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Molecular Diagnostics in Cancer Testing - Product Image

Molecular Diagnostics in Cancer Testing

  • ID: 1195430
  • November 2013
  • Region: Global
  • 232 Pages
  • TriMark Publications

FEATURED COMPANIES

  • Agendia
  • Cancer Genetics, Inc
  • Exagen Diagnostics, Inc
  • Genomic Health, Inc
  • LabCorp
  • Neogenomics
  • MORE

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 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.

FEATURED COMPANIES

  • Agendia
  • Cancer Genetics, Inc
  • Exagen Diagnostics, Inc
  • Genomic Health, Inc
  • LabCorp
  • Neogenomics
  • MORE

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 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
2.7.1 Predictive Cancer Molecular Diagnostics
2.8 Companion Tests for Drug Development
2.9 Opportunities for IVDMIA Companies

3. Cancer Diagnostics Molecular Testing Market
3.1 Market Description
3.1.1 Market Overview
3.1.2 Molecular Diagnostic Markers
3.1.3 Competitive Landscape
3.1.4 Sales and Marketing Strategies for Cancer Tests

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
4.2 Breast Cancer
4.2.1 Cancer Prognostic Assays
4.2.2 Competition and Comparison of Methods
4.2.3 Competitive Structure and Market Share Analysis
4.3 Colorectal Cancer Molecular Diagnostics Market
4.3.1 Colon Cancer Testing Platforms
4.3.2 Players in the Colorectal Cancer Space
4.3.3 Competitive Structure and Market Share Analysis
4.4 Prostate Cancer Molecular Diagnostics Market
4.4.1 Screening for Prostate Cancer
4.4.2 Tests after Positive Biopsy
4.4.3 Tests After Negative Biopsy
4.4.4 Tests After Surgery
4.4.5 Competition and Comparison of Methods
4.4.6 Competitive Structure and Market Share Analysis
4.4.7 Market Drivers and Restraints
4.4.8 Prostate Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
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
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
5.6.1 BRCA1 and BRCA2 Gene Patents
5.6.2 Current Patent Disputes

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 MDx Tests for Cancer Using Medicare Reimbursement Rules
6.2.3 Reimbursement for Insight Dx, MammaPrint and Oncotype Dx
6.2.4 Reimbursement for JAK2 Mutation Testing for Myeloproliferative Neoplasms
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
7.4 State Licensing for Service Laboratories
7.5 FDA Treatment of Multivariate Index Assays
7.6 510(k) Clearance
7.7 Pre-Market Approval
7.8 ASRs
7.9 What Regulatory Guidance is Needed for Companion Biomarkers?
7.10 U.S. Patent and Trademark Office
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
7.15 Microarray Quality Control
7.16 CAP Evidence-based Recommendations to Improve the Accuracy of ER and PR Testing
7.17 ER and PR Proficiency Testing

8. Business Decisions Using Molecular Diagnostic Tests in Cancer Test Development
8.1 What are the Key Opportunities for Development of Cancer Tests Based Upon Molecular Diagnostics Technologies?
8.2 What are the Current Obstacles for MDx Cancer Testing Implementation?
8.3 How do Business Strategies, such as those Relating to Acquisition, Drive Biomarker Strategies?
8.4 Which Types of Cancer MDx Testing should be Developed by Diagnostic Companies at Various Stages in the Development Pipeline?
8.5 How can Regulatory Oversight Drive Approval and Adoption of New Technologies?
8.6 What are the Noteworthy Deals?
8.7 Who are the Acquirers?
8.8 Who are the Target Companies?
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 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 has 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 Biodesix
9.4 bioTheranostics (AviaraDx)
9.5 Cancer Genetics, Inc.
9.6 Clarient, Inc. (GE Healthcare)
9.7 CombiMatrix Corporation
9.8 Epigenomics
9.9 Exact Sciences Corporation
9.10 Exagen Diagnostics, Inc.
9.11 Exiqon
9.12 Ferrer inCode
9.13 Genomic Health, Inc.
9.14 Genoptix, Inc.
9.15 InterGenetics, Inc.
9.16 LabCorp
9.17 Myriad Genetics, Inc.
9.18 Nanostring
9.19 Neogenomics
9.20 Nuvera Biosciences
9.21 Orion Genomics
9.22 QIAGEN NV
9.23 Rosetta Genomics Ltd.
9.24 Seegene
9.25 Sequenom, Inc.
9.26 SABiosciences Corporation (Qiagen)
9.27 Source MDx
9.28 Targeted Molecular Diagnostics

