COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - US ANALYSIS … · reference code gdme1100cfr | publication date may 2014 companion diagnostic tests in oncology - us analysis and market

REFERENCE CODE GDME1100CFR | PUBLICAT ION DATE MAY 2014

COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - US ANALYSIS AND MARKET FORECASTS

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


Executive Summary

Companion Diagnostic Tests: Key Metrics in US Device Market 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

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

Source: GlobalData. 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

67% of the US 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 US Revenue, 2014

Breast Cancer (IHC)27.7%

Colorectal Cancer 5.0%

Non-small cell lung cancer 67.1%

Melanoma0.2%

Source: GlobalData.



Executive Summary

The companion diagnostic tests market is still

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

Ventana, Dako, and Leica. Roche and Qiagen

dominate the molecular testing market, while

Ventana, Dako, and Leica also have a significant

presence within the important IHC market. In most

segments, there is little competition for tests, since

only a few approved companion diagnostic tests

are marketed. Laboratory decisions as to which

brand of test to use are driven by clinical efficacy,

which may vary considerably by regions. The

exception is breast cancer HER2 testing, which, as

the longest-established segment, has attracted the

most competition.

Significant Unmet Needs

A need to improve cancer treatment remains a

significant unmet need. Besides providing a means

to identify patients who will most benefit from the

emerging targeted therapies, there is also a need

to be able to better utilize existing therapies,

including chemotherapies, or even surgical

interventions, through the use of companion

diagnostic tests to better stratify patients.

While the existing tests are well regarded by

physicians, for many, the differences in hardware

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

tests to enable easier decision-making. This

especially applies to IHC tests, which are

considered too subjective, and prone to error.

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

prescribe a new drug, face easy entry to the

market, beyond the reimbursement challenges,

new tests to replace existing companion diagnostic

tests face challenges in adoption by laboratories,

since they may not provide a clear performance

improvement. New tests typically undergo

exhaustive comparison studies by hospitals, rather

than benefiting from published literature studies.

Future Landscape

A significant barrier to increased adoption is

reimbursement. Approval of new companion

diagnostic tests does not signify adoption.

Adoption is highly dependent upon reimbursement

policies. If the molecular test cannot be

reimbursed, there will be low adoption. If the new

therapy cannot be reimbursed, there will be no

need for uptake of the companion diagnostic test,

unless a secondary use can be found that is of

utility to the physician in managing the patient’s

condition.

The emergence of new companion diagnostic tests

is also highly dependent on the success of the

drug pipeline. As a result of increased regulation,

new companion diagnostic tests are developed in

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

companion diagnostic is tied to the success of the

drug during clinical trials. Diagnostic test

manufacturers can de-risk this process through

multiple partnerships, or by developing new

companion diagnostic tests that are also aimed at

stratifying patients for existing therapies. If the



Executive Summary

therapy is one for which there are already

companion diagnostic tests, then the new test

faces adoption challenges. If the therapy has no

existing stratification route, then the test may gain

a considerable advantage, especially if

stratification provides a clear benefit to the patient

or the healthcare provider.

What do Physicians Think?

Despite IHC being the oldest technique used for

companion diagnostic tests, it is still seen as

essential, and in many ways preferable to newer

and more precise genetic tests.

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

FISH [fluorescence in situ hybridization] testing,

because the target is the protein, and not the

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

immuno[histochemistry]. It could be wonderful, if

we could standardize exactly what we are doing.”

Key Opinion Leader

Rapid companion diagnostic tests enable more

timely clinical decisions to be made to manage a

patient’s disease.

“We have turned around our ERs [estrogen

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

biopsy, so we now have the HER2 test available at

the pre-operative discussion cancer [meeting], that

has made the whole discussion so much more

powerful. …We know they will have chemotherapy

straight away – you can tell the patient that kind of

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

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

IHC helps us do that.”

Key Opinion Leader

Fully integrated and validated companion

diagnostic tests are valued by pathologists over

cheaper laboratory-developed tests.

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

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

their quality control, making sure all the reagents,

all the probes, everything works out.”

Key Opinion Leader



Executive Summary

Doubts on the efficacy of some companion

diagnostic tests can push up the cost of identifying

patients for treatment through over-testing.

