Contract Research and Manufacturing Services

  • Publication Date:March 2008
  • Publisher:Cygnus Research
  • Product Type: Report
  • Pages:100

Contract Research and Manufacturing Services

Increasing costs of R&D, coupled with low productivity and poor bottom lines, have forced major pharmaceutical companies worldwide to outsource part of their research and manufacturing activities to low-cost countries, thereby saving costs and time in the process. 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 estimated to be USD55.48 billion. Out of the total global CRAMS market, contract research was USD16.58 billion, growing at a CAGR of 13.8% and contract manufacturing was USD38.89 billion accounting for the major share (approximately 68%) of the total global pharmaceutical outsourcing market.

India, with more than 80 US FDA-approved manufacturing facilities, is one of the most preferred locations for outsourcing manufacturing services in India by the multinationals and global pharmaceutical companies. The Indian pharmaceutical outsourcing market was valued at USD1.27m in 2007 and is expected to reach USD3.33 billion by 2010, growing at a CAGR of 37.6%. The Indian CRAMS market stood at USD1.21 billion in 2007, and is estimated to reach USD3.16 billion by 2010.This report gains significance in view of the growing prospects of CRAMS and the increasing interest of Indian pharma companies in exploiting the current opportunities.CRAMS report provides a brief introduction on CRAMS industry,market overview,India-china emerging players.CRAMS report updates on industrial applications in Pharma,Biotechnology and data management industry. It also highlights the grpwth drivers,issues and challenges in CRAMS industry. It has profiled 20 companies providing introduction,operational details excluding financial details of the companies.CRAMS report presents information about the regulatory issues involved including regulatory systems in india and the government policies.CRAMS report identifies critical success factors involved in the manufacturing/production and research.At the end the report presents future outlook for CRAMS industry.

