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MediPoint: Companion Diagnostic Tests in Oncology - Global 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.

Highlights

Key Questions Answered

- Global cancer incidence is expected to rise. (Q).What role will companion diagnostic tests for play in the forecast period to tackle this global issue? (Q).How many procedures of companion diagnostic tests will be performed in the ten major markets covered in the report?
- What are the reasons to develop a Companion Diagnostic Test. (Q).What motivates companies to develop a companion diagnostic; physician demand or legislative requirement?
- What strategies are adopted in developing a new companion diagnostics test. (Q).When and how is a companion diagnostic test developed? (Q).Who are the stakeholders? (Q).What are the relationships between Big Pharma and Diagnostic test developers?
- (Q).What technologies underpin companion diagnostic tests?. (Q).What are the common technologies used? Which are the most in demand, across all tests. (Q).What are the emerging technologies?
- What Companion Diagnostic tests are available in breast cancer, colorectal cancer, melanoma and non-small cell lung cancer. (Q).Which are the leading tests? (Q).How are the tests performed
- Where are companion diagnostics offered. (Q).What disease is likely to see the most demand for Companion diagnostics, which the least? (Q).Which countries are likely to adopt companion diagnostic tests?
- What do physicians think of currently offered companion. (Q).What are the perceived strengths, weaknesses? (Q).What are the unmet needs?

Key Findings

- The Companion Diagnostic test market for the 4 named cancers will grow at a CAGR of 4.9% over the forecast period. Developed regions, like US and EU showing lowest growth rates. While China and Brazil showing maximum growth rates.
- Breast cancer HER2 testing dominates in terms of volume, but has been overtaken in terms of value by non-small cell lung cancer companion diagnostic testing, mostly for EGFR mutation status.
- The market growth for companion diagnostic testing in the US and EU is heavily dependent on the acceptance into diagnostic guidelines and the stabilisation of test reimbursement. Growth in developing economies is dependant upon patient access to laboratory testing and growth of professional pathology services

Scope

- Overview of companion diagnostic tests in oncology, including core technologies, estimated procedure trends and disease overview.
- Current and Future Players Companies involved in the space with portfolio assessment and SWOT analysis.
- Pipeline analysis: Late-stage pipeline products with SWOT analysis and physician perception
- Other Key topics covered include identification of unmet needs, implications on the companion diagnostic market and how they may be overcome in the near future
- Analysis of the market opportunities in addition to Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications

Reasons to buy

- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline
- Develop business strategies by understanding the trends shaping and driving the companion diagnostic cancer test market
- Drive revenues by understanding the key trends, innovative products and technologies, and companies likely to impact the cancer companion diagnostic test market in the future
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships

Table Of Contents

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

2 Introduction 28
2.1 Catalyst 28
2.2 Related Reports 29
3 Industry Overview 30
3.1 Emergence of Companion Diagnostics 30
3.1.1 Definition of Companion Diagnostics 30
3.1.2 Changing Face of Medicine 31
3.1.3 Definitions of Companion and Personalized Diagnostics 33
3.2 Disease Applications 35
3.2.1 Breast Cancer 35
3.2.2 Colorectal Cancer 38
3.2.3 Melanoma 40
3.2.4 Non-Small Cell Lung Cancer 41
3.3 Companion Diagnostics Technologies 43
3.3.1 Immunochemical Techniques 43
3.3.2 Nucleic Acid Testing 45
3.3.3 Emerging Technologies 52
3.4 Companion Diagnostics Development 54
3.4.1 Economic Value of a Companion Diagnostic 54
3.4.2 When to Develop a Companion Diagnostic Test 55
3.4.3 Strategy 58
3.4.4 Selection of Partner 59
3.4.5 Biomarker Discovery 61
3.5 Clinical Outcomes 62
3.5.1 Role of Companion Diagnostics in Disease Treatment 62
3.5.2 Companion Diagnostic Test Applications 63
3.6 Testing Trends 64
3.6.1 US 64
3.6.2 France 75
3.6.3 Germany 85
3.6.4 Italy 92
3.6.5 Spain 100
3.6.6 UK 106
3.6.7 Japan 120
3.6.8 Brazil 129
3.6.9 China 135
3.6.10 India 143
3.7 Market Access 150
3.7.1 Overview 150
3.7.2 US 150
3.7.3 5EU 154
3.7.4 Japan 165
3.7.5 Brazil 167
3.7.6 China 169
3.7.7 India 172
3.8 Regulatory Issues and Recalls 173
3.8.1 Dako FDA Warning Letter 173
3.8.2 HercepTest Recall 174
3.8.3 Cobas KRAS Test Recall 174
3.8.4 Cobas BRF V600E Test Recall 174
3.8.5 Leica Bond HER2 IHC System 174
3.9 Reimbursement of Companion Diagnostic Tests 175
3.9.1 US 175
3.9.2 Europe 180
3.9.3 APAC 192
3.9.4 South America 197
3.10 MandA, Key Partnerships 199
3.10.1 Significant Mergers and Acquisitions 201
3.10.2 Recent Partnerships 201
3.11 Economic Impact 207
3.11.1 Cost Effectiveness of Companion Diagnostics 207
3.11.2 Cost Effectiveness of Companion Diagnostics: Healthcare Provider Perspective 208
3.12 Market Drivers 214
3.12.1 Driver: Increasing Healthcare Pressures 214
3.12.2 Driver: Adverse Economic Pressures 215
3.12.3 Driver: Availability of New Technologies 215
3.12.4 Driver: FDA Regulatory Changes 216
3.12.5 Driver: Need to Improve Drug Development Processes 216
3.12.6 Driver: Increasing Cancer Incidence 217
3.12.7 Driver: Accelerating Demand for Targeted Therapies 217
3.13 Market Barriers 219
3.13.1 Barrier: Reimbursement Difficulties 219
3.13.2 Barrier: Loss of Indication 219
3.13.3 Barrier: Emergence of Biosimilar Therapies 220
3.13.4 Barrier: Competition with Laboratory-Developed Tests 221
3.13.5 Barrier: Emergence of Next-Generation Gene Sequencing 222
3.13.6 Barrier: Lack of Laboratory Choice in Instrument Selection 223
3.13.7 Barrier: Lack of Patient Awareness about Companion Diagnostic Tests 224
3.13.8 Barrier: Physician Resistance to New Companion Diagnostic Tests 225
4 Competitive Assessment 227
4.1 Overview 227
4.2 Techniques in Use by Currently Marketed Products 227
4.2.1 Immunohistochemistry 227
4.2.2 Fluorescence In Situ Hybridization 227
4.2.3 Polymerase Chain Reaction 228
4.3 Competitive Analysis 228
4.3.1 Breast Cancer Companion Diagnostic Tests 228
4.3.2 Colorectal Cancer Companion Diagnostic Tests 257
4.3.3 Melanoma Companion Diagnostic Tests 267
4.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 273
5 Unmet Needs 290
5.1 Need for Improved Cancer Treatments 290
5.2 Need for Objective Tests 290
5.3 Need for High-Throughput Tests 292
5.4 Certainty of Reimbursement 293
5.5 Amount and Type of Tissue Needed for Test 294
5.6 Who Should be Tested? 297
5.7 Test Accuracy 302
5.8 Increasing Test Complexity and Increased Process Failure 305
6 Pipeline Products 306
6.1 Overview 306
6.2 Pipeline by Phase of Development 308
6.3 Pipeline Product Profiles 310
6.3.1 Breast Cancer Companion Diagnostic Tests 310
6.3.2 Colorectal Cancer Companion Diagnostic Tests 318
6.3.3 Melanoma Companion Diagnostic Tests 324
6.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 331
7 Clinical Trials to Watch 347
7.1 Overview 347
7.2 Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies 351
8 Current and Future Players 352
8.1 Trends in Corporate Strategy 352
8.1.1 Companion Diagnostics Business Models 352
8.2 Company Profiles 353
8.2.1 Pharmaceutical/Therapy Companies Developing Companion Diagnostic Tests 353
8.2.2 Diagnostics Companies Developing Companion Diagnostic Tests (in Partnership with Pharmaceutical Companies) 409
9 Market Outlooks 492
9.1 By Market Segment 492
9.1.1 Breast Cancer Companion Diagnostic Tests 492
9.1.2 Colorectal Cancer Companion Diagnostic Tests 493
9.1.3 Melanoma Companion Diagnostic Tests 496
9.1.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 498
9.1.5 Technique 504
9.2 By Geography 507
9.2.1 10 Major Markets Overview 507
9.2.2 US 509
9.2.3 France 510
9.2.4 Germany 512
9.2.5 Italy 514
9.2.6 Spain 516
9.2.7 UK 518
9.2.8 Japan 520
9.2.9 Brazil 523
9.2.10 China 525
9.2.11 India 527
10 Appendix 530
10.1 Bibliography 530
10.2 Abbreviations 582
10.3 Report Methodology 584
10.3.1 Coverage 584
10.3.2 Secondary Research 585
10.3.3 Forecasting Methodology 585
10.4 Physicians Included in this Study 587
10.5 About the Authors 589
10.5.1 Andrew Thompson, Ph.D., Senior Analyst, In Vitro Diagnostics 589
10.5.2 Derek Archila, MBA, Lead Analyst, Medical Devices 589
10.5.3 Bonnie Bain, PhD, Global Head of Healthcare 590
10.6 Disclaimer 591

