MediPoint: Predictive Breast Cancer Gene Testing - Global Analysis and Market Forecasts

Summary

Breast cancer is the most common form of cancer in women in both the developed and developing world. The incidence of breast cancer is increasing due to the increased life span and increasing adoption of Western lifestyle risk factors. Predictive breast cancer gene tests can be used to identify women who are at increased risk of developing hereditary breast cancer. The Predictive Breast Cancer Gene Testing market has seen exponential growth in the US, dominated by Myriad Genetics. Gene testing in Europe is mostly carried out by the state funded health sector, but increasingly private companies are offering breast cancer gene tests to physicians. Myriad Genetics’ position in the market is dependent on it being the leading provider of the most common breast cancer mutations. By the end of our forecast period, the competitive landscape will experience significant change due to the erosion of Myriad Genetics’ position, as a result of the expiry of key patents, and the emergence of alternative molecular technologies.

Highlights

Key Questions Answered

- Breast cancer can be caused by inherited mutations. Many of these mutations can be detected by genetic tests. How will predictive breast cancer gene testing be affected by the growing incidence of breast cancer? What are the true drivers for volumes of gene tests? Are secondary referrals to patients’ relatives having an indirect effect on the number of tests carried out?
- The most common breast cancer gene test is for the BRCA gene. What shifts are going to happen in the number of BRCA tests carried out?
- Predictive breast cancer gene testing is dominated by a single provider who has exclusive rights to a patented gene test. How will the expiry of patents during the forecast relating to the test affect sales of predictive breast cancer gene tests? How has this monopoly affected sales of predictive breast cancer gene tests?
- Gene testing is a fast evolving technological area. How will change in technology affect sales of predictive breast cancer gene tests? Who are the new players in gene testing? How will patient attitudes affect the predictive breast cancer gene testing market?

Scope

- Overview of breast cancer and breast cancer gene testing, including epidemiology, etiology, diagnosis, pathology, treatment guidelines, gene testing technologies and evolving regulatory structures
- Annualized Predictive Breast Cancer Gene Testing market revenue, annual cost of gene testing and breast cancer gene testing volume data from 2009-2011 and forecast for seven years to 2018
- Key topics covered include strategic competitor assessment, market characterization, identification of unmet needs, reimbursement considerations, and implications for the predictive breast cancer gene testing market
- Pipeline analysis: Emerging breast cancer gene tests, both predictive gene tests and gene expression tests, emerging platform technologies, new breast cancer gene discoveries
- Analysis of the current and future market competition in the global predictive breast cancer gene testing market. Insightful review of the key industry drivers, opportunities, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications

Reasons to buy

- “What Physicians Think” quotes provide a unique insight into how healthcare professionals are reacting to events within the industry, and what their responses could mean for industry strategists. In this report you will understand the perceptions of leading Medical Geneticists, Genetic Counselors and Breast Surgeons from around the world. This information is essential for all strategic decision makers in every organization allowing them to act on high quality information.

