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

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

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MediPoint: Predictive Breast Cancer Gene Testing - APAC 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 Japan and future markets in China and India, 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 APAC Breast Cancer Gene Testing market revenue and future forecasts from 2009 to 2011 and forecast 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 APAC 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 APAC 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 APAC 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 APAC 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 16
2 Introduction 18
2.1 Catalyst 18
3 Disease Overview 19
3.1 Breast Cancer 19
3.2 Anatomy and Physiology 19
3.3 Pathophysiology 20
3.3.1 Inheritable High-Penetrance Gene Mutations 23
3.3.2 Inheritable Medium/Low-Penetrance Gene Mutations 26
3.4 Clinical Presentation 31
3.4.1 Family History 31
3.4.2 Physical Examination 31
3.4.3 Predictive Breast Cancer Gene Testing Overview 33
3.4.4 Clinical Guidelines 34
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 45
3.7.1 Individual Costs 45
3.7.2 Industry Costs 46
4 Competitive Assessment 47
4.1 Overview 47
4.1.1 BRACAnalysis 48
4.1.2 BreastNext 56
4.1.3 BreastCancer 62
4.1.4 PreventionGenetics CHEK2/BARD1 Sequencing 65
4.1.5 NewGene NGS BRCA1/2 67
4.1.6 Centogene Breast Ovarian Cancer NGS Panel 69
4.1.7 Mamma GeneProfile 72
4.1.8 23AndMe DNA Spit Kit 74
4.1.9 DeCodeMe Complete Scan 80
4.1.10 Health Compass 82
5 Unmet Needs 84
5.1 Genetic Counseling 85
5.2 Price 86
5.3 Interpretation of Results 88
5.4 Efficacy of the BRACAnalysis Test 89
5.5 Database Transparency 90
5.6 Test Validation 91
5.7 Undiscovered Mutations 92
5.8 Simplification of the Testing Process 92
5.9 Test Report Formats 93
5.10 Data Security 93
6 Pipeline Products 94
6.1 Predictive Breast Cancer Gene Tests in Development 94
6.1.1 Myriad Genetics RAD51C Breast Cancer Gene Test 94
6.1.2 23AndMe Exome 80X 95
6.2 Breast Cancer Gene Expression Tests 96
6.2.1 BreastGeneDX 97
6.2.2 Diagnostic Test - Breast Cancer (Queens University/Almac Diagnostics) 98
6.2.3 Diagnostic Test - Breast Cancer (NanoIVD) 99
6.2.4 EpiSwitch OBD27 100
6.2.5 Myriad HRD Test 101
6.2.6 PAM50 Breast Cancer Test 102
6.3 Emerging Sequencing Technology 103
6.4 New Gene Discovery 103
7 Industry Overview 104
7.1 Breast Cancer Testing Trends 104
7.1.1 Overview 104
7.1.2 Gene Test Analysis 105
7.1.3 Gene-Testing Hardware 108
7.1.4 Laboratory-Developed Tests 111
7.2 Testing Volumes 113
7.2.1 APAC 113
7.3 Market Access 115
7.3.1 APAC 115
7.4 Adoption of Breast Cancer Gene Testing 116
7.5 Role of Genetic Counseling 119
7.6 Gene Testing Laboratories 122
7.7 Reimbursement Trends 123
7.7.1 APAC 123
7.8 Regulatory Issues/Recalls 123
7.8.1 Activities in the US and EU 123
7.8.2 Recalls 126
7.9 Mergers & Acquisitions and Key Partnerships 127
8 Current and Future Players 129
8.1 Overview 129
8.2 Trends in Corporate Strategy 130
8.3 Common Strengths, Weaknesses, Opportunities and Threats 131
8.3.1 Growing Incidence of Breast Cancer 131
8.3.2 Growing Market Opportunities in Emerging Markets 132
8.3.3 Uncertain R&D Outcomes 133
8.3.4 Stringent Government Regulations 133
8.4 Company Profiles 134
8.4.1 Myriad Genetics 134
8.4.2 Ambry Genetics 145
8.4.3 Complete Genomics 149
8.4.4 Navigenics (now Life Technologies) 154
8.4.5 PreventionGenetics 158
8.4.6 NewGene Ltd. 160
8.4.7 Centogene AG (Centogene Rostock GmBH) 163
8.4.8 Sistemas Genomicos 165
8.4.9 ATS GeneTech 168
8.4.10 23AndMe 172
8.4.11 BGI-Shenzhen 181
8.4.12 Illumina 185
8.4.13 Life Technologies 193
8.4.14 Roche 199
9 Market Drivers, Opportunities and Barriers 203
9.1 Market Drivers 203
9.1.1 Reducing the Cost of Breast Cancer Care 203
9.1.2 Growing Number of Tests for Breast Cancer Gene Tests 205
9.1.3 Increased Awareness of Breast Cancer Gene Testing from Physicians and Patients 206
9.2 Opportunities 207
9.2.1 New Assays and New Sequencing Technologies 207
9.2.2 Alternative Methods to Predict Breast Cancer Risk 208
9.2.3 Population-Based Genomic Profiling 210
9.3 Market Barriers 211
9.3.1 Exhaustion of Test Candidates 211
9.3.2 Demographics 213
9.3.3 Reimbursement 213
9.3.4 Lack of Standardization 213
9.3.5 Complexity of Test Results 215
9.3.6 Shortage of Trained Personnel 216
9.3.7 Development of New Breast Cancer Treatments 217
9.4 Substitutes 218
9.4.1 Improved Risk Assessment Models 218
9.4.2 Development of Tests Based on Gene Expression Products 219
9.4.3 Increased Surveillance 219
9.4.4 Development of Biomarker Assays 220
10 Country Outlooks and Forecasts 221
10.1 APAC Region Markets Overview 221
10.2 Japan 228
10.2.1 Japan Market Analysis 228
10.3 China 229
10.3.1 China Market Analysis 229
10.4 India 230
10.4.1 India Market Analysis 230
11 Appendix 232
11.1 Bibliography 232
11.2 Abbreviations 255
11.3 Research Methodology 257
11.3.1 Overview 257
11.3.2 Coverage 257
11.3.3 Secondary Research 257
11.3.4 Forecast Methodology 258
11.4 Physicians and Specialists Included in this Study 260
11.5 Primary Research 261
11.6 Physician Survey 261
11.7 About the Authors 262
11.7.1 Analysts 262
11.7.2 Global Head of Healthcare 263
11.8 Definitions 263
11.9 About MediPoint 264
11.10 About GlobalData 264
11.11 Contact Us 264
11.12 Disclaimer 265

