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

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

This report focuses on the predictive breast cancer gene testing markets in Europe (France, Germany, Italy, Spain, and the UK), and identifies unmet needs in the market, physician attitudes towards current gene testing, and the future of gene testing in the face of rapid technological advancement.

Scope

- An overview of Breast Cancer, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized EU Breast Cancer Gene Testing market revenue and future forecasts from 2009 to 2011, forecast for 7 years to 2018.
- Investigation of current and future market competition for Breast Cancer Gene Testing
- Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
- Competitor assessment including device approval analysis and device sales forecasts.
- Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
- Analysis of unmet needs within the market and opportunities for future players.
- Technology trends evaluation to assess strength of pipeline.
- An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
- Company profiles including business description, financial overview and SWOT analysis.
- Coverage of key market players.
- Strategic assessment of EU device sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL) as well as oncologists

Reasons to buy

- Understand the trends shaping and driving EU Breast Cancer Gene Testing Market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in EU Breast Cancer Gene Testing Market through 2018.
- Quantify candidate patient populations to better design product pricing & launch plans.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
- Perform benchmarking analysis of growth opportunities against currently marketed products.
- Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
- Take a comprehensive look at the market's device pipeline and identify promising, paradigm-shifting products.
- Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
- What's the next big thing in EU Breast Cancer Gene Testing market landscape? Identify, understand and capitalize.

