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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.
COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
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.
Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts 3 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
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
Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts 4 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
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
Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts 5 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
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
Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts 6 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
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
Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts 7 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
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
Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts 8 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
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
Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts 9 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
3.13.7 Barrier: Lack of Patient Awareness about Companion Diagnostic Tests...................... 224
3.13.8 Barrier: Physician Resistance to New Companion Diagnostic Tests ............................ 225
4 Competitive Assessment ........................................................................................................ 227
4.1 Overview ......................................................................................................................... 227
4.2 Techniques in Use by Currently Marketed Products ........................................................ 227
4.2.1 Immunohistochemistry ................................................................................................ 227
4.2.2 Fluorescence In Situ Hybridization .............................................................................. 227
4.2.3 Polymerase Chain Reaction ........................................................................................ 228
4.3 Competitive Analysis ....................................................................................................... 228
4.3.1 Breast Cancer Companion Diagnostic Tests ............................................................... 228
4.3.2 Colorectal Cancer Companion Diagnostic Tests ......................................................... 257
4.3.3 Melanoma Companion Diagnostic Tests ..................................................................... 267
4.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests ......................................... 273
5 Unmet Needs .......................................................................................................................... 290
5.1 Need for Improved Cancer Treatments ........................................................................... 290
5.2 Need for Objective Tests ................................................................................................. 290
5.3 Need for High-Throughput Tests ..................................................................................... 292
5.4 Certainty of Reimbursement............................................................................................ 293
5.5 Amount and Type of Tissue Needed for Test .................................................................. 294
5.6 Who Should be Tested? .................................................................................................. 297
5.7 Test Accuracy ................................................................................................................. 302
5.8 Increasing Test Complexity and Increased Process Failure ............................................ 305
6 Pipeline Products .................................................................................................................... 306
6.1 Overview ......................................................................................................................... 306
6.2 Pipeline by Phase of Development.................................................................................. 308
6.3 Pipeline Product Profiles ................................................................................................. 310
6.3.1 Breast Cancer Companion Diagnostic Tests ............................................................... 310
Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts 10 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
6.3.2 Colorectal Cancer Companion Diagnostic Tests ......................................................... 318
6.3.3 Melanoma Companion Diagnostic Tests ..................................................................... 324
6.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests ......................................... 331
7 Clinical Trials to Watch ........................................................................................................... 347
7.1 Overview ......................................................................................................................... 347
7.2 Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies ........................................................................................................................ 351
8 Current and Future Players ..................................................................................................... 352
8.1 Trends in Corporate Strategy .......................................................................................... 352
8.1.1 Companion Diagnostics Business Models ................................................................... 352
8.2 Company Profiles ............................................................................................................ 353
8.2.1 Pharmaceutical/Therapy Companies Developing Companion Diagnostic Tests .......... 353
8.2.2 Diagnostics Companies Developing Companion Diagnostic Tests (in Partnership with Pharmaceutical Companies)....................................................................................... 409
9 Market Outlooks...................................................................................................................... 492
9.1 By Market Segment......................................................................................................... 492
9.1.1 Breast Cancer Companion Diagnostic Tests ............................................................... 492
9.1.2 Colorectal Cancer Companion Diagnostic Tests ......................................................... 493
9.1.3 Melanoma Companion Diagnostic Tests ..................................................................... 496
9.1.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests ......................................... 498
9.1.5 Technique ................................................................................................................... 504
9.2 By Geography ................................................................................................................. 507
9.2.1 10 Major Markets Overview ......................................................................................... 507
9.2.2 US ............................................................................................................................... 509
9.2.3 France ......................................................................................................................... 510
9.2.4 Germany ..................................................................................................................... 512
9.2.5 Italy ............................................................................................................................. 514
9.2.6 Spain ........................................................................................................................... 516
Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts 11 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
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
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
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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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
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
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
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
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
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
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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
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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
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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
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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
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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
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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
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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
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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
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Figure 95: Global Sales Forecast for Companion Diagnostic Tests ($m), 2011–2020 ................................... 508
Figure 96: Sales Forecast for Companion Diagnostic Tests ($m) in the US, 2011–2020 ............................... 509
Figure 97: Sales Forecast for Companion Diagnostic Tests ($m) in France, 2011–2020............................... 511
Figure 98: Sales Forecast for Companion Diagnostic Tests ($m) in Germany, 2011–2020 ........................... 513
Figure 99: Sales Forecast for Companion Diagnostic Tests ($m) in Italy, 2011–2020 ................................... 515
Figure 100: Sales Forecast for Companion Diagnostic Tests ($m) in Spain, 2011–2020............................... 517
Figure 101: Sales Forecast for Companion Diagnostic Tests ($m) in the UK, 2011–2020 ............................. 518
Figure 102: Sales Forecast for Companion Diagnostic Tests ($m) in Japan, 2011–2020 .............................. 521
Figure 103: Sales Forecast for Companion Diagnostic Tests ($m) in Brazil, 2011–2020 ............................... 523
Figure 104: Sales Forecast for Companion Diagnostic Tests ($m) in China, 2011–2020 .............................. 525
Figure 105: Sales Forecast for Companion Diagnostic Tests ($m) in India, 2011–2020 ................................ 528
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
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.
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - GLOBAL ANALYSIS AND MARKET FORECASTS
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
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Appendix
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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.