Table Of Contents

Table of Contents

1 Table of Contents 9
1.1 List of Tables 16
1.2 List of Figures 20
2 Introduction 23
2.1 Catalyst 23
2.2 Upcoming Related Reports 23
3 Disease Overview 24
3.1 Breast Cancer 24
3.2 Anatomy and Physiology 24
3.3 Pathophysiology 25
3.3.1 Inheritable High-Penetrance Gene Mutations 28
3.3.2 Inheritable Medium/Low-Penetrance Gene Mutations 31
3.4 Clinical Presentation 36
3.4.1 Family History 36
3.4.2 Physical Examination 36
3.4.3 Predictive Breast Cancer Gene Testing Overview 38
3.4.4 Clinical Guidelines 39
3.4.5 Follow-up Gene Testing 51
3.5 Clinical Outcomes 53
3.5.1 Treatment Options 53
3.5.2 Treatment Paradigm 55
3.6 Epidemiology 56
3.6.1 Prevalence 56
3.7 Economic Impact 60
3.7.1 Individual Costs 60
3.7.2 Industry Costs 61
4 Competitive Assessment 62
4.1 Overview 62
4.1.1 BRACAnalysis 63
4.1.2 BreastNext 71
4.1.3 BreastCancer 78
4.1.4 PreventionGenetics CHEK2/BARD1 Sequencing 81
4.1.5 NewGene NGS BRCA1/2 84
4.1.6 TDL BRCA1/2 Full Screening 86
4.1.7 Centogene Breast Ovarian Cancer NGS Panel 89
4.1.8 Mamma GeneProfile 92
4.1.9 23AndMe DNA Spit Kit 95
4.1.10 DeCodeMe Complete Scan 101
4.1.11 Health Compass 104
5 Unmet Needs 106
5.1 Genetic Counseling 107
5.2 Price 108
5.3 Interpretation of Results 110
5.4 Efficacy of the BRACAnalysis Test 111
5.5 Database Transparency 112
5.6 Test Validation 113
5.7 Undiscovered Mutations 115
5.8 Simplification of the Testing Process 115
5.9 Test Report Formats 115
5.10 Data Security 116
6 Pipeline Products 117
6.1 Predictive Breast Cancer Gene Tests in Development 117
6.1.1 Myriad Genetics RAD51C Breast Cancer Gene Test 118
6.1.2 23AndMe Exome 80X 119
6.2 Breast Cancer Gene Expression Tests 120
6.2.1 BreastGeneDX 121
6.2.2 Diagnostic Test - Breast Cancer (Queens University/Almac Diagnostics) 122
6.2.3 Diagnostic Test - Breast Cancer (NanoIVD) 123
6.2.4 EpiSwitch OBD27 124
6.2.5 Myriad HRD Test 125
6.2.6 PAM50 Breast Cancer Test 126
6.3 Emerging Sequencing Technology 127
6.4 New Gene Discovery 127
7 Industry Overview 128
7.1 Breast Cancer Testing Trends 128
7.1.1 Overview 128
7.1.2 Gene Test Analysis 130
7.1.3 Gene-Testing Hardware 133
7.1.4 Laboratory-Developed Tests 136
7.2 Testing Volumes 140
7.2.1 US 140
7.2.2 EU 141
7.2.3 APAC 144
7.2.4 Brazil 145
7.3 Market Access 146
7.3.1 US 146
7.3.2 EU 146
7.3.3 APAC 148
7.3.4 Brazil 149
7.4 Adoption of Breast Cancer Gene Testing 150
7.5 Role of Genetic Counseling 153
7.6 Gene Testing Laboratories 156
7.7 Reimbursement Trends 157
7.7.1 US 157
7.7.2 EU 158
7.7.3 APAC 159
7.7.4 Brazil 159
7.8 Regulatory Issues/Recalls 160
7.8.1 US 160
7.8.2 EU 162
7.8.3 Recalls 163
7.9 Mergers and Acquisitions and Key Partnerships 164
8 Current and Future Players 166
8.1 Overview 166
8.2 Trends in Corporate Strategy 167
