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MediPoint: Companion Diagnostic Tests in Oncology - US Analysis and Market Forecasts

Summary

A companion diagnostic test is defined as an in vitro diagnostic device or an imaging tool whose use allows the safe application of a therapy. In-vitro Companion Diagnostic tests measure the expression or presence of a specific biomarker that is linked to a disease condition or therapy. This report provides an analysis of the companion diagnostic market for four major cancers in the US, the 5EU (France, Germany, Italy, Spain, and UK), Brazil, and the some of the Asia-Pacific (APAC) regions (Japan, China, and India), and identifies the unmet needs in this companion diagnostics market. This report analyses companion diagnostic tests used in breast, colorectal, melanoma and non-small cell lung cancer. This report also discusses physician attitudes towards current companion diagnostic tests, and the future of companion diagnostic tests. This report focuses on the major test kits that are supplied to pathology laboratories.

The major feature of the companion diagnostic testing market is the current domination of tests for mutations important in the prognosis and diagnosis of non-small cell lung cancer (NSCLC), with the two market leaders being Roche and Qiagen. According to GlobalData’s forecast, in 2014, NSCLC companion diagnostic tests account for 67% of the US market by value. While more human epidermal growth factor receptor 2 (HER2) tests are carried out, because the NSCLC tests have been principally more expensive molecular tests, rather than the cheaper immunohistochemistry (IHC) test that typifies HER2 testing, the value of the NSCLC market is considerably higher.

Scope

- An overview of companion diagnostic, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized US companion diagnostic market revenue and future forecasts from 2011 to 2013, forecast for 7 years to 2020.
- Investigation of current and future market competition for companion diagnostic.
- Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
- Competitor assessment including device approval analysis and device sales forecasts.
- Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
- Analysis of unmet needs within the market and opportunities for future players.
- Technology trends evaluation to assess strength of pipeline.
- An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
- Company profiles including business description, financial overview and SWOT analysis.
- Coverage of key market players.
- Strategic assessment of the companion diagnostic sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL) as well as doctors

Reasons to buy

- Understand the trends shaping and driving the US companion diagnostic market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in US companion diagnostic market through 2018.
- Quantify candidate patient populations to better design product pricing & launch plans.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
- Perform benchmarking analysis of growth opportunities against currently marketed products.
- Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
- Take a comprehensive look at the market’s device pipeline and identify promising, paradigm-shifting products.
- Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
- What’s the next big thing in US companion diagnostic market landscape? Identify, understand and capitalize.

Table Of Contents

MediPoint: Companion Diagnostic Tests in Oncology - US Analysis and Market Forecasts
1 Table of Contents

