Pharmaceuticals

PHARMACEUTICALS
September 2009
PHARMACEUTICAL September 2009
The focus of this presentation is to discuss…
 Market overview
 Policy
 Key trends and drivers
 Key players
 Key opportunities
2
MARKET OVERVIEW
Pharmaceutical September 2009
Indian pharmaceutical market — US$ 7.3 billion opportunity

• India is among the fastest growing pharmaceutical markets in the world.
• The pharmaceutical market was worth US$ 16.6 billion in 2007–08; the domestic retail market is
expected to cross the US$ 10 billion mark in 2010 and reach an estimated US$ 12 billion to US$ 13
billion by 2012.
Domestic pharma retail market

Break up of Indian pharma industry
16
13.6 13.4
14
12 10.1
(US$ million)
10 7.7
8
5.4
6 3.9 4.1 4.8 46%
4 2.5 2.6 54%
1.4 1.1
2
0
2002-03 2005-06 2007-08E 2012-13P
Domestic Formulation Consumption (DFC)

Domestic Formulation Consumption (DFC) Total exports
Formulation exports
Bulk drug export Source: Pharmaceuticals: industry profile, Dec 2008,
CRIS INFAC
Source: Pharmaceuticals: industry profile, Dec 2008, CRIS
INFAC
3
MARKET OVERVIEW
Indian pharmaceutical market — US$ 7.3 billion opportunity
• The outsourcing opportunity is set to grow to Forecasted Indian pharmaceutical retail market in US$ bn
US$ 53 billion in 2010 from US$ 26 billion in
2006.
• Retail sales of pharmaceuticals were US$ 7.7

billion in 2007–08.
• Domestic consumption accounted for nearly 46

per cent and exports for the remaining 54 per
cent of total industry revenues.
Source: Compiled from industry sources
4
MARKET OVERVIEW
Anti-infectives — largest therapeutic category
• The anti-infectives segment was the highest contributor (18 per cent) to total domestic sales in
2007–08.
• Cephalosporins, penicillins and quinolones are key drug classes among anti-infectives.
• Gastrointestinal and cardiac are the second- and the third-largest therapeutic categories, respectively.
• Oral anti-diabetics and anti-peptic ulcerants are the fastest growing therapeutic segments under
alimentary and metabolism therapeutic categories.
Source: Pharmaceuticals: industry profile, Dec 2008, CRIS INFAC
5
MARKET OVERVIEW
Anti-infectives — largest therapeutic category
• Cholesterol reducers have emerged as a key class of cardiovascular drugs in the last few years.
• Anti-epileptics accounted for 35 per cent of total revenues of the central nervous system (CNS)
segment in 2007–08.
Market share of key therapeutic categories (2007–08) Market share of key drug classes (in %, 2007–08)
6
MARKET OVERVIEW
Acute therapy dominates sales, chronic segment to fuel growth
• Chronic therapy contributes 22 per cent to Acute vs. chronic sales mix of top 10 Indian pharmaceutical
total revenues and acute therapy dominates companies
with a share of 78 per cent. 100%
90%
80%
• New products launched in the chronic 70% Chronic 2006
therapy segment outnumbered acute 60% share
50%
segment launches in 2006. 40%
30% Acute 2006
20% share
• The acute segment is expected to grow at a 10%
0%
steady pace due to its mass therapy nature
Ranbaxy
Cipla
GSK
Industry
Pfizer India
Zydus Cadila
Sanofi Aventis
Sun Pharma
Nicholas Piramal
Aristro Pharma
Alkem Labs
and unresolved issues of sanitation and
hygiene in the country.
Source: Pharmaceuticals: industry profile, June 2008, CRIS INFAC
7
MARKET OVERVIEW
Acute therapy dominates sales, chronic segment to fuel growth
Key drivers of chronic therapy segments
• Growing geriatric population: 4.9 per cent of the total Indian population in 2005 consisted of the
65+ age group. This is further expected to increase to 6.4 per cent by 2015 and 7.5 per cent by
2020.
• Rapid urbanisation: An increasing number of people are suffering from lifestyle diseases such as
diabetes, obesity, depression, etc., due to rapid urbanisation. The urban population has grown by 31
per cent in a decade — from 217 million in 1991 to 285 million in 2001 — as against 18 per cent
population growth in rural areas.
8
MARKET OVERVIEW
Indian pharmaceuticals exports
• For 2007–08, export revenues are estimated Formulation export revenues

to be around US$ 8.9 billion.
4.1
• Formulation exports are estimated to

constitute 46 per cent of total revenue, while 24.2
(US$ billion)
bulk drugs are estimated to account for 54 per
cent.
21.8
1.4
• Revenues from formulation exports are
expected to surpass those from bulk drugs by 28
2010–2011.
• By 2012, exports are expected to top US$

23.5 billion, with most of the value generated
by generics and active pharmaceutical
ingredients (API).
9
MARKET OVERVIEW
Indian pharmaceuticals exports

Demand from regulated markets bound to increase
• Exports to regulated markets are expected to Formulation exports demand outlook

surge at a compound annual growth rate
(CAGR) of 25.4 per cent between 2007-08
and 2012-13. In comparison, exports to semi- 10.2
regulated markets clocked a CAGR of 14.6 per
cent from 2000 to 2005. 19.6
(US$ billion)
• Formulation exports to regulated markets are 14.6
expected to grow at a high CAGR of over 25.4 4.1
per cent to reach US$ 5.4 billion by 2012-13.
25.4
• Demand from semi-regulated regions is

estimated to grow at a modest CAGR of
around 14.6 per cent and reach US$ 4.8 billion
in the same period.
Source: Pharmaceuticals: industry profile, Dec 2008,

CRIS INFAC
10
MARKET OVERVIEW
Generics to drive growth of exports from India
• By 2011-12, the share of Indian players in Expected market share of Indian players in the US generics
the US generic market is expected to market
cross 6 per cent from 2.1 per cent in
2006-07.
• Formulation exports to the US are

expected to grow at a CAGR of 38 per
%
cent and reach around US$ 3.03 billion in
2011-12.
• Exports of generic drugs to Europe are

likely to grow at a healthy CAGR of 20
per cent to reach US$ 1.8 billion by
2012-13.
11
MARKET OVERVIEW
Generics to drive growth of exports from India

• India is the world‘s fifth-largest producer India to maintain focus on bulk drug export
of bulk drugs.
DMF filings: Global vs. India
• Demand for bulk drugs has grown at a 900 60.00%
762
CAGR of 31 per cent since 2000–01 to 800
704
745
689 50.00%
reach US$ 4.8 billion in 2007–08. 700 48.20%
600 43.30% 44.60% 40.00%
517 39.80%
• The share of Indian companies in the 500
404
37.30%
30.70% 30.00%
total drug master files (DMF) filed with 400
305
340 359
280 298 274
the USFDA* increased from 14.5 per 300 227 21.10% 20.00%
193
cent in 2000 to 48 per cent in 2008. 200
14.50%
18.60%
124
63 10.00%
100 33 52
• Semi-regulated markets account for a 0 0.00%
majority of bulk drugs' exports with a 50 2000 2001 2002 2003 2004 2005 2006 2007 2008
per cent share. Total DMF filling with USFDA DMF filling from India India's share