1.1 List of Tables

Table 1: Possible Companion Diagnostic Test Platforms 30
Table 2: Specific Breast Cancer Types Associated with Inherited Disorders 37
Table 3: Specific Mutations Associated with Non-Small Cell Lung Cancer 43
Table 4: Weaknesses of ELISA Technique 44
Table 5: Key Stages of PCR Gene Test 47
Table 6: Key Principles Guiding Companion Diagnostic Test Development 58
Table 7: Companion Diagnostic Test Development Partner Selection 59
Table 8: Biomarker Discovery 61
Table 9: Disease Diagnosis, Treatment, and Monitoring 62
Table 10: Application of Companion Diagnostic Tests 63
Table 11: Major Biomarkers currently measured in Cancer Companion Diagnostic Tests 64
Table 12: HER2 Testing in the US, 2011-2020 69
Table 13: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the US, 2011-2020 71
Table 14: Melanoma Companion Diagnostic Testing (BRAF) in the US, 2011-2020 72
Table 15: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the US, 2011-2020 75
Table 16: Types of Genetic Tests Carried Out in France during 2009 76
Table 17: Biomarkers tested for in France 77
Table 18: Tumor Molecular Profiling in France in 2011 and 2012 78
Table 19: Breast Cancer Companion Diagnostic Testing (HER2) in France, 2011-2020 79
Table 20: KRAS Companion Diagnostic Testing in France, 2008-2012 80
Table 21: Colorectal Cancer Companion Diagnostic (KRAS) Testing in France, 2011-2020 81
Table 22: Melanoma Companion Diagnostic Testing (BRAF) in France, 2011-2020 82
Table 23: EGFR Companion Diagnostic Testing in France, 2008-2012 83
Table 24: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in France, 2011-2020 84
Table 25: Breast Cancer Companion Diagnostic Testing (HER2) in Germany, 2011-2020 86
Table 26: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Germany, 2011-2020 87
Table 27: Melanoma Companion Diagnostic Testing (BRAF) in Germany, 2011-2020 89
Table 28: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Germany, 2011-2020 91
Table 29: Breast Cancer Companion Diagnostic Testing (HER2) in Italy, 2011-2020 94
Table 30: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Italy, 2011-2020 96
Table 31: Melanoma Companion Diagnostic Testing (BRAF) in Italy, 2011-2020 97
Table 32: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Italy, 2011-2020 100
Table 33: Breast Cancer Companion Diagnostic Testing (HER2) in Spain, 2011-2020 101
Table 34: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Spain, 2011-2020 103
Table 35: Melanoma Companion Diagnostic Testing (BRAF) in Spain, 2011-2020 104
Table 36: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Spain, 2011-2020 105
Table 37: Tumor Molecular Profiling in UK in 2006 and 2007 108
Table 38: Breast Cancer Companion Diagnostic Testing (HER2) in the UK, 2011-2020 109
Table 39: Cost of Analysis of KRAS Laboratory-Developed Molecular Tests in the UK 110
Table 40: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the UK, 2011-2020 111
Table 41: Melanoma Companion Diagnostic Testing (BRAF) in the UK, 2011-2020 113
Table 42: Lung Cancer EGFR Tests in the UK 115
Table 43: Cost of Analysis of NSCLC Laboratory-Developed Molecular Tests in the UK 116
Table 44: EGFR Method Selection in the UK, 2013 117
Table 45: Cost of EGFR Testing in the UK 118
Table 46: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the UK, 2011-2020 120
Table 47: HER2 Testing for Breast Cancer Patients in Japan 121
Table 48: Breast Cancer Companion Diagnostic Testing (HER2) in Japan, 2011-2020 122
Table 49: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Japan, 2011-2020 123
Table 50: Melanoma Companion Diagnostic Testing (BRAF) in Japan, 2011-2020 124
Table 51: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Japan, 2011-2020 128
Table 52: Breast Cancer Companion Diagnostic Testing (HER2) in Brazil, 2011-2020 130
Table 53: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Brazil, 2011-2020 131
Table 54: Melanoma Companion Diagnostic Testing (BRAF) in Brazil, 2011-2020 132
Table 55: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Brazil, 2011-2020 134
Table 56: Breast Cancer Companion Diagnostic Testing (HER2) in China, 2011-2020 137
