The Future of R&D Outsourcing

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1 OUTSOURCING The Future of R&D Outsourcing Investigating development hurdles, key challenges & strategies to optimize CRO relationships By Alison Sahoo

2 Alison Sahoo Alison Sahoo is a pharmaceutical industry analyst with more than 10 years of experience researching the development of medicines and medical devices. She holds a B.S. in Physics from McGill University and an MBA in International Business from Rutgers University. Copyright 2010 Business Insights Ltd This Management Report is published by Business Insights Ltd. All rights reserved. Reproduction or redistribution of this Management Report in any form for any purpose is expressly prohibited without the prior consent of Business Insights Ltd. The views expressed in this Management Report are those of the publisher, not of Business Insights. Business Insights Ltd accepts no liability for the accuracy or completeness of the information, advice or comment contained in this Management Report nor for any actions taken in reliance thereon. While information, advice or comment is believed to be correct at the time of publication, no responsibility can be accepted by Business Insights Ltd for its completeness or accuracy. ii

3 Table of Contents The Future of R&D Outsourcing Challenges facing drug developers 10 Dynamics of outsourced R&D 11 R&D outsourcing in Asia 12 Strategies to optimize R&D outsourcing relationships 13 The future of R&D outsourcing 14 Chapter 1 Challenges facing drug developers 16 Summary 16 The drug approval process 17 US 17 Europe 21 The Mutual Recognition Procedure (MRP) The National Competent Authorities Rising financial pressure 24 Expiring patents on blockbusters 24 Decreasing market exclusivity 27 Healthcare cost containment 28 Rising usage of generics 28 Elimination of coverage 30 Step therapy 31 Utilization of OTCs 31 Manufacturer rebates Consumer skepticism of drug benefits Drug development imperatives 33 Targeting large markets 34 Focus on efficacy 34 Expansion into biologicals 36 Decreasing time to market 36 Drug development hurdles 37 More complicated disease targets 38 Rapidly escalating costs 38 Reduced R&D staff 40 Heightened regulatory scrutiny 43 Declining drug approvals 44 Conclusion 46 3

4 Chapter 2 Dynamics of outsourced R&D 50 Summary 50 Contract research organizations 51 The role of CROs 51 Services offered by CROs 51 Discovery 53 Preclinical evaluation 54 Clinical trials 54 Repositioning Expanding technological expertise Reasons for outsourcing R&D 56 Types of relationships 60 Preferred vendors 63 Functional service providers 64 Risk sharing 64 Technology partnerships 65 Drug licensing 66 Benefits and limitations of using CROs 66 Long term cost savings vs. high short term expenses 67 Speed to market vs. potential project overruns 68 Access to expertise vs. CRO staff turnover 70 Flexibility vs. loss of control 71 Ability to customize research vs. CRO clutter 72 CRO usage 72 Usage estimates Leading CROs 73 Conclusion 74 Chapter 3 R&D outsourcing in Asia 78 Summary 78 Introduction 79 Offshore outsourcing of clinical research 81 Offshore outsourcing of preclinical research 82 Contract research in India 84 Key outsourcing issues 86 Intellectual property 86 Regulatory issues 87 Business issues and infrastructure Leading players CRO usage and market size 90 CRO developments in India 91 Case study: GlaxoSmithKline 92 Contract research in China 95 4

5 Key outsourcing issues 96 Intellectual property 97 Regulatory issues 98 Business issues and infrastructure Leading players CRO usage and market size 103 CRO developments in China 103 Case study: Eli Lilly 106 Offshore outsourcing partnerships 108 Types of relationships 108 Early stage collaborations 109 Global networks 110 Conclusion 111 Chapter 4 Strategies to optimize R&D outsourcing relationships 114 Summary 114 Introduction 115 Key causes of and remedies for R&D outsourcing failures 116 Outsourcing strategy 118 Supplier evaluation and selection 119 Contracting 122 Renegotiation Project organization and expectations Supplier management 126 Culture 128 Corporate cultural differences 129 Ethnic divergence Management changes and personnel turnover Management changes 131 Personnel turnover Intellectual property R&D outsourcing best practices 134 Case study: Wyeth 134 Case study: AstraZeneca 135 Case study: Eisai 136 Conclusion 137 Chapter 5 The future of R&D outsourcing 140 Summary 140 Introduction 141 The drug development landscape in the US and EU 142 5

6 Near term: Long term: R&D outsourcing trends 147 Near term: Long term: Conclusion 155 Index 156 List of Figures Figure 1.1: US and EU spending on generic drugs, Figure 1.2: US NME approvals vs. R&D spend ($bn), * 46 Figure 1.3: Average US R&D spend per NME approval ($m), * 47 Figure 2.4: Services offered by CROs 52 Figure 2.5: Potential benefits and limitations of using a CRO 68 Figure 2.6: Growth of outsourced R&D by segment ($m), Figure 2.7: Market analysis of major CROs, Figure 3.8: Advantages and disadvantages of leading Asian outsourcing venues 80 Figure 3.9: Clinical and preclinical test capabilities of India and China 83 Figure 3.10: Growth of outsourced R&D to India by segment, Figure 3.11: GlaxoSmithKline sales vs. R&D expense ( m), Figure 3.12: Growth of outsourced R&D to China by segment ($m), Figure 3.13: Eli Lilly sales vs. R&D expense ($m), Figure 3.14: Key characteristics of offshore partnering relationships 109 Figure 4.15: Risk factors when outsourcing R&D 117 Figure 5.16: Confidence level of drug development & outsourcing predictions, near vs. long term 143 Figure 5.17: Drug development trends, near vs. long term 144 Figure 5.18: Relative usage & growth of different types of R&D outsourcing relationships, near vs. long term 148 Figure 5.19: R&D outsourcing trends, near vs. long term 151 List of Tables Table 1.1: CDER Drug Advisory Committees, December Table 1.2: Leading European National Competent Authorities, Table 1.3: Leading European National Competent Authorities, 2009 (ctd) 26 Table 1.4: Revenues and patent expirations for selected companies blockbusters, Table 1.5: Leading medicinal research areas, Table 1.6: Significant R&D staff reductions,

7 Table 1.7: US NME approvals, Table 1.8: US R&D spend for approved NMEs ($), Table 2.9: Key characteristics of CRO partnering relationships 62 Table 4.10: Reasons for time and budget overruns 127 Table 4.11: Corporate cultural characteristics of sponsors and contractors 129 Table 5.12: Global growth of outsourced R&D by stage ($bn),

8 8

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