SPI Infoamtion

1 Executive Summary: Contract Pharma 2008-2023

2 Contract Pharma Prospects in World Regions
2.1 World Market Prospects for Contract Pharma
2.2 Clinical Trial Business Outsourcing will Expand
2.3 Contract Pharma Situation in the US
2.4 Pharmaceutical Industry Still has Reservations
2.5 European CMO Market
2.6 Emerging Opportunities in Contract Manufacturing and Research in India
2.7 Global Companies Build Trust and Reputation
2.8 Japan's Rising Contract Research and Manufacturing Business

3 The Regulatory Aspects of Outsourcing
3.1 Legal Liabilities and Regulatory Considerations in Manufacture Outsourcing
3.2 Summary of GMP Requirements
3.3 Compliance with FDA Provisions is Vital
3.4 EU Regulations and the Qualified Person Role
3.5 Q7A Guidance for Active Pharmaceutical Ingredient (API) and Excipient Production
3.6 Harmonisation of GMP Standards
3.7 EU API Makers for Good Manufacturing Practices Inspections
3.8 Enforcing cGMP Compliance for APIs in EU
3.9 EU Requirements for Outsourcing Services
3.10 Good Manufacturing Practice (GMP) Compliance
3.11 API Requirements Challenge Outsourcing Services from China
3.12 Regulations Affecting the Organisation of Clinical Trials
3.13 Heightened Safety Attention Opens the Door to Contract Pharmacovigilance
3.14 A Brief Account of Regulatory Developments for Clinical Trial

4 Market Analysis for Contract Manufacturing Business
4.1 Revenue Projection for Contract Manufacturing Business
4.2 Summary of the Chapter

5 Contract Manufacturing Businesses to Drive Productivity and Efficiency
5.1 Reasons for Outsourcing
5.2 Drivers for Outsourcing
5.3 Restraints for Outsourcing
5.4 API Manufacturers Closely Linked with Innovative Pharmaceutical Developers
5.5 Various Outsourcing Partners
5.6 Selecting an Appropriate CMO
5.7 Efficient Management of Supply Chain for Low-Cost Contract Manufacturing Industry
5.8 Mergers and Acquisitions for Pharmaceutical Manufacturing
5.9 Interview with Manish Badonia, Cadila
5.10 Contract Pharma for Biotech Products
5.11 Western Companies
5.12 Contract Pharma for Improved Process Tools
5.13 Chinese API Export Growing Rapidly
5.14 Outsourcing to Low-Cost Geographic Areas
5.15 Low-Cost Services in India and China Drive Prices Down
5.16 Main Tendencies in Current Asian IP Law
5.17 Patent Protection Status in Indian Pharmaceutical Industry
5.18 Improvement of China's Intellectual Property Rights Situation
5.19 Interview with Dr Zhang Zhicheng, National Intellectual Property (IP) Strategy Formulation Office, SIPO, China
5.20 Interview with Manish Badonia, Cadila

6 Contract Manufacturing Businesses in India
6.1 Contract Manufacturing in India
6.2 Drivers for Contract Manufacturing for Outsourcing to India
6.3 Contract Manufacturing and Role of Indian Companies
6.3.1 Outsourcing for Generics
6.4 Enforcing cGMP Compliance for APIs in EU
6.5 Growth in Biotechnology Sector of India
6.6 Interview with Dr Jagdish N Sheth, Business School of Emory University

7 Market for Clinical Trial Business
7.1 Outsourcing for Clinical Trial Business
7.2 Phase IIIb and IV Studies
7.3 Safety Concerns and Development Pressures
7.4 Demand for Phase II and Phase I Studies

8 SWOT Analysis for Outsourcing Clinical Research to CROs
8.1 Outsourcing Clinical Trial Business to CROs
8.2 SWOT Analysis for Outsourcing Clinical Trials
8.3 Growth of CRO Industry

9 SWOT Analysis for Outsourcing Clinical Trials to Lower-Cost Regions
9.1 SWOT Analysis for Outsourcing Clinical Trials to Developing Countries
9.2 China
9.3 India
9.4 Clinical Trial Outsourcing

10 Firsthand Interviews for Clinical Trial Business
10.1 Interview with Dr Arun Bhatt, Clininvent
10.2 Interview with Dr Ernst Johannes, Quintiles
10.3 Interview with Dr Louis Christian Clauss, Baxter
10.4 Interview with Dr. Venkat Jasti, Suven Life Sciences
10.5 Interview with Patricia Moenaert, Progenitor International Research

11 Contract Pharma for Specialised Areas
11.1 Value-Added Services and Contract Pharma
11.2 One-Stop Shop (CRO and CMO)
11.3 Interview with Manish Badonia, Cadila
11.4 Presentation at Dissolution Testing, Bioequivalence and Bioavailability Strategies 2008 conference by Kevin Deane
11.5 Interview with Wesley Wheeler, Patheon
11.6 Suitable Trial Supply Chain Management
11.7 Presentation at Clinical Trial Congress 2008 by Carmen Salazar, Cellerix
11.8 CMOs Venture into New Areas
11.9 The Use of CROs as Major Pharma Changes
11.10 Interview with Dr Debra Sponholtz, Chembiotek
11.11 Interview with Dr Arun Bhatt, Clininvent
11.12 Outsourcing Electronic Data Management
11.13 Outsourcing Clinical Data Management
11.14 Forward Planning is Required for Regulatory Affairs Outsourcing
11.15 Outsourcing Bioequivalence Studies for Generic Drugs
11.16 Requesting a Waiver from a Bioequivalence Trial
11.17 Bioequivalence Studies for New Drug Application
11.18 Interview with Helmut Schutz, BEBAC
11.19 Interview with Dr Daniel Abran, Sandoz
11.20 Interview with Manish Badonia, Cadila
11.21 Outsourced Bio-storage Becomes a Strategic Consideration
11.22 Contract Pharma for Lyophilisation
11.23 Outsourcing Sales and Marketing Brings Flexibility
11.24 Contract Packaging Services

12 Conclusions
12.1 Growth Rates will Vary According to Sector
12.2 Contract Pharma Expanded to Include Biotechnology
12.3 Contract Research has an Increasing Role in Lifecycle Management
12.4 Outsourcing Data Management
12.5 Global Companies Required for Global Trials
12.6 Outsourcing for Value-Added Services