Molecular Diagnostics in Cancer Testing

Transcription

1 Product Sheet More information at Molecular Diagnostics in Cancer Testing Published: 2015-AUG-01 Pages: 231 Format: PDF Price: 4000 USD (Single User License) Description 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. TABLE OF CONTENTS 1. Overview Statement of Report About This Report Scope of the Report Objectives Methodology Executive Summary Introduction to Molecular Diagnostics Opening of Opportunities in Molecular Diagnostics Impact of the Human Genome Project on Molecular Diagnostics Considerations for Molecular and Clinical Diagnostics Molecular Diagnostics in the Post-Genomic Era Advances in Molecular Diagnostics Technologies Oligonucleotide Array Platforms Emerging Cancer Personalized Medicine Market Predictive Cancer Molecular Diagnostics Companion Tests for Drug Development Opportunities for IVDMIA Companies Next Generation Sequencing (NGS) Multi-Gene Cancer Panels 33

2 2.12 Liquid Biopsy Cancer Diagnostics Molecular Testing Market Market Description Market Overview Molecular Diagnostic Markers Competitive Landscape Sales and Marketing Strategies for Cancer Tests North American Market International Markets Europe Asia-Pacific Molecular Diagnostic Tests for Cancer Cancer Diagnostic Tests Use of Genomics to Understand Cancer Molecular Diagnostic Tools Solutions Technology of Gene Expression Analysis Amplify and Detect Diminished Amounts of RNA Consistently Analyze Hundreds of Genes Employ Advanced Information Technology Breast Cancer Cancer Prognostic Assays Myriad Genetics (BRCA1 and BRCA2) Genomic Health (Oncotype DX) Single Gene Reporting (ER, PR, HER2) Node Positive Aromatase Inhibitors Product Development Product Development Opportunities in Breast Cancer LabCorp (HER-2) Clarient Diagnostic Services (GE Healthcare) BioTheronostics (AviaraDx) Agendia B.V. (MammaPrint) Genetic Technologies Ltd Ventana Medical Systems (Roche) Ambry Genetics Counsyl Quest Diagnostics Invitae Gene By Gene Bioreference Laboratories Sophia Genetics Competition and Comparison of Methods Competitive Structure and Market Share Analysis Breast Cancer Molecular Diagnostic Testing Market Size Global Market U.S. Market European Market Market Forecasts Revenue Forecasts Market Drivers and Restraints Market Drivers Market Restraints Breast Cancer Molecular Diagnostic Testing Assay Market and Technology Trends Breast Cancer Molecular Diagnostic Testing Assay Market Trends Breast Cancer Molecular Diagnostic Testing Assay Technology Trends 78

3 Breast Cancer Testing Assay Strategic Recommendations Colorectal Cancer Molecular Diagnostics Market Colon Cancer Testing Platforms Genomic Testing IVD Multiplex Index Analysis The BRAF Test KRAS Background on KRAS Mutation msept Screening Test Players in the Colorectal Cancer Space Agendia BioTheranostics Clarient Genomic Health Epigenomics Exact Sciences Qiagen Arctic Dx Myriad Genetics Exiqon Diagnostics Genoptix Medical Genomictree Competitive Structure and Market Share Analysis Colon Cancer Molecular Diagnostic Testing Market Size Global Colon Cancer Testing Market U.S. Colon Cancer Testing Market European Colon Cancer Testing Market Market Forecasts Revenue Forecasts Market Drivers and Restraints Market Drivers Market Restraints Colon Cancer Molecular Diagnostic Testing Assay Market and Technology Trends Colon Cancer Molecular Diagnostic Testing Assay Market Trends Colon Cancer Molecular Diagnostic Testing Assay Technology Trends Colon Cancer Molecular Diagnostic Testing Assay Strategic Recommendations Prostate Cancer Molecular Diagnostics Market Screening for Prostate Cancer PSA Screening Test for Prostate Cancer PCA3 Screening Test for Prostate Cancer Hologic, Inc Beckman Coulter (Danaher) Prostate Health Index Opko Health 4KScore Metabolon Prostarix DRE Urine Test Exome Diagnostics Tests After Positive Biopsy Myriad Genetics (Prolaris) Genomic Health (Oncotype Dx) Bostwick Laboratories (ProstaVysion) Metamark Genetics (ProMark) Tests After Negative Biopsy Mitomics (Prostate Core Test) MDxHealth (ConfirmMDx) Tests After Surgery 107

