PHARMACEUTICALS - IBEF · Pharmaceuticals Pvt Ltd India ISENTRESS® 2010 HIV GSK Cervarix® 2009...

PHARMACEUTICALSNovember 2010

2

Contents

Advantage India

Market overview

Industry infrastructure

Investments

Policy and regulatory framework

Opportunities

Industry associations

PHARMACEUTICALS November 2010

3

Advantage India• The custom manufacturing outsourcing

(CMO) market has recorded a growth

rate of approximately 43 per cent,

thrice that of the global market rate,

during the period 2007–2010.

• India has a significant cost advantage

over the US.

• Manufacturing costs in India are

approximately 35 to 40 per cent of

those in the US due to low installation

and manufacturing costs.

• India’s available talent pool of trained

chemists, which is around six times

that of the US and works at

approximately one-tenth of US

manpower costs, also supports this

trend.

ADVANTAGE INDIA

Preferred

outsourcing

destination for

MNCs

Advantage

IndiaGovernment

support

Wide product

portfolio

Innovative

product

development

• India accounts for 8 per cent of global pharmaceutical production.

• Indian firms produce about 60,000 generic brands across 60 therapeutic categories.

• In addition, Indian firms manufacture approximately 500 different active pharmaceutical ingredients (APIs).

Pharmaceuticals November 2010

NIPER: National Institute of Pharmaceutical Education and Research

Sources: Taking wings, Ernst & Young, 2009; Ernst &Young analysis.

Strong quality

and technical

capabilities

In 2009, India had more than 120 US

Food and Drug Administration (FDA)-

approved plants and approximately 84

UK Medicines and Healthcare products

Regulatory Agency (MHRA)-approved

plants, with capabilities to manufacture

products with exceptional quality

standards.

• The industry is constantly

engaged in upgrading technology

to enhance the quality of

products.

• India is expected to be among the

world’s top five innovative hubs

with contributions of around 50

per cent to drugs discovered

worldwide.

• Approval time for a manufacturing facility has

been reduced in 2008 to about two weeks

from about three months previously.

• In addition, the Government of India (GoI) has

set zero duty for technology upgrades and has

also set up NIPERs as centres of excellence for

pharmaceutical education and research.

4

Contents

Advantage India

Market overview


Investments


Opportunities



5

Market overview

Market size of the Indian pharmaceutical industry

Sources: Taking wings, Ernst & Young, 2009; ―Indian pharma market

valued at over Rs 55K crore in FY’10,‖ The Economic Times, 30 July

2009

F: Forecasts

MARKET OVERVIEW

• India is one of the fastest-growing pharmaceutical markets in the world, and its market size has nearly doubled since 2005.

• The Indian pharmaceutical market is expected to reach US$ 20 billion by 2015, growing at a compound annual growth rate (CAGR) of 11.7 per cent during 2005–2015 and establish its presence among the world’s leading 10 markets.

• It is the third-largest market in the world in terms of volume and fourteenth in terms of value.

US$

bill

ion

5.75

11.5

20

0

5

10

15

20

25

2005 2009(F) 2015(F)


6

Market segments

Contract research and

manufacturing services (CRAMS)Formulations

Active pharmaceutical ingredients

(APIs)

Pharmaceuticals

India is a fast-growing CMO and custom research outsourcing (CRO) destination with a growth rate for CMO thrice the global market rate.

India’s manufacturing prowess in

formulations is validated by the fact

that it manufactures 60,000 packs

across 60 therapy areas.

India is the third-largest player in the

world with 500 different APIs.

Source: Taking wings, Ernst & Young, 2009.

MARKET OVERVIEW


7

Exports

Exports of pharmaceutical products

Sources: Ministry of Commerce and Industry, Government of India; Ernst & Young analysis; ―Pharma exports up by 29% in 2008–09, Anand Sharma

addresses Indo-Africa Pharma Business Meet,‖ Ministry of Commerce and Industry press release,

http://commerce.nic.in/pressrelease/pressrelease_detail.asp?id=2478, 25 September 2009; ―UN comtrade data,‖ UN comtrade website,

http://comtrade.un.org/db/dqBasicQueryResults.aspx?px=HS&cc=30&r=699&p=0&rg=2&y=2009,2008,2007,2006,2005&so=8 , accessed 10 November 2010.

