Brand managed by-

Rishi nagar (B009)

Ridhish ahuja (B026)
Asim dave (B035)
Aditya chaudhari (B037)
Ayush sharma(B046)

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 1. PEST ANALYSIS

1.1 Political
1. Currently, Montelukast Sodium (Singular) is not under price control policy (DPCO)
2. With the election in US, with Republican’s majority, the price briches on the drugs are now relaxed and
as democrats were more seen to have policies to scrutinize the prices of the drugs, hence US still remains
one of the important and profit making market till now.
3. The impact of GST on drug price will be neutral.
4. Demonetization has resulted into a dip in sales of chronic, acute and sub-chronic therapy.

1.2 Social
Demographics -:
1. It affects up to 20 percent of children and 15 to 30 percent of adolescents.
2. Boys are twice as likely to get allergic rhinitis as girls.
3. Half of children develop the condition before age 10, and half after that time.
Geographic-:
1. Some regions of the country are more likely to have the pollens that cause AR, so those areas will
have more children with the condition.
2. Highly polluted regions like Delhi, we can see there is a surge in sales of anti-allergic and anti-
athematic drugs.
3. Pollution levels in the capital are 8-10 times greater than the standard level during winters,
(according to Anumita roy chaudhary,, head of the air pollution and clean transportation
programme at the Centre for Science and Environment.), which has led to high such a high demand
for drugs that even chemists are facing shortage of supply for anti-allergy drugs.

Consumer buying pattern –:

1. For three categories, antihistamines (86% of the national average), decongestants (70%), and pain
relievers (89%), consumers in the western United States report usage rates somewhat below other
parts of the country. Compare this to North westerners, who purchase decongestants (e.g., Mucinex)
at 128% and pain relievers (e.g., Tylenol) at 111% of the national average.

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1.3 Economical -:
1. Due to inflation there is a rise in prices of the drugs affecting the hierarchy of people in the segment.
Those with positive response are the Brand manufacturers, wholesalers & pharmacies. And the worst
affected group in healthcare are the customer along with 3rd party payers like insurance companies.
2. With the rise in US dollar power, exports of anti-allergic medicines will lead to increase in the profit.
3. Demonetization has led to temporary decrease in the sales for the acute allergic rhinitis therapy while the
chronic allergic therapy segment remains unaffected.

1.4 Technology -:
Technology that is used in the therapy area of allergies and asthma are-:
1. Air Purifiers.
2. Bronchial Thermoplasty
3. Immuno Therapy
4. Hypoallergenic Bedding

 PREVELANCE & INCIDENCE

1 The prevalence of bronchial asthma pooled for all the 12 centres was found to be 2.05% (range,
0.4%–4.8%), according to a study on Epidemiology of Asthma, Respiratory Symptoms and Chronic
Bronchitis (INSEARCH) based in India. The study covered 12 centres comprising of both rural and
urban areas spread over different parts of India.
2. Advancing age, smoking, household environmental tobacco smoke (ETS) exposure, asthma in a first
degree relative and use of unclean cooking fuels have been associated with increased odds of asthma,
this again lead to increase in prevalence to asthma in children. In India, it has been studied and the
mean prevalence has been found to be 7.2±5.4 percent.
3. In the socio-demographic analysis, urban children have higher general prevalence with male
predominance. In another study done in school girls (4-17 years), the prevalence of asthma was
found to be 8.8 percent.
4. In a study pointing socio-economic status of family, the prevalence of asthma in children was 9.4%
in lower class, 7.3% in middle class, 9.4% in upper class in urban area of Delhi and 3.9% in village
area of Delhi.

 PATIENT MANAGEMENT

Age-:
The peak incidence of 37 per 1000 occurs at 10 to 15 years of age, with the incidence over 65 years of age
being less than 3 per 1000.
Allergic rhinitis, also known as "hay fever," affects approximately 20 percent of people of all ages.
Allergic rhinitis can begin at any age, although most people first develop symptoms in childhood or young
adulthood. The symptoms are often at their worst in children and in people in their 30s and 40s. However,
the severity of symptoms tends to vary throughout life.
 Paediatrics -: Studies in children 6 to 14 years of age have found a similar efficacy and side effects
profile to that in adults.

