Molecular Biomarkers for Clinical Diagnostics and Drug Discovery and Development

Content

• 1. Major Diseases, Biomarkers and Diagnostics
  • 1.1The Size of Major Disease Populations
• 2. What Biomarkers and Tests Are
  • 2.1 Biomarker Definitions
    • 2.1.1 Pre-Genome
    • 2.1.2 Post Genome
    • 2.1.3 FDA Definition
  • 2.2 The In-Vitro Diagnostics (IVD) Industry
    • 2.2.1 Molecular IVD industry
    • 2.2.2 Top Molecular IVD Industry Players
  • 2.3 Biomarkers and Genetic Diagnostic Tests
    • 2.3.1 Post-Genomic Biomarkers Are Molecular
    • 2.3.2 Pharmacogenomic Tests for Drug Discovery and Development
  • 2.4 Biomarker Advances
    • 2.4.1 FDA Enters Biomarker And Pharmacogenomics Field In 2003
    • 2.4.2 Biomarkers in Multiple Gene Based Diseases
    • 2.4.3 Cost Reducing SNP Genotyping - Disease Association Studies
    • 2.4.4 Multiplexed Protein Patterns Become Biomarkers
  • 2.5 Developing Molecular Biomarker Tests
    • 2.5.1 Development Path To Commercializing Molecular Biomarker Tests
    • 2.5.2 Make A Home Brew Test and Market The Test as a Service
    • 2.5.3 Develop Test Into An In Vitro Diagnostic
    • 2.5.4 Typical Product Prices
    • 2.5.5Healthcare Reimbursement Issues
• 3. Company Activities: Molecular Biomarker Tests in Clinical Diagnostics
  • 3.1 Major Participants by Disease Segment
  • 3.2 Important Findings or Special Notes
    • 3.2.1 Findings of Companies in Molecular Biomarker Tests by Major Disease
    • 3.2.2Findings of Companies in Molecular Biomarker Tests by Product 'Status'
• 4. Technology: Developing Molecular Biomarker Tests for Clinical Diagnostics & Commercial Implication
  • 4.2 Recent Important Molecular Biomarker Test Discoveries
    • 4.2.1 Nucleic Acid Technologies
      • 4.2.1.1 Direct Probe
      • 4.2.1.2 Target Amplification Technology
      • 4.2.1.3 Non-PCR Target Amplification and Signal Amplification
      • 4.2.1.4 Signal Amplification
    • 4.2.2 Microarrays and Labchips
      • 4.2.2.1 Microarrays
      • 4.2.2.2 Labchips
    • 4.2.3 Proteomic Technologies
    • 4.2.4 Metabolomic Technologies
    • 4.2.5 Bioinformatic Software
  • 4.3 Drug Discovery Research & Development
  • 4.4Commercial Implications of Biomarker based Assays or Diagnostics
• 5. Company Activities: Biomarkers and Tests in Drug Discovery and Development
  • 5.1 Major Participants by Disease Segment
  • 5.2 Important Findings or Special Notes
    • 5.2.1 Findings About Company Activities by Major Disease.
