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Diagnostics

Molecular Diagnostics in Cancer Testing

 

Publication Date December 2009
Publisher TriMark Publications
Product Type Report
Pages 175
ISBN Number not applicable
Product Code TRI00099

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Summary

Molecular diagnostics is a rapidly-advancing area of research and medicine, with new technologies and applications being continually added. The technologies that come under the umbrella of molecular diagnostics include first-generation amplification, DNA probes, fluorescent in-situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors and molecular labels, and gene expression profiling using microarrays. These technologies are improving the discovery of therapeutic molecules for cancer, the screening, diagnosis and classification of cancer patients, and the optimization of drug therapy. This TriMark Publications report describes the specific segment of the in vitro diagnostics (IVD) market known as molecular diagnostics (MD), with a specialization in the MD tests for cancer. In the current medical diagnostics market, molecular diagnostics for cancer testing offers one of the brightest areas for growth and innovation. The confluence of breakthroughs in genomics, proteomics, and the development of microarray devices to measure analytes in the blood and various body tissues, has led to this revolutionary market segment offering the power of advanced analytical techniques to the diagnosis and treatment of cancer. This report analyzes the size and growth of the molecular diagnostics market in its applications for cancer detection and therapy, examining the factors that influence the various market segments and the dollar volume of sales, both in the United States and worldwide.

