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  5. > MediPoint: Companion Diagnostic Tests in Oncology - Current and Future Players

MediPoint: Companion Diagnostic Tests in Oncology - Current and Future Players

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.

The report identifies and analyzes the key companies shaping and driving the Companion Diagnostic market. The report provides insight into the competitive Companion Diagnostic landscape, including new companies entering the market and pipeline products in development. This report is built using data and information sourced from proprietary databases, secondary sources and primary research interviews and survey with leading doctors, with in-house analysis conducted by GlobalData’s team of industry experts.

Scope

- Investigation of current and future market competition for Companion Diagnostic
- Competitor assessment including device approval analysis.
- Coverage of key market players and company profiles including business description, financial overview and SWOT analysis.
- Strategic assessment of the device sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL) as well as doctors using Companion Diagnostic in clinical practice.

Reasons to buy

- Gain a high level view of the trends shaping and driving the Companion Diagnostic market.
- Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape
- 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

Table Of Contents

MediPoint: Companion Diagnostic Tests in Oncology - Current and Future Players
1 Table of Contents

2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 12
3 Competitive Assessment 13
3.1 Overview 13
3.2 Techniques in Use by Currently Marketed Products 13
3.2.1 Immunohistochemistry 13
3.2.2 Fluorescence In Situ Hybridization 13
3.2.3 Polymerase Chain Reaction 14
3.3 Competitive Analysis 14
3.3.1 Breast Cancer Companion Diagnostic Tests 14
3.3.2 Colorectal Cancer Companion Diagnostic Tests 43
3.3.3 Melanoma Companion Diagnostic Tests 52
3.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 58
4 Pipeline Products 75
4.1 Overview 75
4.2 Pipeline by Phase of Development 77
4.3 Pipeline Product Profiles 78
4.3.1 Breast Cancer Companion Diagnostic Tests 78
4.3.2 Colorectal Cancer Companion Diagnostic Tests 86
4.3.3 Melanoma Companion Diagnostic Tests 92
4.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 99
5 Current and Future Players 114
5.1 Trends in Corporate Strategy 114
5.1.1 Companion Diagnostics Business Models 114
5.2 Company Profiles 115
5.2.1 Pharmaceutical/Therapy Companies Developing Companion Diagnostic Tests 115
5.2.2 Diagnostics Companies Developing Companion Diagnostic Tests (in Partnership with Pharmaceutical Companies) 169
6 Appendix 252
6.1 Bibliography 252
6.2 Abbreviations 271
6.3 Report Methodology 273
6.3.1 Coverage 273
6.3.2 Secondary Research 274
6.3.3 Forecasting Methodology 274
6.4 Physicians Included in this Study 276
6.5 About the Authors 278
6.5.1 Andrew Thompson, Ph.D., Senior Analyst, In Vitro Diagnostics 278
6.5.2 Derek Archila, MBA, Lead Analyst, Medical Devices 278
6.5.3 Bonnie Bain, PhD, Global Head of Healthcare 279
6.6 Disclaimer 280

