JSB Market Research - MediPoint: Companion Diagnostic Tests in Oncology - Global Analysis and Market Forecasts

MediPoint: Companion Diagnostic Tests in Oncology 

- Global Analysis and Market Forecasts 

Released On 7 th June 2014 

A companion diagnostic test is defined as 

an in vitro diagnostic device or an imaging 

tool whose use allows the safe application 

of a therapy. In-vitro Companion 

Diagnostic tests measure the expression or 

presence of a specific biomarker that is 

linked to a disease condition or therapy. 

This report provides an analysis of the 

companion diagnostic market for four 

major cancers in the US, the 5EU (France, 

Germany, Italy, Spain, and UK), Brazil, 

and the some of the Asia-Pacific (APAC) 

regions (Japan, China, and India), and 

identifies the unmet needs in this 

companion diagnostics market. This report 

analyses companion diagnostic tests used 

in breast, colorectal, melanoma and non-small cell lung cancer. This report also discusses 

physician attitudes towards current companion diagnostic tests, and the future of companion 

diagnostic tests. This report focuses on the major test kits that are supplied to pathology 

laboratories. 

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medical/r-MediPoint-Companion-Diagnostic-Tests-in-Oncology-Global-Analysis-and- 

Market-Forecasts-110214 

Highlights 

Key Questions Answered 

- Global cancer incidence is expected to rise. (Q).What role will companion diagnostic tests for 

play in the forecast period to tackle this global issue? (Q).How many procedures of companion 

diagnostic tests will be performed in the ten major markets covered in the report? 

- What are the reasons to develop a Companion Diagnostic Test. (Q).What motivates companies 

to develop a companion diagnostic; physician demand or legislative requirement? 

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- What strategies are adopted in developing a new companion diagnostics test. (Q).When and 

how is a companion diagnostic test developed? (Q).Who are the stakeholders? (Q).What are the 

relationships between Big Pharma and Diagnostic test developers? 

- (Q).What technologies underpin companion diagnostic tests?. (Q).What are the common 

technologies used? Which are the most in demand, across all tests. (Q).What are the emerging 

technologies? 

- What Companion Diagnostic tests are available in breast cancer, colorectal cancer, melanoma 

and non-small cell lung cancer. (Q).Which are the leading tests? (Q).How are the tests performed 

- Where are companion diagnostics offered. (Q).What disease is likely to see the most demand 

for Companion diagnostics, which the least? (Q).Which countries are likely to adopt companion 

diagnostic tests? 

- What do physicians think of currently offered companion. (Q).What are the perceived 

strengths, weaknesses? (Q).What are the unmet needs? 

Key Findings 

- The Companion Diagnostic test market for the 4 named cancers will grow at a CAGR of 4.9% 

over the forecast period. Developed regions, like US and EU showing lowest growth rates. While 

China and Brazil showing maximum growth rates. 

- Breast cancer HER2 testing dominates in terms of volume, but has been overtaken in terms of 

value by non-small cell lung cancer companion diagnostic testing, mostly for EGFR mutation 

status. 

- The market growth for companion diagnostic testing in the US and EU is heavily dependent on 

the acceptance into diagnostic guidelines and the stabilisation of test reimbursement. Growth in 

developing economies is dependant upon patient access to laboratory testing and growth of 

professional pathology services 

Scope 

- Overview of companion diagnostic tests in oncology, including core technologies, estimated 

procedure trends and disease overview. 

- Current and Future Players Companies involved in the space with portfolio assessment and 

SWOT analysis. 

- Pipeline analysis: Late-stage pipeline products with SWOT analysis and physician perception 

- Other Key topics covered include identification of unmet needs, implications on the companion 

diagnostic market and how they may be overcome in the near future 

- Analysis of the market opportunities in addition to Insightful review of the key industry drivers, 

restraints and challenges. Each trend is independently researched to provide qualitative analysis 

of its implications 



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Reasons to buy 

- Develop and design your in-licensing and out-licensing strategies through a review of pipeline 

products and technologies, and by identifying the companies with the most robust pipeline 

- Develop business strategies by understanding the trends shaping and driving the companion 

diagnostic cancer test market 

- Drive revenues by understanding the key trends, innovative products and technologies, and 

companies likely to impact the cancer companion diagnostic test market in the future 

