Pharma Trends … 1

Emerging Trends in the World Pharmaceutical Industry

Amit Rangnekar

PhD Programme-2004

Narsee Monjee Institute of Management Studies (NMIMS)

 Pharma Trends … 2
Executive Summary

As the young age faster and the old stay younger, the women’s health segment emerges stronger. These key

segments are driving the demand for lifestyle and lifecycle drugs. Dwindling growth rates, reduced margins and

drug safety concerns are fuelling a raging debate in the pharma world over the effectiveness and productivity of

exorbitant R&D spend.

Patent management remains a key area to protect the near total sales erosion of blockbuster drugs post expiry.

Mounting litigation costs are not deterring companies from developing countries to vie for a share of the lucrative

world pharma market through generics and contract manufacturing.

Amid this backdrop, India prepares for the shake out of the Post-2005 patent regime. Can India shed its copycat

image and leverage its adroit intellectual capital and famed reverse engineering skills to finally emerge as a

major global hub in R&D, formulations, bulk actives and intermediates.

 Pharma Trends … 3
Key certainties and their impact

Market Shifts

The frenetic pace of life, stressful and sedentary lifestyles coupled with junk food and irregular eating

habits are triggering worldwide demand for a variety of chronic (long term) therapies like Central

Nervous System (CNS), Cardiovascular and Diabetes drugs. Sales of hypertension, cholesterol,

depression, anxiety, diabetes, obesity and sexual dysfunction drugs are booming.

Acute v Chronic Therapy (Chart 1)

Lifestyle Segment-Leading players (Table1)
Lifestyle Segment World’s Leading Players
100 Obesity Abbott, Sanofi
80 35 Cardiovascular Pfizer, Merck
60 73 Diabetes Aventis, Pfizer
Acute
40 Psychotropics (CNS) Lilly, GSK
65 Chronic Ulcers AstraZeneca, Abbott Source- ORG IMS
20
27 Sexual Dysfunction Pfizer, Lilly, GSK
0
World India

Worldwide, chronic therapies like Cardiovascular, CNS, Diabetes & Nutritional drugs contribute to more

than 65% of the market. In India, acute (short term) therapies like pain, infections, cough, cold & fever

drugs contribute to 73% of the market while chronic therapies contribute only 27%. Anti-Infectives
(1)
account for 27% of the total Indian Pharma market .However there is a perceptible shift towards
(2)
chronic therapies in India with Diabetes, CV & CNS drugs registering robust growth . The future bodes

well for companies focusing on these segments.

The impact of these changes is felt in the vulnerability of the younger age groups to serious disorders.

The age group vulnerable to cardiovascular, diabetic, psychotropic & sexual dysfunction disorders has
(3)
reduced from 60+ years in the 1970s, to 50+ in the 1980s to 40+ in the 1990s to 30+ today . Every

sixth diabetic in the world is an Indian today, but by 2030, every second diabetic is going to be Indian as

the Indian diabetic population is set to explode from 32 Million in 2003 to 81 Million in 2030 (4).

On a contrary note, better healthcare facilities and medicines have led to increased life expectancy

levels worldwide (India 64 years). This has spawned a growing geriatric (Age >55 years) market
 Pharma Trends … 4
resulting in a high incidence of unique geriatric disorders like Alzheimers, Parkinsonism, Kidney (Renal)

& Eye (Retinal) and a variety of Cancers.

Steady Reduction in Vulnerable Age for

Cardiovascular Diseases (Chart 2)
60
50
40
30

1970s 1980s 1990s 2000+

Source- Centaur Pharmaceuticals- Survey of 120 Indian Medical Consultants, November 2003

People contract serious disorders at an young age but through better medicines are living longer,

exposing them to the risk of geriatric diseases. Drugs prescribed for such disorders are rarely changed,

unless there is no drug effect or a side effect. These chronic disorders rarely have outward symptoms.

The average period for which drugs for hypertension, cholesterol, diabetes and mental disorders are

being consumed have doubled over the last decade from eight years to sixteen years (5).

The lifestyle and geriatric segments are thrust areas for pharma researchers and marketers and should

continue to drive growth in the near future.

