companion diagnostic tests in oncology - global …number of late clinical devices 8 key events...

REFERENCE CODE GDME0189MAR | PUBLICATION DATE MAY 2014

COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS

Companion Diagnostic Tests in Oncology - Global 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 10 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

US $262,418,133 5EU $146,925,698 APAC $45,276,324 South America $23,846,544

Total $478,466,698

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 US $365,383,030 5EU $187,933,105 APAC $80,558,751 South America $35,784,576

Total $669,659,462

Source: GlobalData. 5EU = France, Germany, Italy, Spain, and UK; APAC (Asia-Pacific) = Japan, China, and India; South America = Brazil; IHC = immunohistochemistry

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

The major feature of the 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

55% of the 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 Global Revenue, 2014

5EU31%

APAC9%

SA5%

US55%

Source: GlobalData. 5EU = France, Germany, Italy, Spain, and UK; APAC = Japan, China, and India; SA (South America) = Brazil.



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 .................................................................................................................... 12

1.2 List of Figures ................................................................................................................... 23

2 Introduction ............................................................................................................................... 28

2.1 Catalyst ............................................................................................................................. 28

2.2 Related Reports ................................................................................................................ 29

3 Industry Overview ..................................................................................................................... 30

3.1 Emergence of Companion Diagnostics ............................................................................. 30

3.1.1 Definition of Companion Diagnostics ............................................................................. 30

3.1.2 Changing Face of Medicine ........................................................................................... 31

3.1.3 Definitions of Companion and Personalized Diagnostics ............................................... 33

3.2 Disease Applications ......................................................................................................... 35

3.2.1 Breast Cancer ............................................................................................................... 35

3.2.2 Colorectal Cancer ......................................................................................................... 38

3.2.3 Melanoma ..................................................................................................................... 40

3.2.4 Non-Small Cell Lung Cancer ......................................................................................... 41

3.3 Companion Diagnostics Technologies .............................................................................. 43

3.3.1 Immunochemical Techniques ........................................................................................ 43

3.3.2 Nucleic Acid Testing ...................................................................................................... 45

3.3.3 Emerging Technologies ................................................................................................. 52

3.4 Companion Diagnostics Development .............................................................................. 54

3.4.1 Economic Value of a Companion Diagnostic ................................................................. 54

3.4.2 When to Develop a Companion Diagnostic Test ........................................................... 55

3.4.3 Strategy......................................................................................................................... 58

3.4.4 Selection of Partner ....................................................................................................... 59

3.4.5 Biomarker Discovery ..................................................................................................... 61


Table of Contents


3.5 Clinical Outcomes ............................................................................................................. 62

3.5.1 Role of Companion Diagnostics in Disease Treatment .................................................. 62

3.5.2 Companion Diagnostic Test Applications ...................................................................... 63

3.6 Testing Trends .................................................................................................................. 64

3.6.1 US ................................................................................................................................. 64

3.6.2 France ........................................................................................................................... 75

3.6.3 Germany ....................................................................................................................... 85

3.6.4 Italy ............................................................................................................................... 92

3.6.5 Spain ........................................................................................................................... 100

3.6.6 UK ............................................................................................................................... 106

3.6.7 Japan .......................................................................................................................... 120

3.6.8 Brazil ........................................................................................................................... 129

3.6.9 China .......................................................................................................................... 135

3.6.10 India ............................................................................................................................ 143

3.7 Market Access ................................................................................................................ 150

3.7.1 Overview ..................................................................................................................... 150

3.7.2 US ............................................................................................................................... 150

3.7.3 5EU ............................................................................................................................. 154

3.7.4 Japan .......................................................................................................................... 165

3.7.5 Brazil ........................................................................................................................... 167

3.7.6 China .......................................................................................................................... 169

3.7.7 India ............................................................................................................................ 172

3.8 Regulatory Issues and Recalls ........................................................................................ 173

3.8.1 Dako FDA Warning Letter ........................................................................................... 173

3.8.2 HercepTest Recall ....................................................................................................... 174

3.8.3 Cobas KRAS Test Recall ............................................................................................ 174

3.8.4 Cobas BRF V600E Test Recall ................................................................................... 174


Table of Contents


3.8.5 Leica Bond HER2 IHC System .................................................................................... 174

3.9 Reimbursement of Companion Diagnostic Tests ............................................................. 175

3.9.1 US ............................................................................................................................... 175

3.9.2 Europe ........................................................................................................................ 180

3.9.3 APAC .......................................................................................................................... 192

3.9.4 South America............................................................................................................. 197

3.10 M&A, Key Partnerships ................................................................................................... 199

3.10.1 Significant Mergers and Acquisitions ........................................................................... 201

3.10.2 Recent Partnerships .................................................................................................... 201

3.11 Economic Impact ............................................................................................................ 207

3.11.1 Cost Effectiveness of Companion Diagnostics ............................................................ 207

3.11.2 Cost Effectiveness of Companion Diagnostics: Healthcare Provider Perspective ........ 208

3.12 Market Drivers................................................................................................................. 214

3.12.1 Driver: Increasing Healthcare Pressures ..................................................................... 214

3.12.2 Driver: Adverse Economic Pressures .......................................................................... 215

3.12.3 Driver: Availability of New Technologies ...................................................................... 215

3.12.4 Driver: FDA Regulatory Changes ................................................................................ 216

3.12.5 Driver: Need to Improve Drug Development Processes .............................................. 216

3.12.6 Driver: Increasing Cancer Incidence ............................................................................ 217