Note: HS code 30 used for the analysis above

• Exports of pharmaceutical products have more

than doubled over three years to around US$

5.2 billion in 2009–2010.

• The export of drugs, pharmaceuticals and fine

chemicals has increased from US$ 7.24 billion

in 2007–08 to around US$ 9.35 billion in 2008–

09. This increase can be mainly attributed to

increased exports to Africa region, driven by

funding support from the Pharmaceutical

Export Promotion Council (Pharmexcil) for the

brand promotion of the Indian pharmaceutical

industry in Africa. In addition, the

pharmaceutical sector has been included in

market-linked focus product schemes.

MARKET OVERVIEW

US$

bill

ion


1.622.06

2.44

3.18

4.16

5.08 5.19

0

1

2

3

4

5

6

2003-2004 2004-2005 2005-2006 2006-2007 2007-2008 2008-2009 2009-2010

http://commerce.nic.in/pressrelease/pressrelease_detail.asp?id=2478

http://comtrade.un.org/db/dqBasicQueryResults.aspx?px=HS&cc=30&r=699&p=0&rg=2&y=2009,2008,2007,2006,2005&so=8

8

Growth drivers — technical capability

• In 2009, India had more than120 US FDA-approved plants in addition to 84 UK MHRA-approved plants.

• Most of these plants have multiple approvals from regulatory authorities in Canada, Australia, Germany and South Africa.

• These approved sites aptly demonstrate the ability of Indian companies to deliver quality products worldwide and serve as platforms for CRAMS players.


US FDA-approved plants

MARKET OVERVIEW

US

FD

A-a

ppro

ved p

lants


>120

55

27 25

10 8 5

0

20

40

60

80

100

120

140

India Italy China Spain Taiwan Israel Hungary

9

Growth drivers — cost efficiency

India rates higher than other countries on cost efficiency.

• The Indian market has about 8,000 manufacturers, driving the reduction in costs across the life cycle of a product.

• This is visibly reflected in the manufacturing costs of US FDA-approved plants in India, wherein the costs are 65 per cent lower than that in the US and 50 per cent lower than that in Europe.

Percentage overall indexed manufacturing cost (US FDA-approved plants)


MARKET OVERVIEW

100

80-85

35-40

0

20

40

60

80

100

120

US Europe India

Cost

index


10

Growth drivers — government support

Objective Key initiatives undertaken

Reduction in approval

time

The GoI has extended support for the rapid approval of manufacturing and exports of formulations

by reducing the approval time for No Objection Certificate (NOC) manufacturer and NOC export

license from 12 weeks to 2 weeks.

Collaborations between

industry, academia and the

government

The GoI has extended collaborations with developed countries by signing Memorandum of

Understanding (MOUs) with the US FDA, World Health Organisation (WHO), Health Canada and

EMEA region (comprising Europe, Middle East and Asia). The GoI is promoting collaboration among

industry, academia and government through various programmes such as the New Millennium Indian

Technology Leadership (NMITLI) and Drugs and Pharmaceuticals Research Programme (DPRP).

Focus on specialised

pharmaceutical

education

The GoI has set up seven NIPERs as institutes of ―national importance‖ to achieve excellence in

pharmaceutical sciences and technologies, education and training.

Duty relief for technology

upgrades

The GoI has also introduced zero duty for technology upgrades in the pharmaceutical sector

through the Export Promotion Capital Goods Scheme (EPCG) scheme.

Promotion of Indian drug

discovery platforms

The GoI is embarking on a major multi-billion dollar initiative with 50 per cent public funding through

a public-private partnership (PPP) model to harness India’s innovation capability. The vision is to

catapult India into one of the top five pharmaceutical innovation hubs by 2020, targeting to achieve a

global niche with one out of every five to ten drugs discovered worldwide by 2020 originating from

India.