* USFDA: United States Food and Drug Administration
12
MARKET OVERVIEW
Changing paradigm: Indian pharmaceutical industry
2006 2010
Pharmaceutical Pharmaceutical
industry revenues industry revenues
6.6% 93.4% 12% 88%

Services Products Services Products
Domestic Exports Domestic Exports

57% 43% 38% 62%
Source: Ernst & Young analysis
• Although revenues from the domestic market dominated total pharmaceutical revenues in 2006-07,
exports contribution surpassed the domestic turnover in 2007-08.
• The pharma sector is expected to witness an upswing in revenues from the service segment due to
the increase in outsourcing of contract research and manufacturing services (CRAMS) to India.
13
MARKET OVERVIEW
Advantage India: Significant cost arbitrage
The basic production cost in India is up to 50 per cent lower than costs in the US.
• 30 per cent to 50 per cent lower depreciation
• FDA-approved plants can be constructed in India at 30 per cent to 50 per cent lower costs
• Higher utilisation of equipment due to improved processes (not quantified)
• 85 per cent to 90 per cent manpower cost savings
• Labour costs in India typically 10 per cent to 15 per cent of the cost in the US
• Savings applicable across all hierarchal levels (e.g., operators, research scientists, etc.)
• Improved, more efficient processes contribute to lower labour costs per unit (not quantified)
14
MARKET OVERVIEW
Advantage India: Significant cost arbitrage
India‘s cost arbitrage

• 40 per cent to 50 per cent savings in raw
materials
• Bulk drugs can be manufactured in-house at

40 per cent to 50 per cent of ethicals‘ cost
• Excipients and intermediates sourced locally

at 20 per cent to 30 per cent lower costs
• Most other raw materials can be sourced

internally and from China Source: OPPI – Adapted from Monitor Group, Study on
Outsourcing Opportunities in Indian Pharmaceutical Industry
15
MARKET OVERVIEW
Established infrastructure for pharma R&D and manufacturing

Key manufacturing clusters Key R&D clusters
Gujarat- Ahmedabad,
— Ahmedabad,
Ankleshwar,
Ankleshwar,
Vapi, Vadodara
Vapi, Vadodara
Maharashtra– Mumbai,
— Mumbai,
Tarapur,
Tarapur, National Capital Region
Aurangabad, Pune
Traditional Andhra Pradesh
Pradesh– Hyderabad
— Hyderabad Ahmedabad
Bulk drugs
bulk Drugs
Cluster
cluster Tamil Nadu– Chennai
— Chennai Mumbai
Pondicherry Captive R&D Units Aurangabad
Karnataka– —Mysore,
Mysore,
Bangalore
Bangalore Hyderabad
Goa– —
Goa Pangji
Panaji units
Bangalore
Traditional Goa Chennai
Formulation
formulation Mumbai
Cluster
cluster Pune Mumbai
Mumbai,
Hyderabad
Hyderabad
Emerging Contract R&D
Bulk drugs
bulk Drugs –—
Andhra Pradesh Visakhapatnam
Visakhapatnam Units
units
Bangalore
Cluster
cluster Chennai
Emerging Himachal Pradesh – Baddi
— Baddi Ahmedabad
Formulation
formulation
Cluster
cluster Uttranchal- Pantnagar
Uttarakhand — Pantnagar
Source: Ernst & Young analysis
16
MARKET OVERVIEW
Enabling research infrastructure

• The country has over 450 institutes/colleges and departments imparting pharmacy education.
• More than 25,000 pharmacy graduates pass out from these institutes every year.
Key research institutes in India

• Central Drug Research Institute (CDRI), Lucknow
• National Institute of Pharmaceutical Education and Research (NIPER), Mohali
• Indian Institute of Chemical Technology (IICT), Hyderabad
• Centre for Cellular & Molecular Biology (CCMB), Hyderabad
• Indian Institute of Chemical Biology (IICB), Kolkata
• Indian Toxicology Research Institute (ITRI), Lucknow
• Institute of Genomics and Integrative 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), Bangalore
• Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad
• Indian Institute of Science (IISc), Bangalore
• National Institute of Immunology (NII), New Delhi 17
MARKET OVERVIEW
Enabling research infrastructure
Talent statistics Case study: Government

introduces four more NIPERs
• Around 1,000 biotech and biochemistry
postgraduates pass out every year The National Institute of Pharmaceutical
Education and Research, India, was
• Around 10,000 chemistry postgraduate students
graduate every year established by the Government of India
(GoI) to cater to the long-standing demand
• Around 2,500 chemical engineering students for setting up a dedicated nodal institution
pass out every year. India had a pool of around
50,000 chemical engineering graduates until for quality higher education and advanced
2004–05 research in pharmaceutical sciences. The
benefits delivered by NIPER prompted the
• Around 4,500 students pursue PhDs in various
science streams government to set up four new NIPERs at
Kolkata, Ahmedabad, Hyderabad and
• 1,000 students pursue PhDs in engineering
stream Hajipur (Bihar) in 2007.
• 1,000 students pursue PhDs in chemistry
18
 Market overview
 Policy
 Key players
19
POLICY
Regulatory framework
• The main regulatory body in India is the Central Drug Standard Control Organization (CDSCO)
under the Ministry of Health and Family Welfare.
• CDSCO is presided over by the Drug Controller-General of India (DCGI), who is in charge of
approval of licenses for drugs at both the Central and state levels.
• India introduced the product patent regime, in accordance with the TRIPS agreement, in January
2005 with an amendment to the patent act.
• Foreign direct investment (FDI) up to 100 per cent is permitted through the automatic route in
drugs and pharmaceuticals.
• For licensable drugs and pharmaceuticals manufactured by recombinant DNA technology and
specific cell/tissue targeted formulations, FDI needs prior government approvals.
Source: ―India Pharmaceuticals and Healthcare Report Q2 2008,‖ Business Monitor International
20
POLICY
Regulatory framework
• The industry is undergoing consolidation due to recent legislation and policy updates:
– Manufacturing units should adhere to good manufacturing practices (GMP) outlined in

Schedule M of the Drugs and Cosmetics Act
– Manufacturing units are required to comply with the WHO and international standards of
production.
• The National Pharmaceutical Pricing Authority (NPPA) is responsible for fixing and controlling the
prices of 74 bulk drugs and formulations under the Essential Commodities Act.
Source: ―India Pharmaceuticals and Healthcare Report Q2 2008,‖ Business Monitor International
21
POLICY
Drug regulatory environment in India in transition