Focus on Women's Health

Women have emerged as a key consumer, accounting for a greater share of prescriptions and

patients(6), than men. Increase in the number of working women worldwide, is exposing them to the

perils of stress & sedentary lifestyles. Pharma R&D is focused on each stage of the female life cycle in

unique segments like menstrual disorders, pregnancy, infections, hormones, contraception, cancers,

mental disorders and osteoporosis.

 Pharma Trends … 5
Women Life Cycle & Disease / Disorder Profile (Table 2)
Menarche Child Bearing years Pre Menopause Post Menopause
Nutrition Infections Infections Hormone Therapy
Acne Contraception Contraception Osteoporosis
Anxiety Nutrition Nutrition Cancer
Appetite Anxiety Depression Depression
Pregnancy Diabetes Arthritis
Diabetes
Cardiovascular
Post-menopausal cardiovascular disorders have emerged as the leading cause of death in women,
(7)
even exceeding cancer . Besides, women are also existing major markets for nutritionals, skin &

beauty products.

Alternate Therapies

(8)
The world market for Herbals in 2002 was $62 Bn with a steady growth growing steadily with Europe

accounting for a 49% market share. Herbals are traditionally perceived to be devoid of side effects by

the consumers and result in self-medication and long term use. Acceptance is very high as majority of

the drugs are over the counter (OTC or Non prescription). Oral publicity and faith across generations

fuel the demand for these drugs.

The Indian System of Medicine (ISM) includes ayurveda, unani, siddha and homeopathy, but is

concentrated mainly in the unorganized sector and on a smaller scale. The $ 1 Bn Indian market is
(9)
dominated by ayurvedic drugs contributing 83% of sales and showing excellent growth . Even a

Supreme Court judgement (10), restraining doctors of a speciality (eg ayurveda ) from prescribing drugs

of another speciality (eg allopathy) and vice-versa has not deterred prescriptions across specialities

leading to a boom in the ISM products.

 Pharma Trends … 6

2002 World Herbals Market- $62 Billion 2002 Indian System of Medicine-
(Chart 3 ) $ 1 Billion (Chart 4 )

North Others
7% Homeopath Unani Siddha
America y 2% 0%
11% 14%
EU 49%
Japan
16% Ayurveda
ASEAN 84%
17%

Source-The Pharma Review- Alternate Medicine October 2003

(11)
In India, alternate therapy practitioners (6.5 Lakhs) outnumber allopathy practitioners (5.5 Lacs) .

Many practitioners of alternate therapies also dispense these drugs raising serious quality concerns.

Few leading Indian pharma companies market allopathic as well as ayurvedic drugs. Established Indian

ayurvedic companies like Himalaya, Dabur, Zandu and Charak generate majority of their prescriptions

from allopathic doctors and export worldwide.

Leading players are entering this segment as prescriptions for ayurvedic drugs are generated even for

major indications like pregnancy, diabetes, liver, cardiovascular & psychotropic disorders. Earlier

prescriptions were confined only to nutritionals, gastro-intestinal disorders and aphrodisiacs. Alternate

therapies pose a serious threat to allopathic drugs, especially with better standardization.

Key Uncertainties and their impact

New Drug Approvals (NDA)

New drugs take 10-12 years of R&D and $800 Mn+ in investments before approval from the US Food &
(12)
Drugs Administration (USFDA) . R&D investments crossed $50 Bn in 2003 (13) almost quadrupling

from the 1990 R&D spend. R&D costs of the top companies hovered around 10-15% of sales with

Pfizer-Pharmacia R&D budget for 2003 topping $7 Bn. This has raised serious issues of R&D

productivity as heavy investments are yet to pay off.

 Pharma Trends … 7

R&D Spend in $ Bn
(Chart 5 )
50
50 38
40
30 14
12
20
10
0
1980 1990 2000 2003

Source- IMS

New Drug Approvals 1999-2003

(Chart 6 )

50 46
40 38
40 36
30
30
20
10
0
1999 2000 2001 2002 2003

(14)
NDA have steadily reduced to an all time low of only 30 drugs in 2003 raising serious issues over

R&D productivity & feasibility. Reduced NDA have led to drying pipelines among top organizations

threatening their survival.

