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PharmaceuticalsMARKET & OPPORTUNITIES
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CONTENTS
A report by Ernst & Young for IBEF
PharmaceuticalsMARKET & OPPORTUNITIES
Market Overview 2
Policy 10
Key Trends & Drivers 13
Key Players 21
Key Opportunities 27
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M A R K E T & O P P O R T U N I T I E S2
ANTI INEcTIvES -
LARgEST ThERAPEUTIc cATEgORy
Anti-inectives is the highest revenue earning segment with
a contribution o 18 per cent to the total domestic sales in
2005-06. Gastro intestinal (GI) and cardiovascular are the 2nd
and 3rd largest therapeutic categories, respectively.
Cephalosporins, penicillins and quinolones are keydrug classes among anti-inectives, with a share o around
78 per cent o the countrys anti-inectives market.
Market Overview
INdIAN PhARMAcEUTIcAL
MARKET US$ 7.3 bILLION OPPORTUNITy
India is among the astest growing pharmaceutical
markets in the world. The domestic pharmaceutical market
recorded sales o US$ 7.3 billion in 2006 with a growth o
17.5 per cent over the previous year. O this, retail sales were
US$ 6.2 billion, while institutional sales were estimated
to be around US$ 1.2 billion.
The Indian pharmaceutical industry was estimated
to be around US$ 13.2 billion in 2006-07. O this, domestic
consumption o pharmaceuticals accounted or nearly
57 per cent while the rest 43 per cent was constituted
by exports. The domestic market has grown at a composite
CAGR o 9.5 per cent over the past ve years. However,
in 2006, the market witnessed an accelerated growth o
more than 17 per cent, primarily on account o increased
clarity on tax reorms especially the Value Added Tax (VAT)
implementation.
In the long run, the market is expected to maintain
a healthy growth rate o 12-13 per cent. It is expectedto cross US$ 10 billion mark by 2010 and would reach
US$ 12 to 13 billion approximately, by 2012.
Forecasted Indian Pharmaceutica Market
Source: Compied From Industry Sources
US$ billion
12-132012
2006 6.2CAGR
12-14%
0 4 6 8 10 12 142
48%43%
9%
Source: IPA, E&Y anaysis
n Domestic Retail Market n Exports n Institutional Sales
Break-up o Saes-Indian Pharma Industry
Source: US Census Bureau, EIU & Word Trade Atas
2006
2005
2004
2003
2002
2001
Domestic Pharma Retai Market
6.2
5.3
4.6
4.0
3.7
3.2
0 7654321
US$ billion
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3P hA R M A c E U TIc A L S
Alimentary and metabolism constituted around 25
per cent o the domestic ormulation market in 2005-06
and grew by 10.7 per cent between 2003-04 and 2005-06.
Oral anti-diabetics and anti-peptic ulcerants are the astest
growing segments in this category.
KEy dRUg cLASSES
Oral Antiiaetis
It has been one o the astest growing drug classes in the
past ve years. The segment has tremendous growth
potential given the act that the number o diabetics in
India is expected to go up by 57.2 million by 2025 rom the
present 37 million. The market or Oral Anti-diabetics was
estimated around US$ 173 million and has been growing at
a CAGR o nearly 14 per cent.
Antiulerants
The market or anti-ulcerants was around US$ 195 million in2005-06, growing at a CAGR o 13.8 per cent. It constitutes
14.5 per cent o the alimentary and metabolism therapeutic
category. Prevalence o ulcers is very high in India as
4-10 per 1000 people are estimated to be aected by it.
H2 receptor blocker and proton pump inhibitors are the key
drugs in this class.
Respirator Sstem: Anti Astmatis
Respiratory segment constitutes 9.4 per cent o the total
ormulation revenue. The market o anti-asthma drugs was
estimated around US$ 140 million in 2005-06.
carioasular Sstem cvS
Cholesterol Reducers and blood pressure lowering drugs
are key drug classes under CVS. Beta Blockers accounted
or 10.7 per cent o the total revenue generated by CVS
in 2005-06. Calcium channel blockers urther constituted
10.7 per cent o the total CVS segment in 2005-06.
ACE Inhibitors account or around 9 per cent o theCVS market. While angiotensin II receptor blockers
constitute 5 per cent o the CVS sales.
Cholesterol reducers has emerged as a key class o CVS
drugs over the past ew years. In 2005-06, it accounted or
12.5 per cent o the total cardiovascular market. Statins
has emerged as the most important amily o drugs
in cholesterol and triglycerides reducers.
central Nerous Sstem: Antiepressants
Anti-depressants accounted or 17 per cent o the total
revenues o the CNS segment in 2005-06. The immense
potential o this class o drugs in India can be gauged by the
act that one in every 15 adults in the country suers rom
depressive illness and at least 10 per cent o the population
suers rom depression that requires medical attention.
Source: CRIS INFAC, E&Y Anaysis
Market Sare o Ke dru classes200506
Cephalosporins 7.4%
Anti-rheumatic non-steriodal 4.7%
Anti-ulcerant 3.6%
Cough preparations 3.6%
Ampicillin/Amoxycillin 3.3%
Quinolones 3.2%
Oral anti-diabetic 3.2%
Haematinics 2.2%
Anti-epileptics 2.0%
Vitamin B Complex 1.7%Others 65%
Source: CRIS INFAC, E&Y Anaysis
Market Sare o Ke Terapeuti cateories
deemer 2006
Anti-Infectives 18%Gastro Intestinal 11%
Cardiovascular 10%
Respiratory 9%
Vitamins/Minerals 9%
Analgesics 9%
Gynae 5%
CNS 5%
Dermatology 5%
Anti-diabetic 4%
Others 13%
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M A R K E T & O P P O R T U N I T I E S4
MusuloSkeletal Sstem
This therapy segment includes medication or the treatmento Rheumatoid Arthritis, Osteoarthritis and Analgesics. The
Anti-inammatory and Anti-rheumatic category accounted
or 70 per cent o the total musculo-skeletal segment
revenues in 2005-06.
ExPORTS
ormulation eports oul lea te a
With US$ 5.2 billion o estimated revenues in 2005-06, exports
have become the mainstay o the Indian pharmaceutical
industry. Presently, the share o bulk drugs exceeds that
o ormulations in the total pharmaceutical exports.
Formulation exports were estimated at around
US$ 2.4 billion in 2005-06 and constitute 46 per cent o
the total exports revenue pie while, the rest 54 per cent is
constituted by bulk drugs, estimated at US$ 2.8 billion in
the same period.
Overall pharmaceutical exports are estimated
to increase at a CAGR o 30-32 per cent and reach
US$ 18.3 billion in 2010-11. Moving at a healthy CAGR o
30-35 per cent, ormulation exports are estimated to
reach US$ 9.6 billion by 2010-11 and would surpass bulk
drugs which are estimated to reach US$ 8.7 billion at
a CAGR o 25 per cent in the same period.
The predictions made by Indian Pharmaceutical
Alliance (IPA) are more bullish and estimate that the total
export market would generate US$ 27 billion by 2012.
deman rom reulate markets oun to inrease
Traditionally, semi-regulated markets which comprise o
Asia, Arica, Central Asian Republics (CAR), Conederation
o Independent States (CIS) and Latin American nations,
have accounted or the majority o ormulations demand.
However, over the past couple o years a gradual shit has
been observed in the region-wise revenue mix. Over the
past ew years, the increasing demand o generics rom the
regulated regions has driven the proportion o sales to the
regulated markets to 36 per cent in 2005-06 rom 24 per
cent in 2000-01. Exports to regulated markets surged by a
CAGR o 33 per cent as compared to a CAGR o 15 per cent
in the semi-regulated markets during 2000-01 to 2004-05.Formulation exports to regulated markets are estimated
to increase at a high CAGR o over 41 per cent to reach
US$ 4.7 billion, by 2010-11, whereas the demand rom
semi-regulated region would experience a modest CAGR
o around 26 per cent, to reach US$ 4.9 billion in the
same period.
Increasing use o generic medication in the regulated
market is the key reason or the high ormulation demand
rom these regions.
generis to rie te rot o Inian eports
Globally, healthcare authorities are laying greater
emphasis on promoting the use o generics to contain the
public healthcare expenditure. The demand or generic
medicines is expected to be signicant rom both, the
United States (US) and European Union (EU) due to
avourable regulatory ramework.
Generic medication is expected to grow at a CAGR
o 13.7 per cent between 2005-10 to reach US$ 85.7
billion. Patent expiry o existing medication is expected tocontribute 9-10 percent o the total sales.
Forecasted Export Revenues
n Formulations n Bulk Drugs
Source: CRIS INFAC
0 4 6 8 10 12 14 16 18 202
2010-11
2005-06 2.4 2.8
8.79.6
US$ billion
Formuation Exports Demand Outook
n Regulated Markets n Semi-regulated Markets
Source: CRIS INFAC
0 4 6 8 10 122
US$ billion
0.8 1.6 2.42005-06
2010-11 4.94.7 9.6
CAGR32.1%
(CAGR 41.6%) (CAGR 25.6%)
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5P hA R M A c E U TIc A L S
Indian companies are likely to be the key beneciaries
o the growth o the generics segment, owing to higher
emphasis laid by them on this market over the past ewyears. This is evident rom the aggressive Drug Master File
(DMF) and Abbreviated New Drug Application (ANDA)
lings made by Indian players. Indian companies received
57 ANDA approvals rom US FDA during January-November
2006 as compared to 50 ANDA approvals in 2005.
