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MediPoint: Companion Diagnostic Tests in Oncology - APAC 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 APAC companion diagnostic test market, for breast cancer companion diagnostic tests, principally HER2 tests, to have been worth $12.9m in 2012. In China, there has been excellent progress in uptake of HER2 testing among the urban population, thanks to efforts to train pathologists, with IHC uptake rates expected to be comparable to western countries by 2014. In India, HER2 testing has been longer-established than in China, but India shows only modest increases in uptake of HER2 IHC testing. In both countries, FISH test uptake is restricted by the patient’s ability to pay, as these tests are not reimbursed by the state healthcare systems.

Scope

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

Table Of Contents

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

2 Introduction 22
2.1 Catalyst 22
2.2 Related Reports 23
3 Industry Overview 24
3.1 Emergence of Companion Diagnostics 24
3.1.1 Definition of Companion Diagnostics 24
3.1.2 Changing Face of Medicine 25
3.1.3 Definitions of Companion and Personalized Diagnostics 27
3.2 Disease Applications 29
3.2.1 Breast Cancer 29
3.2.2 Colorectal Cancer 32
3.2.3 Melanoma 34
3.2.4 Non-Small Cell Lung Cancer 35
3.3 Companion Diagnostics Technologies 37
3.3.1 Immunochemical Techniques 37
3.3.2 Nucleic Acid Testing 39
3.3.3 Emerging Technologies 46
3.4 Companion Diagnostics Development 48
3.4.1 Economic Value of a Companion Diagnostic 48
3.4.2 When to Develop a Companion Diagnostic Test 49
3.4.3 Strategy 52
3.4.4 Selection of Partner 53
3.4.5 Biomarker Discovery 55
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 Japan 57
3.6.2 China 65
3.6.3 India 73
3.7 Market Access 81
3.7.1 Overview 81
3.7.2 Japan 81
3.7.3 China 83
3.7.4 India 85
3.8 Regulatory Issues and Recalls 87
3.8.1 Dako FDA Warning Letter 87
3.8.2 HercepTest Recall 87
3.8.3 Cobas KRAS Test Recall 88
3.8.4 Cobas BRF V600E Test Recall 88
3.8.5 Leica Bond HER2 IHC System 88
3.9 Reimbursement of Companion Diagnostic Tests 88
3.9.1 Japan 88
3.9.2 China 89
3.9.3 India 91
3.10 MandA, Key Partnerships 93
3.10.1 Significant Mergers and Acquisitions 95
3.10.2 Recent Partnerships 95
3.11 Economic Impact 101
3.11.1 Cost Effectiveness of Companion Diagnostics 101
3.11.2 Cost Effectiveness of Companion Diagnostics: Healthcare Provider Perspective 102
3.12 Market Drivers 108
3.12.1 Driver: Increasing Healthcare Pressures 108
3.12.2 Driver: Adverse Economic Pressures 109
3.12.3 Driver: Availability of New Technologies 109
3.12.4 Driver: FDA Regulatory Changes 110
3.12.5 Driver: Need to Improve Drug Development Processes 110
3.12.6 Driver: Increasing Cancer Incidence 111
3.12.7 Driver: Accelerating Demand for Targeted Therapies 111
3.13 Market Barriers 112
3.13.1 Barrier: Reimbursement Difficulties 112
3.13.2 Barrier: Loss of Indication 113
3.13.3 Barrier: Emergence of Biosimilar Therapies 114
3.13.4 Barrier: Competition with Laboratory-Developed Tests 114
3.13.5 Barrier: Emergence of Next-Generation Gene Sequencing 115
3.13.6 Barrier: Lack of Laboratory Choice in Instrument Selection 116
3.13.7 Barrier: Lack of Patient Awareness about Companion Diagnostic Tests 118
3.13.8 Barrier: Physician Resistance to New Companion Diagnostic Tests 118
4 Competitive Assessment 120
4.1 Overview 120
4.2 Techniques in Use by Currently Marketed Products 120
4.2.1 Immunohistochemistry 120
4.2.2 Fluorescence In Situ Hybridization 120
4.2.3 Polymerase Chain Reaction 121
4.3 Competitive Analysis 121