Contents

  • 1. Overview
    • 1.1 Statement of Report
    • 1.2 About This Report
    • 1.3 Scope of the Report
    • 1.4 Objectives
    • 1.5 Methodology
    • 1.6 Executive Summary
  • 2. Introduction to Molecular Diagnostics
    • 2.1 Opening Up of Opportunities in Molecular Diagnostics
    • 2.2 Impact of the Human Genome Project on Molecular Diagnostics
    • 2.3 Considerations for Molecular and Clinical Diagnostics
    • 2.4 Molecular Diagnostics in the Post-Genomic Era
    • 2.5 Advances in Molecular Diagnostics Technologies
    • 2.6 Oligonucleotide Array Platforms
    • 2.7 Emerging Cancer Personalized Medicine Market
    • 2.8 Companion Tests for Drug Development
  • 3. Cancer Diagnostics Molecular Testing Market
    • 3.1 Market Description
      • 3.1.1 Market Overview
      • 3.1.2 Tumor Markers
      • 3.1.3 Molecular Diagnostic Markers
      • 3.1.4 Competitive Landscape
      • 3.1.5 Sales and Marketing Strategies for Cancer Tests
        • 3.1.5.1 North American Market
        • 3.1.5.2 International Markets
        • 3.1.5.3 Europe
        • 3.1.5.4 Asia/Pacific
  • 4. Molecular Diagnostic Tests for Cancer
    • 4.1 Cancer Diagnostic Tests
      • 4.1.1 Use of Genomics to Understand Cancer
      • 4.1.2 Molecular Diagnostic Tools Solutions
      • 4.1.3 Technology of Gene Expression Analysis
        • 4.1.3.1 Amplify and Detect Diminished Amounts of RNA Consistently
        • 4.1.3.2 Analyze Hundreds of Genes
        • 4.1.3.3 Employ Advanced Information Technology
    • 4.2 Breast Cancer
      • 4.2.1 Cancer Prognostic Assays
        • 4.2.1.1 Oncotype DX
      • 4.2.2 Single Gene Reporting (ER, PR, HER2)
        • 4.2.2.1 Node Positive (N+)
        • 4.2.2.2 Aromatase Inhibitors
      • 4.2.3 Product Development
        • 4.2.3.1 Product Development Opportunities in Breast Cancer
      • 4.2.4 InterGenetics, Incorporated
      • 4.2.5 HER-2
      • 4.2.6 BioTheronostics (AviaraDx)
      • 4.2.7 Agendia B.V
      • 4.2.8 Exagen
      • 4.2.9 Applied Genomics
    • 4.3 Colorectal Cancer Molecular Diagnostics Market
      • 4.3.1 Players in the Colorectal Cancer Space
        • 4.3.1.1 Background on KRAS Mutation
        • 4.3.1.2 BRAF Mutation Analysis
    • 4.4 Prostate Cancer Molecular Diagnostics Market
    • 4.5 Other Cancer Molecular Diagnostic Markets
      • 4.5.1 Bladder Cancer
      • 4.5.2 Ovarian Cancer
      • 4.5.3 Lung Cancer
      • 4.5.4 Melanoma
    • 4.6 Molecular Diagnostic Screening Test for Cancer
      • 4.6.1 Extreme Drug Resistance assay (Oncotech EDR Assay)
      • 4.6.2 Multidrug Resistance Protein (MRP)
    • 4.7 Companion Diagnostic Tests for Cancer Therapeutics
  • 5. Business
    • 5.1 Technology and Market Trends
      • 5.1.1 Technology Trends
      • 5.1.2 Market Trends
    • 5.2 M&A Activity
    • 5.3 Partnerships
    • 5.4 Competitive Analysis
      • 5.4.1 Primary Competitors
      • 5.4.2 Industry Challenges and Strategic Recommendations
      • 5.4.3 Commercialization of Molecular Diagnostic Products
    • 5.5 SWOT Comparison of Business Models for Cancer Diagnostic Testing
    • 5.6 Intellectual Property Rights
  • 6. Reimbursement and Billing
    • 6.1 Overview
    • 6.2 Trends in Reimbursement Practice
      • 6.2.1 Medicare Reimbursement
      • 6.2.2 Analysis of ROI for Molecular Diagnostic Tests for Cancer Using Medicare Reimbursement Rules
      • 6.2.3 Reimbursement for Insight Dx, MammaPrint and Oncotype Dx
    • 6.3 Breast Cancer Tests
    • 6.4 Colon Cancer Tests
    • 6.5 Trends in Patient Care and Reimbursement
    • 6.6 Revenue Threats
      • 6.6.1 Medicare Exceptions
      • 6.6.2 Three Areas for Denial of Claims by Biomarkers
    • 6.7 Billing
      • 6.7.1 Medicare Billing Procedures
      • 6.7.2 Medicare CPT Coding Rules for Cancer Biomarkers
  • 7. Government Regulation
    • 7.1 U.S. Food and Drug Administration
    • 7.2 CLIA Regulations
    • 7.3 Clinical Laboratory Improvement Act (CLIA)
    • 7.4 State Licensing for Service Laboratories
    • 7.5 IVDMIAs
    • 7.6 510(k) Clearance
    • 7.7 Pre-Market Approval (PMA)
    • 7.8 ASRs
    • 7.9 What Regulatory Guidance Is Needed for Companion Biomarkers?
    • 7.10 U.S. Patent and Trademark Office (USPTO)
    • 7.11 IRB Approval in Clinical Trials
    • 7.12 Oncology Biomarkers Qualification Initiative Project
    • 7.13 FDA Clearance Picture for Insight Dx, MammaPrint, and Oncotype DX
    • 7.14 FDA Packaging Requirements for Erbitux
  • 8. Business Decisions Using Molecular Diagnostic Tests in Drug Development
    • 8.1 Advantages of a Pharmacogenomic Assessment of Genetic Biomarkers to Determine Clinical Dose
    • 8.2 What are Key Opportunities in Biomarker Discovery, Development and Commercialization
    • 8.3 What Are the Current Obstacles in Biomarker Implementation?