By 2010-11, share o Indian players in the US market
is expected to cross 10 per cent, up rom 1.9 per cent in
2005-06. Formulation exports to US are expected to grow
at a CAGR o 49 per cent between 2005-06 and 2010-11 to
reach around US$ 2.6 billion.
Pricing pressures and shrinking margins in the generics
space and the increasing litigation instances in the US have
compelled Indian companies to consider opportunities
beyond the US. Exports to Europe are likely to grow with
a healthy CAGR o 32 per cent to reach US$ 1.8 billion by
2010-11. Indian companies have been strengthening their
ocus on the EU market.
Inorganic route has been the preerred entry option
adopted by a majority o players to gain entry into EU.
75 per cent o the acquisitions made by Indian
pharmaceutical companies in 2005 and 2006 (upto June)
were targeted towards the European market.
Inia to maintain ous on ulk ru eports
India has the distinction o being the supplier o highquality cost eective bulk drugs across the globe. Nearly
80 90 per cent o the bulk drugs produced in the country
are being exported. Demand or bulk drugs has grown at a
CAGR o 31 per cent since 2000-01, to reach US$ 2.8 billion in
2005-06. Presently, India is the worlds th largest producero bulk drugs.
Semi-regulated markets account or a majority o bulk
drug demand, with 60 per cent exports directed to these
regions only. However, demand rom the regulated markets
has been growing at a aster rate and would be the key
driver o overall bulk drug export. In addition to this, the
share o innovator pharmaceuticals in the total exports has
increased rom 6 per cent to 10 per cent.
India is rapidly emerging as a trusted outsourcing
destination or not only generic drugs but also high-end,
difcult to manuacture innovator/patented drugs. Indian
companies have been at the oreront in leveraging the
increased outsourcing demand or APIs/Intermediates,
which is reected in the aggressive DMF lings made by
Indian companies.
Indian companies led 306 DMFs in 2006. The share
o Indian companies in the total DMFs led with US FDA
increased to 44 per cent in 2006. In terms o the cumulative
DMF lings, India is way ahead o other countries. Chinas
share o DMF lings is nearly one-third o that o India.
14 Indian companies received 77 tentative approvals or
active ingredients rom US FDA during 2006 (till November).
In comparison, only 9 companies received 77 US FDA
approvals in 2005.
Inian ompanies inestin in uilin
orl lass apaities
In their drive to harness opportunities in internationalmarkets, Indian companies have been investing in building
and scaling capacities to be able to match international
512001
2006
2005
2004
2003
2002
DMF Fiings rom India
Source: US FDA
306
274
66
0 50 100 150 200 300 350250
195
114
numbers
2010
2009
2008
2007
2006
2005
0 2 4 6 8 10 12
Expected Market Share o Indian Payersin the US Generics Market
10.51
n Market share of Indian players
Source: CRIS INFAC
7.43
7.45
5.94
3.84
1.92
per cent
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M A R K E T & O P P O R T U N I T I E S6
quality standards, thus ensuring that their plants comply
with current Good Manuacturing Practices (cGMP).
Presently, India has more than 100 US FDA approvedplants, the highest outside the US. In addition to that, Indian
players are increasingly opting to comply with standards laid
down by various other international regulatory agencies
such as TGA, MHRA, ANVISA, MCC, etc. and are vying or
their accreditation.
Semireulate markets to enale stea rot
Semi-regulated markets with annual sales o US$ 53.6 billion
in 2005-06, provide a source o steady revenue or Indian
companies. Lower regulatory barriers, coupled with lower
operational costs make these markets an attractive export
destination or Indian companies, especially or small and
medium size players.
Majority o exports rom India are directed to Asia, Arica,
CAR and CIS Regions. Exports to Latin American countries
are low at present. However, they have been growing at a
rapid pace and are expected to reach US$ 1.25 billion by
2010-11 rom US$ 0.2 billion in 2005-06.
IMPORTS
India consumes a miniscule portion o the global
pharmaceutical production. The countrys pharmaceutical
imports are primarily conned to the lie-saving drugs
and new generation o ormulations that are under patent
protection. These include anti-neoplastics, cardiovascular
and anti-hypertensive drugs imported primarily by
leading global pharmaceutical companies or sale in the
domestic market.
The key imports consist o penicillin, antibiotics ortreating gastrointestinal inection. Presently, lie saving
drugs can be imported duty ree in the country, whereas all
other pharmaceutical products are subject to import duty.
Revenues rom the import o APIs/intermediates and
nished ormulations have nearly tripled in value romUS$ 516.1 million in 1999 to US$ 1.3 billion in 2005.
Top seven import destinations accounted or around
32 per cent o the total pharmaceutical imports in 2005.
Indias leading import suppliers include Switzerland,
Germany, United States and France.
Imports rom Switzerland, US and Germany primarily
consist o nished medicament in dosage orms or retail
sales. Around 45 MNC pharmaceutical companies are serving
the Indian market through subsidiaries, collaborations
and imports.
Semi-reguated Market: Region-wise Exports
n 2005-06 n 2010-11
1.38
3.67
0.20
0 0.5 1 1.5 2 2.5 3 3.5 4
1.25Latin
America
Asia, Africa,CARs & CIS
counties
Source: CRIS INFAC
US$ billion
Indian Pharmaceutica Imports
1,6001,4001,2001,0008006004002000
Source: Word Trade Atas
US$ million
2000
2001
2002
2003
2004
2005 1,340
1,070
950
860
600
580
country 2002 2003 2004 2005 Jan-June2006
Switzerland 92.6 95.7 82.8 109.2 115
Germany 57.6 52.6 61.9 85.3 51.3
United States 62.6 76.0 77.2 97.2 53.5
France 33.6 30.2 23.1 36.8 25.5
Denmark 31.4 33.3 24.3 42.7 30.9
Belgium 9.6 15.7 10.0 21.9 22.0
UnitedKingdom
24.9 25.6 40.6 34.9 24.5
Tota 312.3 329.7 319.9 428.0 305.2
Source: Word Trade Atas
Indian pharmaceuticas Imports rom Top
7 countries by Vaue (US$ miion)
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INdIA AdvANTAgE
Estalise manuaturin inrastruture
Congregative settlement tendencies o pharmaceutical
units have led to the evolution o dened manuacturing
and R&D clusters in the country.
Traditionally, pharmaceutical manuacturing clusters
in India were limited to ew Indian states such as Andhra
Pradesh, Gujarat, Maharashtra and Goa. However, in the past
decade new clusters have emerged across the country and
have witnessed signicant movement o pharmaceutical
units to these locations.
The primary actors which attributed to this movement
are space constrains, environmental issues and special
incentives oered by ew developing states such as
Himachal Pradesh, Uttarakhand, etc.
Traditional bulk drug clusters are located primarily in
Gujarat, Maharashtra, Andhra Pradesh, Tamil Nadu, Goa,
Pondicherry and Karnataka. Visakhapatnam (Vizag) in
Andhra Pradesh is the upcoming bulk drug cluster that has
generated signicant interest in the APIs players.
Goa, Mumbai, Pune and Hyderabad have been the
preerred destinations or ormulation players in the past.However, Baddi in Himachal Pradesh and Pantnagar and
Haridwar in the state o Uttarakhand are the upcoming
ormulation clusters, attracting ormulation manuacturers
rom across the country due to scal incentives oered by
the Government.
The R&D clusters have ollowed a similar development
pattern. Apart rom the National Capital Region (NCR),
other R&D clusters have been limited to the established
pharmaceutical regions in the country. High quality
lie, coupled with well developed physical and social
inrastructure o tier-I cities has been the key reason or
the development o knowledge intensive R&D clusters in
these regions.
Source: E&Y Anaysis
Key Manuacturing Custers
Pantnagar
Haridwar
AhmedabadAnkleshwar,
Vapi
Vadodara
MumbaiTarapur
AurangabadPune
Hyderabad
Medak
BengaluruMysore
Chennai
Traitional bulkdrus cluster
Gujarat- Ahmedabad, Ankleshwar,Vapi, VadodaraMaharashtra - Mumbai, Tarapur,Aurangabad, Pune
Andhra Pradesh - Hyderabad,MedakTami Nadu - ChennaiPondicherry
Karnataka - Mysore, Bengaluru,Goa
Traitional ormulation
cluster
Goa, Mumbai, Pune, Hyderabad
Emerin bulk
drus cluster
Andhra Pradesh - vizag
Emerin ormulation
cluster
Himachal Pradesh - BaddiUttranchal - Pantnagar
Baddi
Vizag
Pondicherry
Goa
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M A R K E T & O P P O R T U N I T I E S8
deelopin clusters
Based on the lines o biotech clusters in developed
economies, the Government is encouraging the
development o Pharma/Biotech Parks or third party
occupancy based on a public-private partnership model.
These parks act as a geographic concentration/cluster o lie
sciences industry, research institutions, sci-tech academia
and other amenities o scientic and general purpose.
The parks provide plug-and-play R&D and
manuacturing inrastructure at par with international
standards at an aordable cost. Further, many provide
incentives and services or start-up, mid-stage, late-stageand manuacturing pharma/biotech companies seeking
to develop innovative products and services, attract
international organisations to locate their R&D activities
in the parks and create and maintain international and
national linkages, vital or the overall development o thecluster. Consequently, they serve as an ideal mechanism or
ostering an environment o innovation.