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

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

running both tests simultaneously to see what our

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

the score zeroes will be amplified by FISH

and…sometimes three pluses and repeated three

pluses by troubleshooting the FISH is negative.

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

cases, they are those situations where the IHC test

cannot detect accurate results… $100 [cost of the

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

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

critical issue, that even though we are spending

$550 per patient…the accuracy of the test is

needed in order for each individual to have optimal

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

Key Opinion Leader

Patients have limited interest in the types of

companion diagnostic tests being undertaken.

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

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

oncologist, where we try to explain the difficulties

the pathologist may have in evaluating correctly

the results of the test… The patient needs to know

that [the biopsy] specimen is considered an

important part of the evaluation for the final

therapy, they will not know what we are doing with

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

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

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

Key Opinion Leader


Table of Contents


1 Table of Contents

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

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

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

2 Introduction ............................................................................................................................... 21

2.1 Catalyst ............................................................................................................................. 21

2.2 Related Reports ................................................................................................................ 22

3 Industry Overview ..................................................................................................................... 23

3.1 Emergence of Companion Diagnostics ............................................................................. 23

3.1.1 Definition of Companion Diagnostics ............................................................................. 23

3.1.2 Changing Face of Medicine ........................................................................................... 24

3.1.3 Definitions of Companion and Personalized Diagnostics ............................................... 26

3.2 Disease Applications ......................................................................................................... 28

3.2.1 Breast Cancer ............................................................................................................... 28

3.2.2 Colorectal Cancer ......................................................................................................... 31

3.2.3 Melanoma ..................................................................................................................... 33

3.2.4 Non-Small Cell Lung Cancer ......................................................................................... 34

3.3 Companion Diagnostics Technologies .............................................................................. 36

3.3.1 Immunochemical Techniques ........................................................................................ 36

3.3.2 Nucleic Acid Testing ...................................................................................................... 38

3.3.3 Emerging Technologies ................................................................................................. 45

3.4 Companion Diagnostics Development .............................................................................. 47

3.4.1 Economic Value of a Companion Diagnostic ................................................................. 47

3.4.2 When to Develop a Companion Diagnostic Test ........................................................... 48

3.4.3 Strategy......................................................................................................................... 51

3.4.4 Selection of Partner ....................................................................................................... 52

3.4.5 Biomarker Discovery ..................................................................................................... 54


Table of Contents


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

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

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

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

3.6.1 Overview ....................................................................................................................... 57

3.6.2 Breast Cancer Companion Diagnostic Tests ................................................................. 58

3.6.3 Colorectal Cancer Companion Diagnostic Tests ........................................................... 62

3.6.4 Melanoma Companion Diagnostic Tests ....................................................................... 64

3.6.5 Non-Small Cell Lung Cancer Companion Diagnostic Tests ........................................... 66

3.7 Market Access .................................................................................................................. 69

3.7.1 Overview ....................................................................................................................... 69

3.7.2 Regulation ..................................................................................................................... 69

3.7.3 Reimbursement ............................................................................................................. 72

3.8 Regulatory Issues and Recalls .......................................................................................... 73

3.8.1 Dako FDA Warning Letter ............................................................................................. 73

3.8.2 HercepTest Recall ......................................................................................................... 73

3.8.3 Cobas KRAS Test Recall .............................................................................................. 74

3.8.4 Cobas BRF V600E Test Recall ..................................................................................... 74

3.8.5 Leica Bond HER2 IHC System ...................................................................................... 74

3.9 Reimbursement of Companion Diagnostic Tests ............................................................... 75

3.10 M&A, Key Partnerships ..................................................................................................... 80

3.10.1 Significant Mergers and Acquisitions ............................................................................. 82

3.10.2 Recent Partnerships ...................................................................................................... 82

3.11 Economic Impact .............................................................................................................. 88

3.11.1 Cost Effectiveness of Companion Diagnostics .............................................................. 88

3.11.2 Cost Effectiveness of Companion Diagnostics: Healthcare Provider Perspective .......... 89

3.12 Market Drivers................................................................................................................... 95


Table of Contents


3.12.1 Driver: Increasing Healthcare Pressures ....................................................................... 95

3.12.2 Driver: Adverse Economic Pressures ............................................................................ 96

3.12.3 Driver: Availability of New Technologies ........................................................................ 96

3.12.4 Driver: FDA Regulatory Changes .................................................................................. 97