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 Kirsten RNA Associated Rat Sarcoma 2 Virus Gene (KRAS) KRAS Mutation Test by Several Methodologies and Specialty Oncology Laboratories
Appendix 5: Overview of Microarrays

Index 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: Molecular Diagnostic Markets for Cancer Testing Globally, 2012
Figure 3.2: Molecular Diagnostic Markets for Cancer Testing U.S., 2012
Figure 3.3: Market Share for Key Companies in Global Molecular Diagnostics Cancer Testing Markets
Figure 3.4: Market Growth and Evolution of MDx 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: Global Market Size and Share of Breast Cancer Molecular Diagnostic Market, 2012
Figure 4.9: Incidence of CRC by Age Group
Figure 4.10: HNPCC Mutation Increases Risk of Cancer
Figure 4.11: APC Mutation Increases the Risk of Cancer
Figure 4.12: U.S. Market Share of Colon Cancer Molecular Diagnostic Market, 2012
Figure 4.13: Prostate-Specific Membrane Antigen
Figure 4.14: PCA3 Score Nomogram
Figure 4.15: Estimates for PCA3 Test Volume in the U.S., 2005-2012
Figure 4.16: Ovarian Cancer Types
Figure 4.17: U.S. Market Share of Ovarian Cancer Molecular Diagnostic Market, 2012
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, 1991-2011
Figure 7.1: OBQI and the Relationship of Governmental Regulatory Agencies