4 GenomeDx (Decipher) Iris International (Nadia ProsVue) Competition and Comparison of Methods Competitive Structure and Market Share Analysis Market Drivers and Restraints Market Drivers Market Restraints Prostate Cancer Molecular Diagnostic Testing Assay Market and Technology Trends Prostate Cancer Molecular Diagnostic Testing Assay Market Trends Prostate Cancer Molecular Diagnostic Testing Assay Technology Trends Other Cancer Molecular Diagnostic Markets Bladder Cancer Ovarian Cancer Incidence of Ovarian Cancer Key Players in Ovarian Testing Market Ovarian Cancer Market Size Ovarian Cancer Molecular Diagnostic Testing Market Size Global Ovarian Cancer Testing Market U.S. Ovarian Cancer Testing Market European Ovarian Cancer testing Market Market Forecasts Revenue Forecasts Market Drivers and Restraints Market Drivers Market Restraints Ovarian Cancer Molecular Diagnostic Testing Assay Market and Technology Trends Ovarian Cancer Molecular Diagnostic Testing Assay Market Trends Ovarian Cancer Molecular Diagnostic Testing Assay Technology Trends Ovarian Cancer Molecular Diagnostic Testing Assay Strategic Recommendations Lung Cancer Melanoma Molecular Diagnostic Screening Test for Cancer Extreme Drug Resistance Assay (Oncotech EDR Assay) Multidrug Resistance Protein Companion Diagnostic Tests for Cancer Therapeutics Business Technology and Market Trends Technology Trends Market Trends M&A Activity Partnerships Competitive Analysis Primary Competitors Summary of Market Strengths, Weaknesses, Opportunities and Threats Industry Challenges and Strategic Recommendations Commercialization of Molecular Diagnostic Products SWOT Comparison of Business Models for Cancer Diagnostic Testing Intellectual Property Rights BRCA1 and BRCA2 Gene Patents Current Patent Disputes Reimbursement and Billing Overview Trends in Reimbursement Practice Medicare Reimbursement Analysis of ROI for MDx Tests for Cancer Using Medicare Reimbursement Rules 175

5 6.2.3 Reimbursement for Oncotype Dx, MammaPrint Breast Cancer Tests Colon Cancer Tests Trends in Patient Care and Reimbursement Revenue Threats Medicare Exceptions Three Areas for Denial of Claims by Biomarkers Billing Medicare Billing Procedures Medicare CPT Coding Rules for Cancer Biomarkers Government Regulation U.S. Food and Drug Administration CLIA Regulations Clinical Laboratory Improvement Act State Licensing for Service Laboratories FDA Treatment of Multivariate Index Assays (k) Clearance Pre-Market Approval ASRs What Regulatory Guidance is Needed for Companion Biomarkers? U.S. Patent and Trademark Office IRB Approval in Clinical Trials Oncology Biomarkers Qualification Initiative Project FDA Clearance Picture for Insight Dx, MammaPrint and Oncotype DX Microarray Quality Control ER and PR Proficiency Testing Business Decisions Using Molecular Diagnostic Tests in Cancer Test Development What are the Key Opportunities for Development of Cancer Tests Based Upon Molecular Diagnostics Technologies? What are the Current Obstacles for Implementation of Molecular Diagnostics for Cancer? How do Business Strategies, such as those Relating to Acquisition, Drive Biomarker Strategies? Which Types of Cancer Testing should be Developed by Molecular Diagnostic Companies at Various Stages in the Development Pipeline? How can Regulatory Oversight Drive Approval and Adoption of New Technologies? What are the Noteworthy Deals? Who are the Acquirers? Who are the Target Companies? In what Class of Drugs is the Value of Using Genetic Biomarkers in Decision-Making the Highest? How Can Regulatory Oversight Drive Approval and Adoption of New Technologies? How can Big Pharma Co-Develop Genetic Biomarkers for Regulatory Acceptance? How are Genetic Biomarkers Being Used to Reduce the Attrition Rate in Drug Development? How is ROI Measured Using Genetic Biomarkers in Drug Development? How might Organizational Structures Limit the Use of Genetic Biomarkers in Drug Development and how should R&D Organizations Address this Problem? How to Maximize Business Development through Biomarker Strategies? What is the Best Type of Business Model for Developing Genetic Biomarkers? What are Organizational Impediments in Genetic Biomarkers in Drug Development? What are Internal Capabilities for Novel Biomarker Development and Application? How can Key Biomarker Technical Expertise be Applied Across a Complex and Highly-Stratified R&D Value Chain? At what Stage of Drug Development has Genetic Biomarkers Provided the most Benefit? What Companies are the most Innovative in Development of Genetic Cancer Biomarkers? Best Values for Genetic Biomarkers in Drug Development and in Diagnostics Molecular Diagnostic Tests can Increase Value in an Associated Drug Business Developments in Next Generation Sequencing 204