- Formulate effective sales and marketing strategies by understanding the competitive landscape 

and by analysing the performance of various competitors 

- Identify emerging players with potentially strong product portfolios and create effective 

counter-strategies to gain a competitive advantage 

- Organize your sales and marketing efforts by identifying the market categories and segments 

that present maximum opportunities for consolidations, investments and strategic partnerships 

Table of Content: 

1 Table of Contents 6 

1.1 List of Tables 12 

1.2 List of Figures 23 

2 Introduction 28 

2.1 Catalyst 28 

2.2 Related Reports 29 

3 Industry Overview 30 

3.1 Emergence of Companion Diagnostics 30 

3.1.1 Definition of Companion Diagnostics 30 

3.1.2 Changing Face of Medicine 31 

3.1.3 Definitions of Companion and Personalized Diagnostics 33 

3.2 Disease Applications 35 

3.2.1 Breast Cancer 35 

3.2.2 Colorectal Cancer 38 

3.2.3 Melanoma 40 

3.2.4 Non-Small Cell Lung Cancer 41 

3.3 Companion Diagnostics Technologies 43 

3.3.1 Immunochemical Techniques 43 

3.3.2 Nucleic Acid Testing 45 

3.3.3 Emerging Technologies 52 

3.4 Companion Diagnostics Development 54 

3.4.1 Economic Value of a Companion Diagnostic 54 

3.4.2 When to Develop a Companion Diagnostic Test 55 

3.4.3 Strategy 58 



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3.4.4 Selection of Partner 59 

