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


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MediPoint: Predictive Breast Cancer Gene Testing South America 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 South America, principally Brazil, 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 South America 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.
  • 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 South America 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 South America 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 South America 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 markets 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.
  • Whats the next big thing in South America Breast Cancer Gene Testing market landscape? Identify, understand and capitalize.

Table of Contents

 

1 Table of Contents
1 Table of Contents 7
1.1 List of Tables 13
1.2 List of Figures 15

 

2 Introduction 17
2.1 Catalyst 17
 

3 Disease Overview 18
3.1 Breast Cancer 18
3.2 Anatomy and Physiology 18
3.3 Pathophysiology 19
3.3.1 Inheritable High-Penetrance Gene Mutations 22
3.3.2 Inheritable Medium/Low-Penetrance Gene Mutations 25
3.4 Clinical Presentation 30
3.4.1 Family History 30
3.4.2 Physical Examination 30
3.4.3 Predictive Breast Cancer Gene Testing Overview 32
3.4.4 Clinical Guidelines 33
3.5 Clinical Outcomes 36
3.5.1 Treatment Options 36
3.5.2 Treatment Paradigm 37
3.6 Epidemiology 38
3.6.1 Prevalence 38
3.7 Economic Impact 42
3.7.1 Individual Costs 42
3.7.2 Industry Costs 43
 

4 Competitive Assessment 44
4.1 Overview 44
4.1.1 BRACAnalysis 45
4.1.2 BreastNext 53
4.1.3 BreastCancer 60
4.1.4 PreventionGenetics CHEK2/BARD1 Sequencing 63
4.1.5 NewGene NGS BRCA1/2 66
4.1.6 Centogene Breast Ovarian Cancer NGS Panel 68
4.1.7 Mamma GeneProfile 71
4.1.8 23AndMe DNA Spit Kit 74
4.1.9 DeCodeMe Complete Scan 80
4.1.10 Health Compass 83
 

5 Unmet Needs 85
5.1 Genetic Counseling 86
5.2 Price 87
5.3 Interpretation of Results 89
5.4 Efficacy of the BRACAnalysis Test 90
5.5 Database Transparency 91
5.6 Test Validation 92
5.7 Undiscovered Mutations 94
5.8 Simplification of the Testing Process 94
5.9 Test Report Formats 94
5.10 Data Security 95
 

6 Pipeline Products 96
6.1 Predictive Breast Cancer Gene Tests in Development 96
6.1.1 Myriad Genetics RAD51C Breast Cancer Gene Test 97
6.1.2 23AndMe Exome 80X 98
6.2 Breast Cancer Gene Expression Tests 99
6.2.1 BreastGeneDX 100
6.2.2 Diagnostic Test - Breast Cancer (Queens University/Almac Diagnostics) 101
6.2.3 Diagnostic Test - Breast Cancer (NanoIVD) 102
6.2.4 EpiSwitch OBD27 103
6.2.5 Myriad HRD Test 104
6.2.6 PAM50 Breast Cancer Test 105
6.3 Emerging Sequencing Technology 106
6.4 New Gene Discovery 106
 

7 Industry Overview 107
7.1 Breast Cancer Testing Trends 107
7.1.1 Overview 107
7.1.2 Gene Test Analysis 110
7.1.3 Gene-Testing Hardware 112
7.1.4 Laboratory-Developed Tests 116
7.2 Testing Volumes 118
7.3 Market Access 119
7.3.1 Overview 119
7.3.2 Brazil 120
7.4 Adoption of Breast Cancer Gene Testing 121
7.5 Role of Genetic Counseling 124
7.6 Gene Testing Laboratories 127
7.7 Reimbursement Trends 128
7.7.1 Brazil 128
7.8 Regulatory Issues/Recalls 128
7.8.1 US 128
7.8.2 Recalls 131
7.9 Mergers & Acquisitions and Key Partnerships 131
 

8 Current and Future Players 133
8.1 Overview 133
8.2 Trends in Corporate Strategy 134
8.3 Common Strengths, Weaknesses, Opportunities and Threats 135
8.3.1 Growing Incidence of Breast Cancer 135
8.3.2 Growing Market Opportunities in Emerging Markets 136
8.3.3 Uncertain R&D Outcomes 137
8.3.4 Stringent Government Regulations 137
8.4 Company Profiles 138
8.4.1 Myriad Genetics 138
8.4.2 Ambry Genetics 149
8.4.3 Complete Genomics 153
8.4.4 Navigenics (now Life Technologies) 158
8.4.5 PreventionGenetics 162
8.4.6 NewGene Ltd. 164
8.4.7 Centogene AG (Centogene Rostock GmBH) 167
8.4.8 Sistemas Genomicos 169
8.4.9 Grupo Fleury 172
8.4.10 Diagnosticos da America SA (DASA) 175
8.4.11 23AndMe 178
8.4.12 BGI-Shenzhen 187
8.4.13 Illumina 191
8.4.14 Life Technologies 199
8.4.15 Roche 205
 

