Studie - The Future of Contract Research Outsourcing - Market Forecasts to 2015, Geographical Landscape and Competitive Benchmarking

GBI Research
12.2009
69 Seiten

 
Typ:
Studie
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Regionen/­Länder:
  • Europa
  • Asien / Pazifik
  • Mittlerer Osten / Afrika
  • Nordamerika / USA
  • Australien
  • Mittel- / Südamerika
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Deutsch

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Summary

GBI Research, the leading business intelligence provider, has released its latest research, 'The Future of Contract Research Outsourcing - Market Forecasts to 2015, Geographical Landscape and Competitive Benchmarking. The research provides key data, information and analysis of the global contract research outsourcing market. The report provides market overview, competitive landscape and market trends information on the contract research outsourcing market. This report provides comprehensive information on the different service models present in the industry, key trends affecting contract research organizations and key analytical content on the market dynamics. The report also reviews the competitive landscape in terms of mergers and acquisitions, strategic partnerships and service agreements.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts.

Scope

The scope of this report includes:
- Overview of contract research outsourcing and key reasons why pharmaceutical and biotechnology companies outsource to contract research organizations
- Comprehensive analysis of the fully-integrated and functional service models of contract research outsourcing
- Market size (2006-2015) and company share (2008) data for global contract research outsourcing market
- Qualitative analysis of market drivers, restraints and trends
- Geographic landscape covering the emerging regions such as Central and Eastern Europe, Latin America, India and China for contract research outsourcing
- Competitive landscape covering key players Quintiles, Covance, PPD, Charles River Laboratories and PARAXEL International
- M&A landscape and opportunity analysis of the emerging markets
- Regulatory landscape of the US and key European countries in the contract research outsourcing market

Reasons to buy

The report will enhance your decision making capability. It will enable you to:
- Develop key strategies to reduce expenditure on R&D by outsourcing to the contract research organizations
- Develop a clear knowledge and understanding of how companies use contract research outsourcing to improve drug development productivity
- Make informed decisions related to contract research outsourcing by building a thorough understanding of the benefits and drawbacks of contract research outsourcing
- Identify leading contract research outsourcing destinations and the best practices for entering into contract research outsourcing agreements in different countries
- Identify key players best positioned to take advantage of the emerging market opportunities
- Make informed decisions related to the M&A activities in the contract research outsourcing market
- Overcome the regulatory hurdles in the contract research outsourcing market
- Make more informed business decisions from the insightful and in-depth analysis of the global contract research outsourcing market and the factors shaping it

Press Release

GBI Research, the leading business intelligence provider, has released its latest research, 'The Future of Contract Research Outsourcing — Market Forecasts to 2015, Geographical Landscape and Competitive Benchmarking provides key data, information and analysis on the global contract research outsourcing market. The report provides market overview, competitive landscape and market trends information on the contract research outsourcing market. This report provides comprehensive information on the different service models present in the industry, key trends affecting the contract research organizations and key analytical content on the market dynamics. The report also reviews the competitive landscape in terms of mergers and acquisitions, strategic partnerships and service agreements.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research's team of industry experts.
The contract research market will continue to consolidate even as the strategic partnerships with the pharma and biotech industry will continue to drive the market. The contract research outsourcing activity is expected to increase in the clinical trials stage. Emerging regions such as India, China, Latin America and Central and Eastern Europe will drive the market by providing cost advantage. The increasing compliance to international regulations and standards governing the market by these regions will support this trend. The market is driven by the increasing R&D expenditure and a strong need in the biopharmaceutical industry to improve R&D efficiency by cutting costs.

The key challenges to the contract research outsourcing market are the current economic recession which has resulted in reduced demand especially from the biotech industry. The contract research organizations are also impacted by the increasing focus on safety of the drugs and recent cases of failure in clinical trials has led to an increase in concerns over quality. But, the contract research organizations are changing themselves according to the international standards with an aim to take care of the quality concerns of biopharmaceutical companies. Therefore, the quality concerns can be overcome and will have a small impact on the overall contract research outsourcing market.

