Outsourcing in Drug Development: The Contract Research (Clinical Trial ) Market
The cost and time of developing and bringing a drug to market is over $1.3 billion and often takes as long as 15 years, if not longer. Because of this, major pharmaceutical marketers continue to outsource stages of development, and over the years Kalorama Information has observed this process. In past editions of our outsourcing market studies, we found that outsourcing moved from "should" to "must." for manufacturers. This trend has only continued in the past two years.
Contract Research Organizations (CROs) and other entities can expect growing demand for their services. The demand for new drugs remains unabated, but the cost and need to bring those drugs to market is ever-increasing and intensifying. A key cost driver is the large number of failures during the expensive clinical trial phases. Driven by pressures to reduce costs, companies are increasingly implementing outsourcing strategies to increase revenues through faster drug development. By decreasing their in-house facilities and staff, and outsourcing more of their R&D functions, pharmaceutical and biotechnology companies are reshaping the drug development services industry.
Kalorama Information's Outsourcing in Drug Development: The Contract Research (Clinical Trial) Market is the third edition of this study of the drivers for outsourcing drug development, the companies involved in this market and the opportunity for revenues.
As part of its comprehensive coverage of this market, this report contains:
Contract Research Organizations (CROs) and other entities can expect growing demand for their services. The demand for new drugs remains unabated, but the cost and need to bring those drugs to market is ever-increasing and intensifying. A key cost driver is the large number of failures during the expensive clinical trial phases. Driven by pressures to reduce costs, companies are increasingly implementing outsourcing strategies to increase revenues through faster drug development. By decreasing their in-house facilities and staff, and outsourcing more of their R&D functions, pharmaceutical and biotechnology companies are reshaping the drug development services industry.
Kalorama Information's Outsourcing in Drug Development: The Contract Research (Clinical Trial) Market is the third edition of this study of the drivers for outsourcing drug development, the companies involved in this market and the opportunity for revenues.
As part of its comprehensive coverage of this market, this report contains:
- A Detailed Introduction to the Clinical Trial Process
- Statistics of Drugs in Development by Phase
- Market Size and Forecasts for Outsourcing In Drug Development by Academic Medical Center (AMC), Contract Research Organizations and Others.
- Main Drivers for Outsourcing in Drug Development
- How CROs are Meeting the Challenge of Patient Recruitment
- Discussion of Industry and Regulatory TrendsProtocols Funded in FY2009 by Percent and Gender
- Global R&D Expenditures Outsourced by Percent 2003-2010
- Selected Pharmaceutical Company Acquisitions, 2009-2011
- Top Ten Therapeutic Categories in R&D
- Selected Acquisitions of Leading CROs
- Increasing role of EDCs
- Globalization Trends in Drug Development and Breakout of Clinical Trials by Region
- Directory of Companies
- Market Share of Major CROs 2011
- Profiles of CROs, Contract Laboratories, Clinical Trial Labs and EDC Solution Companies
CHAPTER ONE: EXECUTIVE SUMMARY
The Drug Development Process
Government Regulation of Clinical Research
Active Phase I, II & III Clinical Trials
Phase IV Studies: Post Approval
Recruiting for Clinical Trials
The Complexity and Costs Of Clinical Trials Are Increasing
Clinical Trials Worldwide
The Contract Drug Development Industry
R&D Outsourced to Contract Drug Development
Contract Drug Development Market
Trends Affecting Growth of Contract Drug Development Industry
Globalization of Drug Development
Rapid Technological Change Increasing Data
Biotechnology Industry Growth
Increased Regulatory Scrutiny
Need for Fast, Efficient, and Cost-Effective Drug Development
Drug Development Process
CHAPTER TWO: INTRODUCTION
Government Regulation of Clinical Research
Center for Biological Evaluation and Review
Center for Drug Evaluation and Research
Investigational Review Board
Preclinical Research
In Vitro and In Vivo Testing Process
Investigational New Drug Application
Clinical Trials
Preclinical Phase
Phase I
Phase IIa
Phase IIb
Phase III
Phase III
Phase IIIa
Phase IIIb
Phase IV: Post Approval
New Drug Applications
New Molecular Entities and Approval Times
Accelerated Approval
Has FDA’s PDUFA ACT Weakened Safety Standards?