Major companies are outsourcing their R&D needs at various stages to smaller players in speciality

segments or to developing nations. Clinical research & trials although banned earlier are selectively

allowed now in India and this is a major opportunity for India due to its huge population and low costs.

Safety concerns about drugs can arise subsequent to launch or even later which can cause major

implications for the company and drug including withdrawal. Eg Vioxx

 Pharma Trends … 8

The approval process entails animal and human studies across various parameters and phases. Out of

5000 drugs applied for, less than 5 proceed for clinical testing, out of which only 1 is approved (15). If NDA

is unsuccessful, it can threaten the very existence of the company. Today companies merge, essentially

to save on R&D costs which otherwise are as high as 15% of sales (16).

At present, only 10% of Phase I products reach the market. This low success rate is the major reason

for the $800 Mn+ costs of developing each commercialised product – out of which only 30% is

profitable. In 2002, of new drugs approvals only 22% were for new molecular entities, with the majority

being made up of line extensions, new formulations etc.

Drug Development Process of USFDA (Table 3)

Pre-Clinical Phase I Phase II Phase III USFDA Phase IV

Years 6.5 1.5 2 3.5 1.5
Test Lab, Animal 20-100 healthy 100-500 1000-5000 Review

Population studies volunteers patients patients

Purpose Safety and Safety Effectiveness, Effectiveness, Review process Additional

Biological and Dosage Adverse Drug Adverse Drug and approval Post-

Activity, Reactions Reactions, Marketing

Formulations Long term use testing

Success 5000 5 Compounds enter clinical trials 1 compound
required
Rate compounds approved
by USFDA
Costs $ 800 Mn +

Source-Tufts Centre for Drug Development, Nov 2001

For specific segments like HIV or some Cancers, drugs are fast-tracked circumventing the full 10-12

years needed for R&D as these are life saving drugs. Major companies were focused on the following

areas for R&D(17).

 Pharma Trends … 9

Major R&D Therapies Spend in $ Bn -2001 (Chart 7)

GI 1

Respiratory 1.5

Biologicals 2.4

nfections 3.6

CVS 4.1

Cancer, Diabetes 5

CNS 6 Source- Scrip Annual Review 2001

Successful future drugs will be those that are efficacious, safe and can be used across multiple

indications & specialties.

Critical Transforming Technologies (CTT)

CTT like Genomics, Proteomics and Nanotech could obviate the need for drugs in future if they are safe

& commercially viable. With these technologies, the ability of a person to contract a particular disease

could be predicted much earlier with a fair degree of accuracy. Then, the concerned gene could be

modified to avert the disease. Side effects though have not been fully studied of such technologies but

they promise much hope.

Advances in Novel Drug Delivery Systems (NDDS) could ensure ease of administration of medicine,

which if viable, can fuel demand due to sheer convenience. NDDS includes Inhaled Insulin, Nasal Viral

Spray, Anti-Cold Chewing Gums & Angina Patches. Ease of use of such treatments can ensure

excellent compliance levels, a serious concern today.

CTT could look at small but premium markets within major markets to offset huge development costs

rather than concentrate only on mass markets. Eg Drugs for rare cancers whose prevalence is only in

25% of cancer afflicted women have emerged as $ 500 Mn markets for two cancer drugs.
 Pharma Trends … 10
The internet has the potential to make the Medical Representative redundant, the Trade insignificant

and savings in huge promotional costs, leading to fewer channels, easier patient and doctor access,

more information and ultimately cheaper pricing.

Patent Expiry Management

Patents are issued for a period of 20 years from the date of application and not from the date of launch.

This gives the drug a period of 8-10 years in which to recover an investment of more than $800 Mn and

also make profits for sustaining the organization and aiding further R&D.

Pharma industry operates on the ‘Blockbuster‘ model where many drugs reach more than $1 Bn in

sales and companies strive to develop blockbusters which gives them huge profits, trade muscle and

customer support. Currently there are 44 such brands in the WPM with Pfizer alone accounting for 9

blockbusters(18).

