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MediPoint: Companion Diagnostic Tests in Oncology - EU 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.

GlobalData estimates the 5EU companion diagnostic test market, for breast cancer companion diagnostic tests, principally HER2 tests, to have been worth $53.2m in 2012. In the major EU, uptake of the HER2 IHC test is near saturation, and most growth will come from increases in breast cancer incidence. Within the EU, Spain shows the highest growth in breast cancer IHC tests.

Scope

- An overview of companion diagnostic, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized EU 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 EU companion diagnostic market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in EU 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 EU companion diagnostic market landscape? Identify, understand and capitalize.

Table Of Contents

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

2 Introduction 24
2.1 Catalyst 24
2.2 Related Reports 25
3 Industry Overview 26
3.1 Emergence of Companion Diagnostics 26
3.1.1 Definition of Companion Diagnostics 26
3.1.2 Changing Face of Medicine 27
3.1.3 Definitions of Companion and Personalized Diagnostics 29
3.2 Disease Applications 31
3.2.1 Breast Cancer 31
3.2.2 Colorectal Cancer 34
3.2.3 Melanoma 36
3.2.4 Non-Small Cell Lung Cancer 37
3.3 Companion Diagnostics Technologies 39
3.3.1 Immunochemical Techniques 39
3.3.2 Nucleic Acid Testing 41
3.3.3 Emerging Technologies 48
3.4 Companion Diagnostics Development 50
3.4.1 Economic Value of a Companion Diagnostic 50
3.4.2 When to Develop a Companion Diagnostic Test 51
3.4.3 Strategy 54
3.4.4 Selection of Partner 55
3.4.5 Biomarker Discovery 57
3.5 Clinical Outcomes 58
3.5.1 Role of Companion Diagnostics in Disease Treatment 58
3.5.2 Companion Diagnostic Test Applications 59
3.6 Testing Trends 60
3.6.1 France 60
3.6.2 Germany 70
3.6.3 Italy 77
3.6.4 Spain 86
3.6.5 UK 92
3.7 Market Access 106
3.7.1 Regulation 106
3.7.2 Reimbursement 110
3.8 Regulatory Issues and Recalls 117
3.8.1 Dako FDA Warning Letter 117
3.8.2 HercepTest Recall 118
3.8.3 Cobas KRAS Test Recall 118
3.8.4 Cobas BRF V600E Test Recall 118
3.8.5 Leica Bond HER2 IHC System 118
3.9 Reimbursement of Companion Diagnostic Tests 118
3.9.1 Europe 118
3.10 MandA, Key Partnerships 130
3.10.1 Significant Mergers and Acquisitions 131
3.10.2 Recent Partnerships 132
3.11 Economic Impact 137
3.11.1 Cost Effectiveness of Companion Diagnostics 137
3.11.2 Cost Effectiveness of Companion Diagnostics: Healthcare Provider Perspective 138
3.12 Market Drivers 145
3.12.1 Driver: Increasing Healthcare Pressures 145
3.12.2 Driver: Adverse Economic Pressures 146
3.12.3 Driver: Availability of New Technologies 146
3.12.4 Driver: FDA Regulatory Changes 147
3.12.5 Driver: Need to Improve Drug Development Processes 147
3.12.6 Driver: Increasing Cancer Incidence 148
3.12.7 Driver: Accelerating Demand for Targeted Therapies 148
3.13 Market Barriers 149
3.13.1 Barrier: Reimbursement Difficulties 149
3.13.2 Barrier: Loss of Indication 150
3.13.3 Barrier: Emergence of Biosimilar Therapies 151
3.13.4 Barrier: Competition with Laboratory-Developed Tests 151
3.13.5 Barrier: Emergence of Next-Generation Gene Sequencing 152
3.13.6 Barrier: Lack of Laboratory Choice in Instrument Selection 153
3.13.7 Barrier: Lack of Patient Awareness about Companion Diagnostic Tests 154
3.13.8 Barrier: Physician Resistance to New Companion Diagnostic Tests 155
4 Competitive Assessment 157
4.1 Overview 157
4.2 Techniques in Use by Currently Marketed Products 157
4.2.1 Immunohistochemistry 157