6 9. Company Profiles Abbott Molecular Diagnostics Accugenomics, Inc Agendia Ambry Genetics Biodesix biomérieux biotheranostics (AviaraDx) Cancer Genetics, Inc Clarient, Inc. (GE Healthcare) Counsyl Flatiron Health Epigenomics Exact Sciences Corporation Exiqon Genomic Health, Inc Genoptix, Inc. (Novartis) Genmark Diagnostics Genomictree HTG Molecular Diagnostics Invitae LabCorp Myriad Genetics, Inc Nanostring Neogenomics NSTG Nuvera Biosciences Orion Genomics Pathway Genomics Personal Genome Diagnostics Quest Diagnostics Rosetta Genomics Ltd Signal Genetics Source MDx Wilex, Inc. 225 Appendix 1: Definition of Terms for Molecular Diagnostics 226 Appendix 2: Standard Cancer Therapeutic Panels 228 INDEX OF FIGURES Figure 2.1: Finding Genes with Microassays 18 Figure 2.2: Use of Microassays for Studying Gene Expression 18 Figure 2.3: Using DNA Microarrays to Compare Cancer and Normal Cells 19 Figure 2.4: Microarrays for Prediction of Survival in Cancer 21 Figure 2.5: Finding New Drugs with Microarrays 26 Figure 2.6: Using Gene Expression Patterns to Chose Treatment 26 Figure 3.1: Molecular Diagnostic Markets for Cancer Testing Globally, Figure 3.2: Molecular Diagnostic Markets for Cancer Testing in the U.S., Figure 3.3: Market Share for Key Companies in Global Molecular Diagnostics Cancer Testing Market 37 Figure 3.4: Market Growth and Evolution of MDx Cancer Biomarkers 44 Figure 4.1: Using DNA Microassays to Measure Gene Expression 49 Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients 50 Figure 4.3: HER-2/NEU Protein as a Target in Cancer Therapy 63 Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 65 Figure 4.5: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 65

7 Figure 4.6: Action of Herceptin in Breast Cancer Patients 66 Figure 4.7: Analysis of Cancer Tissue by Microarray 68 Figure 4.8: Global Market Size and Share of Breast Cancer Molecular Diagnostic Market, Figure 4.9: Incidence of CRC by Age Group 80 Figure 4.10: HNPCC Mutation Increases Risk of Cancer 89 Figure 4.11: APC Mutation Increases Risk of Cancer 90 Figure 4.12: U.S. Market Share of Colon Cancer Molecular Diagnostic Market, Figure 4.13: Prostate-Specific Membrane Antigen 99 Figure 4.14: PCA3 Score Nomogram 101 Figure 4.15: Estimates for PCA3 Test Volume in the U.S., Figure 4.16: Ovarian Cancer Types 115 Figure 4.17: U.S. Market Share of Ovarian Cancer Molecular Diagnostic Market, Figure 5.1: FDA Co-Developed Products as a Model for Collaboration 144 Figure 5.2: Segmentation of the Biomarker Development Market 166 Figure 6.1: Number of Oncotype DX Tests Performed, Figure 7.1: OBQI and the Relationship of Governmental Regulatory Agencies 191 INDEX OF TABLES Table 2.1: Genes and Cancer Risk 21 Table 2.2: Use of Cancer Biomarkers to Enhance Patient Care 25 Table 2.3: Targeted Drug Therapies for Cancers 26 Table 2.4: Use of Cancer Biomarkers in Drug Development 29 Table 2.5: Utility of Biomarkers as Companion Diagnostics to Drug Development 30 Table 2.6: FDA Approved Companion Diagnostics 30 Table 3.1: Global Market for Molecular Diagnostics Cancer Testing, Table 3.2: U.S. Market for Molecular Diagnostics Cancer Testing, Table 3.3: Molecular Diagnostic Markets for Cancer Testing, Table 3.4: Key Diagnostic Product Companies in the Global Molecular Diagnostics Cancer Testing Market 37 Table 3.5: Key Laboratory Testing Companies in the Global Molecular Diagnostics Cancer Testing Market 38 Table 3.6: Business Factors Influencing Advanced Oncology Testing Services 39 Table 3.7: Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market 40 Table 3.8: Highlights of the Cancer Diagnostic Testing Segment 41 Table 3.9: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular Diagnostic Services 41 Table 3.10: Strategies for Marketing Cancer Diagnostic Products 44 Table 3.11: Key Elements of MDx Diagnostic Companies Marketing Plan 45 Table 4.1: Estimates for the Leading Sites of New Cancer Cases in the U.S. by Gender, Table 4.2: Estimates for the Leading Sites of Cancer Deaths in the U.S. by Gender, Table 4.3: Emerging Molecular Diagnostic Technologies 51 Table 4.4: Key Elements for Business Competition in Gene Expression Profiling for Cancer 53 Table 4.5: FDA Approved Cancer Tests 54 Table 4.6: Breast Cancer Overview 56 Table 4.7: Overview of ER/PR Testing and Response to Therapy 57 Table 4.8: Key Players in the Breast Cancer Molecular Diagnostic Space 58 Table 4.9: Commercially Available Molecular Diagnostic Laboratory Services for Breast Cancer Assay 58 Table 4.10: Clinical Utility and Health Economic Benefits of Oncotype DX 60 Table 4.11: Oncotype DX Overview 60 Table 4.12: Comparison of Agendia vs. Genomic Health Breast Cancer Tests 61 Table 4.13: Overview of HER2/neu and Herceptin 64 Table 4.14: MammaPrint: Key Features 69 Table 4.15: Major Laboratory Testing Companies Marketing Breast Cancer Molecular Diagnostic Tests, Table 4.16: Global Market for Breast Cancer Molecular Diagnostic Testing, Table 4.17: U.S. Market for Breast Cancer Molecular Diagnostic Testing, Table 4.18: Global Market Forecast for Breast Cancer Molecular Diagnostic Testing,