Value of Patent Expiries Therapy wise by 2010- $ 51 Bn

(Chart 8 )

8.7
8.1 7.8

6.3

4.5 4.3

2.9
2.1
1.5 1.4 1.3 1.6
0.8
Respiratory
CV

GI

Other
CNS

Pain

Ophthal
Onco

Neuro

Derma
Metabolites

Hormones
Infections

Source- Generics- CLSA Analyst Report-Oct 2002

Shortening brand reigns for top brands have been the norm in the world pharma market with peak sales

period being only 2-3 years for the major brands. Zantac, Losec and Lipitor all brand leaders, have

enjoyed major brand reigns but increased competition from same-in-class molecules has led to lesser

market share and hence a shorter brand reign.

 Pharma Trends … 11
Companies initially launch a drug only for certain indications and subsequently extend it for other

indications, perpetuating their monopoly eg A pain killer may initially be introduced only for arthritis and

subsequently extended for back ache, head ache, dental pain etc in various strengths (25 mg, 50 mg,

100mg) or across various forms like tablets for adults, syrup for kids and drops for infants.

Companies also work on racemic mixtures/isomers/salts or similar versions of the product that are

launched when the original product expires. Newer dosages like once daily instead of twice or newer

drug delivery systems like extended release could also be introduced.

Other tactics used are to sully the reputation of the existing product when the new isomer is ready, to

protect & expand their market. Combinations with other drugs are also used for synergy through

strategic tie-ups with players in similar markets.

Immediately after the patent expires, the drug can be launched in the generic form by a competitor who

gets an exclusivity of 180 days to market the product at a price determined by the competitor. This is

where smaller generic companies make money or receive windfalls as cost of manufacturing generics is

negligible. However the patent holders fight back and costs of litigation are exceedingly high. In 2003

the litigation costs of Pfizer, GSK & Wyeth were $4.5 Bn (19), almost equivalent to the entire Indian

pharma market.

Patent expiries result in sales erosion to the tune of even 80% in a single year and unless the drug

cannot be approved for newer indications / strengths / extensions / racemic mixtures to perpetuate their

stranglehold, generic approvals can wreak havoc. eg Prozac ( fluoxetine), an anti-depressant from Eli

Lilly lost 80% of sales value in the first year of patent expiry to generic competition (20).

Claritin, an anti-allergy blockbuster drug filed for the drug to be converted to (OTC) from a prescription

drug, immediately on patent expiry and successfully got the decision in their favour from the USFDA.

This was a unique decision and put the plans of Morepen, an Indian company, which had planned for
 Pharma Trends … 12
the generic rights, totally off course. This tactic can only be used for drugs with an OTC appeal like cold,

cough, allergy, fever drugs with a suitable safety profile

Top 10 Countries 2003 (Table 5)

Drugs worth $51 Bn are to go off patents by 2010 (21)
leading to a Markets $ Bn Markets $ Bn
US 211 UK 11
race for their generic drugs. This presents a major opportunity Japan 54 Spain 9
Germany 19 Canada 9
for Indian firms as it entails only a fraction of the cost & time France 17 Mexico 7.5
Italy 14 China 7
needed for new drug development. Ranbaxy is already among

the Top 10 Generic firms in the US. More than 25% of Abbreviated New Drug Approvals (ANDA) for

generic approvals were filed by Indian companies in 2003 (22). Generics account for 40% of all

prescriptions in the US but only 15% of the value(23).

Patented drugs lead to exorbitant pricing as costs of R&D and future drug development needs to be

recovered, which developing markets may not be able to afford. eg GSK's patented AIDS therapy costs

50 times Cipla's AIDS therapy which caters to crucial African & Asian markets. A classic case of rip-off

pricing under the garb of patents by drug majors.

