Keywords : molecular diagnostic, cancer testing, Microarray, In Vitro Diagnostic, Urine Test, clinical laboratory, Microarray device, in vitro
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 us...
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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.
Global In Vitro Diagnostic Industry
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 18
2.1 Opening-up of Opportunities in Molecular Diagnostics 18
2.2 Impact of the Human Genome Project on Molecular Diagnostics 20
2.3 Considerations for Molecular and Clinical Diagnostics 20
2.4 Molecular Diagnostics in the Post-Genomic Era 23
2.5 Advances in Molecular Diagnostics Technologies 24
2.6 Oligonucleotide Array Platforms 26
2.7 Emerging Cancer Personalized Medicine Market 26
2.7.1 Predictive Cancer Molecular Diagnostics 28
2.8 Companion Tests for Drug Development 29
2.9 Opportunities for IVDMIA Companies 31
3. Cancer Diagnostics Molecular Testing Market 32
3.1 Market Description 36
3.1.1 Market Overview 36
3.1.2 Molecular Diagnostic Markers 37
3.1.3 Competitive Landscape 38
3.1.4 Sales and Marketing Strategies for Cancer Tests 40
3.1.4.1 North American Market 42
3.1.4.2 International Markets 43
3.1.4.3 Europe 43
3.1.4.4 Asia-Pacific 44
4. Molecular Diagnostic Tests for Cancer 45
4.1 Cancer Diagnostic Tests 45
4.1.1 Use of Genomics to Understand Cancer 46
4.1.2 Molecular Diagnostic Tools Solutions 48
4.1.3 Technology of Gene Expression Analysis 50
4.1.3.1 Amplify and Detect Diminished Amounts of RNA Consistently 50
4.1.3.2 Analyze Hundreds of Genes 51
4.1.3.3 Employ Advanced Information Technology 51
4.2 Breast Cancer 53
4.2.1 Cancer Prognostic Assays 55
4.2.1.1 Myriad Genetics (BRACA1 and BRACA2) 56
4.2.1.2 Genomic Health (Oncotype DX) 56
4.2.1.2.1 Single Gene Reporting (ER, PR, HER2) 59
4.2.1.2.2 Node Positive (N+) 59
4.2.1.2.3 Aromatase Inhibitors 60
4.2.1.2.4 Product Development 60
4.2.1.2.5 Product Development Opportunities in Breast Cancer 61
4.2.1.3 InterGenetics, Inc. 61
4.2.1.4 LabCorp (HER-2) 62
4.2.1.5 Clarient, Inc. (GE Healthcare) 64
4.2.1.6 BioTheronostics (AviaraDx) 65
4.2.1.7 Agendia B.V. (MammaPrint) 65
4.2.1.8 Oncogene Science (Wilex) 67
4.2.1.9 Ventana Medical Systems 69
4.2.2 Competition and Comparison of Methods 69
4.2.3 Competitive Structure and Market Share Analysis 70
4.2.3.1 Breast Cancer Molecular Diagnostic Testing Market Size 71
4.2.3.1.1 Global Market 71
4.2.3.1.2 U.S. Market 71
4.2.3.1.3 European Market 72
4.2.3.2 Market Forecasts 73
4.2.3.2.1 Revenue Forecasts 73
4.2.3.3 Market Drivers and Restraints 73
4.2.3.3.1 Market Drivers 73
4.2.3.3.2 Market Restraints 74
4.2.3.4 Breast Cancer Molecular Diagnostic Testing Assay Market and Technology
Trends 74
4.2.3.4.1 Breast Cancer Molecular Diagnostic Testing Assay Market Trends 74
4.2.3.4.2 Breast Cancer Molecular Diagnostic Testing Assay Technology Trends 74
4.2.3.4.3 Breast Cancer Testing Assay Strategic Recommendations 74
4.3 Colorectal Cancer Molecular Diagnostics Market 75
4.3.1 Colon Cancer Testing Platforms 77
4.3.1.1 Genomic Testing 77
4.3.1.1.1 IVD Multiplex Index Analysis (MIA) 77
4.3.1.1.2 The BRAF Test 77
4.3.1.1.3 KRAS 78
4.3.1.1.3.1 Background on KRAS Mutation 78
4.3.1.1.4 mSEPT9 82
4.3.1.2 Screening Test 82
4.3.2 Players in the Colorectal Cancer Space 83
4.3.3 Competitive Structure and Market Share Analysis 89
4.3.3.1 Colon Cancer Molecular Diagnostic Testing Market Size 89
4.3.3.1.1 Global Colon Cancer Testing Market 89
4.3.3.1.2 U.S. Colon Cancer Testing Market 90
4.3.3.1.3 European Colon Cancer testing Market 91