3.4.5 Biomarker Discovery 61 

3.5 Clinical Outcomes 62 

3.5.1 Role of Companion Diagnostics in Disease Treatment 62 

3.5.2 Companion Diagnostic Test Applications 63 

3.6 Testing Trends 64 

3.6.1 US 64 

3.6.2 France 75 

3.6.3 Germany 85 

3.6.4 Italy 92 

3.6.5 Spain 100 

3.6.6 UK 106 

3.6.7 Japan 120 

3.6.8 Brazil 129 

3.6.9 China 135 

3.6.10 India 143 

3.7 Market Access 150 

3.7.1 Overview 150 

3.7.2 US 150 

3.7.3 5EU 154 

3.7.4 Japan 165 

3.7.5 Brazil 167 


3.7.7 India 172 

3.8 Regulatory Issues and Recalls 173 

3.8.1 Dako FDA Warning Letter 173 

3.8.2 HercepTest Recall 174 

3.8.3 Cobas KRAS Test Recall 174 

3.8.4 Cobas BRF V600E Test Recall 174 

3.8.5 Leica Bond HER2 IHC System 174 

3.9 Reimbursement of Companion Diagnostic Tests 175 

3.9.1 US 175 

3.9.2 Europe 180 

3.9.3 APAC 192 

3.9.4 South America 197 

3.10 M&A, Key Partnerships 199 

3.10.1 Significant Mergers and Acquisitions 201 

3.10.2 Recent Partnerships 201 

3.11 Economic Impact 207 

3.11.1 Cost Effectiveness of Companion Diagnostics 207 

3.11.2 Cost Effectiveness of Companion Diagnostics: Healthcare Provider Perspective 208 



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3.12 Market Drivers 214 

3.12.1 Driver: Increasing Healthcare Pressures 214 

3.12.2 Driver: Adverse Economic Pressures 215 

3.12.3 Driver: Availability of New Technologies 215 

3.12.4 Driver: FDA Regulatory Changes 216 

3.12.5 Driver: Need to Improve Drug Development Processes 216 

3.12.6 Driver: Increasing Cancer Incidence 217 

3.12.7 Driver: Accelerating Demand for Targeted Therapies 217 

3.13 Market Barriers 219 

3.13.1 Barrier: Reimbursement Difficulties 219 

3.13.2 Barrier: Loss of Indication 219 

3.13.3 Barrier: Emergence of Biosimilar Therapies 220 

3.13.4 Barrier: Competition with Laboratory-Developed Tests 221 

3.13.5 Barrier: Emergence of Next-Generation Gene Sequencing 222 

3.13.6 Barrier: Lack of Laboratory Choice in Instrument Selection 223 

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

3.13.8 Barrier: Physician Resistance to New Companion Diagnostic Tests 225 

4 Competitive Assessment 227 

4.1 Overview 227 

4.2 Techniques in Use by Currently Marketed Products 227 

4.2.1 Immunohistochemistry 227 

4.2.2 Fluorescence In Situ Hybridization 227 

4.2.3 Polymerase Chain Reaction 228 

4.3 Competitive Analysis 228 

4.3.1 Breast Cancer Companion Diagnostic Tests 228 

4.3.2 Colorectal Cancer Companion Diagnostic Tests 257 

4.3.3 Melanoma Companion Diagnostic Tests 267 

4.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 273 

5 Unmet Needs 290 

5.1 Need for Improved Cancer Treatments 290 

5.2 Need for Objective Tests 290 

5.3 Need for High-Throughput Tests 292 

5.4 Certainty of Reimbursement 293 

5.5 Amount and Type of Tissue Needed for Test 294 

5.6 Who Should be Tested? 297 

5.7 Test Accuracy 302 

5.8 Increasing Test Complexity and Increased Process Failure 305 

6 Pipeline Products 306 


6.2 Pipeline by Phase of Development 308 

6.3 Pipeline Product Profiles 310 



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7 Clinical Trials to Watch 347 


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

Therapies 351 

8 Current and Future Players 352 

8.1 Trends in Corporate Strategy 352 

8.1.1 Companion Diagnostics Business Models 352 

8.2 Company Profiles 353 

8.2.1 Pharmaceutical/Therapy Companies Developing Companion Diagnostic Tests 353 

8.2.2 Diagnostics Companies Developing Companion Diagnostic Tests (in Partnership with 

Pharmaceutical Companies) 409 

9 Market Outlooks 492 

9.1 By Market Segment 492 





9.1.5 Technique 504 

9.2 By Geography 507 

9.2.1 10 Major Markets Overview 507 

9.2.2 US 509 

9.2.3 France 510 

9.2.4 Germany 512 

9.2.5 Italy 514 

9.2.6 Spain 516 

9.2.7 UK 518 

9.2.8 Japan 520 

9.2.9 Brazil 523 


9.2.11 India 527 

10 Appendix 530 

10.1 Bibliography 530 

10.2 Abbreviations 582 

10.3 Report Methodology 584 

10.3.1 Coverage 584 

10.3.2 Secondary Research 585 

10.3.3 Forecasting Methodology 585 



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10.4 Physicians Included in this Study 587 

10.5 About the Authors 589 

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

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

10.5.3 Bonnie Bain, PhD, Global Head of Healthcare 590 

10.6 Disclaimer 591 

List of Tables 

Table 1: Possible Companion Diagnostic Test Platforms 30 

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

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

Table 4: Weaknesses of ELISA Technique 44 

Table 5: Key Stages of PCR Gene Test 47 

Table 6: Key Principles Guiding Companion Diagnostic Test Development 58 

Table 7: Companion Diagnostic Test Development Partner Selection 59 

Table 8: Biomarker Discovery 61 

Table 9: Disease Diagnosis, Treatment, and Monitoring 62 

Table 10: Application of Companion Diagnostic Tests 63 

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

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

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

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

Table 15: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the US, 2011- 

2020 75 

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

Table 17: Biomarkers tested for in France 77 

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

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

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

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

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

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

Table 24: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in France, 2011- 

2020 84 

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

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

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

Table 28: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Germany, 

2011-2020 91 

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



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

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

Table 32: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Italy, 2011- 

2020 100 

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

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

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

Table 36: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Spain, 2011- 

2020 105 

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

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

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

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

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

Table 42: Lung Cancer EGFR Tests in the UK 115 

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

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

Table 45: Cost of EGFR Testing in the UK 118 

Table 46: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the UK, 2011- 

2020 120 

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

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

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

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

Table 51: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Japan, 2011- 

2020 128 

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

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

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

Table 55: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Brazil, 2011- 

2020 134 

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

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

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

Table 59: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in China, 2011- 

2020 142 

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

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

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

Table 63: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in India, 2011- 

2020 149 



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Table 64: FDA Medical Device Classifications 151 

