REFERENCE CODE GDME1103CFR | PUBLICAT ION DATE MAY 2014
COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC ANALYSIS AND MARKET FORECASTS
Companion Diagnostic Tests in Oncology - APAC Analysis and Market Forecasts 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC ANALYSIS AND MARKET FORECASTS
Executive Summary
Companion Diagnostic Tests: Key Metrics in APAC Major Device Markets Number of companion diagnostic tests performed in 2014 1,818,299
Number of breast cancer companion diagnostic tests in 2014 (IHC) 889,353
Number of colorectal cancer (CRC) companion diagnostic tests in 2014 294,031
Number of melanoma companion diagnostic tests in 2014 32,740
Number of non-small cell lung cancer companion diagnostic tests in 2014 602,174
2014 Companion Diagnostic Test Market Sales
APAC $45,276,324
Pipeline Assessment
Number of early development tests 6
Number of early clinical devices 12
Number of late clinical devices 8
Key Events (2014–2020)
Completion of NCT01479244 Phase III trial for Neuvax ↑↑↑↑
Completion of NCT00455572 Phase I trial for GSK1572932A ↑
Completion of NCT01740427 Phase III trial for palbociclib ↑↑↑
Completion of NCT02052128 Phase I trial for onapristone ↑↑↑
Completion of NCT01308294 Phase I/II trial ↑↑
2020 Market Sales
APAC $80,558,751
Source: GlobalData. APAC (Asia-Pacific) = Japan, China, and India; IHC = immunohistochemistry
Market Domination by Non-Small Cell Lung Cancer Companion Diagnostic Tests
The major feature of the APAC companion
diagnostic testing market is the current domination
of tests for mutations important in the prognosis
and diagnosis of non-small cell lung cancer
(NSCLC), with the two market leaders being Roche
and Qiagen. According to GlobalData’s forecast, in
2014, NSCLC companion diagnostic tests account
for 51% of the APAC market by value. While more
human epidermal growth factor receptor 2 (HER2)
tests are carried out, because the NSCLC tests
have been principally more expensive molecular
tests, rather than the cheaper
immunohistochemistry (IHC) test that typifies
HER2 testing, the value of the NSCLC market is
considerably higher.
Companion Diagnostic Test Market APAC Revenue, 2014
Japan69%
China24%
India7%
Source: GlobalData. APAC = Japan, China, and India.
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC 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
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC 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
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC 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
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Table of Contents
COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC ANALYSIS AND MARKET FORECASTS
1 Table of Contents
1 Table of Contents ....................................................................................................................... 6
1.1 List of Tables .................................................................................................................... 11
1.2 List of Figures ................................................................................................................... 19
2 Introduction ............................................................................................................................... 22
2.1 Catalyst ............................................................................................................................. 22
2.2 Related Reports ................................................................................................................ 23
3 Industry Overview ..................................................................................................................... 24
3.1 Emergence of Companion Diagnostics ............................................................................. 24
3.1.1 Definition of Companion Diagnostics ............................................................................. 24
3.1.2 Changing Face of Medicine ........................................................................................... 25
3.1.3 Definitions of Companion and Personalized Diagnostics ............................................... 27
3.2 Disease Applications ......................................................................................................... 29
3.2.1 Breast Cancer ............................................................................................................... 29
3.2.2 Colorectal Cancer ......................................................................................................... 32
3.2.3 Melanoma ..................................................................................................................... 34
3.2.4 Non-Small Cell Lung Cancer ......................................................................................... 35
3.3 Companion Diagnostics Technologies .............................................................................. 37
3.3.1 Immunochemical Techniques ........................................................................................ 37
3.3.2 Nucleic Acid Testing ...................................................................................................... 39
3.3.3 Emerging Technologies ................................................................................................. 46
3.4 Companion Diagnostics Development .............................................................................. 48
3.4.1 Economic Value of a Companion Diagnostic ................................................................. 48
3.4.2 When to Develop a Companion Diagnostic Test ........................................................... 49
3.4.3 Strategy......................................................................................................................... 52
3.4.4 Selection of Partner ....................................................................................................... 53
3.4.5 Biomarker Discovery ..................................................................................................... 55
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC ANALYSIS AND MARKET FORECASTS
3.5 Clinical Outcomes ............................................................................................................. 55
3.5.1 Role of Companion Diagnostics in Disease Treatment .................................................. 55
3.5.2 Companion Diagnostic Test Applications ...................................................................... 56
3.6 Testing Trends .................................................................................................................. 57
3.6.1 Japan ............................................................................................................................ 57
3.6.2 China ............................................................................................................................ 65