4.2.2 Fluorescence In Situ Hybridization 157
4.2.3 Polymerase Chain Reaction 158
4.3 Competitive Analysis 158
4.3.1 Breast Cancer Companion Diagnostic Tests 158
4.3.2 Colorectal Cancer Companion Diagnostic Tests 187
4.3.3 Melanoma Companion Diagnostic Tests 196
4.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 202
5 Unmet Needs 219
5.1 Need for Improved Cancer Treatments 219
5.2 Need for Objective Tests 219
5.3 Need for High-Throughput Tests 221
5.4 Certainty of Reimbursement 222
5.5 Amount and Type of Tissue Needed for Test 223
5.6 Who Should be Tested? 226
5.7 Test Accuracy 230
5.8 Increasing Test Complexity and Increased Process Failure 232
6 Pipeline Products 234
6.1 Overview 234
6.2 Pipeline by Phase of Development 236
6.3 Pipeline Product Profiles 237
6.3.1 Breast Cancer Companion Diagnostic Tests 237
6.3.2 Colorectal Cancer Companion Diagnostic Tests 245
6.3.3 Melanoma Companion Diagnostic Tests 251
6.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 258
7 Clinical Trials to Watch 274
7.1 Overview 274
7.2 Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies 278
8 Current and Future Players 279
8.1 Trends in Corporate Strategy 279
8.1.1 Companion Diagnostics Business Models 279
8.2 Company Profiles 280
8.2.1 Pharmaceutical/Therapy Companies Developing Companion Diagnostic Tests 280
8.2.2 Diagnostics Companies Developing Companion Diagnostic Tests (in Partnership with Pharmaceutical Companies) 334
9 Market Outlooks 416
9.1 By Market Segment 416
9.1.1 Breast Cancer Companion Diagnostic Tests 416
9.1.2 Colorectal Cancer Companion Diagnostic Tests 417
9.1.3 Melanoma Companion Diagnostic Tests 418
9.1.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 420
9.1.5 Technique 424
9.2 By Geography 427
9.2.1 Overview 427
9.2.2 France 428
9.2.3 Germany 430
9.2.4 Italy 432
9.2.5 Spain 434
9.2.6 UK 436
10 Appendix 439
10.1 Bibliography 439
10.2 Abbreviations 479
10.3 Report Methodology 481
10.3.1 Coverage 481
10.3.2 Secondary Research 482
10.3.3 Forecasting Methodology 482
10.4 Physicians Included in this Study 484
10.5 About the Authors 486
10.5.1 Andrew Thompson, Ph.D., Senior Analyst, In Vitro Diagnostics 486
10.5.2 Derek Archila, MBA, Lead Analyst, Medical Devices 486
10.5.3 Bonnie Bain, PhD, Global Head of Healthcare 487
10.6 Disclaimer 488

1.1 List of Tables

Table 1: Possible Companion Diagnostic Test Platforms 26
Table 2: Specific Breast Cancer Types Associated with Inherited Disorders 33
Table 3: Specific Mutations Associated with Non-Small Cell Lung Cancer 39
Table 4: Weaknesses of ELISA Technique 40
Table 5: Key Stages of PCR Gene Test 43
Table 6: Key Principles Guiding Companion Diagnostic Test Development 54
Table 7: Companion Diagnostic Test Development Partner Selection 55
Table 8: Biomarker Discovery 57
Table 9: Disease Diagnosis, Treatment, and Monitoring 58
Table 10: Application of Companion Diagnostic Tests 59
Table 11: Major Biomarkers currently measured in Cancer Companion Diagnostic Tests 60
Table 12: Types of Genetic Tests Carried Out in France during 2009 61
Table 13: Biomarkers tested for in France 62
Table 14: Tumor Molecular Profiling in France in 2011 and 2012 63
Table 15: Breast Cancer Companion Diagnostic Testing (HER2) in France, 2011-2020 64
Table 16: KRAS Companion Diagnostic Testing in France, 2008-2012 65
Table 17: Colorectal Cancer Companion Diagnostic (KRAS) Testing in France, 2011-2020 66
Table 18: Melanoma Companion Diagnostic Testing (BRAF) in France, 2011-2020 67
Table 19: EGFR Companion Diagnostic Testing in France, 2008-2012 68
Table 20: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in France, 2011-2020 69