2 Introduction 21
2.1 Catalyst 21
2.2 Related Reports 22
3 Industry Overview 23
3.1 Emergence of Companion Diagnostics 23
3.1.1 Definition of Companion Diagnostics 23
3.1.2 Changing Face of Medicine 24
3.1.3 Definitions of Companion and Personalized Diagnostics 26
3.2 Disease Applications 28
3.2.1 Breast Cancer 28
3.2.2 Colorectal Cancer 31
3.2.3 Melanoma 33
3.2.4 Non-Small Cell Lung Cancer 34
3.3 Companion Diagnostics Technologies 36
3.3.1 Immunochemical Techniques 36
3.3.2 Nucleic Acid Testing 38
3.3.3 Emerging Technologies 45
3.4 Companion Diagnostics Development 47
3.4.1 Economic Value of a Companion Diagnostic 47
3.4.2 When to Develop a Companion Diagnostic Test 48
3.4.3 Strategy 51
3.4.4 Selection of Partner 52
3.4.5 Biomarker Discovery 54
3.5 Clinical Outcomes 55
3.5.1 Role of Companion Diagnostics in Disease Treatment 55
3.5.2 Companion Diagnostic Test Applications 56
3.6 Testing Trends 57
3.6.1 Overview 57
3.6.2 Breast Cancer Companion Diagnostic Tests 58
3.6.3 Colorectal Cancer Companion Diagnostic Tests 62
3.6.4 Melanoma Companion Diagnostic Tests 64
3.6.5 Non-Small Cell Lung Cancer Companion Diagnostic Tests 66
3.7 Market Access 69
3.7.1 Overview 69
3.7.2 Regulation 69
3.7.3 Reimbursement 72
3.8 Regulatory Issues and Recalls 73
3.8.1 Dako FDA Warning Letter 73
3.8.2 HercepTest Recall 73
3.8.3 Cobas KRAS Test Recall 74
3.8.4 Cobas BRF V600E Test Recall 74
3.8.5 Leica Bond HER2 IHC System 74
3.9 Reimbursement of Companion Diagnostic Tests 75
3.10 MandA, Key Partnerships 80
3.10.1 Significant Mergers and Acquisitions 82
3.10.2 Recent Partnerships 82
3.11 Economic Impact 88
3.11.1 Cost Effectiveness of Companion Diagnostics 88
3.11.2 Cost Effectiveness of Companion Diagnostics: Healthcare Provider Perspective 89
3.12 Market Drivers 95
3.12.1 Driver: Increasing Healthcare Pressures 95
3.12.2 Driver: Adverse Economic Pressures 96
3.12.3 Driver: Availability of New Technologies 96
3.12.4 Driver: FDA Regulatory Changes 97
3.12.5 Driver: Need to Improve Drug Development Processes 97
3.12.6 Driver: Increasing Cancer Incidence 98
3.12.7 Driver: Accelerating Demand for Targeted Therapies 98
3.13 Market Barriers 100
3.13.1 Barrier: Reimbursement Difficulties 100
3.13.2 Barrier: Loss of Indication 100
3.13.3 Barrier: Emergence of Biosimilar Therapies 101
3.13.4 Barrier: Competition with Laboratory-Developed Tests 102
3.13.5 Barrier: Emergence of Next-Generation Gene Sequencing 102
3.13.6 Barrier: Lack of Laboratory Choice in Instrument Selection 103
3.13.7 Barrier: Lack of Patient Awareness about Companion Diagnostic Tests 105
3.13.8 Barrier: Physician Resistance to New Companion Diagnostic Tests 105
4 Competitive Assessment 107
4.1 Overview 107
4.2 Techniques in Use by Currently Marketed Products 107
4.2.1 Immunohistochemistry 107
4.2.2 Fluorescence In Situ Hybridization 107
4.2.3 Polymerase Chain Reaction 108
4.3 Competitive Analysis 108
4.3.1 Breast Cancer Companion Diagnostic Tests 108
4.3.2 Colorectal Cancer Companion Diagnostic Tests 137
4.3.3 Melanoma Companion Diagnostic Tests 146
4.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 152
5 Unmet Needs 169
5.1 Need for Improved Cancer Treatments 169
5.2 Need for Objective Tests 169
5.3 Need for High-Throughput Tests 171
5.4 Certainty of Reimbursement 172
5.5 Amount and Type of Tissue Needed for Test 173
5.6 Who Should be Tested? 176
5.7 Test Accuracy 181
5.8 Increasing Test Complexity and Increased Process Failure 183
6 Pipeline Products 185
6.1 Overview 185
6.2 Pipeline by Phase of Development 187
6.3 Pipeline Product Profiles 188
6.3.1 Breast Cancer Companion Diagnostic Tests 188
6.3.2 Colorectal Cancer Companion Diagnostic Tests 196
6.3.3 Melanoma Companion Diagnostic Tests 202
6.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 209
7 Clinical Trials to Watch 225
7.1 Overview 225
7.2 Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies 229
8 Current and Future Players 230
8.1 Trends in Corporate Strategy 230
8.1.1 Companion Diagnostics Business Models 230
8.2 Company Profiles 231
8.2.1 Pharmaceutical/Therapy Companies Developing Companion Diagnostic Tests 231
8.2.2 Diagnostics Companies Developing Companion Diagnostic Tests (in Partnership with Pharmaceutical Companies) 286
9 Market Outlooks 368
9.1 By Market Segment 368
9.1.1 Breast Cancer Companion Diagnostic Tests 368
9.1.2 Colorectal Cancer Companion Diagnostic Tests 369
9.1.3 Melanoma Companion Diagnostic Tests 370
9.1.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 372
9.1.5 Technique 373
9.2 By Geography 376
9.2.1 Overview 376
9.2.2 US 376
10 Appendix 379
10.1 Bibliography 379
10.2 Abbreviations 414
10.3 Report Methodology 416
10.3.1 Coverage 416
10.3.2 Secondary Research 417
10.3.3 Forecasting Methodology 417
10.4 Physicians Included in this Study 418
10.5 About the Authors 420
10.5.1 Andrew Thompson, Ph.D., Senior Analyst, In Vitro Diagnostics 420
10.5.2 Derek Archila, MBA, Lead Analyst, Medical Devices 420
10.5.3 Bonnie Bain, PhD, Global Head of Healthcare 421
10.6 Disclaimer 422

