人工心臓弁の世界市場分析および予測...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 7
1.1 List of Tables 14
1.2 List of Figures 19

2 Introduction 23
2.1 Anatomy 23
2.2 Epidemiology 23
2.3 Related Reports 24

3 Industry Overview 25
3.1 Overview 25
3.1.1 Mechanical Heart Valves 25
3.1.2 Tissue Heart Valves 27
3.1.3 Transcatheter Heart Valves 28
3.2 Indications 29
3.2.1 Valvular Stenosis 29
3.2.2 Valvular Regurgitation 30
3.3 Clinical Presentation 30
3.3.1 Diagnosis 30
3.3.2 Risk Assessment Tools 30
3.4 Clinical Outcomes 32
3.4.1 Treatment Options 32
3.4.2 Life Style Changes 33
3.4.3 Complications 33
3.5 Applications of Technology 34
3.6 Market Access 34
3.6.1 Purchasing Decisions 34
3.7 Influence of Clinical Trials 34
3.8 Brand Loyalty 34
3.9 Adoption 35
3.10 Regulation 36
3.10.1 US 36
3.10.2 5EU 37
3.10.3 APAC 38
3.10.4 South America 41
3.11 Reimbursement 42
3.11.1 US 42
3.11.2 5EU 44
3.11.3 APAC 48
3.11.4 South America 51
3.12 Procedure Trends 52
3.12.1 Global Overview 52
3.12.2 By Country 53
3.13 Regulatory Issues/Recalls 74
3.13.1 Portico TAVR Implants Halted Due to Safety Concerns 74
3.14 M&A, Key Partnerships 74
3.14.1 Licensing Agreement Between Symetis and Endoluminal Sciences 74
3.14.2 Manufacturing Agreement Between Sorin Group and Boston Scientific 74
3.15 Economic Impact 74
3.15.1 Indirect Costs 74
3.15.2 Direct Costs 76

4 Unmet Needs 77
4.1 Delivery & Implantation 77
4.1.1 Mechanism of Deployment 77
4.1.2 Anchoring 77
4.1.3 Retrievability 78
4.1.4 Repositionability 78
4.1.5 Artery Accessibility 78
4.1.6 Rapid Pacing 79
4.1.7 Coronary Ostia Occlusion 80
4.1.8 Motorized Delivery Systems 80
4.2 Performance 81
4.2.1 Durability 81
4.2.2 Thrombogenicity 82
4.2.3 Effective Orifice Area 82
4.2.4 Coefficient of Friction 82
4.3 Crimping 83
4.4 Stenting 83
4.5 Replaceable Leaflets 83
4.6 Embolic Protection 84
4.7 Pacemaker Placement 84

5 Market Opportunity Analysis 86
5.1 Overview 86
5.2 Emerging Markets for TAVR 86
5.3 Increasing Tissue Valve Lifespan 87
5.4 Valve-in-Valve Procedures (Re-replacement) 88
5.5 Transcatheter Mitral Valve Replacement 89
5.6 Balloon Valvuloplasty 90

6 Market Drivers and Barriers 91
6.1 Driver: Rising Disease Prevalence 91
6.2 Driver: Multimodality Imaging 92
6.3 Driver: Alternative Access Routes 93
6.4 Driver: Lower Risk Patient Access 93
6.5 Driver: Patient Demand and Awareness 94
6.6 Driver: Advanced Computational Tools 95
6.7 Driver: Rising Competition and Innovation 95
6.8 Barrier: High Device and Procedure Cost 96
6.9 Barrier: Burden of Rising Regulation 96
6.10 Barrier: Medical Device Excise Tax 97
6.11 Barrier: Proving Long-Term Efficacy 97
6.12 Substitute: Valve Repair 98
6.13 Substitute: Balloon Valvuloplasty 98

7 Competitive Assessment 99
7.1 Overview 99
7.2 Classification Based on Features 99
7.2.1 Mechanical Heart Valves 99
7.2.2 Tissue Heart Valves 102
7.2.3 Transcatheter Heart Valves 105
7.3 Market Dynamics Analysis 106
7.4 Product Profiles 108
7.4.1 Mechanical Heart Valves 108
7.4.2 Tissue Heart Valves 114
7.4.3 Transcatheter Heart Valves 120

