医薬品業界における研究開発動向および戦略

Abstract

This new report has been written to provide members of pharmaceutical, biotechnology and clinical research sectors an analytically-based overview of the mechanisms of the partnering process, and the key issues and trends affecting these arrangements.

The modern pharmaceutical company faces numerous challenges in its efforts to improve productivity and to strengthen the product portfolio. In an attempt to counteract the pressures of operating in a global pharmaceutical market, companies have sought to establish relationships with external partners such as biotechnology companies and Clinical Research Organizations (CROs) as a means to remaining competitive and profitable.

Alliances and external collaborations have provided companies with the opportunity to gain access to new technological breakthroughs and novel expertise regardless of national or geographical boundaries. Evidence of the growing emphasis on alliances and external collaborations as a route to success is highlighted by the fact that partnerships within the biopharmaceutical sector are currently being formed at the rate of $5 billion per year.

This new report is designed to provide information, insight and in-depth analysis of alliance and licensing activity within the pharmaceutical industry in order to identify the challenges faced by members of the pharmaceutical community; current trends in partnering activity; an understanding of the dynamics of the buyer-supplier relationship and best practices for managing external collaborations. The report is aimed at providing an appraisal of the partnering process, and insights into the current environment of pharmaceutical discovery and development.

Strategies for Innovation in Pharmaceutical R&D includes the following features:

• A thorough market analysis of the global pharmaceutical industry, including the challenges faced by pharmaceutical manufacturers and the technological developments currently affecting innovation
• A review of key developments taking place in the environment of pharmaceutical R&D and an evaluation of possible strategies for facilitating the drug discovery and development process
• Analysis of the significance of biotechnology to the pharmaceutical industry, including key trends in pharmaceutical alliance and licensing agreements
• An assessment of the importance of outsourcing to the drug development process, and an overview of the market for contract research, including key trends in pharmaceutical licensing agreements
• Guidelines for partnership management, with profiles of market leaders in the areas of pharmaceuticals, biotechnology and clinical research
• An informative and vital source of reference that provides practitioners with easy to access case studies, tabular data, key competitor profiles and a glossary of key pharmaceutical terms and definitions, with details of alliance and licensing deals within the biopharmaceutical sector

Table of Contents

Chapter 1: Overview of the Global Industry

• 1.1 General Characteristics of the Pharmaceutical Industry
  • 1.1.1 Innovation
  • 1.1.2 Government Regulation and Pricing
  • 1.1.3 The Patent System
• 1.2 Economic Structure of the Pharmaceutical Industry
• 1.3 External Forces Impacting the Industry
  • 1.3.1 Rising Cost of Research & Development
  • 1.3.2 Changing Demographic Trends
  • 1.3.3 Biotechnology
  • 1.3.4 Consumerism
  • 1.3.5 Greater Generic Competition
  • 1.3.6 Information Technology
• 1.4 Technological Developments Affecting Innovation
  • 1.4.1 Co-specialized Research Methods
  • 1.4.2 Generic and Transversal Technologies
  • 1.4.3 Evaluating Technological Advances in Pharmaceutical Innovation

Chapter 2: The Environment of Pharmaceutical R&D

• 2.1 The Drug Development Process
• 2.1.1 Phase (1): Drug Discovery
• 2.1.2 The Pre-Clinical phase: Pharmacological Development
• 2.1.3 Phase (2): Clinical Development Phase I, II, III
• 2.1.4 Phase IV: Post Marketing Surveillance
• 2.1.5 Registration and Launch
• 2.2 R&D Decision-making Models
• 2.2.1 The 'Traditional' Model
• 2.2.2 The 'Modern' Model
• 2.2.3 Strategic Planning of R&D
• 2.3 Global Investment in Pharmaceutical R&D
• 2.3.1 Productivity of the Global Pharmaceutical Industry
• Case Study: The British Pharmaceutical Industry
• 2.3.2 The Cost of Drug Discovery and Development
• 2.3.3 Drug Development Times
• 2.3.4 Rates of Success in Pharmaceutical Innovation
• 2.3.4.1 Selection of Compounds
• 2.3.4.2 Cost Reduction
• 2.3.4.3 Competitive Pressures
• 2.3.5 Declining Productivity in Pharmaceutical Innovation
• 2.4 Key Therapeutic Area Definitions
• Case Study: Efforts to Improve the Productivity of Eli Lilly's Pharmaceutical Value Chain
• 2.5 Future Blockbuster Diseases
• 2.5.1 R&D Investment Priorities
• 2.5.2 Therapeutic Focus

Chapter 3: Strategies for Innovation in R&D

• 3.1 Sources of Stress in the Pharmaceutical Business Model
• 3.2 Generic Strategies for Pharmaceutical R&D
• 3.3 Traditional Approach of Mergers & Acquisitions
• 3.3.1 Reasons for Merging
• 3.3.2 The Advantages of an M&A Strategy
• Case Study: The Merger Between Pfizer Inc. and Pharmacia Corporation
• 3.3.3 The Disadvantages of an M&A Strategy
• 3.4 Alliances as an Alternative Strategy
• 3.4.1 Key Alliance Definitions
• 3.4.2 The Role of Strategic Alliances
• 3.4.3 Motives for Strategic Alliance Formation
• 3.4.4 Motives for Strategic Technology Alliances
• Case Study: Strategic Alliances Between Ligand Pharmaceuticals and Eli Lilly
• 3.5 Knowledge Sharing and Learning in Technology Alliances
• 3.5.1 Key Technology Definitions
• 3.5.2 Tacit Vs Explicit Knowledge
• 3.5.3 Knowledge Valuation
• 3.5.4 Learning Races
• 3.6 Different Types of R&D Partnering Models
• 3.6.1 The Research Phase
• 3.6.2 The Development Phase
• 3.6.3 Characteristics of the Different Types of R&D Partnering Models