3.12.5 Driver: Need to Improve Drug Development Processes ................................................ 97

3.12.6 Driver: Increasing Cancer Incidence .............................................................................. 98

3.12.7 Driver: Accelerating Demand for Targeted Therapies .................................................... 98

3.13 Market Barriers ............................................................................................................... 100

3.13.1 Barrier: Reimbursement Difficulties ............................................................................. 100

3.13.2 Barrier: Loss of Indication ............................................................................................ 100

3.13.3 Barrier: Emergence of Biosimilar Therapies ................................................................ 101

3.13.4 Barrier: Competition with Laboratory-Developed Tests ................................................ 102

3.13.5 Barrier: Emergence of Next-Generation Gene Sequencing ......................................... 102

3.13.6 Barrier: Lack of Laboratory Choice in Instrument Selection ......................................... 103

3.13.7 Barrier: Lack of Patient Awareness about Companion Diagnostic Tests...................... 105

3.13.8 Barrier: Physician Resistance to New Companion Diagnostic Tests ............................ 105

4 Competitive Assessment ........................................................................................................ 107

4.1 Overview ......................................................................................................................... 107

4.2 Techniques in Use by Currently Marketed Products ........................................................ 107

4.2.1 Immunohistochemistry ................................................................................................ 107

4.2.2 Fluorescence In Situ Hybridization .............................................................................. 107

4.2.3 Polymerase Chain Reaction ........................................................................................ 108

4.3 Competitive Analysis ....................................................................................................... 108

4.3.1 Breast Cancer Companion Diagnostic Tests ............................................................... 108

4.3.2 Colorectal Cancer Companion Diagnostic Tests ......................................................... 137

4.3.3 Melanoma Companion Diagnostic Tests ..................................................................... 146

4.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests ......................................... 152


Table of Contents


5 Unmet Needs .......................................................................................................................... 169

5.1 Need for Improved Cancer Treatments ........................................................................... 169

5.2 Need for Objective Tests ................................................................................................. 169

5.3 Need for High-Throughput Tests ..................................................................................... 171

5.4 Certainty of Reimbursement............................................................................................ 172

5.5 Amount and Type of Tissue Needed for Test .................................................................. 173

5.6 Who Should be Tested? .................................................................................................. 176

5.7 Test Accuracy ................................................................................................................. 181

5.8 Increasing Test Complexity and Increased Process Failure ............................................ 183

6 Pipeline Products .................................................................................................................... 185

6.1 Overview ......................................................................................................................... 185

6.2 Pipeline by Phase of Development.................................................................................. 187

6.3 Pipeline Product Profiles ................................................................................................. 188





7 Clinical Trials to Watch ........................................................................................................... 225

7.1 Overview ......................................................................................................................... 225

7.2 Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies ........................................................................................................................ 229

8 Current and Future Players ..................................................................................................... 230

8.1 Trends in Corporate Strategy .......................................................................................... 230

8.1.1 Companion Diagnostics Business Models ................................................................... 230

8.2 Company Profiles ............................................................................................................ 231

8.2.1 Pharmaceutical/Therapy Companies Developing Companion Diagnostic Tests .......... 231

8.2.2 Diagnostics Companies Developing Companion Diagnostic Tests (in Partnership with Pharmaceutical Companies)....................................................................................... 286


Table of Contents


9 Market Outlooks...................................................................................................................... 368

9.1 By Market Segment......................................................................................................... 368





9.1.5 Technique ................................................................................................................... 373

9.2 By Geography ................................................................................................................. 376

9.2.1 Overview ..................................................................................................................... 376

9.2.2 US ............................................................................................................................... 376

10 Appendix................................................................................................................................. 379

10.1 Bibliography .................................................................................................................... 379

10.2 Abbreviations .................................................................................................................. 414

10.3 Report Methodology ........................................................................................................ 416

10.3.1 Coverage .................................................................................................................... 416

10.3.2 Secondary Research ................................................................................................... 417

10.3.3 Forecasting Methodology ............................................................................................ 417

10.4 Physicians Included in this Study .................................................................................... 419

10.5 About the Authors ........................................................................................................... 421