Sources: Taking wings, Ernst & Young report, 2009; ―Pharma exports up by 29% in 2008–09, Anand Sharma addresses Indo-Africa Pharma

Business Meet,‖ Ministry of Commerce and Industry press release, http://commerce.nic.in/pressrelease/pressrelease_detail.asp?id=2478, 25

September 2009.

MARKET OVERVIEW


http://commerce.nic.in/pressrelease/pressrelease_detail.asp?id=2478

11

Key trends — growing global demand for generics

• MNCs are increasingly looking to expand their presence in emerging markets. Growing focus on healthcare reforms and cost reduction has also led many large global pharmaceutical players to rethink their strategies to leverage the growing potential of branded generics and the over-the-counter (OTC) drugs market.

• Globally, the generics segment is expected to grow to about US$ 140 billion by 2015.

• Healthcare reforms and cost-saving initiatives as well as US$ 150 billion worth of brands going off-patent by 2015 are expected to continue driving this growth.

Sources: ―Teva investor presentation,‖ Investor Relations,

Teva Pharmaceuticals Industries website,

www.tevapharm.com, accessed January 28, 2010; Ernst &

Young research.

80

140

0

20

40

60

80

100

120

140

160

2008 2015

MARKET OVERVIEW

US$

bill

ion

Global generics market


http://www.tevapharm.com/

12

Key trends — launch of patented molecules

• The advent of the product patent regime in 2005 has instilled confidence in the intellectual property (IP) regime, with the period between 2008 and 2010 witnessing many patented drug launches.

• With renewed confidence in the IP regime, large pharmaceutical companies are continuing with patented drug launches in India. Global innovators have secured 302 drug patents from the Indian Patent Office as of October 2008, and this number is expected to grow in the next few years. Between 2005 and 2010, the Indian Patent Office has granted 3,488 product patents.

• While pharmaceutical MNCs already present in India are further consolidating their presence through acquisitions, many MNCs have staged a re-entry after 2005. The share of pharmaceutical MNCs in the domestic pharmaceutical market is estimated to increase to 35 per cent by 2015 from 25 per cent in 2008.

Company Product

Launch

year

Treatment

area

Bristol-Myers

Squibb (BMS) Onglyza™ 2010 Diabetes

MSD

Pharmaceuticals

Pvt Ltd India

ISENTRESS® 2010 HIV

GSK Cervarix® 2009Vaccine against cervical

cancer

AstraZeneca Crestor® 2009 Dyslipidemia

Novartis Galvus® 2009 Diabetes

GSK Rotarix® 2008Vaccine against rotavirus

diarrhea

GSK Infanrix™ 2008

Vaccine against

diphtheria, tetanus and

pertussis

Pfizer SUTENT® 2008 Kidney cancer

J&J Intelence™ 2008 HIV

Pfizer Champix® 2008 Smoking cessation

MSD Januvia® 2008 Diabetes

GSK Tykerb® 2008 Breast cancer

MSD Gardasil® 2008Vaccine against cervical

cancer Source: Ernst & Young analysis.

Note: This is an indicative list.

MARKET OVERVIEW


13

Key trends — rural market opportunities

• Robust consumption in the rural economy is expected to be the key growth driver for the Indian market.

• The potential of the rural pharmaceutical market in India has encouraged many MNCs to enhance their focus on this market. The untapped Indian rural market accounts for 45 per cent of the country’s total GDP.

• Rural India accounts for more than 70 per cent of all Indian households and close to two-fifths of the total consumption pie.

• A large number of companies are organising their efforts to derive a major portion of their overall sales from this untapped market.

• Novartis’ rural initiative: Arogya Parivar covers 25

million people in more than 18,000 villages. Through

this novel for-profit programme, the company aims to

create health awareness among rural masses as

opposed to the traditional pharmaceutical marketing

approach. The company has divided its field operations

into 170 independent cells, each covering a radius of

approximately 35 km. Every cell is managed by a

supervisor with the assistance of health educators. It is

estimated that as of end-2009, the company had

operationalised 500 cells.