3.12.7 Driver: Accelerating Demand for Targeted Therapies .................................................. 217

3.13 Market Barriers ............................................................................................................... 219

3.13.1 Barrier: Reimbursement Difficulties ............................................................................. 219

3.13.2 Barrier: Loss of Indication ............................................................................................ 219

3.13.3 Barrier: Emergence of Biosimilar Therapies ................................................................ 220

3.13.4 Barrier: Competition with Laboratory-Developed Tests ................................................ 221

3.13.5 Barrier: Emergence of Next-Generation Gene Sequencing ......................................... 222

3.13.6 Barrier: Lack of Laboratory Choice in Instrument Selection ......................................... 223


Table of Contents


3.13.7 Barrier: Lack of Patient Awareness about Companion Diagnostic Tests...................... 224

3.13.8 Barrier: Physician Resistance to New Companion Diagnostic Tests ............................ 225

4 Competitive Assessment ........................................................................................................ 227

4.1 Overview ......................................................................................................................... 227

4.2 Techniques in Use by Currently Marketed Products ........................................................ 227

4.2.1 Immunohistochemistry ................................................................................................ 227

4.2.2 Fluorescence In Situ Hybridization .............................................................................. 227

4.2.3 Polymerase Chain Reaction ........................................................................................ 228

4.3 Competitive Analysis ....................................................................................................... 228

4.3.1 Breast Cancer Companion Diagnostic Tests ............................................................... 228

4.3.2 Colorectal Cancer Companion Diagnostic Tests ......................................................... 257

4.3.3 Melanoma Companion Diagnostic Tests ..................................................................... 267

4.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests ......................................... 273

5 Unmet Needs .......................................................................................................................... 290

5.1 Need for Improved Cancer Treatments ........................................................................... 290

5.2 Need for Objective Tests ................................................................................................. 290

5.3 Need for High-Throughput Tests ..................................................................................... 292

5.4 Certainty of Reimbursement............................................................................................ 293

5.5 Amount and Type of Tissue Needed for Test .................................................................. 294

5.6 Who Should be Tested? .................................................................................................. 297

5.7 Test Accuracy ................................................................................................................. 302

5.8 Increasing Test Complexity and Increased Process Failure ............................................ 305

6 Pipeline Products .................................................................................................................... 306

6.1 Overview ......................................................................................................................... 306

6.2 Pipeline by Phase of Development.................................................................................. 308

6.3 Pipeline Product Profiles ................................................................................................. 310



Table of Contents





7 Clinical Trials to Watch ........................................................................................................... 347

7.1 Overview ......................................................................................................................... 347

7.2 Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies ........................................................................................................................ 351

8 Current and Future Players ..................................................................................................... 352

8.1 Trends in Corporate Strategy .......................................................................................... 352

8.1.1 Companion Diagnostics Business Models ................................................................... 352

8.2 Company Profiles ............................................................................................................ 353

8.2.1 Pharmaceutical/Therapy Companies Developing Companion Diagnostic Tests .......... 353

8.2.2 Diagnostics Companies Developing Companion Diagnostic Tests (in Partnership with Pharmaceutical Companies)....................................................................................... 409

9 Market Outlooks...................................................................................................................... 492

9.1 By Market Segment......................................................................................................... 492





9.1.5 Technique ................................................................................................................... 504

9.2 By Geography ................................................................................................................. 507

9.2.1 10 Major Markets Overview ......................................................................................... 507

9.2.2 US ............................................................................................................................... 509

9.2.3 France ......................................................................................................................... 510

9.2.4 Germany ..................................................................................................................... 512

9.2.5 Italy ............................................................................................................................. 514

9.2.6 Spain ........................................................................................................................... 516


Table of Contents


9.2.7 UK ............................................................................................................................... 518

9.2.8 Japan .......................................................................................................................... 520

9.2.9 Brazil ........................................................................................................................... 523

9.2.10 China .......................................................................................................................... 525

9.2.11 India ............................................................................................................................ 527

10 Appendix................................................................................................................................. 530

10.1 Bibliography .................................................................................................................... 530

10.2 Abbreviations .................................................................................................................. 582

10.3 Report Methodology ........................................................................................................ 584

10.3.1 Coverage .................................................................................................................... 584

10.3.2 Secondary Research ................................................................................................... 585

10.3.3 Forecasting Methodology ............................................................................................ 585

10.4 Physicians Included in this Study .................................................................................... 587

10.5 About the Authors ........................................................................................................... 589

10.5.1 Andrew Thompson, Ph.D., Senior Analyst, In Vitro Diagnostics .................................. 589

10.5.2 Derek Archila, MBA, Lead Analyst, Medical Devices ................................................... 589

10.5.3 Bonnie Bain, PhD, Global Head of Healthcare ............................................................ 590

10.6 Disclaimer ....................................................................................................................... 591


Table of Contents


1.1 List of Tables

Table 1: Possible Companion Diagnostic Test Platforms ................................................................................ 30

Table 2: Specific Breast Cancer Types Associated with Inherited Disorders ................................................... 37

Table 3: Specific Mutations Associated with Non-Small Cell Lung Cancer ...................................................... 43

Table 4: Weaknesses of ELISA Technique .................................................................................................... 44

Table 5: Key Stages of PCR Gene Test ......................................................................................................... 47

Table 6: Key Principles Guiding Companion Diagnostic Test Development .................................................... 58

Table 7: Companion Diagnostic Test Development Partner Selection ............................................................ 59

