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MediPoint: Predictive Breast Cancer Gene Testing - US 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 the US 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 US 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 the US 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 the US 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 the US 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 the US Breast Cancer Gene Testing market landscape? Identify, understand and capitalize.

TOC

1 Table of Contents

1 Table of Contents 7

  • 1.1 List of Tables 12
  • 1.2 List of Figures 14

2 Introduction 16

  • 2.1 Catalyst 16

3 Disease Overview 17

  • 3.1 Breast Cancer 17
  • 3.2 Anatomy and Physiology 17
  • 3.3 Pathophysiology 18
    • 3.3.1 Inheritable High-Penetrance Gene Mutations 21
    • 3.3.2 Inheritable Medium/Low-Penetrance Gene Mutations 25
  • 3.4 Clinical Presentation 29

3.4.1 Family History 29

    • 3.4.2 Physical Examination 29
    • 3.4.3 Predictive Breast Cancer Gene Testing Overview 31
    • 3.4.4 Clinical Guidelines 33
    • 3.4.5 Follow-up Gene Testing 37
  • 3.5 Clinical Outcomes 39
    • 3.5.1 Treatment Options 39
    • 3.5.2 Treatment Paradigm 40
  • 3.6 Epidemiology 41
    • 3.6.1 Prevalence 41
  • 3.7 Economic Impact 43
    • 3.7.1 Individual Costs 43
    • 3.7.2 Industry Costs 44

4 Competitive Assessment 45

  • 4.1 Overview 45
    • 4.1.1 BRACAnalysis 46
    • 4.1.2 BreastNext 54
    • 4.1.3 BreastCancer 60
    • 4.1.4 PreventionGenetics CHEK2/BARD1 Sequencing 63
    • 4.1.5 23AndMe DNA Spit Kit 66
    • 4.1.6 DeCodeMe Complete Scan 72
    • 4.1.7 Health Compass 75

5 Unmet Needs 77

  • 5.1 Efficacy of the BRACAnalysis Test 78
  • 5.2 Interpretation of Results 79
  • 5.3 Test Report Formats 80
  • 5.4 Price 80
  • 5.5 Data Security 82
  • 5.6 Genetic Counseling 83
  • 5.7 Database Transparency 83
  • 5.8 Test Validation 84
  • 5.9 Undiscovered Mutations 85
  • 5.10 Simplification of the Testing Process 86

6 Pipeline Products 87

  • 6.1 Predictive Breast Cancer Gene Tests in Development 87
    • 6.1.1 Myriad Genetics RAD51C Breast Cancer Gene Test 88
    • 6.1.2 23AndMe Exome 80X 89
  • 6.2 Breast Cancer Gene Expression Tests 90
    • 6.2.1 BreastGeneDX 91
    • 6.2.2 Diagnostic Test - Breast Cancer (Queens University/Almac Diagnostics) 92
    • 6.2.3 Diagnostic Test - Breast Cancer (NanoIVD) 93
    • 6.2.4 EpiSwitch OBD27 94
    • 6.2.5 Myriad HRD Test 95
    • 6.2.6 PAM50 Breast Cancer Test 96
  • 6.3 Emerging Sequencing Technology 97
  • 6.4 New Gene Discovery 97

7 Industry Overview 98

  • 7.1 Breast Cancer Testing Trends 98
    • 7.1.1 Overview 98
    • 7.1.2 Gene Test Analysis 99
    • 7.1.3 Gene-Testing Hardware 102
    • 7.1.4 Laboratory-Developed Tests 105
  • 7.2 Testing Volumes 108
  • 7.3 Market Access 110
    • 7.3.1 Adoption of Breast Cancer Gene Testing 111
  • 7.4 Role of Genetic Counseling 114
  • 7.5 Gene Testing Laboratories 117
  • 7.6 Reimbursement Trends 118
    • 7.6.1 Regulatory Issues/Recalls 119
  • 7.7 Mergers & Acquisitions and Key Partnerships 122

8 Current and Future Players 124

  • 8.1 Overview 124
  • 8.2 Trends in Corporate Strategy 125
  • 8.3 Common Strengths, Weaknesses, Opportunities and Threats 126
    • 8.3.1 Growing Incidence of Breast Cancer 126
    • 8.3.2 Uncertain R&D Outcomes 127
    • 8.3.3 Stringent Government Regulations 127
  • 8.4 Company Profiles 128
    • 8.4.1 Myriad Genetics 128
    • 8.4.2 Ambry Genetics 139
    • 8.4.3 Complete Genomics 143
    • 8.4.4 Navigenics (now Life Technologies) 148
    • 8.4.5 PreventionGenetics 152
    • 8.4.6 23AndMe 154
    • 8.4.7 BGI-Shenzhen 163
    • 8.4.8 Illumina 167
    • 8.4.9 Life Technologies 175
    • 8.4.10 Roche 181