8.3 Common Strengths, Weaknesses, Opportunities and Threats 168
8.3.1 Growing Incidence of Breast Cancer 168
8.3.2 Growing Market Opportunities in Emerging Markets 169
8.3.3 Uncertain RandD Outcomes 170
8.3.4 Stringent Government Regulations 170
8.4 Company Profiles 171
8.4.1 Myriad Genetics 171
8.4.2 Ambry Genetics 182
8.4.3 Complete Genomics 186
8.4.4 Navigenics (now Life Technologies) 191
8.4.5 PreventionGenetics 195
8.4.6 Lab21 Ltd. 197
8.4.7 NewGene Ltd. 201
8.4.8 The Doctors Laboratory Ltd. 204
8.4.9 Bioscientia GmBH 207
8.4.10 Centogene AG (Centogene Rostock GmBH) 209
8.4.11 Sistemas Genomicos 211
8.4.12 Grupo Fleury 214
8.4.13 Diagnosticos da America SA (DASA) 217
8.4.14 ATS GeneTech 220
8.4.15 23AndMe 224
8.4.16 BGI-Shenzhen 233
8.4.17 Illumina 237
8.4.18 Life Technologies 245
8.4.19 Roche 251
9 Market Drivers and Opportunities and Barriers 255
9.1 Market Drivers 255
9.1.1 Reducing the Cost of Breast Cancer Care 255
9.1.2 Growing Number of Tests for Breast Cancer Gene Tests 257
9.1.3 Increased Awareness of Breast Cancer Gene Testing from Physicians and Patients 258
9.2 Opportunities 259
9.2.1 New Assays and New Sequencing Technologies 259
9.2.2 Alternative Methods to Predict Breast Cancer Risk 260
9.2.3 Population-Based Genomic Profiling 262
9.3 Market Barriers 263
9.3.1 Exhaustion of Test Candidates 263
9.3.2 Demographics 264
9.3.3 Reimbursement 265
9.3.4 Lack of Standardization 265
9.3.5 Complexity of Test Results 267
9.3.6 Shortage of Trained Personnel 268
9.3.7 Development of New Breast Cancer Treatments 269
9.4 Substitutes 270
9.4.1 Improved Risk Assessment Models 270
9.4.2 Development of Tests Based on Gene Expression Products 271
9.4.3 Increased Surveillance 271
9.4.4 Development of Biomarker Assays 272
10 Country Outlooks and Forecasts 273
10.1 Major Markets Overview 273
10.2 US 280
10.2.1 US Market Analysis 280
10.3 France 283
10.3.1 France Market Analysis 283
10.4 Germany 285
10.4.1 Germany Market Analysis 285
10.5 Italy 286
10.5.1 Italy Market Analysis 286
10.6 Spain 287
10.6.1 Spain Market Analysis 287
10.7 UK 288
10.7.1 UK Market Analysis 288
10.8 Rest of the World 290
10.8.1 Japan Market Analysis 290
10.8.2 Brazil Market Analysis 291
10.8.3 China Market Analysis 292
10.8.4 India Market Analysis 293
11 Appendix 295
11.1 Bibliography 295
11.2 Abbreviations 321
11.3 Research Methodology 323
11.3.1 Overview 323
11.3.2 Coverage 323
11.3.3 Secondary Research 323
11.3.4 Forecast Methodology 324
11.4 Physicians and Specialists Included in this Study 326
11.5 Primary Research 327
11.6 Physician Survey 327
11.7 About the Authors 328
11.7.1 Analysts 328
11.7.2 Global Head of Healthcare 329
11.8 Definitions 330
11.9 About MediPoint 331
11.10 About GlobalData 331
11.11 Contact Us 331
11.12 Disclaimer 332