Table 8: Biomarker Discovery ........................................................................................................................ 61

Table 9: Disease Diagnosis, Treatment, and Monitoring ................................................................................. 62

Table 10: Application of Companion Diagnostic Tests .................................................................................... 63

Table 11: Major Biomarkers currently measured in Cancer Companion Diagnostic Tests ............................... 64

Table 12: HER2 Testing in the US, 2011–2020 .............................................................................................. 69

Table 13: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the US, 2011–2020 ........................... 71

Table 14: Melanoma Companion Diagnostic Testing (BRAF) in the US, 2011–2020....................................... 72

Table 15: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the US, 2011–2020 .............. 75

Table 16: Types of Genetic Tests Carried Out in France during 2009 ............................................................. 76

Table 17: Biomarkers tested for in France ...................................................................................................... 77

Table 18: Tumor Molecular Profiling in France in 2011 and 2012 ................................................................... 78

Table 19: Breast Cancer Companion Diagnostic Testing (HER2) in France, 2011–2020 ................................ 79

Table 20: KRAS Companion Diagnostic Testing in France, 2008–2012 .......................................................... 80

Table 21: Colorectal Cancer Companion Diagnostic (KRAS) Testing in France, 2011–2020........................... 81

Table 22: Melanoma Companion Diagnostic Testing (BRAF) in France, 2011–2020 ...................................... 82

Table 23: EGFR Companion Diagnostic Testing in France, 2008–2012 ......................................................... 83


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Table 24: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in France, 2011–2020 .............. 84

Table 25: Breast Cancer Companion Diagnostic Testing (HER2) in Germany, 2011–2020 ............................. 86

Table 26: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Germany, 2011–2020 ....................... 87

Table 27: Melanoma Companion Diagnostic Testing (BRAF) in Germany, 2011–2020 ................................... 89

Table 28: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Germany, 2011–2020 .......... 91

Table 29: Breast Cancer Companion Diagnostic Testing (HER2) in Italy, 2011–2020 ..................................... 94

Table 30: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Italy, 2011–2020 ............................... 96

Table 31: Melanoma Companion Diagnostic Testing (BRAF) in Italy, 2011–2020 ........................................... 97

Table 32: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Italy, 2011–2020 ................ 100

Table 33: Breast Cancer Companion Diagnostic Testing (HER2) in Spain, 2011–2020 ................................ 101

Table 34: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Spain, 2011–2020 .......................... 103

Table 35: Melanoma Companion Diagnostic Testing (BRAF) in Spain, 2011–2020 ...................................... 104

Table 36: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Spain, 2011–2020 .............. 105

Table 37: Tumor Molecular Profiling in UK in 2006 and 2007 ....................................................................... 108

Table 38: Breast Cancer Companion Diagnostic Testing (HER2) in the UK, 2011–2020 ............................... 109

Table 39: Cost of Analysis of KRAS Laboratory-Developed Molecular Tests in the UK ................................. 110

Table 40: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the UK, 2011–2020 ......................... 111

Table 41: Melanoma Companion Diagnostic Testing (BRAF) in the UK, 2011–2020..................................... 113

Table 42: Lung Cancer EGFR Tests in the UK ............................................................................................. 115

Table 43: Cost of Analysis of NSCLC Laboratory-Developed Molecular Tests in the UK ............................... 116

Table 44: EGFR Method Selection in the UK, 2013 ...................................................................................... 117

Table 45: Cost of EGFR Testing in the UK ................................................................................................... 118

Table 46: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the UK, 2011–2020 ............ 120

Table 47: HER2 Testing for Breast Cancer Patients in Japan ....................................................................... 121


Table of Contents


Table 48: Breast Cancer Companion Diagnostic Testing (HER2) in Japan, 2011–2020 ................................ 122

Table 49: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Japan, 2011–2020 .......................... 123

Table 50: Melanoma Companion Diagnostic Testing (BRAF) in Japan, 2011–2020 ...................................... 124

Table 51: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Japan, 2011–2020 ............. 128

Table 52: Breast Cancer Companion Diagnostic Testing (HER2) in Brazil, 2011–2020................................. 130

Table 53: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Brazil, 2011–2020 ........................... 131

Table 54: Melanoma Companion Diagnostic Testing (BRAF) in Brazil, 2011–2020 ...................................... 132

Table 55: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Brazil, 2011–2020 .............. 134

Table 56: Breast Cancer Companion Diagnostic Testing (HER2) in China, 2011–2020 ................................ 137

Table 57: Colorectal Cancer Companion Diagnostic (KRAS) Testing in China, 2011–2020 .......................... 139

Table 58: Melanoma Companion Diagnostic Testing (BRAF) in China, 2011–2020 ...................................... 140

Table 59: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in China, 2011–2020 .............. 142

Table 60: Breast Cancer Companion Diagnostic Testing (HER2) in India, 2011–2020 .................................. 144

Table 61: Colorectal Cancer Companion Diagnostic (KRAS) Testing in India, 2011–2020 ............................ 146

Table 62: Melanoma Companion Diagnostic Testing (BRAF) in India, 2011–2020 ........................................ 147

Table 63: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in India, 2011–2020 ............... 149

Table 64: FDA Medical Device Classifications.............................................................................................. 151

Table 65: US Reimbursement Policies for FDA- and Non-FDA-Approved Molecular Tests ........................... 154

Table 66: EU Medical Device Classifications and Conformance Requirements ............................................ 155

Table 67: EU Medical Device Essential Requirements ................................................................................. 156

