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MediPoint: Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts Published on May 2014
Report Summary 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.
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>> Get this Report Now by email! - 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 Content 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
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>> Get this Report Now by email! 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 M&A, 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
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>> Get this Report Now by email! 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
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>> Get this Report Now by email! 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
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>> Get this Report Now by email! 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
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>> Get this Report Now by email! 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
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>> Get this Report Now by email! 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
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>> Get this Report Now by email! 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
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>> Get this Report Now by email! 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 - BioMĂŠrieux 421 Table 211: BioMĂŠrieux 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
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>> Get this Report Now by email! 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
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>> Get this Report Now by email! 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
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>> Get this Report Now by email! 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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