List of Tables

Table 1: Main Breast Cancer Types 25
Table 2: Specific Cancer Types Associated with Inherited Disorders 27
Table 3: BRCA1/2 Mutation Occurrence by Ethnic Group 30
Table 4: BRCA1/2 Mutation Occurrence in Breast Cancer Cases by Ethnic Group 30
Table 5: CHEK2 Carrier Incidence in General Population 31
Table 6: Breast Cancer Risk Factors 37
Table 7: Manchester Scoring System 44
Table 8: Regional Differences in Prescribing Relatives for Breast Cancer Gene Test (Numbers per Physician) Including Expected Uptake (n=69) 51
Table 9: Breast Cancer Chemotherapies 54
Table 10: Cancer Cell Grading 55
Table 11: Selected 2002 Breast Cancer Incidence Rates 57
Table 12: BRACAnalysis Product Profile 63
Table 13: BRACAnalysis SWOT Analysis 70
Table 14: BreastNext Product Profile 71
Table 15: BreastNext SWOT Analysis 77
Table 16: BreastCancer Product Profile 78
Table 17: BreastCancer SWOT Analysis 80
Table 18: PreventionGenetics Product Profile 81
Table 19: PreventionGenetics SWOT Analysis 83
Table 20: NewGene NGS BRCA Product Profile 84
Table 21: NewGene NGS BRCA SWOT Analysis 85
Table 22: TDL BRCA Full Screen Product Profile 86
Table 23: TDL BRCA Full Screen SWOT Analysis 88
Table 24: Centogene Breast Ovarian Cancer NGS Panel Product Profile 89
Table 25: Centogene Breast Ovarian Cancer NGS Panel SWOT Analysis 91
Table 26: Mamma GeneProfile Product Profile 92
Table 27: Mama GeneProfile SWOT Analysis 94
Table 28: 23AndMe Spit Kit Product Profile 95
Table 29: 23AndMe Spit Kit SWOT Analysis 100
Table 30: Complete Scan Product Profile 101
Table 31: Complete Scan SWOT Analysis 103
Table 32: Health Compass Product Profile 104
Table 33: Health Compass SWOT Analysis 105
Table 34: Predictive Breast Cancer Gene Test Product Pipeline 117
Table 35: Myriad Genetics RAD51C Breast Cancer Gene Test SWOT Analysis 118
Table 36: 23AndMe Exome 80X SWOT Analysis 119
Table 37: Breast Cancer Gene Expression Product Pipeline 120
Table 38: BreastDX SWOT Analysis 121
Table 39: Diagnostic Test - Breast Cancer (Queens University/Almac Diagnostics) SWOT Analysis 122
Table 40: NanoIVD Diagnostic Test - Breast Cancer SWOT Analysis 123
Table 41: EpiSwitch OBD27 SWOT Analysis 124
Table 42: Myriad HRD Test SWOT Analysis 125
Table 43: NanoString PAM50 Breast Cancer Test SWOT Analysis 126
Table 44: Key Mergers and Acquisitions during 2012 165
Table 45: Myriad Genetics SWOT Analysis 171
Table 46: Myriad Genetics Product Portfolio 172
Table 47: Myriad Genetics BRACAnalysis Key Patents 176
Table 48: Ambry Genetics SWOT Analysis 182
Table 49: Complete Genomics SWOT Analysis 186
Table 50: Navigenics SWOT Analysis 191
Table 51: PreventionGenetics SWOT Analysis 195
Table 52: Lab21 SWOT Analysis 197
Table 53: Sample Prices for NHS Gene Tests (November 2012) 200
Table 54: NewGene SWOT Analysis 201
Table 55: TDL SWOT Analysis 204
Table 56: Bioscientia SWOT Analysis 207
Table 57: Centogene SWOT Analysis 209
Table 58: Sistemas Genomicos SWOT Analysis 211
Table 59: Grupo Fleury SWOT Analysis 214
Table 60: DASA SWOT Analysis 217
Table 61: ATS GeneTech SWOT Analysis 220
Table 62: BRCA Breast Cancer Scientific Publications and Breast Cancer Incidence 223
Table 63: 23AndMe SWOT Analysis 224
Table 64: BGI-Shenzhen SWOT Analysis 233
Table 65: Illumina SWOT Analysis 237
Table 66: Life Technologies SWOT Analysis 245
Table 67: Roche SWOT Analysis 251
Table 68: Skills Required for Breast Cancer Gene Testing 268
Table 69: Major Events Affecting the Global Predictive Breast Cancer Market 273
Table 70: Sales Forecasts for Predictive Breast Cancer Gene Testing in the 10 Major Markets, 2009-2018 274
Table 71: Forecasts for Numbers of Predictive Breast Cancer Gene Tests in the 10 Major Markets, 2009-2018 275
Table 72: Sales Forecasts for Predictive Breast Cancer Gene Testing in the US, 2009-2018 280
Table 73: Sales Forecasts for Predictive Breast Cancer Gene Testing in France, 2009-2018 283
Table 74: Sales Forecasts for Predictive Breast Cancer Gene Testing in Germany, 2009-2018 285
Table 75: Sales Forecasts for Predictive Breast Cancer Gene Testing in Italy, 2009-2018 286
Table 76: Sales Forecasts for Predictive Breast Cancer Gene Testing in Spain, 2009-2018 287
Table 77: Sales Forecasts for Predictive Breast Cancer Gene Testing in the UK, 2009-2018 288
Table 78: Sales Forecasts for Predictive Breast Cancer Gene Testing in Japan, 2009-2018 290
Table 79: Sales Forecasts for Predictive Breast Cancer Gene Testing in Brazil, 2009-2018 291
Table 80: Sales Forecasts for Predictive Breast Cancer Gene Testing in China, 2009-2018 292
Table 81: Sales Forecasts for Predictive Breast Cancer Gene Testing in India, 2009-2018 293
Table 82: Physicians Surveyed, By Country 327

