【レポートの概要（一部）】
1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 16
1.2 List of Figures 20
2 Introduction 23
2.1 Catalyst 23
2.2 Upcoming Related Reports 23
3 Disease Overview 24
3.1 Breast Cancer 24
3.2 Anatomy and Physiology 24
3.3 Pathophysiology 25
3.3.1 Inheritable High-Penetrance Gene Mutations 28
3.3.2 Inheritable Medium/Low-Penetrance Gene Mutations 31
3.4 Clinical Presentation 36
3.4.1 Family History 36
3.4.2 Physical Examination 36
3.4.3 Predictive Breast Cancer Gene Testing Overview 38
3.4.4 Clinical Guidelines 39
3.4.5 Follow-up Gene Testing 51
3.5 Clinical Outcomes 53
3.5.1 Treatment Options 53
3.5.2 Treatment Paradigm 55
3.6 Epidemiology 56
3.6.1 Prevalence 56
3.7 Economic Impact 60
3.7.1 Individual Costs 60
3.7.2 Industry Costs 61
4 Competitive Assessment 62
4.1 Overview 62
4.1.1 BRACAnalysis 63
4.1.2 BreastNext 71
4.1.3 BreastCancer 78
4.1.4 PreventionGenetics CHEK2/BARD1 Sequencing 81
4.1.5 NewGene NGS BRCA1/2 84
4.1.6 TDL BRCA1/2 Full Screening 86
4.1.7 Centogene Breast Ovarian Cancer NGS Panel 89
4.1.8 Mamma GeneProfile 92
4.1.9 23AndMe DNA Spit Kit 95
4.1.10 DeCodeMe Complete Scan 101
4.1.11 Health Compass 104
5 Unmet Needs 106
5.1 Genetic Counseling 107
5.2 Price 108
5.3 Interpretation of Results 110
5.4 Efficacy of the BRACAnalysis Test 111
5.5 Database Transparency 112
5.6 Test Validation 113
5.7 Undiscovered Mutations 115
5.8 Simplification of the Testing Process 115
5.9 Test Report Formats 115
5.10 Data Security 116
6 Pipeline Products 117
6.1 Predictive Breast Cancer Gene Tests in Development 117
6.1.1 Myriad Genetics RAD51C Breast Cancer Gene Test 118
6.1.2 23AndMe Exome 80X 119
6.2 Breast Cancer Gene Expression Tests 120
6.2.1 BreastGeneDX 121
6.2.2 Diagnostic Test – Breast Cancer (Queens University/Almac Diagnostics) 122
6.2.3 Diagnostic Test – Breast Cancer (NanoIVD) 123
6.2.4 EpiSwitch OBD27 124
6.2.5 Myriad HRD Test 125
6.2.6 PAM50 Breast Cancer Test 126
6.3 Emerging Sequencing Technology 127
6.4 New Gene Discovery 127
7 Industry Overview 128
7.1 Breast Cancer Testing Trends 128
7.1.1 Overview 128
7.1.2 Gene Test Analysis 130
7.1.3 Gene-Testing Hardware 133
7.1.4 Laboratory-Developed Tests 136
7.2 Testing Volumes 140
7.2.1 US 140
7.2.2 EU 141
7.2.3 APAC 144
7.2.4 Brazil 145
7.3 Market Access 146
7.3.1 US 146
7.3.2 EU 146
7.3.3 APAC 148
7.3.4 Brazil 149
7.4 Adoption of Breast Cancer Gene Testing 150
7.5 Role of Genetic Counseling 153
7.6 Gene Testing Laboratories 156
7.7 Reimbursement Trends 157
7.7.1 US 157
7.7.2 EU 158
7.7.3 APAC 159
7.7.4 Brazil 159
7.8 Regulatory Issues/Recalls 160
7.8.1 US 160
7.8.2 EU 162
7.8.3 Recalls 163
7.9 Mergers & Acquisitions and Key Partnerships 164
8 Current and Future Players 166
8.1 Overview 166
8.2 Trends in Corporate Strategy 167
8.3 Common Strengths, Weaknesses, Opportunities and Threats 168
8.3.1 Growing Incidence of Breast Cancer 168
