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The World Contract Research and Manufacturing Market, 2006-2011 (Trends in Outsourcing)

Table of Contents

1. Executive Summary

• 1.1  Aims and Scope of Contract Pharma 2006

2. Introduction to Outsourcing

2.1 Contract Pharma Described

• 2.1.1 Contract Research Organisations (CROs) and Contract Manufacturing Organisations (CMOs) Now Provide a Variety of Services
• 2.2 Why Are Pharma Companies Interested in Contract Pharma?
  • 2.2.1 Lack of Capacity is Still the Major Reason to Outsource for Big Pharma
  • 2.2.2 Small/Mid-sized Pharma and Biotech Have a Flexible Attitude to Outsourcing
  • 2.2.3 Tactical vs. Strategic Use of Outsourcing
• 2.3  The Changing Nature of the Pharmaceutical Market is Affecting the CRM Market
  • 2.3.1 The Rise of Generics
  • 2.3.2  Pipelines are Becoming Expensive
  • 2.3.3 The Fall of the Traditional Blockbuster
• 2.4  Biopharmaceutical Drug Discovery and Development by Contract Pharma Companies is Set to Increase
• 2.5 The Disadvantages of Contracting in the  Pharmaceutical Industry
• 2.6 The Future is Bright but Dynamic for the Contract Pharma Industry

3. The Regulatory Aspects of Outsourcing

• 3.1  Regulations Affecting the Organisation of Clinical Trials
  • 3.1.1 Establishing Standards for Good Clinical Practice and the International Conference on Harmonisation
  • 3.1.2 The EU Clinical Trials Directive
• 3.2 Legal Liabilities and Regulatory Considerations in Manufacture Outsourcing
  • 3.2.1  Summary of GMP requirements
  • 3.2.2 Compliance with FDA Provisions is Vital
  • 3.2.3  EU Regulations and the Qualified Person (QP) Role
  • 3.2.4  Q7A Guidance for Active Pharmaceutical Ingredient (API) and Excipient Production
  • 3.2.5 Harmonisation of GMP Standards
• 3.3 Globilisation helps Pharma Harmonisation

4. The Outsourcing Decision

4.1  Reasons to Outsource

• 4.1.1 Outsourcing as a Tactical Decision
• 4.1.2 Outsourcing as a Strategic Decision
• 4.2 Cost-Benefit Analysis of Outsourcing
• 4.3 Risks Associated with Outsourcing Incur Hidden Costs
  • 4.2.1 Errors and Delays Can Cost Millions
  • 4.2.2 Regulatory Compliance Must be Assured
  • 4.2.3 IP and Other Sensitive Data May be at Risk
  • 4.2.4 Management of Outsourcing Cannot be Ignored
• 4.4 Tech Transfer Considerations
• 4.5 The Virtual Company
  • 4.5.1 'Virtuality' Helps Control Spiralling Costs
  • 4.5.2 Strong Proactive Management is Key for Virtual Companies
  • 4.5.3 The Challenges of Virtual Companies are Relevant Across the Industry
• 4.6 Key Requirements for Successful Outsourcing
  • 4.6.1 Trust and Accountability are Central to Any Outsourcing Agreement
• 4.7 Summary: Forward Planning is the Guiding Principle for Outsourcing

5. The World Outsourcing Market

5.1  Market Forecast by Sector, 2005-2011

• 5.2  Equivalent Levels of Drivers and Restraints Result in Unspectacular Growth
  • 5.2.1  Emphasis on Speed and Efficiency Benefits Contract Pharma
  • 5.2.2  Biotech and Hi-tech Pharma Require Expensive Expertise and Equipment
  • 5.2.3  Global Companies Build Trust and Reputation
  • 5.2.4  Overcapacity in Europe Increases Competition
  • 5.2.5  The Pharmaceutical Industry Still has Reservations
  • 5.2.6  Low Cost Services in India and China Drive Prices Down
• 5.3  Summary: Growth Rates Will Vary According to Sector

