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Outsourcing

Pharmaceutical Outsourcing Strategies

Market expansion, offshoring and strategic management in the CRO and CMO marketplace

Publication Date   April 2006
Publisher   Business Insights
Product Type   Strategic Report
Pages   160
ISBN Number   not applicable
Product Code   RBI070
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Price £1,495.00

approximately: $3,000 | €1,877

Summary


Over the last decade outsourcing has become an important strategic issue for pharmaceutical companies; rising pressure to reduce costs and time-to-market has led to outsourcing not only of traditional non-core functions such as manufacturing and clinical trials, but also increasingly of technically demanding areas such as drug discovery and biotech R&D. Pharmaceutical Outsourcing Strategies is a new report which provides a comprehensive and up to date review of contract research and manufacturing, in addition to key strategies for pharmaceutical companies to optimize their relationships with contractors. Emerging trends are evaluated and offshore outsourcing opportunities are analyzed in the rapidly growing markets of Eastern Europe, China and India. Use this report 's best practice case studies and unique examination of future outsourcing trends -including cutting edge technologies and novel contract alliances to ensure that you implement the optimal strategies for your company 's needs.

Content


  • Executive Summary
    • The Pharmaceutical Outsourcing Market
    • Drivers Of Pharmaceutical Outsourcing
    • Emerging Fields Of Outsourcing
    • Offshore Outsourcing
    • Optimizing The Outsourcing Process
    • The Future Of Pharmaceutical Outsourcing
  • Chapter 1 The Pharmaceutical Outsourcing
    • Market
    • Summary
    • The Concept Of Outsourcing
    • Approaches To Outsourcing
    • Outsourcing Research And Development
    • Services Offered By Cros
    • The Role Of Cros In Clinical Trials
    • The Role Of Cros In Pre-Clinical Trials
    • Outsourcing Manufacturing
    • Services Offered By Cmos
    • Sizing The Cro And Cmo Markets
    • Overview Of The Cro Market
    • Sizing The Cro Market
    • Overview Of The Cmo Market
    • Sizing The Cmo Market
    • Conclusion
  • Chapter 2 Drivers Of Pharmaceutical
    • Outsourcing
    • Summary
    • Introduction
    • Outsourcing Research And Development
    • Drivers Of Outsourcing Research And Development
    • Increased Complexity Of Clinical Trials And Regulatory Submissions
    • Rising Data Requirements
    • Cost Savings
    • Minimizing Time To Market
    • Advantages And Disadvantages Of Using Cros
    • Long Term Cost Savings Vs. High Short Term Expenses
    • Personnel Customization Vs. Cro High Staff Turnover
    • Flexibility Vs. Loss Of Control
    • Outsourcing Manufacturing
    • Drivers Of Outsourcing Manufacturing
    • Cost Savings
    • Increased Supply Of Contract Manufacturing Services
    • Advantages And Disadvantages Of Using Cmos
    • Long Term Cost Savings Vs. High Short Term Expenses
    • Lead Time Savings Vs. Relationship Management Time Losses
    • Access To Expertise Vs. Quality Control
    • Conclusion
  • Chapter 3 Emerging Fields Of Outsourcing
    • Summary
    • Introduction
    • Drug Discovery
    • Specialized Discovery Service Providers
    • Case Study: Wuxi Pharmatech
    • Contract Research Organizations
    • Contract Manufacturing Organizations
    • Biotech
    • Biotech Contractors
    • Contract Research Organizations
    • Contract Manufacturing Organizations
    • Case Study: Ortho Biotech Products
    • Distribution
    • The Mechanics Of Pharmaceutical Distribution
    • Wholesaler Distribution
    • Direct Distribution
    • Agency Distribution
    • Mail Order
    • Self-Distribution
    • Parallel Importing
    • Pharmacy Benefit Management
    • Outsourcing Distribution
    • Conclusion
  • Chapter 4 Offshore Outsourcing
    • Summary
    • Introduction
    • Offshore Outsourcing Of Contract Research
    • Offshore Outsourcing Of Contract Manufacturing
    • Eastern Europe
    • Contract Research In Eastern Europe