List of Tables

Table 1: Main Breast Cancer Types 20
Table 2: Specific Cancer Types Associated with Inherited Disorders 22
Table 3: BRCA1/2 Mutation Occurrence by Ethnic Group 25
Table 4: BRCA1/2 Mutation Occurrence in Breast Cancer Cases by Ethnic Group 25
Table 5: CHEK2 Carrier Incidence in General Population 26
Table 6: Breast Cancer Risk Factors 32
Table 7: Regional Differences in Prescribing Relatives for Breast Cancer Gene Test (Numbers per Physician) Including Expected Uptake (n=69) 37
Table 8: Breast Cancer Chemotherapies 39
Table 9: Cancer Cell Grading 40
Table 10: Selected 2002 Breast Cancer Incidence Rates 42
Table 11: BRACAnalysis Product Profile 48
Table 12: BRACAnalysis SWOT Analysis 55
Table 13: BreastNext Product Profile 56
Table 14: BreastNext SWOT Analysis 62
Table 15: BreastCancer Product Profile 62
Table 16: BreastCancer SWOT Analysis 64
Table 17: PreventionGenetics Product Profile 65
Table 18: PreventionGenetics SWOT Analysis 67
Table 19: NewGene NGS BRCA Product Profile 67
Table 20: NewGene NGS BRCA SWOT Analysis 69
Table 21: Centogene Breast Ovarian Cancer NGS Panel Product Profile 69
Table 22: Centogene Breast Ovarian Cancer NGS Panel SWOT Analysis 71
Table 23: Mamma GeneProfile Product Profile 72
Table 24: Mama GeneProfile SWOT Analysis 73
Table 25: 23AndMe Spit Kit Product Profile 74
Table 26: 23AndMe Spit Kit SWOT Analysis 79
Table 27: Complete Scan Product Profile 80
Table 28: Complete Scan SWOT Analysis 82
Table 29: Health Compass Product Profile 82
Table 30: Health Compass SWOT Analysis 83
Table 31: Predictive Breast Cancer Gene Test Product Pipeline 94
Table 32: Myriad Genetics RAD51C Breast Cancer Gene Test SWOT Analysis 95
Table 33: 23AndMe Exome 80X SWOT Analysis 95
Table 34: Breast Cancer Gene Expression Product Pipeline 96
Table 35: BreastDX SWOT Analysis 97
Table 36: Diagnostic Test - Breast Cancer (Queens University/Almac Diagnostics) SWOT Analysis 98
Table 37: NanoIVD Diagnostic Test - Breast Cancer SWOT Analysis 99
Table 38: EpiSwitch OBD27 SWOT Analysis 100
Table 39: Myriad HRD Test SWOT Analysis 101
Table 40: NanoString PAM50 Breast Cancer Test SWOT Analysis 102
Table 41: Key Mergers and Acquisitions during 2012 128
Table 42: Myriad Genetics SWOT Analysis 134
Table 43: Myriad Genetics Product Portfolio 135
Table 44: Myriad Genetics BRACAnalysis Key Patents 139
Table 45: Ambry Genetics SWOT Analysis 145
Table 46: Complete Genomics SWOT Analysis 149
Table 47: Navigenics SWOT Analysis 154
Table 48: PreventionGenetics SWOT Analysis 158
Table 49: NewGene SWOT Analysis 160
Table 50: Centogene SWOT Analysis 163
Table 51: Sistemas Genomicos SWOT Analysis 165
Table 52: ATS GeneTech SWOT Analysis 168
Table 53: BRCA Breast Cancer Scientific Publications and Breast Cancer Incidence 171
Table 54: 23AndMe SWOT Analysis 172
Table 55: BGI-Shenzhen SWOT Analysis 181
Table 56: Illumina SWOT Analysis 185
Table 57: Life Technologies SWOT Analysis 193
Table 58: Roche SWOT Analysis 199
Table 59: Skills Required for Breast Cancer Gene Testing 216
Table 60: Major Events Affecting the APAC Region Predictive Breast Cancer Gene Testing Market 221
Table 61: Sales Forecasts for Predictive Breast Cancer Gene Testing in the APAC Region Markets, 2009–2018 222
Table 62: Forecasts for Numbers of Predictive Breast Cancer Gene Tests in the APAC Region Market, 2009–2018 223
Table 63: Sales Forecasts for Predictive Breast Cancer Gene Testing in Japan, 2009–2018 228
Table 64: Sales Forecasts for Predictive Breast Cancer Gene Testing in China, 2009–2018 229
Table 65: Sales Forecasts for Predictive Breast Cancer Gene Testing in India, 2009–2018 231
Table 66: Physicians Surveyed, By Country 261