4.3.3.2 Market Forecasts 91
4.3.3.2.1 Revenue Forecasts 91
4.3.3.3 Market Drivers and Restraints 92
4.3.3.3.1 Market Drivers 92
4.3.3.3.2 Market Restraints 92
4.3.3.4 Colon Cancer Molecular Diagnostic Testing Assay Market and Technology
Trends 92
4.3.3.4.1 Colon Cancer Molecular Diagnostic Testing Assay Market Trends 92
4.3.3.4.2 Colon Cancer Molecular Diagnostic Testing Assay Technology Trends 93
4.3.3.4.3 Colon Cancer Molecular Diagnostic Testing Assay Strategic
Recommendations 93
4.4 Prostate Cancer Molecular Diagnostics Market 95
4.4.1 Screening for Prostate Cancer 96
4.4.1.1 PSA Screening Test for Prostate Cancer 96
4.4.1.2 PCA3 Screening Test for Prostate Cancer 97
4.4.1.3 Gen-Probe 99
4.4.1.4 Beckman Coulter (Danaher) Prostate Health Index 101
4.4.1.5 Opko Health 4KScore 101
4.4.1.6 Metabolon Prostarix DRE Urine Test 102
4.4.2 Tests after Positive Biopsy 102
4.2.2.1 Myriad Genetics (Prolaris) 102
4.2.2.2 Genomic Health (Genomic Prostate Score) 102
4.2.2.3 Bostwick Laboratories (ProstaVysion) 103
4.2.2.4 Metamark Genetics (Biopsy Test) 103
4.4.3 Tests After Negative Biopsy 103
4.4.3.1 Mitomics (Prostate Core Test) 103
4.4.3.2 MDxHealth (Confirm MDx) 104
4.4.4 Tests After Surgery 105
4.4.4.1 GenomeDx Sciences (Decipher) 105
4.4.4.2 Iris International (Nadia ProsVue) 105
4.4.5 Competition and Comparison of Methods 105
4.4.6 Competitive Structure and Market Share Analysis 106
4.4.7 Market Drivers and Restraints 107
4.4.7.1 Market Drivers 107
4.4.7.2 Market Restraints 107
4.4.8 Prostate Cancer Molecular Diagnostic Testing Assay Market and Technology
Trends 107
4.4.8.1 Prostate Cancer Molecular Diagnostic Testing Assay Market Trends 107
4.4.8.2 Prostate Cancer Molecular Diagnostic Testing Assay Technology Trends 108
4.4.8.3 Prostate Cancer Testing Assay Strategic Recommendations 108
4.5 Other Cancer Molecular Diagnostic Markets 111
4.5.1 Bladder Cancer 111
4.5.2 Ovarian Cancer 111
4.5.2.1 Incidence of Ovarian Cancer 111
4.5.2.2 Key Players in Ovarian Testing market 116
4.5.2.3 Ovarian Cancer Market Size 119
4.5.2.4 Ovarian Cancer Molecular Diagnostic Testing Market Size 119
4.5.2.4.1 Global Ovarian Cancer Testing Market 119
4.5.2.4.2 U.S. Ovarian Cancer Testing Market 120
4.5.2.4.3 European Ovarian Cancer testing Market 121
4.5.2.5 Market Forecasts 121
4.5.2.5.1 Revenue Forecasts 121
4.5.2.6 Market Drivers and Restraints 122
4.5.2.6.1 Market Drivers 122
4.5.2.6.2 Market Restraints 122
4.5.2.7 Ovarian Cancer Molecular Diagnostic Testing Assay Market and Technology
Trends 122
4.5.2.7.1 Ovarian Cancer Molecular Diagnostic Testing Assay Market Trends 122
4.5.2.7.2 Ovarian Cancer Molecular Diagnostic Testing Assay Technology Trends
123
4.5.2.7.3 Ovarian Cancer Molecular Diagnostic Testing Assay Strategic
Recommendations 123
4.5.3 Lung Cancer 123
4.5.4 Melanoma 130
4.6 Molecular Diagnostic Screening Test for Cancer 131
4.6.1 Extreme Drug Resistance assay (Oncotech EDR Assay) 132
4.6.2 Multidrug Resistance Protein (MRP) 132
4.7 Companion Diagnostic Tests for Cancer Therapeutics 133
5. Business 137
5.1 Technology and Market Trends 137
5.1.1 Technology Trends 138
5.1.2 Market Trends 139
5.2 M&A Activity 141
5.3 Partnerships 144
5.4 Competitive Analysis 147
5.4.1 Primary Competitors 153
5.4.1.1 Summary of Market Strengths, Weaknesses, Opportunities and Threats 154
5.4.2 Industry Challenges and Strategic Recommendations 155
5.4.3 Commercialization of Molecular Diagnostic Products 155
5.5 SWOT Comparison of Business Models for Cancer Diagnostic Testing 157
5.6 Intellectual Property Rights 173
5.6.1 BRCA1 and BRCA2 Gene Patents 174