Table 57: Colorectal Cancer Companion Diagnostic (KRAS) Testing in China, 2011-2020 139
Table 58: Melanoma Companion Diagnostic Testing (BRAF) in China, 2011-2020 140
Table 59: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in China, 2011-2020 142
Table 60: Breast Cancer Companion Diagnostic Testing (HER2) in India, 2011-2020 144
Table 61: Colorectal Cancer Companion Diagnostic (KRAS) Testing in India, 2011-2020 146
Table 62: Melanoma Companion Diagnostic Testing (BRAF) in India, 2011-2020 147
Table 63: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in India, 2011-2020 149
Table 64: FDA Medical Device Classifications 151
Table 65: US Reimbursement Policies for FDA- and Non-FDA-Approved Molecular Tests 154
Table 66: EU Medical Device Classifications and Conformance Requirements 155
Table 67: EU Medical Device Essential Requirements 156
Table 68: Differences Between US FDA Approval and EU CE-Marking 156
Table 69: Healthcare Systems in China 170
Table 70: Healthcare Principles in China 171
Table 71: Timetable to Approve New Medical Devices in France 183
Table 72: Access Opportunities for New Companion Diagnostic Tests in Europe 184
Table 73: Estimate of the Unmet Clinical Need in the UK for the Main Molecular Tests in Solid Tumors 191
Table 74: Tariffs for Companion Diagnostic and Related Tests at the Tata Memorial Hospital 197
Table 75: Key Mergers and Acquisitions during 2013-2014 201
Table 76: Partnerships during 2013-2014 202
Table 77: Impact of Companion Diagnostics on Cancer Treatment Costs in France 213
Table 78: Effectiveness of Disease Therapies 214
Table 79: HER2 FISH/iQFISH PharmDx Product Profile 228
Table 80: Common Reasons for HER2 FISH Failure 230
Table 81: HER2 FISH PharmDx/HER2 iQFISH PharmDx SWOT Analysis 232
Table 82: HercepTest Product Profile 232
Table 83: HercepTest Scoring Algorithm 233
Table 84: HercepTest SWOT Analysis 235
Table 85: HER2 CISH PharmDx Product Profile 236
Table 86: HER2 CISH PharmDx SWOT Analysis 238
Table 87: SPOT-Light HER2 CISH Kit Product Profile 239
Table 88: SPOT-Light HER2 CISH Kit SWOT Analysis 241
Table 89: Leica Bond Oracle HER2 IHC System Product Profile 241
Table 90: Leica Bond Oracle HER2 IHC System Test Algorithm 242
Table 91: Leica Bond Oracle HER2 IHC System SWOT Analysis 244
Table 92: Biogenex INSITE HER2/Neu Product Profile 245
Table 93: Biogenex INSITE HER2/Neu SWOT Analysis 247
Table 94: Abbott Pathvysion HER-2 DNA Probe Kit Product Profile 247
Table 95: Abbott Pathvysion HER-2 DNA Probe Kit SWOT Analysis 249
Table 96: Ventana INFORM HER2 Dual ISH Assay Product Profile 250
Table 97: Ventana INFORM HER2 Dual ISH Assay SWOT Analysis 252
Table 98: Pathway HER2/Neu IHC Product Profile 252
Table 99: Pathway HER2/Neu IHC SWOT Analysis 255
Table 100: HerMark Product Profile 256
Table 101: HerMark SWOT Analysis 257
Table 102: Therascreen KRAS RGQ Product Profile 257
Table 103: Therascreen KRAS RGQ SWOT Analysis 260
Table 104: Cobas KRAS Mutation Test Product Profile 260
Table 105: Cobas KRAS Mutation Test SWOT Analysis 262
Table 106: EGFR PharmDx Kit Product Profile 262
Table 107: EGFR PharmDx Kit SWOT Analysis 266
Table 108: THxID BRAF Product Profile 267
Table 109: Effect of Melanin on the THxID BRAF PCR Test 268
Table 110: THxID BRAF SWOT Analysis 270
Table 111: Cobas 4800 BRAF V600 Mutation Test - Melanoma Product Profile 270
Table 112: Interpretation of Cobas BRAF V600 Mutation Test - Melanoma 271
Table 113: Cobas 4800 BRAF V600 Mutation Test - Melanoma SWOT Analysis 273
Table 114: Vysis ALK Break Apart FISH Probe Kit Product Profile 273
Table 115: Abbott Vysis ALK Break Apart FISH Probe Kit SWOT Analysis 276
Table 116: Amoy-Dx EML4-ALK Fusion Gene Detection Kit Product Profile 276
Table 117: Amoy-Dx EML4-ALK Fusion Gene Detection Kit SWOT Analysis 278
Table 118: Therascreen EGFR RGQ PCR Kit Product Profile 278
Table 119: Therascreen EGFR RGQ PCR Kit SWOT Analysis 283
Table 120: ALK IHC Test Product Profile 284
Table 121: ALK IHC Test SWOT Analysis 286
Table 122: Cobas EGFR Mutation Test Product Profile 287