6. The World Market for the Contract Manufacturing Sector (2005-2011)

• 6.1 The Market for Contract Manufacturers is Diverse
• 6.2 API Manufacturing
  • 6.2.1 API Manufacturing and the Generics Industry
  • 6.2.2 API Manufacturers Closely Linked with Innovative Pharmaceutical Developers
  • 6.2.3  API Manufacturers Focused on Readily Available Bulk APIs
  • 6.2.4 China and India are the New Hubs for APIs
  • 6.2.5 Chinese API Export
  • 6.2.6 Western Companies Can Compete by Moving into Speciality API Manufacturing and a Guarantee of Quality
  • 6.2.7 Custom Peptides are an Opportunity for APIs to Move up the Value Chain
  • 6.2.8 The Trend for Highly Potent Ingredients Can Boost the API Market
• 6.3 Manufacturing Finished Dosage Forms
  • 6.3.1 Solid Dosage Forms Still Constitute the Majority of the Dosage Form Market
  • 6.3.2 CMOs Venture into Development and Product Extensions
• 6.4 The World API Market Will Grow Slowly
• 6.5 Contract Manufacturing of Finished Dosage Forms
• 6.6 Different Models for CMOs
  • 6.6.1 DSM Represents a Traditional Approach to Chemical Contract Manufacturing
  • 6.6.2 Lonza Mixes Exclusive Synthesis and Biotech with Bulk Production
  • 6.6.3  Patheon Moves into Process Development to Secure Early Phase Contracts

7. Outsourcing Biotech Manufacturing

• 7.1 History of the Biotech Contract Manufacturing Industry
  • 7.1.1 Failure of Early Efforts in Contract Biologic Manufacturing
  • 7.1.2 Barriers Existed to Contract Biologic Manufacture in the 1990s
  • 7.1.3 Biologics License Application
• 7.2 Cost Benefits of Outsource Manufacturing in Biotech
• 7.3 The Future of Biotech Outsourcing

8. The World Market for Contract Research (2005-2011)

8.1 A Lack of Innovative Drugs Puts Pressure on the Pipeline

• 8.2 The World Pharma Market is Heading for Low Growth
• 8.3 The Clinical Trials Market Leads R&D Outsourcing
  • 8.3.1 Clinical Trials are an Obvious Target for Outsourcing
• 8.4 The Drive for Patient Recruitment has Pushed Clinical Trials East
  • 8.4.1 Strengths of Outsourcing Clinical Trials in Developing Countries
  • 8.4.2 Weaknesses of Outsourcing Clinical Trials in Developing Countries
• 8.5 The Clinical Trials Market Will Continue to Grow
  • 8.5.1 Clinical Trials Market by Region
  • 8.5.2 The Clinical Trials Markets in India and China Will Increase
• 8.6 Key Technological Advances Promise to Transform Clinical Research
  • 8.6.1 EDC Can Streamline Clinical Trials
  • 8.6.2 Training and Security are Barriers to EDC Conversion
  • 8.6.3 Pharmacogenomics has the Potential to Revolutionise the Pharmaceutical Industry
  • 8.6.4 The Progress of Pharmacogenomics Has Been Slow
  • 8.6.5 Identification of Expression Profiles in Pre-clinical Models
  • 8.6.6 Phase I and II Clinical Trials Will Incorporate More Complex Screening Techniques
• 8.7  Safety Concerns and Development Pressures Will Change the Structure of Clinical Trials
• 8.8 The Use of CROs in Drug Discovery and Development is Increasing as Big Pharma Changes
  • 8.8.1  Contract Research has an Increasing Role in Lifecycle  Management
• 8.9  The Contract Research Market is Dominated by a Few Companies
• 8.10 Quintiles is the Leading CRO
  • 8.10.1 A Global Company is Required for Global Trials
  • 8.10.2 Sale of Business Units Indicates a Strong Emphasis on Late Phase Trials
• 8.11 Covance Successfully Combines Pre-clinical Research with Late Phase Organisation