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 Adolescents -: The pharmacokinetics of the 10-mg tablet are similar in adolescents 15 years of age and
older and young adults; the pharmacokinetics of the 5-mg chewable tablet in children 6 to 14 years of
age are similar to those of the 10-mg tablet in adults.
 Geriatrics-Rhinitis in the elderly is a common but often neglected condition. The pharmacokinetics and
oral bioavailability of Montelukast are similar in elderly and younger adults.

Sex-:
Women who have allergic rhinitis before pregnancy may have worsening, improvement, or no change in
their symptoms during pregnancy. Most women notice some nasal congestion in the later stages of
pregnancy, even if they did not have rhinitis before. This is called rhinitis of pregnancy and is related to
hormone levels. Rhinitis of pregnancy does not respond to medications and goes away after delivery.
1) Reduce exposure to triggers -:
 There are some simple measures that can reduce exposure to allergens and triggers that provoke
allergic rhinitis.

2) Antihistamines
 Antihistamines are a mainstay in treatment of allergic rhinitis. The first-generation or "older"
antihistamines are effective in reducing sneezing, itching, and rhinorrhea. They have untoward side
effects, however, that are particularly notable in the elderly patient.

3) Decongestants
 Decongestants are α-adrenergic agonists that reduce nasal swelling, thus relieving congestion. The
most commonly used agent is pseudoepherine. Central nervous system stimulation by these agents
may result in anxiety, irritability, insomnia, and palpitations.

4) Anti-inflammatory nasal sprays

 These agents may be useful in reducing sneezing, itching, congestion, and rhinorrhea

5) Environmental control
 Reducing exposure to allergens and irritants is an important adjunct in treating patients with allergic
and idiopathic rhinitis.

6) Immunotherapy
 If environmental measures and appropriate medications are not helping the patient with allergic
rhinitis, immunotherapy (allergy injections) can be instituted

Condition of Patient (Important Factors for dosing pattern) -:

1) Elderly Patients-
 There are a number of specific factors that affect medical treatment of the elderly including
polypharmacy, cognitive dysfunction, and changes in body composition, impairment of liver and
renal function.

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 2) Pregnant Women –
 Most women notice some nasal congestion in the later stages of pregnancy, even if they did not have
rhinitis before. This is called rhinitis of pregnancy and is related to hormone levels. Rhinitis of
pregnancy does not respond to medications and goes away after delivery.
*This medication should not be used during pregnancy unless the benefits outweigh the risks.
3) Breast-feeding -
 It is not known if Montelukast passes into breast milk. If you are a breast-feeding mother and are
taking this medication, it may affect your baby.
Children –
 The safety and effectiveness of Montelukast have not been established for children under 2 years old.
Montelukast can be used to treat asthma in children aged 2 years and older and to treat seasonal
allergies in adolescents 15 years and older.
Dosage -:
1. Fertility-: A reduction in fertility was seen in female rats on oral doses of montelukast of 200 mg/kg.
2. Breast Feeding -: It is not known whether montelukast is distributed into breast milk in humans.
Hence, very controlled dose is needed to be prescribed
3. Paediatrics -: Studies in children 6 to 14 years of age have found a similar efficacy and side effects
profile to that in adults. Adverse reactions, such as diarrhoea, laryngitis, pharyngitis, nausea, otitis,
sinusitis, and viral infection were slightly more frequent in the paediatric group.
4. Adolescents -: The pharmacokinetics of the 10-mg tablet is similar in adolescents 15 years of age and
older and young adults; the pharmacokinetics of the 5-mg chewable tablet in children 6 to 14 years
of age is similar to those of the 10-mg tablet in adults.
5. Geriatrics -: The pharmacokinetics and oral bioavailability of montelukast are similar in elderly and
younger adults. Hence there is not much difference in the dose range of elderly patients.