As o October 2006, there were around 32 pharmaceutical
and biotech Special Economic Zone (SEZs) which received
in-principal/ormal approval. Out o these, 20 are dedicated
to the pharmaceutical industry while 12 are dedicated to
biotechnology. Further, several pharma units are expected
to be a part o multi-product SEZs. However, a majority o
these SEZs ocus on manuacturing activities and only a ew
are dedicated to R&D.
Enalin resear inrastruture
The said growth has been urthered due to the presence
o a robust inrastructure and adoption o technologically
advanced processes. Government organisations such
as Department o Science & Technology (DST), Council
o Scientic and Industrial Research (CSIR) have been
instrumental in the creation o world class acilities or
drug discovery and development. These apex bodies have
created a network o national institutions that host worldclass inrastructure to undertake research across various
acets o drug development. These institutions have been
associated with technology transers or scale-up, validation
and commercialisation. Presently, India has more than 200
government laboratories and several private research
institutions, with state-o-the-art equipment and acilities
or undertaking high-end research. Government-unded
laboratories oer a range o preclinical R&D services and
acilities to the pharmaceutical industry, R&D organisations,
academic institutions and other interested organisations.
These laboratories have been the pioneers in improving
the discovery research scenario in the country. CSIR run
laboratories have urther been the prime generators o
expert R&D proessionals in preclinical/chemistry research.
Lare skille manpoer ase
India has a large qualied human resource base. The country
has a well established system o higher and technical
education which is central to the abundant trained and
competent workorce. The country has over 450 institutes/colleges and
departments imparting pharmacy education. More than
Source: E&Y Anaysis
Key R&D Custers
NCR
Ahmedabad
MumbaiAurangabad
Pune
Hyderabad
Bengaluru
Chennai
captie R&d Units
National Capital RegionAhmedabadMumbaiAurangabad
HyderabadBengaluruChennai
contrat R&d Units
MumbaiHyderabadBengaluruChennaiAhmedabad
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9P hA R M A c E U TIc A L S
25,000 pharmacy graduates pass out rom these institutes
every year.
Around 1,000 biotech and biochemistry postgraduatestudents pass out every year
Around 10,000 chemistry postgraduate students pass out
every year
Around 2,500 chemical engineering students pass out
every year. The country had a pool o around 50,000
chemical engineering graduates in 2004-05
Around 4,500 students pursue PhDs in various science
streams
1,000 students pursue PhDs in engineering stream
1,000 PhDs in chemistry
case Stu: goernment to introue
si more NIPERS
The National Institute o Pharmaceutical Education &
Research, India, was established by the Government o
India to cater to the long-standing demand or setting up
a dedicated nodal agency or quality higher education and
advanced research in the pharmaceutical sciences. The
benets derived out o these institutes have prompted
the Government to start six new NIPERs in the country in
Hyderabad, Ahmedabad, Hajipur, Kolkata, Guwahati and
Rae Bareli as a part o the Eleventh Five Year Plan. Institutesat Kolkata, Ahmedabad, Hyderabad and Hajipur (Bihar)
have started unctioning.
Inias cost Aritrae
Indias cost competitiveness is the key reason why MNCspreer to outsource R&D and manuacturing activities. India
oers a 50-55 per cent savings in production cost o basic
pharmaceuticals, compared to the US.
The three major components contributing to such a
signicant cost saving are manpower, raw materials and
depreciation.
basi proution ost in Inia up to 50 per ent loer
tan in te US
30 50 per ent loer epreiation
FDA approved plants can be constructed in India or
30 50 per cent lower costs
Higher utilisation o equipment due to improved
processes (not quantied)
8590 per ent manpoer ost sains
Labour costs in India are typically 10-15 per cent o the
costs in the US
Savings applicable across all hierarchal levels (e.g.,
operators, research scientists, etc)
Improved, more efcient processes contribute to lower
labour costs per unit (not quantied)
4050 per ent sains in ra materials
Bulk drugs can be manuactured in house at 40-50
per cent o ethicals cost
Excipients and intermediates sourced locally at 20-30
per cent lower costs
Most other raw materials can be sourced locally
Ke Resear Institutes
Central Drug Research Institute (CDRI), Lucknow
National Institute of Pharmaceutical Education & Research (NIPER),Mohali
Indian Institute of Chemical Technology (IICT), Hyderabad
Centre for Cell & Molecular Biology (CCMB), Hyderabad
Indian Institute of Chemical Biology (IICB), Kolkata
Indian Toxicology Research Institute (ITRI), Lucknow
Institute of Genomic and Integrated Biology (IGIB), New Delhi
Institute of Microbial Technology (IMTECH), Chandigarh
National Chemical Laboratory (NCL), Pune
National Centre for Biological Sciences (NCBS), Bangalore
Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR),Bengaluru
Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad
Indian Institute of Science (IISc), Bangalore
National Institute of Immunology (NII), New Delhi
Iustrative Cost Bar: Average US Cost Structure=100
US
Manufacturer
IndianManufacturer
45-50
100
Source: OPPI-Adapted rom Monitor Group, Study on Outsourcing Opportunities
in the Indian Pharmaceutica Industry
production cost per unit
n Raw Material n Manpower
n Depreciation n Other Site Costs
1009080706050403020100
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M A R K E T & O P P O R T U N I T I E S10
Policy
REgULATORy RAMEwORK
The Indian pharmaceutical industry has a multi-level
hierarchical regulatory institutional ramework. Two
ministries o the Government o India play a major role in
regulating the pharmaceutical sector in the country. Each
o these ministries deals with dierent aspects o regulations
and works independently. These are:
1. Ministry o Health & Family Welare (MoHFW)
2. Ministry o Chemicals and Fertilisers (MoC&F)
dEPARTMENT O hEALTh (dOh)
The Department o Health is one o the key departments
o the Government o India, which regulates the
pharmaceutical industry. The Department o Health has
the Central Drugs Standard Control Organisation (CDSCO)and the Drugs Controller General o India (DCGI), as its
main agencies which deal with key issues including drug
approvals. Some o the major acts which the department
administers, are:
1. The Drugs & Cosmetics Act, 1940
2. The Prevention o Food Adulteration Act
3. The IMA Act
4. The Tobacco Control Act
central drus Stanar control
Oranisation cdScO
As an agency o Department o Health, the CDSCO works
both at the Central and the State level and is responsibleor ensuring saety, efcacy and quality o drugs supplied
to the public. The agency perorms the above mentioned
unctions with the Drugs Controller General o India (DCGI)
as the executive head.
Te drus controller general o Inia dcgI
DCGI is an apex body in the pharmaceutical industry
governing issues such as product approval and standards,
clinical trials, introduction o new drugs, and import licences
or new drugs. Its major unctions include:
Laying down standards o drugs, cosmetics, diagnostics
and devices
Laying down regulatory measures, amendments to Acts
and Rules
To regulate market authorisation o new drugs
To regulate clinical research in India
To approve licences to manuacture certain categories
o drugs as Central Licence Approving Authority i.e. or
blood banks, large volume parenteral vaccines and sera
To regulate the standards o imported drugs Work relating to the Drugs Technical Advisory Board
(DTAB) and Drugs Consultative Committee
Te got. o Inia
Ministry of Health andFamily Welfare
Ministry of Chemicalsand Fertilisers
Department of HealthNational PharmaceuticalPricing Authority (NPPA)
The Prevention of FoodAdultration Act
The Drugs & Cosmetics Act,1940
The Tobacco Control Act
The Essential CommoditiesAct
Central Drugs Standards ControlOrganisation (CDSCO)/Drugs
Controller General of India (DCGI)
Drugs Price ControlOrder (DPCO)
Drug Approval Quality Clinical Trials
Prices
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11P hA R M A c E U TIc A L S
Testing o drugs by Central Drugs Labs
Publication o Indian Pharmacopoeia
MINISTRy O chEMIcALS ANd ERTILISERS
(MOc&)
The Ministry o Chemicals & Fertilisers constitutes bodies
such as the Department o Chemicals & Petrochemicals,
Department o Fertilisers, National Pharmaceutical Pricing
Authority (NPPA), etc. These departments are entrusted with
the responsibility o policy making, planning, development
and regulations relating to:
Chemicals
Petrochemicals
Pharmaceuticals
National Parmaeutial Priin Autorit NPPA
NPPA was established on 29thAugust, 1997 as an independent
body ollowing the recommendations o Cabinet Committee
ater a review o Drug Policy in September 1994. It has been
entrusted with the task o xation/revision o prices o bulk
drugs and ormulations, enorcement o provisions o theDrugs (Prices Control) Order and monitoring the prices o
controlled and decontrolled drugs in the country.
drus Prie control Orer, 1995
The Drugs Price Control Order (DPCO), 1995 is an orderissued by the Government o India under Section 3 o the
Essential Commodities Act, 1955 to regulate the prices o
drugs. The order was introduced in 1970 and was amended
in 1979, 1987 and 1995, and the corresponding numbers
o drugs put under price control were 347, 145 and 74,
respectively.
DPCO controls the domestic prices o major bulk drugs
and their ormulations with an aim to provide patients with
medicines at aordable prices. DPCO ascertains, as per Drug
Policy guidelines, the bulk drugs (and their ormulations) to
be kept under price control.
cdA - INdIAS NEw dRUg REgULATOR
Presently, India has a biurcated drug regulatory system.
Regulatory unctions are divided between the Centre and
State authorities. Existing inrastructure at the Centre and
the State is inadequate to perorm the assigned unctions
o drug administration with efciency and speed.