Table 123: Cobas EGFR Mutation Test SWOT Analysis 289
Table 124: Companion Diagnostic Tests Pipeline, 2014 308
Table 125: Neuvax Companion Diagnostic Assay Product Profile 310
Table 126: Neuvax Companion Diagnostic Assay Product SWOT Analysis 311
Table 127: Companion Diagnostic Test - Palbociclib Product Profile 312
Table 128: Companion Diagnostic Test - Palbociclib SWOT Analysis 313
Table 129: Companion Diagnostic Test - Breast Cancer Product Profile 314
Table 130: Companion Diagnostic Test - Breast Cancer SWOT Analysis 314
Table 131: Onapristone Companion Diagnostic Assay Product Profile 315
Table 132: Onapristone Companion Diagnostic Assay SWOT Analysis 316
Table 133: Aromatase Inhibitor Biomarker - Companion Diagnostic Test Product Profile 317
Table 134: Aromatase Inhibitor Biomarker - Companion Diagnostic Test SWOT Analysis 317
Table 135: BRAF Companion Diagnostic Assay - Colon Cancer Product Profile 318
Table 136: BRAF Companion Diagnostic Assay - Colon Cancer SWOT Analysis 319
Table 137: KRAS Companion Diagnostic Assay - Colon Cancer Product Profile 320
Table 138: KRAS Companion Diagnostic Assay - Colon Cancer SWOT Analysis 320
Table 139: PIK3CA Companion Diagnostic Assay - Colorectal Cancer Product Profile 321
Table 140: PIK3CA Companion Diagnostic Assay - Colorectal Cancer SWOT Analysis 322
Table 141: Vectibix Companion Diagnostic Product Profile 323
Table 142: Vectibix Companion Diagnostic SWOT Analysis 324
Table 143: MAGE-A3 Companion Skin Cancer Assay Product Profile 325
Table 144: MAGE-A3 Companion Skin Cancer Assay SWOT Analysis 325
Table 145: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma Product Profile 326
Table 146: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma SWOT Analysis 327
Table 147: Companion Diagnostic Test - Melanoma Cancer Product Profile 328
Table 148: Companion Diagnostic Test - Melanoma Cancer SWOT Analysis 328
Table 149: KRAS Companion Diagnostic Assay - Melanoma Product Profile 329
Table 150: KRAS Companion Diagnostic Assay - Melanoma SWOT Analysis 330
Table 151: Companion Diagnostic Test - Melanoma Product Profile 331
Table 152: Companion Diagnostic Test - Melanoma SWOT Analysis 331
Table 153: BRAF Companion Diagnostic Assay - Lung Cancer Product Profile 332
Table 154: BRAF Companion Diagnostic Assay - Lung Cancer SWOT Analysis 332
Table 155: KRAS Companion Diagnostic Assay - Lung Cancer Product Profile 333
Table 156: KRAS Companion Diagnostic Assay - Lung Cancer SWOT Analysis 333
Table 157: MET Companion Diagnostic Assay - Lung Cancer Product Profile 334
Table 158: MET Companion Diagnostic Assay - Lung Cancer SWOT Analysis 335
Table 159: PIK3CA Companion Diagnostic Assay - Lung Cancer Product Profile 336
Table 160: PIK3CA Companion Diagnostic Assay - Lung Cancer SWOT Analysis 336
Table 161: Companion Diagnostic Device - Lung Cancer Product Profile 337
Table 162: Companion Diagnostic Device - Lung Cancer SWOT Analysis 338
Table 163: Companion Diagnostic Test - Crizotinib Product Profile 339
Table 164: Companion Diagnostic Test - Crizotinib SWOT Analysis 339
Table 165: Companion Diagnostic Test - Dacomitinib Product Profile 340
Table 166: Companion Diagnostic Test - Dacomitinib SWOT Analysis 340
Table 167: T790M Mutation Companion Diagnostic Test Product Profile 341
Table 168: T790M Mutation Companion Diagnostic Test SWOT Analysis 342
Table 169: Entinostat Companion Diagnostic Assay Product Profile 343
Table 170: Entinostat Companion Diagnostic Assay SWOT Analysis 343
Table 171: MUC1 Expression Companion Diagnostic Test Product Profile 344
Table 172: MUC1 Expression Companion Diagnostic Test SWOT Analysis 345
Table 173: Companion Diagnostic Assay - NSCLC Product Profile 346
Table 174: Companion Diagnostic Assay - NSCLC SWOT Analysis 346
Table 175: Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies. 351
Table 176: Company Profile - Amgen 354
Table 177: Amgen's Key Products 355
Table 178: Selected Amgen Anti-Cancer Therapies Currently in Clinical Trials 356
Table 179: Amgen SWOT Analysis 361
Table 180: Company Profile - Arno Therapeutics 362
Table 181: Selected Arno Therapeutics Anti-Cancer Therapies Currently in Clinical Trials 362