 EMERGING TREATMENT MANAGEMENT

1. Immunotherapy is a preventive treatment for allergic reactions to substances such as grass

pollens, house dust mites and bee venom.
2. Mast Cell Inhibitors
3. Allergy Shots
4. Dehumidifiers
5. Auto Injectors
6. Anticholinergic nasal sprays

 DISEASE BURDEN
1. Approximately 20% to 30 % of total population suffers from at least one of these allergic diseases in
India.
2. Studies have reported that 20% to 30% of the population suffer from allergic rhinitis and that 15%
develop asthma.
3. The total burden of this disease lies not only in impaired physical and social functioning but also in a
financial burden made greater when considering evidence that AR is a possible causal factor in
comorbid diseases such as asthma or sinusitis.
4. Hidden direct costs include the treatment of comorbid asthma, chronic sinusitis, otitis media, upper
respiratory infection, and nasal polyposis. Nasal congestion, the most prominent symptom in AR, is

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 associated with sleep-disordered breathing, a condition that can have a profound effect on mental
health, including increased psychiatric disorders, depression, anxiety, and alcohol abuse.
5. Furthermore, sleep-disordered breathing in childhood and adolescence is associated with increased
disorders of learning performance, behaviour, and attention.
6. Patients struggle to alleviate their misery, frequently self-adjusting their treatment regimen of over-
the-counter and prescription medications because of lack of efficacy, deterioration of efficacy, lack
of 24-hour relief, and bothersome side effects.

References:
(1) Kumar R, Nagar JK, Raj Neelima, Kumar P, KushwahAlka S, Meena M, et al. Impact of domestic air
pollution from cooking fuel our respiratory allergies in children in India. Asia Pacific J Allergy
Immunother 2008;20:213-22

2. MARKET DEFINITION
The therapeutic class that involves Singulair is anti-asthmatics and for seasonal allergy. This class has a
molecule of Montelukast Sodium.

2.1 MARKET EVOLUTION

Market Size Evolution

2014 2015 2016 2017(FCAST) 2018(FCAST) 2019(FCAST)

69522.279 86974.164 82111.378

Sales (Value of
MAT) 97712.539 93804.037 113502.884

%Change in
Value -2.78% 20.06% -5.92% 19% -4% 21%

%Change in
Units -15.77% 12.70% -14.56% 15% -13.74% 20%

2.2 PRODUCT AND COMPETITOR ANALYSIS

Rs '000 Sales Current Brand % of total

MAT 2016 Company Sales Promotion Level Sales Force

Singulair- MSD Pharma 82111.378 10% M 350

Emlukast FX - Dr. Reddy's Labs 47088.235 M 400

Montair–Cipla 329875.927 M 600

Romilast– Ranbaxy 94832.241 M 550

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Telekast - Lupin Ltd 86079.526 M 400

2.3 INDICATION

Exercise Allergic Ashama

Allergic induced skin with allergic
Asthma Rhinitis Hay Fever bronchospasm conditions rhinitis

Singulair- MSD Pharma X X X X X

Emlukast FX - Dr. Reddy's
Labs X X X X X

Montair–Cipla X X X X X

Romilast– Ranbaxy X X X

Telekast - Lupin Ltd X X X X

3. Customer Analysis
Customers Ranked By Size (#) Influencer Who Contacts
Promotional Priority (Yes, No)
GPs 40000 Yes MR
Specialists 25000 Yes MR, RBM
Hospital HCPs 20000 Yes MR
Key Opinion Leaders 750 Yes MR,ABM

4. PLANNING CONSIDERATIONS

4.1 SWOT ANALYSIS

 Strength
1. Patient Compliance- As it is available in tablet, a chewable tablet, flash tablet and granules to take by
mouth.
2. It can be taken with or without food.
3. Have various applications like- treating Allergies, Asthma, Inflammations, Hay fever and
bronchospasm.
4. It has very few drug- drug interaction, hence safe to use and can be given in combinations.
5. Target specific drug and hence low toxicity.
6. The molecule is not covered under DPCO.
7. Large market size – as 20-30% of people living in India suffers from Allergy Rhinitis.