• Sanofi-Aventis has launched Prayas, a continuing

education programme for rural doctors across India.

• GSK has also strengthened its focus on rural outreach

and has initiated a pilot project in Uttar Pradesh.

Rural initiatives

Source: Ernst & Young research.

MARKET OVERVIEW


14

Key players

Company Sales in US$ million Year-end

Cipla 1,127.08 March 2010

Ranbaxy

Laboratories944.97 December 2009

Dr Reddy's

Laboratories923.47 March 2010

Sun Pharma 813.32 March 2010

Lupin Ltd 993.29 March 2010

Aurobindo

Pharma677.54 March 2010

Piramal Health 416.73 March 2010

Cadila Health 381.85 March 2010

Matrix Labs 310.06 March 2009

Wockhardt 309.68 December 2009

CompanySales in

US$ millionYear-end

GlaxoSmithKline

Pharma 398.49 December 2009

Aventis Pharma 207.45 November 2009

Abbott India 164.60 November 2009

Pfizer 176.76 March 2010

Novartis India 130.05 December 2009

Merck 98.56 November 2009

Wyeth 79.64 December 2009

Astra Zeneca

Pharma80.31 December 2009

Solvay Pharma 50.36 December 2009

Leading foreign players by sales (US$ million)Leading Indian players by sales (US$ million)

Sources: Relevant company websites and annual reports; Ernst & Young research.

Note: All revenues were reported in INR.

MARKET OVERVIEW


15

Contents

Advantage India

Market overview


Investments


Opportunities



16

Industry infrastructure — SEZs … (1/2)

• There are 19 dedicated SEZs in India at various stages of development.

• Functional pharmaceutical SEZs in India include Jawaharlal Nehru Pharma City (JNPC) in Visakhapatnam (Andhra Pradesh), PHARMEZ (Gujarat) developed by Zydus Infrastructure and PhaEZ Park (Gujarat) developed by Cadila Pharma.

INDUSTRY INFRASTRUCTURE

Source: SEZ India, www.sezindia.nic.in, accessed 10 November 2010


http://www.sezindia.nic.in/

17

Gujarat

Maharashtra

Punjab

Goa

• Meditab Specialities Pvt Ltd

• Serum Institute of India Ltd

• Wockhardt Infrastructure

Development Ltd

• Maharashtra Industrial

Development Corporation (MIDC)

• Ajanta Pharma Ltd

• Navi Mumbai SEZ Pvt Ltd

(Kalamboli Pharmaceutical division)

• Zydus Finance Ltd

• CPL Infrastructure Pvt Ltd

• Dishman Infrastructure Ltd

• J.B. SEZ Pvt Ltd

• Ranbaxy Laboratories Ltd

Karnataka

• Karnataka Industrial Areas

Development Board

Andhra Pradesh

• Divi’s Laboratories Ltd

• Ramky Pharma City (India) Ltd

• Hetero Infrastructure SEZ Ltd

• Andhra Pradesh Industrial

Infrastructure Corporation

Ltd(APIIC)

• Dr Reddy's Laboratories Ltd

• Deccan Infrastructure and

Land Holdings Ltd

• Dr Reddy's Laboratories Ltd

Pharmaceutical SEZ developers Pharmaceutical SEZ developers

Location of pharmaceutical SEZs in India

Srikakulam

Visakhapatnam

Mehbubnagar

Medak

Ahmedabad

Bharuch

Ponda, Goa

Hassan

Pune

Aurangabad

Ratnagiri

Raigarh

Mohali

Punjab

Gujarat

Maharashtra

Andhra PradeshKarnataka

INDUSTRY INFRASTRUCTURE

Industry infrastructure — SEZs … (2/2)

Source: SEZ India, www.sezindia.nic.in, accessed 10 November 2010


http://www.sezindia.nic.in/

18

Contents

Advantage India

Market overview


Investments


Opportunities



19

Investments … (1/2)

• Nineteen deals were completed in 2010 (as of October 31, 2010).

