GLOBAL HEALTH SCIENCES

Indian Pharmaceutical Industry: Vision 2010
D A Prasanna Manipal AcuNova Pvt Ltd
Acknowledgement: E & Y

Vision 2010: Glimpse of Indian Pharma’s Future
November 1, 2010

R&D R&D
•• NCE Research: Early days, NCE Research: Early days, Limited pipeline of 18-20 NCEs Limited pipeline of 18-20 NCEs

Manufacturing Manufacturing
•• API/Bulk Sourcing: Emerging sourcing API/Bulk Sourcing: Emerging sourcing base for MNCs base for MNCs

Marketing Marketing
•• Global Distribution: Mostly Global Distribution: Mostly through alliances, through alliances,

Current State(2004) Current State(2004)

•• Contract Research: Custom Contract Research: Custom Synthesis & Analytical services Synthesis & Analytical services •• Clinical Research: Emerging Clinical Research: Emerging destination, about 1% of global destination, about 1% of global trials trials

Threshold (2005) Threshold (2005)

Future State(2010) Future State(2010)

•• at least 100 NCEs in various at least 100 NCEs in various stages of development stages of development •• Contract Research: High end Contract Research: High end drug discovery services drug discovery services •• Clinical Research: At least 10 % Clinical Research: At least 10 % of global trials of global trials

•• API/Bulk Sourcing: Preferred supplier API/Bulk Sourcing: Preferred supplier •• Contract Manufacturing: top 3 global Contract Manufacturing: top 3 global manufacturing sites, in patent protected manufacturing sites, in patent protected molecules molecules

•• Global Distribution: Top 15Global Distribution: Top 1520 Indian players to have direct 20 Indian players to have direct presence presence

August 25, 2005

Vision to Reality : What will get us there ?

• Implementation of new product patent regime • R&D Innovation • Maximizing Generics (For Near Term Growth) • Global outsourcing & partnering

August 25, 2005

Implications of a strict product patent regime post 2005
• higher domestic investment in basic R&D and discovery led research • higher domestic investment in basic R&D and discovery led research -Higher probability of new therapies coming out of India in the future -Higher probability of new therapies coming out of India in the future • MNCs to outsource R&D and manufacture of patented products • MNCs to outsource R&D and manufacture of patented products - Strong boost to FDI in pharma and domestic CRAMS industry - Strong boost to FDI in pharma and domestic CRAMS industry • Collaborative Research involving IP sharing • Collaborative Research involving IP sharing - Indian partners will move up the value chain & will not be mere service providers - Indian partners will move up the value chain & will not be mere service providers

August 25, 2005

R & D Innovation

The economic fundamentals of new drug development are about to be altered radically in the future
A disease led approach to drug development will significantly reduce time and A disease led approach to drug development will significantly reduce time and resources that are required resources that are required

Source: IBM Consulting Source: IBM Consulting

August 25, 2005

Government Run Research Organisations: Industry Collaboration
Government Run Research Organisations: Industry Collaboration

CDRI (Lucknow)
Novo Nordisk, Denmark Krebs Biochemicals Ltd., Hyderabad Avon Organics Ltd., Hyderabad Cipla Ltd., Mumbai Dabur India Ltd., Ghaziabad Duphar Interfran Ltd., Mumbai Hindustan Latex Ltd., Thiruvananthapuram IPCA Labs Ltd., Mumbai Lupin Laboratories Ltd., Mumbai Malladi Drugs & Pharmaceuticals, Chennai Nicholas Piramal India Ltd., Mumbai Lumen Marketing Company, Chennai Ranbaxy Laboratories Ltd., New Delhi Themis Medicare Ltd., Mumbai Torrent Pharmaceuticals Ltd., Ahemdabad Unichem Laboratories Ltd., Mumbai Wockhardt Ltd., Aurangabad.

IICT (Hyderabad)
Dr. Reddy’s Laboratories, Hyderabad Lupin Laboratories, Mumbai Cadila Laboratories Ltd., Ahemdabad SOL Pharmaceuticals Ltd., Hyderabad Neuland Laboratories, Hyderabad Sun Pharmaceuticals Ltd., Mumbai Cipla Ltd., Mumbai Nectar Laboratories Ltd., Hyderabad Orchid Chemicals, Chennai Trident Labs Pvt. Ltd., Hyderabad Unichem Labs Ltd., Mumbai Armour Chemicals Ltd., Mumbai Bombay Drug House, Mumbai Cheminor Drugs Pvt. Ltd., Hyderabad Torrent Chemicals Ltd., Mumbai Coramandal Pharma, Hyderabad IDPL, New Delhi

CCMB (Hyderabad)
Shantha Biotechnics Pvt. Ltd., Hyderabad Dr. Reddy’s Research Foundation, Hyderabad Bangalore Genei Pvt. Ltd., Bangalore Dabur Research Foundation, Sahibabad Biological Evans Ltd., Hyderabad.

August 25, 2005
Compiled by Ernst & Young

Generics India is projected to corner about a third of the market by 2007
Large Indian pharma companies are joining the global league by leveraging their low cost cGMP manufacturing and focusing on regulated markets
India is the largest filer of DMFs outside the US
Product filings (DMFs, ANDAs, CTD/COS) in 2003

200 180 160 140 120 100 80 60 40 20 0 USA India Germany Italy China Israel France Spain

20% of the total DMFs in 2003 by Indian companies

30% 25% 20% 15% 10% 5%

August 25, 2005

Global Pharmaceutical Outsourcing Market estimated to exceed $65 bn by 2005…

Source: OPPI- Monitor Group Source: OPPI- Monitor Group Study 2003 Study 2003

August 25, 2005

Leveraging India’s Capabilities in Clinical Research…
Easy access to genetically diverse patient pool with varied disease profiles Well trained medical professionals and clinical investigators with international exposure

Large number of CROS with capabilities to undertake ICH-GCP compliant studies

Translates into….

Higher speed & ease in recruiting large volume patients Increasing international acceptance of Indian data 30-40% lower costs than the US /Europe

August 25, 2005

Indian Pharmaceutical Industry: Back to the Future !

5 years from today, could 5 years from today, could this be a possible cover this be a possible cover story !!! story !!!

Thank You!!!

August 25, 2005

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