U.S. Contract Research Outsourcing Market: Trends, Challenges and Competition in the New Decade. N8B7-52 December 2010

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1 U.S. Contract Research Outsourcing Market: Trends, Challenges and Competition in the New Decade December 2010

2 Table of Contents Notes on Methodology 8 Market Introduction and Segmentation Introduction and Scope 10 Market Segmentation 11 Market Introduction 12 Types of Outsourcing Relationships 14 CRO Capabilities 15 Contract Services Hybrid Business Models 16 Market Drivers and Restraints Market Engineering Measurements 17 Market: Drivers and Restraints 19 Key Market Drivers and Restraints 20 Market Drivers 21 Market Restraints 23 Market Analysis and Forecasts Market Segments Life-Cycle Stage 26 Forecasting Assumptions 27 Revenue Forecasts 28 4

3 Table of Contents (Contd ) Growth Forecasts by Segment 29 Growth Forecasts by Therapeutic Area 30 Market Growth Segmentation 31 Factors Affecting Market Growth 32 Revenue Forecasts by Segment Preclinical Revenue Forecasts 34 Phase I Revenue Forecasts 35 Phase II Revenue Forecasts 36 Phase III Revenue Forecasts 37 Other Revenue Forecasts 38 Competitive Analysis Competitive Threats by Tier 40 Competitive Structure 41 Company Market Share Analysis 42 Conclusions Conclusions 44 Decision Support Database Biotech Companies 46 Pharmaceutical R&D Expenditure 48 Private Healthcare Expenditure 50 Total Healthcare Expenditure 52 Total Population 54 About Frost & Sullivan About Frost & Sullivan 56 5

4 List of Figures CRO Market: Revenue Forecasts (U.S.), CRO Market: Preclinical Revenue Forecasts (U.S.), CRO Market: Phase I Revenue Forecasts (U.S.), CRO Market: Phase II Revenue Forecasts (U.S.), CRO Market: Phase III Revenue Forecasts (U.S.), CRO Market: Other Revenue Forecasts (U.S.), CRO Market: Competitive Threats by Tier (U.S.), CRO Market: Competitive Structure (U.S.), CRO Market: Company Market Share by Revenues (U.S.), Decision Support Database: Biotech Companies (World), Decision Support Database: Pharmaceutical R&D Expenditure in Million USD (World), Decision Support Database: Private Healthcare Expenditure in Billion USD (World), Decision Support Database: Total Healthcare Expenditure in Billion USD (World), Decision Support Database: Total Population in Million (World),

5 List of Charts CRO Market: Market Segmentation (U.S.), CRO Market: Types of Outsourcing Relationships (U.S.), CRO Market: CRO Capabilities (U.S.), CRO Market: Contract Services Hybrid Business Models (U.S.), CRO Market: Market Engineering Measurements (U.S.), CRO Market: Market Drivers and Restraints (U.S.), CRO Market: Key Market Drivers and Restraints (U.S.), CRO Market: Market Segments Life Cycle Stage (U.S.), CRO Market: Revenue Forecasts (U.S.), CRO Market: Growth Forecasts by Segment (U.S.), CRO Market: Growth Forecasts by Therapeutic Area (U.S.), CRO Market: Market Growth Segmentation (U.S.), CRO Market: Factors Affecting Market Growth (U.S.), CRO Market: Preclinical Revenue Forecasts (U.S.), CRO Market: Phase I Revenue Forecasts (U.S.), CRO Market: Phase II Revenue Forecasts (U.S.), CRO Market: Phase III Revenue Forecasts (U.S.), CRO Market: Other Revenue Forecasts (U.S.), CRO Market: Company Market Share by Revenues (U.S.),

