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Molecular Biomarkers for Clinical Diagnostics and Drug Discovery and Development
Fuji-Keizai USA, Inc., Aug 2004, Pages: 202
1. Major Diseases, Biomarkers and Diagnostics
- 1.1 The 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
- 2.5.5 Healthcare 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
- 3.2.2 Findings 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
- 4.4 Commercial 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.
- 5.2.2 Findings About Company Activities by Product Status
6. R&D Activity and Alliances for Biomarkers/ Molecular Diagnostics
- 6.1 Overview of R&D & Alliances in Biomarker/ Molecular Diagnostics and in Drug Discovery R&D
- 6.2 R&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
- 7.6.2 WW 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
- 8.3.4 Insurance 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
- 9.4 WW 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
- 10.2.1 BioMarker Pharmaceuticals, Inc.
- 10.2.2 Jurilab Ltd.
- 10.2.3 Millennium Pharmaceuticals, Inc.
- 10.2.4 Myriad Genetics, Inc.
- 10.2.5 Samaritan Pharmaceuticals
- 10.2.6 SurroMed, Inc.
- 10.3 Chemistry
- 10.3.1 Axis-Shield, Inc.
- 10.3.2 Gen-Probe, Inc.
- 10.3.3 Matritech, Inc.
- 10.4 IVD Manufacturer
- 10.4.1 BioSite, Inc.
- 10.4.2 CeMines, Inc.
- 10.4.3 Chiron Corporation
- 10.4.4 DakoCytomation A/S
- 10.4.5 diaDexus, Inc.
- 10.4.6 Diagnostics Products Corporation
- 10.4.7 Exact Sciences
- 10.4.8 Nanosphere, Inc.
- 10.5 R&D Service Provider
- 10.5.1 DxS Ltd.
- 10.5.2 Illumina, Inc.
- 10.5.3 Perlegen Sciences, Inc.
- 10.6 Software
- 10.6.1 Paradigm Genetics, Inc.
- 10.7 Tech Platform
- 10.7.1 Genaissance Pharmaceuticals, Inc.
- 10.7.2 Molecular Staging, Inc.
Table of Tables
List of Illustrations
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