    • 5.2.2Findings About Company Activities by Product Status
• 6. R&D Activity and Alliances for Biomarkers/ Molecular Diagnostics
  • 6.1Overview of R&D & Alliances in Biomarker/ Molecular Diagnostics and in Drug Discovery R&D
  • 6.2R&D Activity and Strategic Alliances
• 7. The Market Size and Forecast for Biomarker Clinical Diagnostics
  • 7.1 Market Overview: Biomarker Clinical Diagnostics & Lab Services
  • 7.2 WW Biomarker Clinical Diagnostic Product Market Trends
  • 7.3 Molecular Biomarker Clinical Diagnostic Product Market Share
  • 7.4 WW Biomarker Clinical Diagnostic Market Size by Application Segment
  • 7.5 WW Biomarker Diagnostic Market Size by Region
  • 7.6 WW Biomarker Diagnostic Lab Services Market Size by Applications and Regions
    • 7.6.1 Biomarker Diagnostic Lab Services Market Size by Applications
    • 7.6.2WW Biomarker Diagnostic Lab Services Market Size by Regions
• 8. Future Directions
  • 8.1 Major Trends for Molecular Biomarkers and Diagnostics
    • 8.1.1 Infectious Disease Testing
    • 8.1.2 Interest in Cancer Tests Growing
    • 8.1.3 CNS Disease Progression
    • 8.1.4 Drug Response Assays: Biomarkers for Safety and Efficacy
  • 8.2 Best Opportunities for the Future
    • 8.2.1 Government Regulators Fostering Future Opportunities
    • 8.2.2 Pharmacogenomics Opportunity Cuts Drug R&D Timeline
    • 8.2.3 Emerging Personalized Medicine
  • 8.3 Main Challenges
    • 8.3.1 High Costs of Molecular Diagnostics Today
    • 8.3.2 Acute Shortages of Diagnostics in the Developing World
    • 8.3.3 Regulatory Delays in Approving New Tests
    • 8.3.4Insurance Reimbursement Issues
• 9. The Market Size and Forecast for Biomarkers in Drug Discovery and Development
  • 9.1 WW Biomarkers in Drug Discovery and Development Market Trends
  • 9.2 WW Biomarkers in Drug Discovery and Development, Disease Market Shares
  • 9.3 WW Biomarker in Drug Discovery and Development Market Size by Application Segments
    • 9.3.1 WW Biomarkers in Drug Discovery and Development by Application/ Clinical Phase
    • 9.3.2 WW Biomarkers in Drug Discovery and Development by R&D Tools and R&D Services
  • 9.4WW Biomarker in Drug Discovery and Development Market Size by Region
• 10. Company Activities and Profiles In Biomarker Test R&D
  • 10.1 Company Activities at a Glance
  • 10.2 BioContent (6)
  • 10.3 Chemistry (3)
  • 10.4 IVD Manufacturer (8)
  • 10.5 R&D Service Provider (3)
  • 10.6 Software (1)
  • 10.7 Tech Platform (2)
• List of Tables
  • Table 1. Summary of Patient Populations Sorted by New Patients
  • Table 2. Summary of Patient Populations Sorted by Total Existing Patients
  • Table 4. Top Health Risk Factors Leading to Death in the Developed World
  • Table 5. Molecular IVD Test Applications
  • Table 6. Top Molecular Diagnostics IVD Manufacturers
  • Table 7. Typical Molecular Biomarker Diagnostic Development Path
  • Table 8. Key Companies in Molecular Biomarker Tests by Major Disease
  • Table 9. Company Activities by Major Disease Totals and Shares
  • Table 10. Company Activities by Product 'Status' Segment Totals and Shares
  • Table 11. Technology Overview for Developing Molecular Biomarker Tests by Disease
  • Table 12. Target Amplification Technologies
  • Table 13. Target Signal Amplification Technologies
  • Table 14. Microarray and Labchip Technologies
  • Table 15. Proteomic Technologies for Diagnostics
  • Table 16. Metabolomic Technologies and Biomarkers
  • Table 17. Competitive Environment for Nucleic Acid Amplification Technologies for Clinical Diagnostics
  • Table 18. Activities of Major Biomarker Drug Discovery & Development Participants by Major Disease
  • Table 19. Company Activities by Major Disease Segment Total and Share
  • Table 20. Company Activities by Product Status
  • Table 21. Summary of Strategic Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery R&D by Major Disease (2000-2004)
  • Table 22. Summary Analysis of 'Others' Alliances
  • Table 23. Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery R&D by Major Disease, 1Q/2004
