companion diagnostic tests in oncology - apac … · number of colorectal cancer (crc) companion...

REFERENCE CODE GDME1103CFR | PUBLICAT ION DATE MAY 2014

COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC ANALYSIS AND MARKET FORECASTS

Companion Diagnostic Tests in Oncology - APAC Analysis and Market Forecasts 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.


Executive Summary

Companion Diagnostic Tests: Key Metrics in APAC Major Device Markets Number of companion diagnostic tests performed in 2014 1,818,299

Number of breast cancer companion diagnostic tests in 2014 (IHC) 889,353

Number of colorectal cancer (CRC) companion diagnostic tests in 2014 294,031

Number of melanoma companion diagnostic tests in 2014 32,740

Number of non-small cell lung cancer companion diagnostic tests in 2014 602,174

2014 Companion Diagnostic Test Market Sales

APAC $45,276,324

Pipeline Assessment

Number of early development tests 6

Number of early clinical devices 12

Number of late clinical devices 8

Key Events (2014–2020)

Completion of NCT01479244 Phase III trial for Neuvax ↑↑↑↑

Completion of NCT00455572 Phase I trial for GSK1572932A ↑

Completion of NCT01740427 Phase III trial for palbociclib ↑↑↑

Completion of NCT02052128 Phase I trial for onapristone ↑↑↑

Completion of NCT01308294 Phase I/II trial ↑↑

2020 Market Sales

APAC $80,558,751

Source: GlobalData. APAC (Asia-Pacific) = Japan, China, and India; IHC = immunohistochemistry

Market Domination by Non-Small Cell Lung Cancer Companion Diagnostic Tests

The major feature of the APAC companion

diagnostic testing market is the current domination

of tests for mutations important in the prognosis

and diagnosis of non-small cell lung cancer

(NSCLC), with the two market leaders being Roche

and Qiagen. According to GlobalData’s forecast, in

2014, NSCLC companion diagnostic tests account

for 51% of the APAC market by value. While more

human epidermal growth factor receptor 2 (HER2)

tests are carried out, because the NSCLC tests

have been principally more expensive molecular

tests, rather than the cheaper

immunohistochemistry (IHC) test that typifies

HER2 testing, the value of the NSCLC market is

considerably higher.

Companion Diagnostic Test Market APAC Revenue, 2014

Japan69%

China24%

India7%

Source: GlobalData. APAC = Japan, China, and India.



Executive Summary

The companion diagnostic tests market is still

evolving, but the market is led by Roche, Qiagen,

Ventana, Dako, and Leica. Roche and Qiagen

dominate the molecular testing market, while

Ventana, Dako, and Leica also have a significant

presence within the important IHC market. In most

segments, there is little competition for tests, since

only a few approved companion diagnostic tests

are marketed. Laboratory decisions as to which

brand of test to use are driven by clinical efficacy,

which may vary considerably by regions. The

exception is breast cancer HER2 testing, which, as

the longest-established segment, has attracted the

most competition.

Significant Unmet Needs

A need to improve cancer treatment remains a

significant unmet need. Besides providing a means

to identify patients who will most benefit from the

emerging targeted therapies, there is also a need

to be able to better utilize existing therapies,

including chemotherapies, or even surgical

interventions, through the use of companion

diagnostic tests to better stratify patients.

While the existing tests are well regarded by

physicians, for many, the differences in hardware

remain trivial and as such, there is a clear need for

tests to enable easier decision-making. This

especially applies to IHC tests, which are

considered too subjective, and prone to error.

While new tests for new needs, such as a need to

prescribe a new drug, face easy entry to the

market, beyond the reimbursement challenges,

new tests to replace existing companion diagnostic

tests face challenges in adoption by laboratories,

since they may not provide a clear performance

improvement. New tests typically undergo

exhaustive comparison studies by hospitals, rather

than benefiting from published literature studies.

Future Landscape

A significant barrier to increased adoption is

reimbursement. Approval of new companion

diagnostic tests does not signify adoption.

Adoption is highly dependent upon reimbursement

policies. If the molecular test cannot be

reimbursed, there will be low adoption. If the new

therapy cannot be reimbursed, there will be no

need for uptake of the companion diagnostic test,

unless a secondary use can be found that is of

utility to the physician in managing the patient’s

condition.

The emergence of new companion diagnostic tests

is also highly dependent on the success of the

drug pipeline. As a result of increased regulation,

new companion diagnostic tests are developed in

parallel to a new drug, and thus, the fate of the

companion diagnostic is tied to the success of the

drug during clinical trials. Diagnostic test

manufacturers can de-risk this process through

multiple partnerships, or by developing new

companion diagnostic tests that are also aimed at

stratifying patients for existing therapies. If the



Executive Summary

therapy is one for which there are already

companion diagnostic tests, then the new test

faces adoption challenges. If the therapy has no

existing stratification route, then the test may gain

a considerable advantage, especially if

stratification provides a clear benefit to the patient

or the healthcare provider.