3.6.3 India .............................................................................................................................. 73
3.7 Market Access .................................................................................................................. 81
3.7.1 Overview ....................................................................................................................... 81
3.7.2 Japan ............................................................................................................................ 81
3.7.3 China ............................................................................................................................ 83
3.7.4 India .............................................................................................................................. 85
3.8 Regulatory Issues and Recalls .......................................................................................... 87
3.8.1 Dako FDA Warning Letter ............................................................................................. 87
3.8.2 HercepTest Recall ......................................................................................................... 87
3.8.3 Cobas KRAS Test Recall .............................................................................................. 88
3.8.4 Cobas BRF V600E Test Recall ..................................................................................... 88
3.8.5 Leica Bond HER2 IHC System ...................................................................................... 88
3.9 Reimbursement of Companion Diagnostic Tests ............................................................... 88
3.9.1 Japan ............................................................................................................................ 88
3.9.2 China ............................................................................................................................ 89
3.9.3 India .............................................................................................................................. 91
3.10 M&A, Key Partnerships ..................................................................................................... 93
3.10.1 Significant Mergers and Acquisitions ............................................................................. 95
3.10.2 Recent Partnerships ...................................................................................................... 95
3.11 Economic Impact ............................................................................................................ 101
3.11.1 Cost Effectiveness of Companion Diagnostics ............................................................ 101
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3.11.2 Cost Effectiveness of Companion Diagnostics: Healthcare Provider Perspective ........ 102
3.12 Market Drivers................................................................................................................. 108
3.12.1 Driver: Increasing Healthcare Pressures ..................................................................... 108
3.12.2 Driver: Adverse Economic Pressures .......................................................................... 109
3.12.3 Driver: Availability of New Technologies ...................................................................... 109
3.12.4 Driver: FDA Regulatory Changes ................................................................................ 110
3.12.5 Driver: Need to Improve Drug Development Processes .............................................. 110
3.12.6 Driver: Increasing Cancer Incidence ............................................................................ 111
3.12.7 Driver: Accelerating Demand for Targeted Therapies .................................................. 111
3.13 Market Barriers ............................................................................................................... 112
3.13.1 Barrier: Reimbursement Difficulties ............................................................................. 112
3.13.2 Barrier: Loss of Indication ............................................................................................ 113
3.13.3 Barrier: Emergence of Biosimilar Therapies ................................................................ 114
3.13.4 Barrier: Competition with Laboratory-Developed Tests ................................................ 114
3.13.5 Barrier: Emergence of Next-Generation Gene Sequencing ......................................... 115
3.13.6 Barrier: Lack of Laboratory Choice in Instrument Selection ......................................... 116
3.13.7 Barrier: Lack of Patient Awareness about Companion Diagnostic Tests...................... 118
3.13.8 Barrier: Physician Resistance to New Companion Diagnostic Tests ............................ 118
4 Competitive Assessment ........................................................................................................ 120
4.1 Overview ......................................................................................................................... 120
4.2 Techniques in Use by Currently Marketed Products ........................................................ 120
4.2.1 Immunohistochemistry ................................................................................................ 120
4.2.2 Fluorescence In Situ Hybridization .............................................................................. 120
4.2.3 Polymerase Chain Reaction ........................................................................................ 121
4.3 Competitive Analysis ....................................................................................................... 121
4.3.1 Breast Cancer Companion Diagnostic Tests ............................................................... 121
4.3.2 Colorectal Cancer Companion Diagnostic Tests ......................................................... 150
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC ANALYSIS AND MARKET FORECASTS
4.3.3 Melanoma Companion Diagnostic Tests ..................................................................... 159
4.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests ......................................... 165
5 Unmet Needs .......................................................................................................................... 182
5.1 Need for Improved Cancer Treatments ........................................................................... 182
5.2 Need for Objective Tests ................................................................................................. 182
5.3 Need for High-Throughput Tests ..................................................................................... 184
5.4 Certainty of Reimbursement............................................................................................ 185
5.5 Amount and Type of Tissue Needed for Test .................................................................. 186
