companion diagnostic tests in oncology – current … · table 115: company profile – eli lilly...

REFERENCE CODE GDME1026FPR | PUBLICATION DATE MAY 2014

COMPANION DIAGNOSTIC TESTS IN ONCOLOGY – CURRENT AND FUTURE PLAYERS

Companion Diagnostic Tests in Oncology – Current and Future Players 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Table of Contents


1 Table of Contents

1 Table of Contents ....................................................................................................................... 2

1.1 List of Tables ...................................................................................................................... 4

1.2 List of Figures ................................................................................................................... 10

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


Table of Contents


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


Table of Contents


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


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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


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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


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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


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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


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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 – BioMérieux ................................................................................................... 181

Table 132: BioMérieux 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


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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



Introduction

2 Introduction

Companion diagnostic tests are a fast-emerging new area of in vitro diagnostic tests. Companion

diagnostic tests seek to identify which patients respond to a specific therapy, or how specific

patients will respond to a therapy. While cancer treatments are increasingly effective in producing

significant improvements in survival, the costs for such new therapies are soaring. At the same

time, the incidence of cancer is increasing globally, both in developed and developing nations,

further adding to the pressure placed on healthcare systems. Companion diagnostic tests are now

seen as essential in ensuring that patients are treated with the most appropriate protocol.

Companion diagnostic tests will also herald an era of personalized medicine, where a patient’s

treatment will become increasingly individualized. This report focuses on the companion diagnostic

testing markets in the US, Europe (France, Germany, Italy, Spain, and the UK), Japan, and the

future markets in China, India, and Brazil, to identify unmet needs in the global market, physician

attitudes toward current companion diagnostic testing, and the future of companion diagnostic

testing in the face of rapid technological advancement.

2.1 Catalyst

There is an increased demand for companion diagnostic tests; this is a result of the increased

demand from physicians who want to be better informed of the therapy options for their patients,

from regulatory authorities who are seeking the development of safer and more effective drugs,

and from healthcare authorities (payers) who are looking to control the rising costs of therapies,

while being able to better identify the most suitable patients for treatment.

Physicians look to stratify their patients in order to identify the most appropriate treatment, and the

addition of companion diagnostic tests is seen as an extra tool in the existing prognostic process.

Regulatory authorities, especially the US Food and Drug Administration (FDA), are mindful of not

only the increasing complexity of disease, but also of well-publicized incidents where new therapies

have proven to be ineffective, or even harmful in some groups of patients. As a result, regulatory

authorities are now seeking to improve the clinical trials process by imposing requirements on the

correct patient selection for trials, making, in effect, companion diagnostic tests an essential

requirement for any new drug treatment.



Introduction

Healthcare authorities are mindful of the rising costs of new, but effective therapies, and are

seeking to control costs in the face of economic pressures, either by rationing treatments, or by

making more informed choices as to which patients should be treated with a new therapy.

Companion diagnostic tests are particularly applicable to cancer, which is increasingly seen as a

large collection of syndromes, and where somatic and germline gene mutations play not only a

large role in the type of cancer developed, but also in how the patient responds to the treatment.

This report focuses on the four major cancers for which FDA-approved companion diagnostic tests

exist: breast cancer, colorectal cancer (CRC), non-small cell lung cancer, and melanoma. These

four cancers alone account for over 50% of new cancer cases and nearly 64% of cancer deaths in

the US (National Cancer Institute, 2014).

2.2 Related Reports

GlobalData (2013). MediPoint: Colorectal Cancer Screening Tests – Global Analysis and

Market Forecasts. July, 2013, GDME0204MAR

GlobalData (2013). MediPoint: Predictive Breast Cancer Gene Testing – Global Analysis and

Market Forecasts. February, 2013, GDME0170MAR


Appendix


6.6 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any

form by any means, electronic, mechanical, photocopying, recording, or otherwise without the prior

permission of the publisher, GlobalData.

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