What do Physicians Think?

Despite IHC being the oldest technique used for

companion diagnostic tests, it is still seen as

essential, and in many ways preferable to newer

and more precise genetic tests.

“I think it is correct, that is, it is not based on all

FISH [fluorescence in situ hybridization] testing,

because the target is the protein, and not the

gene…. I think it is correct to test the protein, by

immuno[histochemistry]. It could be wonderful, if

we could standardize exactly what we are doing.”

Key Opinion Leader

Rapid companion diagnostic tests enable more

timely clinical decisions to be made to manage a

patient’s disease.

“We have turned around our ERs [estrogen

receptors] and HER2s in 1.9–2.9 days of taking a

biopsy, so we now have the HER2 test available at

the pre-operative discussion cancer [meeting], that

has made the whole discussion so much more

powerful. …We know they will have chemotherapy

straight away – you can tell the patient that kind of

thing, you know. If that became FISH, it couldn’t be

that quick always. So using an in-house test like

IHC helps us do that.”

Key Opinion Leader

Fully integrated and validated companion

diagnostic tests are valued by pathologists over

cheaper laboratory-developed tests.

“It’s just fantastic, some company is willing to

spend money, to develop a kit, bringing their QC,

their quality control, making sure all the reagents,

all the probes, everything works out.”

Key Opinion Leader



Executive Summary

Doubts on the efficacy of some companion

diagnostic tests can push up the cost of identifying

patients for treatment through over-testing.

“I wasn’t sure about the IHC test being accurate for

HER2, so what I did was just do one year of

running both tests simultaneously to see what our

accuracy…is...and then I found out that…some of

the score zeroes will be amplified by FISH

and…sometimes three pluses and repeated three

pluses by troubleshooting the FISH is negative.

…Even though these are quite [the] minority of the

cases, they are those situations where the IHC test

cannot detect accurate results… $100 [cost of the

IHC test] and $450 [cost of the FISH test]

combines [to] $550 dollars. …To me that became a

critical issue, that even though we are spending

$550 per patient…the accuracy of the test is

needed in order for each individual to have optimal

treatment. That’s why we run both tests.”

Key Opinion Leader

Patients have limited interest in the types of

companion diagnostic tests being undertaken.

“The patient does not know about the test. There is

a meeting with the patient’s surgeon, [or]

oncologist, where we try to explain the difficulties

the pathologist may have in evaluating correctly

the results of the test… The patient needs to know

that [the biopsy] specimen is considered an

important part of the evaluation for the final

therapy, they will not know what we are doing with

the specimen, but some of them will [ask] what a

FISH test [is], they may have read a paper, you

can explain what it is, but that’s all.”

Key Opinion Leader


Table of Contents


1 Table of Contents

1 Table of Contents ....................................................................................................................... 6

1.1 List of Tables .................................................................................................................... 11

1.2 List of Figures ................................................................................................................... 19

2 Introduction ............................................................................................................................... 22

2.1 Catalyst ............................................................................................................................. 22

2.2 Related Reports ................................................................................................................ 23

3 Industry Overview ..................................................................................................................... 24

3.1 Emergence of Companion Diagnostics ............................................................................. 24

3.1.1 Definition of Companion Diagnostics ............................................................................. 24

3.1.2 Changing Face of Medicine ........................................................................................... 25

3.1.3 Definitions of Companion and Personalized Diagnostics ............................................... 27

3.2 Disease Applications ......................................................................................................... 29

3.2.1 Breast Cancer ............................................................................................................... 29

3.2.2 Colorectal Cancer ......................................................................................................... 32

3.2.3 Melanoma ..................................................................................................................... 34

3.2.4 Non-Small Cell Lung Cancer ......................................................................................... 35

3.3 Companion Diagnostics Technologies .............................................................................. 37

3.3.1 Immunochemical Techniques ........................................................................................ 37

3.3.2 Nucleic Acid Testing ...................................................................................................... 39

3.3.3 Emerging Technologies ................................................................................................. 46

3.4 Companion Diagnostics Development .............................................................................. 48

3.4.1 Economic Value of a Companion Diagnostic ................................................................. 48

3.4.2 When to Develop a Companion Diagnostic Test ........................................................... 49

3.4.3 Strategy......................................................................................................................... 52

3.4.4 Selection of Partner ....................................................................................................... 53

3.4.5 Biomarker Discovery ..................................................................................................... 55


Table of Contents


3.5 Clinical Outcomes ............................................................................................................. 55

3.5.1 Role of Companion Diagnostics in Disease Treatment .................................................. 55

3.5.2 Companion Diagnostic Test Applications ...................................................................... 56

3.6 Testing Trends .................................................................................................................. 57

3.6.1 Japan ............................................................................................................................ 57

3.6.2 China ............................................................................................................................ 65

3.6.3 India .............................................................................................................................. 73

3.7 Market Access .................................................................................................................. 81