Index 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, 2008-2018
Table 3.2: U.S. Market for Molecular Diagnostics Cancer Testing, 2008-2018
Table 3.3: Molecular Diagnostic Markets for Cancer Testing, 2012
Table 3.4: Key Diagnostic Companies in the Global Molecular Diagnostics Cancer Testing Market
Table 3.5: Key Laboratory Testing Companies in the Global Molecular Diagnostics Cancer Testing Market
Table 3.6: Business Factors Influencing Advanced Oncology Testing Services
Table 3.7: Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market
Table 3.8: Highlights of the Cancer Diagnostic Testing Segment
Table 3.9: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular Diagnostic Services
Table 3.10: Strategies for Marketing Cancer Diagnostic Products
Table 3.11: Key Elements of MDx Diagnostic Companies Marketing Plan
Table 4.1: Estimates for the Leading Sites of New Cancer Cases in the U.S. by Gender, 2013
Table 4.2: Estimates for the Leading Sites of Cancer Deaths in the U.S. by Gender, 2013
Table 4.3: Emerging Molecular Diagnostic Technologies
Table 4.4: Key Elements for Business Competition in Gene Expression Profiling for Cancer
Table 4.5: Key Elements for Future Success in the Gene Profiling for Cancer Segment
Table 4.6: Companies Marketing Products in the Cancer Molecular Diagnostics Sector
Table 4.7: Breast Cancer Overview
Table 4.8: Overview of ER/PR Testing and Response to Therapy
Table 4.9: Key Players in the Breast Cancer Molecular Diagnostic Space
Table 4.10: Commercially Available Molecular Diagnostic Products for Breast Cancer Assay
Table 4.11: Clinical Utility and Health Economic Benefits of Oncotype DX
Table 4.12: Oncotype DX Overview
Table 4.13: Comparison of Agendia vs. Genomic Health Breast Cancer Tests
Table 4.14: Overview of HER2/neu and Herceptin
Table 4.15: MammaPrint: Key Features
Table 4.16: Oncogene Science Biomarker Group Reagents
Table 4.17: Major Laboratory Testing Companies Marketing Breast Cancer Molecular Diagnostic Tests, 2012
Table 4.18: Global Market for Breast Cancer Molecular Diagnostic Testing, 2005-2012
Table 4.19: U.S. Market for Breast Cancer Molecular Diagnostic Testing, 2005-2012
Table 4.20: Global Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2013-2018
Table 4.21: U.S. Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2013-2018
Table 4.22: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
Table 4.23: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact
Table 4.24: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer Molecular Diagnostic Market
Table 4.25: Colorectal Cancer Overview
Table 4.26: KRAS Mutation Assay
Table 4.27: KRAS Assays by Analytical Type
Table 4.28: KRAS Mutation Analysis Summary
Table 4.29: DxS KRAS Mutation Test Summary
Table 4.30: KRAS and BRAF in Clinical Use
Table 4.31: Product Development Opportunities in Cancer Tumor Types, 2008
Table 4.32: Key Players in the Colorectal Cancer Molecular Diagnostic Space
Table 4.33: ArcticDx Genetic Test, Colo Risk
Table 4.34: NexCourse CRC Test Offering and Treatment Direction
Table 4.35: Global Market for Molecular Diagnostic Colon Cancer Testing, 2005-2012
Table 4.36: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2005-2012
Table 4.37: Global Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2013-2018
Table 4.38: U.S. Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2010-2018
Table 4.39: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
Table 4.40: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact
Table 4.41: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer Market
Table 4.42: Stages in Prostate Cancer Discovery and Diagnosis
Table 4.43: Corporate Players Entering the Prostate Cancer Molecular Diagnostic Space
Table 4.44: Gen-Probe Genetic Testing Product Line
Table 4.45: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
Table 4.46: Prostate Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact
Table 4.47: Summary of Strengths, Weaknesses, Opportunities and Threats of the Prostate Cancer Molecular Diagnostic Market
Table 4.48: Players in the Bladder Cancer Molecular Diagnostic Space
Table 4.49: Clinical Applications of Serum Biomarkers for Ovarian Cancer
Table 4.50: Commercially Available Molecular Diagnostic Products for Ovarian Cancer Assay
Table 4.51: Global Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2012
Table 4.52: U.S. Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2012
Table 4.53: Global Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2013-2016
Table 4.54: U.S. Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2013-2016
Table 4.55: Ovarian Cancer Molecular Diagnostic Testing Market: Market Drivers in Order of Impact
Table 4.56: Ovarian Cancer Molecular Diagnostic Testing Market: Market Restraints in Order of Impact
Table 4.57: Summary of Strengths, Weaknesses, Opportunities and Threats of the Ovarian Cancer Market
Table 4.58: Lung Cancer Survival Rates
Table 4.59: Lung Cancer Facts
Table 4.60: Pharmacogenetic Markers for Select Cancer Drugs
Table 4.61: Potential of Cancer Biomarkers in Drug Delivery and Development
Table 4.62: 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: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market
Table 5.9: Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions
Table 5.10: Total U.S. Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges
Table 5.11: 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, 2006-2012
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 8.1: Effect of Regulation on MDx Cancer Market Technology Platforms, 2007 and 2015
Table 8.2: Partnerships Between Pharmaceutical and Diagnostic Companies, 2009-Present
Table A2.1: Serum Tumor Markers Currently in Common Use

- Agendia
- ArcticDx, Inc
- Biodesix
- bioTheranostics (AviaraDx)
- Cancer Genetics, Inc
- Clarient, Inc (GE Healthcare)
- CombiMatrix Corporation
- Epigenomics
- Exact Sciences Corporation
- Exagen Diagnostics, Inc
- Exiqon
- Ferrer inCode
- Genomic Health, Inc
- Genoptix, Inc
- InterGenetics, Inc
- LabCorp
- Myriad Genetics, Inc
- Nanostring
- Neogenomics
- Nuvera Biosciences
- Orion Genomics
- QIAGEN NV
- Rosetta Genomics Ltd
- Seegene
- Sequenom, Inc
- SABiosciences Corporation (Qiagen)
- Source MDx
- Targeted Molecular Diagnostics

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