all sources of raw materials and signatories of WTO, it is expected that
Development of domestic API market API Park to be completed by 2012

they will not produce raw materials of patented products. In order to take full advantage of the Post-2005 Opportunities, Bangladesh needs to invest in DMF Standard API Facilities with all basic infrastructures, amenities and special facilities. API facilities will not only play a significant role in import substitution, it will also open the doors to mass scale exports. To be able to do this, proper R&D is required. Bangladesh currently has to import 80% of the API from countries including India and China as the local R&D required for the reverse engineering is not adequate. Of the top 15 API molecules, only 6 are locally manufactured which does not include the highest revenue generating molecule. The rest are imported. India and China have been involved in pharmaceutical R&D for several years. In Bangladesh, there is no such R&D facility. In order to take full advantage of the Post-2005 opportunities, Bangladesh needs to invest in R&D for reverse-engineering of patented drugs. Since 2005, India has had to abide by patent protection. Thus, the vast reverse engineering sector in India which is more technically adept than Bangladesh is at a loss. Bangladesh should aim to capitalize on the redundancy of Indias generics industrys significant resource. Investment in R&D outsourcing facilities. Due to low skilled labor costs

Outsourced R&D leveraging a low cost base

and other factors such as subsidized power, Bangladesh has an advantage as a location for possible outsourced R&D. Bangladesh might collaborate with global players and perform outsourced R&D activities for them. Investment in contract manufacturing facilities. Considering the large number of medium and small sized pharmaceutical firms in Bangladesh requiring funds to setup production units for specific drugs, a potential Future Challenges to the growth of the Pharmaceutical Industry of Bangladesh

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Developing a toll manufacturing

investment opportunity lies in establishing such plants. Bangladesh could become a contract manufacturing venue for global players. The toll manufacturing industry in India was worth USD350 mn in 2007. Investment in R&D for developing new drugs. Investment in R&D facilities would enable Bangladesh to develop its own molecules and drugs once the patent exemption period will be over in 2016. In order to compete with global players, the industry has to come up with its own portfolio of

R&D for new drugs key to developing competitive advantage post 2016

product patents. The concept of a privatized common R&D facility can prove to be very promising as a majority of the local companies might not be able to establish self-owned R&D facilities. India has recently started investments in new drug development after entering the patent regime. In 2005, Dr. Reddys committed 14 % of its annual sales to R&D, whereas, Ranbaxy allocated approximately 7 %.10 Investment in plants for certification in developed markets. Bangladesh has export opportunities in the developed and regulated markets in the

Plant certification for foreign markets

form of contract /toll manufacturing and under-license manufacturing. In order to capitalize on these export opportunities, manufacturers of Bangladesh need to invest in manufacturing plants and apply for certification (e.g. USFDA, UKMHRA and TGA) in regulated markets. Optimum capacity utilization and investment in plants is important for penetrating the export market.3 Investment in injectables, insulin and vaccine plants. To take full

Injectables, Insulin and vaccine production

advantage of the Post 2005 opportunities, the country should invest in injectables, insulin and vaccine plants, none of which are currently present. This would ensure substantial import substitution.

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9.

Identification of Critical Success Factor Leadership, Human resource : leadership skills and human resources can be termed as one of the most critical success factor within the industry and square has the core competency in managing their human resources

Key sales personnel: recruiting and selecting key sales personnel is crucial factor for this industry as the sales depend much on personal selling. Square tops in this position as they have the best sales personnel in the country

Production facilities: Depends on number of manufacturing plant in city and outside city. Square and Beximco meets the international standard as they have the huge production capacity.

Star Brand: Beximco, Sanofi-Aventis, ACI Pharmaceuticals, Renata, have at least two or three popular brands in the market which are of always high demand, therefore, having a brand like NAPA is a core competency for Beximco which ensures 25-30% of their sales.

Finance: Square and Incepta have huge financial resources and R & D Capabilities, therefore, the strong financial positions allow them to invest more on quality control, R&D, Human resource Department.

Introduction of new brands per year: Square leads the market in terms of new brand development per year Last year; they introduced 108 brands in therapeutic segments, while Incepta introduced 88 brands. Beximco introduced 54 brands in therapeutic sectors, and is in the 3rd position.

Export base: Beximco pharmaceuticals have huge export base in the market, and last year, they experienced a huge export growth rate of 11.79%,. Incepta, Square also exports their medicines to other countries, especially to developing countries, and also to some

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European countries such as Germany, where the drug cost is very expensive. Category expansion: pharmaceuticals are expanding their categories in therapeutic, animal health care, cardiac, chemical fertilizers, herbal segments. Square pharmaceuticals cover all the segments in pharmaceuticals and market leader in most of those. Research & Development: One of the most crucial factors in pharmaceutical industry, Square and Incepta had huge investment in
Huge R & D investment

their research & Development, small and medium sized firms mostly rely on shared R &D, joint ventures with the manufacturers, and strategic alliances for R & D, quality control.

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10.