5.6.2 Current Patent Disputes 174
6. Reimbursement and Billing 175
6.1 Overview 175
6.2 Trends in Reimbursement Practice 175
6.2.1 Medicare Reimbursement 176
6.2.2 Analysis of ROI for MD Tests for Cancer Using Medicare Reimbursement Rules
179
6.2.3 Reimbursement for Insight Dx, MammaPrint and Oncotype Dx 180
6.2.4 Reimbursement for JAK2 Mutation Testing for Myeloproliferative Neoplasms
180
6.3 Breast Cancer Tests 180
6.4 Colon Cancer Tests 181
6.5 Trends in Patient Care and Reimbursement 184
6.6 Revenue Threats 185
6.6.1 Medicare Exceptions 187
6.6.2 Three Areas for Denial of Claims by Biomarkers 187
6.7 Billing 188
6.7.1 Medicare Billing Procedures 188
6.7.2 Medicare CPT Coding Rules for Cancer Biomarkers 188
7. Government Regulation 190
7.1 U.S. Food and Drug Administration 190
7.2 CLIA Regulations 191
7.3 Clinical Laboratory Improvement Act (CLIA) 192
7.4 State Licensing for Service Laboratories 193
7.5 FDA Treatment of Multivariate Index Assays (IVDMIAs) 194
7.6 510(k) Clearance 195
7.7 Pre-Market Approval (PMA) 195
7.8 ASRs 195
7.9 What Regulatory Guidance is Needed for Companion Biomarkers? 196
7.10 U.S. Patent and Trademark Office (USPTO) 197
7.11 IRB Approval in Clinical Trials 197
7.12 Oncology Biomarkers Qualification Initiative Project 197
7.13 FDA Clearance Picture for Insight Dx, MammaPrint, and Oncotype DX 198
7.14 FDA Packaging Requirements for Erbitux 198
7.15 Micoarray Quality Control (MAQC) 198
7.16 CAP Evidence-based Recommendations to Improve the Accuracy of ER and PR
Testing 199
7.17 ER and PR Proficiency Testing 200
8. Business Decisions Using Molecular Diagnostic Tests in Cancer Test
Development 201
8.1 What are the Key Opportunities for Development of Cancer Tests Based Upon
Molecular Diagnostics Technologies? 201
8.2 What are the Current Obstacles for MD Cancer Testing Implementation? 201
8.3 How do Business Strategies, such as those Relating to Acquisition, Drive
Biomarker Strategies? 202
8.4 Which Types of Cancer MD Testing should be Developed by Diagnostic Companies
at Various Stages in the Development Pipeline? 202
8.5 How can Regulatory Oversight Drive Approval and Adoption of New
Technologies? 202
8.6 What are the Noteworthy Deals? 203
8.7 Who are the Acquirers? 204
8.8 Who are the Target Companies? 204
8.9 In what Class of Drugs is the Value of Using Genetic Biomarkers in
Decision-making the
Highest? 204
8.10 How can Regulatory Oversight Drive Approval and Adoption of New
Technologies? 205
8.11 How can Big Pharma Co-develop Genetic Biomarkers for Regulatory Acceptance?
205
8.12 How are Genetic Biomarkers Being Used to Reduce the Attrition Rate in Drug
Development? 205
8.13 How is ROI Measured Using Genetic Biomarkers in Drug Development? 205
8.14 How might Organizational Structures Limit the Use of Genetic Biomarkers in
Drug Development and how should R&D Organizations Address this Problem? 205
8.15 How to Maximize Business Development through Biomarker Strategies? 206
8.16 What is the Best Type of Business Model for Developing Genetic Biomarkers?
206
8.17 What are Organizational Impediments in Genetic Biomarkers in Drug
Development? 206
8.18 What are Internal Capabilities for Novel Biomarker Development and
Application? 206
8.19 How can Key Biomarker Technical Expertise be Applied across a Complex and
Highly-Stratified R&D Value Chain? 207
8.20 At what Stage of Drug Development has Genetic Biomarkers Provided the Most
Benefit? 207
8.21 What Companies are the most Innovative in Development of Genetic
Biomarkers? 207
8.22 Best Values for Genetic Biomarkers in Drug Development and in Diagnostics
