Strategic Analysis of the World Biogenerics Market

Table of Contents

• 1. Executive Summary
  • 1. Executive Summary
    • 1. Executive Summary
• 2. Introduction
  • 1. Market Overview
    • 1. Glossary and Abbreviations
    • 2. Introducing the Biogenerics Market
    • 3. First Biogeneric Reaches the Market
  • 2. Regulatory Affairs
    • 1. Regulatory Affairs in the United States
    • 2. Regulatory Affairs in Europe
    • 3. Regulatory Affairs in Rest-of-World
• 3. Challenges Drivers and Restraints
  • 1. Industry Challenges
    • 1. Analysis Assumptions
    • 2. Biogenerics Industry Challenges
      • a. Early biogenerics likely to Command High Prices
      • b. Lack of a Clear Definition of Bioequivalence Hinders the Development of Regulatory Guidance
      • c. Cost and Feasibility of Biogeneric Testing Procedures
      • d. Concerns over Drug Quality from India and China
      • e. Stringent Demands for Drug Quality
      • f. Receptivity of Customer Base over the Quality of Biogenerics
      • g. Availability of Bulk Biologic Drug Components
  • 2. Market Drivers and Restraints
    • 1. Market Drivers
      • a. Large Market Size and Profit Margins for Biogeneric Compounds
      • b. Large Number of Biopharmaceuticals about to come off Patent
      • c. Biopharmaceuticals Market Continues to Grow
      • d. Low Competition in the Initial Phases of Biogenerics Market Developmen
      • e. Governmental Demand for Cheaper Products
    • 2. Market Restraints
      • a. Originators of Biologics Defend Their Products
      • b. Slow Pace of Regulatory Proceedings
      • c. Complexity of Patent Battles Slows Market Growth
      • d. No Biogeneric Products Yet on the Market
      • e. BIO Opposition to the Biogenerics Industry
• 4. Market Analysis
  • 1. Biopharmaceuticals Market
    • 1. Market Engineering Measurements
    • 2. Sales Forecast
  • 2. Biogenerics Market
    • 1. Market Engineering Measurements
    • 2. Sales Forecast
• 5. Pipeline Analysis
  • 1. Biogenerics Pipeline
    • 1. Forthcoming Patent Expiries
    • 2. Forecast Biogenerics Pipeline
• 6. Competitive Analysis
  • 1. Competitors in the Biogenerics Market
    • 1. Competitive Analysis
    • 2. Competitive Profiles
• 7. Strategic Analysis and Recommendations
  • 1. Strategy for the Biogenerics Market
    • 1. Strategic Analysis
    • 2. Strategic Recommendations
• 8. Frost & Sullivan Awards
  • 1. Introduction to Frost & Sullivan Awards
    • 1. Industry Recognition
  • 2. Frost & Sullivan Award Recipients
    • 1. Market Leadership Award
    • 2. Growth Strategy Leadership Award
    • 3. Entrepreneurial Company Award
• 9. Decision Support Databases
  • 1. Pharmaceutical and Biotechnology Market Metrics
    • 1. Number of Biotechnology Companies (1999-2006)
    • 2. Biotechnology Private Investment (1999-2006)
    • 3. Biotechnology Government Investment (1999-2006)
    • 4. Total Healthcare Expenditure (1999-2006)
  • 2. Intellectual Property Analysis
    • 1. Patents Granted by EPO (1999 - 2000)
    • 2. Patents Granted by the USPTO (1999-2000)