The leading players in this consolidated market continue to grow through expanding their services and emerging as end to end service providers with global presence. The major contract research organizations are active in the central nervous system (CNS), oncology and cardiovascular therapeutic areas and focusing on the unmet needs of the biopharmaceutical industry. The contract research organizations will continue to expand geographical presence and improve their capabilities in therapeutic areas such as oncology and CNS and also expand functional expertise through partnerships with other contract research organizations.

Contract Research Organizations are Emerging as Strategic Partners to Improve R&D efficiency by Reducing Time to Market and Costs
The pharma and biotech industry today is forming strategic partnerships with the contract research organizations to leverage on their global presence and research expertise. The agreements with contract research organizations are aimed at improving the time to market and reducing costs. The service models of the contract research organizations are evolving to become more functional, where services are outsourced based on the analysis of their core competencies. The increasing focus on strategic partnerships will drive the growth in emerging outsourcing destinations which have many small niche contract research organizations specializing in different functions. For example AstraZeneca and Eli Lilly both extended such agreements with BioFocus DPI. These partnerships help biopharmaceutical companies in reducing the time to approval by approximately a month and reducing costs by about 15-20%. Therefore pharmaceutical companies will rely on the contract research organizations across the world to enhance their product pipeline strength by bringing drugs to approval faster.

Contract Research Outsourcing Market will Continue to Grow at a rate of 13%, Driven by the Demand from the Biopharmaceutical Industry
GBI Research expects the contract research outsourcing market to grow at a rate of 13% over the next seven years. The growth in the market will primarily be driven by the demand from biopharmaceutical companies. The biopharmaceutical industry is facing challenges such as declining R&D productivity, patent expiries and generic competition. These challenges have increased the pressure on industry resources, leaving companies to look for ways to increase efficient use of resources. Also, the biopharmaceutical companies are under pressure to bring products faster to market in order to maximize its profits from the product. The market will also be driven by an increase in the clinical trials outsourcing to emerging regions. Clinical trials account for the largest share of R&D expenditure in the industry. In addition, the increasing complexity of clinical trials and stringent safety requirements by regulatory bodies across the world will drive pharmaceutical industries to leverage on the expertise of the contract research organizations.

Global Contract Research Outsourcing Market Forecasts, 2006-2015


Source: GBI Research

Therefore, the increasing strategic partnerships and the need of biopharmaceutical companies to improve R&D productivity to bring products to market quickly will drive the market in the future.

The Global Contract Research Outsourcing Market is Dominated by Large Companies with Global Presence of Operations
The global market for contract research outsourcing is dominated by a few large players which have geographic presence in many countries. The top six leading players in the contract research outsourcing market account for approximately 50% of the market. All the market leaders are diversified and provide comprehensive contract research services to their clients in the biopharmaceutical industry. The large players have operations in many countries globally, which allows them to exploit the market potential of all geographies. The big contract research organizations are dominating their presence in the market by acquiring the small and medium players. The contract research outsourcing market is expected to be more consolidated in the future due to increasing M&A activities within the contract research organizations.

The Key Players in the Market Look to Strengthen Competitive Positions through M&A and Strategic Collaborations with the Industry
The M&A activities, service agreements, and strategic collaboration have increased over the last four years. The increase in these deals suggests a highly competitive and active market.
Deals Activity of Top Ten Contract Research Organizations, 2006-2009

Source: GBI Research

Majority of the deals in the contract research outsourcing market focused on establishing strategic alliances with other contract research organizations, technology providers and pharmaceutical and biotech companies. The players have entered into the strategic alliances and collaboration with other companies in order to enhance their competitive positioning. The increased number of M&A suggests a further consolidation which will increase the competition in the industry and are aimed at enhancing service portfolios and expand geographic presence. The intense competition will force medium sized players to expand services or geographic presence. The niche players focusing only on a specific function or therapeutic area will also continue to grow. Therefore, the larger diversified players or niche contract research organizations will be competitively placed in the future.
Regions such as Latin America, India and China Attract Increased Contract Research Outsourcing due to Competitive Benefits and Increased Regulatory Compliance
The US and Europe dominate the contract research outsourcing market and account for a majority of clinical research activities. However, this trend is changing with the emergence of regions such as Central and Eastern Europe, Latin America, India and China as preferred location for outsourcing. These regions provide a cost advantage, better patient enrollment and expert personnel. The emerging regions are more cost effective with comparable quality standards with the developed regions such as the US and Europe. However, the emerging countries compete amongst themselves on parameters such as experience in therapeutic areas, skill set of personnel involved in clinical trials, and government support. All the countries have aligned the clinical research regulations in line with the international standards and requirements which allows them to conduct clinical trials and research on behalf of pharmaceutical companies in developed countries. Therefore, pharma and biotech companies will increasingly outsource to emerging countries in order to benefit from the cost, time and expertise benefits and also to leverage emerging countries� compliance with international standards such as the Good Laboratory Practices (GLP) and Good Clinical Practices (GCP).