Table 182: Arno Therapeutics SWOT Analysis 366
Table 183: Company Profile - AstraZeneca 367
Table 184: Key Events in the Development of AstraZeneca's Drug Portfolio Since 2011 369
Table 185: Key Project Terminations by AstraZeneca Since 2008 371
Table 186: AstraZeneca SWOT Analysis 375
Table 187: Company Profile - Bristol-Myers Squibb 376
Table 188: Recent Key Product Approvals from Bristol-Myers Squibb 379
Table 189: Recent Key BMS Partnerships and Agreements 380
Table 190: Bristol-Myers Squibb SWOT Analysis 381
Table 191: Company Profile - Clovis Oncology 382
Table 192: Clovis Oncology's Key Products 383
Table 193: Clovis Oncology SWOT Analysis 387
Table 194: Company Profile - Eli Lilly and Company 388
Table 195: Eli Lilly and Company SWOT Analysis 394
Table 196: Company Profile - Genentech 394
Table 197: Selected Genentech Marketed Products 395
Table 198: Genentech SWOT Analysis 400
Table 199: Company Profile - Pfizer 401
Table 200: Pfizer SWOT Analysis 407
Table 201: Company Profile - Syndax Pharmaceuticals 408
Table 202: Syndax Pharmaceuticals SWOT Analysis 409
Table 203: Company Profile - Abbott Laboratories 410
Table 204: Abbott's Key Product Areas 411
Table 205: Abbott Laboratories SWOT Analysis, 2013 416
Table 206: Company Profile - Amoy Diagnostics 417
Table 207: Amoy Diagnostics SWOT Analysis, 2013 418
Table 208: Company Profile - Biogenex Laboratories 419
Table 209: Biogenex Laboratories SWOT Analysis, 2013 420
Table 210: Company Profile - BioMerieux 421
Table 211: BioMerieux SWOT Analysis, 2013 429
Table 212: Company Profile - Dako (Agilent Technologies) 430
Table 213: Dako/Agilent Technologies SWOT Analysis 435
Table 214: Company Profile - Illumina 436
Table 215: Illumina Product Areas 437
Table 216: Illumina SWOT Analysis 444
Table 217: Company Profile - Leica Biosystems (Danaher) 445
Table 218: Leica Biosystems/Danaher SWOT Analysis 451
Table 219: Company Profile - Life Technologies (Thermo Fisher Scientific) 452
Table 220: Life Technologies SWOT Analysis 459
Table 221: Company Profile - MolecularMD 460
Table 222: MolecularMD SWOT Analysis 461
Table 223: Company Profile - Myriad Genetics 462
Table 224: Myriad Genetics Major Product Areas 463
Table 225: Myriad Genetics SWOT Analysis 467
Table 226: Company Profile - Qiagen 468
Table 227: Qiagen Major Product Areas 469
Table 228: Qiagen SWOT Analysis 474
Table 229: Company Profile - Roche Diagnostics 475
Table 230: Roche SWOT Analysis 481
Table 231: Company Profile - Siemens Healthcare 482
Table 232: Siemens Healthcare SWOT Analysis 487
Table 233: Company Profile - Ventana Medical Systems 488
Table 234: Ventana Medical Systems SWOT Analysis 491
Table 235: Global Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020 492
Table 236: Global Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020 494
Table 237: Global Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020 497
Table 238: Global Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020 499
Table 239: Global Sales Forecast for IHC and Molecular Tests ($m), 2011-2020 505
Table 240: Major Events Affecting the Companion Diagnostic Test Market 507
Table 241: Global Sales Forecast for Companion Diagnostic Tests ($m), 2011-2020 508
Table 242: Sales Forecast for Companion Diagnostic Tests ($m) in the US, 2011-2020 509
Table 243: Sales Forecast for Companion Diagnostic Tests ($m) in France, 2011-2020 511
Table 244: Sales Forecast for Companion Diagnostic Tests ($m) in Germany, 2011-2020 513
Table 245: Sales Forecast for Companion Diagnostic Tests ($m) in Italy, 2011-2020 515
Table 246: Sales Forecast for Companion Diagnostic Tests ($m) in Spain, 2011-2020 517
Table 247: Sales Forecast for Companion Diagnostic Tests ($m) in the UK, 2011-2020 519
Table 248: Sales Forecast for Companion Diagnostic Tests ($m) in Japan, 2011-2020 521
Table 249: Sales Forecast for Companion Diagnostic Tests ($m) in Brazil, 2011-2020 523
Table 250: Sales Forecast for Companion Diagnostic Tests ($m) in China, 2011-2020 525
Table 251: Sales Forecast for Companion Diagnostic Tests ($m) in India, 2011-2020 528