List of Figures

Figure 1: Breast Anatomy 19
Figure 2: Incidence of Inherited Breast Cancer Mutations amongst Diagnosed Breast Cancer Patients 21
Figure 3: BRCA1 and BRCA2 Gene Arrangement 23
Figure 4: Breast Cancer Gene Test Selection Process in India 35
Figure 5: Global Trends in Breast Cancer Incidence, 2008–2018 41
Figure 6: Breast Cancer Risk Factors 43
Figure 7: Compound Annual Growth Rate of Breast Cancer, 2012–2018 44
Figure 8: BRACAnalysis Product Family (2012) 49
Figure 9: BRACAnalysis, Number of Tests, 1997–2012 53
Figure 10: BreastNext Mutation Detection Frequency 57
Figure 11: Average Selling Price of Breast Cancer Gene Tests (November 2012) 61
Figure 12: Growth in 23AndMe Gene Testing, 2007–2012 78
Figure 13: Global Concerns on Breast Cancer Gene Testing (n=10) 87
Figure 14: Genomic Sequencing Costs, 2001–2012 110
Figure 15: Numbers of Patient Relatives Recommended for Breast Cancer Gene Testing Following a Positive Result, n=10 117
Figure 16: Reasons to Refuse a Breast Cancer Gene Test, n=10 118
Figure 17: Myriad Genetics Revenue and Profit, 2005–2012 136
Figure 18: BRCA Gene Testing by the UK Genetics Testing Network in 2010 142
Figure 19: Visual Representation of Hereditary Breast Cancer Genes (Ambry Genetics) 147
Figure 20: Gene Test Provider Brand Recognition in India, n=7 169
Figure 21: Estimated growth in 23AndMe Revenue, 2007–2012 173
Figure 22: Illumina Revenue and Profit, 2005–2011 189
Figure 23: Life Technologies Revenue and Profit, 2007–2011 195
Figure 24: Roche Revenue and Profit, 2005–2011 200
Figure 25: Growth in Physician-Ordered Breast Cancer Gene Tests, n=10 205
Figure 26: Growth in Patient-Demanded Breast Cancer Gene Tests, n=10, 2009–2015 206
Figure 27: Breast Cancer Occurrence Following a Gene Test, n=10 215
Figure 28: Breast Cancer Incidence and Mortality in England, 1971–2010 217
Figure 29: Predictive Breast Cancer Gene Tests Per Year in the APAC Region, 2009–2018 221
Figure 30: APAC Region Sales Forecast for Predictive Breast Cancer Gene Testing, 2009–2018 222
Figure 31: APAC Region Forecast for Numbers of Predictive Breast Cancer Gene Tests, 2009–2018 223
Figure 32:APAC Region Sales for Breast Cancer Gene Testing, by Country, 2011 and 2018 224
Figure 33: APAC Region Revenue Segmentation for Gene Tests, by Type, 2011 and 2018 226
Figure 34: Sales Forecasts for Predictive Breast Cancer Gene Testing in Japan, 2009–2018 228
Figure 35: Sales Forecasts for Predictive Breast Cancer Gene Testing in China, 2009–2018 229
Figure 36: Sales Forecasts for Predictive Breast Cancer Gene Testing in India, 2009–2018 230

Companies Mentioned

Myriad Genetics
Ambry Genetics
Complete Genomics
Navigenics (now Life Technologies)
PreventionGenetics
NewGene Ltd.
Centogene AG (Centogene Rostock GmBH)
Sistemas Genomicos
ATS GeneTech
23AndMe
BGI-Shenzhen
Illumina
Life Technologies
Roche

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

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