AArkstore enterprise 16th September 2014
Aarkstore Enterprise - Molecular Diagnostics in Cancer Testing Browse Full Report @ http://www.aarkstore.com/healthcare/35962/Molecular-Diagnostics-inCancer-Testing Published: Nov 2013 No. Of Pages: 232 Pages PDF: $3400 | Site Licence: $6800 | Enterprise Wide Licence: $10200
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.
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Table of Contents: 1. Overview 9 1.1 Statement of Report 9 1.2 About This Report 9 1.3 Scope of the Report 10 1.4 Objectives 10 1.5 Methodology 10 1.6 Executive Summary 12 2. Introduction to Molecular Diagnostics 16 2.1 Opening of Opportunities in Molecular Diagnostics 16 2.2 Impact of the Human Genome Project on Molecular Diagnostics 18 2.3 Considerations for Molecular and Clinical Diagnostics 18 2.4 Molecular Diagnostics in the Post-Genomic Era 21 2.5 Advances in Molecular Diagnostics Technologies 22 2.6 Oligonucleotide Array Platforms 24 2.7 Emerging Cancer Personalized Medicine Market 24 2.7.1 Predictive Cancer Molecular Diagnostics 26 2.8 Companion Tests for Drug Development 27 2.9 Opportunities for IVDMIA Companies 29 3. Cancer Diagnostics Molecular Testing Market 30 3.1 Market Description 34 3.1.1 Market Overview 34 3.1.2 Molecular Diagnostic Markers 35
AArkstore enterprise 3.1.3 Competitive Landscape 36 3.1.4 Sales and Marketing Strategies for Cancer Tests 38 4. Molecular Diagnostic Tests for Cancer 42 4.1 Cancer Diagnostic Tests 42 4.1.1 Use of Genomics to Understand Cancer 43 4.1.2 Molecular Diagnostic Tools Solutions 45 4.1.3 Technology of Gene Expression Analysis 47 4.2 Breast Cancer 49 4.2.1 Cancer Prognostic Assays 51 4.2.2 Competition and Comparison of Methods 65 4.2.3 Competitive Structure and Market Share Analysis 66 4.3 Colorectal Cancer Molecular Diagnostics Market 71 4.3.1 Colon Cancer Testing Platforms 73 4.3.2 Players in the Colorectal Cancer Space 79 4.3.3 Competitive Structure and Market Share Analysis 85 4.4 Prostate Cancer Molecular Diagnostics Market 91 4.4.1 Screening for Prostate Cancer 91 4.4.2 Tests after Positive Biopsy 97 4.4.3 Tests After Negative Biopsy 99 4.4.4 Tests After Surgery 100 4.4.5 Competition and Comparison of Methods 100 4.4.6 Competitive Structure and Market Share Analysis 101 4.4.7 Market Drivers and Restraints 102 4.4.8 Prostate Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 103 4.5 Other Cancer Molecular Diagnostic Markets 106 4.5.1 Bladder Cancer 106 4.5.2 Ovarian Cancer 107 4.5.3 Lung Cancer 118 4.5.4 Melanoma 124 4.6 Molecular Diagnostic Screening Test for Cancer 125 4.6.1 Extreme Drug Resistance assay (Oncotech EDR Assay) 126 4.6.2 Multidrug Resistance Protein 127 4.7 Companion Diagnostic Tests for Cancer Therapeutics 127
AArkstore enterprise 5. Business 131 5.1 Technology and Market Trends 131 5.1.1 Technology Trends 132 5.1.2 Market Trends 133 5.2 M&A Activity 135 5.3 Partnerships 138 5.4 Competitive Analysis 141 5.4.1 Primary Competitors 147 5.4.2 Industry Challenges and Strategic Recommendations 149 5.4.3 Commercialization of Molecular Diagnostic Products 149 5.5 SWOT Comparison of Business Models for Cancer Diagnostic Testing 151 5.6 Intellectual Property Rights 167 5.6.1 BRCA1 and BRCA2 Gene Patents 168 5.6.2 Current Patent Disputes 168 6. Reimbursement and Billing 169 6.1 Overview 169 6.2 Trends in Reimbursement Practice 169 6.2.1 Medicare Reimbursement 170 6.2.2 Analysis of ROI for MDx Tests for Cancer Using