210
8.23 Molecular Diagnostic Tests can Increase Value in an Associated Drug 210
9. Company Profiles 212
9.1 Agendia 212
9.2 ArcticDx, Inc. 212
9.3 Arcxis Biotechnologies 212
9.4 Biodesix 213
9.5 bioTheranostics (AviaraDx) 213
9.6 Cancer Genetics, Inc. 214
9.7 Clarient, Inc. (GE Healthcare) 215
9.8 CombiMatrix Corporation 216
9.9 Epigenomics 216
9.10 Exact Sciences Corporation 216
9.11 Exagen Diagnostics, Inc. 217
9.12 Exiqon 217
9.13 Ferrer inCode 218
9.14 Genomic Health, Inc. 218
9.15 Genoptix, Inc. 219
9.16 InterGenetics, Inc. 219
9.17 LabCorp 220
9.18 Myriad Genetics, Inc. 220
9.19 Nanostring 222
9.20 Neogenomics 222
9.21 Nuvera Biosciences 222
9.22 Orion Genomics 222
9.23 QIAGEN NV 222
9.24 Rosetta Genomics Ltd. 224
9.25 Seegene 224
9.26 Sequenom, Inc. 224
9.27 SABiosciences Corporation (Qiagen) 224
9.28 Source MDx 225
9.29 Targeted Molecular Diagnostics 225
9.30 Trovagene, Inc. 225
Appendix 1: Definition of Terms for Molecular Diagnostics 227
Appendix 2: Standard Cancer Therapeutic Panels 229
Appendix 3: Menu of Specialized Technologies Used to Assess and Characterize
Cancer 232
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 234
Appendix 5: Overview of Microarrays 236
INDEX OF FIGURES
Figure 2.1: Finding Genes with Microassays 19
Figure 2.2: Use of Microassays for Studying Gene Expression 19
Figure 2.3: Using DNA Microarrays to Compare Cancer and Normal Cells 20
Figure 2.4: Microarrays for Prediction of Survival in Cancer 22
Figure 2.5: Finding New Drugs with Microarrays 27
Figure 2.6: Using Gene Expression Patterns to Chose Treatment 28
Figure 2.7: Segmentation of the Biomarker Development Market 29
Figure 3.1: Molecular Diagnostic Markets for Cancer Testing Globally, 2012 33
Figure 3.2: Molecular Diagnostic Markets for Cancer Testing U.S., 2012 33
Figure 3.3: Key Players Market Share in Global Molecular Diagnostics Cancer
Testing Markets 34
Figure 3.4: Market Growth and Evolution of MD Cancer Biomarkers 41
Figure 4.1: Using DNA Microassays to Measure Gene Expression 47
Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in
Patients 48
Figure 4.3: HER-2/NEU Protein as a Target in Cancer Therapy 62
Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal
Results with IHC 63
Figure 4.5: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by
FISH 63
Figure 4.6: Action of Herceptin in Breast Cancer Patients 64
Figure 4.7: Analysis of Cancer Tissue by Microarray 66
Figure 4.8: Global Market Size and Share of Breast Cancer Molecular Diagnostic
Market, 2012 72
Figure 4.9: Incidence of CRC by Age Group 77
Figure 4.10: HNPCC Mutation Increases Risk of Cancer 87
Figure 4.11: APC Mutation Increases the Risk of Cancer 88
Figure 4.12: U.S. Market Share of Colon Cancer Molecular Diagnostic Market, 2012
90
Figure 4.13: Prostate-Specific Membrane Antigen 96
Figure 4.14: PCA3 Score Nomogram 99
Figure 4.15: Estimates for PCA3 Test Volume in the U.S., 2005-2012 100
Figure 4.16: Ovarian Cancer Types 112
Figure 4.17: U.S. Market Share of Ovarian Cancer Molecular Diagnostic Market,
2012 120
Figure 5.1: FDA Co-developed Products as a Model for Collaboration 145
Figure 5.2: Segmentation of the Biomarker Development Market 171
Figure 6.1: Number of Oncotype DX Tests Performed, 1991-2011 180
Figure 7.1: OBQI and the Relationship of Governmental Regulatory Agencies 198
INDEX OF TABLES
Table 2.1: Genes and Cancer Risk 22
Table 2.2: Use of Cancer Biomarkers to Enhance Patient Care 27
Table 2.3: Targeted Drug Therapies for Cancers 27
Table 2.4: Use of Cancer Biomarkers in Drug Development 30