Table 68: Differences Between US FDA Approval and EU CE-Marking ........................................................ 156

Table 69: Healthcare Systems in China ....................................................................................................... 170

Table 70: Healthcare Principles in China ...................................................................................................... 171

Table 71: Timetable to Approve New Medical Devices in France.................................................................. 183


Table of Contents


Table 72: Access Opportunities for New Companion Diagnostic Tests in Europe ......................................... 184

Table 73: Estimate of the Unmet Clinical Need in the UK for the Main Molecular Tests in Solid Tumors ....... 191

Table 74: Tariffs for Companion Diagnostic and Related Tests at the Tata Memorial Hospital ...................... 197

Table 75: Key Mergers and Acquisitions during 2013–2014 ......................................................................... 201

Table 76: Partnerships during 2013–2014 .................................................................................................... 202

Table 77: Impact of Companion Diagnostics on Cancer Treatment Costs in France ..................................... 213

Table 78: Effectiveness of Disease Therapies .............................................................................................. 214

Table 79: HER2 FISH/iQFISH PharmDx Product Profile .............................................................................. 228

Table 80: Common Reasons for HER2 FISH Failure .................................................................................... 230

Table 81: HER2 FISH PharmDx/HER2 iQFISH PharmDx SWOT Analysis ................................................... 232

Table 82: HercepTest Product Profile .......................................................................................................... 232

Table 83: HercepTest Scoring Algorithm ...................................................................................................... 233

Table 84: HercepTest SWOT Analysis ......................................................................................................... 235

Table 85: HER2 CISH PharmDx Product Profile .......................................................................................... 236

Table 86: HER2 CISH PharmDx SWOT Analysis ......................................................................................... 238

Table 87: SPOT-Light HER2 CISH Kit Product Profile .................................................................................. 239

Table 88: SPOT-Light HER2 CISH Kit SWOT Analysis ................................................................................ 241

Table 89: Leica Bond Oracle HER2 IHC System Product Profile .................................................................. 241

Table 90: Leica Bond Oracle HER2 IHC System Test Algorithm................................................................... 242

Table 91: Leica Bond Oracle HER2 IHC System SWOT Analysis................................................................. 244

Table 92: Biogenex INSITE HER2/Neu Product Profile ................................................................................ 245

Table 93: Biogenex INSITE HER2/Neu SWOT Analysis ............................................................................... 247

Table 94: Abbott Pathvysion HER-2 DNA Probe Kit Product Profile ............................................................. 247

Table 95: Abbott Pathvysion HER-2 DNA Probe Kit SWOT Analysis ............................................................ 249


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Table 96: Ventana INFORM HER2 Dual ISH Assay Product Profile ............................................................. 250

Table 97: Ventana INFORM HER2 Dual ISH Assay SWOT Analysis ............................................................ 252

Table 98: Pathway HER2/Neu IHC Product Profile....................................................................................... 252

Table 99: Pathway HER2/Neu IHC SWOT Analysis ..................................................................................... 255

Table 100: HerMark Product Profile ............................................................................................................. 256

Table 101: HerMark SWOT Analysis ............................................................................................................ 257

Table 102: Therascreen KRAS RGQ Product Profile .................................................................................... 257

Table 103: Therascreen KRAS RGQ SWOT Analysis .................................................................................. 260

Table 104: Cobas KRAS Mutation Test Product Profile ................................................................................ 260

Table 105: Cobas KRAS Mutation Test SWOT Analysis .............................................................................. 262

Table 106: EGFR PharmDx Kit Product Profile ............................................................................................ 262

Table 107: EGFR PharmDx Kit SWOT Analysis ........................................................................................... 266

Table 108: THxID BRAF Product Profile ...................................................................................................... 267

Table 109: Effect of Melanin on the THxID BRAF PCR Test ......................................................................... 268

Table 110: THxID BRAF SWOT Analysis ..................................................................................................... 270

Table 111: Cobas 4800 BRAF V600 Mutation Test – Melanoma Product Profile .......................................... 270

Table 112: Interpretation of Cobas BRAF V600 Mutation Test – Melanoma ................................................. 271

Table 113: Cobas 4800 BRAF V600 Mutation Test – Melanoma SWOT Analysis ......................................... 273

Table 114: Vysis ALK Break Apart FISH Probe Kit Product Profile ............................................................... 273

Table 115: Abbott Vysis ALK Break Apart FISH Probe Kit SWOT Analysis ................................................... 276

Table 116: Amoy-Dx EML4-ALK Fusion Gene Detection Kit Product Profile ................................................. 276

Table 117: Amoy-Dx EML4-ALK Fusion Gene Detection Kit SWOT Analysis ............................................... 278

Table 118: Therascreen EGFR RGQ PCR Kit Product Profile ...................................................................... 278

Table 119: Therascreen EGFR RGQ PCR Kit SWOT Analysis ..................................................................... 283


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Table 120: ALK IHC Test Product Profile ..................................................................................................... 284

Table 121: ALK IHC Test SWOT Analysis .................................................................................................... 286

Table 122: Cobas EGFR Mutation Test Product Profile ................................................................................ 287

Table 123: Cobas EGFR Mutation Test SWOT Analysis .............................................................................. 289

Table 124: Companion Diagnostic Tests Pipeline, 2014 ............................................................................... 308

Table 125: Neuvax Companion Diagnostic Assay Product Profile ................................................................ 310

Table 126: Neuvax Companion Diagnostic Assay Product SWOT Analysis .................................................. 311

