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

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 81.1 List of Tables 141.2 List of Figures 172 Introduction 192.1 Catalyst 193 Disease Overview 203.1 Breast Cancer 203.2 Anatomy and Physiology 203.3 Pathophysiology 213.3.1 Inheritable High-Penetrance Gene Mutations 243.3.2 Inheritable Medium/Low-Penetrance Gene Mutations 273.4 Clinical Presentation 323.4.1 Family History 323.4.2 Physical Examination 323.4.3 Predictive Breast Cancer Gene Testing Overview 343.4.4 Clinical Guidelines 363.4.5 Follow-up Gene Testing 413.5 Clinical Outcomes 433.5.1 Treatment Options 433.5.2 Treatment Paradigm 443.6 Epidemiology 453.6.1 Prevalence 453.7 Economic Impact 493.7.1 Individual Costs 493.7.2 Industry Costs 504 Competitive Assessment 514.1 Overview 514.1.1 BRACAnalysis 524.1.2 BreastNext 614.1.3 BreastCancer 684.1.4 PreventionGenetics CHEK2/BARD1 Sequencing 714.1.5 NewGene NGS BRCA1/2 744.1.6 TDL BRCA1/2 Full Screening 764.1.7 Centogene Breast Ovarian Cancer NGS Panel 794.1.8 Mamma GeneProfile 824.1.9 23AndMe DNA Spit Kit 85 4.1.10 DeCodeMe Complete Scan 91 4.1.11 Health Compass 945 Unmet Needs 965.1 Genetic Counseling 975.2 Price 985.3 Interpretation of Results 1005.4 Efficacy of the BRACAnalysis Test 1015.5 Database Transparency 1025.6 Test Validation 1035.7 Undiscovered Mutations 1045.8 Simplification of the Testing Process 1045.9 Test Report Formats 1055.10 Data Security 1056 Pipeline Products 1066.1 Predictive Breast Cancer Gene Tests in Development 1066.1.1 Myriad Genetics RAD51C Breast Cancer Gene Test 1076.1.2 23AndMe Exome 80X 1086.2 Breast Cancer Gene Expression Tests 1096.2.1 BreastGeneDX 1106.2.2 Diagnostic Test - Breast Cancer ( Queens University/Almac Diagnostics) 1116.2.3 Diagnostic Test - Breast Cancer (NanoIVD) 1126.2.4 EpiSwitch OBD27 1136.2.5 Myriad HRD Test 1146.2.6 PAM50 Breast Cancer Test 1156.3 Emerging Sequencing Technology 1166.4 New Gene Discovery 1167 Industry Overview 1177.1 Breast Cancer Testing Trends 1177.1.1 Overview 1177.1.2 Gene Test Analysis 1197.1.3 Gene-Testing Hardware 1227.2 Testing Volumes 1277.2.1 Predictive Gene Test Volumes 1277.2.2 Market Access 1307.3 Adoption of Breast Cancer Gene Testing 1327.4 Role of Genetic Counseling 1357.5 Gene Testing Laboratories 1387.6 Reimbursement Trends 1397.7 Regulatory Issues/Recalls 1407.7.1 Regulatory Issues 1407.7.2 Recalls 1427.8 Mergers & Acquisitions and Key Partnerships 1438 Current and Future Players 1458.1 Overview 1458.2 Trends in Corporate Strategy 1468.3 Common Strengths, Weaknesses, Opportunities and Threats 1478.3.1 Growing Incidence of Breast Cancer 1478.3.2 Uncertain R&D Outcomes 1488.3.3 Stringent Government Regulations 1488.4 Company Profiles 1498.4.1 Myriad Genetics 1498.4.2 Ambry Genetics 1608.4.3 Complete Genomics 1648.4.4 Navigenics (now Life Technologies) 1698.4.5 PreventionGenetics 1738.4.6 Lab21 Ltd. 1758.4.7 NewGene Ltd. 1798.4.8 The Doctors Laboratory Ltd. 1828.4.9 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 2199 Market Drivers and Opportunities and Barriers 2239.1 Market Drivers 2239.1.1 Reducing the Cost of Breast Cancer Care 2239.1.2 Growing Number of Tests for Breast Cancer Gene Tests 2259.1.3 Increased Awareness of Breast Cancer Gene Testing from Physicians and Patients 2269.2 Opportunities 2279.2.1 New Assays and New Sequencing Technologies 2279.2.2 Alternative Methods to Predict Breast Cancer Risk 2289.2.3 Population-Based Genomic Profiling 2309.3 Market Barriers 2319.3.1 Exhaustion of Test Candidates 2319.3.2 Demographics 2339.3.3 Reimbursement 2339.3.4 Lack of Standardization 2339.3.5 Complexity of Test Results 2359.3.6 Shortage of Trained Personnel 2369.3.7 Development of New Breast Cancer Treatments 2379.4 Substitutes 2389.4.1 Improved Risk Assessment Models 2389.4.2 Development of Tests Based on Gene Expression Products 2399.4.3 Increased Surveillance 2399.4.4 Development of Biomarker Assays 24010 Country Outlooks and Forecasts 24110.1 EU Markets Overview 24110.2 France 24710.2.1 France Market Analysis 24710.3 Germany 24910.3.1 Germany Market Analysis 24910.4 Italy 25010.4.1 Italy Market Analysis 25010.5 Spain 25110.5.1 Spain Market Analysis 25110.6 UK 25210.6.1 UK Market Analysis 25211 Appendix 25411.1 Bibliography 25411.2 Abbreviations 27811.3 Research Methodology 28011.3.1 Overview 28011.3.2 Coverage 28011.3.3 Secondary Research 28011.3.4 Forecast Methodology 28111.4 Physicians and Specialists Included in this Study 28211.5 Primary Research 28311.6 Physician Survey 28311.7 About the Authors 28411.7.1 Analysts 28411.7.2 Global Head of Healthcare 28511.8 Definitions 28511.9 About MediPoint 28611.10 About GlobalData 28611.11 Contact Us 28611.12 Disclaimer 287

List of Tables

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

List of Figures

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

To order this report: Pathology Industry: MediPoint: Predictive Breast Cancer Gene Testing - EU Analysis and Market Forecasts

__________________________Contact Clare: US:(339) 368 6001 Intl:+1 339 368 6001

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Copyright 2011 PR Newswire. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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