4.3.1 Breast Cancer Companion Diagnostic Tests 121
4.3.2 Colorectal Cancer Companion Diagnostic Tests 150
4.3.3 Melanoma Companion Diagnostic Tests 159
4.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 165
5 Unmet Needs 182
5.1 Need for Improved Cancer Treatments 182
5.2 Need for Objective Tests 182
5.3 Need for High-Throughput Tests 184
5.4 Certainty of Reimbursement 185
5.5 Amount and Type of Tissue Needed for Test 186
5.6 Who Should be Tested? 189
5.7 Test Accuracy 194
5.8 Increasing Test Complexity and Increased Process Failure 196
6 Pipeline Products 198
6.1 Overview 198
6.2 Pipeline by Phase of Development 200
6.3 Pipeline Product Profiles 201
6.3.1 Breast Cancer Companion Diagnostic Tests 201
6.3.2 Colorectal Cancer Companion Diagnostic Tests 209
6.3.3 Melanoma Companion Diagnostic Tests 215
6.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 222
7 Clinical Trials to Watch 237
7.1 Overview 237
7.2 Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies 241
8 Current and Future Players 242
8.1 Trends in Corporate Strategy 242
8.1.1 Companion Diagnostics Business Models 242
8.2 Company Profiles 243
8.2.1 Pharmaceutical/Therapy Companies Developing Companion Diagnostic Tests 243
8.2.2 Diagnostics Companies Developing Companion Diagnostic Tests (in Partnership with Pharmaceutical Companies) 297
9 Market Outlooks 379
9.1 By Market Segment 379
9.1.1 Breast Cancer Companion Diagnostic Tests 379
9.1.2 Colorectal Cancer Companion Diagnostic Tests 380
9.1.3 Melanoma Companion Diagnostic Tests 382
9.1.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 384
9.1.5 Technique 386
9.2 By Geography 389
9.2.1 10 Major Markets Overview 389
9.2.2 Japan 389
9.2.3 China 392
9.2.4 India 394
10 Appendix 397
10.1 Bibliography 397
10.2 Abbreviations 436
10.3 Report Methodology 438
10.3.1 Coverage 438
10.3.2 Secondary Research 439
10.3.3 Forecasting Methodology 439
10.4 Physicians Included in this Study 441
10.5 About the Authors 443
10.5.1 Andrew Thompson, Ph.D., Senior Analyst, In Vitro Diagnostics 443
10.5.2 Derek Archila, MBA, Lead Analyst, Medical Devices 443
10.5.3 Bonnie Bain, PhD, Global Head of Healthcare 444
10.6 Disclaimer 445

1.1 List of Tables

Table 1: Possible Companion Diagnostic Test Platforms 24
Table 2: Specific Breast Cancer Types Associated with Inherited Disorders 31
Table 3: Specific Mutations Associated with Non-Small Cell Lung Cancer 37
Table 4: Weaknesses of ELISA Technique 38
Table 5: Key Stages of PCR Gene Test 41
Table 6: Key Principles Guiding Companion Diagnostic Test Development 52
Table 7: Companion Diagnostic Test Development Partner Selection 53
Table 8: Biomarker Discovery 55
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 for Breast Cancer Patients in Japan 58
Table 13: Breast Cancer Companion Diagnostic Testing (HER2) in Japan, 2011-2020 59
Table 14: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Japan, 2011-2020 60
Table 15: Melanoma Companion Diagnostic Testing (BRAF) in Japan, 2011-2020 61
Table 16: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Japan, 2011-2020 65
Table 17: Breast Cancer Companion Diagnostic Testing (HER2) in China, 2011-2020 68
Table 18: Colorectal Cancer Companion Diagnostic (KRAS) Testing in China, 2011-2020 69
Table 19: Melanoma Companion Diagnostic Testing (BRAF) in China, 2011-2020 71
Table 20: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in China, 2011-2020 73
Table 21: Breast Cancer Companion Diagnostic Testing (HER2) in India, 2011-2020 75
Table 22: Colorectal Cancer Companion Diagnostic (KRAS) Testing in India, 2011-2020 77
Table 23: Melanoma Companion Diagnostic Testing (BRAF) in India, 2011-2020 78