About GBI Research

GBI Research is a leading business information company providing global business information reports and services.

Our highly qualified team of Analysts, Researchers, and Solution Consultants use proprietary data sources and various tools and techniques to gather, analyze and represent the latest and the most reliable information essential for businesses to sustain a competitive edge.

Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GBI Research.

The facts of this report are believed to be correct at the time of publication but cannot be guaranteed. Please note that the findings, conclusions and recommendations that GBI Research delivers will be based on information gathered in good faith from both primary and secondary sources, whose accuracy we are not always in a position to guarantee. As such GBI Research can accept no liability whatever for actions taken based on any information that may subsequently prove to be incorrect.
1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 7

1.2 List of Figures 7

2 Contract Research Outsourcing — Introduction 9

2.1 GBI Research Report Guidance 10

3 Contract Research Outsourcing — Overview 11

3.1 Global Contract Research Outsourcing 11

3.1.1 The Clinical Research Process 12

3.2 Outsourcing of Clinical Research and Trial Processes 13

3.2.1 Clinical Research Outsourcing is Seen as a Solution to Problems Such as Rising Costs or Low Productivity 14

3.2.2 Strategic Outsourcing Delivers Greater Value by Understanding the Core Competencies of the Vendor and Outsourcing Companies 14

3.3 Key Reasons for Outsourcing to Contract Research Organizations 14

3.3.1 Desire to Reduce Costs is a Prime Reason for Contract Research Outsourcing 15

3.3.2 Contract Research Organizations are Engaged in Reducing Time to Market in Order to Achieve a Competitive Edge 15

3.3.3 Outsourcing Critical but Resource and Time Intensive Functions such as Data Management Allows Biopharmaceutical Companies to Focus on Core Competencies 16

3.3.4 Evolving Risk Sharing Agreements Attract Biopharmaceutical Companies to Increase Contract Research Outsourcing 16

3.3.5 Contract Research Organizations are Helping to Improve Clinical Research Quality Through Better Regulatory Understanding and Keeping Pace with Technological Advances 17

3.3.6 Small and Medium Biopharmaceutical Companies can Leverage on the Resources of Contract Research Organizations 17

3.3.7 Biopharmaceutical Companies Benefit from New Technologies that Contract Research Organization Have Access to 17

4 Contract Research Outsourcing — Service Models 19

4.1 Contract Research Outsourcing Service Model 19

4.1.1 Fully Integrated Service Model 19

4.1.2 Functional Service Model 20

4.2 Criteria for Selecting a Contract Research Organization 21

4.3 Early Stage Drug Development Outsourcing 22

4.3.1 Strategic or Tactical Advantages of Outsourcing 22

4.3.2 Case Study 22

4.4 Clinical Stage Drug Development Outsourcing 23

4.4.1 Strategic or Tactical Advantages of Outsourcing 23

4.4.2 Case Studies 23

4.5 Late Stage Development Outsourcing 25

4.5.1 Strategic or Tactical Advantages of Outsourcing 25

5 Contract Research Outsourcing — Market Characterization 27

5.1 The Contract Research Outsourcing Market will Continue to Grow, Driven by the Demand by the Biopharmaceutical Industry 27

5.2 Key Market Drivers 28

5.2.1 Increasing R&D Expenditure and Decreasing Productivity in the Biopharmaceutical Industry - Promoting R&D Outsourcing 28

5.2.2 Stringent Regulations and Complex Clinical Trials Forcing Biopharmaceutical Companies to Leverage on the Contract Research Organizations 31