9 Market Drivers and Opportunities and Barriers 209
9.1 Market Drivers 209
9.1.1 Reducing the Cost of Breast Cancer Care 209
9.1.2 Growing Number of Tests for Breast Cancer Gene Tests 211
9.1.3 Increased Awareness of Breast Cancer Gene Testing from Physicians and Patients 212
9.2 Opportunities 213
9.2.1 New Assays and New Sequencing Technologies 213
9.2.2 Alternative Methods to Predict Breast Cancer Risk 214
9.2.3 Population-Based Genomic Profiling 216
9.3 Market Barriers 217
9.3.1 Exhaustion of Test Candidates 217
9.3.2 Demographics 219
9.3.3 Reimbursement 219
9.3.4 Lack of Standardization 219
9.3.5 Complexity of Test Results 221
9.3.6 Shortage of Trained Personnel 222
9.3.7 Development of New Breast Cancer Treatments 223
9.4 Substitutes 224
9.4.1 Improved Risk Assessment Models 224
9.4.2 Development of Tests Based on Gene Expression Products 225
9.4.3 Increased Surveillance 225
9.4.4 Development of Biomarker Assays 226
 

10 Country Outlooks and Forecasts 227
10.1 South America Markets Overview 228
10.2 Brazil 231
10.2.1 Brazil Market Analysis 231
 

11 Appendix 232
11.1 Bibliography 232
11.2 Abbreviations 254
11.3 Research Methodology 256
11.3.1 Overview 256
11.3.2 Coverage 256
11.3.3 Secondary Research 256
11.3.4 Forecast Methodology 257
11.4 Physicians and Specialists Included in this Study 259
11.5 Primary Research 260
11.6 Physician Survey 260
11.7 About the Authors 261
11.7.1 Analysts 261
11.7.2 Global Head of Healthcare 262
11.8 Definitions 262
11.9 About MediPoint 263
11.10 About GlobalData 263
11.11 Contact Us 264
11.12 Disclaimer 264


Table 1: Main Breast Cancer Types 19
Table 2: Specific Cancer Types Associated with Inherited Disorders 21
Table 3: BRCA1/2 Mutation Occurrence by Ethnic Group 24
Table 4: BRCA1/2 Mutation Occurrence in Breast Cancer Cases by Ethnic Group 24
Table 5: CHEK2 Carrier Incidence in General Population 25
Table 6: Breast Cancer Risk Factors 31
Table 7: Regional Differences in Prescribing Relatives for Breast Cancer Gene Test (Numbers per Physician) Including Expected Uptake (n=69) 34
Table 8: Breast Cancer Chemotherapies 36
Table 9: Cancer Cell Grading 37
Table 10: Selected 2002 Breast Cancer Incidence Rates 39
Table 11: BRACAnalysis Product Profile 45
Table 12: BRACAnalysis SWOT Analysis 52
Table 13: BreastNext Product Profile 53
Table 14: BreastNext SWOT Analysis 59
Table 15: BreastCancer Product Profile 60
Table 16: BreastCancer SWOT Analysis 62
Table 17: PreventionGenetics Product Profile 63
Table 18: PreventionGenetics SWOT Analysis 65
Table 19: NewGene NGS BRCA Product Profile 66
Table 20: NewGene NGS BRCA SWOT Analysis 67
Table 21: Centogene Breast Ovarian Cancer NGS Panel Product Profile 68
Table 22: Centogene Breast Ovarian Cancer NGS Panel SWOT Analysis 70
Table 23: Mamma GeneProfile Product Profile 71
Table 24: Mamma 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 83
Table 30: Health Compass SWOT Analysis 84
Table 31: Predictive Breast Cancer Gene Test Product Pipeline 96
Table 32: Myriad Genetics RAD51C Breast Cancer Gene Test SWOT Analysis 97
Table 33: 23AndMe Exome 80X SWOT Analysis 98
Table 34: Breast Cancer Gene Expression Product Pipeline 99
Table 35: BreastDX SWOT Analysis 100
Table 36: Diagnostic Test - Breast Cancer (Queens University/Almac Diagnostics) SWOT Analysis 101
Table 37: NanoIVD Diagnostic Test - Breast Cancer SWOT Analysis 102
Table 38: EpiSwitch OBD27 SWOT Analysis 103
Table 39: Myriad HRD Test SWOT Analysis 104
Table 40: NanoString PAM50 Breast Cancer Test SWOT Analysis 105
Table 41: Key Mergers and Acquisitions during 2012 132
Table 42: Myriad Genetics SWOT Analysis 138
Table 43: Myriad Genetics Product Portfolio 139
Table 44: Myriad Genetics BRACAnalysis Key Patents 143
Table 45: Ambry Genetics SWOT Analysis 149
Table 46: Complete Genomics SWOT Analysis 153
Table 47: Navigenics SWOT Analysis 158
Table 48: PreventionGenetics SWOT Analysis 162
Table 49: NewGene SWOT Analysis 164
Table 50: Centogene SWOT Analysis 167
Table 51: Sistemas Genomicos SWOT Analysis 169
Table 52: Grupo Fleury SWOT Analysis 172
Table 53: DASA SWOT Analysis 175
Table 54: 23AndMe SWOT Analysis 178
Table 55: BGI-Shenzhen SWOT Analysis 187
Table 56: Illumina SWOT Analysis 191
Table 57: Life Technologies SWOT Analysis 199
Table 58: Roche SWOT Analysis 205
Table 59: Skills Required for Breast Cancer Gene Testing 222
Table 60: Major Events Affecting the South American Predictive Breast Cancer Market 228
Table 61: Sales Forecasts for Predictive Breast Cancer Gene Testing in Brazil, 20092018 231
Table 62: Physicians Surveyed, By Country 260