Table 24: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in India, 2011-2020 80
Table 25: Healthcare Systems in China 84
Table 26: Healthcare Principles in China 85
Table 27: Tariffs for Companion Diagnostic and Related Tests at the Tata Memorial Hospital 93
Table 28: Key Mergers and Acquisitions during 2013-2014 95
Table 29: Partnerships during 2013-2014 96
Table 30: Impact of Companion Diagnostics on Cancer Treatment Costs in France 107
Table 31: Effectiveness of Disease Therapies 108
Table 32: HER2 FISH/iQFISH PharmDx Product Profile 121
Table 33: Common Reasons for HER2 FISH Failure 123
Table 34: HER2 FISH PharmDx/HER2 iQFISH PharmDx SWOT Analysis 125
Table 35: HercepTest Product Profile 125
Table 36: HercepTest Scoring Algorithm 126
Table 37: HercepTest SWOT Analysis 128
Table 38: HER2 CISH PharmDx Product Profile 129
Table 39: HER2 CISH PharmDx SWOT Analysis 131
Table 40: SPOT-Light HER2 CISH Kit Product Profile 132
Table 41: SPOT-Light HER2 CISH Kit SWOT Analysis 134
Table 42: Leica Bond Oracle HER2 IHC System Product Profile 134
Table 43: Leica Bond Oracle HER2 IHC System Test Algorithm 135
Table 44: Leica Bond Oracle HER2 IHC System SWOT Analysis 137
Table 45: Biogenex INSITE HER2/Neu Product Profile 138
Table 46: Biogenex INSITE HER2/Neu SWOT Analysis 140
Table 47: Abbott Pathvysion HER-2 DNA Probe Kit Product Profile 140
Table 48: Abbott Pathvysion HER-2 DNA Probe Kit SWOT Analysis 142
Table 49: Ventana INFORM HER2 Dual ISH Assay Product Profile 143
Table 50: Ventana INFORM HER2 Dual ISH Assay SWOT Analysis 145
Table 51: Pathway HER2/Neu IHC Product Profile 145
Table 52: Pathway HER2/Neu IHC SWOT Analysis 148
Table 53: HerMark Product Profile 149
Table 54: HerMark SWOT Analysis 150
Table 55: Therascreen KRAS RGQ Product Profile 150
Table 56: Therascreen KRAS RGQ SWOT Analysis 153
Table 57: Cobas KRAS Mutation Test Product Profile 153
Table 58: Cobas KRAS Mutation Test SWOT Analysis 154
Table 59: EGFR PharmDx Kit Product Profile 155
Table 60: EGFR PharmDx Kit SWOT Analysis 159
Table 61: THxID BRAF Product Profile 159
Table 62: Effect of Melanin on the THxID BRAF PCR Test 161
Table 63: THxID BRAF SWOT Analysis 162
Table 64: Cobas 4800 BRAF V600 Mutation Test - Melanoma Product Profile 163
Table 65: Interpretation of Cobas BRAF V600 Mutation Test - Melanoma 164
Table 66: Cobas 4800 BRAF V600 Mutation Test - Melanoma SWOT Analysis 165
Table 67: Vysis ALK Break Apart FISH Probe Kit Product Profile 166
Table 68: Abbott Vysis ALK Break Apart FISH Probe Kit SWOT Analysis 168
Table 69: Amoy-Dx EML4-ALK Fusion Gene Detection Kit Product Profile 168
Table 70: Amoy-Dx EML4-ALK Fusion Gene Detection Kit SWOT Analysis 170
Table 71: Therascreen EGFR RGQ PCR Kit Product Profile 170
Table 72: Therascreen EGFR RGQ PCR Kit SWOT Analysis 175
Table 73: ALK IHC Test Product Profile 176
Table 74: ALK IHC Test SWOT Analysis 178
Table 75: Cobas EGFR Mutation Test Product Profile 179
Table 76: Cobas EGFR Mutation Test SWOT Analysis 181
Table 77: Companion Diagnostic Tests Pipeline, 2014 200
Table 78: Neuvax Companion Diagnostic Assay Product Profile 202
Table 79: Neuvax Companion Diagnostic Assay Product SWOT Analysis 202
Table 80: Companion Diagnostic Test - Palbociclib Product Profile 203
Table 81: Companion Diagnostic Test - Palbociclib SWOT Analysis 204
Table 82: Companion Diagnostic Test - Breast Cancer Product Profile 205
Table 83: Companion Diagnostic Test - Breast Cancer SWOT Analysis 205
Table 84: Onapristone Companion Diagnostic Assay Product Profile 206
Table 85: Onapristone Companion Diagnostic Assay SWOT Analysis 207