Existing drug regulatory system
• India has a bifurcated drug regulatory system — regulatory functions are divided between the Centre
and state authorities.
• Existing infrastructure at the Centre and in states is inadequate to perform the assigned functions of
drug administration with efficiency and speed, though there is a renewed focus on the same.
Proposed new system
• The Central Cabinet approved the formation of the Central Drug Authority (CDA) in January 2007.
• The proposed organisational structure of the CDA is to be analogous to the USFDA.
• It will be a strong, well-equipped, empowered, independent and professionally managed body.
• It is expected to facilitate upgradation of the national drugs regulator, uniformity of licensing, and
enforcement and improvement in drug regulations.
• The efficiency and efficacy of drug administration is expected to be much higher after this transition.
22
POLICY
CDA — India‘s new drug regulator
Existing Proposed
Central Drug Administration
Central government • Three joint drug controllers
Drug Controller-General of India • Two deputy drug controllers
(expert committees) • Six assistant drug controllers
• 50 drug inspectors
• Five technical experts
Responsibilities:
• One administrative officer
Broad policy issues
• One accounts officer
Responsibilities:
• Regulatory affairs and environment
State governments • New drugs and clinical trails
• Biologicals and biotechnology products
State drug authorities • Pharmacovigilance
(State drug controller and food and drug inspectors) • Medical devices and diagnostics
• Imports
Responsibilities: • Organisational services
• Licensing and monitoring manufacturing
• Training and empowerment
• Legal cell
• Spurious drug monitoring • Quality control affairs
• Pharmacies • Legal and consumer affairs
23
POLICY
Budget 2009–2010 and policy changes
Budget measures:
• Budget 2009–2010 reduced the customs duty from 10 per cent to 5 per cent on imports of select life
saving drugs and their bulk drugs for treating ailments such as breast cancer, hepatitis, rheumatic arthritis,
etc.
• Customs duty has been reduced from 7.5 per cent to 5 per cent on two specified life saving devices used in
the treatment of heart conditions.These devices are now fully exempt from excise duty and countervailing
duty (CVD) also.
Source: India Budget 2009, Ernst & Young 2009
24
POLICY
Budget 2009–2010 and policy changes

Policy changes:
• The government has approved the Drugs and Cosmetic (Amendment) Bill, 2008, which inter alia enhances
the term for imprisonment from five years to at least 10 years, which may extend to lifetime, and raises the
fine from Rs. 10,000 to Rs. 10,00,000 or three times the value of the drug confiscated, for manufacturers of
spurious and adulterated drugs.
• The DCGI has directed state drug regulators not to allow companies to sell drugs that have undergone a
composition change under their old brand names. Such drugs will be treated as new drugs and the
companies would have to go through scrutiny before getting fresh approvals.
• The DCGI has made the registration of all clinical trials compulsory for trials initiated after June 15, 2009.
Earlier, the registration of clinical trials by various institutions and companies was voluntary.
• The DCGI has withdrawn the powers given to state-level regulators to issue Certificate of Pharmaceutical
Product (CoPP).
• The DCGI has discontinued issuance of the WHO-GMP certificate for both pharmaceutical products and
plant audits.
Source: India Budget 2009, Ernst & Young 2009
25
 Market overview
 Policy
 Key players
26
KEY TRENDS AND DRIVERS
Changing growth fundamentals of the domestic market

Increasing penetration driving growth Expansion of private sector healthcare Increasing penetration of medical
driving accessibility insurance
• Expansion of healthcare facilities in the • Medical value travel has led to an • Penetration of medical insurance
rural and far-flung areas has enhanced investment spurt in private would grow at a higher pace due to
accessibility. healthcare services in the country. the increasing influx of foreign
players.
• Increased government spending on • There has been accelerated
roads, telecommunication and health investment from the private sector • Favourable regulatory changes such
infrastructure has facilitated the foray of in healthcare facilities across tier-I as permitting FDI of up to 51 per
pharmaceutical companies into relatively and tier-II cities in the country. cent in stand-alone health insurance
distant pockets of the market. companies and setting the minimum
capital requirement at US$ 5.4
• An estimated one million beds million would drive growth in this
• With sales revenues of US$ 1.4 billion, would be added by 2012, taking the segment.
the Indian pharmaceutical market in total beds available in the country to
rural areas witnessed a growth of 39 per over two million.**
cent as compared to the growth of 18 • The Indian middle class, with its
per cent in the overall domestic market increasing purchasing potential, is
in November 2006.* • An estimated US$ 69.7 billion would expected to become a major buyer
be invested by the private sector in segment.
healthcare infrastructure by 2012.
• New product launches in 2006–07
accounted for only 1 per cent of the • Increasing penetration of customised
market, while 15 per cent of the growth • The number of patients visiting insurance plans would drive
was contributed by volume growth. Indian hospitals is expected to rise affordability, influencing the
by 30 per cent to 22 million by consumption of medical and
*Source: The Economic Times, January 26, 2007 2015. healthcare products.
*Source: The Economic Times, January 26, 2007 **Source: Ernst & Young FICCI healthcare report
27
Rising disposable income to drive drug consumption
• There were 16.4 million middle-class households with an annual income ranging between US$ 4,849
and US$ 24,242 in 2006.
• The segment is expected to grow at a CAGR of 14 per cent; it is likely to touch 28.4 million by 2010
and be the key driver of consumption.
• There were 1.7 million households in the upper-income group with an annual income greater than
US$ 24,242 in 2006.
• The aggregated household expenditure on healthcare services increased at a CAGR of 9.3 per cent
between 1993–94 and 2001–02.*
• Healthcare expenditure is expected to rise by 15 per cent per annum.*
• The high purchasing potential of the burgeoning Indian middle class is set to drive the consumption of
healthcare services, including pharmaceuticals which constituted 22.6 per cent of the total healthcare
expenditure in 2007.**
28
Rising disposable income to drive drug consumption

Income distribution across households
Source: ―The Great Indian Market‖, August 2005, National Council of Applied Economic Research
*Source: Ernst & Young FICCI healthcare report **Source: Espicom
29
Focus of Indian companies shifting from the US
• Pricing pressures and shrinking margins in the generics space and increasing litigation instances in the
US are compelling Indian companies to consider opportunities beyond the US.
• Indian companies have invested more than US$ 1.2 billion in European markets.
Increasing focus on Japan Key pro-generic reforms in Japan
• Japan is the world‘s second-largest • Generics substitution is allowed.