6 Notes on Methodology Market Size and Forecast Main sources of data: secondary data and interviews with contract research organizations (CROs), pharmaceutical and biotechnology companies, and industry groups. Each one of these sources has the following limitations: Details for revenues are not reported by all CROs Secondary data do not cover all distribution channels Sponsor interviews can yield either faulty or no information All sources were employed to try to limit the bias. The estimates used as the basis for extrapolation were derived by Frost & Sullivan. Base Year Market Assumptions The compound annual growth rate (CAGR) has been determined based on information obtained during primary and secondary research. Base year revenues are determined and cross verified from public filings and interviews with market participants. Market size is estimated and cross verified through extensive research of the market. Restraints in Forecasting It is impossible to take into account in our forecasting the unexpected shifts in demand that result from unforeseen price changes, regulatory changes, sudden changes in sponsor and CRO characteristics, or any other event that are not known during the period of market research. Only aggregate calculations and estimates have been utilized in this study; therefore, the data should not be considered to be representative, or an actual facility of a group of facilities. 8

7 Market Introduction and Segments 9

8 Introduction and Scope For the purpose of this research service, the U.S. contract research outsourcing (CRO) market comprises the clinical services provided by contract research organizations for pharmaceutical and biotechnology sponsors within the United States in the following areas: Pre-clinical Phase I Phase II Phase III Others including candidates in NDA, BLA, Phase IV, unclear status For the purpose of this research service, the U.S. CRO market include revenues derived from the preclinical and clinical services offered by CROs to pharmaceutical and biotechnology sponsors in conducting clinical trials. The markets are approached from a service provider's perspective. Revenues for the base year and historical period have been determined by evaluating the CRO market's expenditure globally. Once the total value is validated, it is then segmented based on the geographical region and service types. Assumptions are made to adjust for any differences in financial reporting structures. 10

9 Market Segmentation CRO Market: Market Segmentation (U.S.), 2010 U.S. CRO Market Therapeutic Areas Segments Oncology Preclinical Infectious Diseases Phase I Central Nervous System Phase II Cardiovascular Phase III Metabolic Disorders Others Respiratory Others Note: Other therapeutic areas include ophthalmology, specialty disorders, orphan diseases, neurology and others. Source: Frost & Sullivan 11

10 Market Introduction Contract research organizations (CROs) provide independent development services for pharmaceutical, and biotechnology markets. Services offered by CROs have evolved from providing basic support services initially to providing a wide range of clinical, central lab and analytical services that presently suit the demand of the market and the sponsors. The United States continues to remain the world's largest market for drugs and accounts for nearly xx.x percent of research and development (R&D) spending in the pharmaceutical and biotechnology markets. Hence, CROs continue to have a strong presence in this market and have invested in new facilities and technologies to cater to a wide range of sponsors. CROs have also expanded globally to a large extent and account for over two-thirds of all Phase I-III trials globally. The rising cost of drug development and stringent regulatory guidelines have been major drivers for outsourcing of drug development by pharmaceutical and biotechnology companies. While the cost of a new drug on average was $xxx.x million from conception stage to Food & Drug Administration (FDA) approval in 1975, the average development cost had risen to approximately $xxx.x million by 2000 and is expected to reach over $x,xxx.x million by end Clinical trials have become significantly more expensive than pre-clinical testing largely due to the high cost of recruiting patients with chronic and degenerative diseases and the risk of failure of drug in providing desired efficacy and safety. 12

11 Market Introduction (Contd ) This study pertains to the United States market. The study period is 2007 to 2017 and the base year is The forecast period is 2011 to In 2010, revenues for the U.S. CRO market were $xx,xxx.x million, an increase of x.x percent over the previous year, growing at a CAGR of x.x percent from 2010 to Revenues are expected to reach $xx,xxx.x million in For the purposes of this research service, CRO services include those provided by independent CROs as well as CROs that operate as outsourcing businesses of pharmaceutical and biotechnology companies. Revenues generated by CROs outside the U.S. are not included in the revenue forecasts. For publicly traded CROs, revenue estimates have been based on financial filings and primary interviews. For privately owned CROs, revenue forecasts have been modeled based on an internal financial model. CRO services provided to medical device companies have not been included within the scope of this research service. 13

12 Types of Outsourcing Relationships CRO Market: Types of Outsourcing Relationships (U.S.), 2010 Vendor One-Off, commoditized, tactical Timing vs. Cost trade-off Preferred Provider Two-way relationship, quasi-strategic Better than average timelines and prices Partner Work toward common goal and benefits Long-term, vested interest in success; asset transfer to provider Source: Frost & Sullivan 14

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