Table 21: Breast Cancer Companion Diagnostic Testing (HER2) in Germany, 2011-2020 71
Table 22: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Germany, 2011-2020 72
Table 23: Melanoma Companion Diagnostic Testing (BRAF) in Germany, 2011-2020 74
Table 24: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Germany, 2011-2020 76
Table 25: Breast Cancer Companion Diagnostic Testing (HER2) in Italy, 2011-2020 79
Table 26: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Italy, 2011-2020 81
Table 27: Melanoma Companion Diagnostic Testing (BRAF) in Italy, 2011-2020 82
Table 28: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Italy, 2011-2020 85
Table 29: Breast Cancer Companion Diagnostic Testing (HER2) in Spain, 2011-2020 87
Table 30: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Spain, 2011-2020 89
Table 31: Melanoma Companion Diagnostic Testing (BRAF) in Spain, 2011-2020 90
Table 32: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Spain, 2011-2020 92
Table 33: Tumor Molecular Profiling in UK in 2006 and 2007 94
Table 34: Breast Cancer Companion Diagnostic Testing (HER2) in the UK, 2011-2020 95
Table 35: Cost of Analysis of KRAS Laboratory-Developed Molecular Tests in the UK 96
Table 36: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the UK, 2011-2020 97
Table 37: Melanoma Companion Diagnostic Testing (BRAF) in the UK, 2011-2020 99
Table 38: Lung Cancer EGFR Tests in the UK 101
Table 39: Cost of Analysis of NSCLC Laboratory-Developed Molecular Tests in the UK 102
Table 40: EGFR Method Selection in the UK, 2013 103
Table 41: Cost of EGFR Testing in the UK 104
Table 42: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the UK, 2011-2020 106
Table 43: EU Medical Device Classifications and Conformance Requirements 107
Table 44: EU Medical Device Essential Requirements 108
Table 45: Differences Between US FDA Approval and EU CE-Marking 108
Table 46: Timetable to Approve New Medical Devices in France 121
Table 47: Access Opportunities for New Companion Diagnostic Tests in Europe 122
Table 48: Estimate of the Unmet Clinical Need in the UK for the Main Molecular Tests in Solid Tumors 129
Table 49: Key Mergers and Acquisitions during 2013-2014 131
Table 50: Partnerships during 2013-2014 132
Table 51: Impact of Companion Diagnostics on Cancer Treatment Costs in France 144
Table 52: Effectiveness of Disease Therapies 145
Table 53: HER2 FISH/iQFISH PharmDx Product Profile 158
Table 54: Common Reasons for HER2 FISH Failure 160
Table 55: HER2 FISH PharmDx/HER2 iQFISH PharmDx SWOT Analysis 162
Table 56: HercepTest Product Profile 162
Table 57: HercepTest Scoring Algorithm 163
Table 58: HercepTest SWOT Analysis 165
Table 59: HER2 CISH PharmDx Product Profile 166
Table 60: HER2 CISH PharmDx SWOT Analysis 168
Table 61: SPOT-Light HER2 CISH Kit Product Profile 169
Table 62: SPOT-Light HER2 CISH Kit SWOT Analysis 171
Table 63: Leica Bond Oracle HER2 IHC System Product Profile 171
Table 64: Leica Bond Oracle HER2 IHC System Test Algorithm 172
Table 65: Leica Bond Oracle HER2 IHC System SWOT Analysis 174
Table 66: Biogenex INSITE HER2/Neu Product Profile 175
Table 67: Biogenex INSITE HER2/Neu SWOT Analysis 177
Table 68: Abbott Pathvysion HER-2 DNA Probe Kit Product Profile 177
Table 69: Abbott Pathvysion HER-2 DNA Probe Kit SWOT Analysis 179
Table 70: Ventana INFORM HER2 Dual ISH Assay Product Profile 180
Table 71: Ventana INFORM HER2 Dual ISH Assay SWOT Analysis 182
Table 72: Pathway HER2/Neu IHC Product Profile 182
Table 73: Pathway HER2/Neu IHC SWOT Analysis 185
Table 74: HerMark Product Profile 186
Table 75: HerMark SWOT Analysis 187
Table 76: Therascreen KRAS RGQ Product Profile 187
