Outsourcing in Drug Development: The Contract CRO Market, 3rd Edition

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Published Oct 1, 2008 | 250 Pages | Pub ID: KLI1646604

Driven by mounting market pressures, 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 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. Part of the CMO Market Series, this volume joins Outsourcing in Drug Discovery, published earlier this year.

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
  • Markets and Forecasts for Outsourcing In Drug Development (broken down by AMC, CMO and other)
  • Main Drivers for Outsourcing in Drug Development
  • Discussion of Industry and Regulatory Trends
  • CMO Market Share
  • Detailed Profiles of CMOs, Contract Laboratories, Clinical Trial Labs and EDC Solution Companies

As part of Kalorama Information's research process, information for this report is gathered from sources including trade press, company reports and government databases. Kalorama Information's analyst also interviewed dozens of experts in the industry to discover new trends and confirm assumptions.

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      •   Number of Active Clinical Drug Development Programs (May 11, 2007)
      •   Total Average Number of Active Clinical Drug Development Programs, 2001-2007
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      •   Contract Research Market, 2002-2012

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      •   Investigational New Drug Submissions, 1992-2006

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      •   Number of Clinical Trials Initiated Annually for U.S. Submissions

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      •   Median Total Approval Time for Standard NDAs, 1993-2006
      •   Median Total Approval Time for Priority NDAs, 1993-2004

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      •   Median Total Approval Time for Standard NMEs, 1995-2004
      •   Median Total Approval time for Priority NMEs, 1995-2004
      •   U.S. NMEs 2006 Approvals: Review Times by Drug
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      •   Key Clinical Trial Enrollment Statistics for NMEs Approved in 2000-2006
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      •   Number of Active Clinical Drug Development Programs (May 11, 2007)
      •   Total Average Number of Active Clinical Drug Development Programs, 2001-2007
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      •   Summary Of Postmarketing Study Commitments (Numbers as of September 30, 2007)
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      •   Benefits and Risks of Participating in Clinical Trials
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      •   Guidance for Using Computerized Systems in Clinical investigations: Differences Between the Draft and the Final Guidance
      •   Guidance for Using Computerized Systems in Clinical investigations: Key Requirements
      •   Guidance for Using Computerized Systems in Clinical investigations: Recommendations for Implementation
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      •   New Paradigm for R&D
      •   Improvements in the Drug Development Process Reduce Development Costs
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      •   Percentage of Industry-Sponsored Clinical Trials Awarded to Academic Medical Centers Versus Private Sector Companies: 1991, 1996,2001 and 2006
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    •   Global Drug Development Spending, 2002-2012
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      •   R&D Expenditures of Leading Pharmaceutical Developers, 2006 vs. 2005
      •   Number of Companies with Active Product Development Projects, 1997-2006

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      •   Total Average Number of Active Phase I-III Clinical Trials Worldwide, 2001-2007
      •   Top Ten Therapeutic Categories in R&D Worldwide, March 2007

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      •   Clinical Trials Phase IIIb/IV Market 2004-2008 (in U.S. billions)

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      •   Global R&D Spending and Portion Outsourced to Contract Research, 2002-2012 (in US Billions)
      •   Contract Drug Development Market, 2002-2012 (Outsourced to CROs, Others)

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      •   Contract Research Market (CRO, AMC, Other) Revenue by Competitor, 2002-2012

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      •   CRO Market Share, 2007

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      •   Selected Acquisitions of Leading CROs, 2006 to present
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