1.2 List of Figures
Figure 1: Breast Anatomy 24
Figure 2: Incidence of Inherited Breast Cancer Mutations amongst Diagnosed Breast Cancer Patients 26
Figure 3: BRCA1 and BRCA2 Gene Arrangement 28
Figure 4: USPSTF Guidelines for Inherited Breast Cancer Gene Testing 40
Figure 5: Wellcare Treatment Guidelines 42
Figure 6: NICE Guidelines 43
Figure 7: Genetic Tests Carried Out in England and Regional Genetics Centers, 1994-2002 45
Figure 8: Breast Cancer Gene Test Selection Process in India 49
Figure 9: Global Trends in Breast Cancer Incidence, 2008-2018 56
Figure 10: Breast Cancer Risk Factors 58
Figure 11: Compound Annual Growth Rate of Breast Cancer, 2012-2018 59
Figure 12: BRACAnalysis Product Family (2012) 64
Figure 13: BRACAnalysis, Number of Tests, 1997-2012 68
Figure 14: BreastNext Mutation Detection Frequency 72
Figure 15: Average Selling Price of Breast Cancer Gene Tests (November 2012) 76
Figure 16: Growth in 23AndMe Gene Testing, 2007-2012 99
Figure 17: Global Concerns on Breast Cancer Gene Testing (n=69) 109
Figure 18: Estimated Number of BRCA Tests Conducted Annually in the US and Europe, 2000-2012 129
Figure 19: Cumulative Numbers of BRCA Gene Tests in the US and Europe, 2000-2012 129
Figure 20: Genomic Sequencing Costs, 2001-2011 135
Figure 21: Growth in Gene Testing Capability in the US 137
Figure 22: DTP and DTC Gene Tests offered by CLIA-Accredited Laboratories, 2011 137
Figure 23: Growth in Genetic Testing in Europe, 1998-2002 139
Figure 24: Estimated Number of BRCA Tests Conducted Annually in the US, 2000-2012 140
Figure 25: Estimated Number of BRCA Tests Conducted Annually in Europe, 2000-2012 141
Figure 26: Projection of Increase in UK National Clinical Genomic Sequencing Capacity, 2014-2018 143
Figure 27: Adoption of Gene Tests by the UK NHS 147
Figure 28: Numbers of Patient Relatives Recommended for Breast Cancer Gene Testing Following a Positive Result, n=69 151
Figure 29: Reasons to Refuse a Breast Cancer Gene Test, n=69 152
Figure 30: Myriad Genetics Revenue and Profit, 2005-2012 173
Figure 31: BRCA Gene Testing by the UK Genetics Testing Network in 2010 179
Figure 32: Visual Representation of Hereditary Breast Cancer Genes (Ambry Genetics) 184
Figure 33: Fleury Revenue and Profitability, 2006-2011 215
Figure 34: DASA Financial Performance, 2005-2011 218
Figure 35: Gene Test Provider Brand Recognition in India, n=7 221
Figure 36: Estimated growth in 23AndMe Revenue, 2007-2012 225
Figure 37: Illumina Revenue and Profit, 2005-2011 241
Figure 38: Life Technologies Revenue and Profit, 2007-2011 247
Figure 39: Roche Revenue and Profit, 2005-2011 252
Figure 40: Growth in Physician-Ordered Breast Cancer Gene Tests, n=69 257
Figure 41: Growth in Patient-Demanded Breast Cancer Gene Tests, n=69, 2009-2015 258
Figure 42: Breast Cancer Occurrence Following a Gene Test, n=69 267
Figure 43: Breast Cancer Incidence and Mortality in England, 1970-2010 269
Figure 44: Predictive Breast Cancer Gene Tests Per Year in the US and 5EU, 2009-2018 273
Figure 45: Global Sales Forecast for Predictive Breast Cancer Gene Testing, 2009-2018 274
Figure 46: Global Forecast for Numbers of Predictive Breast Cancer Gene Tests, 2009-2018 275
Figure 47: Global Sales for Breast Cancer Gene Testing, by Region, 2018 276
Figure 48: Global Revenue Segmentation for Gene Tests, by Type, 2011 and 2018 277
Figure 49: Market by Company (Gene Test Revenue, All Tests), 2011 279
Figure 50: Market by Number of BRCA Tests Performed, 2011 279
Figure 51: Sales Forecasts for Predictive Breast Cancer Gene Testing in the US, 2009-2018 280
Figure 52: US Segmentation for Gene Tests, by Type, 2011 and 2018 281
Figure 53: Sales Forecasts for Predictive Breast Cancer Gene Testing in France, 2009-2018 283
Figure 54: Sales Forecasts for Predictive Breast Cancer Gene Testing in Germany, 2009-2018 285
Figure 55: Sales Forecasts for Predictive Breast Cancer Gene Testing in Italy, 2009-2018 286
Figure 56: Sales Forecasts for Predictive Breast Cancer Gene Testing in Spain, 2009-2018 287
Figure 57: Sales Forecasts for Predictive Breast Cancer Gene Testing in the UK, 2009-2018 288
Figure 58: UK Segmentation for Gene Tests, by Type, 2011 and 2018 289
Figure 59: Sales Forecasts for Predictive Breast Cancer Gene Testing in Japan, 2009-2018 290
Figure 60: Sales Forecasts for Predictive Breast Cancer Gene Testing in Brazil, 2009-2018 291
Figure 61: Sales Forecasts for Predictive Breast Cancer Gene Testing in China, 2009-2018 292
Figure 62: Sales Forecasts for Predictive Breast Cancer Gene Testing in India, 2009-2018 293



Companies Mentioned

Myriad Genetics
Ambry Genetics
Complete Genomics
Navigenics (now Life Technologies)
PreventionGenetics
Lab21 Ltd.
NewGene Ltd.
The Doctors Laboratory Ltd.
Bioscientia GmBH
Centogene AG (Centogene Rostock GmBH)
Sistemas Genomicos
Grupo Fleury
Diagnosticos da America SA (DASA)
ATS GeneTech
23AndMe
BGI-Shenzhen
Illumina
Life Technologies
Roche

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