10.5.1 Andrew Thompson, Ph.D., Senior Analyst, In Vitro Diagnostics .................................. 421

10.5.2 Derek Archila, MBA, Lead Analyst, Medical Devices ................................................... 421

10.5.3 Bonnie Bain, PhD, Global Head of Healthcare ............................................................ 422

10.6 Disclaimer ....................................................................................................................... 423


Table of Contents


1.1 List of Tables

Table 1: Possible Companion Diagnostic Test Platforms ................................................................................ 23

Table 2: Specific Breast Cancer Types Associated with Inherited Disorders ................................................... 30

Table 3: Specific Mutations Associated with Non-Small Cell Lung Cancer ...................................................... 36

Table 4: Weaknesses of ELISA Technique .................................................................................................... 37

Table 5: Key Stages of PCR Gene Test ......................................................................................................... 40

Table 6: Key Principles Guiding Companion Diagnostic Test Development .................................................... 51

Table 7: Companion Diagnostic Test Development Partner Selection ............................................................ 52

Table 8: Biomarker Discovery ........................................................................................................................ 54

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 in the US, 2011–2020 .............................................................................................. 62

Table 13: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the US, 2011–2020 ........................... 64

Table 14: Melanoma Companion Diagnostic Testing (BRAF) in the US, 2011–2020....................................... 65

Table 15: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the US, 2011–2020 .............. 68

Table 16: FDA Medical Device Classifications................................................................................................ 70

Table 17: US Reimbursement Policies for FDA- and Non-FDA-Approved Molecular Tests ............................. 73

Table 18: Key Mergers and Acquisitions during 2013–2014 ........................................................................... 82

Table 19: Partnerships during 2013–2014 ...................................................................................................... 83

Table 20: Impact of Companion Diagnostics on Cancer Treatment Costs in France ....................................... 94

Table 21: Effectiveness of Disease Therapies ................................................................................................ 95

Table 22: HER2 FISH/iQFISH PharmDx Product Profile .............................................................................. 108

Table 23: Common Reasons for HER2 FISH Failure .................................................................................... 110


Table of Contents


Table 24: HER2 FISH PharmDx/HER2 iQFISH PharmDx SWOT Analysis ................................................... 112

Table 25: HercepTest Product Profile .......................................................................................................... 112

Table 26: HercepTest Scoring Algorithm ...................................................................................................... 113

Table 27: HercepTest SWOT Analysis ......................................................................................................... 115

Table 28: HER2 CISH PharmDx Product Profile .......................................................................................... 116

Table 29: HER2 CISH PharmDx SWOT Analysis ......................................................................................... 118

Table 30: SPOT-Light HER2 CISH Kit Product Profile .................................................................................. 119

Table 31: SPOT-Light HER2 CISH Kit SWOT Analysis ................................................................................ 121

Table 32: Leica Bond Oracle HER2 IHC System Product Profile .................................................................. 121

Table 33: Leica Bond Oracle HER2 IHC System Test Algorithm................................................................... 122

Table 34: Leica Bond Oracle HER2 IHC System SWOT Analysis................................................................. 124

Table 35: Biogenex INSITE HER2/Neu Product Profile ................................................................................ 125

Table 36: Biogenex INSITE HER2/Neu SWOT Analysis ............................................................................... 127

Table 37: Abbott Pathvysion HER-2 DNA Probe Kit Product Profile ............................................................. 127

Table 38: Abbott Pathvysion HER-2 DNA Probe Kit SWOT Analysis ............................................................ 129

Table 39: Ventana INFORM HER2 Dual ISH Assay Product Profile ............................................................. 130

Table 40: Ventana INFORM HER2 Dual ISH Assay SWOT Analysis ............................................................ 132

Table 41: Pathway HER2/Neu IHC Product Profile....................................................................................... 132

Table 42: Pathway HER2/Neu IHC SWOT Analysis ..................................................................................... 135

Table 43: HerMark Product Profile ............................................................................................................... 136

Table 44: HerMark SWOT Analysis.............................................................................................................. 137

Table 45: Therascreen KRAS RGQ Product Profile ...................................................................................... 137

Table 46: Therascreen KRAS RGQ SWOT Analysis .................................................................................... 140

Table 47: Cobas KRAS Mutation Test Product Profile .................................................................................. 140


Table of Contents


Table 48: Cobas KRAS Mutation Test SWOT Analysis ................................................................................ 142