Table 86: Aromatase Inhibitor Biomarker - Companion Diagnostic Test Product Profile 208
Table 87: Aromatase Inhibitor Biomarker - Companion Diagnostic Test SWOT Analysis 208
Table 88: BRAF Companion Diagnostic Assay - Colon Cancer Product Profile 209
Table 89: BRAF Companion Diagnostic Assay - Colon Cancer SWOT Analysis 210
Table 90: KRAS Companion Diagnostic Assay - Colon Cancer Product Profile 211
Table 91: KRAS Companion Diagnostic Assay - Colon Cancer SWOT Analysis 211
Table 92: PIK3CA Companion Diagnostic Assay - Colorectal Cancer Product Profile 212
Table 93: PIK3CA Companion Diagnostic Assay - Colorectal Cancer SWOT Analysis 213
Table 94: Vectibix Companion Diagnostic Product Profile 214
Table 95: Vectibix Companion Diagnostic SWOT Analysis 215
Table 96: MAGE-A3 Companion Skin Cancer Assay Product Profile 216
Table 97: MAGE-A3 Companion Skin Cancer Assay SWOT Analysis 216
Table 98: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma Product Profile 217
Table 99: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma SWOT Analysis 218
Table 100: Companion Diagnostic Test - Melanoma Cancer Product Profile 219
Table 101: Companion Diagnostic Test - Melanoma Cancer SWOT Analysis 219
Table 102: KRAS Companion Diagnostic Assay - Melanoma Product Profile 220
Table 103: KRAS Companion Diagnostic Assay - Melanoma SWOT Analysis 221
Table 104: Companion Diagnostic Test - Melanoma Product Profile 222
Table 105: Companion Diagnostic Test - Melanoma SWOT Analysis 222
Table 106: BRAF Companion Diagnostic Assay - Lung Cancer Product Profile 223
Table 107: BRAF Companion Diagnostic Assay - Lung Cancer SWOT Analysis 223
Table 108: KRAS Companion Diagnostic Assay - Lung Cancer Product Profile 224
Table 109: KRAS Companion Diagnostic Assay - Lung Cancer SWOT Analysis 224
Table 110: MET Companion Diagnostic Assay - Lung Cancer Product Profile 225
Table 111: MET Companion Diagnostic Assay - Lung Cancer SWOT Analysis 226
Table 112: PIK3CA Companion Diagnostic Assay - Lung Cancer Product Profile 227
Table 113: PIK3CA Companion Diagnostic Assay - Lung Cancer SWOT Analysis 227
Table 114: Companion Diagnostic Device - Lung Cancer Product Profile 228
Table 115: Companion Diagnostic Device - Lung Cancer SWOT Analysis 229
Table 116: Companion Diagnostic Test - Crizotinib Product Profile 230
Table 117: Companion Diagnostic Test - Crizotinib SWOT Analysis 230
Table 118: Companion Diagnostic Test - Dacomitinib Product Profile 231
Table 119: Companion Diagnostic Test - Dacomitinib SWOT Analysis 231
Table 120: T790M Mutation Companion Diagnostic Test Product Profile 232
Table 121: T790M Mutation Companion Diagnostic Test SWOT Analysis 232
Table 122: Entinostat Companion Diagnostic Assay Product Profile 233
Table 123: Entinostat Companion Diagnostic Assay SWOT Analysis 234
Table 124: MUC1 Expression Companion Diagnostic Test Product Profile 235
Table 125: MUC1 Expression Companion Diagnostic Test SWOT Analysis 235
Table 126: Companion Diagnostic Assay - NSCLC Product Profile 236
Table 127: Companion Diagnostic Assay - NSCLC SWOT Analysis 236
Table 128: Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies. 241
Table 129: Company Profile - Amgen 244
Table 130: Amgen's Key Products 244
Table 131: Selected Amgen Anti-Cancer Therapies Currently in Clinical Trials 245
Table 132: Amgen SWOT Analysis 250
Table 133: Company Profile - Arno Therapeutics 251
Table 134: Selected Arno Therapeutics Anti-Cancer Therapies Currently in Clinical Trials 251
Table 135: Arno Therapeutics SWOT Analysis 255
Table 136: Company Profile - AstraZeneca 256
Table 137: Key Events in the Development of AstraZeneca's Drug Portfolio Since 2011 258