Table 77: Therascreen KRAS RGQ SWOT Analysis 190
Table 78: Cobas KRAS Mutation Test Product Profile 190
Table 79: Cobas KRAS Mutation Test SWOT Analysis 192
Table 80: EGFR PharmDx Kit Product Profile 192
Table 81: EGFR PharmDx Kit SWOT Analysis 196
Table 82: THxID BRAF Product Profile 196
Table 83: Effect of Melanin on the THxID BRAF PCR Test 198
Table 84: THxID BRAF SWOT Analysis 199
Table 85: Cobas 4800 BRAF V600 Mutation Test - Melanoma Product Profile 200
Table 86: Interpretation of Cobas BRAF V600 Mutation Test - Melanoma 201
Table 87: Cobas 4800 BRAF V600 Mutation Test - Melanoma SWOT Analysis 202
Table 88: Vysis ALK Break Apart FISH Probe Kit Product Profile 203
Table 89: Abbott Vysis ALK Break Apart FISH Probe Kit SWOT Analysis 205
Table 90: Amoy-Dx EML4-ALK Fusion Gene Detection Kit Product Profile 205
Table 91: Amoy-Dx EML4-ALK Fusion Gene Detection Kit SWOT Analysis 207
Table 92: Therascreen EGFR RGQ PCR Kit Product Profile 207
Table 93: Therascreen EGFR RGQ PCR Kit SWOT Analysis 212
Table 94: ALK IHC Test Product Profile 213
Table 95: ALK IHC Test SWOT Analysis 215
Table 96: Cobas EGFR Mutation Test Product Profile 216
Table 97: Cobas EGFR Mutation Test SWOT Analysis 218
Table 98: Companion Diagnostic Tests Pipeline, 2014 236
Table 99: Neuvax Companion Diagnostic Assay Product Profile 238
Table 100: Neuvax Companion Diagnostic Assay Product SWOT Analysis 238
Table 101: Companion Diagnostic Test - Palbociclib Product Profile 239
Table 102: Companion Diagnostic Test - Palbociclib SWOT Analysis 240
Table 103: Companion Diagnostic Test - Breast Cancer Product Profile 241
Table 104: Companion Diagnostic Test - Breast Cancer SWOT Analysis 241
Table 105: Onapristone Companion Diagnostic Assay Product Profile 242
Table 106: Onapristone Companion Diagnostic Assay SWOT Analysis 243
Table 107: Aromatase Inhibitor Biomarker - Companion Diagnostic Test Product Profile 244
Table 108: Aromatase Inhibitor Biomarker - Companion Diagnostic Test SWOT Analysis 244
Table 109: BRAF Companion Diagnostic Assay - Colon Cancer Product Profile 245
Table 110: BRAF Companion Diagnostic Assay - Colon Cancer SWOT Analysis 246
Table 111: KRAS Companion Diagnostic Assay - Colon Cancer Product Profile 247
Table 112: KRAS Companion Diagnostic Assay - Colon Cancer SWOT Analysis 247
Table 113: PIK3CA Companion Diagnostic Assay - Colorectal Cancer Product Profile 248
Table 114: PIK3CA Companion Diagnostic Assay - Colorectal Cancer SWOT Analysis 249
Table 115: Vectibix Companion Diagnostic Product Profile 250
Table 116: Vectibix Companion Diagnostic SWOT Analysis 251
Table 117: MAGE-A3 Companion Skin Cancer Assay Product Profile 252
Table 118: MAGE-A3 Companion Skin Cancer Assay SWOT Analysis 252
Table 119: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma Product Profile 253
Table 120: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma SWOT Analysis 254
Table 121: Companion Diagnostic Test - Melanoma Cancer Product Profile 255
Table 122: Companion Diagnostic Test - Melanoma Cancer SWOT Analysis 255
Table 123: KRAS Companion Diagnostic Assay - Melanoma Product Profile 256
Table 124: KRAS Companion Diagnostic Assay - Melanoma SWOT Analysis 257
Table 125: Companion Diagnostic Test - Melanoma Product Profile 258
Table 126: Companion Diagnostic Test - Melanoma SWOT Analysis 258
Table 127: BRAF Companion Diagnostic Assay - Lung Cancer Product Profile 259
Table 128: BRAF Companion Diagnostic Assay - Lung Cancer SWOT Analysis 259
Table 129: KRAS Companion Diagnostic Assay - Lung Cancer Product Profile 260
Table 130: KRAS Companion Diagnostic Assay - Lung Cancer SWOT Analysis 260