Table 49: EGFR PharmDx Kit Product Profile .............................................................................................. 142

Table 50: EGFR PharmDx Kit SWOT Analysis ............................................................................................. 146

Table 51: THxID BRAF Product Profile ........................................................................................................ 146

Table 52: Effect of Melanin on the THxID BRAF PCR Test........................................................................... 148

Table 53: THxID BRAF SWOT Analysis ....................................................................................................... 149

Table 54: Cobas 4800 BRAF V600 Mutation Test – Melanoma Product Profile ............................................ 150

Table 55: Interpretation of Cobas BRAF V600 Mutation Test – Melanoma ................................................... 151

Table 56: Cobas 4800 BRAF V600 Mutation Test – Melanoma SWOT Analysis ........................................... 152

Table 57: Vysis ALK Break Apart FISH Probe Kit Product Profile ................................................................. 153

Table 58: Abbott Vysis ALK Break Apart FISH Probe Kit SWOT Analysis..................................................... 155

Table 59: Amoy-Dx EML4-ALK Fusion Gene Detection Kit Product Profile ................................................... 155

Table 60: Amoy-Dx EML4-ALK Fusion Gene Detection Kit SWOT Analysis ................................................. 157

Table 61: Therascreen EGFR RGQ PCR Kit Product Profile ........................................................................ 157

Table 62: Therascreen EGFR RGQ PCR Kit SWOT Analysis....................................................................... 162

Table 63: ALK IHC Test Product Profile ....................................................................................................... 163

Table 64: ALK IHC Test SWOT Analysis ...................................................................................................... 165

Table 65: Cobas EGFR Mutation Test Product Profile .................................................................................. 166

Table 66: Cobas EGFR Mutation Test SWOT Analysis ................................................................................ 168

Table 67: Companion Diagnostic Tests Pipeline, 2014 ................................................................................. 187

Table 68: Neuvax Companion Diagnostic Assay Product Profile .................................................................. 189

Table 69: Neuvax Companion Diagnostic Assay Product SWOT Analysis .................................................... 189

Table 70: Companion Diagnostic Test – Palbociclib Product Profile ............................................................. 190

Table 71: Companion Diagnostic Test – Palbociclib SWOT Analysis ............................................................ 191


Table of Contents


Table 72: Companion Diagnostic Test – Breast Cancer Product Profile ........................................................ 192

Table 73: Companion Diagnostic Test – Breast Cancer SWOT Analysis ...................................................... 192

Table 74: Onapristone Companion Diagnostic Assay Product Profile ........................................................... 193

Table 75: Onapristone Companion Diagnostic Assay SWOT Analysis .......................................................... 194

Table 76: Aromatase Inhibitor Biomarker – Companion Diagnostic Test Product Profile ............................... 195

Table 77: Aromatase Inhibitor Biomarker – Companion Diagnostic Test SWOT Analysis ............................. 195

Table 78: BRAF Companion Diagnostic Assay – Colon Cancer Product Profile ............................................ 196

Table 79: BRAF Companion Diagnostic Assay – Colon Cancer SWOT Analysis .......................................... 197

Table 80: KRAS Companion Diagnostic Assay – Colon Cancer Product Profile............................................ 198

Table 81: KRAS Companion Diagnostic Assay – Colon Cancer SWOT Analysis .......................................... 198

Table 82: PIK3CA Companion Diagnostic Assay – Colorectal Cancer Product Profile .................................. 199

Table 83: PIK3CA Companion Diagnostic Assay – Colorectal Cancer SWOT Analysis................................. 200

Table 84: Vectibix Companion Diagnostic Product Profile ............................................................................ 201

Table 85: Vectibix Companion Diagnostic SWOT Analysis ........................................................................... 202

Table 86: MAGE-A3 Companion Skin Cancer Assay Product Profile ............................................................ 203

Table 87: MAGE-A3 Companion Skin Cancer Assay SWOT Analysis .......................................................... 203

Table 88: GNAQ/GNA11 Companion Diagnostic Assays – Melanoma Product Profile .................................. 204

Table 89: GNAQ/GNA11 Companion Diagnostic Assays – Melanoma SWOT Analysis ................................ 205

Table 90: Companion Diagnostic Test – Melanoma Cancer Product Profile ................................................. 206