The World and Indian Pharma

% Contribution of Major Pharma Markets (Table 4)
% 2000 2001 2002 2003 Markets- Insights
North America 48 50 51 49
Europe 24 24 25 28 and Issues
Japan 16 13 12 11
Latin America 6 5 4 4
Asia, Australia, Africa 6 8 8 8
World Pharma Market ($ Bn) 364 392 434 492 Source IMS

The World Pharma Market (WPM) grew @ 8% in 2003 to nudge $500 Bn in sales (24). It is slated to touch

$ 800 Bn by 2010(25). The top 10 countries account for 86% of world pharma sales with the US

alone contributing 47% and growing @ 10%(26). It is said that the country that wins in the US,

wins the world pharma market and every major player wants a slice of the hugely profitable US
(27)
market. The Top10 companies in the WPM contribute 45% while the Top10 companies in

India contribute 33% clearly conveying the fragmented nature (28).

 Pharma Trends … 13
The largest therapeutic class (TC) is cholesterol reducers but obesity & hypertension are slated to be

the biggest TCs by 2010(29). Lipitor (Pfizer), a cholesterol reducer (statin) continued its reign as the

worlds biggest brand clocking sales in excess of $ 10 Bn (30) (Twice the Indian Pharma market). The

Cardiovascular segment is the largest segment with a 20% market share, a pattern seen across the top

15 countries except for China & India where Anti-Infectives (24 & 30%) is the largest segment (31).

The Indian Pharma Market manages only 1% world pharma market share with a $5 Bn market growing

@ 8%. It is the world’s 14th largest market in value terms but 4th largest unit wise. By 2010, it is

estimated to double to $ 10 Bn with a 1.25% share. Chronic therapies would then contribute 50% and

major segments would be Cardiovasculars and CNS. Antibiotics would reduce from 30% today to 23%

in 2010(32).

Therapeutic Contribution- India 2000-2010 (Chart 9 )

100%

80%

60%

40%

20%

0%
CNS Cardio Nutrients GI Infections Pain Respiratory Others

2010* 10 23 6 10 23 9 8 11
2005* 9 15 7 11 29 6 8 15
2000 6 9 10 11 32 6 8 18

Source- India’s Pharma challenge-The Mckinsey Quarterly 2001

The Indian Pharma Market has seen dwindling growth rates from 15%+ growth of the 1980s & 10%+

growth of the 1990s to 8% today. Out of this 8% growth, new products contribute 8% and price

increases 1%. but degrowing existing products @ -1% ensured overall growth remained at 8% (33).

With product patents effective Jan’05, the frequency and as a result, value of new products would

considerably shrink, further curbing growth. Seven Indian companies rank among the top 10

companies against only three MNCs (GSK, Pfizer and Aventis) in 2003, a far cry from the 1980s when

six MNCs ranked in the top10.

 Pharma Trends … 14

Growth Components
Plummeting Growth Rates (Chart 11 )
(Chart 10 )

20
20 15 -1
Old Products
10
8 1
10
New Products 8
0
1980 2000 -2 0 2 4 6 8 10

Source- The Indian Pharma Market Intelligence, IMS Direct Issue, December 2002

The Indian patents act of 1970 acknowledged process patents and not product patents, which gave

local players an impetus to emerge strong producers of formulations and bulk actives by copying

patented drugs through reverse engineering, and sell at affordable prices. This act thwarted plans of

MNCs, who then did not file patents in India. Post 2005 this would change as product patents would be

applicable which would facilitate patented new drugs from the MNC stables at exorbitant prices.

A vagary of the Indian pharma market is that eight out of the top 10 brands are more than thirty years

old(34) and have withstood intense industry competition. In India, MNCs have been more adept at

building and sustaining huge brands than Indian companies.

Traditionally new products have taken time to enter the top brands league eg There is only one brand

(Zifi) launched in the last five years among the top 50 brands in India unlike in the world market, where

all brands in the top 40 are less than fifteen years old except for Adalat (Bayer’s Nifedipine) launched in

the late 70s.

Government pricing pressures are severely affecting margins worldwide especially in EU, Japan &

India. Net profits of the top 15 firms worldwide averaged only 5.5% in 2003 against 9% in 1998. In India,

the Top 10 Indian firms garnered average net profits of 9% in 2003 (35).

Appeasement of trade channels continues worldwide, with retailer margins @ twice the industry

margins. Average margins of pharmacies on drugs are 16-20% in India and 20% + outside.
 Pharma Trends … 15
Synergies in M&A are not evident either in terms of major R&D savings or increased New Drug

Approvals. Shareholders are dismayed and worker lay-offs continue to mount.