1.1 List of Tables

Table 1: Possible Companion Diagnostic Test Platforms 23
Table 2: Specific Breast Cancer Types Associated with Inherited Disorders 30
Table 3: Specific Mutations Associated with Non-Small Cell Lung Cancer 36
Table 4: Weaknesses of ELISA Technique 37
Table 5: Key Stages of PCR Gene Test 40
Table 6: Key Principles Guiding Companion Diagnostic Test Development 51
Table 7: Companion Diagnostic Test Development Partner Selection 52
Table 8: Biomarker Discovery 54
Table 9: Disease Diagnosis, Treatment, and Monitoring 55
Table 10: Application of Companion Diagnostic Tests 56
Table 11: Major Biomarkers currently measured in Cancer Companion Diagnostic Tests 57
Table 12: HER2 Testing in the US, 2011-2020 62
Table 13: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the US, 2011-2020 64
Table 14: Melanoma Companion Diagnostic Testing (BRAF) in the US, 2011-2020 65
Table 15: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the US, 2011-2020 68
Table 16: FDA Medical Device Classifications 70
Table 17: US Reimbursement Policies for FDA- and Non-FDA-Approved Molecular Tests 73
Table 18: Key Mergers and Acquisitions during 2013-2014 82
Table 19: Partnerships during 2013-2014 83
Table 20: Impact of Companion Diagnostics on Cancer Treatment Costs in France 94
Table 21: Effectiveness of Disease Therapies 95
Table 22: HER2 FISH/iQFISH PharmDx Product Profile 108
Table 23: Common Reasons for HER2 FISH Failure 110
Table 24: HER2 FISH PharmDx/HER2 iQFISH PharmDx SWOT Analysis 112
Table 25: HercepTest Product Profile 112
Table 26: HercepTest Scoring Algorithm 113
Table 27: HercepTest SWOT Analysis 115
Table 28: HER2 CISH PharmDx Product Profile 116
Table 29: HER2 CISH PharmDx SWOT Analysis 118
Table 30: SPOT-Light HER2 CISH Kit Product Profile 119
Table 31: SPOT-Light HER2 CISH Kit SWOT Analysis 121
Table 32: Leica Bond Oracle HER2 IHC System Product Profile 121
Table 33: Leica Bond Oracle HER2 IHC System Test Algorithm 122
Table 34: Leica Bond Oracle HER2 IHC System SWOT Analysis 124
Table 35: Biogenex INSITE HER2/Neu Product Profile 125
Table 36: Biogenex INSITE HER2/Neu SWOT Analysis 127
Table 37: Abbott Pathvysion HER-2 DNA Probe Kit Product Profile 127
Table 38: Abbott Pathvysion HER-2 DNA Probe Kit SWOT Analysis 129
Table 39: Ventana INFORM HER2 Dual ISH Assay Product Profile 130
Table 40: Ventana INFORM HER2 Dual ISH Assay SWOT Analysis 132
Table 41: Pathway HER2/Neu IHC Product Profile 132
Table 42: Pathway HER2/Neu IHC SWOT Analysis 135
Table 43: HerMark Product Profile 136
Table 44: HerMark SWOT Analysis 137
Table 45: Therascreen KRAS RGQ Product Profile 137
Table 46: Therascreen KRAS RGQ SWOT Analysis 140
Table 47: Cobas KRAS Mutation Test Product Profile 140
Table 48: Cobas KRAS Mutation Test SWOT Analysis 142
Table 49: EGFR PharmDx Kit Product Profile 142
Table 50: EGFR PharmDx Kit SWOT Analysis 146
Table 51: THxID BRAF Product Profile 146
Table 52: Effect of Melanin on the THxID BRAF PCR Test 148
Table 53: THxID BRAF SWOT Analysis 149
Table 54: Cobas 4800 BRAF V600 Mutation Test - Melanoma Product Profile 150
Table 55: Interpretation of Cobas BRAF V600 Mutation Test - Melanoma 151
Table 56: Cobas 4800 BRAF V600 Mutation Test - Melanoma SWOT Analysis 152
Table 57: Vysis ALK Break Apart FISH Probe Kit Product Profile 153
Table 58: Abbott Vysis ALK Break Apart FISH Probe Kit SWOT Analysis 155
Table 59: Amoy-Dx EML4-ALK Fusion Gene Detection Kit Product Profile 155
Table 60: Amoy-Dx EML4-ALK Fusion Gene Detection Kit SWOT Analysis 157
Table 61: Therascreen EGFR RGQ PCR Kit Product Profile 157
Table 62: Therascreen EGFR RGQ PCR Kit SWOT Analysis 162
Table 63: ALK IHC Test Product Profile 163
Table 64: ALK IHC Test SWOT Analysis 165