pharmaceutical market after the US.
• Physicians are incentivised to prescribe
• With sales worth US$ 60 billion in 2006, it generic medications over branded ones.
constitutes around 11 per cent of the global
market.
• The regulatory body expedites the drug
approval process.
• Generics penetration has been extremely low
until now in Japan.
• Obligations to manufacture locally have been
removed with these reforms.
• The Japanese government has initiated a string
of pro-generics legislation reforms to increase
the penetration up to 40 per cent from the
present 16 per cent.
30
Focus of Indian companies shifting from the US
Key initiatives of Indian companies in Japan
Zydus Cadila acquired Nippon Universal Pharmaceutical Ltd
Lupin acquired a majority stake in Japanese generic drug maker Kyowa Pharmaceutical.
Dishman established a joint venture with (JV) Azzuro Corporation in 2007
Strides entered into a JV with Sorm Corporation Ltd
31
Indian companies preferring the inorganic growth route
Announced total
Announcement date value US$ (mn) Target name Target country Acquirer name
MUTLICARE THE
March 27, 2009 N/A PHARMACEUTICALS PHILIPPINES LUPIN LTD
January 28, 2009 4.2 RxELITE HOLDINGS INC UNITED STATES PIRAMAL HEALTHCARE LTD
December 23, 2008 44.8 MINRAD INTERNATIONAL INC UNITED STATES PIRAMAL HEALTHCARE LTD
ZYDUS PHARMACEUTICALS
December 17, 2008 NA INC UNITED STATES CADILA HEALTHCARE LTD
CIS RETAIL PHARMACY CHAIN
November 28, 2008 20.0 CO HONG KONG PLETHICO PHARMACEUTICALS LTD
September 18, 2008 N/A PHARMA DYNAMICS SOUTH AFRICA LUPIN LTD
PI DRUGS & PHARMACEUTICALS
September 16, 2008 N/A DIASPA SPA ITALY LTD
August 21, 2008 N/A GENERIC HEALTH PTY LTD AUSTRALIA LUPIN LTD
July 30, 2008 NA HORMOSAN PHARMA GMBH GERMANY LUPIN LTD
July 21, 2008 BILCARE, ALONG WITH US-BASED
NA INTERNATIONAL LABS INC UNITED STATES MEADWESTVACO CORP
June 18, 2008 SYNOVICS PHARMACEUTICALS
18.5 INC UNITED STATES MANEESH PHARMACEUTICALS PVT
32
Indian companies preferring the inorganic growth route
• M&A has been the key strategy adopted by Indian companies to gain a foothold in export markets,
although a significant slowdown was seen in outbound activity in 2009.
• Large Indian companies have increased their foothold in regulated markets worldwide.
• Small- and medium-sized players are focussing on semi-regulated markets such as Latin America.
• Increased penetration, access to established distribution networks and increase in buyer confidence
due to localised presence have been the key factors driving acquisition-led growth.
33
Rising confidence of global pharma companies in the Indian

market
Patented molecule launches in India after Split of Indian pharmaceutical market
enactment of Product Patent Regime in 2005
Therapeutic Launch
Product Company
category date
Systemic
VFend Pfizer Feb 2005 MNCs 20-
anti-fungal
22%
Erectile Domestic
Viagra Pfizer Dec 2005
dysfunction 78-80%
Lyrica Pfizer Neuropathic Jan 2006
Caduet Pfizer Cardiovascular Feb 2006

MNCs Domestic
Carvedilol GSK Cardiovascular Mar 2006 Source: Ernst & Young research
Avastin Roche Various cancers Apr 2006
Tarceva Roche Lung cancer Apr 2006
Tamiflu Roche Bird flu Apr 2006
34
Rising confidence of global pharma companies in the Indian

market
Patented molecule launches in India after
enactment of Product Patent Regime in 2005 • The enactment of product patent in 2005
has reposed the confidence of innovator
Pegasys Roche Hepatitis C May 2006 pharmaceutical companies in the Indian
Wet age-related market.
Macugen Pfizer macular Jun 2006
degeneration
• Since January 2005, about 15 patented
Sanofi
Avalide Cardiovascular Jul 2006 products have been launched in the
Aventis
country (until March 2008).
Wet age-related
Lucentis Novartis macular Nov 2006
degeneration
• Innovators are treading a cautious path
Sanofi
Ambien Insomnia Jan 2007 and are awaiting further clarity on several
Aventis
issues such as data protection, patenting
Champix Pfizer Smoke cessation Feb 2008 of derivatives and pre- and post-grant
Tykerb GSK Breast cancer May 2008 opposition.
Source: Pharmaceuticals: industry profile, Dec 2008, CRIS
Abraxane Abraxis Breast cancer Jul 2008
INFAC
Januvia Merck Diabetes Jul 2008
35
Global pharmaceutical companies establishing local presence

Recent global players to enter the Indian market
Company Area of focus in India Investment (US$

million)
Allergan Inc. Inflammatory, infection, urological indications 3–5
Eisai Pharmaceuticals API processes 120
Dupont Molecular biology, bio-informatics and polymer synthesis 23
Ratiopharm GmbH Basic processes 36
Teva Basic processes 3–4
AstraZeneca TB and NCE** research, process and development 15
BMS-Syngene Basic drug discovery N/A
Pliva Basic studies for generics 1
Nektar Therapeutics Pre-clinical and bio-analytical development 10
Daiichi Sankyo Company Strengthening generic presence through acquisition of Ranbaxy 3,400–4,600
Ltd
Actavis Group 60 per cent of Grandix Pharmaceuticals and API division of Sanmar N/A
Specialty Chemicals
Merieux Alliance 60 per cent of Shantha Biotechnics Ltd N/A
Mylan Laboratories Inc. Strengthening generic presence through acquisition of Matrix 736
Laboratories
Source: Business Standard: August 27, 2007
36
** NCE = New chemical entities
Global pharmaceutical companies establishing local presence
Case Study: AMRI extends its R&D centre at Hyderabad, India*
Albany Molecular Research, Inc. (AMRI), a global drug discovery company that provides chemistry
services to pharmaceutical and biotechnology companies, has completed the construction of a new
50,000 sq.ft. R&D centre at the Shapoorji Pallonji Biotech Park at Hyderabad, India. Completed in the
latter part of 2007, the R&D centre conducts contract projects in early stage drug discovery research,
including custom chemical synthesis and medicinal chemistry. In addition, a scale-up laboratory will be
used to develop efficient methods for producing larger quantities of APIs and intermediates. When fully
staffed, the new facility would add over 100 employees to the company's existing Hyderabad operations.
* Source: EY USAIC Position Paper ―Pharma-Biotech

Research: Decoding the Indian link‖
37
Increasing quest for NCEs
Indian pharmaceutical R&D expenditure No. of molecules in various stages of drug development
pipeline of key Indian companies
Specifics 2001 2008 Comments
Phases
R&D expenditure as a percentage of Discovery/ pre-
sales 1.4% 9.9% 7 times clinical phase I II III
R&D expenditure in absolute terms Ranbaxy 6 0 1 0
(US$ mn) 55 660 22 times
Dr. Reddy's 1 1 0 1
Source: Taking wings, Ernst & Young, 2009
Glenmark 6 2 3 0
Zydus Cadila 4 3 2 0
• Indian pharmaceutical companies are looking to
Piramal Healthcare 10 3 4 0
move up the value chain and make place for
themselves in the innovator league. Lupin 4 1 2 1
Sun 3 0 1 0
Source: ―Taking wings,‖ Ernst & Young, 2009
• The level of investments in R&D capabilities and
infrastructure have been enhanced by both the
industry and the government.
• Dr. Reddy‘s Laboratories‘ NCE Balaglitazone is India‘s first indigenously developed molecule to enter the
Phase III trial.
• Growing R&D pipeline of Indian companies presents significant in-licensing opportunities for global
companies.
38
Strategic partnerships on the rise, 2007–08