1.2 List of Figures
Figure 1: Genomic Sequencing Costs, 2001-2012 32
Figure 2: Use of Proteomics in Personalized Medicine 34
Figure 3: Incidence of Inherited Breast Cancer Mutations among Diagnosed Breast Cancer Patients 36
Figure 4: Basic FISH Process 46
Figure 5: Basic PCR Process 48
Figure 6: Impact of Sample Storage on PCR Outcome 49
Figure 7: Genomic Sequencing Costs, 2001-2012 51
Figure 8: Scientific and Economic Potential of Companion Diagnostics 55
Figure 9: Drug and Diagnostic Test Co-Development 56
Figure 10: Roche Lifecycle Algorithm for Co-Development of a Predictive Diagnostic 57
Figure 11: Key Development Drivers for Companion Diagnostic Tests 59
Figure 12: Qiagen Model to Build a JAK2 Companion Diagnostic Tests Business 61
Figure 13: Uptake of HER2 Testing among Invasive Breast Cancer Patients 66
Figure 14: HER2 Testing in the US, 2011-2020 68
Figure 15: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the US, 2011-2020 70
Figure 16: Melanoma Companion Diagnostic Testing (BRAF) in the US, 2011-2020 72
Figure 17: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the US, 2011-2020 74
Figure 18: Breast Cancer Companion Diagnostic Testing (HER2) in France, 2011-2020 79
Figure 19: KRAS Testing in France 2008-2012 80
Figure 20: Colorectal Cancer Companion Diagnostic (KRAS) Testing in France, 2011-2020 81
Figure 21: Melanoma Companion Diagnostic Testing (BRAF) in France, 2011-2020 82
Figure 22: EGFR Testing in France, 2008-2012 83
Figure 23: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in France, 2011-2020 84
Figure 24: Breast Cancer Companion Diagnostic Testing (HER2) in Germany, 2011-2020 86
Figure 25: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Germany, 2011-2020 87
Figure 26: Melanoma Companion Diagnostic Testing (BRAF) in Germany, 2011-2020 89
Figure 27: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Germany, 2011-2020 91
Figure 28: Treatment Index: Italy versus Rest of EU in Use of Herceptin per Head of Population, 2002 92
Figure 29: Percentage of All Breast Cancer Patients Tested for HER2, Italy versus Rest of EU, 2002 93
Figure 30: Breast Cancer Companion Diagnostic Testing (HER2) in Italy, 2011-2020 94
Figure 31: Methods Used for KRAS Genotyping by the Centers Participating in the Italian Quality Assessment Scheme 95
Figure 32: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Italy, 2011-2020 96
Figure 33: Melanoma Companion Diagnostic Testing (BRAF) in Italy, 2011-2020 97
Figure 34: Methods Used for EGFR Genotyping by the Centers Participating in the Italian Quality Assessment Scheme in 2013 98
Figure 35: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Italy, 2011-2020 99
Figure 36: Breast Cancer Companion Diagnostic Testing (HER2) in Spain, 2011-2020 101
Figure 37: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Spain, 2011-2020 102
Figure 38: Melanoma Companion Diagnostic Testing (BRAF) in Spain, 2011-2020 104
Figure 39: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Spain, 2011-2020 105
Figure 40: UK HER2 Status Testing Algorithm 107
Figure 41: Breast Cancer Companion Diagnostic Testing (HER2) in the UK, 2011-2020 108
Figure 42: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the UK, 2011-2020 111
Figure 43: Melanoma Companion Diagnostic Testing (BRAF) in the UK, 2011-2020 113
Figure 44: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the UK, 2011-2020 119
Figure 45: Breast Cancer Companion Diagnostic Testing (HER2) in Japan, 2011-2020 121
Figure 46: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Japan, 2011-2020 123
Figure 47: Melanoma Companion Diagnostic Testing (BRAF) in Japan, 2011-2020 124
Figure 48: EGFR Testing in Japan, 2006-2011 125
Figure 49: Japanese Lung Cancer Society Diagnostic Testing Algorithm 127
Figure 50: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Japan, 2011-2020 128
Figure 51: Breast Cancer Companion Diagnostic Testing (HER2) in Brazil, 2011-2020 130
Figure 52: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Brazil, 2011-2020 131
Figure 53: Melanoma Companion Diagnostic Testing (BRAF) in Brazil, 2011-2020 132