3.7.1 Overview ....................................................................................................................... 81

3.7.2 Japan ............................................................................................................................ 81

3.7.3 China ............................................................................................................................ 83

3.7.4 India .............................................................................................................................. 85

3.8 Regulatory Issues and Recalls .......................................................................................... 87

3.8.1 Dako FDA Warning Letter ............................................................................................. 87

3.8.2 HercepTest Recall ......................................................................................................... 87

3.8.3 Cobas KRAS Test Recall .............................................................................................. 88

3.8.4 Cobas BRF V600E Test Recall ..................................................................................... 88

3.8.5 Leica Bond HER2 IHC System ...................................................................................... 88

3.9 Reimbursement of Companion Diagnostic Tests ............................................................... 88

3.9.1 Japan ............................................................................................................................ 88

3.9.2 China ............................................................................................................................ 89

3.9.3 India .............................................................................................................................. 91

3.10 M&A, Key Partnerships ..................................................................................................... 93

3.10.1 Significant Mergers and Acquisitions ............................................................................. 95

3.10.2 Recent Partnerships ...................................................................................................... 95

3.11 Economic Impact ............................................................................................................ 101

3.11.1 Cost Effectiveness of Companion Diagnostics ............................................................ 101


Table of Contents


3.11.2 Cost Effectiveness of Companion Diagnostics: Healthcare Provider Perspective ........ 102

3.12 Market Drivers................................................................................................................. 108

3.12.1 Driver: Increasing Healthcare Pressures ..................................................................... 108

3.12.2 Driver: Adverse Economic Pressures .......................................................................... 109

3.12.3 Driver: Availability of New Technologies ...................................................................... 109

3.12.4 Driver: FDA Regulatory Changes ................................................................................ 110

3.12.5 Driver: Need to Improve Drug Development Processes .............................................. 110

3.12.6 Driver: Increasing Cancer Incidence ............................................................................ 111

3.12.7 Driver: Accelerating Demand for Targeted Therapies .................................................. 111

3.13 Market Barriers ............................................................................................................... 112

3.13.1 Barrier: Reimbursement Difficulties ............................................................................. 112

3.13.2 Barrier: Loss of Indication ............................................................................................ 113

3.13.3 Barrier: Emergence of Biosimilar Therapies ................................................................ 114

3.13.4 Barrier: Competition with Laboratory-Developed Tests ................................................ 114

3.13.5 Barrier: Emergence of Next-Generation Gene Sequencing ......................................... 115

3.13.6 Barrier: Lack of Laboratory Choice in Instrument Selection ......................................... 116

3.13.7 Barrier: Lack of Patient Awareness about Companion Diagnostic Tests...................... 118

3.13.8 Barrier: Physician Resistance to New Companion Diagnostic Tests ............................ 118

4 Competitive Assessment ........................................................................................................ 120

4.1 Overview ......................................................................................................................... 120

4.2 Techniques in Use by Currently Marketed Products ........................................................ 120

4.2.1 Immunohistochemistry ................................................................................................ 120

4.2.2 Fluorescence In Situ Hybridization .............................................................................. 120

4.2.3 Polymerase Chain Reaction ........................................................................................ 121

4.3 Competitive Analysis ....................................................................................................... 121

4.3.1 Breast Cancer Companion Diagnostic Tests ............................................................... 121

4.3.2 Colorectal Cancer Companion Diagnostic Tests ......................................................... 150


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4.3.3 Melanoma Companion Diagnostic Tests ..................................................................... 159

4.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests ......................................... 165

5 Unmet Needs .......................................................................................................................... 182

5.1 Need for Improved Cancer Treatments ........................................................................... 182

5.2 Need for Objective Tests ................................................................................................. 182

5.3 Need for High-Throughput Tests ..................................................................................... 184

5.4 Certainty of Reimbursement............................................................................................ 185

5.5 Amount and Type of Tissue Needed for Test .................................................................. 186

5.6 Who Should be Tested? .................................................................................................. 189

5.7 Test Accuracy ................................................................................................................. 194

5.8 Increasing Test Complexity and Increased Process Failure ............................................ 196

6 Pipeline Products .................................................................................................................... 198

6.1 Overview ......................................................................................................................... 198

6.2 Pipeline by Phase of Development.................................................................................. 200

6.3 Pipeline Product Profiles ................................................................................................. 201





7 Clinical Trials to Watch ........................................................................................................... 237

7.1 Overview ......................................................................................................................... 237

7.2 Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies ........................................................................................................................ 241

8 Current and Future Players ..................................................................................................... 242

8.1 Trends in Corporate Strategy .......................................................................................... 242

8.1.1 Companion Diagnostics Business Models ................................................................... 242

8.2 Company Profiles ............................................................................................................ 243

8.2.1 Pharmaceutical/Therapy Companies Developing Companion Diagnostic Tests .......... 243


Table of Contents


8.2.2 Diagnostics Companies Developing Companion Diagnostic Tests (in Partnership with Pharmaceutical Companies)....................................................................................... 297