1.1 List of Tables

Table 1: HER2 FISH/iQFISH PharmDx Product Profile 14
Table 2: Common Reasons for HER2 FISH Failure 16
Table 3: HER2 FISH PharmDx/HER2 iQFISH PharmDx SWOT Analysis 18
Table 4: HercepTest Product Profile 18
Table 5: HercepTest Scoring Algorithm 19
Table 6: HercepTest SWOT Analysis 21
Table 7: HER2 CISH PharmDx Product Profile 22
Table 8: HER2 CISH PharmDx SWOT Analysis 24
Table 9: SPOT-Light HER2 CISH Kit Product Profile 24
Table 10: SPOT-Light HER2 CISH Kit SWOT Analysis 26
Table 11: Leica Bond Oracle HER2 IHC System Product Profile 27
Table 12: Leica Bond Oracle HER2 IHC System Test Algorithm 28
Table 13: Leica Bond Oracle HER2 IHC System SWOT Analysis 30
Table 14: Biogenex INSITE HER2/Neu Product Profile 30
Table 15: Biogenex INSITE HER2/Neu SWOT Analysis 33
Table 16: Abbott Pathvysion HER-2 DNA Probe Kit Product Profile 33
Table 17: Abbott Pathvysion HER-2 DNA Probe Kit SWOT Analysis 35
Table 18: Ventana INFORM HER2 Dual ISH Assay Product Profile 36
Table 19: Ventana INFORM HER2 Dual ISH Assay SWOT Analysis 38
Table 20: Pathway HER2/Neu IHC Product Profile 38
Table 21: Pathway HER2/Neu IHC SWOT Analysis 41
Table 22: HerMark Product Profile 42
Table 23: HerMark SWOT Analysis 43
Table 24: Therascreen KRAS RGQ Product Profile 43
Table 25: Therascreen KRAS RGQ SWOT Analysis 46
Table 26: Cobas KRAS Mutation Test Product Profile 46
Table 27: Cobas KRAS Mutation Test SWOT Analysis 47
Table 28: EGFR PharmDx Kit Product Profile 48
Table 29: EGFR PharmDx Kit SWOT Analysis 52
Table 30: THxID BRAF Product Profile 52
Table 31: Effect of Melanin on the THxID BRAF PCR Test 54
Table 32: THxID BRAF SWOT Analysis 55
Table 33: Cobas 4800 BRAF V600 Mutation Test - Melanoma Product Profile 56
Table 34: Interpretation of Cobas BRAF V600 Mutation Test - Melanoma 57
Table 35: Cobas 4800 BRAF V600 Mutation Test - Melanoma SWOT Analysis 58
Table 36: Vysis ALK Break Apart FISH Probe Kit Product Profile 59
Table 37: Abbott Vysis ALK Break Apart FISH Probe Kit SWOT Analysis 61
Table 38: Amoy-Dx EML4-ALK Fusion Gene Detection Kit Product Profile 61
Table 39: Amoy-Dx EML4-ALK Fusion Gene Detection Kit SWOT Analysis 63
Table 40: Therascreen EGFR RGQ PCR Kit Product Profile 63
Table 41: Therascreen EGFR RGQ PCR Kit SWOT Analysis 68
Table 42: ALK IHC Test Product Profile 69
Table 43: ALK IHC Test SWOT Analysis 71
Table 44: Cobas EGFR Mutation Test Product Profile 72
Table 45: Cobas EGFR Mutation Test SWOT Analysis 74
Table 46: Companion Diagnostic Tests Pipeline, 2014 77
Table 47: Neuvax Companion Diagnostic Assay Product Profile 79
Table 48: Neuvax Companion Diagnostic Assay Product SWOT Analysis 79
Table 49: Companion Diagnostic Test - Palbociclib Product Profile 80
Table 50: Companion Diagnostic Test - Palbociclib SWOT Analysis 81
Table 51: Companion Diagnostic Test - Breast Cancer Product Profile 82
Table 52: Companion Diagnostic Test - Breast Cancer SWOT Analysis 82
Table 53: Onapristone Companion Diagnostic Assay Product Profile 83
Table 54: Onapristone Companion Diagnostic Assay SWOT Analysis 84
Table 55: Aromatase Inhibitor Biomarker - Companion Diagnostic Test Product Profile 85
Table 56: Aromatase Inhibitor Biomarker - Companion Diagnostic Test SWOT Analysis 85
Table 57: BRAF Companion Diagnostic Assay - Colon Cancer Product Profile 86
Table 58: BRAF Companion Diagnostic Assay - Colon Cancer SWOT Analysis 87
Table 59: KRAS Companion Diagnostic Assay - Colon Cancer Product Profile 88
Table 60: KRAS Companion Diagnostic Assay - Colon Cancer SWOT Analysis 88
Table 61: PIK3CA Companion Diagnostic Assay - Colorectal Cancer Product Profile 89
Table 62: PIK3CA Companion Diagnostic Assay - Colorectal Cancer SWOT Analysis 90
Table 63: Vectibix Companion Diagnostic Product Profile 91
Table 64: Vectibix Companion Diagnostic SWOT Analysis 92
Table 65: MAGE-A3 Companion Skin Cancer Assay Product Profile 93
Table 66: MAGE-A3 Companion Skin Cancer Assay SWOT Analysis 93
Table 67: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma Product Profile 94
Table 68: GNAQ/GNA11 Companion Diagnostic Assays - Melanoma SWOT Analysis 95
Table 69: Companion Diagnostic Test - Melanoma Cancer Product Profile 96
Table 70: Companion Diagnostic Test - Melanoma Cancer SWOT Analysis 96
Table 71: KRAS Companion Diagnostic Assay - Melanoma Product Profile 97
Table 72: KRAS Companion Diagnostic Assay - Melanoma SWOT Analysis 98
Table 73: Companion Diagnostic Test - Melanoma Product Profile 99
Table 74: Companion Diagnostic Test - Melanoma SWOT Analysis 99
Table 75: BRAF Companion Diagnostic Assay - Lung Cancer Product Profile 100
Table 76: BRAF Companion Diagnostic Assay - Lung Cancer SWOT Analysis 100
Table 77: KRAS Companion Diagnostic Assay - Lung Cancer Product Profile 101