Table 91: Companion Diagnostic Test – Melanoma Cancer SWOT Analysis ................................................ 206

Table 92: KRAS Companion Diagnostic Assay – Melanoma Product Profile................................................. 207

Table 93: KRAS Companion Diagnostic Assay – Melanoma SWOT Analysis ............................................... 208

Table 94: Companion Diagnostic Test – Melanoma Product Profile .............................................................. 209

Table 95: Companion Diagnostic Test – Melanoma SWOT Analysis ............................................................ 209


Table of Contents


Table 96: BRAF Companion Diagnostic Assay – Lung Cancer Product Profile ............................................. 210

Table 97: BRAF Companion Diagnostic Assay – Lung Cancer SWOT Analysis ........................................... 210

Table 98: KRAS Companion Diagnostic Assay – Lung Cancer Product Profile ............................................. 211

Table 99: KRAS Companion Diagnostic Assay – Lung Cancer SWOT Analysis ........................................... 211

Table 100: MET Companion Diagnostic Assay – Lung Cancer Product Profile ............................................. 212

Table 101: MET Companion Diagnostic Assay – Lung Cancer SWOT Analysis ........................................... 213

Table 102: PIK3CA Companion Diagnostic Assay – Lung Cancer Product Profile ........................................ 214

Table 103: PIK3CA Companion Diagnostic Assay – Lung Cancer SWOT Analysis....................................... 214

Table 104: Companion Diagnostic Device – Lung Cancer Product Profile .................................................... 215

Table 105: Companion Diagnostic Device – Lung Cancer SWOT Analysis ................................................... 216

Table 106: Companion Diagnostic Test – Crizotinib Product Profile ............................................................. 217

Table 107: Companion Diagnostic Test – Crizotinib SWOT Analysis ............................................................ 217

Table 108: Companion Diagnostic Test – Dacomitinib Product Profile .......................................................... 218

Table 109: Companion Diagnostic Test – Dacomitinib SWOT Analysis ........................................................ 218

Table 110: T790M Mutation Companion Diagnostic Test Product Profile ...................................................... 219

Table 111: T790M Mutation Companion Diagnostic Test SWOT Analysis .................................................... 220

Table 112: Entinostat Companion Diagnostic Assay Product Profile ............................................................. 221

Table 113: Entinostat Companion Diagnostic Assay SWOT Analysis ........................................................... 221

Table 114: MUC1 Expression Companion Diagnostic Test Product Profile ................................................... 222

Table 115: MUC1 Expression Companion Diagnostic Test SWOT Analysis ................................................. 223

Table 116: Companion Diagnostic Assay – NSCLC Product Profile ............................................................. 224

Table 117: Companion Diagnostic Assay – NSCLC SWOT Analysis ............................................................ 224

Table 118: Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug

Therapies. ................................................................................................................................. 229

Table 119: Company Profile – Amgen .......................................................................................................... 232


Table of Contents


Table 120: Amgen’s Key Products ............................................................................................................... 232

Table 121: Selected Amgen Anti-Cancer Therapies Currently in Clinical Trials ............................................. 233

Table 122: Amgen SWOT Analysis .............................................................................................................. 238

Table 123: Company Profile – Arno Therapeutics ........................................................................................ 239

Table 124: Selected Arno Therapeutics Anti-Cancer Therapies Currently in Clinical Trials ........................... 239

Table 125: Arno Therapeutics SWOT Analysis............................................................................................. 243

Table 126: Company Profile – AstraZeneca ................................................................................................. 244

Table 127: Key Events in the Development of AstraZeneca’s Drug Portfolio Since 2011 .............................. 246

Table 128: Key Project Terminations by AstraZeneca Since 2008 ................................................................ 248

Table 129: AstraZeneca SWOT Analysis ..................................................................................................... 252

Table 130: Company Profile – Bristol-Myers Squibb ..................................................................................... 253

Table 131: Recent Key Product Approvals from Bristol-Myers Squibb .......................................................... 256

Table 132: Recent Key BMS Partnerships and Agreements ......................................................................... 257

Table 133: Bristol-Myers Squibb SWOT Analysis ......................................................................................... 258

Table 134: Company Profile – Clovis Oncology............................................................................................ 259

Table 135: Clovis Oncology’s Key Products ................................................................................................. 260

