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MediPoint: Companion Diagnostic Tests in Oncology - South America 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 companion diagnostic test market in South America, for breast cancer companion diagnostic tests, principally HER2 tests, to have been worth $15.0m in 2012. Breast cancer companion diagnostic testing is expected to increase in Brazil mainlyt as a result of increasing incidence of the diseasde, with only a modest increase in access to testing amongst breast cancer patients.

Scope

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

Table Of Contents

MediPoint: Companion Diagnostic Tests in Oncology - South America 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 54
3.5.1 Role of Companion Diagnostics in Disease Treatment 54
3.5.2 Companion Diagnostic Test Applications 55
3.6 Testing Trends 56
3.6.1 Brazil 56
3.7 Market Access 63
3.7.1 Brazil 63
3.8 Regulatory Issues and Recalls 65
3.8.1 Dako FDA Warning Letter 65
3.8.2 HercepTest Recall 65
3.8.3 Cobas KRAS Test Recall 65
3.8.4 Cobas BRF V600E Test Recall 66
3.8.5 Leica Bond HER2 IHC System 66
3.9 Reimbursement of Companion Diagnostic Tests 66
3.9.1 South America 66
3.10 MandA, Key Partnerships 68
3.10.1 Significant Mergers and Acquisitions 69
3.10.2 Recent Partnerships 70
3.11 Economic Impact 75
3.11.1 Cost Effectiveness of Companion Diagnostics 75
3.11.2 Cost Effectiveness of Companion Diagnostics: Healthcare Provider Perspective 76
3.12 Market Drivers 83
3.12.1 Driver: Increasing Healthcare Pressures 83
3.12.2 Driver: Adverse Economic Pressures 84
3.12.3 Driver: Availability of New Technologies 84
3.12.4 Driver: FDA Regulatory Changes 85
3.12.5 Driver: Need to Improve Drug Development Processes 85
3.12.6 Driver: Increasing Cancer Incidence 86
3.12.7 Driver: Accelerating Demand for Targeted Therapies 86
3.13 Market Barriers 87
3.13.1 Barrier: Reimbursement Difficulties 87
3.13.2 Barrier: Loss of Indication 88
3.13.3 Barrier: Emergence of Biosimilar Therapies 89
3.13.4 Barrier: Competition with Laboratory-Developed Tests 89
3.13.5 Barrier: Emergence of Next-Generation Gene Sequencing 90
3.13.6 Barrier: Lack of Laboratory Choice in Instrument Selection 91
3.13.7 Barrier: Lack of Patient Awareness about Companion Diagnostic Tests 93
3.13.8 Barrier: Physician Resistance to New Companion Diagnostic Tests 93
4 Competitive Assessment 95
4.1 Overview 95
4.2 Techniques in Use by Currently Marketed Products 95
4.2.1 Immunohistochemistry 95
4.2.2 Fluorescence In Situ Hybridization 95
4.2.3 Polymerase Chain Reaction 96
4.3 Competitive Analysis 96
4.3.1 Breast Cancer Companion Diagnostic Tests 96
4.3.2 Colorectal Cancer Companion Diagnostic Tests 125
4.3.3 Melanoma Companion Diagnostic Tests 134
4.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 140
5 Unmet Needs 157
5.1 Need for Improved Cancer Treatments 157
5.2 Need for Objective Tests 157
5.3 Need for High-Throughput Tests 159
5.4 Certainty of Reimbursement 160
5.5 Amount and Type of Tissue Needed for Test 161
5.6 Who Should be Tested? 164
5.7 Test Accuracy 169
5.8 Increasing Test Complexity and Increased Process Failure 171
6 Pipeline Products 173
6.1 Overview 173
6.2 Pipeline by Phase of Development 175
6.3 Pipeline Product Profiles 176
6.3.1 Breast Cancer Companion Diagnostic Tests 176
6.3.2 Colorectal Cancer Companion Diagnostic Tests 184
6.3.3 Melanoma Companion Diagnostic Tests 190
6.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 197
7 Clinical Trials to Watch 212
7.1 Overview 212