Table 138: Key Project Terminations by AstraZeneca Since 2008 260
Table 139: AstraZeneca SWOT Analysis 264
Table 140: Company Profile - Bristol-Myers Squibb 265
Table 141: Recent Key Product Approvals from Bristol-Myers Squibb 268
Table 142: Recent Key BMS Partnerships and Agreements 269
Table 143: Bristol-Myers Squibb SWOT Analysis 270
Table 144: Company Profile - Clovis Oncology 271
Table 145: Clovis Oncology's Key Products 272
Table 146: Clovis Oncology SWOT Analysis 276
Table 147: Company Profile - Eli Lilly and Company 277
Table 148: Eli Lilly and Company SWOT Analysis 283
Table 149: Company Profile - Genentech 283
Table 150: Selected Genentech Marketed Products 284
Table 151: Genentech SWOT Analysis 289
Table 152: Company Profile - Pfizer 290
Table 153: Pfizer SWOT Analysis 296
Table 154: Company Profile - Syndax Pharmaceuticals 296
Table 155: Syndax Pharmaceuticals SWOT Analysis 297
Table 156: Company Profile - Abbott Laboratories 298
Table 157: Abbott's Key Product Areas 299
Table 158: Abbott Laboratories SWOT Analysis, 2013 304
Table 159: Company Profile - Amoy Diagnostics 305
Table 160: Amoy Diagnostics SWOT Analysis, 2013 306
Table 161: Company Profile - Biogenex Laboratories 307
Table 162: Biogenex Laboratories SWOT Analysis, 2013 308
Table 163: Company Profile - BioMerieux 309
Table 164: BioMerieux SWOT Analysis, 2013 317
Table 165: Company Profile - Dako (Agilent Technologies) 318
Table 166: Dako/Agilent Technologies SWOT Analysis 323
Table 167: Company Profile - Illumina 324
Table 168: Illumina Product Areas 324
Table 169: Illumina SWOT Analysis 331
Table 170: Company Profile - Leica Biosystems (Danaher) 332
Table 171: Leica Biosystems/Danaher SWOT Analysis 338
Table 172: Company Profile - Life Technologies (Thermo Fisher Scientific) 339
Table 173: Life Technologies SWOT Analysis 346
Table 174: Company Profile - MolecularMD 347
Table 175: MolecularMD SWOT Analysis 348
Table 176: Company Profile - Myriad Genetics 349
Table 177: Myriad Genetics Major Product Areas 350
Table 178: Myriad Genetics SWOT Analysis 354
Table 179: Company Profile - Qiagen 355
Table 180: Qiagen Major Product Areas 356
Table 181: Qiagen SWOT Analysis 361
Table 182: Company Profile - Roche Diagnostics 362
Table 183: Roche SWOT Analysis 368
Table 184: Company Profile - Siemens Healthcare 369
Table 185: Siemens Healthcare SWOT Analysis 374
Table 186: Company Profile - Ventana Medical Systems 375
Table 187: Ventana Medical Systems SWOT Analysis 378
Table 188: APAC Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020 379
Table 189: APAC Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020 381
Table 190: APAC Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020 383
Table 191: APAC Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020 385
Table 192: APAC Sales Forecast for IHC and Molecular Tests ($m), 2011-2020 387
Table 193: Major Events Affecting the Companion Diagnostic Test Market 389
Table 194: Sales Forecast for Companion Diagnostic Tests ($m) in Japan, 2011-2020 390
Table 195: Sales Forecast for Companion Diagnostic Tests ($m) in China, 2011-2020 393
Table 196: Sales Forecast for Companion Diagnostic Tests ($m) in India, 2011-2020 395

1.2 List of Figures
Figure 1: Genomic Sequencing Costs, 2001-2012 26
Figure 2: Use of Proteomics in Personalized Medicine 28
Figure 3: Incidence of Inherited Breast Cancer Mutations among Diagnosed Breast Cancer Patients 30
Figure 4: Basic FISH Process 40
Figure 5: Basic PCR Process 42
Figure 6: Impact of Sample Storage on PCR Outcome 43
Figure 7: Genomic Sequencing Costs, 2001-2012 45