Table of Contents

Table of Contents 8
1.1 List of Tables 14
1.2 List of Figures 17
2 Introduction 19
2.1 Catalyst 19
3 Disease Overview 20
3.1 Breast Cancer 20
3.2 Anatomy and Physiology 20
3.3 Pathophysiology 21
3.3.1 Inheritable High-Penetrance Gene Mutations 24
3.3.2 Inheritable Medium/Low-Penetrance Gene Mutations 27
3.4 Clinical Presentation 32
3.4.1 Family History 32
3.4.2 Physical Examination 32
3.4.3 Predictive Breast Cancer Gene Testing Overview 34
3.4.4 Clinical Guidelines 36
3.4.5 Follow-up Gene Testing 41
3.5 Clinical Outcomes 43
3.5.1 Treatment Options 43
3.5.2 Treatment Paradigm 44
3.6 Epidemiology 45
3.6.1 Prevalence 45
3.7 Economic Impact 49
3.7.1 Individual Costs 49
3.7.2 Industry Costs 50
4 Competitive Assessment 51
4.1 Overview 51
4.1.1 BRACAnalysis 52
4.1.2 BreastNext 61
4.1.3 BreastCancer 68
4.1.4 PreventionGenetics CHEK2/BARD1 Sequencing 71
4.1.5 NewGene NGS BRCA1/2 74
4.1.6 TDL BRCA1/2 Full Screening 76
4.1.7 Centogene Breast Ovarian Cancer NGS Panel 79
4.1.8 Mamma GeneProfile 82
4.1.9 23AndMe DNA Spit Kit 85
4.1.10 DeCodeMe Complete Scan 91
4.1.11 Health Compass 94
5 Unmet Needs 96
5.1 Genetic Counseling 97
5.2 Price 98
5.3 Interpretation of Results 100
5.4 Efficacy of the BRACAnalysis Test 101
5.5 Database Transparency 102
5.6 Test Validation 103
5.7 Undiscovered Mutations 104
5.8 Simplification of the Testing Process 104
5.9 Test Report Formats 105
5.10 Data Security 105
6 Pipeline Products 106
6.1 Predictive Breast Cancer Gene Tests in Development 106
6.1.1 Myriad Genetics RAD51C Breast Cancer Gene Test 107
6.1.2 23AndMe Exome 80X 108
6.2 Breast Cancer Gene Expression Tests 109
6.2.1 BreastGeneDX 110
6.2.2 Diagnostic Test - Breast Cancer (Queens University/Almac Diagnostics) 111
6.2.3 Diagnostic Test - Breast Cancer (NanoIVD) 112
6.2.4 EpiSwitch OBD27 113
6.2.5 Myriad HRD Test 114
6.2.6 PAM50 Breast Cancer Test 115
6.3 Emerging Sequencing Technology 116
6.4 New Gene Discovery 116
7 Industry Overview 117
7.1 Breast Cancer Testing Trends 117
7.1.1 Overview 117
7.1.2 Gene Test Analysis 119
7.1.3 Gene-Testing Hardware 122
7.2 Testing Volumes 127
7.2.1 Predictive Gene Test Volumes 127
7.2.2 Market Access 130
7.3 Adoption of Breast Cancer Gene Testing 132
7.4 Role of Genetic Counseling 135
7.5 Gene Testing Laboratories 138
7.6 Reimbursement Trends 139
7.7 Regulatory Issues/Recalls 140
7.7.1 Regulatory Issues 140
7.7.2 Recalls 142
7.8 Mergers & Acquisitions and Key Partnerships 143
8 Current and Future Players 145
8.1 Overview 145
8.2 Trends in Corporate Strategy 146
8.3 Common Strengths, Weaknesses, Opportunities and Threats 147
8.3.1 Growing Incidence of Breast Cancer 147
8.3.2 Uncertain R&D Outcomes 148
8.3.3 Stringent Government Regulations 148
8.4 Company Profiles 149
8.4.1 Myriad Genetics 149
8.4.2 Ambry Genetics 160
8.4.3 Complete Genomics 164
8.4.4 Navigenics (now Life Technologies) 169
8.4.5 PreventionGenetics 173
8.4.6 Lab21 Ltd. 175
8.4.7 NewGene Ltd. 179
8.4.8 The Doctors Laboratory Ltd. 182
8.4.9 Bioscientia GmBH 185
8.4.10 Centogene AG (Centogene Rostock GmBH) 187
8.4.11 Sistemas Genomicos 189
8.4.12 23AndMe 192
8.4.13 BGI-Shenzhen 201
8.4.14 Illumina 205
8.4.15 Life Technologies 213
8.4.16 Roche 219
9 Market Drivers and Opportunities and Barriers 223
9.1 Market Drivers 223
9.1.1 Reducing the Cost of Breast Cancer Care 223
9.1.2 Growing Number of Tests for Breast Cancer Gene Tests 225
9.1.3 Increased Awareness of Breast Cancer Gene Testing from Physicians and Patients 226
9.2 Opportunities 227
9.2.1 New Assays and New Sequencing Technologies 227
9.2.2 Alternative Methods to Predict Breast Cancer Risk 228
9.2.3 Population-Based Genomic Profiling 230
9.3 Market Barriers 231
9.3.1 Exhaustion of Test Candidates 231
9.3.2 Demographics 233
9.3.3 Reimbursement 233
9.3.4 Lack of Standardization 233
9.3.5 Complexity of Test Results 235
9.3.6 Shortage of Trained Personnel 236
9.3.7 Development of New Breast Cancer Treatments 237
9.4 Substitutes 238
9.4.1 Improved Risk Assessment Models 238
9.4.2 Development of Tests Based on Gene Expression Products 239
9.4.3 Increased Surveillance 239
9.4.4 Development of Biomarker Assays 240
10 Country Outlooks and Forecasts 241
10.1 EU Markets Overview 241
10.2 France 247
10.2.1 France Market Analysis 247
10.3 Germany 249
10.3.1 Germany Market Analysis 249
10.4 Italy 250
10.4.1 Italy Market Analysis 250
10.5 Spain 251
10.5.1 Spain Market Analysis 251
10.6 UK 252
10.6.1 UK Market Analysis 252
11 Appendix 254
11.1 Bibliography 254
11.2 Abbreviations 278
11.3 Research Methodology 280
11.3.1 Overview 280
11.3.2 Coverage 280
11.3.3 Secondary Research 280
11.3.4 Forecast Methodology 281
11.4 Physicians and Specialists Included in this Study 282
11.5 Primary Research 283
11.6 Physician Survey 283
11.7 About the Authors 284
11.7.1 Analysts 284
11.7.2 Global Head of Healthcare 285
11.8 Definitions 285
11.9 About MediPoint 286
11.10 About GlobalData 286
11.11 Contact Us 286
11.12 Disclaimer 287

