Presentation akshay lal

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Transcript of Presentation akshay lal

  • 1. Indian Pharmaceutical Evolution India Advantage Emerging Trends & Opportunities Key Partnership Considerations

2. Phase V Phase IV Innovation and Research Growth PhaseNew IP law Phase III Development Phase Rapid expansion of Discovery Research domestic market ProcessConvergencePhase II development International marketGovernment Control development ProductionPhase I Indian Patent Act infrastructureResearch orientationEarly Years 1970 creationMarket share Drug prices cappedExport initiativesdomination by Local companies beginforeign companies to make an impactRelative absenceof organizedIndian companies19701980199020002010 3. VALUE InnovativeProducts Specialty GenericGeneric exportsProductsexports to to under-developed developed &countriesdeveloping API countriesExports TIME 4. Large skill base Experts in process chemistry Long history of reverse engineering Vast talent pool Sheer number of scientists Motivated & English speaking Large number of trained Indians returning home from NorthAmerica and Europe Unmatched cost competitiveness Lower cost of infrastructure and skilled manpower Vertical integration 5. Strong local industry 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 6. Geographic Convergence Established and growing destination for Generic productdevelopment and manufacturing Leading Indian companies seeking overseas marketsand global scale Generic Innovator Convergence Leading Indian companies trying to climb the valuechain into innovative research India developing into a Drug Discovery servicesoutsourcing destination 7. Leader in API DMF filings in the US 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 FDAapproved 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 outgenerics faster than you can say copy In 5 years, 30-35% of the global demand for generic products isexpected to be met by India 8. Leading global/regional generic players establishing apresence: Teva acquired an Indian co in 2003, setting up newdevelopment 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 forUS$ 736 mn Ratiopharm development centre, manufacturing facilities 9. Aggressive Growth Strategies For building a global scale Ranbaxy aims to be one of the Top5 For market entry acquiring local co or setting up subsidiaries Recent M&A activity size of deals growing Ranbaxy going after acquisitions in US & Europe Acquired 3 companies in Europe in March/April 2006 Terapia (Romania) for US$ 324 million Raising 1.5 billion to fund further acquisitions Dr. Reddys Acquired Betapharm (Germany) for US$ 570 million in March 2006 Matrix (now part of Mylan) Acquired Docpharma (Belgium) for US$ 263 million in 2005. 10. Partnership opportunities Large number of large and mid-sized Indian companies with world-classgeneric product development and manufacturing capabilities and facilities Lot of under-utilized manufacturing capacities These companies prefer focusing attention & resources on some keymarkets (US/EU) and look for partners in other markets Opportunities for supplementing pipelines, filling pipeline gaps andreducing/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 Indiancompanies for other markets 11. Increasing number of Indian companies moving up the value chain fromgeneric 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 Dr. Reddys 3 projects in Phase II 2 projects in Phase I 4 projects in Pre-Clinical Glenmark 2 projects in Phase II deals with US$ 190 million signed 4 projects in Pre-Clinical Opportunities for in-licensing & out-licensing 12. Global outsourcing market: 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 tolower 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 toretain their cost advantages Albany Molecular & Nektar have already established a presence Indian industry hoping to see 3-4 global discovery servicescompanies emerging out of India 13. Leading Indian Service Providers: 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 14. Supplier/Partner mapping/selection Capability / Keenness / Reliability / Competitiveness Key team members development, regulatory & commercial Optimal Number of Partners Strategic markets/product lines Opportunistic product specific Relationship management Relationship oriented culture Contract negotiation Clear distribution of responsibilities and timelines Demand performance - penalties for not meeting deliverables Project management Regular visits and video/teleconferences a must 15. India is an acquired tasteGive it some time & it will grow onyou 16. Thank you!Merci!