7.2 Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies 216
8 Current and Future Players 217
8.1 Trends in Corporate Strategy 217
8.1.1 Companion Diagnostics Business Models 217
8.2 Company Profiles 218
8.2.1 Pharmaceutical/Therapy Companies Developing Companion Diagnostic Tests 218
8.2.2 Diagnostics Companies Developing Companion Diagnostic Tests (in Partnership with Pharmaceutical Companies) 272
9 Market Outlooks 354
9.1 By Market Segment 354
9.1.1 Breast Cancer Companion Diagnostic Tests 354
9.1.2 Colorectal Cancer Companion Diagnostic Tests 355
9.1.3 Melanoma Companion Diagnostic Tests 356
9.1.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 357
9.1.5 Technique 359
9.2 By Geography 362
9.2.1 Overview 362
9.2.2 Brazil 362
10 Appendix 365
10.1 Bibliography 365
10.2 Abbreviations 399
10.3 Report Methodology 401
10.3.1 Coverage 401
10.3.2 Secondary Research 401
10.3.3 Forecasting Methodology 402
10.4 Physicians Included in this Study 403
10.5 About the Authors 405
10.5.1 Andrew Thompson, Ph.D., Senior Analyst, In Vitro Diagnostics 405
10.5.2 Derek Archila, MBA, Lead Analyst, Medical Devices 405
10.5.3 Bonnie Bain, PhD, Global Head of Healthcare 406
10.6 Disclaimer 407

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 54
Table 10: Application of Companion Diagnostic Tests 55
Table 11: Major Biomarkers currently measured in Cancer Companion Diagnostic Tests 56
Table 12: Breast Cancer Companion Diagnostic Testing (HER2) in Brazil, 2011-2020 58
Table 13: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Brazil, 2011-2020 59
Table 14: Melanoma Companion Diagnostic Testing (BRAF) in Brazil, 2011-2020 60
Table 15: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Brazil, 2011-2020 62
Table 16: Key Mergers and Acquisitions during 2013-2014 69
Table 17: Partnerships during 2013-2014 70
Table 18: Impact of Companion Diagnostics on Cancer Treatment Costs in France 82
Table 19: Effectiveness of Disease Therapies 83
Table 20: HER2 FISH/iQFISH PharmDx Product Profile 96
Table 21: Common Reasons for HER2 FISH Failure 98
Table 22: HER2 FISH PharmDx/HER2 iQFISH PharmDx SWOT Analysis 100
Table 23: HercepTest Product Profile 100
Table 24: HercepTest Scoring Algorithm 101
Table 25: HercepTest SWOT Analysis 103
Table 26: HER2 CISH PharmDx Product Profile 104
Table 27: HER2 CISH PharmDx SWOT Analysis 106
Table 28: SPOT-Light HER2 CISH Kit Product Profile 107
Table 29: SPOT-Light HER2 CISH Kit SWOT Analysis 109
Table 30: Leica Bond Oracle HER2 IHC System Product Profile 109
Table 31: Leica Bond Oracle HER2 IHC System Test Algorithm 110
Table 32: Leica Bond Oracle HER2 IHC System SWOT Analysis 112
Table 33: Biogenex INSITE HER2/Neu Product Profile 113
Table 34: Biogenex INSITE HER2/Neu SWOT Analysis 115
Table 35: Abbott Pathvysion HER-2 DNA Probe Kit Product Profile 115
Table 36: Abbott Pathvysion HER-2 DNA Probe Kit SWOT Analysis 117
Table 37: Ventana INFORM HER2 Dual ISH Assay Product Profile 118
Table 38: Ventana INFORM HER2 Dual ISH Assay SWOT Analysis 120
Table 39: Pathway HER2/Neu IHC Product Profile 120
Table 40: Pathway HER2/Neu IHC SWOT Analysis 123
Table 41: HerMark Product Profile 124
Table 42: HerMark SWOT Analysis 125
Table 43: Therascreen KRAS RGQ Product Profile 125
Table 44: Therascreen KRAS RGQ SWOT Analysis 128
Table 45: Cobas KRAS Mutation Test Product Profile 128
Table 46: Cobas KRAS Mutation Test SWOT Analysis 130
Table 47: EGFR PharmDx Kit Product Profile 130
Table 48: EGFR PharmDx Kit SWOT Analysis 134
Table 49: THxID BRAF Product Profile 134
