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Presentation Structure
India Advantage
Emerging Trends & Opportunities Key Partnership Considerations
Phase IV
Phase III Development Phase Phase II Government Control Phase I Early Years Market share domination by foreign companies Indian Patent Act 1970 Drug prices capped Local companies begin to make an impact Process development Production infrastructure creation Export initiatives Growth Phase Rapid expansion of domestic market International market development Research orientation
1970
1980
1990
2000
2010
API Exports
TIME
India Advantage
Sheer number of scientists Motivated & English speaking Large number of trained Indians returning home from North America and Europe
Growing expertise with international regulatory compliance High quality manufacturing with abundant capacities
Speed
Very strong entrepreneurial spirit Hungry for growth and recognition Quick learners and fast movers
Availability of capital
Stock market has seen unprecedented growth in the last decade Continues to be bullish on the pharma industry
Geographic Convergence
Established and growing destination for Generic product development and manufacturing Leading Indian companies seeking overseas markets and global scale
Leading Indian companies trying to climb the value chain into innovative research India developing into a Drug Discovery services outsourcing destination
Jan-Jun 2006 175 of the 601 DMFs filed were by Indian companies 2005 - 313 of the 946 DMFs filed were by Indian companies
Leader in capital investments - largest number of US FDA approved manufacturing facilities (outside the US) Almost 20% of ANDA filings in the US No place like India for generics R&D and manufacturing of APIs & formulations Indias biggest assets cost, speed & scientists churning out generics faster than you can say copy In 5 years, 30-35% of the global demand for generic products is expected to be met by India
Teva acquired an Indian co in 2003, setting up new development centre & another manufacturing facility Sandoz development centre, 3 manufacturing facilities, more than 1000 employees Actavis - development centre, acquired CRO (Lotus) Mylan acquired controlling stake in Matrix last month for US$ 736 mn Ratiopharm development centre, manufacturing facilities
For building a global scale Ranbaxy aims to be one of the Top 5 For market entry acquiring local co or setting up subsidiaries
Acquired 3 companies in Europe in March/April 2006 Terapia (Romania) for US$ 324 million Raising 1.5 billion to fund further acquisitions Acquired Betapharm (Germany) for US$ 570 million in March 2006 Acquired Docpharma (Belgium) for US$ 263 million in 2005.
Dr. Reddys
Partnership opportunities
Large number of large and mid-sized Indian companies with world-class generic product development and manufacturing capabilities and facilities Lot of under-utilized manufacturing capacities These companies prefer focusing attention & resources on some key markets (US/EU) and look for partners in other markets
Opportunities for supplementing pipelines, filling pipeline gaps and reducing/optimizing cost of development and cost of goods: In-licensing products Dossier and API development Contract Manufacturing Contract Research pilot & pivotal bio-equivalence studies Opportunities for out-licensing and supplying products to leading Indian companies for other markets
Increasing number of Indian companies moving up the value chain from generic to NDDS/NCE research Low cost development/manufacturing to Low cost innovation Some examples:
Ranbaxy
1 project in Phase II 1 project in Phase I 7 projects in Pre-Clinical 2 with GSK 3 projects in Phase II 2 projects in Phase I 4 projects in Pre-Clinical 2 projects in Phase II deals with US$ 190 million signed 4 projects in Pre-Clinical
Dr. Reddys
Glenmark
US$ 15-20 billion Manufacturing US$ 3-4 billion Research (informatics, chemistry services & chemical custom synthesis)
Big pharma is entering into deals with Indian companies to lower their cost of R&D
Collaborative R&D GSK - Ranbaxy Service outsourcing - Wyeth GVK, Jubilant, Lilly Suven
Global discovery services companies are looking at India to retain their cost advantages
Indian industry hoping to see 3-4 global discovery services companies emerging out of India
Contract Manufacturing Jubilant, Shasun, Divis Clinical Research Syngene (Biocon), Aurigene (Reddys), Synchron Bio-informatics & other IT services TCS, Satyam, Infosys, GVK Bio, Jubilant Drug Discovery/Medicinal Chemistry Aurigene, Divis, Syngene, Suven, GVK Bio Pre-clinicals Vimta, Lambda Central laboratory services SRL Ranbaxy, Vimta
Supplier/Partner mapping/selection
Capability / Keenness / Reliability / Competitiveness Key team members development, regulatory & commercial
Strategic markets/product lines Opportunistic product specific Relationship oriented culture Clear distribution of responsibilities and timelines Demand performance - penalties for not meeting deliverables Regular visits and video/teleconferences a must
Relationship management
Contract negotiation
Project management
Closing Comment
India is an acquired taste Give it some time & it will grow on you
Thank you!