Table 136: Clovis Oncology SWOT Analysis ................................................................................................ 264

Table 137: Company Profile – Eli Lilly and Company ................................................................................... 265

Table 138: Eli Lilly and Company SWOT Analysis........................................................................................ 271

Table 139: Company Profile – Genentech .................................................................................................... 271

Table 140: Selected Genentech Marketed Products ..................................................................................... 272

Table 141: Genentech SWOT Analysis ........................................................................................................ 277

Table 142: Company Profile – Pfizer ............................................................................................................ 278

Table 143: Pfizer SWOT Analysis ................................................................................................................ 284


Table of Contents


Table 144: Company Profile – Syndax Pharmaceuticals .............................................................................. 285

Table 145: Syndax Pharmaceuticals SWOT Analysis ................................................................................... 286

Table 146: Company Profile – Abbott Laboratories ...................................................................................... 287

Table 147: Abbott’s Key Product Areas ........................................................................................................ 288

Table 148: Abbott Laboratories SWOT Analysis, 2013 ................................................................................. 293

Table 149: Company Profile – Amoy Diagnostics ......................................................................................... 294

Table 150: Amoy Diagnostics SWOT Analysis, 2013 ................................................................................... 295

Table 151: Company Profile – Biogenex Laboratories .................................................................................. 296

Table 152: Biogenex Laboratories SWOT Analysis, 2013............................................................................. 297

Table 153: Company Profile – BioMérieux ................................................................................................... 298

Table 154: BioMérieux SWOT Analysis, 2013 .............................................................................................. 306

Table 155: Company Profile – Dako (Agilent Technologies) ......................................................................... 307

Table 156: Dako/Agilent Technologies SWOT Analysis ................................................................................ 312

Table 157: Company Profile – Illumina ......................................................................................................... 313

Table 158: Illumina Product Areas ............................................................................................................... 313

Table 159: Illumina SWOT Analysis ............................................................................................................. 320

Table 160: Company Profile – Leica Biosystems (Danaher) ......................................................................... 321

Table 161: Leica Biosystems/Danaher SWOT Analysis ................................................................................ 327

Table 162: Company Profile – Life Technologies (Thermo Fisher Scientific) ................................................. 328

Table 163: Life Technologies SWOT Analysis .............................................................................................. 335

Table 164: Company Profile – MolecularMD ................................................................................................ 336

Table 165: MolecularMD SWOT Analysis .................................................................................................... 337

Table 166: Company Profile – Myriad Genetics............................................................................................ 338

Table 167: Myriad Genetics Major Product Areas ........................................................................................ 339


Table of Contents


Table 168: Myriad Genetics SWOT Analysis ................................................................................................ 343

Table 169: Company Profile – Qiagen ......................................................................................................... 344

Table 170: Qiagen Major Product Areas ...................................................................................................... 345

Table 171: Qiagen SWOT Analysis .............................................................................................................. 350

Table 172: Company Profile – Roche Diagnostics ........................................................................................ 351

Table 173: Roche SWOT Analysis ............................................................................................................... 357

Table 174: Company Profile – Siemens Healthcare ..................................................................................... 358

Table 175: Siemens Healthcare SWOT Analysis .......................................................................................... 363

Table 176: Company Profile – Ventana Medical Systems ............................................................................ 364

Table 177: Ventana Medical Systems SWOT Analysis ................................................................................. 367

Table 178: US Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011–2020 ................ 368

Table 179: US Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011–2020 ........... 369

Table 180: USl Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011–2020 ..................... 371

Table 181: US Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011–2020 ........................... 372

Table 182: US Sales Forecast for IHC and Molecular Tests ($m), 2011–2020 .............................................. 374

Table 183: Major Events Affecting the Companion Diagnostic Test Market .................................................. 376

Table 184: Sales Forecast for Companion Diagnostic Tests ($m) in the US, 2011–2020 .............................. 377


Table of Contents


1.2 List of Figures

Figure 1: Genomic Sequencing Costs, 2001–2012......................................................................................... 25

Figure 2: Use of Proteomics in Personalized Medicine ................................................................................... 27

Figure 3: Incidence of Inherited Breast Cancer Mutations among Diagnosed Breast Cancer Patients ............. 29

Figure 4: Basic FISH Process ........................................................................................................................ 39