Government Initiatives to Improve Research and the Review Process
FDA’s Critical Path Report
Exploratory IND Studies—An Approach to Complying with CGMP
INDs—Approaches to Complying with CGMP During Phase 1
Biotechnology Industry Endorses FDA’s Critical Path
Globalization Trends in Drug Development
Clinical Trials Worldwide
China is Ranked First
India's Growing Market
Russia Dominates Eastern Europe
CHAPTER THREE: CLINICAL TRIAL OPERATIONS
Conducting Clinical Trails
Government Sponsored Clinical Trials
Organizations Contracted to Conduct Clinical Trials
Contract Research Organizations (CROs)
Managed Site Networks
Major Elements of Clinical Trials
Protocol
Eligibility Criteria
Endpoints
Randomization
Stratification
Blinding
Data Collection and Management Tools
Statistical Interpretation
Data Collection and Management Tools
Statistical Interpretation
Phase IV Studies
Post Approval Studies
Sentinel Initiative
Recruiting for clinical Trials
Clinical Trials Recruitment Promotion
Internet-Enabled Recruitment
Recruiting Principal Investigators
Physician as Principal Investigator
Recruiting Patients
Use of Homecare Services
Patient Recruitment Outside the U.S.
Delays in Patient Recruiting Increases Project Costs
Factors Influencing Participation in Clinical Trials
Increasing Complexity of Clinical Trials
Informed Consent Process
Demographics and Clinical Trials
Ethnicity and Gender in Clinical Trials
Electronic Data Management
Traditional Paper-based Case Report Forms
Advantages of EDC
Current Assessment of EDC Adoption
Need for an EDC Standard
FDA Releases Guidance for Using Computerized Systems for Clinical investigations
Electronic Patient Diaries
CHAPTER FOUR: TRENDS
Drug Development Costs
Outsourcing Drug Development
A Brief History of Contract Research Outsourcing
Focus Shifts in Outsourced Clinical Research Operations from Phase II-III to Phase I to IIIb/IV
Major Factors Driving Contract Research Outsourcing Strategy
Outsourcing as a Cost Reduction Strategy
Number of New Chemical Entities (NCEs) in Pipeline Increasing
Growing Complexity of Regulatory Requirements
Outsourcing to Gain Rapid Access to Patient Recruiting
Contract Research Competitors
Academic Medical Centers (AMCs)
Competing Factors
Contract Research Organizations (CROs)
CRO Contracts
Competing Factors
Managed Site Networks
Competing Factors
Clinical Trial Laboratories
Competing Factors
Clinical Trials as a Business Opportunity
Community Physicians
Electronic Technology Solutions
Internet Patient/Investigator Recruiting
Clinical Trials Packaging
Effective Packaging Promotes Patient Compliance
CHAPTER FIVE: MARKETS
R&D Spending Increasing
Leading Pharmaceutical Developers
Clinical Research Products in Development
Shift in Spending for Clinical Research
Spending for Phase I Trials Slows from Highs in 2004
Safety Issues Drive Phase IIIb/IV Trial Spending
Contract Drug Research Market
Contract Research Competitors
CROs Market Share
CROs Broaden Services through Acquisitions
CROs Expanding Laboratory Services
AMC Market Share
AMCs Reassess Role in Industry-funded Clinical Research
Academic Clinical Reseach Organizations Expanding
Niche Competitors’ Market Share
Clinical Trial Laboratory Services
EDC Services Gaining Market Share
Managed Site Networks
Trends Affecting Growth in Contract Drug Development Industry
Globalization of Drug Development
Rapid Technological Change Increasing Data
Biotechnology Industry Growth
Increased Regulatory Scrutiny
Need for Fast, Efficient, and Cost-Effective Drug Development
CHAPTER SIX: COMPANY PROFILES
Charles River Laboratories International, Inc.
Covance, Inc.
Encorium Group, Inc.