A strong, well equipped, empowered, independent
and proessionally managed body, which could be giventhe status o Central Drug Administration (CDA), reporting
directly to the Ministry o Health, has been contemplated
Eistin Propose
central goernment
State goernment
central dru Aministration
3 Joint Drug Controllers 2 Deputy Drug Controllers 6 Assistant Drug Controllers
50 Drug Inpectors 5 Technical Experts 1 Administrative Officer 1 Accounts Officer
Responsiilities:
Regulatory affairs & environment New drugs & clinical trails Biological & biotechnology products Pharmacovigilance Medical devices & diagnostics Imports Organisational services Training & empowerment Quality control affairs
Legal & consumer affairs
dru controller general o Inia
(Expert Committees)
Responsiilities:
Broad Policy Issues
State dru Autorities
(State Drug Controller and Food & DrugInspectors)
Responsiilities:
Licencing & monitoring of manufacturing Legal cell Spurious drug monitoring
Pharmacies
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M A R K E T & O P P O R T U N I T I E S12
as the most appropriate solution to address the above
mentioned issues.
The Central Cabinet approved the same in January 2007.The move is expected to acilitate upgradation o national
drugs regulator, uniormity o licencing and enorcement
and improvement in drug regulations. The proposed
organisation structure o the CDA would be analogous to
US FDA. The efciency and efcacy o drug administration
is expected to be much higher, post this transition. This
should augur well or getting approvals or protocols and
permissions or conducting clinical trials.
buet 200708: Perspetie o te
Parmaeutial Inustr
Reduction in import duty on medical equipment to
7.5 per cent
Section 35 (2AB) that allows a weighted deduction o
150 per cent or expenditure relating to in-house research
and development extended or ve more years, until
March 2012
Lie saving vaccines exempt rom excise duty
Free samples not under the purview o Fringe Benet Tax
(FBT) Clinical trials o new drugs exempt rom service tax to
make India a preerred destination or drug testing
Provision o US$ 215 millionn or AIDS control
programme
Provision o US$ 288 million in FY08 to und polio rounds
and vaccines or better outreach/penetration in the
20 high risk districts o Uttar Pradesh and 10 districts
o Bihar
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13P h A R M A c E U T I c A L S
chANgINg PARAdIgM
The pharmaceutical industry has been witnessing a
transormation in the recent past. Earlier, the industry
ollowed a product centric approach, with manuacturing
aimed towards ullling the domestic demand ,while exports
were largely conned to supplying APIs & intermediates
to the less regulated markets. Further, the contribution o
services has been miniscule in the total revenues o the
pharmaceutical industry.
Presently, services account or only 6.6 per cent o
the total revenues o the Indian pharmaceutical industry.
However, it is estimated to increase upto 12 per cent by
2010-11 due to continuous spurt in clinical research
outsourcing, coupled with increase in discovery and
preclinical research activities.
The contribution o exports to the total product revenues
in 2006-07 was 43 per cent. However, moving at a high
CAGR o 30-32 per cent, contribution o export revenues
would surpass the share o the domestic market in the total
revenue mix. By 2010-11, exports would contribute 62 per
cent to the total product revenues.
Further, unlocking o US$ 80 billion revenues patentexpiry during 2006 2010 would present signicant
opportunities or generic players, especially the Indian
Key Trends & Drivers
companies who would be among the rst to capitalise on
this opportunity.
INcREASINg PENETRATION dRIvINg gROwTh
The growth undamentals o the domestic market are
undergoing a sea change. Over the past ew years, new
product launches have been the mainstay o the growth
in the domestic market. However, with expansion o
healthcare acilities in the rural and ar ung areas, increased
penetration has been driving the growth.
With total sales revenues o US$ 1.4 billion, the Indianpharma market in rural areas witnessed a growth o 39 per
cent as compared to the growth o 18 per cent in the overall
domestic market in November 2006 . This is in stark contrast
with previous years growth pattern. While new product
launches used to contribute to a large share o revenues,
in 2006 they contributed to only around 1 per cent o
the market, while 15 per cent o the growth is now being
contributed by volume growth.
In 2006, while the number o new product launches
increased or the top 10 players, it decreased or the
next 15 players in comparison with the previous year.
The contribution o new sales rom new product
launches to overall sales declined to around 4.8 per
cent rom 5.1 per cent or the top 10 players and
8 per cent rom 9.6 per cent or the next 15 players.
Expansion o healthcare inrastructure in rural areas has
acilitated the said change. Increased government spending
on roads, telecommunication and healthcare inrastructure
has acilitated the oray o pharmaceutical companies into
relatively distant pockets o the market.
2006 2010
Inustr Inustr
Services Products Services Products
Domestic Exports Domestic Exports
6.6% 93.4%
57% 43%
12% 88%
38% 62%
Source: E&Y Anaysis
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15P hA R M A c E U TIc A L S
Rising disposable incomes would drive the aordability
and would enable the Indian population to not only seek
medical attention or major ailments, but also or minormedical conditions. Hence, rising consumer base coupled
with the accessibility and aordability would be the key
uture growth drivers o the Indian pharmaceutical market.
AcUTE ThERAPy dOMINATE SALES,
chRONIc ThERAPy TO UEL gROwTh
Globally, more than 57 per cent o the top 10 therapy
classes, which account or around 30 per cent o global
sales, belong to the chronic segment which is growing
aster than the acute segment, propelled by the rise in
liestyle diseases and the increasing stress levels. In India,
chronic therapy contributes to only 23 per cent o the total
revenues, while acute therapy dominates with a share o
77 per cent.
New products launched in the chronic therapy segment
outnumbered the launches in an acute therapy segment in
2006. Key actors that would uel the growth o the chronic
therapy segment are -
Growing geriatric population : 4.9 per cent o the total
Indian population in 2005 consisted o 65+ age group.This is urther expected to increase to 6.4 per cent by 2015
and 7.5 per cent by 2020
Rapid urbanisation o rural population, which would lead
to increase in the number o people suering rom liestyle
diseases such as diabetes, obesity, depression, etc. 28 outo every 100 persons in India live in urban areas. Urban
population has grown by 31 per cent rom 217 million
in 1991 to 285 million in 2001 - as against 18 per cent in
rural areas
Though the share o the acute segment such as anti-
inectives would decrease in the uture revenue mix, it
would continue to grow at a steady pace due to its mass
therapy nature and the unresolved issues o sanitation
and hygiene in the country. Other therapeutic categories
ocusing on diseases related to blood, ophthalmology, HIV
and stomatology are expected to grow above industry
average in the long term.
ShITINg OcUS O INdIAN PhARMA
TOwARdS MARKETS SUch AS JAPAN
Although US is still the largest pharmaceutical market
and has been the prime target or generics players across
the globe, Indian companies are aggressively eyeing thegenerics opportunities in other markets such as Japan.
Japan is the worlds largest pharmaceutical market ater
the US. With sales worth US$ 60 billion in 2006, it constitutes
around 11 per cent o the global market. However, generics
penetration has been extremely low till date due to the
unavourable legislation and their perceived reputation as
inerior products.
The Japanese Governments spending on health
insurance exceeded US$ 35billion in 2007. In order to
contain the burgeoning healthcare cost, the Government
has initiated a string o pro-generics legislation reorms to
increase the penetration upto 40 per cent rom the present
16 per cent. The key reorms undertaken by the Government
are as below
Generics substitution allowed
Physicians are given incentives to prescribe generic
medications over branded ones
Faster system to approve drugs
Removal o obligations to manuacture locally
Indian companies have been quick to leverage the Japaneseopportunity.
Cadila Healthcare acquired Nippon Universal
Acute vs Chronic Saes Mix o Top 10 IndianPharmaceutica Companies
n Chronic n Acute
Source: CRIS INFAC
7723
7327
6832
8911
94
3862
33 67
28 72
5743
18 82
95
Industry
DRL
Lupin
Pfizer
Alkem
Sun
Zydus
NPIL
Cipla
Ranbaxy
GSK
0 10 20 30 40 50 60 70 80 90 100
per cent
6
5
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M A R K E T & O P P O R T U N I T I E S16
Pharmaceutical Ltd.
Lupin has acquired a majority stake in Japanese generic
drug maker Kyowa Pharmaceutical Industry Co. Ltd. Dishman has established a Joint Venture (JV) with Azzuro
Corporation in 2007
Ranbaxy has established a JV with Nippon Chemiphar
Stride has entered into a JV with Sorm Corporation Ltd.
With the introduction o generics substitution in 2006, the
market is now poised to become an important destination
or many global generics players.
INdIAN PhARMAcEUTIcAL cOMPANIES
PREERRINg ThE INORgANIc gROwTh ROUTE
Over the past couple o years, Indian pharmaceutical
companies have adopted an aggressive approach towards
pharmaceutical exports. While the large Indian companies
have increased their oothold in the regulated markets,
small and medium size players are ocusing on semi-
regulated markets.
Mergers & Acquisitions (M&A) has been the key strategy
adopted by Indian companies to gain an instant ootholdin the exports market. Increased penetration, access to
an established distribution network and increase in buyer
condence due to localised presence has been the key
reason or the acquisition spree o Indian companies.
M&A deals Inian companies 2006
Auirer Taret Prie
US$ millionNatco Pharma Ltd. Nicks Drug Store NA
Aurobindo Pharma Ltd. Milpharm Limited NA
Dr Reddys Laboratories Betapharm ArzneimittelGmbH
597.33
Marksans Pharma Ltd. Novo PharmaceuticalsAustralsia PTY Limited
NA
Ranbaxy Laboratories Ltd. Unbranded genericsbusiness of Allen S.p.A(GSK unit)
NA
Ranbaxy Laboratories Ltd. Terpia S.A 321.11
Ranbaxy Laboratories Ltd. Ethimed NV NA
Shasun Chemicals &Drugs Ltd.