9 Market Outlooks...................................................................................................................... 379

9.1 By Market Segment......................................................................................................... 379





9.1.5 Technique ................................................................................................................... 386

9.2 By Geography ................................................................................................................. 389

9.2.1 10 Major Markets Overview ......................................................................................... 389

9.2.2 Japan .......................................................................................................................... 389

9.2.3 China .......................................................................................................................... 392

9.2.4 India ............................................................................................................................ 394

10 Appendix................................................................................................................................. 397

10.1 Bibliography .................................................................................................................... 397

10.2 Abbreviations .................................................................................................................. 436

10.3 Report Methodology ........................................................................................................ 438

10.3.1 Coverage .................................................................................................................... 438

10.3.2 Secondary Research ................................................................................................... 439

10.3.3 Forecasting Methodology ............................................................................................ 439

10.4 Physicians Included in this Study .................................................................................... 441

10.5 About the Authors ........................................................................................................... 443

10.5.1 Andrew Thompson, Ph.D., Senior Analyst, In Vitro Diagnostics .................................. 443

10.5.2 Derek Archila, MBA, Lead Analyst, Medical Devices ................................................... 443

10.5.3 Bonnie Bain, PhD, Global Head of Healthcare ............................................................ 444

10.6 Disclaimer ....................................................................................................................... 445


Table of Contents


1.1 List of Tables

Table 1: Possible Companion Diagnostic Test Platforms ................................................................................ 24

Table 2: Specific Breast Cancer Types Associated with Inherited Disorders ................................................... 31

Table 3: Specific Mutations Associated with Non-Small Cell Lung Cancer ...................................................... 37

Table 4: Weaknesses of ELISA Technique .................................................................................................... 38

Table 5: Key Stages of PCR Gene Test ......................................................................................................... 41

Table 6: Key Principles Guiding Companion Diagnostic Test Development .................................................... 52

Table 7: Companion Diagnostic Test Development Partner Selection ............................................................ 53

Table 8: Biomarker Discovery ........................................................................................................................ 55

Table 9: Disease Diagnosis, Treatment, and Monitoring ................................................................................. 55

Table 10: Application of Companion Diagnostic Tests .................................................................................... 56

Table 11: Major Biomarkers currently measured in Cancer Companion Diagnostic Tests ............................... 57

Table 12: HER2 Testing for Breast Cancer Patients in Japan ......................................................................... 58

Table 13: Breast Cancer Companion Diagnostic Testing (HER2) in Japan, 2011–2020 .................................. 59

Table 14: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Japan, 2011–2020 ............................ 60

Table 15: Melanoma Companion Diagnostic Testing (BRAF) in Japan, 2011–2020 ........................................ 61

Table 16: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Japan, 2011–2020 ............... 65

Table 17: Breast Cancer Companion Diagnostic Testing (HER2) in China, 2011–2020 .................................. 68

Table 18: Colorectal Cancer Companion Diagnostic (KRAS) Testing in China, 2011–2020 ............................ 69

Table 19: Melanoma Companion Diagnostic Testing (BRAF) in China, 2011–2020 ........................................ 71

Table 20: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in China, 2011–2020 ................ 73

Table 21: Breast Cancer Companion Diagnostic Testing (HER2) in India, 2011–2020 .................................... 75

Table 22: Colorectal Cancer Companion Diagnostic (KRAS) Testing in India, 2011–2020 .............................. 77

Table 23: Melanoma Companion Diagnostic Testing (BRAF) in India, 2011–2020 .......................................... 78


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Table 24: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in India, 2011–2020 ................. 80

Table 25: Healthcare Systems in China ......................................................................................................... 84

Table 26: Healthcare Principles in China ........................................................................................................ 85

Table 27: Tariffs for Companion Diagnostic and Related Tests at the Tata Memorial Hospital ........................ 93

Table 28: Key Mergers and Acquisitions during 2013–2014 ........................................................................... 95

Table 29: Partnerships during 2013–2014 ...................................................................................................... 96

Table 30: Impact of Companion Diagnostics on Cancer Treatment Costs in France ..................................... 107

Table 31: Effectiveness of Disease Therapies .............................................................................................. 108

Table 32: HER2 FISH/iQFISH PharmDx Product Profile .............................................................................. 121

Table 33: Common Reasons for HER2 FISH Failure .................................................................................... 123

Table 34: HER2 FISH PharmDx/HER2 iQFISH PharmDx SWOT Analysis ................................................... 125

Table 35: HercepTest Product Profile .......................................................................................................... 125

Table 36: HercepTest Scoring Algorithm ...................................................................................................... 126

Table 37: HercepTest SWOT Analysis ......................................................................................................... 128

Table 38: HER2 CISH PharmDx Product Profile .......................................................................................... 129

Table 39: HER2 CISH PharmDx SWOT Analysis ......................................................................................... 131