Indian company Overseas company Description
Bayer Healthcare Register and market insulin in China
Biocon Invitrogen Develop and market pharmaceutical-grade insulin
BMS Establish a research facility in Bangalore with more than 400 scientists
Clin Tech Development of an anti-cancer compound
7TM Pharma Identification of drugs to treat metabolic disorders
Dr. Reddy's
Albemarle Corp Dr. Reddy‘s to distribute Ibuprofen, a drug used for relief from pain and fever,
globally
The Medical House Create a new self-injectable disposable injector
Ceragenix Distribute and market EpiCeram, a cream used to treat atopic dermatitis
Pharmaceuticals, Inc.
39
Strategic partnerships on the rise, 2007–08

Indian company Overseas company Description
GVK Biosciences Wyeth Develop drug candidates for Wyeth
Forest Laboratories Develop drug candidate to treat a novel metabolic disorders
Jubilant Amgen Novel drugs in new target areas of interest across multiple therapeutic areas
Eli Lilly Collaboration in the area of discovery research
GlaxoSmithKline Ranbaxy will advance leads beyond candidate selection to completion of clinical
proof of concept. GSK thereafter will conduct further clinical development
Ranbaxy Merck & Co. Develop new products in the field of anti-infectives
Cipher Develop and market Cipher's Cip-Isotretinoin in the US market
Pharmaceuticals
Pharma (Yemen) Marketing alliance
Suven Life Sciences Ltd Eli Lilly NCE research for nervous system disorders
Karo Bio AB Develop glucocorticoid receptor modulators used in the treatment of
Zydus Cadila rheumatoid arthritis
Prolong Pharma Development of PEG-EPO, therapeutic protein used for the treatment of
anaemia
Source: Ernst & Young research

40
In and out licensing deals, 2007–08

Indian Partner Deal value (US$ mn) Nature Year Molecule/technology
company of deal
Alembic UCB, Milestone payment Out 2007 Novel drug delivery systems (NDDS) for Keppra XR
Belgium of US$11 million and licensing
royalties on sales
Glenmark Eli Lilly 350 Out 2007 GRC 6211, pain treatment molecule
licensing
Lupin Labs Laboratories 26.7 Out 2007 Sale of patent applications and other intellectual
Servier licensing property for Perindopril, a drug used to treat
hypertension and cardiac diseases
Eli Lilly Milestone payments In 2007 Pre-clinical drug candidate for metabolic disorder
of up to US$100 licensing
Piramal million and royalties
Healthcare on sales
Merck & Co. Milestone payments In 2007 Two oncology targets
of up to US$ 175 licensing
million and royalties
on sales
Out
Ranbaxy PPD Inc. 44 2007 RBx 10558 (dyslipidemia)
licensing
Jiangsu
Venus Provincial In
N/A 2007 Amino-glycoside
Remedies Institute of licensing
Microbiology

41
Private equity (PE) deals in pharmaceuticals and healthcare,

2008–09
Target Name Amount Deal Announcem Investor(s)
(US$ mn) Stake % ent Date
Anjan Drugs Pvt Ltd 5.3 - June 2009 3 Logi Capital (United Arab Emirates)
November Baring Private Equity Partners India Pvt Ltd (United
Sphaera Pharma Pvt Ltd 10.0 - 2008 Kingdom)
September International Finance Corporation (IFC) (United
Hikal Ltd 15.0 - 2008 States)
Marck Biosciences Ltd 4.7 - August 2008 IFCI Venture Capital Funds Ltd (India)
Citigroup Venture Capital International–India
Nectar Lifesciences Ltd 2.5 1.3 August 2008 (United States)
Rubicon Research Pvt Ltd - - August 2008 Kotak Investment Advisors Ltd (India)
Themis Laboratories Pvt Ltd 21.0 - July 2008 Jacob Ballas Capital India Pvt Ltd (India)
42
Private equity (PE) deals in pharmaceuticals and healthcare,

2008–09
Target Name Amount Deal Announcem Investor(s)
(US$ mn) Stake % ent Date
3 Logi Capital (United Arab Emirates); BioImagene
India Pvt Ltd (India); The Halo Funds Management
AgilityBio Pvt Ltd India - - June 2008 Company (United States)
BioPlus Life Sciences Pvt Ltd 31.0 - June 2008 AIF Capital (India) Pvt Ltd (Hong Kong)
Centaur Group 7.0 - May 2008 SIDBI Venture Capital Ltd (India)
Sai Advantium Pharma Ltd 20.0 12.0 May 2008 MPM Capital L.P (United States)
Parabolic Drugs Ltd 7.0 - May 2008 BTS Investment Advisors Private Ltd (India)
Century Pharmaceuticals Ltd
(India) - - January 2008 GVFL Ltd (India)
Gland Pharma Ltd 30.4 - January 2008 3 Logi Capital (United Arab Emirates)

43
 Market overview
 Policy
 Key players
44
KEY PLAYERS
Key players
Leading players by annual sales
Company name Year end Sales ( US$ mn)

Cipla 200903 1,091.33
Ranbaxy Laboratories Ltd 200812 1,004.29
Dr. Reddy's Laboratories Ltd 200903 914.96
Sun Pharmaceutical Industries Ltd 200903 850.62
Lupin 200903 637.81
Piramal Health 200903 510.16
Cadila Health 200903 373.85
GlaxoSmithKline 200812 366.36
Wockhardt 200812 327.86
Torrent Pharmaceuticals Ltd 200903 256.80
Alembic 200903 238.75
Aventis Pharma 200812 218.98
Intas Pharmaceuticals Ltd 200803 208.30
Alkem Lab 200703 196.90
USV 200903 184.17
Source: Capitaline
45
KEY PLAYERS
Key players
Leading players by annual sales
Company name Year end Sales ( US$ mn)
Aristo Pharmaceuticals 200903 170.07

Pfizer 200811 155.56
Abbott India 200811 152.97
Unichem Laboratories Ltd 200903 143.26
Novartis India 200903 132.11
FDC Ltd 200903 126.83
Source: Capitaline
Key MNC companies in India
46
KEY PLAYERS
Select domestic players
Ranbaxy Dr. Reddy‘s Labs
• Incorporated in 1961 • Established in 1984
• Ranked among the top 10 generics companies in the world • Ranks among the top 15 generics players in the world.
• Ground operations in 49 countries and manufacturing • First pharmaceutical company in Asia-Pacific (outside
operations in 11 nations Japan) to be listed on NYSE
• Sales in India during first quarter of 2008–09 reached US$ 7.3 • Presence in 35 countries with operations in over 115
million, a 5 per cent over the first quarter of the previous year countries
• Aspires to become a research-based pharmaceutical company • Overall revenues at US$ 381 million in first quarter of
with revenues of US$ 5 billion by 2012 2009–10, as against US$ 315 million the corresponding
period of the previous year
• Envisions being among the top five global generics players by
2012 • TC presence; anti-infectives, CVS, diabetes,
dermatological, pain management, GI, nutritional, dental,
• TC presence; anti-infectives, cardio-vascular system (CVS) and
urological and oncology
diabetes, dermatological, neuro-psychiatry, pain management,
gastro-intestinal (GI) and nutritional
47
KEY PLAYERS
Select domestic players
Cipla Nicholas Piramal India Ltd (NPIL)