9. Other Areas to Outsource

9.1  Outsourcing Sales and Marketing Brings Flexibility

• 9.1.1  An Integrated Approach Will Help Sustain the Contract Sales Market
• 9.2  Contract Packaging Services
  • 9.2.1  Contract Packaging is Not Just Boxes
  • 9.2.2  Advantages Offered by Contract Packaging Organisations
• 9.3  Outsourced Biostorage Becomes a Strategic Consideration
• 9.4  Forward Planning is Required for Regulatory Affairs  Outsourcing
• 9.5  Electronic Data Management
• 9.6 Heightened Safety Attention Opens the Door to Contract Pharmacovigilance

10. Conclusion

• 10.1 The Contract Pharma Industry is Maturing
• 10.2 The Lines of Distinction are Blurring
• 10.3 Contract Pharma Companies Must be Willing to Change to Survive in the Market

 

List of Tables

Table 2.1  Reasons Given for Pharmaceutical  Outsourcing

Table 2.2  Biotech Drugs in Late Development for  Leading Pharmaceutical Companies, 2006

Table 5.1  World Market Forecast ($bn) for the Contract Pharma Market, 2005-2011

Table 6.1  World API Market by Region, 2004

Table 6.2 Leading Chinese Exported APIs, 2005

Table 6.3 The World Market Forecast for APIs, 2005-2011

Table 6.4 The World Market Forecast for Finished Dosage Forms, 2005-2011

Table 6.5   Lonza Revenue ($m) by Service Activity, 2005

Table 6.6   Lonza Worldwide Manufacturing Capacity  (Pharmaceutical), 2005

Table 6.7  Patheon Worldwide Manufacturing Capacity, 2005

Table 6.8  Patheon Revenue ($m) and Growth Rates (%), 2002-2005

Table 6.9  Patheon Revenue ($m) by Service Activity, 2005

Table 8.1  The World Pharmaceutical Market by Region, 2005

Table 8.2  Clinical Trials Revenue ($m), 2004-2011

Table 8.3  Assessment of EDC Solutions

Table 8.4  Leading CROs by Total Revenue ($m), 2004-2005

Table 8.5 Leading CROs by Clinical Trial Revenue ($m) Only, 2004-2005

Table 8.6  Growth of Covance Revenues ($m) for Early and Late Development, 2002-2005

List of Figures

Figure 2.1  Common Examples of Contract Services During Drug Lifecycle

Figure 2.2  The Role of Contract Pharma Organisations n Drug Development

Figure 2.3  Comparison of R&D Costs and the Number   of Approved NMEs

Figure 2.4  Predicted Spending on Outsourcing by the Pharmaceutical Industry, 2006

Figure 5.1 World Market Forecast for the Main Sectors of the Contract Pharma Market, 2005-2011

Figure 5.2 The Contract Pharma Industry, 2005

Figure 6.1 Market Share (%) of the Chinese API Market

by Class, 2005

Figure 6.2 Global Distribution of Chinese API Exports, 2005

Figure 6.3 Global Revenues for APIs, 2005-2011

Figure 6.4 Global Revenues for Finished Dosage Forms, 2005-2011

Figure 6.5  Total Revenues from DSM Services, 2005

Figure 6.6  DSM Revenue by Business Sector, 2005

Figure 6.7  Revenues from DSM Life Sciences

Figure 6.8  Lonza Total Revenues, 2002-2005

Figure 6.9 Patheon Revenue by Geographic Region, 2005

Figure 8.1  Growth Rate (%) for the World Pharmaceutical Market, 2000-2005

Figure 8.2  Revenues ($m) from The Clinical Trials Market, 2004-2011

Figure 8.3  Revenues ($m) of the Clinical Trials Industry by Region, 2004-2011

Figure 8.4  Clinical Trial Market Share by Region, 2004

Figure 8.5  Clinical Trial Market Share by Region, 2011

Figure 8.6 Top Ten CROs by Clinical trials Market Share (%), 2005

Figure 8.7  Revenues ($m) from Quintiles Developmental Services Group 2002-2005

Figure 8.8  Growth Rate (%) for Quintiles Clinical Services Revenues, 2003-2005

Figure 8.9  Revenues ($m) for Covance, 2002-2005

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