Table 40: SPOT-Light HER2 CISH Kit Product Profile .................................................................................. 132

Table 41: SPOT-Light HER2 CISH Kit SWOT Analysis ................................................................................ 134

Table 42: Leica Bond Oracle HER2 IHC System Product Profile .................................................................. 134

Table 43: Leica Bond Oracle HER2 IHC System Test Algorithm................................................................... 135

Table 44: Leica Bond Oracle HER2 IHC System SWOT Analysis................................................................. 137

Table 45: Biogenex INSITE HER2/Neu Product Profile ................................................................................ 138

Table 46: Biogenex INSITE HER2/Neu SWOT Analysis ............................................................................... 140

Table 47: Abbott Pathvysion HER-2 DNA Probe Kit Product Profile ............................................................. 140


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Table 48: Abbott Pathvysion HER-2 DNA Probe Kit SWOT Analysis ............................................................ 142

Table 49: Ventana INFORM HER2 Dual ISH Assay Product Profile ............................................................. 143

Table 50: Ventana INFORM HER2 Dual ISH Assay SWOT Analysis ............................................................ 145

Table 51: Pathway HER2/Neu IHC Product Profile....................................................................................... 145

Table 52: Pathway HER2/Neu IHC SWOT Analysis ..................................................................................... 148

Table 53: HerMark Product Profile ............................................................................................................... 149

Table 54: HerMark SWOT Analysis.............................................................................................................. 150

Table 55: Therascreen KRAS RGQ Product Profile ...................................................................................... 150

Table 56: Therascreen KRAS RGQ SWOT Analysis .................................................................................... 153

Table 57: Cobas KRAS Mutation Test Product Profile .................................................................................. 153

Table 58: Cobas KRAS Mutation Test SWOT Analysis ................................................................................ 154

Table 59: EGFR PharmDx Kit Product Profile .............................................................................................. 155

Table 60: EGFR PharmDx Kit SWOT Analysis ............................................................................................. 159

Table 61: THxID BRAF Product Profile ........................................................................................................ 159

Table 62: Effect of Melanin on the THxID BRAF PCR Test........................................................................... 161

Table 63: THxID BRAF SWOT Analysis ....................................................................................................... 162

Table 64: Cobas 4800 BRAF V600 Mutation Test – Melanoma Product Profile ............................................ 163

Table 65: Interpretation of Cobas BRAF V600 Mutation Test – Melanoma ................................................... 164

Table 66: Cobas 4800 BRAF V600 Mutation Test – Melanoma SWOT Analysis ........................................... 165

Table 67: Vysis ALK Break Apart FISH Probe Kit Product Profile ................................................................. 166

Table 68: Abbott Vysis ALK Break Apart FISH Probe Kit SWOT Analysis..................................................... 168

Table 69: Amoy-Dx EML4-ALK Fusion Gene Detection Kit Product Profile ................................................... 168

Table 70: Amoy-Dx EML4-ALK Fusion Gene Detection Kit SWOT Analysis ................................................. 170

Table 71: Therascreen EGFR RGQ PCR Kit Product Profile ........................................................................ 170


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Table 72: Therascreen EGFR RGQ PCR Kit SWOT Analysis....................................................................... 175

Table 73: ALK IHC Test Product Profile ....................................................................................................... 176

Table 74: ALK IHC Test SWOT Analysis ...................................................................................................... 178

Table 75: Cobas EGFR Mutation Test Product Profile .................................................................................. 179

Table 76: Cobas EGFR Mutation Test SWOT Analysis ................................................................................ 181

Table 77: Companion Diagnostic Tests Pipeline, 2014 ................................................................................. 200

Table 78: Neuvax Companion Diagnostic Assay Product Profile .................................................................. 202

Table 79: Neuvax Companion Diagnostic Assay Product SWOT Analysis .................................................... 202

Table 80: Companion Diagnostic Test – Palbociclib Product Profile ............................................................. 203

Table 81: Companion Diagnostic Test – Palbociclib SWOT Analysis ............................................................ 204

Table 82: Companion Diagnostic Test – Breast Cancer Product Profile ........................................................ 205

Table 83: Companion Diagnostic Test – Breast Cancer SWOT Analysis ...................................................... 205

Table 84: Onapristone Companion Diagnostic Assay Product Profile ........................................................... 206

Table 85: Onapristone Companion Diagnostic Assay SWOT Analysis ......................................................... 207

Table 86: Aromatase Inhibitor Biomarker – Companion Diagnostic Test Product Profile ............................... 208

Table 87: Aromatase Inhibitor Biomarker – Companion Diagnostic Test SWOT Analysis ............................. 208

Table 88: BRAF Companion Diagnostic Assay – Colon Cancer Product Profile ............................................ 209

Table 89: BRAF Companion Diagnostic Assay – Colon Cancer SWOT Analysis .......................................... 210

Table 90: KRAS Companion Diagnostic Assay – Colon Cancer Product Profile............................................ 211

