Indian companies have recently focused a lot on R&D in the pharmaceutical sector.
Many companies now spend 8% or more of revenues on research.
Many pharma companies are now actively targeting international companies for contract research and manufacturing (CRAM) deals.
Medicinal chemistry, custom synthesis, and clinical studies are some areas in which Indian firms are pitching and winning new business.
The global pharmaceutical outsourcing market was worth USD57.2 billion in 2007. It is expected to grow at a CAGR of 10% to reach USD76 billion by 2010. Global market for Contract Research and Manufacturing Services (CRAMS) in 2007 is USD55.48 bn. Out of the total global CRAMS market, Contract research wasUSD16.58 bn, growing at a CAGR of 13.8% and Contract manufacturing was USD38.89 bn accounting for themajor share (approximately 68%) of the total global pharmaceutical outsourcing market.
Indian pharma outsourcing market was valued at USD1.27m in 2007 and is expected to reach USD3.33 bn by 2010, growing at a CAGR of 37.6%. The Indian CRAMS market stood at USD1.21 bn in 2007, and is estimated to reach USD3.16 bn by 2010.
SCOPE Pharmaceutical companies increasingly outsource to third parties to save money, speed up processes and get products into the market quicker. Outsourcing allows companies to focus on their core competency areas and expedite the entire process. In Asia pacific, large biopharmaceutical companies outsource to their local and regional partners. CRO's (Contract Research Organizations) move up the value chain with the desire to serve only few global customers rather than diversify in different areas. Additionally, they are slowly converting into SMO's (Site Management Organizations), where protocol development and monitoring takes place in addition to R&D.
APIs Discovery Chemistry Formulations Advanced Intermediates Process R&D Outsourcing Business Space Range of Services From Clinical quantities to Commercial scale
Business Space Discovery Chemistry Process R& D Pipeline Intermediates Matured Intermediates BIG PHARMA Pipeline API’s Matured API’s Dosage Development Commercial Drug Product Discovery Chemistry Process R& D EMERGING PHARMA Pipeline Intermediates Matured Intermediates Pipeline API’s Dosage Development FINE CHEMICAL COMPANIES Pipeline & Matured Intermediates
Global Pharmaceutical Outsourcing Opportunity Estimated Potential Market: Packaging/ Assembly Dosage Form Produc- tion Dosage Form Develop- ment Drug Substance Produc- tion Process Develop- ment Clinical Develop- ment Pre- clinical Develop- ment Discovery Research Pharmaceutical R&D Drug Substance Supply Formulated Drug Supply 30-35 ~50 60-80 (in $ bn) Current share of outsourcing in defined Contract R&D/Manufacturing space is around ~$35 bn Source: Dow Report, AD Little, Cardinal Health
Declining R&D output & high costs continue to pose challenges to profitability
Blockbuster drug launches expected to drop from 14 in ’03 to 4 in ’08
Drug Product Withdrawls (Vioxx) and safety concerns (Crestor)
By ’08 patent expirations will account for $ 72 bn in current sales
Leading to Global Outsourcing DRIVERS Cost Increase Productivity Speed up New product Development D. Expand skills & capabilities Source: AT Kearney Report
Facts & Figures - INDIA Highest number of FDA approved plants outside USA Largely English speaking workforce IT capital of the world Democracy of 1 billion TRIP compliant UK based legal system Structured and reasonably transparent financial markets & banking system Dependent on oil for energy Well entrenched entrepreneurial culture & developed private sector Superior education level Infra-structure in need of development Largest market-share in generic API production Export & Western oriented Economic growth in terms of GDP just slightly behind China
Discovery Chemistry Formulations Advanced Intermediates APIs Process R&D Changing Paradigm Range of Services From Clinical quantities to Commercial scale Outsourcing services + In License the product for Indian & Asian Markets Indian Companies are positioning themselves as partners to Innovator companies
India’s Conclusion of Strengths… Speed Competitive Pricing Full cGMP …combining the best of both worlds
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Thank You Vikram Sathish.A Director -Marketing &Sales Tri Inpharmex Services Pvt.Ltd