Medicare Reimbursement Rules 173 6.2.3 Reimbursement for Insight Dx, MammaPrint and Oncotype Dx 174 6.2.4 Reimbursement for JAK2 Mutation Testing for Myeloproliferative Neoplasms 174 6.3 Breast Cancer Tests 174 6.4 Colon Cancer Tests 176 6.5 Trends in Patient Care and Reimbursement 178 6.6 Revenue Threats 180 6.6.1 Medicare Exceptions 181 6.6.2 Three Areas for Denial of Claims by Biomarkers 181 6.7 Billing 182 6.7.1 Medicare Billing Procedures 182 6.7.2 Medicare CPT Coding Rules for Cancer Biomarkers 183 7. Government Regulation 184
AArkstore enterprise 7.1 U.S. Food and Drug Administration 184 7.2 CLIA Regulations 185 7.3 Clinical Laboratory Improvement Act 186 7.4 State Licensing for Service Laboratories 187 7.5 FDA Treatment of Multivariate Index Assays 188 7.6 510(k) Clearance 189 7.7 Pre-Market Approval 189 7.8 ASRs 189 7.9 What Regulatory Guidance is Needed for Companion Biomarkers? 190 7.10 U.S. Patent and Trademark Office 191 7.11 IRB Approval in Clinical Trials 191 7.12 Oncology Biomarkers Qualification Initiative Project 191 7.13 FDA Clearance Picture for Insight Dx, MammaPrint, and Oncotype DX 192 7.14 FDA Packaging Requirements for Erbitux 192 7.15 Microarray Quality Control 192 7.16 CAP Evidence-based Recommendations to Improve the Accuracy of ER and PR Testing 193 7.17 ER and PR Proficiency Testing 193 8. Business Decisions Using Molecular Diagnostic Tests in Cancer Test Development 194 8.1 What are the Key Opportunities for Development of Cancer Tests Based Upon Molecular Diagnostics Technologies? 194 8.2 What are the Current Obstacles for MDx Cancer Testing Implementation? 194 8.3 How do Business Strategies, such as those Relating to Acquisition, Drive Biomarker Strategies? 195 8.4 Which Types of Cancer MDx Testing should be Developed by Diagnostic Companies at Various Stages in the Development Pipeline? 195 8.5 How can Regulatory Oversight Drive Approval and Adoption of New Technologies? 195 8.6 What are the Noteworthy Deals? 196 8.7 Who are the Acquirers? 197 8.8 Who are the Target Companies? 197 8.9 In what Class of Drugs is the Value of Using Genetic Biomarkers in Decision-making the Highest? 197 8.10 How can Regulatory Oversight Drive Approval and Adoption of New Technologies? 198 8.11 How can Big Pharma Co-develop Genetic Biomarkers for Regulatory Acceptance? 198
AArkstore enterprise 8.12 How are Genetic Biomarkers Being Used to Reduce the Attrition Rate in Drug Development? 198 8.13 How is ROI Measured Using Genetic Biomarkers in Drug Development? 198 8.14 How might Organizational Structures Limit the Use of Genetic Biomarkers in Drug Development and How Should R&D Organizations Address this Problem? 198 8.15 How to Maximize Business Development through Biomarker Strategies? 199 8.16 What is the Best Type of Business Model for Developing Genetic Biomarkers? 199 8.17 What are Organizational Impediments in Genetic Biomarkers in Drug Development? 199 8.18 What are Internal Capabilities for Novel Biomarker Development and Application? 199 8.19 How can Key Biomarker Technical Expertise be Applied across a Complex and HighlyStratified R&D Value Chain? 200 8.20 At what Stage of Drug Development has Genetic Biomarkers Provided the Most Benefit? 200 8.21 What Companies are the most Innovative in Development of Genetic Biomarkers? 200 8.22 Best Values for Genetic Biomarkers in Drug Development and in Diagnostics 203 8.23 Molecular Diagnostic Tests can Increase Value in an Associated Drug 204 9. Company Profiles 205 9.1 Agendia 205 9.2 ArcticDx, Inc. 205 9.3 Biodesix 206 9.4 bioTheranostics (AviaraDx) 206 9.5 Cancer Genetics, Inc. 207 9.6 Clarient, Inc. (GE Healthcare) 208 9.7 CombiMatrix Corporation 208 9.8 Epigenomics 209 9.9 Exact Sciences Corporation 210 9.10 Exagen Diagnostics, Inc. 210 9.11 Exiqon 211 9.12 Ferrer inCode 211 9.13 Genomic Health, Inc. 211 9.14 Genoptix, Inc. 212 9.15 InterGenetics, Inc. 213 9.16 LabCorp 213 9.17 Myriad Genetics, Inc. 213