Table 91: KRAS Companion Diagnostic Assay – Colon Cancer SWOT Analysis .......................................... 211

Table 92: PIK3CA Companion Diagnostic Assay – Colorectal Cancer Product Profile .................................. 212

Table 93: PIK3CA Companion Diagnostic Assay – Colorectal Cancer SWOT Analysis................................. 213

Table 94: Vectibix Companion Diagnostic Product Profile ............................................................................ 214

Table 95: Vectibix Companion Diagnostic SWOT Analysis ........................................................................... 215


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Table 96: MAGE-A3 Companion Skin Cancer Assay Product Profile ............................................................ 216

Table 97: MAGE-A3 Companion Skin Cancer Assay SWOT Analysis .......................................................... 216

Table 98: GNAQ/GNA11 Companion Diagnostic Assays – Melanoma Product Profile .................................. 217

Table 99: GNAQ/GNA11 Companion Diagnostic Assays – Melanoma SWOT Analysis ................................ 218

Table 100: Companion Diagnostic Test – Melanoma Cancer Product Profile................................................ 219

Table 101: Companion Diagnostic Test – Melanoma Cancer SWOT Analysis .............................................. 219

Table 102: KRAS Companion Diagnostic Assay – Melanoma Product Profile ............................................... 220

Table 103: KRAS Companion Diagnostic Assay – Melanoma SWOT Analysis ............................................. 221

Table 104: Companion Diagnostic Test – Melanoma Product Profile ............................................................ 222

Table 105: Companion Diagnostic Test – Melanoma SWOT Analysis .......................................................... 222

Table 106: BRAF Companion Diagnostic Assay – Lung Cancer Product Profile ........................................... 223

Table 107: BRAF Companion Diagnostic Assay – Lung Cancer SWOT Analysis .......................................... 223

Table 108: KRAS Companion Diagnostic Assay – Lung Cancer Product Profile ........................................... 224

Table 109: KRAS Companion Diagnostic Assay – Lung Cancer SWOT Analysis ......................................... 224

Table 110: MET Companion Diagnostic Assay – Lung Cancer Product Profile ............................................. 225

Table 111: MET Companion Diagnostic Assay – Lung Cancer SWOT Analysis ........................................... 226

Table 112: PIK3CA Companion Diagnostic Assay – Lung Cancer Product Profile ........................................ 227

Table 113: PIK3CA Companion Diagnostic Assay – Lung Cancer SWOT Analysis....................................... 227

Table 114: Companion Diagnostic Device – Lung Cancer Product Profile .................................................... 228

Table 115: Companion Diagnostic Device – Lung Cancer SWOT Analysis ................................................... 229

Table 116: Companion Diagnostic Test – Crizotinib Product Profile ............................................................. 230

Table 117: Companion Diagnostic Test – Crizotinib SWOT Analysis ............................................................ 230

Table 118: Companion Diagnostic Test – Dacomitinib Product Profile .......................................................... 231

Table 119: Companion Diagnostic Test – Dacomitinib SWOT Analysis ........................................................ 231


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Table 120: T790M Mutation Companion Diagnostic Test Product Profile ...................................................... 232

Table 121: T790M Mutation Companion Diagnostic Test SWOT Analysis .................................................... 232

Table 122: Entinostat Companion Diagnostic Assay Product Profile ............................................................. 233

Table 123: Entinostat Companion Diagnostic Assay SWOT Analysis ........................................................... 234

Table 124: MUC1 Expression Companion Diagnostic Test Product Profile ................................................... 235

Table 125: MUC1 Expression Companion Diagnostic Test SWOT Analysis ................................................. 235

Table 126: Companion Diagnostic Assay – NSCLC Product Profile ............................................................. 236

Table 127: Companion Diagnostic Assay – NSCLC SWOT Analysis ............................................................ 236

Table 128: Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug

Therapies. ................................................................................................................................. 241

Table 129: Company Profile – Amgen .......................................................................................................... 244

Table 130: Amgen’s Key Products ............................................................................................................... 244

Table 131: Selected Amgen Anti-Cancer Therapies Currently in Clinical Trials ............................................. 245

Table 132: Amgen SWOT Analysis .............................................................................................................. 250

Table 133: Company Profile – Arno Therapeutics ........................................................................................ 251

Table 134: Selected Arno Therapeutics Anti-Cancer Therapies Currently in Clinical Trials ........................... 251

Table 135: Arno Therapeutics SWOT Analysis............................................................................................. 255

Table 136: Company Profile – AstraZeneca ................................................................................................. 256

Table 137: Key Events in the Development of AstraZeneca’s Drug Portfolio Since 2011 .............................. 258

Table 138: Key Project Terminations by AstraZeneca Since 2008 ................................................................ 260

Table 139: AstraZeneca SWOT Analysis ..................................................................................................... 264

Table 140: Company Profile – Bristol-Myers Squibb ..................................................................................... 265