• US-based Abbott Laboratories acquired the healthcare solutions business of Piramal Healthcare Ltd, a Mumbai-based manufacturer and wholesaler of prescription pharmaceuticals at a deal value of US$ 3.7 billion.

Cumulative FDI inflow

Period: November 2000 to August 2010

Sector Amount of FDI inflow

(US$ million)

Drugs and pharmaceuticals 1,822.6

M&A scenario — details

Period: January 1, 2010 to October 31, 2010

Deal type No of

deals

Deal value

(US$ million)

Inbound 8 4,587.1

Outbound 4 101.22

Domestic 7 -

Sources: Thomson One Banker, accessed 12 November

2010; Ernst & Young analysis

*―Abbott completes acquisition of Piramal's Healthcare

Solutions business, becomes leading pharmaceutical

company in India,‖ Abbott Press release,

www.abbott.com/global/url/pressRelease/en_US/60.5:5/Pre

ss_Release_0890.htm, 8 September 2010

Source:―Fact Sheet On Foreign Direct Investment (FDI)‖, Department

of Industrial Policy and Promotion website, www.dipp.nic.in, accessed

29 January 2009.

INVESTMENTS


http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0890.htm

http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0890.htm

http://www.dipp.nic.in/

20

Key deals

Deal type Acquirer TargetTotal value

(US$ million)

Completion

date

Inbound Abbott Laboratories Piramal Healthcare Ltd 3,712.8 September 2010

Inbound Taro Pharma Sun Pharma India 332.4 September 2010

Outbound Strides Arcolab Ltd Aspen Pharmacare Hldg Ltd 75.0 July 2010

Outbound Solvay Pharma India Ltd Abbott Capital India Ltd 66.8 April 2010

Inbound Hospira, Inc Orchid Chemicals Injectible business 400.0 March 2010

Source: ―Transactions,‖ via Thomson One Banker accessed 12 November 2010.

NA: Not available

INVESTMENTS

Investments … (2/2)


21

Contents

Advantage India

Market overview


Investments


Opportunities



22

• The Central Drug Standard Control Organisation (CDSCO), which falls under the purview of the Ministry of Health and Family Welfare, is the primary regulatory body in India.

• The Drug Controller General of India (DCGI) presides over the CDSCO and is in charge of the approval of licenses for drugs at both the central and state levels.

• In January 2005, India introduced the product patent regime in accordance with the TRIPS agreement with an amendment to the Indian Patents Act. Further, in 2008, the introduction of the Drugs and Cosmetics (Amendment) Act 2008 put forth stringent penalties and imprisonment.

• FDI of up to 100 per cent in drugs and pharmaceuticals is permitted through the automatic route. For licensable drugs and pharmaceuticals manufactured by recombinant DNA technology and specific cell/tissue-targeted formulations, FDI requires prior government approval.

Policy and regulatory framework … (1/4)

POLICY AND REGULATORY FRAMEWORK

Source: ―Capping FDI at 40%,‖ Pharmabiz website, www.pharmabiz.com/article/detnews.asp?articleid=58159&sectionid=47,

accessed 16 November 2010.

TRIPS: Trade-Related Intellectual Property Rights


http://www.pharmabiz.com/article/detnews.asp?articleid=58159&sectionid=47

23

• The GoI plans to set up a pharmacopeial commission to support ayurveda, yoga and naturopathy, unani, siddha and homoeopathy (AYUSH) through guidelines laid down in the review of the Eleventh Plan.

• As stated on the National Pharmaceutical Pricing Authority (NPPA) website, the NPPA is responsible for fixing and controlling the prices of 76 bulk drugs under the Essential Commodities Act.

• The Department of Pharmaceuticals was formed on July 2, 2008, under the Ministry of Chemicals and Fertilisers with the objective of focusing on the development of the pharmaceutical sector in the country and to regulate various activities related to the pricing and availability of medicines at affordable prices, R&D, the protection of intellectual property (IP) rights and international commitments related to the pharmaceutical sector.