Figure 8: Scientific and Economic Potential of Companion Diagnostics 49
Figure 9: Drug and Diagnostic Test Co-Development 50
Figure 10: Roche Lifecycle Algorithm for Co-Development of a Predictive Diagnostic 51
Figure 11: Key Development Drivers for Companion Diagnostic Tests 53
Figure 12: Qiagen Model to Build a JAK2 Companion Diagnostic Tests Business 54
Figure 13: Breast Cancer Companion Diagnostic Testing (HER2) in Japan, 2011-2020 59
Figure 14: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Japan, 2011-2020 60
Figure 15: Melanoma Companion Diagnostic Testing (BRAF) in Japan, 2011-2020 61
Figure 16: EGFR Testing in Japan, 2006-2011 62
Figure 17: Japanese Lung Cancer Society Diagnostic Testing Algorithm 64
Figure 18: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Japan, 2011-2020 65
Figure 19: Breast Cancer Companion Diagnostic Testing (HER2) in China, 2011-2020 67
Figure 20: Colorectal Cancer Companion Diagnostic (KRAS) Testing in China, 2011-2020 69
Figure 21: Melanoma Companion Diagnostic Testing (BRAF) in China, 2011-2020 70
Figure 22: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in China, 2011-2020 72
Figure 23: Breast Cancer Companion Diagnostic Testing (HER2) in India, 2011-2020 75
Figure 24: Colorectal Cancer Companion Diagnostic (KRAS) Testing in India, 2011-2020 77
Figure 25: Melanoma Companion Diagnostic Testing (BRAF) in India, 2011-2020 78
Figure 26: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in India, 2011-2020 80
Figure 27: Registration of Domestic and Imported Medical Devices in China 90
Figure 28: Multiple Partnerships in Companion Diagnostics during 2013-2014 99
Figure 29: Building a Companion Diagnostics Business: Forming Multiple Partnerships 100
Figure 30: Increasing Medicare Cost of Treatment 104
Figure 31: Growth of Drug Therapy Expenditure in France, 2004-2009 105
Figure 32: Share of Targeted Therapies of Anti-Cancer Drug Costs in France 106
Figure 33: Increase in Approvals of Biologic (Targeted) Therapies 112
Figure 34: EGFR PharmDx Test Adoption Curve 156
Figure 35: Probe Arrangement in the Vysis ALK Break Apart FISH Probe Kit 166
Figure 36: Scorpion Primers 172
Figure 37: Increase in High- and Moderate-Complexity Molecular Tests 175
Figure 38: Reasons for Companion Diagnostic Test Failure 187
Figure 39: Female Breast Cancer Treatment Patterns by Stage, 2008 190
Figure 40: Colon Cancer Treatment Patterns by Stage, 2008 191
Figure 41: Lung Cancer Treatment Patterns by Stage, 2008 192
Figure 42: Expected Companion Diagnostic Test Pipeline, US Approvals, 2014-2019 199
Figure 43: Sponsors of Clinical Trials for Targeted Cancer Therapies 238
Figure 44: Sponsors of Clinical Trials for Targeted Cancer Therapies Based on Mutational Status 239
Figure 45: Sponsors of Clinical Trials for Targeted Cancer Therapies, by Phase 240
Figure 46: APAC Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020 379
Figure 47: APAC Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020 381
Figure 48: APAC Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020 383
Figure 49: APAC Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020 385
Figure 50: APAC Sales Forecast for IHC and Molecular Tests ($m), 2011-2020 387
Figure 51: APAC Market Share of Molecular Tests and Immunohistochemistry Tests in 2012 and 2020 388
Figure 52: Sales Forecast for Companion Diagnostic Tests ($m) in Japan, 2011-2020 390
Figure 53: Sales Forecast for Companion Diagnostic Tests ($m) in China, 2011-2020 392
Figure 54: Sales Forecast for Companion Diagnostic Tests ($m) in India, 2011-2020 395

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