Table 127: Companion Diagnostic Test – Palbociclib Product Profile ........................................................... 312

Table 128: Companion Diagnostic Test – Palbociclib SWOT Analysis .......................................................... 313

Table 129: Companion Diagnostic Test – Breast Cancer Product Profile ...................................................... 314

Table 130: Companion Diagnostic Test – Breast Cancer SWOT Analysis .................................................... 314

Table 131: Onapristone Companion Diagnostic Assay Product Profile ......................................................... 315

Table 132: Onapristone Companion Diagnostic Assay SWOT Analysis ....................................................... 316

Table 133: Aromatase Inhibitor Biomarker – Companion Diagnostic Test Product Profile ............................. 317

Table 134: Aromatase Inhibitor Biomarker – Companion Diagnostic Test SWOT Analysis............................ 317

Table 135: BRAF Companion Diagnostic Assay – Colon Cancer Product Profile .......................................... 318

Table 136: BRAF Companion Diagnostic Assay – Colon Cancer SWOT Analysis ........................................ 319

Table 137: KRAS Companion Diagnostic Assay – Colon Cancer Product Profile.......................................... 320

Table 138: KRAS Companion Diagnostic Assay – Colon Cancer SWOT Analysis ........................................ 320

Table 139: PIK3CA Companion Diagnostic Assay – Colorectal Cancer Product Profile ................................ 321

Table 140: PIK3CA Companion Diagnostic Assay – Colorectal Cancer SWOT Analysis ............................... 322

Table 141: Vectibix Companion Diagnostic Product Profile .......................................................................... 323

Table 142: Vectibix Companion Diagnostic SWOT Analysis ......................................................................... 324

Table 143: MAGE-A3 Companion Skin Cancer Assay Product Profile .......................................................... 325


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Table 144: MAGE-A3 Companion Skin Cancer Assay SWOT Analysis ........................................................ 325

Table 145: GNAQ/GNA11 Companion Diagnostic Assays – Melanoma Product Profile ................................ 326

Table 146: GNAQ/GNA11 Companion Diagnostic Assays – Melanoma SWOT Analysis .............................. 327

Table 147: Companion Diagnostic Test – Melanoma Cancer Product Profile................................................ 328

Table 148: Companion Diagnostic Test – Melanoma Cancer SWOT Analysis .............................................. 328

Table 149: KRAS Companion Diagnostic Assay – Melanoma Product Profile ............................................... 329

Table 150: KRAS Companion Diagnostic Assay – Melanoma SWOT Analysis ............................................. 330

Table 151: Companion Diagnostic Test – Melanoma Product Profile ............................................................ 331

Table 152: Companion Diagnostic Test – Melanoma SWOT Analysis .......................................................... 331

Table 153: BRAF Companion Diagnostic Assay – Lung Cancer Product Profile ........................................... 332

Table 154: BRAF Companion Diagnostic Assay – Lung Cancer SWOT Analysis .......................................... 332

Table 155: KRAS Companion Diagnostic Assay – Lung Cancer Product Profile ........................................... 333

Table 156: KRAS Companion Diagnostic Assay – Lung Cancer SWOT Analysis ......................................... 333

Table 157: MET Companion Diagnostic Assay – Lung Cancer Product Profile ............................................. 334

Table 158: MET Companion Diagnostic Assay – Lung Cancer SWOT Analysis ........................................... 335

Table 159: PIK3CA Companion Diagnostic Assay – Lung Cancer Product Profile ........................................ 336

Table 160: PIK3CA Companion Diagnostic Assay – Lung Cancer SWOT Analysis....................................... 336

Table 161: Companion Diagnostic Device – Lung Cancer Product Profile .................................................... 337

Table 162: Companion Diagnostic Device – Lung Cancer SWOT Analysis ................................................... 338

Table 163: Companion Diagnostic Test – Crizotinib Product Profile ............................................................. 339

Table 164: Companion Diagnostic Test – Crizotinib SWOT Analysis ............................................................ 339

Table 165: Companion Diagnostic Test – Dacomitinib Product Profile .......................................................... 340

Table 166: Companion Diagnostic Test – Dacomitinib SWOT Analysis ........................................................ 340

Table 167: T790M Mutation Companion Diagnostic Test Product Profile ...................................................... 341


Table of Contents


Table 168: T790M Mutation Companion Diagnostic Test SWOT Analysis .................................................... 342

Table 169: Entinostat Companion Diagnostic Assay Product Profile ............................................................. 343

Table 170: Entinostat Companion Diagnostic Assay SWOT Analysis ........................................................... 343

Table 171: MUC1 Expression Companion Diagnostic Test Product Profile ................................................... 344

Table 172: MUC1 Expression Companion Diagnostic Test SWOT Analysis ................................................. 345

Table 173: Companion Diagnostic Assay – NSCLC Product Profile ............................................................. 346

Table 174: Companion Diagnostic Assay – NSCLC SWOT Analysis ............................................................ 346

Table 175: Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug

Therapies. ................................................................................................................................. 351

Table 176: Company Profile – Amgen .......................................................................................................... 354

Table 177: Amgen’s Key Products ............................................................................................................... 355

Table 178: Selected Amgen Anti-Cancer Therapies Currently in Clinical Trials ............................................. 356

Table 179: Amgen SWOT Analysis .............................................................................................................. 361

Table 180: Company Profile – Arno Therapeutics ........................................................................................ 362

Table 181: Selected Arno Therapeutics Anti-Cancer Therapies Currently in Clinical Trials ........................... 362