9 Market Drivers, Opportunities and Barriers 185

  • 9.1 Market Drivers 185
    • 9.1.1 Reducing the Cost of Breast Cancer Care 185
    • 9.1.2 Growing Number of Tests for Breast Cancer Gene Tests 186
    • 9.1.3 Increased Awareness of Breast Cancer Gene Testing from Physicians and Patients 187
  • 9.2 Opportunities 188
    • 9.2.1 New Assays and New Sequencing Technologies 188
    • 9.2.2 Alternative Methods to Predict Breast Cancer Risk 189
    • 9.2.3 Population-Based Genomic Profiling 191
  • 9.3 Market Barriers 192
    • 9.3.1 Exhaustion of Test Candidates 192
    • 9.3.2 Demographics 193
    • 9.3.3 Reimbursement 194
    • 9.3.4 Lack of Standardization 194
    • 9.3.5 Complexity of Test Results 196
    • 9.3.6 Shortage of Trained Personnel 197
    • 9.3.7 Development of New Breast Cancer Treatments 198
  • 9.4 Substitutes 199
    • 9.4.1 Improved Risk Assessment Models 199
    • 9.4.2 Development of Tests Based on Gene Expression Products 200
    • 9.4.3 Increased Surveillance 200
    • 9.4.4 Development of Biomarker Assays 201

10 US Outlook and Forecasts 202

  • 10.1 Market Overview 202
  • 10.2 US Market Analysis 202

11 Appendix 206

  • 11.1 Bibliography 206
  • 11.2 Abbreviations 227
  • 11.3 Research Methodology 229
    • 11.3.1 Overview 229
    • 11.3.2 Coverage 229
    • 11.3.3 Secondary Research 229
    • 11.3.4 Forecast Methodology 230
  • 11.4 Physicians and Specialists Included in this Study 231
  • 11.5 Primary Research 232
  • 11.6 Physician Survey 232
  • 11.7 About the Authors 232
    • 11.7.1 Analysts 232
    • 11.7.2 Global Head of Healthcare 233
  • 11.8 Definitions 234
  • 11.9 About MediPoint 235
  • 11.10 About GlobalData 235
  • 11.11 Contact Us 235
  • 11.12 Disclaimer 235

List of Tables

1.1 List of Tables

  • Table 1: Main Breast Cancer Types 18
  • Table 2: Specific Cancer Types Associated with Inherited Disorders 20
  • Table 3: BRCA1/2 Mutation Occurrence by Ethnic Group 23
  • Table 4: BRCA1/2 Mutation Occurrence in Breast Cancer Cases by Ethnic Group 23
  • Table 5: Breast Cancer Risk Factors 30
  • Table 6: Patterns in Prescribing Relatives for Breast Cancer Gene Test (Numbers per Physician) Including Expected Uptake (n=25) 37
  • Table 7: Breast Cancer Chemotherapies 39
  • Table 8: Cancer Cell Grading 40
  • Table 9: Selected 2002 Breast Cancer Incidence Rates 41
  • Table 10: BRACAnalysis Product Profile 46

Table 11: BRACAnalysis SWOT Analysis 53

  • Table 12: BreastNext Product Profile 54

Table 13: BreastNext SWOT Analysis 59

  • Table 14: BreastCancer Product Profile 60

Table 15: BreastCancer SWOT Analysis 62

  • Table 16: PreventionGenetics Product Profile 63

Table 17: PreventionGenetics SWOT Analysis 65

  • Table 18: 23AndMe Spit Kit Product Profile 66

Table 19: 23AndMe Spit Kit SWOT Analysis 71

  • Table 20: Complete Scan Product Profile 72

Table 21: Complete Scan SWOT Analysis 74

  • Table 22: Health Compass Product Profile 75

Table 23: Health Compass SWOT Analysis 76

  • Table 24: Predictive Breast Cancer Gene Test Product Pipeline 87

Table 25: Myriad Genetics RAD51C Breast Cancer Gene Test SWOT Analysis 88

Table 26: 23AndMe Exome 80X SWOT Analysis 89

  • Table 27: Breast Cancer Gene Expression Product Pipeline 90

Table 28: BreastDX SWOT Analysis 91

Table 29: Diagnostic Test - Breast Cancer (Queens University/Almac Diagnostics) SWOT Analysis 92