Table 2.5: Utility of Biomarkers as Companion Diagnostics to Drug Development 30
Table 2.6: Time Line for Development of Companion Diagnostics 31
Table 3.1: Global Market for Molecular Diagnostics Cancer Testing, 2008-2018 32
Table 3.2: U.S. Market for Molecular Diagnostics Cancer Testing, 2008-2018 32
Table 3.3: Molecular Diagnostic Markets for Cancer Testing, 2012 33
Table 3.4: Key Diagnostic Company Players and Market Share in Global Molecular
Diagnostics Cancer Testing Market 34
Table 3.5: Key Laboratory Testing Players and Market Share in Global Molecular
Diagnostics Cancer Testing Market 34
Table 3.6: Business Factors Influencing Advanced Oncology Testing Services 35
Table 3.7: Specific Diagnostic Products Categories Comprising the Cancer
Diagnostic Market 37
Table 3.8: Highlights of the Cancer Diagnostic Testing Segment 37
Table 3.9: Highlights of Certified Clinical Labs Specializing in Cancer Genetics
and Molecular Diagnostic
Services 38
Table 3.10: Strategies for Marketing Cancer Diagnostic Products 42
Table 3.11: Key Elements of MD Diagnostic Companies Marketing Plan 42
Table 4.1: Estimates for the Leading Sites of New Cancer Cases and Deaths in the
U.S. by Gender 45
Table 4.2: Emerging Molecular Diagnostic Technologies 49
Table 4.3: Key Elements for Business Competition in Gene Expression Profiling
for Cancer 52
Table 4.4: Key Elements for Future Success in the Gene Profiling for Cancer
Segment 52
Table 4.5: Companies Marketing Products in the Cancer Molecular Diagnostics
Sector 52
Table 4.6: Breast Cancer Overview 53
Table 4.7: Overview of ER/PR Testing and Response to Therapy 54
Table 4.8: Key Players in the Breast Cancer Molecular Diagnostic Space 55
Table 4.9: Commercially Available Molecular Diagnostic Products for Breast
Cancer Assay 56
Table 4.10: Clinical Utility and Health Economic Benefits of Oncotype DX 58
Table 4.11: Oncotype DX Overview 58
Table 4.12: Comparison of Agendia vs. Genomic Health Breast Cancer Tests 59
Table 4.13: Overview of HER2/neu and Herceptin 62
Table 4.14: MammaPrint: Key Features 67
Table 4.15: Oncogene Science Biomarker Group Reagents 68
Table 4.16: Major Laboratory Testing Companies Marketing Breast Cancer Molecular
Diagnostic
Tests, 2012 70
Table 4.17: Global Market for Breast Cancer Molecular Diagnostic Testing,
2005-2012 71
Table 4.18: U.S. Market for Breast Cancer Molecular Diagnostic Testing,
2005-2012 71
Table 4.19: Global Market Forecast for Breast Cancer Molecular Diagnostic
Testing, 2013-2018 73
Table 4.20: U.S. Market Forecast for Breast Cancer Molecular Diagnostic Testing,
2013-2018 73
Table 4.21: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers
Ranked in Order of
Impact 73
Table 4.22: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints
Ranked in Order of
Impact 74
Table 4.23: Summary of Strengths, Weaknesses, Opportunities and Threats of the
Breast Cancer Molecular Diagnostic Market 75
Table 4.24: Colorectal Cancer Overview 76
Table 4.25: KRAS Mutation Assay 78
Table 4.26: KRAS Assays by Analytical Type 79
Table 4.27: KRAS Mutation Analysis Summary 79
Table 4.28: DxS KRAS Mutation Test Summary 80
Table 4.29: KRAS and BRAF in Clinical Use 82
Table 4.30: Product Development Opportunities in Cancer Tumor Types, 2008 82
Table 4.31: Key Players in the Colorectal Cancer Molecular Diagnostic Space 83
Table 4.32: ArcticDx Genetic Test, Colo Risk 86
Table 4.33: NexCourse CRC Test Offering and Treatment Direction 88
Table 4.34: Global Market for Molecular Diagnostic Colon Cancer Testing,
2005-2012 90
Table 4.35: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2005-2012
90