Table 182: Arno Therapeutics SWOT Analysis............................................................................................. 366

Table 183: Company Profile – AstraZeneca ................................................................................................. 367

Table 184: Key Events in the Development of AstraZeneca’s Drug Portfolio Since 2011 .............................. 369

Table 185: Key Project Terminations by AstraZeneca Since 2008 ................................................................ 371

Table 186: AstraZeneca SWOT Analysis ..................................................................................................... 375

Table 187: Company Profile – Bristol-Myers Squibb ..................................................................................... 376

Table 188: Recent Key Product Approvals from Bristol-Myers Squibb .......................................................... 379

Table 189: Recent Key BMS Partnerships and Agreements ......................................................................... 380

Table 190: Bristol-Myers Squibb SWOT Analysis ......................................................................................... 381

Table 191: Company Profile – Clovis Oncology............................................................................................ 382


Table of Contents


Table 192: Clovis Oncology’s Key Products ................................................................................................. 383

Table 193: Clovis Oncology SWOT Analysis ................................................................................................ 387

Table 194: Company Profile – Eli Lilly and Company ................................................................................... 388

Table 195: Eli Lilly and Company SWOT Analysis........................................................................................ 394

Table 196: Company Profile – Genentech .................................................................................................... 394

Table 197: Selected Genentech Marketed Products ..................................................................................... 395

Table 198: Genentech SWOT Analysis ........................................................................................................ 400

Table 199: Company Profile – Pfizer ............................................................................................................ 401

Table 200: Pfizer SWOT Analysis ................................................................................................................ 407

Table 201: Company Profile – Syndax Pharmaceuticals .............................................................................. 408

Table 202: Syndax Pharmaceuticals SWOT Analysis ................................................................................... 409

Table 203: Company Profile – Abbott Laboratories ...................................................................................... 410

Table 204: Abbott’s Key Product Areas ........................................................................................................ 411

Table 205: Abbott Laboratories SWOT Analysis, 2013 ................................................................................. 416

Table 206: Company Profile – Amoy Diagnostics ......................................................................................... 417

Table 207: Amoy Diagnostics SWOT Analysis, 2013 ................................................................................... 418

Table 208: Company Profile – Biogenex Laboratories .................................................................................. 419

Table 209: Biogenex Laboratories SWOT Analysis, 2013............................................................................. 420

Table 210: Company Profile – BioMérieux ................................................................................................... 421

Table 211: BioMérieux SWOT Analysis, 2013 .............................................................................................. 429

Table 212: Company Profile – Dako (Agilent Technologies) ......................................................................... 430

Table 213: Dako/Agilent Technologies SWOT Analysis ................................................................................ 435

Table 214: Company Profile – Illumina ......................................................................................................... 436

Table 215: Illumina Product Areas ............................................................................................................... 437


Table of Contents


Table 216: Illumina SWOT Analysis ............................................................................................................. 444

Table 217: Company Profile – Leica Biosystems (Danaher) ......................................................................... 445

Table 218: Leica Biosystems/Danaher SWOT Analysis ................................................................................ 451

Table 219: Company Profile – Life Technologies (Thermo Fisher Scientific) ................................................. 452

Table 220: Life Technologies SWOT Analysis .............................................................................................. 459

Table 221: Company Profile – MolecularMD ................................................................................................ 460

Table 222: MolecularMD SWOT Analysis .................................................................................................... 461

Table 223: Company Profile – Myriad Genetics............................................................................................ 462

Table 224: Myriad Genetics Major Product Areas ........................................................................................ 463

Table 225: Myriad Genetics SWOT Analysis ................................................................................................ 467

Table 226: Company Profile – Qiagen ......................................................................................................... 468

Table 227: Qiagen Major Product Areas ...................................................................................................... 469

Table 228: Qiagen SWOT Analysis .............................................................................................................. 474

Table 229: Company Profile – Roche Diagnostics ........................................................................................ 475

Table 230: Roche SWOT Analysis ............................................................................................................... 481

Table 231: Company Profile – Siemens Healthcare ..................................................................................... 482

Table 232: Siemens Healthcare SWOT Analysis .......................................................................................... 487

Table 233: Company Profile – Ventana Medical Systems ............................................................................ 488

Table 234: Ventana Medical Systems SWOT Analysis ................................................................................. 491

Table 235: Global Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011–2020 ........... 492

Table 236: Global Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011–2020...... 494

Table 237: Global Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011–2020 ................. 497

Table 238: Global Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011–2020 ..................... 499

Table 239: Global Sales Forecast for IHC and Molecular Tests ($m), 2011–2020 ........................................ 505


Table of Contents


Table 240: Major Events Affecting the Companion Diagnostic Test Market .................................................. 507

Table 241: Global Sales Forecast for Companion Diagnostic Tests ($m), 2011–2020 .................................. 508

Table 242: Sales Forecast for Companion Diagnostic Tests ($m) in the US, 2011–2020 .............................. 509

Table 243: Sales Forecast for Companion Diagnostic Tests ($m) in France, 2011–2020 .............................. 511

Table 244: Sales Forecast for Companion Diagnostic Tests ($m) in Germany, 2011–2020 .......................... 513

Table 245: Sales Forecast for Companion Diagnostic Tests ($m) in Italy, 2011–2020 .................................. 515

Table 246: Sales Forecast for Companion Diagnostic Tests ($m) in Spain, 2011–2020 ................................ 517