Table 30: NanoIVD Diagnostic Test - Breast Cancer SWOT Analysis 93

Table 31: EpiSwitch OBD27 SWOT Analysis 94

Table 32: Myriad HRD Test SWOT Analysis 95

Table 33: NanoString PAM50 Breast Cancer Test SWOT Analysis 96

  • Table 34: Key Mergers and Acquisitions during 2012 123

Table 35: Myriad Genetics SWOT Analysis 128

  • Table 36: Myriad Genetics Product Portfolio 129
  • Table 37: Myriad Genetics BRACAnalysis Key Patents 133

Table 38: Ambry Genetics SWOT Analysis 139

Table 39: Complete Genomics SWOT Analysis 143

Table 40: Navigenics SWOT Analysis 148

Table 41: PreventionGenetics SWOT Analysis 152

Table 42: 23AndMe SWOT Analysis 154

Table 43: BGI-Shenzhen SWOT Analysis 163

Table 44: Illumina SWOT Analysis 167

Table 45: Life Technologies SWOT Analysis 175

Table 46: Roche SWOT Analysis 181

  • Table 47: Skills Required for Breast Cancer Gene Testing 197
  • Table 48: Major Events Affecting the US Predictive Breast Cancer Gene Test Market 202
  • Table 49: Sales Forecasts for Predictive Breast Cancer Gene Testing in the US, 2009-2018 203

List of Figures

1.2 List of Figures

  • Figure 1: Breast Anatomy 17
  • Figure 2: Incidence of Inherited Breast Cancer Mutations amongst Diagnosed Breast Cancer Patients 19
  • Figure 3: BRCA1 and BRCA2 Gene Arrangement 21
  • Figure 4: USPSTF Guidelines for Inherited Breast Cancer Gene Testing 34
  • Figure 5: Wellcare Treatment Guidelines 36
  • Figure 6: US Trends in Breast Cancer Incidence, 2009-2018 41
  • Figure 7: Breast Cancer Risk Factors 42
  • Figure 8: BRACAnalysis Product Family (2012) 47
  • Figure 9: BRACAnalysis, Number of Tests, 1997-2012 51
  • Figure 10: BreastNext Mutation Detection Frequency 55
  • Figure 11: Average Selling Price of Breast Cancer Gene Tests (November 2012) 58
  • Figure 12: Growth in 23AndMe Gene Testing, 2007-2012 70
  • Figure 13: US Concerns on Breast Cancer Gene Testing (n=25) 82
  • Figure 14: Genomic Sequencing Costs, 2001-2012 104
  • Figure 15: Growth in Gene Testing Capability in the US 105
  • Figure 16: DTP and DTC Gene Tests offered by CLIA-Accredited Laboratories, 2011 106
  • Figure 17: Estimated Number of BRCA Tests Conducted Annually in the US, 2000-2012 108
  • Figure 18: Cumulative Numbers of BRCA Gene Tests in the US, 2000-2012 109
  • Figure 19: Numbers of Patient Relatives Recommended for Breast Cancer Gene Testing Following a Positive Result, n=69 112
  • Figure 20: Reasons to Refuse a Breast Cancer Gene Test, n=25 113
  • Figure 21: Myriad Genetics Revenue and Profit, 2005-2012 130
  • Figure 22: BRCA Gene Testing by the UK Genetics Testing Network in 2010 136
  • Figure 23: Visual Representation of Hereditary Breast Cancer Genes (Ambry Genetics) 141
  • Figure 24: Estimated growth in 23AndMe Revenue, 2007-2012 155
  • Figure 25: Illumina Revenue and Profit, 2005-2011 171
  • Figure 26: Life Technologies Revenue and Profit, 2007-2011 177
  • Figure 27: Roche Revenue and Profit, 2005-2011 182
  • Figure 28: Growth in Patient-Demanded Breast Cancer Gene Tests, n=25, 2009-2015 187
  • Figure 29: Breast Cancer Occurrence Following a Gene Test, n=25 196
  • Figure 30: Breast Cancer Incidence and Mortality in England, 1971-2010 198
  • Figure 31: Sales Forecasts for Predictive Breast Cancer Gene Testing in the US, 2009-2018 202
  • Figure 32: US Segmentation for Gene Tests, by Type, 2011 and 2018 203
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