5.6 Who Should be Tested? .................................................................................................. 189
5.7 Test Accuracy ................................................................................................................. 194
5.8 Increasing Test Complexity and Increased Process Failure ............................................ 196
6 Pipeline Products .................................................................................................................... 198
6.1 Overview ......................................................................................................................... 198
6.2 Pipeline by Phase of Development.................................................................................. 200
6.3 Pipeline Product Profiles ................................................................................................. 201
6.3.1 Breast Cancer Companion Diagnostic Tests ............................................................... 201
6.3.2 Colorectal Cancer Companion Diagnostic Tests ......................................................... 209
6.3.3 Melanoma Companion Diagnostic Tests ..................................................................... 215
6.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests ......................................... 222
7 Clinical Trials to Watch ........................................................................................................... 237
7.1 Overview ......................................................................................................................... 237
7.2 Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies ........................................................................................................................ 241
8 Current and Future Players ..................................................................................................... 242
8.1 Trends in Corporate Strategy .......................................................................................... 242
8.1.1 Companion Diagnostics Business Models ................................................................... 242
8.2 Company Profiles ............................................................................................................ 243
8.2.1 Pharmaceutical/Therapy Companies Developing Companion Diagnostic Tests .......... 243
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8.2.2 Diagnostics Companies Developing Companion Diagnostic Tests (in Partnership with Pharmaceutical Companies)....................................................................................... 297
9 Market Outlooks...................................................................................................................... 379
9.1 By Market Segment......................................................................................................... 379
9.1.1 Breast Cancer Companion Diagnostic Tests ............................................................... 379
9.1.2 Colorectal Cancer Companion Diagnostic Tests ......................................................... 380
9.1.3 Melanoma Companion Diagnostic Tests ..................................................................... 382
9.1.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests ......................................... 384
9.1.5 Technique ................................................................................................................... 386
9.2 By Geography ................................................................................................................. 389
9.2.1 10 Major Markets Overview ......................................................................................... 389
9.2.2 Japan .......................................................................................................................... 389
9.2.3 China .......................................................................................................................... 392
9.2.4 India ............................................................................................................................ 394
10 Appendix................................................................................................................................. 397
10.1 Bibliography .................................................................................................................... 397
10.2 Abbreviations .................................................................................................................. 436
10.3 Report Methodology ........................................................................................................ 438
10.3.1 Coverage .................................................................................................................... 438
10.3.2 Secondary Research ................................................................................................... 439
10.3.3 Forecasting Methodology ............................................................................................ 439
10.4 Physicians Included in this Study .................................................................................... 441
10.5 About the Authors ........................................................................................................... 443
10.5.1 Andrew Thompson, Ph.D., Senior Analyst, In Vitro Diagnostics .................................. 443
10.5.2 Derek Archila, MBA, Lead Analyst, Medical Devices ................................................... 443
10.5.3 Bonnie Bain, PhD, Global Head of Healthcare ............................................................ 444
10.6 Disclaimer ....................................................................................................................... 445
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC ANALYSIS AND MARKET FORECASTS
1.1 List of Tables
Table 1: Possible Companion Diagnostic Test Platforms ................................................................................ 24
Table 2: Specific Breast Cancer Types Associated with Inherited Disorders ................................................... 31
Table 3: Specific Mutations Associated with Non-Small Cell Lung Cancer ...................................................... 37
Table 4: Weaknesses of ELISA Technique .................................................................................................... 38
Table 5: Key Stages of PCR Gene Test ......................................................................................................... 41
Table 6: Key Principles Guiding Companion Diagnostic Test Development .................................................... 52
Table 7: Companion Diagnostic Test Development Partner Selection ............................................................ 53