Rhodia PharmaSolutions
NA
Lifecell Associate ofShasun Chemicals &Drugs
Saneron CCELLTherapeutics Inc.
NA
Dishman Pharmaceuticals& Chemicals Ltd.
Solutia Inc. 74.50
Nicholas Piramal Pfizer manufacturingunit at Morpeth in UK
NA
Ranbaxy Laboratories Ltd. Mundogen genericsbusiness (GSK)
NA
Aurobindo Pharma Ltd. US FDA compliantcGMP facility
19.00
Orchids Chemicals &Pharmaceuticals Ltd.
Bexel Pharmaceuticals 3.00
Serum Institute India Ltd. Lipoxen PLC 4.98
Kemwell Pvt. Ltd. Pfizers Swedish Plant NA
Dr Reddys Laboratories Litaphar SA 4.45
Bilcare Ltd. DHP Ltd 5.00
Stride Acrolab Pvt Ltd. Drug House of Australia(Asia) Pvt Ltd.
12.48
Wockhardt Ltd. Pinewood Laboratories 150
Nicholas Piramal IndiaLtd.
Boots PiramalHealthcare Pvt Ltd.
3.96 (51%stake)
Wanbury Ltd. Cantabria Pharma 62.22
VVF Ltd. Colgate PalmolivesAmerican Plant
NA
Ranbaxy Laboratories Ltd. Be-Tab Pharmaceuticals 70.00
Panacea Biotec Ltd. Cambridge Biostabili tyLtd.
3.78
Reliance Life Science GeneMedix Plc 63.2
JB Chemical &Pharmaceuticals Ltd.
Biotech LaboratoriesLtd.
5.10
Source: Grant Thronton Dea Tracker
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17P hA R M A c E U TIc A L S
RISINg cONIdENcE O gLObAL INNOvATOR
PhARMA cOMPANIES IN ThE INdIAN MARKET
Enactment o Product Patent in 2005 has reposed the
condence o innovator pharma companies in the Indian
market. Since January 2005 to date, about eight patented
products have been launched in the country. Pzer has
launched ve o them, while Roche and GSK launched two
and one, respectively.
The launch o patented products in India has been rather
slow, as the innovators are treading a cautious approach
and are awaiting urther clarity on various issues such as
data protection, patenting o derivatives and pre- and post-
grant opposition.
Product patent regime is unlikely to impact the current
market scenario in the medium term till 2009-10 since
majority o the drugs are already available in the country
at competitive prices. However, in the long term, more
patented products are expected to be launched in the
domestic market.
gLObAL PhARMAcEUTIcAL cOMPANIES
ESTAbLIShINg LOcAL PRESENcE
Going a step urther, international companies are
increasingly looking at India as a avourable option or
setting up research and development units, as well as global
clinical trial centres, a trend that is likely to gain momentum.
Global R&D companies such as US based AMRI and Nektarand Germany based Taros have already set up their centres
in dierent parts o India.
case Stu: AMRI etens its R&d entre
at heraa, Inia
Albany Molecular Research Inc., a global drug
discovery company that provides chemistry servicesto pharmaceutical and biotechnology companies, has
announced the construction o a new 50,000 sq. t. R&D
centre at the Shapoorji Pallonji Biotech Park in Hyderabad,
India. Slated to be completed in the later part o 2007,
the new R&D centre would conduct contract projects in
early stage drug discovery research, including custom
chemical synthesis and medicinal chemistry. In addition,
the new acility would house a scale-up laboratory, which
would be used to develop efcient methods or producing
larger quantities o active pharmaceutical ingredients
and intermediates. When ully staed, the new acility
would add over 100 employees to the companys existing
Hyderabad operations, which currently has 19 employees
in the acility at ICICI Knowledge Park. The current acility
can accommodate upto 40 employees and is expected to
reach ull capacity in the coming months.
Patente Moleule Launes in Inia ater Enatment o
Prout Patent
Prouts compan Terapeuti cateor Laundate
VFend Pfizer Systemic Anti-fungal Feb 05
Viagra Pfizer Erectile Dysfunction Dec 05
Lyrica Pfizer Neuropathic Jan 06
Caduet Pfizer Cardiovascular Feb 06
Macugen Pfizer Wet Age-Related MacularDegeneration
-
Carvedilol GSK Cardiovascular Mar 06
Tamiflu Roche Bird flu Apr 06
Pegasys Roche Hepatitis C May 06
Source: E&Y Research
Inestment gloal Parma companies in Inia
compan Area o ous in Inia Inestment
US$million
Allergan Inc Inflammatory, infection,urological indications
3 5
EisaiPharmaceuticals
API processes 120
Dupont Molecular biology, bio-informatics and polymersynthesis
23
Ratiopharm GmbH Basic processes 36
Teva Basic processes 3 4
AstraZeneca TB & NCE research, process &development
15
BMS-Syngene Basic drug discovery N/A
Pliva Basic studies for generics 1
Nektar Therapeutics Pre-clinical and bio-analyticaldevelopment
10
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M A R K E T & O P P O R T U N I T I E S18
STRATEgIc PARTNERShIPS ARE RISINg
An emerging trend is the symbiotic collaboration betweeninternational and Indian companies with research and
development capabilities. A step urther to cost-based
outsourcing, these partnerships reect increased interest
and condence in Indias research competencies and
inrastructure. Collaborative alliances, wherein both the
stakeholders pursue a high-risk, high-reward strategy,are increasingly appearing on the alliance landscape.
These alliances involve joint research agreements and co-
development arrangements between companies.
The nature o in-licensing deals in India is evolving rom
being marketing oriented to research driven. Furthermore,
early-stage products are increasingly gaining a share o the
investment pie, primarily due to their lower valuations.
Outlicensing has urther been on the rise, driven
by small companies with promising candidates or
Selet Stratei Alliane Inian companies
Inian
compan
Oerseas
compan
desription
AdvinusTherapeutics
Merck & Co. Discovery and clinicaldevelopment collaboration inmetabolic disorders
Nicholas Piramal BioSymtech Inc The collaboration centres on the
drug BST- InPod, which is beingdeveloped to alleviate chronicheel pain
MorvusTechnology
To undertake research in thearea of cancer, diabetes, arthitis
GVK Biosciences INC Research JV will establish a dedicatedresources capability to offerphase I-IV clinical developmentprogrammes in India
Ranbaxy Glaxosmithkline Ranbaxy will advance leadsbeyond candidate selectionto completion of clinical proofof concept. GSK, thereafter,will conduct further clinical
development for eachprogramme and take resultingproducts through the regulatoryapproval process to finalcommercialisation
Medicinefor MalariaVentures
Research for discovering newmedicines for treating malaria
BioconsSyngene
BMS Syngene International, willwork with Bristol- Myers Squibbto establish a research facilityin Bangalore with more than400 scientists to help advanceBristol- Myers Squibbs discovery
and early drug developmentJuibilantOrganosys
ELI Lilly Collaboration in the area of discovery research
Connexios Rheoscience Developing anti-diabetesmolecule
Suven LifeSciences
ELI Lilly NCE research for nervous systemdisorders
Zydus Cadila Onconova For research in the field ofoncology
Dr. Reddys Rheoscience Developing anti-diabetesmolecule
Argenta Research in the field of respiratory diseases
Clin Tech Development of anti-cancercompound
Source: E&Y Research
Selet Outliensin deals Inian companies
Inianirm
Partner Moleule/Tenolo
dealvalue
US$
million
year deelopmentPase
Ranbaxy Bayer Cipro XR
(NDDS)
65 1999 NA
PPD Inc RBx 10558
(Dyslipidemia)
44 2007 NA
Torrent Novartis AGE Breaker(diabetic)
3 2001 Developmentstage
Glenmark Forest (for N.America) Oglemliast(Asthma/
COPD)
190 2004 Phase I
Tejin (for
Japan)
GRC 3886
(Asthma/
COPD)
53 2005 Phase II
Merck GRC 8200 247 2006 Phase II
Eli Lilly GRC 6211 135 2007 Phase II
Lupin CornerstoreBioparm
Anti-infective(NDDS)
10.5 2005 NA
LaboratoriesServier
IP data onPerindopril
26.7 2007 NA
Source: E&Y Research
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19P hA R M A c E U TIc A L S
technologies lacking nancial muscle to take them through
the investment- heavy clinical development and marketing
phases.An increasing number o companies rom the regions
with a mature pharma-biotech industry, other than the
US, are eyeing India as a potential destination or orging
strategic alliances in lie sciences. As a powerhouse o
biopharmaceutical technologies and products, the interest
shown by these companies in India is a testimony o the
countrys growing prominence in the global lie sciences
space.
ThE INcREASINg qUEST OR
NEw chEMIcAL ENTITIES (NcE)
Having ocused their eorts on generics research or
decades and transorming the global generics landscape,
Indian companies are now striving to move up the value
chain and establish themselves in the innovator league o
pharmaceutical companies.
Enactment o Product Patent Act in 2005 has urther
acted as the catalyst, encouraging Indian companies
to dedicate substantial unds or the NCE research toaccomplish a sustainable long term growth. Annual R&D
spend o Indian companies has witnessed a CAGR o
38 per cent between 2000-01 and 2005-06.
Investment over the past has started reecting in
the ever burgeoning NCE pipeline o Indian companies.