Table 50: Effect of Melanin on the THxID BRAF PCR Test 136
Table 51: THxID BRAF SWOT Analysis 137
Table 52: Cobas 4800 BRAF V600 Mutation Test - Melanoma Product Profile 138
Table 53: Interpretation of Cobas BRAF V600 Mutation Test - Melanoma 139
Table 54: Cobas 4800 BRAF V600 Mutation Test - Melanoma SWOT Analysis 140
Table 55: Vysis ALK Break Apart FISH Probe Kit Product Profile 141
Table 56: Abbott Vysis ALK Break Apart FISH Probe Kit SWOT Analysis 143
Table 57: Amoy-Dx EML4-ALK Fusion Gene Detection Kit Product Profile 143
Table 58: Amoy-Dx EML4-ALK Fusion Gene Detection Kit SWOT Analysis 145
Table 59: Therascreen EGFR RGQ PCR Kit Product Profile 145
Table 60: Therascreen EGFR RGQ PCR Kit SWOT Analysis 150
Table 61: ALK IHC Test Product Profile 151
Table 62: ALK IHC Test SWOT Analysis 153
Table 63: Cobas EGFR Mutation Test Product Profile 154
Table 64: Cobas EGFR Mutation Test SWOT Analysis 156
Table 65: Companion Diagnostic Tests Pipeline, 2014 175
Table 66: Neuvax Companion Diagnostic Assay Product Profile 177
Table 67: Neuvax Companion Diagnostic Assay Product SWOT Analysis 177
Table 68: Companion Diagnostic Test - Palbociclib Product Profile 178
Table 69: Companion Diagnostic Test - Palbociclib SWOT Analysis 179
Table 70: Companion Diagnostic Test - Breast Cancer Product Profile 180
Table 71: Companion Diagnostic Test - Breast Cancer SWOT Analysis 180
Table 72: Onapristone Companion Diagnostic Assay Product Profile 181
Table 73: Onapristone Companion Diagnostic Assay SWOT Analysis 182
Table 74: Aromatase Inhibitor Biomarker - Companion Diagnostic Test Product Profile 183
Table 75: Aromatase Inhibitor Biomarker - Companion Diagnostic Test SWOT Analysis 183
Table 76: BRAF Companion Diagnostic Assay - Colon Cancer Product Profile 184
Table 77: BRAF Companion Diagnostic Assay - Colon Cancer SWOT Analysis 185
Table 78: KRAS Companion Diagnostic Assay - Colon Cancer Product Profile 186
Table 79: KRAS Companion Diagnostic Assay - Colon Cancer SWOT Analysis 186
Table 80: PIK3CA Companion Diagnostic Assay - Colorectal Cancer Product Profile 187
Table 81: PIK3CA Companion Diagnostic Assay - Colorectal Cancer SWOT Analysis 188
Table 82: Vectibix Companion Diagnostic Product Profile 189
Table 83: Vectibix Companion Diagnostic SWOT Analysis 190
Table 84: MAGE-A3 Companion Skin Cancer Assay Product Profile 191
Table 85: MAGE-A3 Companion Skin Cancer Assay SWOT Analysis 191
Table 86: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma Product Profile 192
Table 87: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma SWOT Analysis 193
Table 88: Companion Diagnostic Test - Melanoma Cancer Product Profile 194
Table 89: Companion Diagnostic Test - Melanoma Cancer SWOT Analysis 194
Table 90: KRAS Companion Diagnostic Assay - Melanoma Product Profile 195
Table 91: KRAS Companion Diagnostic Assay - Melanoma SWOT Analysis 196
Table 92: Companion Diagnostic Test - Melanoma Product Profile 197
Table 93: Companion Diagnostic Test - Melanoma SWOT Analysis 197
Table 94: BRAF Companion Diagnostic Assay - Lung Cancer Product Profile 198
Table 95: BRAF Companion Diagnostic Assay - Lung Cancer SWOT Analysis 198
Table 96: KRAS Companion Diagnostic Assay - Lung Cancer Product Profile 199
Table 97: KRAS Companion Diagnostic Assay - Lung Cancer SWOT Analysis 199
Table 98: MET Companion Diagnostic Assay - Lung Cancer Product Profile 200
Table 99: MET Companion Diagnostic Assay - Lung Cancer SWOT Analysis 201
Table 100: PIK3CA Companion Diagnostic Assay - Lung Cancer Product Profile 202