Table 8: Biomarker Discovery ........................................................................................................................ 55
Table 9: Disease Diagnosis, Treatment, and Monitoring ................................................................................. 55
Table 10: Application of Companion Diagnostic Tests .................................................................................... 56
Table 11: Major Biomarkers currently measured in Cancer Companion Diagnostic Tests ............................... 57
Table 12: HER2 Testing for Breast Cancer Patients in Japan ......................................................................... 58
Table 13: Breast Cancer Companion Diagnostic Testing (HER2) in Japan, 2011–2020 .................................. 59
Table 14: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Japan, 2011–2020 ............................ 60
Table 15: Melanoma Companion Diagnostic Testing (BRAF) in Japan, 2011–2020 ........................................ 61
Table 16: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Japan, 2011–2020 ............... 65
Table 17: Breast Cancer Companion Diagnostic Testing (HER2) in China, 2011–2020 .................................. 68
Table 18: Colorectal Cancer Companion Diagnostic (KRAS) Testing in China, 2011–2020 ............................ 69
Table 19: Melanoma Companion Diagnostic Testing (BRAF) in China, 2011–2020 ........................................ 71
Table 20: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in China, 2011–2020 ................ 73
Table 21: Breast Cancer Companion Diagnostic Testing (HER2) in India, 2011–2020 .................................... 75
Table 22: Colorectal Cancer Companion Diagnostic (KRAS) Testing in India, 2011–2020 .............................. 77
Table 23: Melanoma Companion Diagnostic Testing (BRAF) in India, 2011–2020 .......................................... 78
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC ANALYSIS AND MARKET FORECASTS
Table 24: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in India, 2011–2020 ................. 80
Table 25: Healthcare Systems in China ......................................................................................................... 84
Table 26: Healthcare Principles in China ........................................................................................................ 85
Table 27: Tariffs for Companion Diagnostic and Related Tests at the Tata Memorial Hospital ........................ 93
Table 28: Key Mergers and Acquisitions during 2013–2014 ........................................................................... 95
Table 29: Partnerships during 2013–2014 ...................................................................................................... 96
Table 30: Impact of Companion Diagnostics on Cancer Treatment Costs in France ..................................... 107
Table 31: Effectiveness of Disease Therapies .............................................................................................. 108
Table 32: HER2 FISH/iQFISH PharmDx Product Profile .............................................................................. 121
Table 33: Common Reasons for HER2 FISH Failure .................................................................................... 123
Table 34: HER2 FISH PharmDx/HER2 iQFISH PharmDx SWOT Analysis ................................................... 125
Table 35: HercepTest Product Profile .......................................................................................................... 125
Table 36: HercepTest Scoring Algorithm ...................................................................................................... 126
Table 37: HercepTest SWOT Analysis ......................................................................................................... 128
Table 38: HER2 CISH PharmDx Product Profile .......................................................................................... 129
Table 39: HER2 CISH PharmDx SWOT Analysis ......................................................................................... 131
Table 40: SPOT-Light HER2 CISH Kit Product Profile .................................................................................. 132
Table 41: SPOT-Light HER2 CISH Kit SWOT Analysis ................................................................................ 134
Table 42: Leica Bond Oracle HER2 IHC System Product Profile .................................................................. 134
Table 43: Leica Bond Oracle HER2 IHC System Test Algorithm................................................................... 135
Table 44: Leica Bond Oracle HER2 IHC System SWOT Analysis................................................................. 137
Table 45: Biogenex INSITE HER2/Neu Product Profile ................................................................................ 138
Table 46: Biogenex INSITE HER2/Neu SWOT Analysis ............................................................................... 140
Table 47: Abbott Pathvysion HER-2 DNA Probe Kit Product Profile ............................................................. 140
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC ANALYSIS AND MARKET FORECASTS
Table 48: Abbott Pathvysion HER-2 DNA Probe Kit SWOT Analysis ............................................................ 142
Table 49: Ventana INFORM HER2 Dual ISH Assay Product Profile ............................................................. 143
Table 50: Ventana INFORM HER2 Dual ISH Assay SWOT Analysis ............................................................ 145
Table 51: Pathway HER2/Neu IHC Product Profile....................................................................................... 145
Table 52: Pathway HER2/Neu IHC SWOT Analysis ..................................................................................... 148
Table 53: HerMark Product Profile ............................................................................................................... 149
Table 54: HerMark SWOT Analysis.............................................................................................................. 150
Table 55: Therascreen KRAS RGQ Product Profile ...................................................................................... 150
Table 56: Therascreen KRAS RGQ SWOT Analysis .................................................................................... 153
Table 57: Cobas KRAS Mutation Test Product Profile .................................................................................. 153
Table 58: Cobas KRAS Mutation Test SWOT Analysis ................................................................................ 154
Table 59: EGFR PharmDx Kit Product Profile .............................................................................................. 155
Table 60: EGFR PharmDx Kit SWOT Analysis ............................................................................................. 159