Apart rom established companies such as Ranbaxy and
Dr. Reddys, players such as Wockhardt and Zydus Cadila,
Orchid, etc. have invested signicantly in their discovery
research programmes.
Recently, with Dr. Reddys NCE, Balaglitazone, becoming
the rst indigenous molecule to enter the Phase III trial,
Indian pharma industry has crossed a major landmark.
Growing R&D pipeline o Indian companies presents
signicant in-licensing opportunities or global companies.
Given the presence o a large number o NCEs/ NDDS
projects in Phase I and Phase II, some o these projects
are likely to approach commercialisation over the next
2-3 years. Success o even a ew o these molecules
will lead to substantial value creation within the Indian
pharma industry.
IMPROvINg PRIvATE EqUITy (PE) ScENARIO
Over the past couple o years private equity has emerged
as the trusted nancing option or the Indian lie sciences
industry. The PE unds are not only assisting Indian
companies in their expansion plans, but have also been
providing unds or venturing into high risk and capital
intensive segments such as discovery research. Further,
increasing availability o venture capital and angle investors
has acilitated the number o start-ups in these segments.
In 2006, private equity investment rose by over
230 per cent to US$ 7.46 billion, compared to US$ 2.26
billion invested in 2005. The PE buoyant condence was
evident by the act that Lie Sciences emerged as one o
the leading recipients o unds, accounting or 18 per cent
share o all VC&PE investments in 2005. In 2006 more than
US$ 4 billion worth o private equity deals materialised in
the lie sciences space in India.
PE players are increasingly taking a positive bet on the
Indian pharmaceutical industry as it has demonstratedtremendous growth potential and is emerging as a key
outsourcing hub or global companies. Further, it is expected
0 100 200 300 400 500 600
Indian Pharmaceutica R&D Expenditure
2000-01
2001-02
2002-03
2003-04
2004-05
2005-06 495.2
392.4
280.0
175.3
130.5
97.8
Source: Assocham
US$ million
CAGR 38%
dru deelopment Pipeline o Ke R&d ompanies in Inia
disoer/Prelinial
Pase
Pase I Pase II Pase III
Ranbaxy 4-6 0 1 0
Dr Reddy 2 3 1 1
Glenmark 3 1 2 0
Wockhardt 4 1 1 0
Zydus Cadilla 1 2 2 0
Nicholas Piramal 2 1 2 0
Lupin 0 1 2 1
Orchid 12 2* 1* 0
Sun 3 0 1 0Torrent 7 0 0 0
Source: Company Websites, Secondary Research, *expected to enter
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M A R K E T & O P P O R T U N I T I E S20
that the increasing appetite o Indian companies or
cross-border deals would inuence the capital requirement
and urther boost the PE market.
Priate Euit deal in Parma & healtare 2006
Inestors Inestee %Stake deal value
Carlyle Group Claris Life sciences NA 20.0
Xenox & Agnus Grandix Pharmaceuticals 30 2.0
Actis Paras Pharmaceuticals 23 42
Actis Capital LLP Add Life Medical Institute Ltd. NA 15.50
Aureos India Accutest Research Labs NA 4.11
Bennett Coleman & Co. Ltd. Thyrocare Technologies Ltd. NA NA
Chrys Capital Intas Pharmaceuticals 12.47 11.78
Citi Venture Capital Elder Pharma 4.50 NA
Fidelity Investment Avesthagen 12-14 11
Gujarat Venture Finance Ltd Celestial Biologicals Ltd. NA 0.45
HSBC Global Investment Fund Glenmark Pharmaceuticals 6.70 67.56
ICICI Venture Funds Metropolis Health Services NA 7.78
ICICI Venture Funds Arch Pharmalabs Increasing to 33 22
IDFC Pvt. Equity Healthcare Global Enterprises NA 11.11
IDFC Pvt. Equity Manipal Health System Pvt. Ltd. NA 20.0
International Finance Corporation Ocimum Biosolutions Minority Stake 6.50
New Vemon Pvt Equity Ltd. Unichem Laboratories Ltd. 5.20 12.44
Nomura Group Dishman Pharmaceuticals 5 11.30
Paul Capital Partners Glenmark Pharmaceuticals Ltd. NA 27.0
Sequoia Capital India Paras Pharmaceuticals NA 12.0
Soros Pvt. Equity Partners and Blue River Capital Fortis Healthcare 6 33.33
Swiss Reinsurance Company (Swiss Re) TTK Healthcare Services Pvt. Ltd. 26 NA
The Blackstone Group Emcure Pharmaceuticals NA 50
Trikona Capital Fortis Healthcare NA 18
Source: Grant Thronton Dea Tracker
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21P h A R M A c E U T I c A L S
INdIAN PLAyERS dOMINATE ThE
dOMESTIc MARKET
Indian companies dominate the domestic market, while
MNCs have signicant presence, with GSK leading the
domestic sales tally. 8 out o the top 10 pharma companies
are domestic players.
Presently, multinational pharma companies have a share
o around 20-22 per cent in the domestic pharma market.
GSK was the market leader in 2006 with a share o around
6.45 per cent o the total retail sales, ollowed by Ranbaxy
which is Indias number one pharmaceutical company.
RANbAxy LAbORATORIES
Introution
Ranbaxy Laboratories Limited is Indias largest integrated
research based pharmaceutical company. Incorporated in
1961, it is ranked among the top 10 generics companies
in the world. The company employs more than
11,000 employees.
Key Players
Top 20 Parmaeutial companies
Sales de
2006US$ million
Ranbaxy Laboratories Ltd. 997.29
Cipla Ltd. 738.96
Dr. Reddys Laboratories Ltd. 557.42
Lupin Ltd. 408.91
Glaxosmithkline Pharmaceuticals Ltd. 408.02
Nicholas Piramal India Ltd. 359.14
Aurobindo Pharma Ltd. 351.36
Sun Pharmaceutical Ltd. 322.43
Cadila Healthcare Ltd. 318.76
Wockhardt Ltd. 255.03
Aventis Pharma Ltd. 231.16Orchid Chemicals & Pharmaceuticals Ltd. 210.28
Ipca Laboratories Ltd. 195.34
Pfizer Ltd. 189.95
Matrix Laboratories Ltd. 187.73
Torrent Pharmaceuticals Ltd. 177.22
Biocon Ltd. 173.48
Alembic Ltd. 158.57
Glenmark Pharmaceuticals Ltd. 147.83
U S V Ltd. 138.48
Source: Prowess
Source: Company Websites, Secondary Research
n MNCs n Domestic
20-22%
78-80%
Break-up o Saes o Indian Pharma Market
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M A R K E T & O P P O R T U N I T I E S22
ootprints
The company has ground operations in 49 countriesand manuacturing operations spread across 11 nations.
Presently, the companys products are available in more
than 125 countries.
business untions
Active pharmaceutical ingredients
Branded ormulations
Generics
NCE research
Reenue & grot
The companys revenue in 2006 was US$ 1.33 billion. Exports
contributed around 80 per cent o the total revenues. In the
domestic market, Ranbaxy is the largest pharmaceutical
company by sales, with a market share o 5.10 per cent.
ous Terapeuti Areas
Anti-inectives, antiretrovirals, cardiovascular, musculo-
skeletal, dermatological, gastrointestinal, central nervous
system, respiratory, genito-urinary and nutritional
segments.
capailities
Ranbaxy has proven capabilities in generics and innovativeresearch. It has world class API and dosage orms
manuacturing acilities which are cGMP compliant and has
international accreditations across the globe.
Ranbaxys research ocus is on NCE and developing
New Drug Delivery System (NDDS) or creating a dierential
product portolio. Key NCE ocus areas are inectious
diseases, urology, metabolic diseases and inammatory/
respiratory diseases. The company has a strong NCE pipeline
o 10 molecules under dierent phases o drug discovery.
uture Outlook
Ranbaxy aspires to become a research based pharmaceutical
company with revenues o US$ 5 billion by 2012. Further, the
company envisions eaturing among the 5 global generics
players by 2012.
dR. REddyS LAbORATORIES
Introution
Dr Reddys Laboratories Limited was established in 1984.
The company ranks among the top 15 generics players in
the world. It employs around 6,120 employees worldwide.
It was the rst pharma company in Asia-Pacic (outside
Japan) to be listed on New York Stock Exchange (NYSE) and
rst Indian company to out-license NCE to a global pharma
major or clinical trials.
ootprints
Presently, the company has a presence in 35 countries with
operations in over 115 countries. It markets pharmaceutical
products in more than 100 countries. The company has JVs
in China and South Arica, wholly owned subsidiaries in US,
UK, Russia and Brazil, representative ofces in 11 countries
worldwide and NCE drug discovery research centers in
Atlanta, US and Hyderabad, India.
Region-wise Revenue Mix (2006)
28%
27%
23%
22%
Source: Companys corporate presentation
n Europe n RoW n Asia n North America
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23P hA R M A c E U TIc A L S
business untions
Active pharmaceutical ingredients Branded ormulations
Generics
Specialty Pharmaceuticals
Custom pharma services
Biologics
Reenue & grot
The company has a well established business o
manuacturing APIs and branded ormulations. It started
generics operations in 2001 and ocuses primarily on North
America and EU. In addition to this, the company is investing
in creating businesses o the uture- the innovation led
businesses - o specialty and drug discovery
In 2006-07, the company generated revenues o
US$ 1.5 billion. Overseas business contributed around
86 per cent the total revenues. The companys branded
ormulation business is the largest and contributes around
41 per cent the total revenues, ollowed by APIs with a share
o 34 per cent.
capailities
The companys NCE research ocus is in the areas ometabolic disorders, cardiovascular indications and
cancer. The company has led 81 patents with the US
PTO, o which 41 have been granted. About 951 scientists
worldwide and 323 scientists, are dedicated to new drug
discovery research. The company has proven skills insynthetic and analytical chemistry to develop innovative
cost eective manuacturing processes and expertise in
developing innovative ormulations
uture Outlook
The company aspires to become a discovery led global
pharmaceutical company. Its aim is to become one o the
top 10 generic companies in the world.
cIPLA
Introution
Cipla was set up in 1935 in Mumbai. Presently, Cipla is
known as the worlds largest manuacturer o cost eective
anti-retroviral drugs.