Table 141: Recent Key Product Approvals from Bristol-Myers Squibb .......................................................... 268

Table 142: Recent Key BMS Partnerships and Agreements ......................................................................... 269

Table 143: Bristol-Myers Squibb SWOT Analysis ......................................................................................... 270


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Table 144: Company Profile – Clovis Oncology............................................................................................ 271

Table 145: Clovis Oncology’s Key Products ................................................................................................. 272

Table 146: Clovis Oncology SWOT Analysis ................................................................................................ 276

Table 147: Company Profile – Eli Lilly and Company ................................................................................... 277

Table 148: Eli Lilly and Company SWOT Analysis........................................................................................ 283

Table 149: Company Profile – Genentech .................................................................................................... 283

Table 150: Selected Genentech Marketed Products ..................................................................................... 284

Table 151: Genentech SWOT Analysis ........................................................................................................ 289

Table 152: Company Profile – Pfizer ............................................................................................................ 290

Table 153: Pfizer SWOT Analysis ................................................................................................................ 296

Table 154: Company Profile – Syndax Pharmaceuticals .............................................................................. 296

Table 155: Syndax Pharmaceuticals SWOT Analysis ................................................................................... 297

Table 156: Company Profile – Abbott Laboratories ...................................................................................... 298

Table 157: Abbott’s Key Product Areas ........................................................................................................ 299

Table 158: Abbott Laboratories SWOT Analysis, 2013 ................................................................................. 304

Table 159: Company Profile – Amoy Diagnostics ......................................................................................... 305

Table 160: Amoy Diagnostics SWOT Analysis, 2013 ................................................................................... 306

Table 161: Company Profile – Biogenex Laboratories .................................................................................. 307

Table 162: Biogenex Laboratories SWOT Analysis, 2013............................................................................. 308

Table 163: Company Profile – BioMérieux ................................................................................................... 309

Table 164: BioMérieux SWOT Analysis, 2013 .............................................................................................. 317

Table 165: Company Profile – Dako (Agilent Technologies) ......................................................................... 318

Table 166: Dako/Agilent Technologies SWOT Analysis ................................................................................ 323

Table 167: Company Profile – Illumina ......................................................................................................... 324


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Table 168: Illumina Product Areas ............................................................................................................... 324

Table 169: Illumina SWOT Analysis ............................................................................................................. 331

Table 170: Company Profile – Leica Biosystems (Danaher) ......................................................................... 332

Table 171: Leica Biosystems/Danaher SWOT Analysis ................................................................................ 338

Table 172: Company Profile – Life Technologies (Thermo Fisher Scientific) ................................................. 339

Table 173: Life Technologies SWOT Analysis .............................................................................................. 346

Table 174: Company Profile – MolecularMD ................................................................................................ 347

Table 175: MolecularMD SWOT Analysis .................................................................................................... 348

Table 176: Company Profile – Myriad Genetics............................................................................................ 349

Table 177: Myriad Genetics Major Product Areas ........................................................................................ 350

Table 178: Myriad Genetics SWOT Analysis ................................................................................................ 354

Table 179: Company Profile – Qiagen ......................................................................................................... 355

Table 180: Qiagen Major Product Areas ...................................................................................................... 356

Table 181: Qiagen SWOT Analysis .............................................................................................................. 361

Table 182: Company Profile – Roche Diagnostics ........................................................................................ 362

Table 183: Roche SWOT Analysis ............................................................................................................... 368

Table 184: Company Profile – Siemens Healthcare ..................................................................................... 369

Table 185: Siemens Healthcare SWOT Analysis .......................................................................................... 374

Table 186: Company Profile – Ventana Medical Systems ............................................................................ 375

Table 187: Ventana Medical Systems SWOT Analysis ................................................................................. 378

Table 188: APAC Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011–2020 ............ 379

Table 189: APAC Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011–2020 ...... 381

Table 190: APAC Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011–2020 .................. 383

Table 191: APAC Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011–2020 ...................... 385


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Table 192: APAC Sales Forecast for IHC and Molecular Tests ($m), 2011–2020 ......................................... 387

Table 193: Major Events Affecting the Companion Diagnostic Test Market .................................................. 389

Table 194: Sales Forecast for Companion Diagnostic Tests ($m) in Japan, 2011–2020 ............................... 390

Table 195: Sales Forecast for Companion Diagnostic Tests ($m) in China, 2011–2020................................ 393

Table 196: Sales Forecast for Companion Diagnostic Tests ($m) in India, 2011–2020 ................................. 395

1.2 List of Figures

Figure 1: Genomic Sequencing Costs, 2001–2012......................................................................................... 26

Figure 2: Use of Proteomics in Personalized Medicine ................................................................................... 28

Figure 3: Incidence of Inherited Breast Cancer Mutations among Diagnosed Breast Cancer Patients ............. 30

Figure 4: Basic FISH Process ........................................................................................................................ 40

Figure 5: Basic PCR Process ......................................................................................................................... 42