Table 61: THxID BRAF Product Profile ........................................................................................................ 159
Table 62: Effect of Melanin on the THxID BRAF PCR Test........................................................................... 161
Table 63: THxID BRAF SWOT Analysis ....................................................................................................... 162
Table 64: Cobas 4800 BRAF V600 Mutation Test – Melanoma Product Profile ............................................ 163
Table 65: Interpretation of Cobas BRAF V600 Mutation Test – Melanoma ................................................... 164
Table 66: Cobas 4800 BRAF V600 Mutation Test – Melanoma SWOT Analysis ........................................... 165
Table 67: Vysis ALK Break Apart FISH Probe Kit Product Profile ................................................................. 166
Table 68: Abbott Vysis ALK Break Apart FISH Probe Kit SWOT Analysis..................................................... 168
Table 69: Amoy-Dx EML4-ALK Fusion Gene Detection Kit Product Profile ................................................... 168
Table 70: Amoy-Dx EML4-ALK Fusion Gene Detection Kit SWOT Analysis ................................................. 170
Table 71: Therascreen EGFR RGQ PCR Kit Product Profile ........................................................................ 170
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC ANALYSIS AND MARKET FORECASTS
Table 72: Therascreen EGFR RGQ PCR Kit SWOT Analysis....................................................................... 175
Table 73: ALK IHC Test Product Profile ....................................................................................................... 176
Table 74: ALK IHC Test SWOT Analysis ...................................................................................................... 178
Table 75: Cobas EGFR Mutation Test Product Profile .................................................................................. 179
Table 76: Cobas EGFR Mutation Test SWOT Analysis ................................................................................ 181
Table 77: Companion Diagnostic Tests Pipeline, 2014 ................................................................................. 200
Table 78: Neuvax Companion Diagnostic Assay Product Profile .................................................................. 202
Table 79: Neuvax Companion Diagnostic Assay Product SWOT Analysis .................................................... 202
Table 80: Companion Diagnostic Test – Palbociclib Product Profile ............................................................. 203
Table 81: Companion Diagnostic Test – Palbociclib SWOT Analysis ............................................................ 204
Table 82: Companion Diagnostic Test – Breast Cancer Product Profile ........................................................ 205
Table 83: Companion Diagnostic Test – Breast Cancer SWOT Analysis ...................................................... 205
Table 84: Onapristone Companion Diagnostic Assay Product Profile ........................................................... 206
Table 85: Onapristone Companion Diagnostic Assay SWOT Analysis ......................................................... 207
Table 86: Aromatase Inhibitor Biomarker – Companion Diagnostic Test Product Profile ............................... 208
Table 87: Aromatase Inhibitor Biomarker – Companion Diagnostic Test SWOT Analysis ............................. 208
Table 88: BRAF Companion Diagnostic Assay – Colon Cancer Product Profile ............................................ 209
Table 89: BRAF Companion Diagnostic Assay – Colon Cancer SWOT Analysis .......................................... 210
Table 90: KRAS Companion Diagnostic Assay – Colon Cancer Product Profile............................................ 211
Table 91: KRAS Companion Diagnostic Assay – Colon Cancer SWOT Analysis .......................................... 211
Table 92: PIK3CA Companion Diagnostic Assay – Colorectal Cancer Product Profile .................................. 212
Table 93: PIK3CA Companion Diagnostic Assay – Colorectal Cancer SWOT Analysis................................. 213
Table 94: Vectibix Companion Diagnostic Product Profile ............................................................................ 214
Table 95: Vectibix Companion Diagnostic SWOT Analysis ........................................................................... 215
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Table 96: MAGE-A3 Companion Skin Cancer Assay Product Profile ............................................................ 216
Table 97: MAGE-A3 Companion Skin Cancer Assay SWOT Analysis .......................................................... 216
Table 98: GNAQ/GNA11 Companion Diagnostic Assays – Melanoma Product Profile .................................. 217
Table 99: GNAQ/GNA11 Companion Diagnostic Assays – Melanoma SWOT Analysis ................................ 218
Table 100: Companion Diagnostic Test – Melanoma Cancer Product Profile................................................ 219
Table 101: Companion Diagnostic Test – Melanoma Cancer SWOT Analysis .............................................. 219
Table 102: KRAS Companion Diagnostic Assay – Melanoma Product Profile ............................................... 220
Table 103: KRAS Companion Diagnostic Assay – Melanoma SWOT Analysis ............................................. 221
Table 104: Companion Diagnostic Test – Melanoma Product Profile ............................................................ 222
Table 105: Companion Diagnostic Test – Melanoma SWOT Analysis .......................................................... 222
Table 106: BRAF Companion Diagnostic Assay – Lung Cancer Product Profile ........................................... 223
Table 107: BRAF Companion Diagnostic Assay – Lung Cancer SWOT Analysis .......................................... 223
Table 108: KRAS Companion Diagnostic Assay – Lung Cancer Product Profile ........................................... 224
Table 109: KRAS Companion Diagnostic Assay – Lung Cancer SWOT Analysis ......................................... 224
Table 110: MET Companion Diagnostic Assay – Lung Cancer Product Profile ............................................. 225
Table 111: MET Companion Diagnostic Assay – Lung Cancer SWOT Analysis ........................................... 226
Table 112: PIK3CA Companion Diagnostic Assay – Lung Cancer Product Profile ........................................ 227
Table 113: PIK3CA Companion Diagnostic Assay – Lung Cancer SWOT Analysis....................................... 227
Table 114: Companion Diagnostic Device – Lung Cancer Product Profile .................................................... 228
Table 115: Companion Diagnostic Device – Lung Cancer SWOT Analysis ................................................... 229