  • Table 24. Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery R&D by Major Disease, 2003
  • Table 25. Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery R&D by Major Disease, 2002
  • Table 26. Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery R&D by Major Disease, 2001
  • Table 27. Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery R&D by Major Disease, 2Q/2000
  • Table 28. Summary of Strategic Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery R&D by Type and Year
  • Table 29. WW Molecular Biomarker Clinical Diagnostic, Tests, Tools, & Lab Services, 2003 & 200
  • Table 30. WW Molecular Biomarker Clinical Diagnostics (ASR/ IVD) Products by Disease Area, 2003-2007
  • Table 31. WW Molecular Biomarker Clinical Diagnostic Product Market Share, 2003 & 2007
  • Table 32. WW Molecular Biomarker-based Clinical Diagnostic Products by Application, 2003-2007
  • Table 33. WW Molecular Biomarker-based Clinical Diagnostic Products by Regions, 2003-2007
  • Table 34. WW Molecular Biomarker Clinical Diagnostic Lab Services by Applications, 2003-2007
  • Table35. WW Est. Molecular Biomarker Clinical Diagnostic Lab Services by World Regions, 2003-200
  • Table 36. Future Direction of Infectious Disease Tests
  • Table 37. Future Direction of Cancer Companion Tests
  • Table 38. Future Direction of Cancer Disease Progression Tests
  • Table 39. CNS Tests Likely in Five Years
  • Table 42. WW Biomarkers in Drug Discovery and Development, Revenues by Major Diseases
  • Table 43. Biomarker in Drug Discovery and Development Market Share, 2004 & 2007
  • Table 44. WW Biomarkers in Drug Discovery and Development by Application/ Clinical Phase, 2003-2007
  • Table 45. WW Biomarkers in Drug Discovery and Development by R&D Tools and R&D Services, 2003-2007
  • Table 46. WW Biomarker in Drug Discovery and Development Market Size by World Region
  • Table 47. Company Activities at a Glance and Disease Areas
• List of Figures
  • Figure 1. Molecular Biomarker and Diagnostic Test Market
  • Figure 2. Company Activities by Major Disease Segment Totals
  • Figure 3. Company Activities by Major Disease Segment Shares
  • Figure 4. Company Activities by Product 'Status' Totals
  • Figure 5. Company Activities by Product Status Shares
  • Figure 6. Company Activities by Major Disease Segment Total
  • Figure 7. Company Activities by Major Disease Segment Share
  • Figure 8. Company Activities by Product Status Total
  • Figure 9. Company Activities by Product Status Share
  • Figure 10. Summary of Strategic Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery R&D by Major Disease (2000-2004)
  • Figure 11. Summary Analysis of the 'Others' Alliances
  • Figure 12. Summary of Strategic Alliances for Biomarker/ Molecular Diagnostics and Drug Discovery R&D by Type and Year
  • Figure 13. WW Molecular Biomarker Clinical Diagnostic, Tests, Tools, & Lab Services, 2003 & 2007
  • Figure 14. WW Molecular Biomarker Clinical Diagnostics (ASR/ IVD) Products by Disease Area, 2003-2007
  • Figure 15. WW Molecular Biomarker Clinical Diagnostic Product Market Share, 2004 & 2007
  • Figure 16. WW Molecular Biomarker-based Clinical Diagnostic Products by Application, 2003-2007
  • Figure 17. WW Molecular Biomarker-based Clinical Diagnostic Products by Regions, 2003-2007
  • Figure 18. WW Molecular Biomarker Clinical Diagnostic Lab Services by Applications, 2003-2007
  • Figure 19. WW Est. Molecular Biomarker Clinical Diagnostic Lab Services by World Regions, 2003-2007
  • Figure 20. WW Biomarker in Drug Discovery and Development Revenues by Major Diseases
  • Figure 21. Biomarker in Drug Discovery and Development by Disease and Market Shares, 2004 & 2007
  • Figure 22. WW Biomarkers in Drug Discovery and Development by Application/ Clinical Phase, 2003-2007
  • Figure 23. WW Biomarkers in Drug Response and Development by R&D Tools, 2003-2007
  • Figure 24. WW Biomarker in Drug Discovery and Development Market Size by World Region