8 Table 4.19: U.S. Market Forecast for Breast Cancer Molecular Diagnostic Testing, Table 4.20: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact 77 Table 4.21: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact 78 Table 4.22: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer Molecular Diagnostic Market 79 Table 4.23: Colorectal Cancer Overview 81 Table 4.24: KRAS Mutation Assay 82 Table 4.25: KRAS Assays by Analytical Type 83 Table 4.26: KRAS Mutation Analysis Summary 83 Table 4.27: DxS KRAS Mutation Test Summary 84 Table 4.28: KRAS and BRAF in Clinical Use 84 Table 4.29: Key Players in the Colorectal Cancer Molecular Diagnostic Space 85 Table 4.30: NexCourse CRC Test Offering and Treatment Direction 91 Table 4.31: Global Market for Molecular Diagnostic Colon Cancer Testing, Table 4.32: U.S. Market for Molecular Diagnostic Colon Cancer Testing, Table 4.33: Global Market Forecast for Colon Cancer Molecular Diagnostic Testing, Table 4.34: U.S. Market Forecast for Colon Cancer Molecular Diagnostic Testing, Table 4.35: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact 94 Table 4.36: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact 95 Table 4.37: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer Market 97 Table 4.38: Stages in Prostate Cancer Discovery and Diagnosis 98 Table 4.39: Corporate Players Entering the Prostate Cancer Molecular Diagnostic Space 99 Table 4.40: Hologic Genetic Testing Product Line 103 Table 4.41: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact 109 Table 4.42: Prostate Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact 110 Table 4.43: Summary of Strengths, Weaknesses, Opportunities and Threats of the Prostate Cancer Molecular Diagnostic Market 110 Table 4.44: Players in the Bladder Cancer Molecular Diagnostic Space 113 Table 4.45: Commercially Available Molecular Diagnostic Products for Ovarian Cancer Assay 118 Table 4.46: Global Market for Molecular Diagnostic Ovarian Cancer Testing, Table 4.47: U.S. Market for Molecular Diagnostic Ovarian Cancer Testing, Table 4.48: Global Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, Table 4.49: U.S. Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, Table 4.50: Ovarian Cancer Molecular Diagnostic Testing Market: Market Drivers in Order of Impact 121 Table 4.51: Ovarian Cancer Molecular Diagnostic Testing Market: Market Restraints in Order of Impact 122 Table 4.52: Summary of Strengths, Weaknesses, Opportunities and Threats of the Ovarian Cancer Market 123 Table 4.53: Lung Cancer Survival Rates 123 Table 4.54: Lung Cancer Facts 124 Table 4.55: Pharmacogenetic Markers for Select Cancer Drugs 128 Table 4.56: Potential of Cancer Biomarkers in Drug Delivery and Development 132 Table 4.57: Barriers to Adoption of Biomarkers in Clinical Use 132 Table 5.1: Technology Trends in Cancer Testing 136 Table 5.2: Trends in Theranostics 137 Table 5.3: Market Trends in Cancer Testing 138 Table 5.4: Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order of Impact 138 Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in Order of Impact 138 Table 5.6: Companies that Offer Products to Profile Gene Expression in Breast Cancer 150 Table 5.7: Principal Competitive Factors in the Cancer Screening Market 150 Table 5.8: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market 151 Table 5.9: Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions 152 Table 5.10: Total U.S. Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges 152 Table 5.11: Utility of Biomarkers as Companion Diagnostics to Drug Development 168 Table 6.1: CPT Codes for Tumor Markers 174 Table 6.2: Genomic Health Oncotype DX Sales,