Table 247: Sales Forecast for Companion Diagnostic Tests ($m) in the UK, 2011–2020 .............................. 519

Table 248: Sales Forecast for Companion Diagnostic Tests ($m) in Japan, 2011–2020 ............................... 521

Table 249: Sales Forecast for Companion Diagnostic Tests ($m) in Brazil, 2011–2020 ................................ 523

Table 250: Sales Forecast for Companion Diagnostic Tests ($m) in China, 2011–2020................................ 525

Table 251: Sales Forecast for Companion Diagnostic Tests ($m) in India, 2011–2020 ................................. 528


Table of Contents


1.2 List of Figures

Figure 1: Genomic Sequencing Costs, 2001–2012......................................................................................... 32

Figure 2: Use of Proteomics in Personalized Medicine ................................................................................... 34

Figure 3: Incidence of Inherited Breast Cancer Mutations among Diagnosed Breast Cancer Patients ............. 36

Figure 4: Basic FISH Process ........................................................................................................................ 46

Figure 5: Basic PCR Process ......................................................................................................................... 48

Figure 6: Impact of Sample Storage on PCR Outcome................................................................................... 49

Figure 7: Genomic Sequencing Costs, 2001–2012......................................................................................... 51

Figure 8: Scientific and Economic Potential of Companion Diagnostics .......................................................... 55

Figure 9: Drug and Diagnostic Test Co-Development ..................................................................................... 56

Figure 10: Roche Lifecycle Algorithm for Co-Development of a Predictive Diagnostic ..................................... 57

Figure 11: Key Development Drivers for Companion Diagnostic Tests ........................................................... 59

Figure 12: Qiagen Model to Build a JAK2 Companion Diagnostic Tests Business .......................................... 61

Figure 13: Uptake of HER2 Testing among Invasive Breast Cancer Patients.................................................. 66

Figure 14: HER2 Testing in the US, 2011–2020 ............................................................................................. 68

Figure 15: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the US, 2011–2020 .......................... 70

Figure 16: Melanoma Companion Diagnostic Testing (BRAF) in the US, 2011–2020 ..................................... 72

Figure 17: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the US, 2011–2020 ............. 74

Figure 18: Breast Cancer Companion Diagnostic Testing (HER2) in France, 2011–2020 ............................... 79

Figure 19: KRAS Testing in France 2008–2012 ............................................................................................. 80

Figure 20: Colorectal Cancer Companion Diagnostic (KRAS) Testing in France, 2011–2020 ......................... 81

Figure 21: Melanoma Companion Diagnostic Testing (BRAF) in France, 2011–2020 ..................................... 82

Figure 22: EGFR Testing in France, 2008–2012 ............................................................................................ 83

Figure 23: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in France, 2011–2020 ............. 84


Table of Contents


Figure 24: Breast Cancer Companion Diagnostic Testing (HER2) in Germany, 2011–2020 ............................ 86

Figure 25: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Germany, 2011–2020 ...................... 87

Figure 26: Melanoma Companion Diagnostic Testing (BRAF) in Germany, 2011–2020 .................................. 89

Figure 27: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Germany, 2011–2020 ......... 91

Figure 28: Treatment Index: Italy versus Rest of EU in Use of Herceptin per Head of Population, 2002 .......... 92

Figure 29: Percentage of All Breast Cancer Patients Tested for HER2, Italy versus Rest of EU, 2002 ............ 93

Figure 30: Breast Cancer Companion Diagnostic Testing (HER2) in Italy, 2011–2020 .................................... 94

Figure 31: Methods Used for KRAS Genotyping by the Centers Participating in the Italian Quality Assessment

Scheme....................................................................................................................................... 95

Figure 32: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Italy, 2011–2020 .............................. 96

Figure 33: Melanoma Companion Diagnostic Testing (BRAF) in Italy, 2011–2020 .......................................... 97

Figure 34: Methods Used for EGFR Genotyping by the Centers Participating in the Italian Quality Assessment

Scheme in 2013 .......................................................................................................................... 98

Figure 35: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Italy, 2011–2020 ................. 99

Figure 36: Breast Cancer Companion Diagnostic Testing (HER2) in Spain, 2011–2020 ............................... 101

Figure 37: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Spain, 2011–2020 ......................... 102

Figure 38: Melanoma Companion Diagnostic Testing (BRAF) in Spain, 2011–2020 ..................................... 104

Figure 39: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Spain, 2011–2020 ............. 105

Figure 40: UK HER2 Status Testing Algorithm ............................................................................................. 107

Figure 41: Breast Cancer Companion Diagnostic Testing (HER2) in the UK, 2011–2020 ............................. 108

Figure 42: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the UK, 2011–2020 ........................ 111

Figure 43: Melanoma Companion Diagnostic Testing (BRAF) in the UK, 2011–2020 ................................... 113

Figure 44: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the UK, 2011–2020 ........... 119

Figure 45: Breast Cancer Companion Diagnostic Testing (HER2) in Japan, 2011–2020 ............................... 121

Figure 46: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Japan, 2011–2020 ......................... 123


Table of Contents


Figure 47: Melanoma Companion Diagnostic Testing (BRAF) in Japan, 2011–2020..................................... 124

Figure 48: EGFR Testing in Japan, 2006–2011............................................................................................ 125

Figure 49: Japanese Lung Cancer Society Diagnostic Testing Algorithm...................................................... 127

Figure 50: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Japan, 2011–2020 ............ 128

Figure 51: Breast Cancer Companion Diagnostic Testing (HER2) in Brazil, 2011–2020 ............................... 130