5.2.3 Restriction on Pricing and Reimbursement of Drugs — Need for Managing Costs from Earliest Stages of Development 31

5.2.4 The Increasing Number of Clinical Trials 32

5.3 Key Market Restraints/ Challenges 33

5.3.1 Quality Concerns 33

5.3.2 Economic Recession 34

5.4 Contract Research Outsourcing — Market Trends 34

5.4.1 The Number of Services Focusing on the Late Stage Clinical Development is Increasing 35

5.4.2 The Clinical Research and Trials are Becoming more Globalized 36

5.4.3 Pharmaceutical Companies are Moving to Strategic Partnerships with Contract Research Organizations 37

5.4.4 Emerging Tools to Enhance Drug Discovery Process Will be Key Drivers in the Future 37

5.5 Contract Research Outsourcing — Unmet Needs 38

5.5.1 High Technology Needs and Integration 38

5.5.2 Lack of Therapeutic Expertise 38

5.5.3 Contract Research Organizations are Short of Experienced Research Professionals to Conduct the Clinical Trial Studies 38

6 Contract Research Outsourcing — Geographical Landscape 39

6.1 Emerging Regions in the Global Contract Research Outsourcing Market 40

6.1.1 Latin America 40

6.1.2 Central and Eastern Europe (CEE) 40

6.1.3 India 41

6.1.4 China 42

7 Contract Research Outsourcing — Regulatory Issues 44

7.1 Contract Research Organizations are Subject to the Same Regulations as Biopharmaceutical Companies 44

7.1.1 Regulation in the Drug Discovery Stage 45

7.1.2 Regulation in the Preclinical Stage 45

7.1.3 Regulation in the Clinical Trials Stage 45

7.2 Regulations Governing Outsourcing to Other Regions 46

8 Contract Research Outsourcing — Competitive Landscape 48

8.1 Overview 48

8.2 Market Share Analysis 49

8.3 Competitive Profiling 50

8.4 Quintiles Transnational Corp. 51

8.4.1 Snapshot 51

8.4.2 Business Description 51

8.4.3 Recent M&A Deals and Strategic Alliances 51

8.5 Covance Inc. 53

8.5.1 Business Description 53

8.5.2 Recent M&A Deals and Alliances 53

8.6 Pharmaceutical Product Development (PPD) Inc. 54

8.6.1 Business Description 54

8.6.2 Recent M&A Deals and Alliances 55

8.7 Charles River Laboratories International, Inc. 56

8.7.1 Business Description 56

8.7.2 Recent M&A Deals and Alliances 57

8.8 PAREXEL International 57

8.8.1 Business Description 58

8.8.2 Recent M&A Deals and Alliances 58

9 Contract Research Outsourcing — Deals Analysis 59

9.1 Mergers and Acquisitions 59

9.1.1 Quintiles Acquires Targeted Molecular Diagnostics 60

9.1.2 Quintiles Acquires Bio-Trials 60

9.1.3 PPD Acquired Magen BioSciences 60

9.1.4 Charles River Laboratories Acquired PPD, Inc.'s Subsidiary Piedmont Research Center for $46m Cash 60

9.1.5 ICON Acquires Prevalere Life Sciences Inc. 60

9.1.6 ICON Acquires DOCS International 61

9.1.7 MDS Inc Acquires Molecular Devices Corporation 61

9.1.8 Kendle Acquires International Clinical Research 61

9.1.9 PRA International Acquires Pharma Bio-Research 61

9.2 Strategic Alliances, Service Agreements and Other Deals 61

9.3 Deals by Year 62

9.4 Deals by Therapeutic Area 63

10 Contract Research Outsourcing — Appendix 65

10.1 Market Definitions 65

10.2 Abbreviations 65

10.3 Sources 66

10.4 Methodology 66

10.4.1 Coverage 67

10.4.2 Secondary Research 67

10.4.3 Primary Research 68

10.4.4 Expert Panel Validation 68

10.5 Contact Us 68

10.6 Disclaimer 68



1.1 List of Tables

Table 1: Drug Development Outsourcing Models, November 2009 19

Table 2: Contract Research Outsourcing Market, Global, Benchmarking Analysis for Top Five Contract Research Organizations, 2008, November 2009 50