Table 101: PIK3CA Companion Diagnostic Assay - Lung Cancer SWOT Analysis 202
Table 102: Companion Diagnostic Device - Lung Cancer Product Profile 203
Table 103: Companion Diagnostic Device - Lung Cancer SWOT Analysis 204
Table 104: Companion Diagnostic Test - Crizotinib Product Profile 205
Table 105: Companion Diagnostic Test - Crizotinib SWOT Analysis 205
Table 106: Companion Diagnostic Test - Dacomitinib Product Profile 206
Table 107: Companion Diagnostic Test - Dacomitinib SWOT Analysis 206
Table 108: T790M Mutation Companion Diagnostic Test Product Profile 207
Table 109: T790M Mutation Companion Diagnostic Test SWOT Analysis 207
Table 110: Entinostat Companion Diagnostic Assay Product Profile 208
Table 111: Entinostat Companion Diagnostic Assay SWOT Analysis 209
Table 112: MUC1 Expression Companion Diagnostic Test Product Profile 210
Table 113: MUC1 Expression Companion Diagnostic Test SWOT Analysis 210
Table 114: Companion Diagnostic Assay - NSCLC Product Profile 211
Table 115: Companion Diagnostic Assay - NSCLC SWOT Analysis 211
Table 116: Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies. 216
Table 117: Company Profile - Amgen 219
Table 118: Amgen's Key Products 219
Table 119: Selected Amgen Anti-Cancer Therapies Currently in Clinical Trials 220
Table 120: Amgen SWOT Analysis 225
Table 121: Company Profile - Arno Therapeutics 226
Table 122: Selected Arno Therapeutics Anti-Cancer Therapies Currently in Clinical Trials 226
Table 123: Arno Therapeutics SWOT Analysis 230
Table 124: Company Profile - AstraZeneca 231
Table 125: Key Events in the Development of AstraZeneca's Drug Portfolio Since 2011 233
Table 126: Key Project Terminations by AstraZeneca Since 2008 235
Table 127: AstraZeneca SWOT Analysis 239
Table 128: Company Profile - Bristol-Myers Squibb 240
Table 129: Recent Key Product Approvals from Bristol-Myers Squibb 243
Table 130: Recent Key BMS Partnerships and Agreements 244
Table 131: Bristol-Myers Squibb SWOT Analysis 245
Table 132: Company Profile - Clovis Oncology 246
Table 133: Clovis Oncology's Key Products 247
Table 134: Clovis Oncology SWOT Analysis 251
Table 135: Company Profile - Eli Lilly and Company 252
Table 136: Eli Lilly and Company SWOT Analysis 258
Table 137: Company Profile - Genentech 258
Table 138: Selected Genentech Marketed Products 259
Table 139: Genentech SWOT Analysis 264
Table 140: Company Profile - Pfizer 265
Table 141: Pfizer SWOT Analysis 270
Table 142: Company Profile - Syndax Pharmaceuticals 271
Table 143: Syndax Pharmaceuticals SWOT Analysis 272
Table 144: Company Profile - Abbott Laboratories 273
Table 145: Abbott's Key Product Areas 274
Table 146: Abbott Laboratories SWOT Analysis, 2013 279
Table 147: Company Profile - Amoy Diagnostics 280
Table 148: Amoy Diagnostics SWOT Analysis, 2013 281
Table 149: Company Profile - Biogenex Laboratories 282
Table 150: Biogenex Laboratories SWOT Analysis, 2013 283
Table 151: Company Profile - BioMerieux 284
Table 152: BioMerieux SWOT Analysis, 2013 292
Table 153: Company Profile - Dako (Agilent Technologies) 293
Table 154: Dako/Agilent Technologies SWOT Analysis 298
Table 155: Company Profile - Illumina 299
Table 156: Illumina Product Areas 299
Table 157: Illumina SWOT Analysis 306
Table 158: Company Profile - Leica Biosystems (Danaher) 307
Table 159: Leica Biosystems/Danaher SWOT Analysis 313
Table 160: Company Profile - Life Technologies (Thermo Fisher Scientific) 314
Table 161: Life Technologies SWOT Analysis 321
Table 162: Company Profile - MolecularMD 322