Table 4.36: Global Market Forecast for Colon Cancer Molecular Diagnostic
Testing, 2013-2018 91
Table 4.37: U.S. Market Forecast for Colon Cancer Molecular Diagnostic Testing,
2010-2018 91
Table 4.38: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers
Ranked in Order of
Impact 92
Table 4.39: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints
Ranked in Order of
Impact 92
Table 4.40: Summary of Strengths, Weaknesses, Opportunities and Threats of the
Colon Cancer Market 94
Table 4.41: Stages in Prostate Cancer Discovery and Diagnosis 95
Table 4.42: Corporate Players Entering the Prostate Cancer Molecular Diagnostic
Space 97
Table 4.43: Gen-Probe Genetic Testing Product Line 101
Table 4.44: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers
Ranked in Order of
Impact 107
Table 4.45: Prostate Cancer Molecular Diagnostic Testing Market: Market
Restraints Ranked in Order of
Impact 107
Table 4.46: Summary of Strengths, Weaknesses, Opportunities and Threats of the
Prostate Cancer Molecular Diagnostic Market 108
Table 4.47: Players in the Bladder Cancer Molecular Diagnostic Space 111
Table 4.48: Clinical Applications of Serum Biomarkers for Ovarian Cancer 113
Table 4.49: Commercially Available Molecular Diagnostic Products for Ovarian
Caner Assay 119
Table 4.50: Global Market for Molecular Diagnostic Ovarian Cancer Testing,
2005-2012 120
Table 4.51: U.S. Market for Molecular Diagnostic Ovarian Cancer Testing,
2005-2012 120
Table 4.52: Global Market Forecast for Ovarian Cancer Molecular Diagnostic
Testing, 2013-2016 121
Table 4.53: U.S. Market Forecast for Ovarian Cancer Molecular Diagnostic
Testing, 2013-2016 121
Table 4.54: Ovarian Cancer Molecular Diagnostic Testing Market: Market Drivers
in Order of Impact 122
Table 4.55: Ovarian Cancer Molecular Diagnostic Testing Market: Market
Restraints in Order of Impact 122
Table 4.56: Summary of Strengths, Weaknesses, Opportunities and Threats of the
Ovarian Cancer Market 123
Table 4.57: Lung Cancer Survival Rates 124
Table 4.58: Lung Cancer Facts 125
Table 4.59: Potential of Cancer Biomarkers in Drug Delivery and Development 134
Table 4.60: Barriers to Adoption of Biomarkers in Clinical Use 134
Table 5.1: Technology Trends in Cancer Testing 138
Table 5.2: Trends in Theranostics 139
Table 5.3: Market Trends in Cancer Testing 140
Table 5.4: Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order
of Impact 140
Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in
Order of Impact 141
Table 5.6: Companies That Offer Products to Profile Gene Expression in Breast
Cancer 153
Table 5.7: Principal Competitive Factors in the Cancer Screening Market 153
Table 5.8: Summary of Strengths, Weaknesses, Opportunities and Threats of the
Glucose Point of Care
Market 154
Table 5.9: Molecular Diagnostics Cancer Market: Strategic Recommendations on
Molecular Diagnostic Sector Business Functions 155
Table 5.10: Total Molecular Diagnostics Cancer Market: Impact of Top Industry
Challenges (U.S.) 155
Table 5.11: Utility of Biomarkers as Companion Diagnostics to Drug Development
172
Table 6.1: CPT Codes for Tumor Markers 178
Table 6.2: Genomic Health Oncotype DX Sales, 2006-2012 181
Table 6.3: Drivers in KRAS Testing 183
Table 6.4: Factors Determining Third-Party Payment for Advanced Cancer Tests 186
Table 7.1: Rules that Affect the Ability of a Cancer Diagnostic Service Lab to
Conduct Business 190
Table 7.2: Focus Areas for the FDA Critical Path Initiative 197
Table 8.1: Effect of Regulation on MD Cancer Market Technology Platforms, 2007
and 2015 202
Table A2.1: Serum Tumor Markers Currently in Common Use 231