Table 3: Major M&A Deals in the Contract Research Outsourcing Market Between 2006-2009 60



1.2 List of Figures

Figure 1: Contract Research Outsourcing Market, Global, Basic Services Provided,

November 2009 11

Figure 2: Clinical Research Process, November 2009 12

Figure 3: Contract Research Outsourcing — Reasons for Outsourcing, November 2009 15

Figure 4: Contract Research Outsourcing — Fully Integrated Service Model, November 2009 19

Figure 5: Contract Research Outsourcing — Functional Service Model, November 2009 20

Figure 6: Key Factors Considered for Evaluating and Selecting a Contract Research Organization, November 2009 21

Figure 7: Strategic or Tactical Advantages in Early Stage Drug Development Outsourcing, November 2009 22

Figure 8: Strategic or Tactical Advantages of Outsourcing in the Clinical Stage of the Drug Development Process, November 2009 23

Figure 9: Strategic or Tactical Advantages of Outsourcing in the Late Stage of the Drug Development Process, November 2009 25

Figure 10: Global Contract Research Outsourcing Market Forecasts, 2006-2015 27

Figure 11: Contract Research Outsourcing Market, Global, Market Share by Phase, 2008 28

Figure 12: Comparison of CAGR of R&D Expenditure vs. Turnover for the Top 5 Companies,

2003-2008 29

Figure 13: Increasing R&D Expenditure and Decline in NME Approvals by the FDA, 1996-2008 30

Figure 14: Impact of Increasing R&D Expenditure and Lower R&D Productivity in the Pharma/Biotech Industry, November 2009 30

Figure 15: Impact of Changing Regulatory Requirements in the Pharma/Biotech Industry, November 2009 31

Figure 16: Impact due to Pricing and Reimbursement of Drugs in the Pharma/Biotech Industry, November 2009 32

Figure 17: Impact of Increasing Number of Clinical Trials in the Pharma/Biotech Industry, November 2009 33

Figure 18: Impact of Quality Concerns on the Biopharmaceutical Industry, November 2009 34

Figure 19: Impact of Economic Recession on the Biopharmaceutical Industry, November 2009 34

Figure 20: Research and Development Expenditure Split by Phases, 2008 35

Figure 21: Value of Spending in Research and Development by Phases, 2008 36

Figure 22: Average Number of Patients Enrolled Per Site by Geography, 2008 37

Figure 23: Clinical Studies by Region, November 2009 39

Figure 24: Outsourcing to Latin America, November 2009 40

Figure 25: Outsourcing to Central and Eastern Europe (CEE), November 2009 41

Figure 26: Outsourcing to India, November 2009 42

Figure 27: Outsourcing to China, November 2009 43

Figure 28: Drug Development Process and Regulation, November 2009 44

Figure 29: Key Guiding Principles of Good Laboratory Practice, November 2009 45

Figure 30: Key Guiding Principles of Good Clinical Practice, November 2009 46

Figure 31: Global Contract Research Outsourcing Market, Revenue Analysis of Major Contract Research Organizations, 2006-2008 48

Figure 32: Contract Research Outsourcing Market, Global Competitive Analysis of Top 5 Players, 2006-2008 49

Figure 33: Contract Research Outsourcing Market, Market Share of Top Service Providers, 2008 49

Figure 34: Quintiles - Snapshot, November 2009 51

Figure 35: Covance - Snapshot, November 2009 53

Figure 36: PPD - Snapshot, November 2009 54

Figure 37: Charles River Laboratories - Snapshot, November 2009 56

Figure 38: PAREXEL International - Snapshot, November 2009 57

Figure 39: Deals Activity of Top Ten Contract Research Organizations, 2006-2009 59

Figure 40: Global Contract Research Outsourcing Market, Major Deals by Phase, 2006-2009 62

Figure 41: Global Contract Research Outsourcing Market, Major Deals by Year, 2006-2009 63

Figure 42: Global Contract Research Outsourcing Market, Major Deals by Therapeutic Area,

2006-2009 64

Figure 43: GBI Research Methodology 66

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