Figure 6: Impact of Sample Storage on PCR Outcome................................................................................... 43

Figure 7: Genomic Sequencing Costs, 2001–2012......................................................................................... 45

Figure 8: Scientific and Economic Potential of Companion Diagnostics .......................................................... 49

Figure 9: Drug and Diagnostic Test Co-Development ..................................................................................... 50

Figure 10: Roche Lifecycle Algorithm for Co-Development of a Predictive Diagnostic ..................................... 51

Figure 11: Key Development Drivers for Companion Diagnostic Tests ........................................................... 53

Figure 12: Qiagen Model to Build a JAK2 Companion Diagnostic Tests Business .......................................... 54

Figure 13: Breast Cancer Companion Diagnostic Testing (HER2) in Japan, 2011–2020 ................................. 59

Figure 14: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Japan, 2011–2020 ........................... 60

Figure 15: Melanoma Companion Diagnostic Testing (BRAF) in Japan, 2011–2020....................................... 61

Figure 16: EGFR Testing in Japan, 2006–2011.............................................................................................. 62

Figure 17: Japanese Lung Cancer Society Diagnostic Testing Algorithm........................................................ 64


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Figure 18: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Japan, 2011–2020 .............. 65

Figure 19: Breast Cancer Companion Diagnostic Testing (HER2) in China, 2011–2020 ................................. 67

Figure 20: Colorectal Cancer Companion Diagnostic (KRAS) Testing in China, 2011–2020 ........................... 69

Figure 21: Melanoma Companion Diagnostic Testing (BRAF) in China, 2011–2020 ....................................... 70

Figure 22: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in China, 2011–2020 .............. 72

Figure 23: Breast Cancer Companion Diagnostic Testing (HER2) in India, 2011–2020................................... 75

Figure 24: Colorectal Cancer Companion Diagnostic (KRAS) Testing in India, 2011–2020 ............................. 77

Figure 25: Melanoma Companion Diagnostic Testing (BRAF) in India, 2011–2020 ........................................ 78

Figure 26: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in India, 2011–2020 ................ 80

Figure 27: Registration of Domestic and Imported Medical Devices in China .................................................. 90

Figure 28: Multiple Partnerships in Companion Diagnostics during 2013–2014 .............................................. 99

Figure 29: Building a Companion Diagnostics Business: Forming Multiple Partnerships ............................... 100

Figure 30: Increasing Medicare Cost of Treatment ....................................................................................... 104

Figure 31: Growth of Drug Therapy Expenditure in France, 2004–2009 ....................................................... 105

Figure 32: Share of Targeted Therapies of Anti-Cancer Drug Costs in France .............................................. 106

Figure 33: Increase in Approvals of Biologic (Targeted) Therapies ............................................................... 112

Figure 34: EGFR PharmDx Test Adoption Curve ......................................................................................... 156

Figure 35: Probe Arrangement in the Vysis ALK Break Apart FISH Probe Kit ............................................... 166

Figure 36: Scorpion Primers ........................................................................................................................ 172

Figure 37: Increase in High- and Moderate-Complexity Molecular Tests....................................................... 175

Figure 38: Reasons for Companion Diagnostic Test Failure ......................................................................... 187

Figure 39: Female Breast Cancer Treatment Patterns by Stage, 2008 ......................................................... 190

Figure 40: Colon Cancer Treatment Patterns by Stage, 2008 ....................................................................... 191

Figure 41: Lung Cancer Treatment Patterns by Stage, 2008 ........................................................................ 192


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Figure 42: Expected Companion Diagnostic Test Pipeline, US Approvals, 2014–2019 ................................. 199

Figure 43: Sponsors of Clinical Trials for Targeted Cancer Therapies .......................................................... 238

Figure 44: Sponsors of Clinical Trials for Targeted Cancer Therapies Based on Mutational Status ............... 239

Figure 45: Sponsors of Clinical Trials for Targeted Cancer Therapies, by Phase .......................................... 240

Figure 46: APAC Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011–2020 ............ 379

Figure 47: APAC Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011–2020 ....... 381

Figure 48: APAC Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011–2020 .................. 383

Figure 49: APAC Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011–2020 ....................... 385

Figure 50: APAC Sales Forecast for IHC and Molecular Tests ($m), 2011–2020 .......................................... 387

Figure 51: APAC Market Share of Molecular Tests and Immunohistochemistry Tests in 2012 and 2020 ....... 388

Figure 52: Sales Forecast for Companion Diagnostic Tests ($m) in Japan, 2011–2020 ................................ 390

Figure 53: Sales Forecast for Companion Diagnostic Tests ($m) in China, 2011–2020 ................................ 392

Figure 54: Sales Forecast for Companion Diagnostic Tests ($m) in India, 2011–2020 .................................. 395



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 Japan, and the future markets in China and India, to identify unmet needs in

the APAC 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.

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.



Introduction

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, 2014a).

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


10.6 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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