GLOBAL HEALTH SCIENCES

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

2005 . 2010 R&D R&D •• NCE Research: Early days. 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 molecules molecules •• Global Distribution: Top 15Global Distribution: Top 1520 Indian players to have direct 20 Indian players to have direct presence presence August 25. in patent protected manufacturing sites. 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.Vision 2010: Glimpse of Indian Pharma’s Future November 1. 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. about 1% of global destination. NCE Research: Early days.

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 .

Indian partners will move up the value chain & will not be mere service providers .Strong boost to FDI in pharma and domestic CRAMS industry • Collaborative Research involving IP sharing • Collaborative Research involving IP sharing .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 .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 .

. Ahemdabad SOL Pharmaceuticals Ltd. Mumbai Malladi Drugs & Pharmaceuticals. Mumbai Armour Chemicals Ltd. New Delhi CCMB (Hyderabad) Shantha Biotechnics Pvt. Ahemdabad Unichem Laboratories Ltd. Hyderabad Unichem Labs Ltd.. Mumbai Cipla Ltd. Hyderabad Torrent Chemicals Ltd. Hyderabad Neuland Laboratories. Denmark Krebs Biochemicals Ltd. Hyderabad Sun Pharmaceuticals Ltd. Hyderabad... Reddy’s Laboratories. Hyderabad Orchid Chemicals.. Mumbai Lumen Marketing Company. Ghaziabad Duphar Interfran Ltd... Hyderabad Avon Organics Ltd. Chennai Nicholas Piramal India Ltd. Mumbai Bombay Drug House.. Ltd. Mumbai Lupin Laboratories Ltd...... Mumbai Cadila Laboratories Ltd.Government Run Research Organisations: Industry Collaboration Government Run Research Organisations: Industry Collaboration CDRI (Lucknow) Novo Nordisk. Hyderabad Lupin Laboratories. Bangalore Dabur Research Foundation... Mumbai Dabur India Ltd. Chennai Trident Labs Pvt.. 2005 Compiled by Ernst & Young . IICT (Hyderabad) Dr.. Hyderabad Bangalore Genei Pvt. Mumbai Coramandal Pharma. Chennai Ranbaxy Laboratories Ltd. Reddy’s Research Foundation. Mumbai Hindustan Latex Ltd. Ltd.. Mumbai Torrent Pharmaceuticals Ltd.. Hyderabad Dr. Mumbai Wockhardt Ltd. Sahibabad Biological Evans Ltd. Hyderabad IDPL..... Mumbai Cheminor Drugs Pvt. Thiruvananthapuram IPCA Labs Ltd.. Ltd. Ltd. Hyderabad Cipla Ltd. New Delhi Themis Medicare Ltd.. Aurangabad... Mumbai Nectar Laboratories Ltd. August 25.

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.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. 2005 .

Global Pharmaceutical Outsourcing Market estimated to exceed $65 bn by 2005… Source: OPPI. 2005 .Monitor Group Study 2003 Study 2003 August 25.Monitor Group Source: OPPI.

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 .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….

could this be a possible cover this be a possible cover story !!! story !!! Thank You!!! August 25.Indian Pharmaceutical Industry: Back to the Future ! 5 years from today. could 5 years from today. 2005 .

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