• Set up in 1935 • Came into existence in 1988
• World‘s largest manufacturer of cost-effective anti-retroviral • Fourth-largest pharmaceutical company and leader in
drugs CVS segment
• Products sold in over 170 countries • Has grown primarily on acquisitions, mergers and
alliances in last 15 years
• Partnerships with nine companies for over 125 products
• Operating income for the year ended March 31, 2008,
• Registered an 18 per cent year-on-year (y-o-y) rise in net profit
was US$ 558 millon, a 16.2 per cent increase compared
during the first quarter of 2008–09
to the previous year.
• Over 100 DMF registrations in the US and over 85 in Europe
• Profit-after-tax rose by 53.1 per cent to US$ 65 million
• Presence across most therapeutic categories
• TC presence; anti-infectives, CVS, diabetes,
dermatological, pain management, GI, respiratory,
nutritional, central nervous system (CNS) and urological
48
KEY PLAYERS
Select foreign players
GlaxoSmithKline Pfizer India
• Two manufacturing units in India at Nashik and Thane • Entered the Indian market in 1950
• 2,000-strong field worker strength and a country-wide • Manufacturing facility at Thane, Maharashtra
network of over 4,000 stockists
• Launched five patented products since 2005 — Vfend,
• Indian subsidiary looking to touch US$ 1 billion in sales by Viagra, Lyrica, Caduet and Macugen
2015
• Clinical research investments of US $ 15.75 million in
• Two R&D centres, which are approved by the Department of India
Scientific and Industrial Research, Government of India.
• TC presence: anti-infectives, CVS, dermatological, sera
• TC presence: anti-infectives, CVS, diabetes, dermatological, and immunoglobulin, pain management, diabetes, CNS,
pain management, CNS, GI, nutritional, gynaecological, GI, nutritional, gynaecological and respiratory
respiratory, sera and immunoglobulin, hormones
49
KEY PLAYERS
Select foreign players
AstraZeneca Sanofi Aventis
• R&D, manufacturing and marketing offices at Bangalore • Incorporated in1956 under the name Hoechst Fedco
Pharma Pvt Ltd
• R&D centre is dedicated to the 'Discovery of Novel Therapies
for the Developing World‗; the centre has more than 90 • 1,840 employees
scientists • Manufacturing facilities in Ankleshwar and Goa
• Added a state-of-the-art process R&D facility, which employs • TC presence: CVS, thrombosis, oncology, metabolic
more than 50 scientists disorders, CNS, internal medicine and vaccines
• TC presence: focus on respiratory, maternal health, oncology
infection, pain control and anaesthesia
50
KEY PLAYERS
Key contract research organisations in India
Company Services portfolio Clients

Advinus Therapeutic Drug discovery, medicinal chemistry, toxicology studies Development projects for Merck
Product chemistry, organic synthesis, chiral synthesis and Top 20 big pharmaceutical and
Avra Labs
technology biotech companies
BioArc Research Medicinal chemistry, custom synthesis and formulations, pre- N/A
Solutions clinical pharmabiology, BA/BE, CRAMS
Lead generation and optimisation and early computational Collaborative discovery
chemistry aided ligand design, mining and screening of novel programmes with Novo Nordisk
Aurigene
chemical entities. Early animal work involving ADME and toxicity on diabetes and discovery services
with Rheosciences, Denmark
Medicinal chemistry, bioinformatics, clinical trials, custom Pharma/biotech companies across
synthesis and drug discovery US, UK, Germany and Japan;
GVK Biosciences
Wyeth, Biogen, Merck & Co. (50
projects)
Medicinal chemistry, custom synthesis, CRAMS Five pharmaceutical companies also
Hikal Ltd
work in agrochemical
Innovasynth Medicinal chemistry, custom synthesis, CRAMS Work for big pharmaceuticals
Bioinformatics, clinical trials, CRAMS, medicinal chemistry 60 clients/20 projects at any time
Jubilant Organosys
services, custom synthesis and drug discovery services
51
KEY PLAYERS
Key contract research organisations in India

Company Services portfolio Clients
CRAMS, medicinal chemistry, custom synthesis and dossier Rigen Inc., GSK India, Merck
Matrix
development. KGaA
Medicinal chemistry, custom synthesis, biology services, N/A
Procitius Research
clinical trials and CRAMS
Medicinal chemistry services, scale-up services 200 projects for almost 30
Sai Life Sciences MNC pharmaceutical and
biotech companies
CRAMS, organic chemistry, medicinal chemistry, custom N/A
Shasun Chemicals
synthesis and biology services like protein purification,
and Drugs
microbial fermentation and process optimisation
CRAMS, medicinal chemistry services, custom synthesis and About 18 to 20 international
Suven Life Sciences clinical trials (ACT and Sipra), drug discovery services clients from across US and
Europe
Medicinal chemistry, custom synthesis and drug discovery, Novartis, Merck & Co.
Syngene
affiliate clinigene
TCG Silicogene, medicinal chemistry, drug discovery services N/A
Medicinal chemistry services, custom synthesis and drug 20 to 25 ongoing projects.
Bharavi Labs discovery services Works on FTE and ongoing
contracts
52
 Market overview
 Policy
 Key players
53
KEY OPPURTUNITIES
Contract research — India an emerging hotspot
• Indian drug discovery and development outsourcing market is projected to grow at a rate of 50 per
cent to reach US$ 900 million in 2009.
• Presently, a major portion of the services are limited to chemistry-based lead

identification/optimisation, pre-clinical and clinical research stages.
• Select companies provide biology-based services for target validation; notable examples are
Avesthagen, Ocimum Biosolutions and TCG Life Sciences.
• Bioinformatics companies that offer research-enabling software technologies are also emerging as a
valuable segment.
54
KEY OPPURTUNITIES
Contract research — India an emerging hotspot
Areas Specialised segments

Target
Target Genetics Proteomics Chemoinformatics Bioinformatics Genesequencing
Identification
Identification
Target
Discovery research
Target
Functional Protein Disease model Genetically Bioimaging
Validation
Validation
genomics biochemistry modified mice
Compund
Generation Analogue Synthesis Drug design Structural Analytical
prepration chemistry chemistry
Scanning
Compound HTS Assay
synthesis development
Lead Assay SAR Medicinal Cell based model for