Table 131: MET Companion Diagnostic Assay - Lung Cancer Product Profile 261
Table 132: MET Companion Diagnostic Assay - Lung Cancer SWOT Analysis 262
Table 133: PIK3CA Companion Diagnostic Assay - Lung Cancer Product Profile 263
Table 134: PIK3CA Companion Diagnostic Assay - Lung Cancer SWOT Analysis 263
Table 135: Companion Diagnostic Device - Lung Cancer Product Profile 264
Table 136: Companion Diagnostic Device - Lung Cancer SWOT Analysis 265
Table 137: Companion Diagnostic Test - Crizotinib Product Profile 266
Table 138: Companion Diagnostic Test - Crizotinib SWOT Analysis 266
Table 139: Companion Diagnostic Test - Dacomitinib Product Profile 267
Table 140: Companion Diagnostic Test - Dacomitinib SWOT Analysis 267
Table 141: T790M Mutation Companion Diagnostic Test Product Profile 268
Table 142: T790M Mutation Companion Diagnostic Test SWOT Analysis 269
Table 143: Entinostat Companion Diagnostic Assay Product Profile 270
Table 144: Entinostat Companion Diagnostic Assay SWOT Analysis 270
Table 145: MUC1 Expression Companion Diagnostic Test Product Profile 271
Table 146: MUC1 Expression Companion Diagnostic Test SWOT Analysis 272
Table 147: Companion Diagnostic Assay - NSCLC Product Profile 273
Table 148: Companion Diagnostic Assay - NSCLC SWOT Analysis 273
Table 149: Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies. 278
Table 150: Company Profile - Amgen 281
Table 151: Amgen's Key Products 281
Table 152: Selected Amgen Anti-Cancer Therapies Currently in Clinical Trials 282
Table 153: Amgen SWOT Analysis 287
Table 154: Company Profile - Arno Therapeutics 288
Table 155: Selected Arno Therapeutics Anti-Cancer Therapies Currently in Clinical Trials 288
Table 156: Arno Therapeutics SWOT Analysis 292
Table 157: Company Profile - AstraZeneca 293
Table 158: Key Events in the Development of AstraZeneca's Drug Portfolio Since 2011 295
Table 159: Key Project Terminations by AstraZeneca Since 2008 297
Table 160: AstraZeneca SWOT Analysis 301
Table 161: Company Profile - Bristol-Myers Squibb 302
Table 162: Recent Key Product Approvals from Bristol-Myers Squibb 305
Table 163: Recent Key BMS Partnerships and Agreements 306
Table 164: Bristol-Myers Squibb SWOT Analysis 307
Table 165: Company Profile - Clovis Oncology 308
Table 166: Clovis Oncology's Key Products 309
Table 167: Clovis Oncology SWOT Analysis 313
Table 168: Company Profile - Eli Lilly and Company 314
Table 169: Eli Lilly and Company SWOT Analysis 320
Table 170: Company Profile - Genentech 320
Table 171: Selected Genentech Marketed Products 321
Table 172: Genentech SWOT Analysis 326
Table 173: Company Profile - Pfizer 327
Table 174: Pfizer SWOT Analysis 332
Table 175: Company Profile - Syndax Pharmaceuticals 333
Table 176: Syndax Pharmaceuticals SWOT Analysis 334
Table 177: Company Profile - Abbott Laboratories 335
Table 178: Abbott's Key Product Areas 336
Table 179: Abbott Laboratories SWOT Analysis, 2013 341
Table 180: Company Profile - Amoy Diagnostics 342
Table 181: Amoy Diagnostics SWOT Analysis, 2013 343
Table 182: Company Profile - Biogenex Laboratories 344
Table 183: Biogenex Laboratories SWOT Analysis, 2013 345
Table 184: Company Profile - BioMerieux 346
Table 185: BioMerieux SWOT Analysis, 2013 354
Table 186: Company Profile - Dako (Agilent Technologies) 355
Table 187: Dako/Agilent Technologies SWOT Analysis 360
Table 188: Company Profile - Illumina 361
Table 189: Illumina Product Areas 361
Table 190: Illumina SWOT Analysis 368
Table 191: Company Profile - Leica Biosystems (Danaher) 369
Table 192: Leica Biosystems/Danaher SWOT Analysis 375
Table 193: Company Profile - Life Technologies (Thermo Fisher Scientific) 376