Figure 1: Breast Anatomy 18
Figure 2: Incidence of Inherited Breast Cancer Mutations amongst Diagnosed Breast Cancer Patients 20
Figure 3: BRCA1 and BRCA2 Gene Arrangement 22
Figure 4: South America (Brazil) Trends in Breast Cancer Incidence, 20092018 38
Figure 5: Breast Cancer Risk Factors 40
Figure 6: Compound Annual Growth Rate of Breast Cancer, 20122018 41
Figure 7: BRACAnalysis Product Family (2012) 46
Figure 8: BRACAnalysis, Number of Tests, 19972012 50
Figure 9: BreastNext Mutation Detection Frequency 55
Figure 10: Average Selling Price of Breast Cancer Gene Tests (November 2012) 58
Figure 11: Growth in 23AndMe Gene Testing, 20072012 78
Figure 12: Global Concerns on Breast Cancer Gene Testing (n=69) 88
Figure 13: Estimated Number of BRCA Tests Conducted Annually in South America (Brazil), 20062012 108
Figure 14: Cumulative Numbers of BRCA Gene Tests in South America (Brazil), 20062012 109
Figure 15: Genomic Sequencing Costs, 20012012 115
Figure 16: Estimated Number of BRCA Tests Conducted Annually in Brazil, 20062012 118
Figure 17: Numbers of Patient Relatives Recommended for Breast Cancer Gene Testing Following a Positive Result, n=69 122
Figure 18: Reasons to Refuse a Breast Cancer Gene Test, n=69 123
Figure 19: Myriad Genetics Revenue and Profit, 20052012 140
Figure 20: BRCA Gene Testing by the UK Genetics Testing Network in 2010 146
Figure 21: Visual Representation of Hereditary Breast Cancer Genes (Ambry Genetics) 151
Figure 22: Fleury Revenue and Profitability, 20062011 173
Figure 23: DASA Financial Performance, 20052011 176
Figure 24: Estimated growth in 23AndMe Revenue, 20072012 179
Figure 25: Illumina Revenue and Profit, 20052011 195
Figure 26: Life Technologies Revenue and Profit, 20072011 201
Figure 27: Roche Revenue and Profit, 20052011 206
Figure 28: Growth in Physician-Ordered Breast Cancer Gene Tests, n=69 211
Figure 29: Growth in Patient-Demanded Breast Cancer Gene Tests, n=69, 20092015 212
Figure 30: Action Following a Gene Test, n=69 221
Figure 31: Breast Cancer Incidence and Mortality in England, 19702010 223
Figure 32: Predictive Breast Cancer Gene Tests Per Year in Soth America, 20092018 227
Figure 33: South America Revenue Segmentation for Gene Tests, by Type, 2011 and 2018 229
Figure 34: Sales Forecasts for Predictive Breast Cancer Gene Testing in Brazil, 20092018 231