Icon, Plc
Kendle International, Inc.
MDS Pharma Services
Omnicare Clinical Research
Paraxel International Corporation
Pharmanet Development Inc.
Pharmaceutical Product Development, Inc.
PRA Internation, Inc.
Radiant Development
Bioanalytical Research Corporation
Calvert Laboratories, Inc.
CRL Medinet, Inc.
Kronos Science Laboratories, Inc.
Lab Corp
Medtox Scientific Inc.
Pacific Biometric, Inc.
PRL Central Laboratory Services
Quest Diagnostics, inc.
TGA Sciences, Inc.
CNS Clinical Trials
DaVita Clinical Research
SMO-USA, Inc.
Synarc, Inc.
Advanced Clinical Software
eTrials Worldwide, Inc.
Interactive Clinical Technologies, Inc.
Medidata Solutions Worldwide
Perceptive Informatiocs
Pharsight Corporation
APPENDIX: COMPANY DIRECTORY
The Drug Development Process
Government Regulation of Clinical Research
Active Phase I, II & III Clinical Trials
Phase IV Studies: Post Approval
Recruiting for Clinical Trials
The Complexity and Costs Of Clinical Trials Are Increasing
Clinical Trials Worldwide
The Contract Drug Development Industry
R&D Outsourced to Contract Drug Development
Contract Drug Development Market
Trends Affecting Growth of Contract Drug Development Industry
Globalization of Drug Development
Rapid Technological Change Increasing Data
Biotechnology Industry Growth
Increased Regulatory Scrutiny
Need for Fast, Efficient, and Cost-Effective Drug Development
Drug Development Process
CHAPTER TWO: INTRODUCTION
Government Regulation of Clinical Research
Center for Biological Evaluation and Review
Center for Drug Evaluation and Research
Investigational Review Board
Preclinical Research
In Vitro and In Vivo Testing Process
Investigational New Drug Application
Clinical Trials
Preclinical Phase
Phase I
Phase IIa
Phase IIb
Phase III
Phase III
Phase IIIa
Phase IIIb
Phase IV: Post Approval
New Drug Applications
New Molecular Entities and Approval Times
Accelerated Approval
Has FDA’s PDUFA ACT Weakened Safety Standards?
Government Initiatives to Improve Research and the Review Process
FDA’s Critical Path Report
Exploratory IND Studies—An Approach to Complying with CGMP
INDs—Approaches to Complying with CGMP During Phase 1
Biotechnology Industry Endorses FDA’s Critical Path
Globalization Trends in Drug Development
Clinical Trials Worldwide
China is Ranked First
India's Growing Market
Russia Dominates Eastern Europe
CHAPTER THREE: CLINICAL TRIAL OPERATIONS
Conducting Clinical Trails
Government Sponsored Clinical Trials
Organizations Contracted to Conduct Clinical Trials
Contract Research Organizations (CROs)
Managed Site Networks
Major Elements of Clinical Trials
Protocol
Eligibility Criteria
Endpoints
Randomization
Stratification
Blinding
Data Collection and Management Tools
Statistical Interpretation
Data Collection and Management Tools
Statistical Interpretation
Phase IV Studies
Post Approval Studies
Sentinel Initiative
Recruiting for clinical Trials
Clinical Trials Recruitment Promotion
Internet-Enabled Recruitment
Recruiting Principal Investigators
Physician as Principal Investigator
Recruiting Patients
Use of Homecare Services
Patient Recruitment Outside the U.S.