    • 8.4 How Do Business Strategies, Such as Those Relating to Acquisition, Drive Biomarker Strategies?
    • 8.5 What is the Right Balance between Using External Partnerships and Developing Internal Infrastructure?
    • 8.6 How Might Novel Biomarker Development Lead to Acquisition Strategies?
    • 8.7 Which Types of Genetic Biomarkers Should Be Developed by Diagnostic Companies?
    • 8.8 What Strategies Help Translate Genetic biomarkers From Preclinical to Clinical Development?
    • 8.9 In What Class of Drugs Is the Value of Using Genetic biomarkers in Decision Making the Highest?
    • 8.10 How Can Regulatory Oversight Drive Approval and Adoption of New Technologies?
    • 8.11 How Can Big Pharma Co-develop Genetic biomarkers in a Cost-sharing Model for Regulatory Acceptance?
    • 8.12 How Are Genetic Biomarkers Being Used to Reduce the Attrition Rate in Drug Development?
    • 8.13 How Is ROI Measured Using Genetic Biomarkers in Drug Development?
    • 8.14 How Might Organizational Structures Limit the Use of Genetic Biomarkers in Drug Development and How Should R&D Organizations Address This Problem?
    • 8.15 How to Maximize Business Development through Biomarker Strategies
    • 8.16 What Is the Best Type of Business Model for Developing Genetic Biomarkers?
    • 8.17 What Are Organizational Impediments in Genetic Biomarkers in Drug Development?
    • 8.18 What Are Internal Capabilities for Novel Biomarker Development and Application?
    • 8.19 How Can Key Biomarker Technical Expertise Be Applied Across a Complex and Highly-Stratified R&D Value Chain?
    • 8.20 At What Stage of Drug Development Have Genetic Biomarkers Provided the Most Benefit
    • 8.21 What Companies Are the Most Innovative in Development of Genetic Biomarkers?
    • 8.22 Best Values for Genetic biomarkers in Drug Development and in Diagnostics
    • 8.23 Molecular Diagnostic Tests Can Increase Value in an Associated Drug
  • 9. Company Profiles
    • 9.1 Agendia
    • 9.2 ArcticDx Inc
    • 9.3 Arcxis Biotechnologies
    • 9.4 Aureon Laboratories
    • 9.5 bioTheranostics (AviaraDx)
    • 9.6 Clarient, Inc
    • 9.7 CombiMatrix Corporation
    • 9.8 DiagnoCure
    • 9.9 DxS
    • 9.10 Exagen Diagnostics, Inc
    • 9.11 Exiqon
    • 9.12 Ferrer in Code
    • 9.13 Genomic Health Inc
    • 9.14 Genoptix, Inc
    • 9.15 Gen-Probe
    • 9.16 InterGenetics, Incorporated
    • 9.17 LabCorp
    • 9.18 Myriad Genetics
    • 9.19 Nuerva Biosciences
    • 9.20 Orion Genomics
    • 9.21 QIAGEN
    • 9.22 Rosetta Genomics
    • 9.23 Sequenom
    • 9.24 SABiosciences Corporation
    • 9.25 Source MDx
    • 9.26 Targeted Molecular Diagnostics
    • 9.27 Xenomics, Inc
    • Appendix 1: Definition of Terms for Molecular Diagnostics
    • Appendix 2: Standard Cancer Therapeutic Panels
    • Appendix 3: Menu of Specialized Technologies Used To Assess and Characterize Cancer
    • Appendix 4: Technical Assessment of the KRAS Mutation Test by Several Methodologies and Specialty Oncology Laboratories
    • Appendix 5: Overview of Microarrays
  • List of Figures
    • Figure 2.1: Finding Genes with Microassays
    • Figure 2.2: Use of Microassays for Studying Gene Expression
    • Figure 2.3: Using DNA Microarrays to Compare Cancer and Normal Cells
    • Figure 2.4: Microarrays for Prediction of Survival in Cancer
    • Figure 2.5: Finding New Drugs with Microarrays
    • Figure 2.6: Using Gene Expression Patterns to Chose Treatment
    • Figure 2.7: Segmentation of the Biomarker Development Market
    • Figure 3.1: Applications of Key Players and Market Share in Molecular Diagnostics Testing Markets
    • Figure 3.2: Market Growth and Evolution of MD Cancer Biomarkers
    • Figure 4.1: Using DNA Microassays to Measure Gene Expression
    • Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients
    • Figure 4.3: HER-2/NEU Protein as a Target in Cancer Therapy
    • Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC
    • Figure 4.5: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH
    • Figure 4.6: Action of Herceptin in Breast Cancer Patients
    • Figure 4.7: Analysis of Cancer Tissue by Microarray
    • Figure 4.8: Incidence of CRC by Age Group
    • Figure 4.9: HNPCC Mutation Increases Risk of Cancer
    • Figure 4.10: APC Mutation Increases the Risk of Cancer
    • Figure 4.11: KRAS Mutation Assay from Exiqon Diagnostics
    • Figure 4.12: KRAS Assays by Analytical Type
    • Figure 4.13: DxS KRAS Mutation Test Summary
    • Figure 4.14: Prostate Specific Membrane Antigen
    • Figure 4.15: Estimates for PCA3 Test Volume in U.S., 2005-2008
    • Figure 5.1: FDA Co-Developed Products as a Model for Collaboration
    • Figure 5.2: Segmentation of the Biomarker Development Market
    • Figure 6.1: Number of Oncotype DX Tests Performed, 2006-2009