Table 116: Companion Diagnostic Test – Crizotinib Product Profile ............................................................. 230
Table 117: Companion Diagnostic Test – Crizotinib SWOT Analysis ............................................................ 230
Table 118: Companion Diagnostic Test – Dacomitinib Product Profile .......................................................... 231
Table 119: Companion Diagnostic Test – Dacomitinib SWOT Analysis ........................................................ 231
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Table 120: T790M Mutation Companion Diagnostic Test Product Profile ...................................................... 232
Table 121: T790M Mutation Companion Diagnostic Test SWOT Analysis .................................................... 232
Table 122: Entinostat Companion Diagnostic Assay Product Profile ............................................................. 233
Table 123: Entinostat Companion Diagnostic Assay SWOT Analysis ........................................................... 234
Table 124: MUC1 Expression Companion Diagnostic Test Product Profile ................................................... 235
Table 125: MUC1 Expression Companion Diagnostic Test SWOT Analysis ................................................. 235
Table 126: Companion Diagnostic Assay – NSCLC Product Profile ............................................................. 236
Table 127: Companion Diagnostic Assay – NSCLC SWOT Analysis ............................................................ 236
Table 128: Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug
Therapies. ................................................................................................................................. 241
Table 129: Company Profile – Amgen .......................................................................................................... 244
Table 130: Amgen’s Key Products ............................................................................................................... 244
Table 131: Selected Amgen Anti-Cancer Therapies Currently in Clinical Trials ............................................. 245
Table 132: Amgen SWOT Analysis .............................................................................................................. 250
Table 133: Company Profile – Arno Therapeutics ........................................................................................ 251
Table 134: Selected Arno Therapeutics Anti-Cancer Therapies Currently in Clinical Trials ........................... 251
Table 135: Arno Therapeutics SWOT Analysis............................................................................................. 255
Table 136: Company Profile – AstraZeneca ................................................................................................. 256
Table 137: Key Events in the Development of AstraZeneca’s Drug Portfolio Since 2011 .............................. 258
Table 138: Key Project Terminations by AstraZeneca Since 2008 ................................................................ 260
Table 139: AstraZeneca SWOT Analysis ..................................................................................................... 264
Table 140: Company Profile – Bristol-Myers Squibb ..................................................................................... 265
Table 141: Recent Key Product Approvals from Bristol-Myers Squibb .......................................................... 268
Table 142: Recent Key BMS Partnerships and Agreements ......................................................................... 269
Table 143: Bristol-Myers Squibb SWOT Analysis ......................................................................................... 270
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Table 144: Company Profile – Clovis Oncology............................................................................................ 271
Table 145: Clovis Oncology’s Key Products ................................................................................................. 272
Table 146: Clovis Oncology SWOT Analysis ................................................................................................ 276
Table 147: Company Profile – Eli Lilly and Company ................................................................................... 277
Table 148: Eli Lilly and Company SWOT Analysis........................................................................................ 283
Table 149: Company Profile – Genentech .................................................................................................... 283
Table 150: Selected Genentech Marketed Products ..................................................................................... 284
Table 151: Genentech SWOT Analysis ........................................................................................................ 289
Table 152: Company Profile – Pfizer ............................................................................................................ 290
Table 153: Pfizer SWOT Analysis ................................................................................................................ 296
Table 154: Company Profile – Syndax Pharmaceuticals .............................................................................. 296
Table 155: Syndax Pharmaceuticals SWOT Analysis ................................................................................... 297
Table 156: Company Profile – Abbott Laboratories ...................................................................................... 298
Table 157: Abbott’s Key Product Areas ........................................................................................................ 299
Table 158: Abbott Laboratories SWOT Analysis, 2013 ................................................................................. 304
Table 159: Company Profile – Amoy Diagnostics ......................................................................................... 305
Table 160: Amoy Diagnostics SWOT Analysis, 2013 ................................................................................... 306
Table 161: Company Profile – Biogenex Laboratories .................................................................................. 307
Table 162: Biogenex Laboratories SWOT Analysis, 2013............................................................................. 308
Table 163: Company Profile – BioMérieux ................................................................................................... 309
Table 164: BioMérieux SWOT Analysis, 2013 .............................................................................................. 317
Table 165: Company Profile – Dako (Agilent Technologies) ......................................................................... 318