Development research
Optimization execution chemistry efficacy
Pre-clinical
Development Pharmacology PKDM Toxicology Animal models
Clinical
Development Trial Data Regulatory Strong
management management consulting
Weak
Source: “Offshoring in the Pharmaceutical Industry,‖ Mridula Pore, Yu Pu, Charles

Cooney, MIT, Ernst & Young analysis
55
KEY OPPURTUNITIES
Clinical research — leveraging India‘s advantage

Forecasted clinical research market Key disease populations
No. of people in (millions)

(US$ million)
• The clinical trials market in India is currently sized at approximately US$ 250 million to US$ 275
million and is expected to grow at a robust CAGR of 30 per cent over the next few years, at almost
double the global average.
• Clinical trials for NCEs constitute around 60 per cent of the total revenue mix, while 40 per cent is
accounted for by bioavailabilty/bioequivalence (BA/BE) studies for generics development. However, by
volume, around 70 per cent of the work is directed towards generic research.
• The market for BA/BE studies in India was estimated to be around US$ 60 million to US$ 70 million in
2006. It is estimated to reach US$ 150 million to US$ 200 million by 2010–11 growing at a CAGR of
18 to 20 per cent.
Source: ―The glorious metamorphosis,‖ Ernst & Young 2009
56
KEY OPPURTUNITIES
Contract manufacturing (CM)

• The Indian pharmaceutical manufacturing outsourcing market is valued at US$ 1.1 billion and the
segment is growing at thrice the global market rate.
• India‘s share of the outsourcing market is estimated to increase from 2.8 per cent in 2007 to 5.5 per
cent in 2010.
• APIs /intermediate outsourcing is more prevalent in India than formulation outsourcing; around 64 per
cent of total outsourcing is in the area of APIs/intermediates.
• The market is estimated to increase to US$ 1 billion by 2010.
• By 2010, the demand for contract manufacturing of formulations is likely to be around US$ 210 million
to US$ 300 million. APIs and intermediate demand is likely to be in the range of US$ 600 million to
US$ 700 million by 2010.
57
KEY OPPURTUNITIES
Contract manufacturing (CM)
Key growth drivers Indian custom manufacturing

outsourcing market
• Closure of assets: As majority of big pharma is
operating at only 20 to 30 per cent of their
capacity as companies are looking at divesting
these plants and outsourcing manufacturing.
(US$ billion)
• Biologics: As a high percentage of the current
pipeline globally is biologics, the cost of investing
in a new facility is high.
Source: ―Taking wings,‖ Ernst & Young, 2009
58
KEY OPPURTUNITIES
Oncology — Indian players eyeing the global opportunity
• Cancer accounts for an estimated 7.6 million annual deaths globally.
• Treatment for cancer is estimated to become the largest therapeutic segment by sales at US$ 55
billion by 2009, from the current US$ 45 billion.
• The oncology pipeline is the richest in number, with a large number of pharmaceutical and biotech
companies focussing on oncology drugs.
• Over 50 new oncology products are expected to be launched in the next five years with new players
entering the market.
• About 30 per cent of all launches by 2010 will be in oncology.
• The global oncology drug market is growing at 17 per cent annually.
• Presently, the Indian oncology market stands at US$ 18.6 million and it is expected to treble by 2010.
59
KEY OPPURTUNITIES
Oncology — Indian players eyeing the global opportunity
Biocon recently launched its monoclonal antibody-based drug BIOMAb-EGFR for treating solid tumors. The
company is looking at introducing products in the US and Europe.
Dabur Pharmaceuticals introduced a nano technology-based chemotherapy agent, Nanoxel, in the country
and plans to take it to the US and the European markets, and has already planned clinical trials there.
Ranbaxy Laboratories Ltd has entered into a strategic alliance with Zenotech Laboratories Ltd Ranbaxy
will market Zenotech's oncology cytotoxic injectible products under the Ranbaxy label, leveraging its global
marketing and distribution network in the key markets of Latin America, including Brazil and Mexico, Russia
and other CIS markets.
60
KEY OPPURTUNITIES
Pharmaceutical retail-emerging growth segment
• With revenues of US$ 200 million in 2009, organised pharmaceutical retail constitutes just 2 per cent of
the pharmaceutical retail market in India.
• It is expected to grow at a high y-o-y growth of 30 to 40 per cent and is likely to become a US$ 400
million to US$ 530 million market by 2010.
• The government is contemplating the increase of FDI cap to up to 51 per cent in the case of retail of
single-brand products.
• New entrants include Emami Group (Frank Ross Pharmacies), Dabur (Health and Wellness chain by the
name of NewU), Reliance Wellness (in a joint venture with Alliance Boots of the UK) and Manipal Cure &
Care.
* Religare Wellness acquired CRS Health and LifeKen (formerly owned by Lifetime Heathcare Pvt Ltd)
Source: Neha Jain and Shailendra Gupta, "Pharma retail in India," EY CBK, August 2009, via IRAD
61
KEY OPPURTUNITIES
Pharmaceutical retail-emerging growth segment
Year of starting Company owned or

Brand Ownership Number of outlets
operations franchised
Apollo Pharmacy Apollo Hospitals Enterprises Ltd 1983 740 Company owned
570 – company owned
Medplus Medplus Health Services Pvt Ltd 2006 600
30 – franchised
Himalaya Himalaya Drug Co 1930 150 (200 shop-in-shop) N/A
Guardian The Guardian Lifecare Pvt Ltd 2003 180 Franchised
Health & Glow Dairy Farm International N/A 59 N/A
Medicine Shoppe Medicine Shoppe (India) 1999 140 Franchised
98.4 The Global Healthline Pvt Ltd 2002 30 N/A
Religare Wellness* Formerly Fortis Healthworld 1996 200 Franchised
Trust Chemists And Druggists
Trust 2003 41 N/A
Ltd
Frank Ross Emami Group 1906 30 N/A
* Religare Wellness acquired CRS Health and LifeKen (formerly owned by Lifetime Heathcare Pvt Ltd)
Source: Neha Jain and Shailendra Gupta, "Pharma retail in India," EY CBK, August 2009, via IRAD
62
KEY OPPURTUNITIES
Indian pharmaceutical players-retail plans
Case study: Reliance Retail Case study: AIOCD
The Mukesh Dhirubhai Ambani Group is The All India Organisation of Chemists and
planning a foray into the pharma retail segment. Druggists (AIOCD) is a leading industry
This is part of an overall strategy for building association with a membership of around
super-malls in 21 zones across India. Through its 600,000 pharma retailers and wholesalers in the
biopharmaceutical venture, Reliance Life country. It has taken steps to facilitate the
Sciences, the firm is looking to increase creation of a centralised procurement system
investments, targeting US$ 33 billion of the local and a special purpose vehicle (SPV) network in
market by 2012. each state.
The company has allocated US$ 2.2 billion for A centralised procurement system is part of the
setting up production facilities. The firm is also general push by AIOCD towards a network of
keen on acquiring small, local drug-producing small pharma retailers, who have dominated the
units and companies to offer low-margin drugs Indian market for decades. This initiative was
at the retail level. test-piloted last year in Maharashtra, where the
largest network of small pharma retailers exists.
63
KEY OPPURTUNITIES
Indian pharmaceutical players-retail plans
Case study: Zydus Cadila
Zydus Cadila plans to create a separate company from its health product lines. The first outlet of this
new company was commissioned in 2007.The company expects to enhance its product range by
launching a smoking-cessation product and hopes to improve its revenues by close to 300 per cent to
US$ 1 billion from the current US$ 266 million.
64
KEY OPPURTUNITIES
Rural market-opportunities at the bottom of the pyramid
• 65 per cent of the population resides in rural Volume Growth (2005-06)