Counterfeiting of drugs is rampant, as one in ten medicines sold worldwide is fake, treating nothing but

providing about $ 32 Bn (six and half times the Indian pharma market) in annual sales for drug dealers.

WHO estimates 200,000 annual deaths from malaria could be avoided if available medicines were of

high enough quality to be effective. China, Nigeria, former Soviet republics, India and Bangladesh are

countries regularly singled out by pharmaceutical firms as centres of counterfeit production, and its

distribution follows routes used by established drug traffickers. This menace can only be arrested by

stricter controls and policies.

The Future for India …. Opportunities unlimited

Post 2005, the Indian pharmaceutical market is due for a paradigm shift and many of India’s 20,000+

pharma companies may not survive the post patent scenario as it will shut out the one opportunity that

allowed most Indian drug manufacturers to flourish - reverse engineering. But, local majors could even

benefit, as drug prices in the country may rise. With a lead time of ten years to prepare for TRIPs since

1995, many home grown companies have embarked on survival strategies, including:

 Mergers and acquisitions, within India and overseas eg Wockhardt

 Presence in new markets, particularly in the developed and developing countries eg IPCA

 Licensing agreements, in- and out- eg Glenmark

 New chemical entities (NCE) R&D and new drug delivery for old products eg Dr Reddys

 Consolidation to emerge as specialty pharma company with critical mass eg Cipla

 Niching into specialty segments eg Natco

 Establishing capacities abroad eg Ajanta Pharma

 Contract manufacturing eg Nicholas Piramal

 Generics eg Ranbaxy

 Tie-ups for bulk actives and intermediates eg Centaur

 Pharma Trends … 16
Lack of patent protection in India, enabled local companies to build their businesses largely on the

manufacture and sale of drugs discovered by other firms, often launching copies in India before the

originator had introduced them in leading global markets. To avoid patent litigation, many developed

new production methods to avoid infringing process patents, which are considered valid in India. US

companies lose $1.7 Bn(37) annually to Indian companies due to lack of intellectual property protection

exports to countries with poor patent protection.

Technical expertise has put Indian producers in pole position to launch their generics in more lucrative

developed markets once the brand’s patents and/or exclusivity periods have expired. Ironically, the

adoption of TRIPs in their domestic market has encouraged companies like Ranbaxy, Dr Reddy’s and

Cipla to turn to the US, where a number of blockbusters have still to go off-patent.

Strategic options for Indian companies

Local

 Only 40% Indians afford medicines. This latent demand can be exploited through government

support and medical Insurance to profitably market to the bottom of the pyramid

 India can emerge as a major market for developing new drug intermediates for pharma majors

 Existing Indian companies can consolidate operations to achieve critical mass locally and build

substantial presence in lifestyle segments especially CV, CNS, Diabetes, Obesity. Niche by

encashing doctor franchise across therapeutic categories and doctor specialities

 Explore OTC and Herbals options in India

 Leverage distribution and marketing reach to form alliances and explore co-marketing options

International

 Acquire smaller manufacturing firms in strategic markets with access to major markets eg

Eastern Europe catering to the EU or Central America catering to the US and Latin America.

 Cost of drug discovery in India is a fraction of the cost in the US. India’s quality intellectual

capital can be used productively for clinical research, biotechnology and R&D.
 Pharma Trends … 17
 Optimise low operational costs and reverse engineering skills to emerge as ‘Pill factory to the

world’. Affirm status as the country with the largest number of USFDA-approved manufacturing

plants outside US through major contract and generic manufacturing tie-ups

 India’s strategic location can cater effectively to the orient or the occident. Exports currently

worth $2 billion a year, could be boosted to make the Indian industry a truly global player

 Foray into Herbals especially in Europe or Asia

 Provide low cost technology inputs to major players

 Establish presence in least developed countries (LDC) where patents would be applicable in

2014 eg Nepal and Bangladesh

Post 2005, 15% or (Rs 3000 Crore) worth of patented products manufactured by Indian firms would

have to be withdrawn due to patent infringements. The initial impact of TRIPs could be modest,

especially as the Indian government is expected to do the minimum necessary to comply. MNCs may

keep their drug prices at the lower end of the global scale but as MNCs seek to have their products

protected, strong lobbies would press for the continuing manufacture of cheap retro drugs.