Table 65: Cobas EGFR Mutation Test Product Profile 166
Table 66: Cobas EGFR Mutation Test SWOT Analysis 168
Table 67: Companion Diagnostic Tests Pipeline, 2014 187
Table 68: Neuvax Companion Diagnostic Assay Product Profile 189
Table 69: Neuvax Companion Diagnostic Assay Product SWOT Analysis 189
Table 70: Companion Diagnostic Test - Palbociclib Product Profile 190
Table 71: Companion Diagnostic Test - Palbociclib SWOT Analysis 191
Table 72: Companion Diagnostic Test - Breast Cancer Product Profile 192
Table 73: Companion Diagnostic Test - Breast Cancer SWOT Analysis 192
Table 74: Onapristone Companion Diagnostic Assay Product Profile 193
Table 75: Onapristone Companion Diagnostic Assay SWOT Analysis 194
Table 76: Aromatase Inhibitor Biomarker - Companion Diagnostic Test Product Profile 195
Table 77: Aromatase Inhibitor Biomarker - Companion Diagnostic Test SWOT Analysis 195
Table 78: BRAF Companion Diagnostic Assay - Colon Cancer Product Profile 196
Table 79: BRAF Companion Diagnostic Assay - Colon Cancer SWOT Analysis 197
Table 80: KRAS Companion Diagnostic Assay - Colon Cancer Product Profile 198
Table 81: KRAS Companion Diagnostic Assay - Colon Cancer SWOT Analysis 198
Table 82: PIK3CA Companion Diagnostic Assay - Colorectal Cancer Product Profile 199
Table 83: PIK3CA Companion Diagnostic Assay - Colorectal Cancer SWOT Analysis 200
Table 84: Vectibix Companion Diagnostic Product Profile 201
Table 85: Vectibix Companion Diagnostic SWOT Analysis 202
Table 86: MAGE-A3 Companion Skin Cancer Assay Product Profile 203
Table 87: MAGE-A3 Companion Skin Cancer Assay SWOT Analysis 203
Table 88: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma Product Profile 204
Table 89: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma SWOT Analysis 205
Table 90: Companion Diagnostic Test - Melanoma Cancer Product Profile 206
Table 91: Companion Diagnostic Test - Melanoma Cancer SWOT Analysis 206
Table 92: KRAS Companion Diagnostic Assay - Melanoma Product Profile 207
Table 93: KRAS Companion Diagnostic Assay - Melanoma SWOT Analysis 208
Table 94: Companion Diagnostic Test - Melanoma Product Profile 209
Table 95: Companion Diagnostic Test - Melanoma SWOT Analysis 209
Table 96: BRAF Companion Diagnostic Assay - Lung Cancer Product Profile 210
Table 97: BRAF Companion Diagnostic Assay - Lung Cancer SWOT Analysis 210
Table 98: KRAS Companion Diagnostic Assay - Lung Cancer Product Profile 211
Table 99: KRAS Companion Diagnostic Assay - Lung Cancer SWOT Analysis 211
Table 100: MET Companion Diagnostic Assay - Lung Cancer Product Profile 212
Table 101: MET Companion Diagnostic Assay - Lung Cancer SWOT Analysis 213
Table 102: PIK3CA Companion Diagnostic Assay - Lung Cancer Product Profile 214
Table 103: PIK3CA Companion Diagnostic Assay - Lung Cancer SWOT Analysis 214
Table 104: Companion Diagnostic Device - Lung Cancer Product Profile 215
Table 105: Companion Diagnostic Device - Lung Cancer SWOT Analysis 216
Table 106: Companion Diagnostic Test - Crizotinib Product Profile 217
Table 107: Companion Diagnostic Test - Crizotinib SWOT Analysis 217
Table 108: Companion Diagnostic Test - Dacomitinib Product Profile 218
Table 109: Companion Diagnostic Test - Dacomitinib SWOT Analysis 218
Table 110: T790M Mutation Companion Diagnostic Test Product Profile 219
Table 111: T790M Mutation Companion Diagnostic Test SWOT Analysis 220
Table 112: Entinostat Companion Diagnostic Assay Product Profile 221
Table 113: Entinostat Companion Diagnostic Assay SWOT Analysis 221
Table 114: MUC1 Expression Companion Diagnostic Test Product Profile 222
Table 115: MUC1 Expression Companion Diagnostic Test SWOT Analysis 223
Table 116: Companion Diagnostic Assay - NSCLC Product Profile 224