Table 166: Dako/Agilent Technologies SWOT Analysis ................................................................................ 323
Table 167: Company Profile – Illumina ......................................................................................................... 324
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Table 168: Illumina Product Areas ............................................................................................................... 324
Table 169: Illumina SWOT Analysis ............................................................................................................. 331
Table 170: Company Profile – Leica Biosystems (Danaher) ......................................................................... 332
Table 171: Leica Biosystems/Danaher SWOT Analysis ................................................................................ 338
Table 172: Company Profile – Life Technologies (Thermo Fisher Scientific) ................................................. 339
Table 173: Life Technologies SWOT Analysis .............................................................................................. 346
Table 174: Company Profile – MolecularMD ................................................................................................ 347
Table 175: MolecularMD SWOT Analysis .................................................................................................... 348
Table 176: Company Profile – Myriad Genetics............................................................................................ 349
Table 177: Myriad Genetics Major Product Areas ........................................................................................ 350
Table 178: Myriad Genetics SWOT Analysis ................................................................................................ 354
Table 179: Company Profile – Qiagen ......................................................................................................... 355
Table 180: Qiagen Major Product Areas ...................................................................................................... 356
Table 181: Qiagen SWOT Analysis .............................................................................................................. 361
Table 182: Company Profile – Roche Diagnostics ........................................................................................ 362
Table 183: Roche SWOT Analysis ............................................................................................................... 368
Table 184: Company Profile – Siemens Healthcare ..................................................................................... 369
Table 185: Siemens Healthcare SWOT Analysis .......................................................................................... 374
Table 186: Company Profile – Ventana Medical Systems ............................................................................ 375
Table 187: Ventana Medical Systems SWOT Analysis ................................................................................. 378
Table 188: APAC Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011–2020 ............ 379
Table 189: APAC Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011–2020 ...... 381
Table 190: APAC Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011–2020 .................. 383
Table 191: APAC Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011–2020 ...................... 385
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Table 192: APAC Sales Forecast for IHC and Molecular Tests ($m), 2011–2020 ......................................... 387
Table 193: Major Events Affecting the Companion Diagnostic Test Market .................................................. 389
Table 194: Sales Forecast for Companion Diagnostic Tests ($m) in Japan, 2011–2020 ............................... 390
Table 195: Sales Forecast for Companion Diagnostic Tests ($m) in China, 2011–2020................................ 393
Table 196: Sales Forecast for Companion Diagnostic Tests ($m) in India, 2011–2020 ................................. 395
1.2 List of Figures
Figure 1: Genomic Sequencing Costs, 2001–2012......................................................................................... 26
Figure 2: Use of Proteomics in Personalized Medicine ................................................................................... 28
Figure 3: Incidence of Inherited Breast Cancer Mutations among Diagnosed Breast Cancer Patients ............. 30
Figure 4: Basic FISH Process ........................................................................................................................ 40
Figure 5: Basic PCR Process ......................................................................................................................... 42
Figure 6: Impact of Sample Storage on PCR Outcome................................................................................... 43
Figure 7: Genomic Sequencing Costs, 2001–2012......................................................................................... 45
Figure 8: Scientific and Economic Potential of Companion Diagnostics .......................................................... 49
Figure 9: Drug and Diagnostic Test Co-Development ..................................................................................... 50
Figure 10: Roche Lifecycle Algorithm for Co-Development of a Predictive Diagnostic ..................................... 51
Figure 11: Key Development Drivers for Companion Diagnostic Tests ........................................................... 53
Figure 12: Qiagen Model to Build a JAK2 Companion Diagnostic Tests Business .......................................... 54
Figure 13: Breast Cancer Companion Diagnostic Testing (HER2) in Japan, 2011–2020 ................................. 59
Figure 14: Colorectal Cancer Companion Diagnostic (KRAS) Testing in Japan, 2011–2020 ........................... 60
Figure 15: Melanoma Companion Diagnostic Testing (BRAF) in Japan, 2011–2020....................................... 61
Figure 16: EGFR Testing in Japan, 2006–2011.............................................................................................. 62
Figure 17: Japanese Lung Cancer Society Diagnostic Testing Algorithm........................................................ 64
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Figure 18: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Japan, 2011–2020 .............. 65
Figure 19: Breast Cancer Companion Diagnostic Testing (HER2) in China, 2011–2020 ................................. 67
Figure 20: Colorectal Cancer Companion Diagnostic (KRAS) Testing in China, 2011–2020 ........................... 69
Figure 21: Melanoma Companion Diagnostic Testing (BRAF) in China, 2011–2020 ....................................... 70
Figure 22: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in China, 2011–2020 .............. 72