List of Tables

Table 1: Main Breast Cancer Types 21
Table 2: Specific Cancer Types Associated with Inherited Disorders 23
Table 3: BRCA1/2 Mutation Occurrence by Ethnic Group 26
Table 4: BRCA1/2 Mutation Occurrence in Breast Cancer Cases by Ethnic Group 26
Table 5: CHEK2 Carrier Incidence in General Population 27
Table 6: Breast Cancer Risk Factors 33
Table 7: Manchester Scoring System 37
Table 8: Regional Differences in Prescribing Relatives for Breast Cancer Gene Test (Numbers per Physician) Including Expected Uptake (n=34) 41
Table 9: Breast Cancer Chemotherapies 43
Table 10: Cancer Cell Grading 44
Table 11: Selected 2002 Breast Cancer Incidence Rates 46
Table 12: BRACAnalysis Product Profile 52
Table 13: BRACAnalysis SWOT Analysis 60
Table 14: BreastNext Product Profile 61
Table 15: BreastNext SWOT Analysis 67
Table 16: BreastCancer Product Profile 68
Table 17: BreastCancer SWOT Analysis 70
Table 18: PreventionGenetics Product Profile 71
Table 19: PreventionGenetics SWOT Analysis 73
Table 20: NewGene NGS BRCA Product Profile 74
Table 21: NewGene NGS BRCA SWOT Analysis 75
Table 22: TDL BRCA Full Screen Product Profile 76
Table 23: TDL BRCA Full Screen SWOT Analysis 78
Table 24: Centogene Breast Ovarian Cancer NGS Panel Product Profile 79
Table 25: Centogene Breast Ovarian Cancer NGS Panel SWOT Analysis 81
Table 26: Mamma GeneProfile Product Profile 82
Table 27: Mamma GeneProfile SWOT Analysis 84
Table 28: 23AndMe Spit Kit Product Profile 85
Table 29: 23AndMe Spit Kit SWOT Analysis 90
Table 30: Complete Scan Product Profile 91
Table 31: Complete Scan SWOT Analysis 93
Table 32: Health Compass Product Profile 94
Table 33: Health Compass SWOT Analysis 95
Table 34: Predictive Breast Cancer Gene Test Product Pipeline 106
Table 35: Myriad Genetics RAD51C Breast Cancer Gene Test SWOT Analysis 107
Table 36: 23AndMe Exome 80X SWOT Analysis 108
Table 37: Breast Cancer Gene Expression Product Pipeline 109
Table 38: BreastDX SWOT Analysis 110
Table 39: Diagnostic Test - Breast Cancer (Queens University/Almac Diagnostics) SWOT Analysis 111
Table 40: NanoIVD Diagnostic Test - Breast Cancer SWOT Analysis 112
Table 41: EpiSwitch OBD27 SWOT Analysis 113
Table 42: Myriad HRD Test SWOT Analysis 114
Table 43: NanoString PAM50 Breast Cancer Test SWOT Analysis 115
Table 44: Key Mergers and Acquisitions during 2012 144
Table 45: Myriad Genetics SWOT Analysis 149
Table 46: Myriad Genetics Product Portfolio 150
Table 47: Myriad Genetics BRACAnalysis Key Patents 154
Table 48: Ambry Genetics SWOT Analysis 160
Table 49: Complete Genomics SWOT Analysis 164
Table 50: Navigenics SWOT Analysis 169
Table 51: PreventionGenetics SWOT Analysis 173
Table 52: Lab21 SWOT Analysis 175
Table 53: Sample Prices for NHS Gene Tests (November 2012) 178
Table 54: NewGene SWOT Analysis 179
Table 55: TDL SWOT Analysis 182
Table 56: Bioscientia SWOT Analysis 185
Table 57: Centogene SWOT Analysis 187
Table 58: Sistemas Genomicos SWOT Analysis 189
Table 59: 23AndMe SWOT Analysis 192
Table 60: BGI-Shenzhen SWOT Analysis 201
Table 61: Illumina SWOT Analysis 205
Table 62: Life Technologies SWOT Analysis 213
Table 63: Roche SWOT Analysis 219
Table 64: Skills Required for Breast Cancer Gene Testing 236
Table 65: Major Events Affecting the EU Predictive Breast Cancer Gene Test Market 241
Table 66: Sales Forecasts for Predictive Breast Cancer Gene Testing in the EU Markets, 2009–2018 242
Table 67: Forecasts for Numbers of Predictive Breast Cancer Gene Tests in the EU, 2009–2018 243
Table 68: Sales Forecasts for Predictive Breast Cancer Gene Testing in France, 2009–2018 247
Table 69: Sales Forecasts for Predictive Breast Cancer Gene Testing in Germany, 2009–2018 249
Table 70: Sales Forecasts for Predictive Breast Cancer Gene Testing in Italy, 2009–2018 250
Table 71: Sales Forecasts for Predictive Breast Cancer Gene Testing in Spain, 2009–2018 251
Table 72: Sales Forecasts for Predictive Breast Cancer Gene Testing in the UK, 2009–2018 252
Table 73: Physicians Surveyed, By Country 283