  • 1. Introduction
    • 141.1 Contract Research (Cr)
    • 1.2 Contract Manufacturing (Cm)
      • 1.2.1 Generics
      • 1.2.2 Patented Drugs
      • 1.2.3 Intermediates For Nces
    • 1.3 Industry Specific Applications
      • 1.3.1 Pharmaceuticals
      • 1.3.2 Biotechnology
      • 1.3.3 Health Care
    • 1.4 Advantages
    • 1.5 Disadvantages
  • 2. Market Overview
    • 2.1 Characteristics Of The Crams Companies Of India
    • 2.2 Areas Of Government Support Critical To The Company
    • 2.3 R&D Strategies Of Companies In Crams
    • 2.4 Research On Local Disease Conditions
    • 2.5 Emerging Business Strategies
    • 2.6 Fda-Approved Manufacturing Plants In India
    • 2.7 Trips Compliance And Impact On Companies
    • 2.8 Emerging Business Model
    • 2.9 Service Providers In Contract Manufacturing
    • 2.10 Current Market
      • 2.10.1 Pharmaceutical Industry: A Major Player
      • 2.10.2 Market Status
      • 2.10.3 Contract Research
      • 2.10.4 Contract Manufacturing
      • 2.10.5 Contract Research Through Clinical Trials
    • 2.11 Historical Development
    • 2.12 Market Players
    • 2.13 Planning Outsourcing Process
    • 2.14 India-China Emerging Players
    • 2.15 R&D Spin-Off
  • 3. Industrial Applications
    • 3.1 Pharmaceuticals
    • 3.2 Biotechnology
    • 3.3 Data Management
  • 4. Crams Outsourcing
    • 4.1 Introduction
    • 4.2 Market Status
    • 4.3 Outsourcing In Clinical Research
    • 4.4 Reasons For Outsourcing To Cros
    • 4.5 Some Important Outsourcing Activities
  • 5. Growth Drivers
    • 5.1 Arising Need In Pharma Value Chain
    • 5.2 Demand For Nces And Inds
    • 5.3 Need For Speedy And Low Cost R&D
    • 5.4 Patenting Requirements
    • 5.5 Manpower Development
    • 5.6 Mncs, Leveraging On Their Indian Subsidiaries For Global Support
  • 6. Issues And Challenges
    • 6.1 Non-Availability Of Skilled Manpower
    • 6.2 Growing Global Competition
    • 6.3 Mncs Opening Captive Cros
    • 6.4 Manufacturing Units
    • 6.5 Others
    • 6.6 Competition From China
  • 7. Major Players
    • 7.1 Introduction
    • 7.2 Indian Companies
    • 7.3 Multinational Companies
    • 7.4 Major Players Foraying Areas
    • 7.5 Major Players And Their Crams Revenues
    • 7.6 M&A In Crams
    • 7.7 Some Alliances In Crams
  • 8. Regulatory Issues
    • 8.1 Government Regulations
      • 8.1.1 Fda
    • 8.2 Patent Regime
      • 8.2.1 Changes In India's Patent Regime And Access To Medicine
    • 8.3 Customs Duty
    • 8.4 Gatt/Trips/Wto
    • 8.5 Unsafe Drugs
    • 8.6 Industry's Growing Influence Over Research
    • 8.7 Academia And Industry - Eroding Boundaries
    • 8.8 Regulatory System In India: Government Policies
      • 8.8.1 Exemption Of Customs Duty
      • 8.8.2 Tax Benefit
      • 8.8.3 Role Of Iacuc
    • 8.9 Regulation Of Ethical Issues
      • 8.9.1 Animal-To-Human Transplants: Ethics Of Xeno-Transplantation
      • 8.9.2 Human Tissue: Ethical And Legal Issues
      • 8.9.3 Clinical Trials Without Ethical Review
    • 8.10 Indian Government's Stand
    • 8.11 Research And Development Regulations
    • 8.12 Government Policies
        • 8.1.2.1 Infrastructural Support
        • 8.1.2.2 Incentives
        • 8.1.2.3 Single Window Clearance
  • 9. Critical Success Factors
    • 9.1 Manufacturing/Production
      • 9.1.1 Supply Chain Management
      • 9.1.2 New Product Development
      • 9.1.3 Application Of E-Sourcing
    • 9.2 Research
      • 9.2.1 Infrastructure
      • 9.2.2 Research Design
      • 9.2.3 Professionally Trained Manpower
      • 9.2.4 Government Procedures/Sanctions
      • 9.2.5 Data Management
  • 10. Future Outlook
    • 10.1 High Expectations, Lot Of Promises
    • 10.2 Manufacturing And Licensing Opportunities
    • 10.3 Mergers And Acquisitions
    • 10.4 Licensed Production
    • 10.5 Marketing Tie-Ups
    • 10.6 Budding Research Base
    • 10.7 Increasing R&D Investment Of Global Pharma Companies
    • 10.8 Conclusion
  • Annexure 1
  • Bibliography
    • Annexure 2
    • Annexure 3
    • Annexure 4 87 Avra Laboratories Pvt. Ltd. 87 Bioarc Research Solutions 87 Biocon 88 Cadila Healthcare 89 Chembiotek Research International 89 Dishman Pharmaceuticals And Chemicals Ltd 89 Divis Lab 90 Ind-Swift Laboratories Ltd. 91 Ipca Laboratories Limited 92 Jb Chemicals And Pharmaceuticals Ltd. 92 Jubilant Organosys Ltd. 93 Matrix Laboratories Ltd. 94 Nicholas Piramal 95 Orchid Pharmaceuticals 96 Reliance Research And Development Services 96 Sai Life Sciences Ltd.97 Shashun Chemicals & Drugs Ltd 98 Suven Life Sciences Ltd. 98 Vimta Labs Limited 99 Wockhardt Ltd 100 List Of Tables
    • Table 1: Major Business Motives To Outsource
    • Table 2: Crams Areas Of Operation
    • Table 3: Areas Of Government Support
    • Table 4: Drawbacks In Trips Compliance
    • Table 5: Contract Manufacturing Deals In India
    • Table 6: A Comparison Between India And China
    • Table 7:R&D Spending For Top Companies
    • Table 8: Outsourcing Industry Partnership Analysis
    • Table 9: Patent Expiry Dates Of Some Major Molecules
    • Table 10: List Of Drugs Withdrawn From Commercial Activities
    • Table 11: Suggestive Operational Model List Of Figures
    • Figure 1: Dynamics Of Pharmaceutical Industry
    • Figure 2: New Molecular Entities (Nmes) And Biologic License Applications Approved By The Us Fda, 2001-2007
    • Figure 3: Future Estimated R&D Cost
    • Figure 4: Trends In Pharma Industry
    • Figure 5: Need For Crams In Pharma Industry
    • Figure 6: Sourcing Opportunity Evaluation By Pharma Companies
    • Figure 7: Post-2005 R&D Strategies Of Indian Cram Companies
    • Figure 8: Research On Local Disease Conditions
    • Figure 9: Business Strategies Of Indian Companies In Cram
    • Figure 10: Number Of Fda Approved Manufacturing Units In 2006
    • Figure 11: Emerging Business Model
    • Figure 12: Global Pharmaceutical Outsourcing Industry
    • Figure 13: Indian Pharmaceutical Outsourcing Market
    • Figure 14: Segment Of Indian Pharma Outsourcing Market (2006)
    • Figure 15: Indian Cro Market (2006)
    • Figure 16: Indian Cmo Market Segment (2006)
    • Figure 17: Big Pharma Partnering With Indian Pharma
    • Figure 18: Reasons For Outsourcing
    • Figure 19: Global R&D Expenditure, Development Times, Global Pharmaceutical Sales And New Molecular Entity Output 1996-2006
    • Figure 20: Annual Sales Value For Products Losing Exclusivity
    • Figure 21: Different Aspects Of Patenting Requirements
    • Figure 22: Dmf's Fillings (January 2000-June2007)
    • Figure 23: Future Market Outlook
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