Delays in Patient Recruiting Increases Project Costs
Factors Influencing Participation in Clinical Trials
Increasing Complexity of Clinical Trials
Informed Consent Process
Demographics and Clinical Trials
Ethnicity and Gender in Clinical Trials
Electronic Data Management
Traditional Paper-based Case Report Forms
Advantages of EDC
Current Assessment of EDC Adoption
Need for an EDC Standard
FDA Releases Guidance for Using Computerized Systems for Clinical investigations
Electronic Patient Diaries
CHAPTER FOUR: TRENDS
Drug Development Costs
Outsourcing Drug Development
A Brief History of Contract Research Outsourcing
Focus Shifts in Outsourced Clinical Research Operations from Phase II-III to Phase I to IIIb/IV
Major Factors Driving Contract Research Outsourcing Strategy
Outsourcing as a Cost Reduction Strategy
Number of New Chemical Entities (NCEs) in Pipeline Increasing
Growing Complexity of Regulatory Requirements
Outsourcing to Gain Rapid Access to Patient Recruiting
Contract Research Competitors
Academic Medical Centers (AMCs)
Competing Factors
Contract Research Organizations (CROs)
CRO Contracts
Competing Factors
Managed Site Networks
Competing Factors
Clinical Trial Laboratories
Competing Factors
Clinical Trials as a Business Opportunity
Community Physicians
Electronic Technology Solutions
Internet Patient/Investigator Recruiting
Clinical Trials Packaging
Effective Packaging Promotes Patient Compliance
CHAPTER FIVE: MARKETS
R&D Spending Increasing
Leading Pharmaceutical Developers
Clinical Research Products in Development
Shift in Spending for Clinical Research
Spending for Phase I Trials Slows from Highs in 2004
Safety Issues Drive Phase IIIb/IV Trial Spending
Contract Drug Research Market
Contract Research Competitors
CROs Market Share
CROs Broaden Services through Acquisitions
CROs Expanding Laboratory Services
AMC Market Share
AMCs Reassess Role in Industry-funded Clinical Research
Academic Clinical Reseach Organizations Expanding
Niche Competitors’ Market Share
Clinical Trial Laboratory Services
EDC Services Gaining Market Share
Managed Site Networks
Trends Affecting Growth in Contract Drug Development Industry
Globalization of Drug Development
Rapid Technological Change Increasing Data
Biotechnology Industry Growth
Increased Regulatory Scrutiny
Need for Fast, Efficient, and Cost-Effective Drug Development
CHAPTER SIX: COMPANY PROFILES
Charles River Laboratories International, Inc.
Covance, Inc.
Encorium Group, Inc.
Icon, Plc
Kendle International, Inc.
MDS Pharma Services
Omnicare Clinical Research
Paraxel International Corporation
Pharmanet Development Inc.
Pharmaceutical Product Development, Inc.
PRA Internation, Inc.
Radiant Development
Bioanalytical Research Corporation
Calvert Laboratories, Inc.
CRL Medinet, Inc.
Kronos Science Laboratories, Inc.
Lab Corp
Medtox Scientific Inc.
Pacific Biometric, Inc.
PRL Central Laboratory Services
Quest Diagnostics, inc.
TGA Sciences, Inc.
CNS Clinical Trials
DaVita Clinical Research
SMO-USA, Inc.
Synarc, Inc.
Advanced Clinical Software
eTrials Worldwide, Inc.
Interactive Clinical Technologies, Inc.