• The GoI has been actively supporting the industry with various measures. It is embarking on a major multi-billion dollar initiative, with 50 per cent public funding through a PPP model, to harness India’s innovation capability.




24

Central Government

State Governments

Drug Controller-General of India

(DCGI)(expert committees)

State drug authorities(State drug controller and food and drug inspectors)

Responsibilities• Licensing and monitoring manufacturing

• Legal cell

• Spurious drug monitoring

• Pharmacies

Central Drug Administration

• Three joint drug controllers

• Two deputy drug controllers

• Six assistant drug controllers

• 50 drug inspectors

• Five technical experts

• One administrative officer

• One accounts officer

Responsibilities

• Regulatory affairs and environment

• New drugs and clinical trails

• Biologicals and biotechnology products

• Pharmacovigilance

• Medical devices and diagnostics

• Imports

• Organisational services

• Training and empowerment

• Quality control affairs

• Legal and consumer affairs

Existing Proposed




25

Budget measures

• There has been an increase in weighted reduction from 150 to 200 per cent on expenditure incurred on in-house R&D activities and from 125 to 175 per cent on activities outsourced to specific institutions.

• The Union Budget of 2010 permitted a partial rollback in excise duty from 8 to 10 per cent (to impact raw-material costs).

Policy measures

• The DCGI has made the registration of all clinical trials compulsory for trials initiated after June 15, 2009. Previously, the registration of clinical trials by various institutions and companies was voluntary.

• The DCGI has discontinued the issuance of the WHO-GMP certificate for both pharmaceutical products and plant audits.

• The GoI has issued the draft Drugs and Cosmetics (4th Amendment) Rules, 2009, which provides for product licenses for narcotic drugs and psychotropic substances to be issued by the Central Licensing Approval Authority (CLAA), which were previously issued by state licensing authorities.

Source: India Budget 2010.

Note: WHO – World Health Organisation, GMP – Good manufacturing practice




26

Contents

Advantage India

Market overview


Investments


Opportunities



27

Opportunities – R&D

OPPORTUNITIES

Indian pharmaceutical R&D expenditure

Specifics 2001–022009–

2010#

R&D expenditure as a

percentage of sales1.4 7.5

R&D expenditure in

absolute terms (US$ million)55 622

Number of Abbreviated New Drug Applications (ANDA)

approved by US FDA till June 2010

ANDAs

Ranbaxy (subsidiary of Daichii Sankyo) 5

Dr Reddy's 7

Glenmark 9

Aurobindo Pharma 7

Matrix Lab ( subsidiary of Marylan) 10

Lupin 8

Sun 7

Source: Taking wings, Ernst & Young 2009; Pharmexcil, http://pharmexcil.org/data/media_files/Pharmabiz2_media_file_1151.pdf , accessed 12 November 2010.

Note: # represents top 20 pharmaceutical companies


• Indian pharmaceutical companies are ascending the value chain with a focus on innovation. By June 2010, the country’s top 20 leading pharmaceutical companies and their subsidiaries had received US FDA approval for 72 ANDAs.

• Both the industry and the GoI have enhanced the level of investments in R&D capabilities and infrastructure. Ranbaxy Laboratories, a subsidiary of Daiichi Sankyo, was the top R&D spender during 2009–2010 at US$ 102 million.

• Few indigenous pharmaceutical companies such as Sun Pharma and Piramal Healthcare have demerged their research divisions to form separate companies in the last few years.

• Dr Reddy’s Laboratories’ NCE Balaglitazone is India’s first indigenously-developed molecule to enter the Phase III trial.

• The growing R&D pipeline of Indian companies presents significant in-licensing opportunities for global companies.

http://pharmexcil.org/data/media_files/Pharmabiz2_media_file_1151.pdf

28

Opportunities — contract manufacturing

• Pharmaceutical companies’ preference for outsourcing as a strategic initiative has increased from 43 per cent in 2006 to 57 per cent in 2009.