Figure 54: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Brazil, 2011-2020 134
Figure 55: Breast Cancer Companion Diagnostic Testing (HER2) in China, 2011-2020 137
Figure 56: Colorectal Cancer Companion Diagnostic (KRAS) Testing in China, 2011-2020 139
Figure 57: Melanoma Companion Diagnostic Testing (BRAF) in China, 2011-2020 140
Figure 58: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in China, 2011-2020 142
Figure 59: Breast Cancer Companion Diagnostic Testing (HER2) in India, 2011-2020 144
Figure 60: Colorectal Cancer Companion Diagnostic (KRAS) Testing in India, 2011-2020 146
Figure 61: Melanoma Companion Diagnostic Testing (BRAF) in India, 2011-2020 147
Figure 62: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in India, 2011-2020 149
Figure 63: EU Medical Device Approval and Post-Market Surveillance Process 157
Figure 64: Healthcare Coverage Frameworks 178
Figure 65: German Reimbursement Establishment Process 185
Figure 66: Increase in EGFR Testing at AstraZeneca-Funded Test Centers in the UK 190
Figure 67: UK Regional Access to Cancer Diagnostic Testing 192
Figure 68: Registration of Domestic and Imported Medical Devices in China 194
Figure 69: Multiple Partnerships in Companion Diagnostics during 2013-2014 205
Figure 70: Building a Companion Diagnostics Business: Forming Multiple Partnerships 206
Figure 71: Increasing Medicare Cost of Treatment 210
Figure 72: Growth of Drug Therapy Expenditure in France, 2004-2009 211
Figure 73: Share of Targeted Therapies of Anti-Cancer Drug Costs in France 212
Figure 74: Increase in Approvals of Biologic (Targeted) Therapies 218
Figure 75: EGFR PharmDx Test Adoption Curve 263
Figure 76: Probe Arrangement in the Vysis ALK Break Apart FISH Probe Kit 274
Figure 77: Scorpion Primers 280
Figure 78: Increase in High- and Moderate-Complexity Molecular Tests 283
Figure 79: Reasons for Companion Diagnostic Test Failure 295
Figure 80: Female Breast Cancer Treatment Patterns by Stage, 2008 298
Figure 81: Colon Cancer Treatment Patterns by Stage, 2008 299
Figure 82: Lung Cancer Treatment Patterns by Stage, 2008 300
Figure 83: Expected Companion Diagnostic Test Pipeline, US Approvals, 2014-2019 307
Figure 84: Sponsors of Clinical Trials for Targeted Cancer Therapies 348
Figure 85: Sponsors of Clinical Trials for Targeted Cancer Therapies Based on Mutational Status 349
Figure 86: Sponsors of Clinical Trials for Targeted Cancer Therapies, by Phase 350
Figure 87: Global Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020 492
Figure 88: Global Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020 494
Figure 89: Global Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020 497
Figure 90: Global Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020 499
Figure 91: Uptake in ALK Mutation IHC and FISH Testing in France, 2011-2020 501
Figure 92: Uptake of ALK Mutation IHC and FISH Testing in Germany 2011-2020 502
Figure 93: Global Sales Forecast for IHC and Molecular Tests ($m), 2011-2020 505
Figure 94: Global Market Share of Molecular Tests and Immunohistochemistry Tests in 2012 and 2020 506
Figure 95: Global Sales Forecast for Companion Diagnostic Tests ($m), 2011-2020 508
Figure 96: Sales Forecast for Companion Diagnostic Tests ($m) in the US, 2011-2020 509
Figure 97: Sales Forecast for Companion Diagnostic Tests ($m) in France, 2011-2020 511
Figure 98: Sales Forecast for Companion Diagnostic Tests ($m) in Germany, 2011-2020 513
Figure 99: Sales Forecast for Companion Diagnostic Tests ($m) in Italy, 2011-2020 515
Figure 100: Sales Forecast for Companion Diagnostic Tests ($m) in Spain, 2011-2020 517
Figure 101: Sales Forecast for Companion Diagnostic Tests ($m) in the UK, 2011-2020 518
Figure 102: Sales Forecast for Companion Diagnostic Tests ($m) in Japan, 2011-2020 521
Figure 103: Sales Forecast for Companion Diagnostic Tests ($m) in Brazil, 2011-2020 523
Figure 104: Sales Forecast for Companion Diagnostic Tests ($m) in China, 2011-2020 525
Figure 105: Sales Forecast for Companion Diagnostic Tests ($m) in India, 2011-2020 528

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