Table 194: Life Technologies SWOT Analysis 383
Table 195: Company Profile - MolecularMD 384
Table 196: MolecularMD SWOT Analysis 385
Table 197: Company Profile - Myriad Genetics 386
Table 198: Myriad Genetics Major Product Areas 387
Table 199: Myriad Genetics SWOT Analysis 391
Table 200: Company Profile - Qiagen 392
Table 201: Qiagen Major Product Areas 393
Table 202: Qiagen SWOT Analysis 398
Table 203: Company Profile - Roche Diagnostics 399
Table 204: Roche SWOT Analysis 405
Table 205: Company Profile - Siemens Healthcare 406
Table 206: Siemens Healthcare SWOT Analysis 411
Table 207: Company Profile - Ventana Medical Systems 412
Table 208: Ventana Medical Systems SWOT Analysis 415
Table 209: 5EU Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020 416
Table 210: 5EU Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020 418
Table 211: 5EU Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020 419
Table 212: 5EU Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020 421
Table 213: 5EU Sales Forecast for IHC and Molecular Tests ($m), 2011-2020 425
Table 214: Major Events Affecting the Companion Diagnostic Test Market 427
Table 215: Sales Forecast for Companion Diagnostic Tests ($m) in France, 2011-2020 428
Table 216: Sales Forecast for Companion Diagnostic Tests ($m) in Germany, 2011-2020 430
Table 217: Sales Forecast for Companion Diagnostic Tests ($m) in Italy, 2011-2020 432
Table 218: Sales Forecast for Companion Diagnostic Tests ($m) in Spain, 2011-2020 434
Table 219: Sales Forecast for Companion Diagnostic Tests ($m) in the UK, 2011-2020 436

1.2 List of Figures
Figure 1: Genomic Sequencing Costs, 2001-2012 28
Figure 2: Use of Proteomics in Personalized Medicine 30
Figure 3: Incidence of Inherited Breast Cancer Mutations among Diagnosed Breast Cancer Patients 32
Figure 4: Basic FISH Process 42
Figure 5: Basic PCR Process 44
Figure 6: Impact of Sample Storage on PCR Outcome 45
Figure 7: Genomic Sequencing Costs, 2001-2012 47
Figure 8: Scientific and Economic Potential of Companion Diagnostics 51
Figure 9: Drug and Diagnostic Test Co-Development 52
Figure 10: Roche Lifecycle Algorithm for Co-Development of a Predictive Diagnostic 53
Figure 11: Key Development Drivers for Companion Diagnostic Tests 55
Figure 12: Qiagen Model to Build a JAK2 Companion Diagnostic Tests Business 57
Figure 13: Breast Cancer Companion Diagnostic Testing (HER2) in France, 2011-2020 64
Figure 14: KRAS Testing in France 2008-2012 65
Figure 15: Colorectal Cancer Companion Diagnostic (KRAS) Testing in France, 2011-2020 66
Figure 16: Melanoma Companion Diagnostic Testing (BRAF) in France, 2011-2020 67
Figure 17: EGFR Testing in France, 2008-2012 68
Figure 18: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in France, 2011-2020 69
Figure 19: Breast Cancer Companion Diagnostic Testing (HER2) in Germany, 2011-2020 71
Figure 20: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Germany, 2011-2020 72
Figure 21: Melanoma Companion Diagnostic Testing (BRAF) in Germany, 2011-2020 74
Figure 22: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Germany, 2011-2020 76
Figure 23: Treatment Index: Italy versus Rest of EU in Use of Herceptin per Head of Population, 2002 77
Figure 24: Percentage of All Breast Cancer Patients Tested for HER2, Italy versus Rest of EU, 2002 78
Figure 25: Breast Cancer Companion Diagnostic Testing (HER2) in Italy, 2011-2020 79
Figure 26: Methods Used for KRAS Genotyping by the Centers Participating in the Italian Quality Assessment Scheme 80
Figure 27: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Italy, 2011-2020 81