areas with limited or absolutely no access to
medicines and other healthcare facilities.
• With a growth rate of 39 per cent in 2006, the

rural market has outstripped the growth in the
urban region across most of the therapeutic
(In %)
categories in both value and volume terms.
• General physician-driven segments such as anti-

infectives, analgesics, etc., have registered high
growth compared to specialist-driven segments
such as CNS.
Source: Enam
• Non-communicable diseases such as cancer,

blindness, mental illness, hypertension, diabetes,
HIV/AIDS, accidents and injuries are also on the
rise.
65
KEY OPPURTUNITIES
Rural market-opportunities at the bottom of the pyramid
Lifestyle diseases on the rise in rural areas Value Growth (2005-06)
According to a 2007 study conducted by the

George Institute for International Health in 45
villages in the east and west Godavari districts of
Andhra Pradesh, diseases of the cardiovascular
(In %)
system, such as heart attacks and stroke, caused
32 per cent of the deaths in the region.
Source: Enam
66
KEY OPPURTUNITIES
Biopharma-domestic players eying the global biosimilar

market
• Globally, sales of biological drugs are estimated to reach US$ 52 billion by 2010.
• Leading Indian companies are intensifying their focus on the biotech segment.
• Moreover, Indian players are also eyeing the huge opportunity presented by biosimilars across the
globe.
• Biosimilars are expected to be a US$10 billion market in the US and the EU by 2015.
• Further, biologics as a drug class is itself growing rapidly and estimates suggest that by 2014 seven of
the top 10 drugs by sales globally would be biologics.
• Leading Indian pharmaceutical companies such as Biocon, Dr. Reddy‘s, Wockhardt, Intas and Zenotech,
etc., have invested in manufacturing facilities for biosimilars..
• A legal framework for biosimilars has been established in the EU.
• Further, the US is expected to set up an approval framework for biosimilars soon.
67
KEY OPPURTUNITIES
Biopharma-domestic players eying the global bio-similar

market
Key initiatives of Indian companies
Ranbaxy Laboratories has signed a development and marketing agreement with generic injectables company Zenotech
Laboratories to produce its first biosimilar G-CSF.
Reliance Life Sciences has bought 74 per cent stake in GeneMedix. The joint entity will develop biosimilar drugs and offer full
service in CRAMS.
Dr. Reddy‘s has created a copy of Roche‘s Rituximab, which is used to treat non-Hodgkin's lymphoma. Marketed by Genentech
Inc. and Biogen Idec Inc. as Rituxan in the US, the drug generated a global revenue of more than US$ 2 billion in 2007.
Dr. Reddy's sells Grafeel, or filgrastim, in India. The drug is used to boost white blood cell production and is marketed by Amgen
in the US.
Glenmark has set up a biologics research facility in Switzerland with more than 25 scientists. It expects the first biological lead to
enter into clinics in 2009 and two more by 2010.
Glenmark has tied up with US-based Dyax to expedite biologics research. Dyax will perform funded research for three of
Glenmark‘s targets in the areas of inflammation and oncology.
Biocon has started clinical trials on Insugen, BIOMab-EGFR trials in regulated markets.
Source: ―Biosimilars 101,‖ Credit Suisse, September 16, 2009,

via Thomson Research
68
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has been prepared by Ernst & Young in consultation with the content is not to be construed in any manner
IBEF. whatsoever as a substitute for professional advice.
All rights reserved. All copyright in this presentation and Ernst & Young and IBEF neither recommend nor endorse
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PHARMACEUTICALS

The focus of this presentation is to discuss…

 Key trends and drivers

Indian pharmaceutical market — US$ 7.3 billion opportunity

Domestic pharma retail market

Domestic Formulation Consumption (DFC)

Indian pharmaceutical market — US$ 7.3 billion opportunity

• Retail sales of pharmaceuticals were US$ 7.7

• Domestic consumption accounted for nearly 46

Source: Compiled from industry sources

Anti-infectives — largest therapeutic category

Anti-infectives — largest therapeutic category

Source: Pharmaceuticals: industry profile, Dec 2008, CRIS INFAC

Acute therapy dominates sales, chronic segment to fuel growth

Source: Pharmaceuticals: industry profile, June 2008, CRIS INFAC

Acute therapy dominates sales, chronic segment to fuel growth

Key drivers of chronic therapy segments

Indian pharmaceuticals exports

• For 2007–08, export revenues are estimated Formulation export revenues

• Formulation exports are estimated to

• By 2012, exports are expected to top US$

Indian pharmaceuticals exports

• Exports to regulated markets are expected to Formulation exports demand outlook

• Demand from semi-regulated regions is

Source: Pharmaceuticals: industry profile, Dec 2008,

Generics to drive growth of exports from India

• Formulation exports to the US are

• Exports of generic drugs to Europe are

Source: Pharmaceuticals: industry profile, Dec 2007, CRIS INFAC

Generics to drive growth of exports from India

Source: Pharmaceuticals: industry profile, Dec 2008, CRIS INFAC

Changing paradigm: Indian pharmaceutical industry

6.6% 93.4% 12% 88%

Domestic Exports Domestic Exports

Source: Ernst & Young analysis

Advantage India: Significant cost arbitrage

• 30 per cent to 50 per cent lower depreciation

• Higher utilisation of equipment due to improved processes (not quantified)

• 85 per cent to 90 per cent manpower cost savings

Advantage India: Significant cost arbitrage

India‘s cost arbitrage

• Bulk drugs can be manufactured in-house at

• Excipients and intermediates sourced locally

• Most other raw materials can be sourced

Established infrastructure for pharma R&D and manufacturing

Enabling research infrastructure

Key research institutes in India

Enabling research infrastructure

Talent statistics Case study: Government

• 1,000 students pursue PhDs in chemistry

Source: Pharmaceuticals: industry profile, Dec 2007, CRIS INFAC

The focus of this presentation is to discuss…

 Key trends and drivers

– Manufacturing units should adhere to good manufacturing practices (GMP) outlined in

Drug regulatory environment in India in transition

Proposed new system

• The proposed organisational structure of the CDA is to be analogous to the USFDA.

• It will be a strong, well-equipped, empowered, independent and professionally managed body.

CDA — India‘s new drug regulator

Budget 2009–2010 and policy changes