Table 117: Companion Diagnostic Assay - NSCLC SWOT Analysis 224
Table 118: Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies. 229
Table 119: Company Profile - Amgen 232
Table 120: Amgen's Key Products 232
Table 121: Selected Amgen Anti-Cancer Therapies Currently in Clinical Trials 233
Table 122: Amgen SWOT Analysis 238
Table 123: Company Profile - Arno Therapeutics 239
Table 124: Selected Arno Therapeutics Anti-Cancer Therapies Currently in Clinical Trials 239
Table 125: Arno Therapeutics SWOT Analysis 243
Table 126: Company Profile - AstraZeneca 244
Table 127: Key Events in the Development of AstraZeneca's Drug Portfolio Since 2011 246
Table 128: Key Project Terminations by AstraZeneca Since 2008 248
Table 129: AstraZeneca SWOT Analysis 252
Table 130: Company Profile - Bristol-Myers Squibb 253
Table 131: Recent Key Product Approvals from Bristol-Myers Squibb 256
Table 132: Recent Key BMS Partnerships and Agreements 257
Table 133: Bristol-Myers Squibb SWOT Analysis 258
Table 134: Company Profile - Clovis Oncology 259
Table 135: Clovis Oncology's Key Products 260
Table 136: Clovis Oncology SWOT Analysis 264
Table 137: Company Profile - Eli Lilly and Company 265
Table 138: Eli Lilly and Company SWOT Analysis 271
Table 139: Company Profile - Genentech 271
Table 140: Selected Genentech Marketed Products 272
Table 141: Genentech SWOT Analysis 277
Table 142: Company Profile - Pfizer 278
Table 143: Pfizer SWOT Analysis 284
Table 144: Company Profile - Syndax Pharmaceuticals 285
Table 145: Syndax Pharmaceuticals SWOT Analysis 286
Table 146: Company Profile - Abbott Laboratories 287
Table 147: Abbott's Key Product Areas 288
Table 148: Abbott Laboratories SWOT Analysis, 2013 293
Table 149: Company Profile - Amoy Diagnostics 294
Table 150: Amoy Diagnostics SWOT Analysis, 2013 295
Table 151: Company Profile - Biogenex Laboratories 296
Table 152: Biogenex Laboratories SWOT Analysis, 2013 297
Table 153: Company Profile - BioMerieux 298
Table 154: BioMerieux SWOT Analysis, 2013 306
Table 155: Company Profile - Dako (Agilent Technologies) 307
Table 156: Dako/Agilent Technologies SWOT Analysis 312
Table 157: Company Profile - Illumina 313
Table 158: Illumina Product Areas 313
Table 159: Illumina SWOT Analysis 320
Table 160: Company Profile - Leica Biosystems (Danaher) 321
Table 161: Leica Biosystems/Danaher SWOT Analysis 327
Table 162: Company Profile - Life Technologies (Thermo Fisher Scientific) 328
Table 163: Life Technologies SWOT Analysis 335
Table 164: Company Profile - MolecularMD 336
Table 165: MolecularMD SWOT Analysis 337
Table 166: Company Profile - Myriad Genetics 338
Table 167: Myriad Genetics Major Product Areas 339
Table 168: Myriad Genetics SWOT Analysis 343
Table 169: Company Profile - Qiagen 344
Table 170: Qiagen Major Product Areas 345
Table 171: Qiagen SWOT Analysis 350
Table 172: Company Profile - Roche Diagnostics 351
Table 173: Roche SWOT Analysis 357
Table 174: Company Profile - Siemens Healthcare 358
Table 175: Siemens Healthcare SWOT Analysis 363
Table 176: Company Profile - Ventana Medical Systems 364
Table 177: Ventana Medical Systems SWOT Analysis 367
Table 178: US Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020 368
Table 179: US Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020 369
Table 180: USl Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020 371
Table 181: US Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020 372
Table 182: US Sales Forecast for IHC and Molecular Tests ($m), 2011-2020 374
Table 183: Major Events Affecting the Companion Diagnostic Test Market 376
Table 184: Sales Forecast for Companion Diagnostic Tests ($m) in the US, 2011-2020 377