Source: Company Website
Reenue business
Branded Formulations 41%
APIs 34%
Generics (including betapharm) 17%
CPS (including Falcon) 5%
Emerging Business 3%
FY 2006-07 Net Revenues: US$ 1.51 biion
Source: Company Website
Reenue Market
North America 44%
Europe 23%
India 14%
Rest of the world 12%
Russia & CIS 7%
Ke
Markets
Ke eatures
USA Largest market for the companyIntroduced the first product in 1998Sales of US$ 379 Million in 20062nd largest manufacturing hub for Ranbaxy with fourmanufacturing locationsRobust product portfolio with a cumulative basket of197 ANDAs with 121 approvals10 product filings under U.S. Presidents EmergencyPlan For Aids Relief (PEPFAR) in 2005 with 3 tentativeapprovals under PEPFAR in 2005
Germany Sales of US$ 29 mill ion (2006)Changing market environment due to governmentregulations on healthcare
UK Sales of US$ 35 million (2006)
Launched Ondansetron on day 1 of patent expiryEnhanced focus on branded business in Respiratorysegment
France Sales of US$ 69 million (2006)
Brazil Sales of US$ 27 million (2006)5 new molecules launched during 20065th largest generic company
Russia &Ukraine
Sales in Russia US$ 65 million (2006)Amongst top 10 foreign generic companiesZanocin OD ranked No.1 Ofloxacin
China Sales of US$ 13 million (2006)Focus on patent protected products/ limitedcompetitionChange in business model to increase hospital reach
South Africa Sales of US$ 24 million (2006)5th largest generic companyAcquisition of BE TABS
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M A R K E T & O P P O R T U N I T I E S24
ootprints
Ciplas products are bought by over 170 countries across allthe continents-US, Latin America, Europe, Australia, Arica,
and Asia. Cipla has partnerships with nine companies or
over 125 products.
business untions
Active Pharmaceutical Ingredients/ Intermediates
Generics
Formulations
Veterinary products
Agrochemicals
Reenue & grot
Ciplas turnover in 2007 was around US$ 800 million with
a growth o 17 per cent over the previous year. Exports
accounted or over 50 per cent o the overall sales.
The company has led over 100 DMF registrations
in the US and over 85 in Europe. They already have more
than 5,000 approvals or ormulations in South and Central
America, the Middle East and Arica
NIchOLAS PIRAMAL INdIA LTd. (NPIL)
Introution
NPIL is the agship company o the US$ 500 million Piramal
Enterprises (PEL), one o Indias largest diversied business
houses. NPIL came into existence in 1988 when it acquired
Nicholas Laboratories rom Sara Lee. It is Indias 4 th largest
pharmaceutical company and is the leader in the CVS
segment. In the past 15 years, the company has grown
primarily through acquisitions, mergers and alliances.
ous Terapeuti Sements
Antibiotics, neuropsychiatry, cardiovascular, diabetes,gastrointestinal, vitamins, neurology, inhalation anaesthesia,
respiratory, pain management and dermatology
ootprints
To expand its global ootprint and diversiy and enhance
its product portolio, Nicholas Piramal has acquired a
number o oreign and domestic companies. In 2003, it
merged with Global Bulk Drugs and Fine Chemicals (India)
to obtain access to the regulated markets o the United
States, Europe and Japan. Nicholas Piramal acquired Pzers
custom manuacturing plant located in Morpeth (UK) to
supply more than 300 nished dosage orms to more than
100 markets, including the United States, Western Europe,
and Japan.
capailities
The company is among the worlds top 10 leading
pharmaceutical outsourcing rms with capabilities across
the entire Contract Research and Manuacturing Services(CRAMS) value chain. NPIL operates 7 APIs and nished
dosage production acilities in India. The companys state-
o-the art R&D acilities are in Mumbai and Chennai. NPIL has
also emerged as one o the leading custom manuacturing
organisations in the country.
Ke Auisitions an Allianes
In January 2007, Nicholas Piramal entered into a development
agreement with Eli Lilly (US) to conduct non-clinical studies
and human clinical trials. Thus it gained strategic entry into
Pzers global sourcing network to become Pzers largest
global contract manuacturing partner.
Nicholas Piramal acquired 51 percent equity stake
held by Boots Company in the joint venture Boots Piramal
Healthcare. It also acquired the Indian subsidiaries o
F.Homan-La Roche (Roche), Boehringer-Mannheim, Rhone
Poulenc, Hoechst Marrion Roussel research centre, ICI Indias
pharma division and Aventis research acilities. It entered
into joint ventures or marketing relationships with Boots
Healthcare, F. Homann-La Roche (Switzerland), GileadSciences (U.S.), Cheissi (Italy) Stryker Corporation, Allergan
(U.S.), and IVAX (UK) or a wide range o products.
Eports
North, Central & South America 33%
Africa 28%
Europe 21%
Australasia 11%
Middle East 7%
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25P hA R M A c E U TIc A L S
Reenue & grot
For 2005-06, NPIL recorded a turnover o US$ 343.9 millionand prots ater tax were US$ 41.4 million. The domestic
Indian market accounts or approximately 87 percent o
the companys annual sales. Brands such as Phensedyl,
Ismo, Supradyn, Gardenal, Stemetil, Haemaccel and Rejoint
account or 67 per cent o the total revenue.
gLAxOSMIThKLINE
Introution
GlaxoSmithKline is a leading, global, research-based
healthcare and pharmaceutical company. In India, it is the
number one pharmaceutical company with a market share
o 6.45 per cent in December 2006. The company has two
manuacturing units in India, located at Nasik and Thane.
The company has a 2000-strong eld and a nation wide
network o over 4000 stockists, which ensures that the
companys products are readily available across the nation.
business untions
The company has two main business segments in India,
one is pharmaceuticals and the other is Qualigens Fine
Chemicals (QFC). QFC has an estimated market share o 29
per cent in the laboratory chemicals market. The company
also has a signicant presence in the diagnostics business.
Reenue & grot
Net sales o the pharmaceuticals business segment was
US$ 327 million which constitutes 92 per cent o the
companys total sales (excluding the AFC business).
Exports recorded a sales turnover o US$ 7.1 million,
comprising o both bulk drugs and ormulations. Exports o
bulk drugs were to major markets including Japan, Mexico,
France, Germany, Holland, UK, South Arica and Denmark.
Formulations were exported to Sri Lanka, Myanmar
and Vietnam.
Resear & deelopment
The company has two R&D centres, which are approvedby the Department o Scientic and Industrial Research,
Government o India.
NPIL has developed a number o new products in the
area o palatable liquid orals (aqueous and oily), as also
topical steroid in emollient cream base. The R&D division oNPIL is also involved in collaborative development o new
products along with leading pharma companies.
uture Outlook
The company will continue to lay emphasis on the key areas
particularly on the development o new products such as
multivitamin-multimineral in novel orm, Cephalosporin
ormulations and line extensions and collaborative research
work with other companies and GSK UK.
PIzER
Introution
Pzer rst came to the Indian market in 1950, through a
company named Dumex Limited. The rst production acility
was set up at Darukhanna in Mumbai, where products such
as Protinex and Isonex (isoniazid - an anti -TB drug) were
manuactured. The company is headquartered in Mumbaiand it employs around 2,000 employees across the country.
The company has a state-o-the art manuacturing acility
at Thane, Maharashtra.
Ke Prouts
Pzer has demonstrated tremendous aith in the potential o
Indian pharmaceutical market. The company has launched
5 products since 2005 - Vend, Viagra, Lyrica, Caduet and
Macugen.
7 o Pzers brands eature among the top 100
pharmaceutical brands in India, while 2 o Pzer brands,
Corex (cough ormulation) and Becosules (multivitamin),
continue to rank as the No.1 & 2 brands amongst all
pharmaceutical drugs sold in the country.
Reenue & grot
Pzer Limited (India) had a turnover o US$ 172 million
(November 2006) and as o is one o the astest growing
pharmaceutical companies in India with a consistent higherthan market growth rate in 2006.
Globally it is one o the highest spenders in
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M A R K E T & O P P O R T U N I T I E S26
pharmaceutical R&D. Pzer has made clinical research
investments o US$ 15.75 million in India and it is among
the most respected MNC pharma companies in India.
Oter Atiities
1. Created the Academy o Clinical Excellence (ACE) in
collaboration with Bombay College o Pharmacy to
provide proessional training to investigators and other
clinical research personnel.
2. Pzer has also partnered with other pharmaceutical
companies, contract research organisations and
investigators to establish Indian Society or Clinical
Research (ISCR) a proessional society aimed at raising
the standards o clinical research.
3. Pzer Education And Research League (PEARL) is an
initiative in which Pzer seeks to partner with institutes
to improve existing clinical research and continuing
medical educational capabilities.