• The Indian pharmaceutical manufacturing outsourcing market was valued at US$ 1.1 billion in 2008, and the segment is currently growing at thrice the global market rate.

• India’s share of the outsourcing market is estimated to grow from 2.8 per cent in 2007 to 5.5 per cent in 2010. The outsourcing market is estimated to grow to US$ 1 billion by 2010. By 2010, the demand for the contract manufacturing of formulations is likely to range between US$ 210 million and US$ 300 million. The demand for APIs and intermediates is expected to amount to US$ 600 million and US$ 700 million, respectively, by 2010.

• APIs/intermediate outsourcing is more prevalent in India than formulation outsourcing; 64 per cent of total outsourcing is in the area of APIs/intermediates.

58

42

43

57

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2006 2009

In-house operations MNCs outsourcing

Percentage increase in outsourcing activities


OPPORTUNITIES

Perc

enta

geSource: Taking wings, Ernst & Young, 2009

29

Opportunities — clinical research

• The clinical trials market in India, valued at US$ 275 million in 2008 is expected to grow at a CAGR of

about 24 per cent during 2008–2011, nearly double the global average.

Source: The glorious metamorphosis, Ernst & Young, 2009.

Market size forecast for Indian clinical research market (US$ million)

95124

161

211

275

360

468

608

0

100

200

300

400

500

600

700

2005 2006 2006 2007 2008 2009 2010 2011F FF


OPPORTUNITIES

30

Opportunities — biosimilars

• The increasing use of biologics in disease areas such as cancer and auto-immune and orphan diseases, in addition to healthcare cost containment, has driven the growth of biosimilars.

• Companies in this space include Reliance Biopharma, Shantha Biotech, Panacea Biotec, Wockhardt, Dr Reddy’s, Biocon, Intas Biopharmaceuticals and Avesthagen.

Future opportunity in biosimilars (US$ billion)

Sources: ―Teva investor presentation,‖ Teva Pharm website, www.tevapharm.com, accessed 28 January 2010; Ernst & Young research.

14.0

39.0

23.0

76.0

115.0

Patents expired before 2010 Patents expiring 2010-2015 Patents expiring 2016-2020 Biosimilar opportunity-2008 brand value

Biosimilar opportunity-2015 brand value


OPPORTUNITIES

http://www.tevapharm.com/

31

Contents

Advantage India

Market overview


Investments


Opportunities



32


The Indian Pharmaceutical Association

Kalina, Santacruz (E),

Mumbai – 400 098

Phone: 91-22-2667 1072

Fax: 91 22 2667 0744

E-mail: [email protected]

www.ipapharma.org

Indian Drug Manufacturers' Association

102-B, Poonam Chambers, Dr A.B. Road

Worli, Mumbai – 400 018

Phone: 91-22-2494 4624/2497 4308

Fax: 9122 24950723


www.idma-assn.org

Organisation of Pharmaceutical

Producers of India

Peninsula Chambers, Ground Floor,

Ganpatrao Kadam Marg, Lower Parel,

Mumbai – 400 013

Phone: 9122 24918123, 24912486, 66627007

Fax: 9122 24915168


www.indiaoppi.com

Bulk Drug Manufacturers Association

C-25, Industrial Estate, Sanath Nagar

Hyderabad – 500018

Phone: 91 40 23703910/23706718

Fax: 91 40 23704804


www.bdmai.org

INDUSTRY ASSOCIATIONS


mailto:[email protected]

http://www.ipapharma.org/


http://www.idma-assn.org/




http://www.indiaoppi.com/


http://www.bdmai.org/

33

Note

Wherever applicable, numbers in the report have been rounded off to their nearest whole number.

Conversion rate used: US$ 1= INR 48

INDUSTRY ASSOCIATIONS


34

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PHARMACEUTICALS - IBEF · Pharmaceuticals Pvt Ltd India ISENTRESS® 2010 HIV GSK Cervarix® 2009...

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