8.3.2 Growing Market Opportunities in Emerging Markets 169
8.3.3 Uncertain R&D Outcomes 170
8.3.4 Stringent Government Regulations 170
8.4 Company Profiles 171
8.4.1 Myriad Genetics 171
8.4.2 Ambry Genetics 182
8.4.3 Complete Genomics 186
8.4.4 Navigenics (now Life Technologies) 191
8.4.5 PreventionGenetics 195
8.4.6 Lab21 Ltd. 197
8.4.7 NewGene Ltd. 201
8.4.8 The Doctors Laboratory Ltd. 204
8.4.9 Bioscientia GmBH 207
8.4.10 Centogene AG (Centogene Rostock GmBH) 209
8.4.11 Sistemas Genomicos 211
8.4.12 Grupo Fleury 214
8.4.13 Diagnosticos da America SA (DASA) 217
8.4.14 ATS GeneTech 220
8.4.15 23AndMe 224
8.4.16 BGI-Shenzhen 233
8.4.17 Illumina 237
8.4.18 Life Technologies 245
8.4.19 Roche 251
9 Market Drivers and Opportunities and Barriers 255
9.1 Market Drivers 255
9.1.1 Reducing the Cost of Breast Cancer Care 255
9.1.2 Growing Number of Tests for Breast Cancer Gene Tests 257
9.1.3 Increased Awareness of Breast Cancer Gene Testing from Physicians and Patients 258
9.2 Opportunities 259
9.2.1 New Assays and New Sequencing Technologies 259
9.2.2 Alternative Methods to Predict Breast Cancer Risk 260
9.2.3 Population-Based Genomic Profiling 262
9.3 Market Barriers 263
9.3.1 Exhaustion of Test Candidates 263
9.3.2 Demographics 264
9.3.3 Reimbursement 265
9.3.4 Lack of Standardization 265
9.3.5 Complexity of Test Results 267
9.3.6 Shortage of Trained Personnel 268
9.3.7 Development of New Breast Cancer Treatments 269
9.4 Substitutes 270
9.4.1 Improved Risk Assessment Models 270
9.4.2 Development of Tests Based on Gene Expression Products 271
9.4.3 Increased Surveillance 271
9.4.4 Development of Biomarker Assays 272
10 Country Outlooks and Forecasts 273
10.1 Major Markets Overview 273
10.2 US 280
10.2.1 US Market Analysis 280
10.3 France 283
10.3.1 France Market Analysis 283
10.4 Germany 285
10.4.1 Germany Market Analysis 285
10.5 Italy 286
10.5.1 Italy Market Analysis 286
10.6 Spain 287
10.6.1 Spain Market Analysis 287
10.7 UK 288
10.7.1 UK Market Analysis 288
10.8 Rest of the World 290
10.8.1 Japan Market Analysis 290
10.8.2 Brazil Market Analysis 291
10.8.3 China Market Analysis 292
10.8.4 India Market Analysis 293
11 Appendix 295
11.1 Bibliography 295
11.2 Abbreviations 321
11.3 Research Methodology 323
11.3.1 Overview 323
11.3.2 Coverage 323
11.3.3 Secondary Research 323
11.3.4 Forecast Methodology 324
11.4 Physicians and Specialists Included in this Study 326
11.5 Primary Research 327
11.6 Physician Survey 327
11.7 About the Authors 328
11.7.1 Analysts 328
11.7.2 Global Head of Healthcare 329
11.8 Definitions 330
11.9 About MediPoint 331
11.10 About GlobalData 331
11.11 Contact Us 331
11.12 Disclaimer 332
【レポート販売概要】
■ タイトル：乳癌の予測遺伝子検査：グローバル市場分析と予測■ 英文：MediPoint: Predictive Breast Cancer Gene Testing - Global Analysis and Market Forecasts
■ 発行日：2013年2月25日
■ 調査会社：GlobalData
■ 商品コード：GDATA403160446
■ 調査対象地域：グローバル
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