Chapter 4: Enhancing R&D through External Collaboration - The Case of Biotechnology

• 4.1 The Importance of Establishing R&D Partnerships
• 4.1.1 Trends in Pharmaceutical Alliances
• 4.1.2 Trends in Licensing Agreements
• 4.2 The Significance of Biotechnology to the Pharmaceutical Industry
• 4.2.1 Biotechnology Products
• 4.2.2 Industry Structure
• 4.2.3 The Global Biotechnology Industry
• Case Study: Growth Strategies of the Japanese Biotechnology Industry
• 4.2.4 The Biotechnology Industry in the US
• 4.2.5 The Biotechnology Industry in Europe
• 4.2.6 Biotechnology R&D
• 4.2.7 Reasons for Entering into Licensing Agreements
• Case Study: Licensing Agreement Between Vertex Pharmaceuticals and Novartis Pharma
• 4.2.8 The Future of the Biotechnology Industry

Chapter 5: Enhancing R&D through External Collaboration - The Case of Outsourcing

• 5.1 The Importance of Outsourcing in Drug Development
• 5.1.1 Industry Structure
• 5.1.2 Perceptions of the Pharmaceutical Industry
• 5.1.3 The Role of the CRO
• Case Study: Outsourcing Strategies of Merck & Co.
• 5.1.4 The Market for Contract Research
• Case Study: The Acquisition of BioReliance Corporation by Invitrogen Corporation
• 5.1.5 Reasons for Entering into Contract Manufacturing Agreements
• 5.1.6 The Future of Outsourcing

Chapter 6: Strategies for Success, Reasons for Failures in R&D Alliances

• 6.1 The Advantages of External Partnerships
• Case Study: Licensing Collaboration Between Bristol-Myers Squibb and Lexicon Genetics
• 6.2 The Problems of External Partnerships

Chapter 7: Guidelines for Alliance Management

• 7.1 Managing External Partnerships
• 7.1.1 Effective Alliance Management Strategies
• Case Study: Alliance Management Strategies at Pfizer Inc.
• 7.1.2 Managing Intellectual Property Issues
• Case Study: Government IP Protection Strategies for Singapore's Biopharmaceutical Industry

Chapter 8: Key Company Profiles

• 8.1 Pharmaceutical Company Profiles
• 8.2 Biotechnology Company Profiles
• 8.3 Clinical Research Organization Company Profiles

Appendix: Summary of Key Trends in Partnering Activity

References

List of Figures

• Figure 1.1 External Forces Impacting the Pharmaceutical Industry
• Figure 2.1 Pharmaceutical Research and Development Process
• Figure 2.2 Composition of Global Pharmaceutical R&D
• Figure 2.3 Product Development Times for Pharmaceuticals
• Figure 2.4 Number of NMEs Launched Worldwide, 1994-2002
• Figure 2.5 R&D Investment by US Pharmaceutical Firms by Therapeutic Area
• Figure 3.1 Generic R&D Strategies
• Figure 4.1 Number of Major Alliances by Company, 1999-2003
• Figure 4.2 Growth in Pharmaceutical Alliances, 1993-2001
• Figure 4.3 Composition of Global Pharmaceutical Licensing Agreements
• Figure 4.4 Composition of Global Biotechnology R&D
• Figure 4.5 Composition of the EU Biotechnology Industry
• Figure 5.1 Composition of the Clinical Research Market, 2003
• Figure 5.2 Composition of Clinical Research Activities
• Figure 6.1 Most Commonly Occurring Problems in Alliances

List of Tables

• Table 1.1 Top 10 Companies by Pharmaceutical R&D Expenditure, 2003
• Table 1.2 Top 10 Companies by Pharmaceutical Operating Profit, 2003
• Table 1.3 Typology of Drugs Produced by the Pharmaceutical Industry
• Table 2.1 Contrasting Characteristics of R&D
• Table 3.1 Major Mergers in the Pharmaceutical Industry, 1987-2003
• Table 3.2 Motives for Strategic Alliances in Pharmaceuticals
• Table 3.3 Different R&D Partnering Models
• Table 4.1 Principal Technologies within Biotechnology
• Table 4.2 Top 10 Biopharmaceutical Companies by Sales Revenue, 2003
• Table 4.3 Biopharmaceutical Research Companies in Kansai, Japan
• Table 5.1 Companies with Clinical Development Expertise
• Table 5.2 ChemBridge Research Laboratories Alliance Partners
• Table 5.3 Top 10 Clinical Research Organizations by Sales Revenue, 2003
• Table 6.1 Benefits of Strategic Licensing Agreements