    • Figure 7.1: OBQI and the Relationship of Governmental Regulatory Agencies
    • Figure 8.1: Discovery, Validation and Use of Genetic Biomarkers
  • List of Tables
    • Table 2.1: Genes and Cancer Risk
    • Table 2.2: Use of Cancer Biomarkers to Enhance Patient Care
    • Table 2.3: Targeted Drug Therapies for Cancers
    • Table 2.4: Use of Cancer Biomarkers in Drug Development
    • Table 2.5: Utility of Biomarkers as Companion Diagnostics to Drug Development
    • Table 2.6: Time Line for Development of Companion Diagnostics
    • Table 3.1: Global Market for Molecular Diagnostics Cancer Testing, 2008-2012
    • Table 3.2: Global Market for Molecular Diagnostics Testing, 2008-2012
    • Table 3.3: U.S. Market for Molecular Diagnostics Testing, 2004-2012
    • Table 3.4: Key Players and Market Share in Molecular Diagnostics Testing Market
    • Table 3.5: Business Factors Influencing Advanced Oncology Testing Services
    • Table 3.6: Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market
    • Table 3.7: In Vitro Cancer Marker Market Segments Worldwide, 2001 and 2007
    • Table 3.8: Tumor Markers Currently in Common Use
    • Table 3.9: Global IVD Cancer Tumor Marker Testing Market Segments Growth Rates
    • Table 3.10: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010
    • Table 3.11: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010
    • Table 3.12: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
    • Table 3.13: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
    • Table 3.14: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
    • Table 3.15: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
    • Table 3.16: Global Distribution of IVD Cancer Tumor Marker Diagnostic Testing
    • Table 3.17: Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market
    • Table 3.18: Major Presence in Cancer Tumor Marker Diagnostics Markets
    • Table 3.19: Leading Segments of the Molecular Diagnostic Testing Market
    • Table 3.20: Highlights of the Cancer Diagnostic Testing Segment
    • Table 3.21: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular Diagnostic Services
    • Table 3.22: Strategies for Marketing Cancer Diagnostic Products
    • Table 3.23: Key Elements of MD Diagnostic Companies Marketing Plan
    • Table 4.1: Estimates for the Leading Sites of New Cancer Cases and Deaths in the U.S. by Gender
    • Table 4.2: Key Elements for Business Competition in Gene Expression Profiling for Cancer
    • Table 4.3: Key Elements for Future Success in the Gene Profiling for Cancer Segment
    • Table 4.4: Breast Cancer Overview
    • Table 4.5: Overview of ER/PR Testing and Response to Therapy
    • Table 4.6: Players in the Breast Cancer Molecular Diagnostic Space
    • Table 4.7: Clinical Utility and Health Economic Benefits of Oncotype DX
    • Table 4.8: Overview of HER2/neu and Herceptin
    • Table 4.9: MammaPrint: Key Features
    • Table 4.10: Siemens Oncogene Science Biomarker Group Reagents
    • Table 4.11: Colorectal Cancer Overview
    • Table 4.12: TNM Staging System for Colorectal Cancer
    • Table 4.13: Players in the Colorectal Cancer Molecular Diagnostic Space
    • Table 4.14: ArcticDx Genetic Test, Colo Risk
    • Table 4.15: Product Development Opportunities in Cancer Tumor Types
    • Table 4.16: Players in the Prostate Cancer Molecular Diagnostic Space
    • Table 4.17: Players in the Bladder Cancer Molecular Diagnostic Space
    • Table 4.18: Lung Cancer Survival Rates
    • Table 4.19: Lung Cancer Facts
    • Table 4.20: Potential of Cancer Biomarkers in Drug Delivery and Development
    • Table 4.21: Barriers to Adoption of Biomarkers in Clinical Use
    • Table 5.1: Technology Trends in Cancer Testing
    • Table 5.2: Trends in Theranostics
    • Table 5.3: Market Trends in Cancer Testing
    • Table 5.4: Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order of Impact
    • Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in Order of Impact
    • Table 5.6: Companies That Offer Products to Profile Gene Expression in Breast Cancer
    • Table 5.7: Principal Competitive Factors in the Cancer Screening Market
    • Table 5.8: Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions
    • Table 5.9: Total Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges (U.S.)
    • Table 5.10: Utility of Biomarkers as Companion Diagnostics to Drug Development
    • Table 6.1: CPT Codes for Tumor Markers
    • Table 6.2: Genomic Health Oncotype DX Sales
    • Table 6.3: Drivers in KRAS Testing
    • Table 6.4: Factors Determining Third Party Payment for Advanced Cancer Tests
    • Table 7.1: Rules that Affect the Ability of a Cancer Diagnostic Service Lab to Conduct Business
    • Table 7.2: Focus Areas for the FDA Critical Path Initiative
    • Table A1: Tumor Markers Currently in Common Use