    • Cro Developments In Eastern Europe
    • Contract Manufacturing In Eastern Europe
    • Cmo Developments In Eastern Europe
    • India
    • Contract Research In India
    • Patent Issues In India
    • Cro Developments In India
    • Contract Manufacturing In India
    • Cmo Developments In India
    • Early Stage Collaborations
    • China
    • Contract Research In China
    • Patent Issues In China
    • Cro Developments In China
    • Contract Manufacturing In China
    • Cmo Developments In China
    • Offshore Outsourcing Market
    • Case Study: Wyeth
    • Conclusion
  • Chapter 5 Optimizing The Outsourcing
    • Process
    • Summary
    • Introduction
    • Outsourcing Agreements
    • Contract Research Agreements
    • Case Study: Pharmaceutical Product Development (Ppdi)
    • Contract Manufacturing Agreements
    • Assessing Sourcing Needs, Opportunity And Difficulty
    • Assessing Quality Vs. Cost Savings
    • Strategic Management Of Outsourcing
    • Selecting Outsourcing Partners
    • Managing Partnerships
    • Timelines And Preventing Overruns
    • Risks And Mitigation
    • Confidentiality And Intellectual Property Risks
    • Personnel Risks
    • Company Volatility Risks
    • Production Risks
    • Case Study: Novartis
    • Conclusion
  • Chapter 6 The Future Of Pharmaceutical
    • Outsourcing
    • Summary
    • Introduction
    • Pharmaceutical Contract Research Alliances
    • Etechnology
    • Internet-Based Recruitment Of Clinical Trial Patients
    • Electronic Data Capture, Storage And Retrieval
    • Clinical Trial Data
    • Central Laboratory Data
    • In Silico Technologies
    • Case Study: Entelos
    • Virtual Drug Development Companies
    • Non-Profit Virtual Drug Development Groups
    • Big Pharma Virtual Drug Development Groups
    • Case Study: Glaxosmithkline
    • Conclusion
  • Chapter 7 Appendix
    • Index
  • List Of Figures
    • Figure 1.1: Degree Of Outsourcing To Be Conducted By Pharmaceutical Outsourcers In 2006
    • Figure 1.2: Importance Of Contract Organization Characteristics To Pharmaceutical Outsourcers
    • Figure 1.3: In-House Versus Outsourced Expenditure On R&d And Manufacturing, 2000-2005 ($Bn)
    • Figure 1.4: Contract Research Revenues By Segment, 2005 ($M)
    • Figure 1.5: Revenues Of Leading Cros, 2005 ($M)
    • Figure 1.6: Cro Market Growth, 2005-2010 ($M)
    • Figure 1.7: Contract Manufacturing Revenues By Segment, 2005 ($M)
    • Figure 1.8: Cmo Market Growth, 2005 - 2010 ($M)
    • Figure 2.9: Drivers Of Cro And Cmo USAge, 2005
    • Figure 2.10: Us R&d Spending Versus New Drug Approvals, 1995-2004
    • Figure 2.11: Potential Advantages And Disadvantages Of Using A Cro
    • Figure 2.12: Potential Advantages And Disadvantages Of Using A Cmo
    • Figure 3.13: Importance Of Different Characteristics In Biotech Cmo Selection, 2005
    • Figure 4.14: Relative Pharmaceutical Research And Manufacturing Capabilities In India, China And Eastern Europe, 2005
    • Figure 4.15: Contract Research Revenues By Region, 2005 ($M)
    • Figure 4.16: Contract Manufacturing Revenues By Region, 2005 ($M)
    • Figure 5.17: Outsourcing Difficulty Vs. Opportunity
    • Figure 5.18: Impact Of Low Prices On Outsourcing Outcomes
    • Figure 6.19: Characteristics Of Different Contractor Relationships
  • List Of Tables
    • Table 1.1: Summary Of Drug Testing Objectives By Phase
    • Table 2.2: Recent Drug Recalls, 2000-2006
    • Table 3.3: Capabilities Of Leading Cros And Cmos In Emerging Areas
    • Table 3.4: Selected Specialty Drug Discovery Contractors
    • Table 4.5: Advantages And Disadvantages Of International Outsourcing
    • Table 4.6: Eastern European Operations Of Leading Cros
    • Table 4.7: Us Fda New Drug Application Data Generated From India
    • Table 5.8: Typical Opportunities And Difficulties Of Outsourcing
    • Table 5.9: Selected Pharmaceutical Manufacturing Violations
    • Table 5.10: Reasons For Time And Budget Overruns
    • Table 6.11: Relationships Between Virtual Pharma Sponsor And Contractors
    • Table 6.12: Selected Virtual Drug Development Companies