1.2 List of Figures
Figure 1: Genomic Sequencing Costs, 2001-2012 25
Figure 2: Use of Proteomics in Personalized Medicine 27
Figure 3: Incidence of Inherited Breast Cancer Mutations among Diagnosed Breast Cancer Patients 29
Figure 4: Basic FISH Process 39
Figure 5: Basic PCR Process 41
Figure 6: Impact of Sample Storage on PCR Outcome 42
Figure 7: Genomic Sequencing Costs, 2001-2012 44
Figure 8: Scientific and Economic Potential of Companion Diagnostics 48
Figure 9: Drug and Diagnostic Test Co-Development 49
Figure 10: Roche Lifecycle Algorithm for Co-Development of a Predictive Diagnostic 50
Figure 11: Key Development Drivers for Companion Diagnostic Tests 52
Figure 12: Qiagen Model to Build a JAK2 Companion Diagnostic Tests Business 54
Figure 13: Uptake of HER2 Testing among Invasive Breast Cancer Patients 59
Figure 14: HER2 Testing in the US, 2011-2020 61
Figure 15: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the US, 2011-2020 63
Figure 16: Melanoma Companion Diagnostic Testing (BRAF) in the US, 2011-2020 65
Figure 17: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the US, 2011-2020 68
Figure 18: Healthcare Coverage Frameworks 78
Figure 19: Multiple Partnerships in Companion Diagnostics during 2013-2014 86
Figure 20: Building a Companion Diagnostics Business: Forming Multiple Partnerships 87
Figure 21: Increasing Medicare Cost of Treatment 91
Figure 22: Growth of Drug Therapy Expenditure in France, 2004-2009 92
Figure 23: Share of Targeted Therapies of Anti-Cancer Drug Costs in France 93
Figure 24: Increase in Approvals of Biologic (Targeted) Therapies 99
Figure 25: EGFR PharmDx Test Adoption Curve 143
Figure 26: Probe Arrangement in the Vysis ALK Break Apart FISH Probe Kit 153
Figure 27: Scorpion Primers 159
Figure 28: Increase in High- and Moderate-Complexity Molecular Tests 162
Figure 29: Reasons for Companion Diagnostic Test Failure 174
Figure 30: Female Breast Cancer Treatment Patterns by Stage, 2008 177
Figure 31: Colon Cancer Treatment Patterns by Stage, 2008 178
Figure 32: Lung Cancer Treatment Patterns by Stage, 2008 179
Figure 33: Expected Companion Diagnostic Test Pipeline, US Approvals, 2014-2019 186
Figure 34: Sponsors of Clinical Trials for Targeted Cancer Therapies 226
Figure 35: Sponsors of Clinical Trials for Targeted Cancer Therapies Based on Mutational Status 227
Figure 36: Sponsors of Clinical Trials for Targeted Cancer Therapies, by Phase 228
Figure 37: US Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020 368
Figure 38: US Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020 369
Figure 39: US Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020 371
Figure 40: US Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020 372
Figure 41: US Sales Forecast for IHC and Molecular Tests ($m), 2011-2020 373
Figure 42: Global Market Share of Molecular Tests and Immunohistochemistry Tests in 2012 and 2020 375
Figure 43: Sales Forecast for Companion Diagnostic Tests ($m) in the US, 2011-2020 377

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