"India's not there yet, not in the same category as China or Mexico as it is only about to

recognise IPR next year. And it will take some years... before there really is a sound base for a

multinational company to develop and launch its new products in India with great success. But

it will come in time and I'm confident India will become an important market." Sir Tom McKillop,

CEO-AstraZeneca, October 2004 commenting on the company’s decision not to launch any

new molecule in India till 2008 due to weak Intellectual Property Rights (IPR) (38).

Research Questions that emerge

 The young get older but the old stay younger- Key dynamics driving these pharma market shifts

 Leveraging its huge intellectual capital, reverse engineering skills and low cost base, can India

emerge as the ‘Pill factory & Research capital of the world’

 Can accessibility & affordability of quality medicines be increased in India to profitably market to

the bottom of the pyramid

 Pharma Trends … 18
 Is Generics the big opportunity for pharma companies in the developing world or would they be

washed away in the legal muddle

 Will India unleash its potential to emerge as a pharma global giant or would it remain an

underachieving pygmy

 Could the patent regime be the beginning of the end for the adroit Indian pharma industry or

would homegrown reverse engineering skills and tacit government support see them flourish

 Can R&D be made more productive, effective and profitable

 What would be the key sustainable strategies in successfully marketing drugs to Women

 Can critical transforming technologies be made efficacious, viable and safe; obviating the need

for traditional drugs, and hence pharma companies

 What are the crucial factors affecting the marketing performance of pharmaceutical firms

Bibliography

 IMS Annual Review-1995, 2000, 2001,2002,2003

 Scrip Annual Issue- 1999, 2001, 2002, 2003

 Express Pharma Pulse

 Pharmabiz www.pharmabiz.com

 The Mckinsey Quarterly

 www.coreynahaman.com

 Business World

 The Economic Times

 Pharmawire

 Datamonitor

 ORG-IMS

 IDMA Bulletin

 WTO-TRIPS Draft
 Pharma Trends … 19
 Merck Manual

 Business World

 USFDA

 NPPA

 WTO

 New England Journal of Medicine

 The Lancet

 IndiaInfoLine-Pharmaline

 Medline plus

 PhRMA

 World Bank

 WHO

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(3) Survey of 120 Indian Medical Consultants, Centaur Pharmaceuticals, November 2003

(4) Poinasamy,D., Kermani,F.,Diabetes and the Developing World, Chiltern,31 March 2004

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(6),(7) Blackwell D, Becoming Woman Wise, Pharma Marketing News,Vol.3,No.8:September 2004

(8),(9) Alternate Medicine,The Pharma Review- October 2003 P 62-63

 Pharma Trends … 20
(10) Mukhtiar Chand v State of Punjab, SC judgement

(11) Alternate Medicine,The Pharma Review- October 2003 P 62-63

(12) Tufts Centre for Drug Development, Nov 2001

(13) Lipitor leads the way in 2003, IMS Global (18 March 2004), Retrieved on 19 March 2004 from

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(14) Treating the poor health of the industry, IMS Global (29 September 2004), Retrieved on 30

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(15) Tufts Centre for Drug Development, Nov 2001

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(17) Annual Report, IMS 2001

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(21) CLSA, Analyst Report-Pharma, 2002

(22) Could Indian drugmakers TRIP on patent reform. IMS Global (27 October 2004), Retrieved on 28

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(23) Annual Report PhrMA 2003

(24) Annual Report, IMS 2001,2002,2003,2004

(25) Global Pharma Market-2003,Datamonitor, June 2004

 Pharma Trends … 21
(26),(27) Lipitor leads the way in 2003, IMS Global (18 March 2004), Retrieved on 19 March 2004 from

http://www.ims-global.com/insight/news_story/0403/news_story_040316.htm

(28) ORG-IMS July 2004

(29)

(30) Lipitor leads the way in 2003, IMS Global (18 March 2004), Retrieved on 19 March 2004 from

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