AArkstore enterprise 9.18 Nanostring 215 9.19 Neogenomics 215 9.20 Nuvera Biosciences 215 9.21 Orion Genomics 216 9.22 QIAGEN NV 216 9.23 Rosetta Genomics Ltd. 217 9.24 Seegene 217 9.25 Sequenom, Inc. 217 9.26 SABiosciences Corporation (Qiagen) 218 9.27 Source MDx 218 9.28 Targeted Molecular Diagnostics 219 Appendix 1: Definition of Terms for Molecular Diagnostics 220 Appendix 2: Standard Cancer Therapeutic Panels 222 Appendix 3: Menu of Specialized Technologies Used to Assess and Characterize Cancer 225 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 227 Appendix 5: Overview of Microarrays 229
List of Tables Table 2.1: Genes and Cancer Risk 20 Table 2.2: Use of Cancer Biomarkers to Enhance Patient Care 25 Table 2.3: Targeted Drug Therapies for Cancers 25 Table 2.4: Use of Cancer Biomarkers in Drug Development 28 Table 2.5: Utility of Biomarkers as Companion Diagnostics to Drug Development 28 Table 2.6: Time Line for Development of Companion Diagnostics 29 Table 3.1: Global Market for Molecular Diagnostics Cancer Testing, 2008-2018 30 Table 3.2: U.S. Market for Molecular Diagnostics Cancer Testing, 2008-2018 30 Table 3.3: Molecular Diagnostic Markets for Cancer Testing, 2012 31 Table 3.4: Key Diagnostic Companies in the Global Molecular Diagnostics Cancer Testing Market 32
AArkstore enterprise Table 3.5: Key Laboratory Testing Companies in the Global Molecular Diagnostics Cancer Testing Market 32 Table 3.6: Business Factors Influencing Advanced Oncology Testing Services 33 Table 3.7: Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market 34 Table 3.8: Highlights of the Cancer Diagnostic Testing Segment 35 Table 3.9: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular Diagnostic Services 35 Table 3.10: Strategies for Marketing Cancer Diagnostic Products 39 Table 3.11: Key Elements of MDx Diagnostic Companies Marketing Plan 40 Table 4.1: Estimates for the Leading Sites of New Cancer Cases in the U.S. by Gender, 2013 42 Table 4.2: Estimates for the Leading Sites of Cancer Deaths in the U.S. by Gender, 2013 42 Table 4.3: Emerging Molecular Diagnostic Technologies 46 Table 4.4: Key Elements for Business Competition in Gene Expression Profiling for Cancer 48 Table 4.5: Key Elements for Future Success in the Gene Profiling for Cancer Segment 48 Table 4.6: Companies Marketing Products in the Cancer Molecular Diagnostics Sector 49 Table 4.7: Breast Cancer Overview 50 Table 4.8: Overview of ER/PR Testing and Response to Therapy 51 Table 4.9: Key Players in the Breast Cancer Molecular Diagnostic Space 52 Table 4.10: Commercially Available Molecular Diagnostic Products for Breast Cancer Assay 52 Table 4.11: Clinical Utility and Health Economic Benefits of Oncotype DX 54 Table 4.12: Oncotype DX Overview 54 Table 4.13: Comparison of Agendia vs. Genomic Health Breast Cancer Tests 55 Table 4.14: Overview of HER2/neu and Herceptin 58 Table 4.15: MammaPrint: Key Features 63 Table 4.16: Oncogene Science Biomarker Group Reagents 64 Table 4.17: Major Laboratory Testing Companies Marketing Breast Cancer Molecular Diagnostic Tests, 2012 66 Table 4.18: Global Market for Breast Cancer Molecular Diagnostic Testing, 2005-2012 67 Table 4.19: U.S. Market for Breast Cancer Molecular Diagnostic Testing, 2005-2012 68 Table 4.20: Global Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2013-2018 69 Table 4.21: U.S. Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2013-2018 69 Table 4.22: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact 69
AArkstore enterprise Table 4.23: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact 70 Table 4.24: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer Molecular Diagnostic Market 71 Table 4.25: Colorectal Cancer Overview 73 Table 4.26: KRAS Mutation Assay 74 Table 4.27: KRAS Assays by Analytical Type 75 Table 4.28: KRAS Mutation Analysis Summary 75 Table 4.29: DxS KRAS Mutation Test Summary 76 Table 4.30: KRAS and BRAF in Clinical Use 77 Table 4.31: Product Development Opportunities in Cancer Tumor Types, 2008 78 Table 4.32: Key Players in the Colorectal Cancer Molecular Diagnostic Space 79 Table 4.33: ArcticDx Genetic Test, Colo Risk 82 Table 4.34: NexCourse CRC Test Offering and Treatment Direction 84 Table 4.35: Global Market for Molecular Diagnostic Colon Cancer Testing, 2005-2012 85 Table 4.36: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2005-2012 86 Table 4.37: Global Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2013-2018 87 Table 4.38: U.S. Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2010-2018 87 Table 4.39: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact 87 Table 4.40: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact 88 Table 4.41: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer Market 90 Table 4.42: Stages in Prostate Cancer Discovery and Diagnosis 91 Table 4.43: Corporate Players Entering the Prostate Cancer Molecular Diagnostic Space 92 Table 4.44: Gen-Probe Genetic Testing Product Line 96 Table 4.45: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact 102 Table 4.46: Prostate Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact 102 Table 4.47: Summary of Strengths, Weaknesses, Opportunities and Threats of the Prostate Cancer Molecular Diagnostic Market 103
AArkstore enterprise Table 4.48: Players in the Bladder Cancer Molecular Diagnostic Space 106 Table 4.49: Clinical Applications of Serum Biomarkers for Ovarian Cancer 108 Table 4.50: Commercially Available Molecular Diagnostic Products for Ovarian Cancer Assay 114 Table 4.51: Global Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2012 114 Table 4.52: U.S. Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2012 115 Table 4.53: Global Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2013-2016 116 Table 4.54: U.S. Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2013-2016 116 Table 4.55: Ovarian Cancer Molecular Diagnostic Testing Market: Market Drivers in Order of Impact 116 Table 4.56: Ovarian Cancer Molecular Diagnostic Testing Market: Market Restraints in Order of Impact 117 Table 4.57: Summary of Strengths, Weaknesses, Opportunities and Threats of the Ovarian Cancer Market 118 Table 4.58: Lung Cancer Survival Rates 118 Table 4.59: Lung Cancer Facts 119 Table 4.60: Pharmacogenetic Markers for Select Cancer Drugs 123 Table 4.61: Potential of Cancer Biomarkers in Drug Delivery and Development 128 Table 4.62: Barriers to Adoption of