Recommendations

From the analysis it is clear that as a multinational pharmaceutical company operating in Bangladesh is helping the pharmaceutical industry with the supply of different types of drugs medicine sealing in the market with the local competitors. Only sale of a few drugs under patent will be affected. But this will, hopefully, not affect the market share of domestic pharmaceuticals. The possible recommendations for ensuring continuous growth are: Expanding Pharma Market: Every Pharmaceutical company faces ever-increasing pressure to keep
Knowledge & technology transfer and sharing

pipelines full control R&D costs, deliver more drugs to market and build shareholder value. To succeed in this environment, it needs a partner with the knowledge and esthetes to propel innovation and accelerate the drug development process. Market Development for Pharmaceutical Product: All Pharmaceutical companies in world have become competitive and require a professional approach in reaching to the markets. An effective

Channel build up

market development for Pharmaceutical products in various countries can bring key success for it. Proper channel should be built. The channel to such market is a part of the Market Management Program, where the organization brings to the client the understanding approach to a specific market and helps the organization to manage the market for better profits. Apply Field Force Strategy: Field force is one of the most important parts for any pharmaceutical

Field force utilization

company. If the pharmaceutical company needs to create good market share then Field Force, Medical Promotion Officers, Regional managers are Future Challenges to the growth of the Pharmaceutical Industry of Bangladesh

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the key personnel. They must know a better way of marketing management. The total marketing strategy should be very clear to these people. Again with the expert field force it is not possible for the pharmaceutical company to sell their products. Proper Distribution and Sells through the help of HR: Each department of the organization should have to help each other. Not only to help each other should the departmental heads work as a team to achieve the goal of the organization. Human Resource department should be playing the key assembler of the entire department. Marketing and other department should help the management to take quick decisions as well as if any problem regarding pharmacy found any problem and solve it as soon as possible. Introduction of new products: The Introduction of new product is essential for maintaining growth of
New product development focus

domestic companies and also helps in promoting of products of the companies. Launching of new products makes a company different among the competitors. Leading domestic companies take this issue very seriously as a matter of prestige. Establishment of joint venture projects: Joint Venture projects are profitable for Bangladesh, as this will ensure technology transfer. Government of Bangladesh has to do much in this regard for attracting foreign investments to foster pharmaceutical industry. Pharmaceutical Industry & Government have to build a separate plant and also a Pharmaceutical Industry Park for Manufacturing Medicine immediately.

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Government has to employ more skilled workforce to monitoring the Pharmaceutical Industry properly. Policy should be taken to ensure transformation of all pharmaceutical plants of Bangladesh according to WHO guidelines for producing generic version of patented or molecule through Reverse Engineering. Active support for R and D is needed on molecule and innovative health care items. New entrepreneurs should be encouraged to establish plants for producing patented necessary drugs through Compulsory Licensing as per regulations of USFDA and UKMHRA to earn the necessary norms to export in regulatory market under the government support and supervision.

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11.

Conclusion

The pharmaceutical industry is highly complex. The technologies leading to drug discovery and development are at the limits of human knowledge. The huge size of the companies and the complexities of their processes and technologies presents many organizational and management challenges. The development and management of the distribution system is highly costly. However while excellence in managing all these aspects of the industry is a necessary condition for the survival of the global pharmaceutical companies, the uncertainty of the discovery process and the potentially huge returns from the discovery of a single drug means that like drilling for oil or randomly choosing the black beans from a jar of overwhelmingly white ones, success in the industry depends on a high measure of luck. Pharmaceutical sector has the potential to emerge as second largest export sector after readymade garments (RMG) sector. To get the maximum benefit of this potentiality, Government should attract foreign investors in establishing world class manufacturing facilities and also needs to make the domestic companies to perform bioequivalence tests after establishing a test center in the country. Consideration should be taken of the claim of pharmaceutical sector for cash incentives where companies can be given facilities to produce their products at reasonable cost. Wholehearted support from all stakeholders for growth of a potential sector like Pharmaceutical can bring great benefits for the countrys economy.

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12.

References

Bangladesh Statistical Year Book -2010,2011 Bangladesh Economic Review -2010 Export Receipt 2004-2010. (BEPZA, Contributions of Pharmaceutical Products in total export of BD, 15) The Daily Star, April 04, 2008 (Vulnerability Analysis of Pharmaceutical Industry of BD, 6) IMS. (2008). IMS Quarterly Review, 4th Quarter 2010. Begum, R. (2006). Pharmaceutical industries: Potential and Possibilities. NDC Journal. Available at http://www.ndc.gov.bd/pdf/2007/73-89.pdf. Official website of Board of Investment Bangladesh at www.boi.gov.bd. Official website of Export Promotion Bureau at www.epb.gov.bd. Official website of Directorate of Drugs Administration (DDA) at www.ddabd.org. World Bank. (2007). Improving the Competitiveness of the Pharmaceuticals Sector in Bangladesh. World Bank Draft Policy Note. Official website of Centre of Trade and Development at www.centad.org.

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13.

Appendix

Interview checklist Market share Sales turnover Profits Exports Global and local reach Total employees Forecasting data Future plans on market expansion Capacity API issue

Future Challenges to the growth of the Pharmaceutical Industry of Bangladesh