ASTRAzENEcA
Introution
AstraZeneca India Pvt. Limited (AZIPL) is an integral parto the global organisation with a mandate to discover new
chemical entities or the treatment o inectious diseases o
the developing world.
business untions
The company has R&D, manuacturing and marketing
unctions in the country with ofces in Bangalore. The
R&D acility in India has more than 90 scientists o
international repute.
The company is in the process o adding a new state-o-
the-art process R&D acility across 3.5 acres. It would house
a team o upto 50 scientists.
ous Terapeuti Sements
The company ocuses on respiratory, maternal health,
oncology inection, pain control and anaesthesia.
Reenue & grot
Added a state-o-the-art process R&D acility employing morethan 50 scientists. The company registered a sales turnover
o US$ 62.9 million in 2006 with a Prot Ater Tax (PAT) o
US$ 11.5 million
SANOI AvENTIS
Aventis Pharma Limited was incorporated in May 1956
under the name Hoechst Fedco Pharma Private Limited.
The company has around 1,840 employees in the country.
business untions
The company is engaged in the manuacturing and
marketing o drugs and pharmaceutical products in the
country. It has two state-o-the-art manuacturing acilities
at Ankleshwar, Gujarat (chemistry and pharmaceuticals)
and at Verna, Goa (pharmaceuticals). Both sites have been
identied as global sourcing units.
ous Terapeuti Sements
The key ocus areas are cardiovascular disease, thrombotic
diseases, metabolic disorders, oncology, disorders o the
central nervous system, internal medicine and vaccines.
Reenue & grot
The company registered sales o US$ 223 million or
the year ended as o December 2006 with a net prot o
US$ 40.3 million.
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cONTRAcT RESEARch
INdIA AN EMERgINg hOTSPOT
The Indian contract research outsourcing industry recorded
a growth o 45 per cent to reach US$ 175 million in 2006,
establishing the countrys status o a preerred service
provider. The trend o orging strategic alliances within the
drug discovery and development arena is urther gaining
momentum and is an indicator o the move towards a
preerred partner position.
Another major trend that has been witnessed is the
enhanced level o investment in R&D capabilities and
inrastructure by the industry and the Government alike.
Outsourcing R&D to India is increasingly being looked
at as integral to the strategic decisions o innovators,
indicating the sectors shit rom a cost-driven, low-value
service, to a research-driven, high value activity. In addition
to conventional clinical research, the segment has expanded
to include contract research or preclinical drug discovery.
Presently, a major portion o the services are limited
to chemistry based lead identication/optimisation,
preclinical and clinical research stages. However, there are
a handul o companies that provide biology based services
or target validation. Notable examples are Avesthagen,
Key Opportunities
Areas
Taret
Ientiiation
Taretvaliation
compoun
generation
Sannin
LeaOptimisation
Prelinial
deelopment
clinialdeelopment
Speialise Sements
Genetics Proteomics Chemoinformatics BioinformaticsGene
Sequencing
FuncionalGenomics
ProteinBiochemistry
Disease Model GeneticallyModified Mice
Bioimaging
AnaloguePreparation
Synthesis Drug Design StructuralChemistry
AnalyticalChemistry
CompoundSynthesis
HTSAssay
Development
Cell-based modelfor efficacy
AssayExecution
SARMedicinalChemistry
Pharmacology PKDM Toxicology Animal Models
TrialManagement
RegulatoryConsulting
DataManagement
Source: Ofshoring in the Pharmaceutica Industry: Mridua Pore, Yu Pu, Chares Cooney, MIT, E&Y Anaysis
developmentResearch
discoveryResearch
Strong
Week
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M A R K E T & O P P O R T U N I T I E S28
Ocimum Biosolutions and TCG Liesciences. Though still
at a nascent stage, these services are beginning to gain
momentum. Bioinormatics companies that oer research
enabling sotware technologies are also emerging as a
valuable segment.
There is an increasing trend o Indian Clinical Research
Organisations (CROs) becoming preerred vendors or
outsourcing activities in the early drug discovery phase,
with high margin contracts, such as researching and/or
developing proprietary technologies or the client.
Estimates suggest that India has the potential to attract
between 5-10 per cent o the global contract research
outsourced market over the next ve years. This includeschemistry services, toxicology services and clinical research
activities. The said business would be US$ 0.8-1.7 billion by
2008 and US$1-2 billion by 2010. Approximately, 40-50 per
cent o this would come rom clinical research.
cLINIcAL RESEARch
LEvERAgINg INdIAS AdvANTAgE
India is rapidly gaining ground as the preerred destination
or oshoring clinical research which primarily involves
Phase II to IV trials and BA/BE studies or generic drugs, by
pharmaceutical companies across the globe.
Clinical research market in India was estimated around
US$ 200 million in 2006 and is expected to become US$
400-500 million by 2010, moving at a high CAGR o 3035per cent. Presently, India constitutes less than 2 per cent o
the global clinical trials market.
compan Series Oere clients
Advinus Therapeutic (Pune) Drug discovery services, medicinal chemistry services,toxicology studies
Development projects for Merck
Avra Labs (Hyderabad) Product chemistry, organic synthesis, chiral synthesis andtechnology
Top 20 big pharma and biotechcompanies
BioArc Research Solutions (Vadodara) Medicinal chemistry services, custom synthesis andformulations, preclinical pharmabiology, BA/BE, CRAM
NA
Aurigene (Bangalore) Lead generation and optimisation and early computationalchemistry aided ligand design, mining and screening of novelchemical entities, thus providing direction for lead discoveryand medicinal chemistry. Early animal work involving ADMEand toxicity improves the probability of success
Collaborative discovery programmeswith Novo Nordisk on diabetes anddiscovery services with Rheosciences,Denmark
GVK Biosciences (Hyderabad) Medicinal chemistry services, Bioinformatics, clinical trials,custom synthesis and drug discovery services
Pharma/biotech companies across US,UK, Germany and Japan; Wyeth, Biogen,Merck & Co. (50 projects)
Hikal (Mumbai) Medicinal chemistry services, custom synthesis , CRAM 5 pharma companies also work in
agrochemicals
Innovasynth (Mumbai) Medicinal chemistry services, custom synthesis, CRAM Work for big pharma companies
Jubilant Organosys (New Delhi) Bioinformatics, clinical trials, CRAM, medicinal chemistryservices, custom synthesis and drug discovery services
60 clients/20 projects at any given time
Matrix (Hyderabad) CRAM, medicinal chemistry services, custom synthesis anddossier development
Rigen Inc., GSK India, Merck KGaA
Procitius Research (Chennai) Medicinal chemistry services, custom synthesis, biologyservices, clinical trials and CRAM
NA
Sai Life Sciences (Hyderabad) Medicinal chemistry services, scale up services 200 projects for almost 30 MNC pharmaand biotech companies
Shasun Chemicals & Drugs (Chennai) CRAM, organic chemistry, medicinal chemistry services,custom synthesis and biology services like protein purification,
microbial fermentation and process optimisation
NA
Suven Life Sciences (Hyderabad) CRAM, medicinal chemistry services, custom synthesis andclinical trials ( ACT and Sipra), drug discovery services
About 18-20 international clients fromacross US and Europe
Syngene (Bangalore) Medicinal chemistry services, custom synthesis and drugdiscovery services, affiliate Clinigene
Novartis, Merck & Co.
TCG (Kolkata) Silicogene, medicinal chemistry, drug discovery services NA
Bharavi Labs (Bangalore) Medicinal chemistry services, custom synthesis and drugdiscovery services
20-25 ongoing projects. Works on FTEand ongoing contracts
Source: E&Y Research
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Clinical trials or NCEs constitute around 60 per cent
o the total revenue mix, while the rest 40 per cent is
contributed by the BA/BE studies or generics development.
However, in terms o volume, around 70 per cent o the
work is directed towards generics research.
The market or BA/BE studies in India was estimated to
be around US$ 60-70 million in 2006. It is estimated to reach
US$ 150 - 200 million by 2010-11 growing at a CAGR o
18-20 percent.
At present, a majority o the clinical trials are being
outsourced by the MNCs. Indian generics companies are
the primary sponsors o BA/BE studies. However, in the
uture a signicant portion o these studies are likely to be
sponsored by global generics companies.
Eli Lilly, Pzer and Quintiles were the pioneers toinitiate clinical research activities in India around a decade
ago. Since then, the number o CROs has increased to
around 120.
Majority o these companies started o by oering
bioequivalence services and then gradually expanded
their operations into clinical research using their existing
talent pool.
INdIA AdvANTAgE
Aailailit o sujets, inestiators an sites
Huge patient population, genetically distinct groups,
specialty hospitals with state-o-the-art acilities, nearly
700,000 hospital beds and 221 medical colleges and
skilled English speaking investigators are Indias trump
cards. By 2010, an estimated 2,500-3,000 GCP trained
investigators are likely to be available in India
India oers the ease at which subjects can be recruited
and investigators and sites can be identied, whichhas tremendous impact on the speed at which a drug
is marketed. The prevalence o diseases o both, the
tropical and the industrialised world and the availability
o treatment nave patients allows or quick recruitment.
Patients can be recruited 3-4 times aster or trials than inthe traditional geographies in the West
cost benefts
The cost o conducting phase I trials in India is 50 per cent
lower than the US$ 20 million required in the US and 60
per cent lower than the US$ 50 million required or the
phase II study
Support series an inrastruture
An integrated support inrastructure in the orm o central
reerence labs, hospitals, courier services, etc. is essential
or timely and successul completion o a trial. India has
robust IT inrastructure and