Figure 23: Breast Cancer Companion Diagnostic Testing (HER2) in India, 2011–2020................................... 75
Figure 24: Colorectal Cancer Companion Diagnostic (KRAS) Testing in India, 2011–2020 ............................. 77
Figure 25: Melanoma Companion Diagnostic Testing (BRAF) in India, 2011–2020 ........................................ 78
Figure 26: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in India, 2011–2020 ................ 80
Figure 27: Registration of Domestic and Imported Medical Devices in China .................................................. 90
Figure 28: Multiple Partnerships in Companion Diagnostics during 2013–2014 .............................................. 99
Figure 29: Building a Companion Diagnostics Business: Forming Multiple Partnerships ............................... 100
Figure 30: Increasing Medicare Cost of Treatment ....................................................................................... 104
Figure 31: Growth of Drug Therapy Expenditure in France, 2004–2009 ....................................................... 105
Figure 32: Share of Targeted Therapies of Anti-Cancer Drug Costs in France .............................................. 106
Figure 33: Increase in Approvals of Biologic (Targeted) Therapies ............................................................... 112
Figure 34: EGFR PharmDx Test Adoption Curve ......................................................................................... 156
Figure 35: Probe Arrangement in the Vysis ALK Break Apart FISH Probe Kit ............................................... 166
Figure 36: Scorpion Primers ........................................................................................................................ 172
Figure 37: Increase in High- and Moderate-Complexity Molecular Tests....................................................... 175
Figure 38: Reasons for Companion Diagnostic Test Failure ......................................................................... 187
Figure 39: Female Breast Cancer Treatment Patterns by Stage, 2008 ......................................................... 190
Figure 40: Colon Cancer Treatment Patterns by Stage, 2008 ....................................................................... 191
Figure 41: Lung Cancer Treatment Patterns by Stage, 2008 ........................................................................ 192
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Figure 42: Expected Companion Diagnostic Test Pipeline, US Approvals, 2014–2019 ................................. 199
Figure 43: Sponsors of Clinical Trials for Targeted Cancer Therapies .......................................................... 238
Figure 44: Sponsors of Clinical Trials for Targeted Cancer Therapies Based on Mutational Status ............... 239
Figure 45: Sponsors of Clinical Trials for Targeted Cancer Therapies, by Phase .......................................... 240
Figure 46: APAC Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011–2020 ............ 379
Figure 47: APAC Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011–2020 ....... 381
Figure 48: APAC Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011–2020 .................. 383
Figure 49: APAC Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011–2020 ....................... 385
Figure 50: APAC Sales Forecast for IHC and Molecular Tests ($m), 2011–2020 .......................................... 387
Figure 51: APAC Market Share of Molecular Tests and Immunohistochemistry Tests in 2012 and 2020 ....... 388
Figure 52: Sales Forecast for Companion Diagnostic Tests ($m) in Japan, 2011–2020 ................................ 390
Figure 53: Sales Forecast for Companion Diagnostic Tests ($m) in China, 2011–2020 ................................ 392
Figure 54: Sales Forecast for Companion Diagnostic Tests ($m) in India, 2011–2020 .................................. 395
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC 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 Japan, and the future markets in China and India, to identify unmet needs in
the APAC market, physician attitudes toward current companion diagnostic testing, and the future
of companion diagnostic testing in the face of rapid technological advancement.
2.1 Catalyst
There is an increased demand for companion diagnostic tests; this is a result of the increased
demand from physicians who want to be better informed of the therapy options for their patients,
from regulatory authorities who are seeking the development of safer and more effective drugs,
and from healthcare authorities (payers) who are looking to control the rising costs of therapies,
while being able to better identify the most suitable patients for treatment.
Physicians look to stratify their patients in order to identify the most appropriate treatment, and the
addition of companion diagnostic tests is seen as an extra tool in the existing prognostic process.
Regulatory authorities, especially the US Food and Drug Administration (FDA), are mindful of not
only the increasing complexity of disease, but also of well-publicized incidents where new therapies
have proven to be ineffective, or even harmful in some groups of patients. As a result, regulatory
authorities are now seeking to improve the clinical trials process by imposing requirements on the
correct patient selection for trials, making, in effect, companion diagnostic tests an essential
requirement for any new drug treatment.
Healthcare authorities are mindful of the rising costs of new, but effective therapies, and are
seeking to control costs in the face of economic pressures, either by rationing treatments, or by
making more informed choices as to which patients should be treated with a new therapy.
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COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC ANALYSIS AND MARKET FORECASTS
Introduction
Companion diagnostic tests are particularly applicable to cancer, which is increasingly seen as a
large collection of syndromes, and where somatic and germline gene mutations play not only a
large role in the type of cancer developed, but also in how the patient responds to the treatment.
This report focuses on the four major cancers for which FDA-approved companion diagnostic tests
exist: breast cancer, colorectal cancer (CRC), non-small cell lung cancer, and melanoma. These
four cancers alone account for over 50% of new cancer cases and nearly 64% of cancer deaths in
the US (National Cancer Institute, 2014a).
2.2 Related Reports
GlobalData (2013). MediPoint: Colorectal Cancer Screening Tests – Global Analysis and
Market Forecasts. July, 2013, GDME0204MAR
GlobalData (2013). MediPoint: Predictive Breast Cancer Gene Testing – Global Analysis and
Market Forecasts. February, 2013, GDME0170MAR
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Appendix
COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - APAC ANALYSIS AND MARKET FORECASTS
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.