Medidata Solutions Worldwide
Perceptive Informatiocs
Pharsight Corporation
APPENDIX: COMPANY DIRECTORY
TABLE OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
Exhibit 1-1: The U.S. Drug Discovery, Development, and Approval Process
Exhibit 1-2: Number of Active Clinical Drug Development Programs (May 11, 2007)
Exhibit 1-3: Total Average Number of Active Clinical Drug Development Programs, 2001-2007
Exhibit 1-4: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006
Exhibit 1-5: Worldwide Clinical Trial Sites, by Region and Percent, (as of 7/12/2008)
Exhibit 1-6: Portion of Global R&D Expenditures Outsourced: 2003-2008 by percent
Exhibit 1-7: Contract Drug Development Market Share, Percent by Competitor Type (AMC, CRO’s Others), 2007
Exhibit 1-8: Contract Research Market, 2002-2012
CHAPTER TWO: INTRODUCTION
Exhibit 2-1: Investigational New Drug Submissions, 1992-2006
Exhibit 2-2: Investigational New Drug Submissions, 1986-2008
Exhibit 2-3: Number of Clinical Trials Initiated Annually for U.S. Submissions
Exhibit 2-4: Median Total Approval Time for Standard NDAs,1993-2006
Exhibit 2-5: Median Total Approval Time for Priority NDAs,1993-2004
Exhibit 2-6: Median Total Approval Time for Standard NMEs, 1995-2004
Exhibit 2-7: Median Total Approval time for Priority NMEs, 1995-2004
Exhibit 2-8: U.S. NMEs 2006 Approvals: Review Times by Drug
Exhibit 2-10: Median Approval times for Safety vs All Drugs, By Decade
Exhibit 2-11: Number and Location of Clinical Trial Sites Worldwide, as of 7/12/2008
Exhibit 2-12: Worldwide Clinical Trial Sites, by Region and Percent, as of 7/12/2008
CHAPTER THREE:CLINICAL TRIAL OPERATIONS
Exhibit 3-1: Key Clinical Trial Enrollment Statistics for: NMEs Approved in 2000-2006
Exhibit 3-2: Number of Active Clinical Drug Development Programs (May 11, 2007)
Exhibit 3-3: Total Average Number of Active Clinical Drug Development Programs, 2001-2007
Exhibit 3-4: Summary Of Postmarketing Study Commitments (Numbers as of September 30, 2007)
Exhibit 3-5: Benefits and Risks of Participating in Clinical Trials
Exhibit 3-6: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006
Exhibit 3-7: Aggregate Enrollment Data for All Extramural and Intramural Research Protocols Funded in FY2005 and Reported in FY2006, by Percent and Gender
CHAPTER FOUR: TRENDS
Exhibit 4-1: New Paradigm for R&D
Exhibit 4-2: Improvements in the Drug Development Process Reduce Development Costs
Exhibit 4-3: Portion of Global R&D Expenditures Outsourced: 2003-2008 by percent
Exhibit 4-4: Percentage of Industry-Sponsored Clinical Trials Awarded to Academic Medical Centers Versus Private Sector Companies: 1991, 1996,2001 and 2006
CHAPTER FIVE: MARKETS
Exhibit 5-1: Global Drug Development Spending, 2002-2012
Exhibit 5-2: Global Drug Development Spending, 2002-2012
Exhibit 5-3: R&D Expenditures of Leading Pharmaceutical Developers, 2006 vs. 2005
Exhibit 5-4: Number of Companies with Active Product Development Projects, 1997-2006
Exhibit 5-5: Total Average Number of Active Phase I-III Clinical Trials Worldwide, 2001-2007
Exhibit 5-6: Top Ten Therapeutic Categories in R&D Worldwide, March 2007
Exhibit 5-7: A Comparison of Spending Rates in Phase I and Phase II/III Trials, 2004-2008
Exhibit 5-8: Clinical Trials Phase IIIb/IV Market 2004-2008 (in U.S. billions)
Exhibit 5-9: Global R&D Spending and Portion Outsourced to Contract Research, 2002-2012 (in US Billions)
Exhibit 5-10: Contract Drug Development Market, 2002-2012 (Outsourced to CROs, Others)
Exhibit 5-11 Contract Drug Development Market Share, Percent by Competitor Type (AMCs, CROs, Others), 2007
Exhibit 5-12: Contract Research Market (CRO, AMC, Other)
Exhibit 5-13: CRO Market Share, 2007
Exhibit 5-14: Selected Acquisitions of Leading CROs, 2006 to present