9 Table 6.3: Factors Determining Third-Party Payment for Advanced Cancer Tests 180 Table 7.1: Rules that Affect the Ability of a Cancer Diagnostic Service Lab to Conduct Business 184 Table 7.2: Focus Areas for the FDA Critical Path Initiative 190 Table 8.1: Effect of Regulation on MDx Cancer Market Technology Platforms, 2007 and Table 8.2: Partnerships Between Pharmaceutical and Diagnostic Companies, 2009-Present 201 Table 9.1: Clarient Molecular/PCR Tests 210 Table of Contents 1. Overview Statement of Report About This Report Scope of the Report Objectives Methodology Executive Summary Introduction to Molecular Diagnostics Opening of Opportunities in Molecular Diagnostics Impact of the Human Genome Project on Molecular Diagnostics Considerations for Molecular and Clinical Diagnostics Molecular Diagnostics in the Post-Genomic Era Advances in Molecular Diagnostics Technologies Oligonucleotide Array Platforms Emerging Cancer Personalized Medicine Market Predictive Cancer Molecular Diagnostics Companion Tests for Drug Development Opportunities for IVDMIA Companies Next Generation Sequencing (NGS) Multi-Gene Cancer Panels Liquid Biopsy Cancer Diagnostics Molecular Testing Market Market Description Market Overview Molecular Diagnostic Markers Competitive Landscape Sales and Marketing Strategies for Cancer Tests North American Market International Markets Europe Asia-Pacific Molecular Diagnostic Tests for Cancer Cancer Diagnostic Tests Use of Genomics to Understand Cancer Molecular Diagnostic Tools Solutions Technology of Gene Expression Analysis Amplify and Detect Diminished Amounts of RNA Consistently Analyze Hundreds of Genes Employ Advanced Information Technology Breast Cancer Cancer Prognostic Assays Myriad Genetics (BRCA1 and BRCA2) Genomic Health (Oncotype DX) Single Gene Reporting (ER, PR, HER2) Node Positive Aromatase Inhibitors Product Development Product Development Opportunities in Breast Cancer LabCorp (HER-2) Clarient Diagnostic Services (GE Healthcare) BioTheronostics (AviaraDx) Agendia B.V. (MammaPrint) Genetic Technologies Ltd Ventana Medical Systems (Roche) Ambry Genetics Counsyl Quest Diagnostics Invitae Gene By Gene Bioreference Laboratories 72

10 Sophia Genetics Competition and Comparison of Methods Competitive Structure and Market Share Analysis Breast Cancer Molecular Diagnostic Testing Market Size Global Market U.S. Market European Market Market Forecasts Revenue Forecasts Market Drivers and Restraints Market Drivers Market Restraints Breast Cancer Molecular Diagnostic Testing Assay Market and Technology Trends Breast Cancer Molecular Diagnostic Testing Assay Market Trends Breast Cancer Molecular Diagnostic Testing Assay Technology Trends Breast Cancer Testing Assay Strategic Recommendations Colorectal Cancer Molecular Diagnostics Market Colon Cancer Testing Platforms Genomic Testing IVD Multiplex Index Analysis The BRAF Test KRAS Background on KRAS Mutation msept Screening Test Players in the Colorectal Cancer Space Agendia BioTheranostics 86 Ordering Order Online - Order by Fax - using the form below Order by Post - print the order form below and send to: BioMarket Group Björnnäsvägen STOCKHOLM SWEDEN

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