Figure 28: Melanoma Companion Diagnostic Testing (BRAF) in Italy, 2011-2020 82
Figure 29: Methods Used for EGFR Genotyping by the Centers Participating in the Italian Quality Assessment Scheme in 2013 83
Figure 30: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Italy, 2011-2020 85
Figure 31: Breast Cancer Companion Diagnostic Testing (HER2) in Spain, 2011-2020 87
Figure 32: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Spain, 2011-2020 88
Figure 33: Melanoma Companion Diagnostic Testing (BRAF) in Spain, 2011-2020 90
Figure 34: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Spain, 2011-2020 91
Figure 35: UK HER2 Status Testing Algorithm 93
Figure 36: Breast Cancer Companion Diagnostic Testing (HER2) in the UK, 2011-2020 94
Figure 37: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the UK, 2011-2020 97
Figure 38: Melanoma Companion Diagnostic Testing (BRAF) in the UK, 2011-2020 99
Figure 39: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the UK, 2011-2020 105
Figure 40: EU Medical Device Approval and Post-Market Surveillance Process 109
Figure 41: German Reimbursement Establishment Process 123
Figure 42: Increase in EGFR Testing at AstraZeneca-Funded Test Centers in the UK 128
Figure 43: UK Regional Access to Cancer Diagnostic Testing 130
Figure 44: Multiple Partnerships in Companion Diagnostics during 2013-2014 135
Figure 45: Building a Companion Diagnostics Business: Forming Multiple Partnerships 137
Figure 46: Increasing Medicare Cost of Treatment 141
Figure 47: Growth of Drug Therapy Expenditure in France, 2004-2009 142
Figure 48: Share of Targeted Therapies of Anti-Cancer Drug Costs in France 143
Figure 49: Increase in Approvals of Biologic (Targeted) Therapies 149
Figure 50: EGFR PharmDx Test Adoption Curve 193
Figure 51: Probe Arrangement in the Vysis ALK Break Apart FISH Probe Kit 203
Figure 52: Scorpion Primers 209
Figure 53: Increase in High- and Moderate-Complexity Molecular Tests 212
Figure 54: Reasons for Companion Diagnostic Test Failure 224
Figure 55: Female Breast Cancer Treatment Patterns by Stage, 2008 226
Figure 56: Colon Cancer Treatment Patterns by Stage, 2008 227
Figure 57: Lung Cancer Treatment Patterns by Stage, 2008 228
Figure 58: Expected Companion Diagnostic Test Pipeline, US Approvals, 2014-2019 235
Figure 59: Sponsors of Clinical Trials for Targeted Cancer Therapies 275
Figure 60: Sponsors of Clinical Trials for Targeted Cancer Therapies Based on Mutational Status 276
Figure 61: Sponsors of Clinical Trials for Targeted Cancer Therapies, by Phase 277
Figure 62: 5EU Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020 416
Figure 63: 5EU Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020 417
Figure 64: 5EU Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020 419
Figure 65: 5EU Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020 420
Figure 66: Uptake in ALK Mutation IHC and FISH Testing in France, 2011-2020 422
Figure 67: Uptake of ALK Mutation IHC and FISH Testing in Germany 2011-2020 423
Figure 68: 5EU Sales Forecast for IHC and Molecular Tests ($m), 2011-2020 424
Figure 69: 5EU Market Share of Molecular Tests and Immunohistochemistry Tests in 2012 and 2020 426
Figure 70: Sales Forecast for Companion Diagnostic Tests ($m) in France, 2011-2020 428
Figure 71: Sales Forecast for Companion Diagnostic Tests ($m) in Germany, 2011-2020 430
Figure 72: Sales Forecast for Companion Diagnostic Tests ($m) in Italy, 2011-2020 432
Figure 73: Sales Forecast for Companion Diagnostic Tests ($m) in Spain, 2011-2020 434
Figure 74: Sales Forecast for Companion Diagnostic Tests ($m) in the UK, 2011-2020 436

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