Exhibit 5-15: Market Share of Niche Participants in Contract Drug Development, 2007 (MSN, EDC, nonCRO Labs)
CHAPTER ONE: EXECUTIVE SUMMARY
Exhibit 1-1: The U.S. Drug Discovery, Development, and Approval Process
Exhibit 1-2: Number of Active Clinical Drug Development Programs (May 11, 2007)
Exhibit 1-3: Total Average Number of Active Clinical Drug Development Programs, 2001-2007
Exhibit 1-4: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006
Exhibit 1-5: Worldwide Clinical Trial Sites, by Region and Percent, (as of 7/12/2008)
Exhibit 1-6: Portion of Global R&D Expenditures Outsourced: 2003-2008 by percent
Exhibit 1-7: Contract Drug Development Market Share, Percent by Competitor Type (AMC, CRO’s Others), 2007
Exhibit 1-8: Contract Research Market, 2002-2012
CHAPTER TWO: INTRODUCTION
Exhibit 2-1: Investigational New Drug Submissions, 1992-2006
Exhibit 2-2: Investigational New Drug Submissions, 1986-2008
Exhibit 2-3: Number of Clinical Trials Initiated Annually for U.S. Submissions
Exhibit 2-4: Median Total Approval Time for Standard NDAs,1993-2006
Exhibit 2-5: Median Total Approval Time for Priority NDAs,1993-2004
Exhibit 2-6: Median Total Approval Time for Standard NMEs, 1995-2004
Exhibit 2-7: Median Total Approval time for Priority NMEs, 1995-2004
Exhibit 2-8: U.S. NMEs 2006 Approvals: Review Times by Drug
Exhibit 2-10: Median Approval times for Safety vs All Drugs, By Decade
Exhibit 2-11: Number and Location of Clinical Trial Sites Worldwide, as of 7/12/2008
Exhibit 2-12: Worldwide Clinical Trial Sites, by Region and Percent, as of 7/12/2008
CHAPTER THREE:CLINICAL TRIAL OPERATIONS
Exhibit 3-1: Key Clinical Trial Enrollment Statistics for: NMEs Approved in 2000-2006
Exhibit 3-2: Number of Active Clinical Drug Development Programs (May 11, 2007)
Exhibit 3-3: Total Average Number of Active Clinical Drug Development Programs, 2001-2007
Exhibit 3-4: Summary Of Postmarketing Study Commitments (Numbers as of September 30, 2007)
Exhibit 3-5: Benefits and Risks of Participating in Clinical Trials
Exhibit 3-6: Change in Protocol Eligibility Criteria, Comparison of 1999-2000 and 2003-2006
Exhibit 3-7: Aggregate Enrollment Data for All Extramural and Intramural Research Protocols Funded in FY2005 and Reported in FY2006, by Percent and Gender
CHAPTER FOUR: TRENDS
Exhibit 4-1: New Paradigm for R&D
Exhibit 4-2: Improvements in the Drug Development Process Reduce Development Costs
Exhibit 4-3: Portion of Global R&D Expenditures Outsourced: 2003-2008 by percent
Exhibit 4-4: Percentage of Industry-Sponsored Clinical Trials Awarded to Academic Medical Centers Versus Private Sector Companies: 1991, 1996,2001 and 2006
CHAPTER FIVE: MARKETS
Exhibit 5-1: Global Drug Development Spending, 2002-2012
Exhibit 5-2: Global Drug Development Spending, 2002-2012
Exhibit 5-3: R&D Expenditures of Leading Pharmaceutical Developers, 2006 vs. 2005
Exhibit 5-4: Number of Companies with Active Product Development Projects, 1997-2006
Exhibit 5-5: Total Average Number of Active Phase I-III Clinical Trials Worldwide, 2001-2007
Exhibit 5-6: Top Ten Therapeutic Categories in R&D Worldwide, March 2007
Exhibit 5-7: A Comparison of Spending Rates in Phase I and Phase II/III Trials, 2004-2008
Exhibit 5-8: Clinical Trials Phase IIIb/IV Market 2004-2008 (in U.S. billions)
Exhibit 5-9: Global R&D Spending and Portion Outsourced to Contract Research, 2002-2012 (in US Billions)
Exhibit 5-10: Contract Drug Development Market, 2002-2012 (Outsourced to CROs, Others)
Exhibit 5-11 Contract Drug Development Market Share, Percent by Competitor Type (AMCs, CROs, Others), 2007
Exhibit 5-12: Contract Research Market (CRO, AMC, Other)
Exhibit 5-13: CRO Market Share, 2007
Exhibit 5-14: Selected Acquisitions of Leading CROs, 2006 to present
Exhibit 5-15: Market Share of Niche Participants in Contract Drug Development, 2007 (MSN, EDC, nonCRO Labs)