Table 78: KRAS Companion Diagnostic Assay - Lung Cancer SWOT Analysis 101
Table 79: MET Companion Diagnostic Assay - Lung Cancer Product Profile 102
Table 80: MET Companion Diagnostic Assay - Lung Cancer SWOT Analysis 102
Table 81: PIK3CA Companion Diagnostic Assay - Lung Cancer Product Profile 103
Table 82: PIK3CA Companion Diagnostic Assay - Lung Cancer SWOT Analysis 104
Table 83: Companion Diagnostic Device - Lung Cancer Product Profile 105
Table 84: Companion Diagnostic Device - Lung Cancer SWOT Analysis 105
Table 85: Companion Diagnostic Test - Crizotinib Product Profile 106
Table 86: Companion Diagnostic Test - Crizotinib SWOT Analysis 106
Table 87: Companion Diagnostic Test - Dacomitinib Product Profile 107
Table 88: Companion Diagnostic Test - Dacomitinib SWOT Analysis 108
Table 89: T790M Mutation Companion Diagnostic Test Product Profile 109
Table 90: T790M Mutation Companion Diagnostic Test SWOT Analysis 109
Table 91: Entinostat Companion Diagnostic Assay Product Profile 110
Table 92: Entinostat Companion Diagnostic Assay SWOT Analysis 111
Table 93: MUC1 Expression Companion Diagnostic Test Product Profile 112
Table 94: MUC1 Expression Companion Diagnostic Test SWOT Analysis 112
Table 95: Companion Diagnostic Assay - NSCLC Product Profile 113
Table 96: Companion Diagnostic Assay - NSCLC SWOT Analysis 113
Table 97: Company Profile - Amgen 116
Table 98: Amgen's Key Products 116
Table 99: Selected Amgen Anti-Cancer Therapies Currently in Clinical Trials 117
Table 100: Amgen SWOT Analysis 122
Table 101: Company Profile - Arno Therapeutics 123
Table 102: Selected Arno Therapeutics Anti-Cancer Therapies Currently in Clinical Trials 123
Table 103: Arno Therapeutics SWOT Analysis 127
Table 104: Company Profile - AstraZeneca 128
Table 105: Key Events in the Development of AstraZeneca's Drug Portfolio Since 2011 130
Table 106: Key Project Terminations by AstraZeneca Since 2008 132
Table 107: AstraZeneca SWOT Analysis 136
Table 108: Company Profile - Bristol-Myers Squibb 137
Table 109: Recent Key Product Approvals from Bristol-Myers Squibb 140
Table 110: Recent Key BMS Partnerships and Agreements 141
Table 111: Bristol-Myers Squibb SWOT Analysis 142
Table 112: Company Profile - Clovis Oncology 143
Table 113: Clovis Oncology's Key Products 144
Table 114: Clovis Oncology SWOT Analysis 148
Table 115: Company Profile - Eli Lilly and Company 149
Table 116: Eli Lilly and Company SWOT Analysis 155
Table 117: Company Profile - Genentech 155
Table 118: Selected Genentech Marketed Products 156
Table 119: Genentech SWOT Analysis 161
Table 120: Company Profile - Pfizer 162
Table 121: Pfizer SWOT Analysis 167
Table 122: Company Profile - Syndax Pharmaceuticals 168
Table 123: Syndax Pharmaceuticals SWOT Analysis 169
Table 124: Company Profile - Abbott Laboratories 170
Table 125: Abbott's Key Product Areas 171
Table 126: Abbott Laboratories SWOT Analysis, 2013 176
Table 127: Company Profile - Amoy Diagnostics 177
Table 128: Amoy Diagnostics SWOT Analysis, 2013 178
Table 129: Company Profile - Biogenex Laboratories 179
Table 130: Biogenex Laboratories SWOT Analysis, 2013 180
Table 131: Company Profile - BioMerieux 181
Table 132: BioMerieux SWOT Analysis, 2013 189
Table 133: Company Profile - Dako (Agilent Technologies) 190
Table 134: Dako/Agilent Technologies SWOT Analysis 195
Table 135: Company Profile - Illumina 196
Table 136: Illumina Product Areas 196
Table 137: Illumina SWOT Analysis 203
Table 138: Company Profile - Leica Biosystems (Danaher) 204
Table 139: Leica Biosystems/Danaher SWOT Analysis 210
Table 140: Company Profile - Life Technologies (Thermo Fisher Scientific) 211
Table 141: Life Technologies SWOT Analysis 219
Table 142: Company Profile - MolecularMD 220
Table 143: MolecularMD SWOT Analysis 221
Table 144: Company Profile - Myriad Genetics 222
Table 145: Myriad Genetics Major Product Areas 223
Table 146: Myriad Genetics SWOT Analysis 227
Table 147: Company Profile - Qiagen 228
Table 148: Qiagen Major Product Areas 229
Table 149: Qiagen SWOT Analysis 234
Table 150: Company Profile - Roche Diagnostics 235
Table 151: Roche SWOT Analysis 241
Table 152: Company Profile - Siemens Healthcare 242
Table 153: Siemens Healthcare SWOT Analysis 247
Table 154: Company Profile - Ventana Medical Systems 248
Table 155: Ventana Medical Systems SWOT Analysis 251

1.2 List of Figures
Figure 1: EGFR PharmDx Test Adoption Curve 49
Figure 2: Probe Arrangement in the Vysis ALK Break Apart FISH Probe Kit 59
Figure 3: Scorpion Primers 65
Figure 4: Increase in High- and Moderate-Complexity Molecular Tests 68
Figure 5: Expected Companion Diagnostic Test Pipeline, US Approvals, 2014-2019 76

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