 Weakness
1. Side effects like- Gastrointestinal distress, headaches and hypersensitivity.
2. Delivery system of the drug is conventional. While many modified delivery systems are available.
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 3. Singulair doesn’t treats allergic skin conditions while other drugs in the market do.
4. Adverse effect may worsen the condition of the patient. Like- Abdominal pain, fever, fatigue,
headache, etc.
5. Many generic drugs available.

 Opportunity
1. Wide range of upcoming applications, like it may be used to treat Parkinson’s disease.
2. With high pollution, the demand for the drug is going to increase.
3. Around 20-30% of population in India suffers from Allergy Rhinitis and the number is increasing
with the change in climatic conditions.
4. Combination drugs can be made as it has a lower drug-drug interaction.

 Threats
1. Many generic version of this molecule is out.
2. Many combination drugs are out of the competitors with more applications.
3. Biologic agents possess a big threat as they can replace the existing treatment with more advanced
and targeted therapy.

5. POSITIONING

Key customer benefit:

1) It is indicated for prophylaxis and for chronic treatment of asthma.
2) Montelukast can be used before exercise to reduce breathing problems during exercise.
3) It is used to control symptoms of allergic rhinitis.
4) It can be given to children & adults.
5) Singulair can be taken with or without food.

To To pulmonologists and GPs that treat patients of asthma and allergic

rhinitis
Singulair is the Is a brand of drug montelukast sodium

That Is the choice of drug for asthma and allergic rhinitis

That’s because It is a safe drug which can be taken with or without food and can be
administered to pediatrics as well as to elder patients and improves
the patient’s quality of life, by preventing exercise induced bronchial
constriction so as to make better and asthma free world.

6. BCG MATRIX
Singulair as a brand for the treatment for Asthma and Allergy Rhinitis, contributes to give 10% of total
company’s sales. Although it aims to treat a growing therapy area with some unique benefits which its
competitors doesn’t shares, even though its competitors has acquired relatively high market share as
compared to Singulair (with Rs. 8,21,11,378 of sales , MAT 2016).
Hence, it falls into the category of Dogs.

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It could be still considered to invest as it has a good future potential, (as studies for its clinical benefits for
Parkinson’s disease is going on and high demand for anti-asthmatic drug is increasing) with that it also gives
a tough fight to its competitors for its wide range of applications.
It is also important for the company to be in this therapy area, as the demand for the anti-asthmatic drugs is
escalating. Hence, Singulair should be in the market, which will make the company’s presence felt.

SINGULAIR

7. BUSINESS GROWTH DRIVERS

1) Pollution
2) Price is not capped by DPCO
3) R&D Pipeline (At lower dose, can be used for dementia according to clinical studies.)
4) Combination drug (Less drug interactions)

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 8. PERCEPTUAL MAPPING

Expensive

Montair Singulair
allergic skin
conditions

Asthama
Telekast

Emlukast

Romilast

Affordable

9. Patient Funnel:

INDIAN population 1.3 Billion

300 million asthmatics worldwide and 1/10th are

from INDIA, so 33.3%

Geriatrics suffering from Asthma (21- Paediatrics suffering from Asthma (10-
22%) 11%)

Price of SINGULAIR (INR ₹ 105

for one pack (Volume of 7)

10% of Asthmatic population can’t afford the drug

(Lower class of people)

27 million is the targeted population

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 10. PROFIT AND LOSS ACCOUNT

Profit AND Loss Statements

Attributes

Total sales 82111370

COGS 32844548

Gross Margin 49266822 60%

Marketing Expenses 98,53,364.40 20%

Administrative Exp 34,48,677.50 7%

Sales & Distribution 49,26,682.20 10%

Brnad Profit 3,10,38,099 37.80%

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