List of Figures

Figure 1: Breast Anatomy 20
Figure 2: Incidence of Inherited Breast Cancer Mutations amongst Diagnosed Breast Cancer Patients 22
Figure 3: BRCA1 and BRCA2 Gene Arrangement 24
Figure 4: NICE Guidelines 36
Figure 5: Genetic Tests Carried Out in England and Regional Genetics Centers, 1994–2002 38
Figure 6: EU Trends in Breast Cancer Incidence, 2009–2018 45
Figure 7: Breast Cancer Risk Factors 47
Figure 8: Compound Annual Growth Rate of Breast Cancer, 2012–2018 48
Figure 9: BRACAnalysis Product Family (2012) 54
Figure 10: BRACAnalysis, Number of Tests, 1997–2012 58
Figure 11: BreastNext Mutation Detection Frequency 62
Figure 12: Average Selling Price of Breast Cancer Gene Tests (November 2012) 66
Figure 13: Growth in 23AndMe Gene Testing, 2007–2012 89
Figure 14: EU Concerns on Breast Cancer Gene Testing (n=34) 99
Figure 15: Estimated Number of BRCA Tests Conducted Annually in the US and Europe, 2000–2012 118
Figure 16: Cumulative Numbers of BRCA Gene Tests in the US and Europe, 2000–2012 118
Figure 17: Genomic Sequencing Costs, 2001–2012 124
Figure 18: Growth in Genetic Testing in Europe, 1998–2002 125
Figure 19: Estimated Number of BRCA Tests Conducted Annually in the EU and US, 2000–2012 127
Figure 20: Projection of Increase in UK National Clinical Genomic Sequencing Capacity, 2014–2018 129
Figure 21: Adoption of Gene Tests by the UK NHS 130
Figure 22: Numbers of Patient Relatives Recommended for Breast Cancer Gene Testing Following a Positive Result, n=34 133
Figure 23: Reasons to Refuse a Breast Cancer Gene Test, n=34 134
Figure 24: Myriad Genetics Revenue and Profit, 2005–2012 151
Figure 25: BRCA Gene Testing by the UK Genetics Testing Network in 2010 157
Figure 26: Visual Representation of Hereditary Breast Cancer Genes (Ambry Genetics) 162
Figure 27: Estimated growth in 23AndMe Revenue, 2007–2012 193
Figure 28: Illumina Revenue and Profit, 2005–2011 209
Figure 29: Life Technologies Revenue and Profit, 2007–2011 215
Figure 30: Roche Revenue and Profit, 2005–2011 220
Figure 31: Growth in Physician-Ordered Breast Cancer Gene Tests within the EU (n=34) 225
Figure 32: Growth in Patient-Demanded Breast Cancer Gene Tests in the EU, (n=34), 2009–2015 226
Figure 33: Action Following a Gene Test, (n=34) 235
Figure 34: Breast Cancer Incidence and Mortality in England, 1971–2010 237
Figure 35: Predictive Breast Cancer Gene Tests Per Year in the EU, 2009–2018 241
Figure 36: EU Sales Forecast for Predictive Breast Cancer Gene Testing, 2009–2018 242
Figure 37: EU Forecast for Numbers of Predictive Breast Cancer Gene Tests, 2009–2018 243
Figure 38: EU Revenue Segmentation for Gene Tests, by Type, 2011 and 2018 244
Figure 39: Market by Company (Gene Test Revenue, All Tests), 2011 245
Figure 40: EU Market by Number of BRCA Tests Performed, 2011 246
Figure 41: Sales Forecasts for Predictive Breast Cancer Gene Testing in France, 2009–2018 247
Figure 42: Sales Forecasts for Predictive Breast Cancer Gene Testing in Germany, 2009–2018 249
Figure 43: Sales Forecasts for Predictive Breast Cancer Gene Testing in Italy, 2009–2018 250
Figure 44: Sales Forecasts for Predictive Breast Cancer Gene Testing in Spain, 2009–2018 251
Figure 45: Sales Forecasts for Predictive Breast Cancer Gene Testing in the UK, 2009–2018 252
Figure 46: UK Segmentation for Gene Tests, by Type, 2011 and 2018 253

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Pathology Industry: MediPoint: Predictive Breast Cancer Gene Testing - EU Analysis and Market Forecasts

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