Figure 52: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Brazil, 2011–2020.......................... 131

Figure 53: Melanoma Companion Diagnostic Testing (BRAF) in Brazil, 2011–2020 ..................................... 132

Figure 54: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Brazil, 2011–2020 ............. 134

Figure 55: Breast Cancer Companion Diagnostic Testing (HER2) in China, 2011–2020 ............................... 137

Figure 56: Colorectal Cancer Companion Diagnostic (KRAS) Testing in China, 2011–2020 ......................... 139

Figure 57: Melanoma Companion Diagnostic Testing (BRAF) in China, 2011–2020 ..................................... 140

Figure 58: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in China, 2011–2020 ............ 142

Figure 59: Breast Cancer Companion Diagnostic Testing (HER2) in India, 2011–2020................................. 144

Figure 60: Colorectal Cancer Companion Diagnostic (KRAS) Testing in India, 2011–2020 ........................... 146

Figure 61: Melanoma Companion Diagnostic Testing (BRAF) in India, 2011–2020 ...................................... 147

Figure 62: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in India, 2011–2020 .............. 149

Figure 63: EU Medical Device Approval and Post-Market Surveillance Process ........................................... 157

Figure 64: Healthcare Coverage Frameworks .............................................................................................. 178

Figure 65: German Reimbursement Establishment Process ......................................................................... 185

Figure 66: Increase in EGFR Testing at AstraZeneca-Funded Test Centers in the UK ................................. 190

Figure 67: UK Regional Access to Cancer Diagnostic Testing ...................................................................... 192

Figure 68: Registration of Domestic and Imported Medical Devices in China ................................................ 194

Figure 69: Multiple Partnerships in Companion Diagnostics during 2013–2014 ............................................ 205

Figure 70: Building a Companion Diagnostics Business: Forming Multiple Partnerships ............................... 206


Table of Contents


Figure 71: Increasing Medicare Cost of Treatment ....................................................................................... 210

Figure 72: Growth of Drug Therapy Expenditure in France, 2004–2009 ....................................................... 211

Figure 73: Share of Targeted Therapies of Anti-Cancer Drug Costs in France .............................................. 212

Figure 74: Increase in Approvals of Biologic (Targeted) Therapies ............................................................... 218

Figure 75: EGFR PharmDx Test Adoption Curve ......................................................................................... 263

Figure 76: Probe Arrangement in the Vysis ALK Break Apart FISH Probe Kit ............................................... 274

Figure 77: Scorpion Primers ........................................................................................................................ 280

Figure 78: Increase in High- and Moderate-Complexity Molecular Tests....................................................... 283

Figure 79: Reasons for Companion Diagnostic Test Failure ......................................................................... 295

Figure 80: Female Breast Cancer Treatment Patterns by Stage, 2008 ......................................................... 298

Figure 81: Colon Cancer Treatment Patterns by Stage, 2008 ....................................................................... 299

Figure 82: Lung Cancer Treatment Patterns by Stage, 2008 ........................................................................ 300

Figure 83: Expected Companion Diagnostic Test Pipeline, US Approvals, 2014–2019 ................................. 307

Figure 84: Sponsors of Clinical Trials for Targeted Cancer Therapies .......................................................... 348

Figure 85: Sponsors of Clinical Trials for Targeted Cancer Therapies Based on Mutational Status ............... 349

Figure 86: Sponsors of Clinical Trials for Targeted Cancer Therapies, by Phase .......................................... 350

Figure 87: Global Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011–2020 ............ 492

Figure 88: Global Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011–2020 ...... 494

Figure 89: Global Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011–2020 .................. 497

Figure 90: Global Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011–2020 ...................... 499

Figure 91: Uptake in ALK Mutation IHC and FISH Testing in France, 2011–2020 ......................................... 501

Figure 92: Uptake of ALK Mutation IHC and FISH Testing in Germany 2011–2020 ...................................... 502

Figure 93: Global Sales Forecast for IHC and Molecular Tests ($m), 2011–2020 ......................................... 505

Figure 94: Global Market Share of Molecular Tests and Immunohistochemistry Tests in 2012 and 2020 ...... 506


Table of Contents


Figure 95: Global Sales Forecast for Companion Diagnostic Tests ($m), 2011–2020 ................................... 508

Figure 96: Sales Forecast for Companion Diagnostic Tests ($m) in the US, 2011–2020 ............................... 509

Figure 97: Sales Forecast for Companion Diagnostic Tests ($m) in France, 2011–2020............................... 511

Figure 98: Sales Forecast for Companion Diagnostic Tests ($m) in Germany, 2011–2020 ........................... 513

Figure 99: Sales Forecast for Companion Diagnostic Tests ($m) in Italy, 2011–2020 ................................... 515

Figure 100: Sales Forecast for Companion Diagnostic Tests ($m) in Spain, 2011–2020............................... 517

Figure 101: Sales Forecast for Companion Diagnostic Tests ($m) in the UK, 2011–2020 ............................. 518

Figure 102: Sales Forecast for Companion Diagnostic Tests ($m) in Japan, 2011–2020 .............................. 521

Figure 103: Sales Forecast for Companion Diagnostic Tests ($m) in Brazil, 2011–2020 ............................... 523

Figure 104: Sales Forecast for Companion Diagnostic Tests ($m) in China, 2011–2020 .............................. 525

Figure 105: Sales Forecast for Companion Diagnostic Tests ($m) in India, 2011–2020 ................................ 528



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, 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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