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

Table 66: EU Medical Device Classifications and Conformance Requirements 155 

Table 67: EU Medical Device Essential Requirements 156 

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

Table 69: Healthcare Systems in China 170 

Table 70: Healthcare Principles in China 171 

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

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

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

Tumors 191 

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

197 

Table 75: Key Mergers and Acquisitions during 2013-2014 201 

Table 76: Partnerships during 2013-2014 202 

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

Table 78: Effectiveness of Disease Therapies 214 

Table 79: HER2 FISH/iQFISH PharmDx Product Profile 228 

Table 80: Common Reasons for HER2 FISH Failure 230 

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

Table 82: HercepTest Product Profile 232 

Table 83: HercepTest Scoring Algorithm 233 

Table 84: HercepTest SWOT Analysis 235 

Table 85: HER2 CISH PharmDx Product Profile 236 

Table 86: HER2 CISH PharmDx SWOT Analysis 238 

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

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

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

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

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

Table 92: Biogenex INSITE HER2/Neu Product Profile 245 

Table 93: Biogenex INSITE HER2/Neu SWOT Analysis 247 

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

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

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

Table 97: Ventana 

List of Figures 

Figure 1: Genomic Sequencing Costs, 2001-2012 32 

Figure 2: Use of Proteomics in Personalized Medicine 34 



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Figure 3: Incidence of Inherited Breast Cancer Mutations among Diagnosed Breast Cancer 

Patients 36 

Figure 4: Basic FISH Process 46 

Figure 5: Basic PCR Process 48 

Figure 6: Impact of Sample Storage on PCR Outcome 49 

Figure 7: Genomic Sequencing Costs, 2001-2012 51 

Figure 8: Scientific and Economic Potential of Companion Diagnostics 55 

Figure 9: Drug and Diagnostic Test Co-Development 56 

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

Figure 11: Key Development Drivers for Companion Diagnostic Tests 59 

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

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

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

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

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

Figure 17: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the US, 2011- 

2020 74 

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

Figure 19: KRAS Testing in France 2008-2012 80 

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

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

Figure 22: EGFR Testing in France, 2008-2012 83 

Figure 23: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in France, 2011- 

2020 84 

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

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

87 

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

Figure 27: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Germany, 

2011-2020 91 

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

2002 92 

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

2002 93 

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

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

Quality Assessment Scheme 95 

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

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

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

Quality Assessment Scheme in 2013 98 



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Figure 35: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Italy, 2011- 

2020 99 

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

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

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

Figure 39: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Spain, 2011- 

2020 105 

Figure 40: UK HER2 Status Testing Algorithm 107 

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

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

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

Figure 44: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in the UK, 2011- 

2020 119 

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

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

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

Figure 48: EGFR Testing in Japan, 2006-2011 125 

Figure 49: Japanese Lung Cancer Society Diagnostic Testing Algorithm 127 

Figure 50: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Japan, 2011- 

2020 128 

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

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

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

Figure 54: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in Brazil, 2011- 

2020 134 

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

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

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

Figure 58: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in China, 2011- 

2020 142 

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

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

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

Figure 62: NSCLC Companion Diagnostic Testing (EGFR and ALK Mutation) in India, 2011- 

2020 149 

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

Figure 64: Healthcare Coverage Frameworks 178 

Figure 65: German Reimbursement Establishment Process 185 

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

Figure 67: UK Regional Access to Cancer Diagnostic Testing 192 

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



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

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

Figure 71: Increasing Medicare Cost of Treatment 210 

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

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

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

Figure 75: EGFR PharmDx Test Adoption Curve 263 

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

Figure 77: Scorpion Primers 280 

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

Figure 79: Reasons for Companion Diagnostic Test Failure 295 

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

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

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

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

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

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

349 

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

Figure 87: Global Sales Forecast for Breast Cancer Companion Diagnostic Tests ($m), 2011- 

2020 492 

Figure 88: Global Sales Forecast for Colorectal Cancer Companion Diagnostic Tests ($m), 2011- 

2020 494 

Figure 89: Global Sales Forecast for Melanoma Companion Diagnostic Tests ($ 

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