Figure 5: Basic PCR Process ......................................................................................................................... 41

Figure 6: Impact of Sample Storage on PCR Outcome................................................................................... 42

Figure 7: Genomic Sequencing Costs, 2001–2012......................................................................................... 44

Figure 8: Scientific and Economic Potential of Companion Diagnostics .......................................................... 48

Figure 9: Drug and Diagnostic Test Co-Development ..................................................................................... 49

Figure 10: Roche Lifecycle Algorithm for Co-Development of a Predictive Diagnostic ..................................... 50

Figure 11: Key Development Drivers for Companion Diagnostic Tests ........................................................... 52

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

Figure 13: Uptake of HER2 Testing among Invasive Breast Cancer Patients.................................................. 59

Figure 14: HER2 Testing in the US, 2011–2020 ............................................................................................. 61

Figure 15: Colorectal Cancer Companion Diagnostic (KRAS) Testing in the US, 2011–2020 .......................... 63

Figure 16: Melanoma Companion Diagnostic Testing (BRAF) in the US, 2011–2020 ..................................... 65

Figure 17: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the US, 2011–2020 ............. 68

Figure 18: Healthcare Coverage Frameworks ................................................................................................ 78

Figure 19: Multiple Partnerships in Companion Diagnostics during 2013–2014 .............................................. 86

Figure 20: Building a Companion Diagnostics Business: Forming Multiple Partnerships ................................. 87

Figure 21: Increasing Medicare Cost of Treatment ......................................................................................... 91

Figure 22: Growth of Drug Therapy Expenditure in France, 2004–2009 ......................................................... 92

Figure 23: Share of Targeted Therapies of Anti-Cancer Drug Costs in France ................................................ 93


Table of Contents


Figure 24: Increase in Approvals of Biologic (Targeted) Therapies ................................................................. 99

Figure 25: EGFR PharmDx Test Adoption Curve ......................................................................................... 143

Figure 26: Probe Arrangement in the Vysis ALK Break Apart FISH Probe Kit ............................................... 153

Figure 27: Scorpion Primers ........................................................................................................................ 159

Figure 28: Increase in High- and Moderate-Complexity Molecular Tests....................................................... 162

Figure 29: Reasons for Companion Diagnostic Test Failure ......................................................................... 174

Figure 30: Female Breast Cancer Treatment Patterns by Stage, 2008 ......................................................... 177

Figure 31: Colon Cancer Treatment Patterns by Stage, 2008 ....................................................................... 178

Figure 32: Lung Cancer Treatment Patterns by Stage, 2008 ........................................................................ 179

Figure 33: Expected Companion Diagnostic Test Pipeline, US Approvals, 2014–2019 ................................. 186

Figure 34: Sponsors of Clinical Trials for Targeted Cancer Therapies .......................................................... 226

Figure 35: Sponsors of Clinical Trials for Targeted Cancer Therapies Based on Mutational Status ............... 227

Figure 36: Sponsors of Clinical Trials for Targeted Cancer Therapies, by Phase .......................................... 228

Figure 37: US Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011–2020 ................. 368

Figure 38: US Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011–2020............ 369

Figure 39: US Sales Forecast for Melanoma Companion Diagnostic Tests ($m), 2011–2020 ....................... 371

Figure 40: US Sales Forecast for NSCLC Companion Diagnostic Tests ($m), 2011–2020 ........................... 372

Figure 41: US Sales Forecast for IHC and Molecular Tests ($m), 2011–2020 .............................................. 373

Figure 42: Global Market Share of Molecular Tests and Immunohistochemistry Tests in 2012 and 2020 ...... 375

Figure 43: Sales Forecast for Companion Diagnostic Tests ($m) in the US, 2011–2020 ............................... 377



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, 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.

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

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

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



Introduction

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

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

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

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

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

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

the US (National Cancer Institute, 2014a).

2.2 Related Reports

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

Market Forecasts. July, 2013, GDME0204MAR

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

Market Forecasts. February, 2013, GDME0170MAR


Appendix


10.6 Disclaimer

All Rights Reserved.

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

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

permission of the publisher, GlobalData.

COMPANION DIAGNOSTIC TESTS IN ONCOLOGY - US ANALYSIS … · reference code gdme1100cfr | publication date may 2014 companion diagnostic tests in oncology - us analysis and market

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