Biomarkers in Clinical Use 128 Table 5.1: Technology Trends in Cancer Testing 132 Table 5.2: Trends in Theranostics 133 Table 5.3: Market Trends in Cancer Testing 134 Table 5.4: Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order of Impact 134 Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in Order of Impact 135 Table 5.6: Companies That Offer Products to Profile Gene Expression in Breast Cancer 147 Table 5.7: Principal Competitive Factors in the Cancer Screening Market 147 Table 5.8: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market 148 Table 5.9: Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions 149 Table 5.10: Total U.S. Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges 149
AArkstore enterprise Table 5.11: Utility of Biomarkers as Companion Diagnostics to Drug Development 166 Table 6.1: CPT Codes for Tumor Markers 172 Table 6.2: Genomic Health Oncotype DX Sales, 2006-2012 175 Table 6.3: Drivers in KRAS Testing 177 Table 6.4: 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 191 Table 8.1: Effect of Regulation on MDx Cancer Market Technology Platforms, 2007 and 2015 195 Table 8.2: Partnerships Between Pharmaceutical and Diagnostic Companies, 2009-Present 201 Table A2.1: Serum Tumor Markers Currently in Common Use 224
List of Figures Figure 2.1: Finding Genes with Microassays 17 Figure 2.2: Use of Microassays for Studying Gene Expression 17 Figure 2.3: Using DNA Microarrays to Compare Cancer and Normal Cells 18 Figure 2.4: Microarrays for Prediction of Survival in Cancer 20 Figure 2.5: Finding New Drugs with Microarrays 25 Figure 2.6: Using Gene Expression Patterns to Chose Treatment 26 Figure 2.7: Segmentation of the Biomarker Development Market 27 Figure 3.1: Molecular Diagnostic Markets for Cancer Testing Globally, 2012 31 Figure 3.2: Molecular Diagnostic Markets for Cancer Testing U.S., 2012 31 Figure 3.3: Market Share for Key Companies in Global Molecular Diagnostics Cancer Testing Markets 32 Figure 3.4: Market Growth and Evolution of MDx Cancer Biomarkers 39 Figure 4.1: Using DNA Microassays to Measure Gene Expression 44 Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients 44 Figure 4.3: HER-2/NEU Protein as a Target in Cancer Therapy 58 Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 59 Figure 4.5: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 59 Figure 4.6: Action of Herceptin in Breast Cancer Patients 60
AArkstore enterprise Figure 4.7: Analysis of Cancer Tissue by Microarray 62 Figure 4.8: Global Market Size and Share of Breast Cancer Molecular Diagnostic Market, 2012 67 Figure 4.9: Incidence of CRC by Age Group 72 Figure 4.10: HNPCC Mutation Increases Risk of Cancer 83 Figure 4.11: APC Mutation Increases the Risk of Cancer 83 Figure 4.12: U.S. Market Share of Colon Cancer Molecular Diagnostic Market, 2012 86 Figure 4.13: Prostate-Specific Membrane Antigen 92 Figure 4.14: PCA3 Score Nomogram 94 Figure 4.15: Estimates for PCA3 Test Volume in the U.S., 2005-2012 95 Figure 4.16: Ovarian Cancer Types 107 Figure 4.17: U.S. Market Share of Ovarian Cancer Molecular Diagnostic Market, 2012 115 Figure 5.1: FDA Co-developed Products as a Model for Collaboration 139 Figure 5.2: Segmentation of the Biomarker Development Market 165 Figure 6.1: Number of Oncotype DX Tests Performed, 1991-2011 174 Figure 7.1: OBQI and the Relationship of Governmental Regulatory Agencies 192 Related reports:
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