Table 163: MolecularMD SWOT Analysis 323
Table 164: Company Profile - Myriad Genetics 324
Table 165: Myriad Genetics Major Product Areas 325
Table 166: Myriad Genetics SWOT Analysis 329
Table 167: Company Profile - Qiagen 330
Table 168: Qiagen Major Product Areas 331
Table 169: Qiagen SWOT Analysis 336
Table 170: Company Profile - Roche Diagnostics 337
Table 171: Roche SWOT Analysis 343
Table 172: Company Profile - Siemens Healthcare 344
Table 173: Siemens Healthcare SWOT Analysis 349
Table 174: Company Profile - Ventana Medical Systems 350
Table 175: Ventana Medical Systems SWOT Analysis 353
Table 176: South America Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020 354
Table 177: South America Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020 355
Table 178: South America Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020 357
Table 179: South America Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020 358
Table 180: South America Sales Forecast for IHC and Molecular Tests ($m), 2011-2020 360
Table 181: Major Events Affecting the Companion Diagnostic Test Market 362
Table 182: Sales Forecast for Companion Diagnostic Tests ($m) in Brazil, 2011-2020 363

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 53
Figure 13: Breast Cancer Companion Diagnostic Testing (HER2) in Brazil, 2011-2020 58
Figure 14: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Brazil, 2011-2020 59
Figure 15: Melanoma Companion Diagnostic Testing (BRAF) in Brazil, 2011-2020 60
Figure 16: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Brazil, 2011-2020 62
Figure 17: Multiple Partnerships in Companion Diagnostics during 2013-2014 73
Figure 18: Building a Companion Diagnostics Business: Forming Multiple Partnerships 75
Figure 19: Increasing Medicare Cost of Treatment 79
Figure 20: Growth of Drug Therapy Expenditure in France, 2004-2009 80
Figure 21: Share of Targeted Therapies of Anti-Cancer Drug Costs in France 81
Figure 22: Increase in Approvals of Biologic (Targeted) Therapies 87
Figure 23: EGFR PharmDx Test Adoption Curve 131
Figure 24: Probe Arrangement in the Vysis ALK Break Apart FISH Probe Kit 141
Figure 25: Scorpion Primers 147
Figure 26: Increase in High- and Moderate-Complexity Molecular Tests 150
Figure 27: Reasons for Companion Diagnostic Test Failure 162
Figure 28: Female Breast Cancer Treatment Patterns by Stage, 2008 165
Figure 29: Colon Cancer Treatment Patterns by Stage, 2008 166
Figure 30: Lung Cancer Treatment Patterns by Stage, 2008 167
Figure 31: Expected Companion Diagnostic Test Pipeline, US Approvals, 2014-2019 174
Figure 32: Sponsors of Clinical Trials for Targeted Cancer Therapies 213
Figure 33: Sponsors of Clinical Trials for Targeted Cancer Therapies Based on Mutational Status 214
Figure 34: Sponsors of Clinical Trials for Targeted Cancer Therapies, by Phase 215
Figure 35: South Amercia Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011-2020 354
Figure 36: South America Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011-2020 355
Figure 37: South America Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011-2020 356
Figure 38: South America Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011-2020 358
Figure 39: South America Sales Forecast for IHC and Molecular Tests ($m), 2011-2020 359
Figure 40: South America Market Share of Molecular Tests and Immunohistochemistry Tests in 2012 and 2020 361
Figure 41: Sales Forecast for Companion Diagnostic Tests ($m) in Brazil, 2011-2020 363

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