8 Pipeline Assessment 132
8.1 Overview 132
8.2 Product Profiles 132
8.2.1 Cytograft Tissue Valve (Cytograft Tissue Engineering) 132
8.2.2 Centera Valve (Edwards Lifesciences) 133
8.2.3 Colibri Heart Valve (Colibri Heart Valve) 134
8.2.4 Cormove (Perouse Medical) 135
8.2.5 Endovalve (Micro Interventional Devices) 136
8.2.6 HLT Transcatheter Valve System (Heart Leaflet Technology) 137
8.2.7 Inovare Valve (Braile Biomédica) 138
8.2.8 Kalangos Valve (Leman Cardiovascular) 139
8.2.9 Tiara Valve (Neovasc) 140
8.2.10 Trinity Valve (Transcatheter Technologies GmbH) 141
8.2.11 Vanguard Exchangeable Heart Valve System (ValveXchange) 142

9 Clinical Trials to Watch 144
9.1 Overview 144
9.2 CoreValve Evolut R (Medtronic) 144
9.3 TRANSFORM Trial – Intuity Valve System (Edwards Lifesciences) 144
9.4 PROACT Trial – On-X Plus 1.5 Mechanical Heart Valve (On-X Life Technologies) 145
9.5 PARTNER II Trial – Sapien XT (Edwards Lifesciences) 145
9.6 PARTNER III Trial – Sapien 3 (Edwards Lifesciences) 145
9.7 REPRISE III IDE/PMA Trial – Lotus Valve System (Boston Scientific) 146
9.8 SENTINEL-H Trial – Sentinel Cerebral Protection System (Claret Medical) 146

10 Current and Future Players 147
10.1 Overview 147
10.2 Trends in Corporate Strategy 147
10.3 Company Profiles 148
10.3.1 AorTech International 148
10.3.2 Boston Scientific 150
10.3.3 Braile Biomédica 151
10.3.4 CardiAQ Valve Technologies 152
10.3.5 Claret Medical 153
10.3.6 Colibri Heart Valve 154
10.3.7 Cytograft Tissue Engineering 155
10.3.8 Direct Flow Medical 156
10.3.9 Edwards Lifesciences 157
10.3.10 Heart Leaflet Technologies 159
10.3.11 JenaValve Technology 160
10.3.12 Leman Cardiovascular 161
10.3.13 Micro Interventional Devices 162
10.3.14 Neovasc 163
10.3.15 On-X Life Technologies, Inc. 164
10.3.16 Perouse Medical 165
10.3.17 Sorin Group 166
10.3.18 St. Jude Medical 167
10.3.19 Symetis 169
10.3.20 Transcatheter Technologies GmbH 170
10.3.21 TTK Healthcare 171
10.3.22 ValveXchange 172

11 Strategic Competitive Assessment 174
11.1 Company Market Share 174
11.1.1 Global Overview 174
11.1.2 By Region 175
11.1.3 By Country 177

12 Market Outlooks by Market Segment 185
12.1 Market Segment Share 185
12.1.1 Global 185
12.1.2 By Region 186

13 Market Outlooks by Geography 190
13.1 Global Overview 190
13.2 US 194
13.3 France 197
13.4 Germany 201
13.5 Italy 205
13.6 Spain 209
13.7 UK 212
13.8 Japan 216
13.9 China 220
13.10 India 224
13.11 Brazil 228

14 Appendix 232
14.1 Bibliography 232
14.2 Abbreviations 243
14.3 Report Methodology 246
14.3.1 Overview 246
14.3.2 Coverage 246
14.3.3 Secondary Research 246
14.4 Forecasting Methodology 248
14.5 Physicians and Specialists Included in This Study 249
14.6 About the Authors 250
14.6.1 Analysts 250
14.6.2 Global Head of Healthcare 251
14.7 About GlobalData 252
14.8 Disclaimer 252