心調律管理装置：グローバル市場分析と予測...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 22
2 Introduction 25
2.1 Catalyst 25
2.2 Related Reports 26
2.3 Upcoming Related Reports 26
3 Disease Overview 27
3.1 Anatomy and Physiology 27
3.1.1 Risk Factors 28
3.1.2 Etiology 30
3.2 Pathophysiology 31
3.2.1 Cardiac Arrhythmias 31
3.3 Clinical Presentation 37
3.3.1 Symptoms 37
3.4 Diagnosis 38
3.4.1 Blood and Urine Diagnostic Procedures 38
3.4.2 Electrocardiography-Based Diagnostic Procedures 39
3.4.3 Computerized Tomographic Angiography 40
3.4.4 Electrophysiological Testing 40
3.4.5 Electromechanical Wave Imaging 40
3.4.6 Echocardiography 41
3.4.7 Tilt-Table Testing 41
3.4.8 Diagnostic and Electrophysiological Studies 41
3.4.9 New York Heart Association Scale 41
3.4.10 American College of Cardiology Scale 42
3.4.11 Level of Evidence 42
3.5 Epidemiology 43
3.5.1 Prevalence 43
4 Industry Overview 47
4.1 Overview 47
4.2 Clinical Outcomes 47
4.2.1 Pacemakers 47
4.2.2 ICDs 55
4.2.3 CRT-Ps 62
4.2.4 CRT-Ds 63
4.3 Procedure Trends 64
4.3.1 Single-Chamber Devices More Popular than Dual-Chamber Devices in Developing Economies 64
4.3.2 Cardiac Resynchronization Therapy Increasingly Popular Around the World 68
4.3.3 Device Reuse Programs to Transform Currently Wasted Resource 71
4.3.4 Hospital Market Growth 72
4.4 Market Access 72
4.4.1 US 72
4.4.2 Europe 74
4.4.3 Asia-Pacific 75
4.4.4 South America 76
4.4.5 Reimbursement Trends 77
4.5 Regulatory Issues/Recalls 89
4.5.1 Medtronic Pacemakers Recalled over Failure Risk, 2009 89
4.5.2 St. Jude Riata ICD Leads Recalled, 2011 89
4.6 Mergers and Acquisitions 90
4.6.1 Boston Scientific Acquires C.R. Bard’s Electrophysiology Business 90
4.6.2 Sorin Group Closes Further Investment and Option-to-Buy in Enopace Biomedical 90
4.7 Key Partnerships 91
4.7.1 Leti Forms Partnership with Sorin, TIMA, Cedrat Technologies, Tronics and EASII IC 91
4.7.2 St. Jude Medical to Invest in Nanostim 91
4.7.3 Sorin Group Signs Supply Agreement for Boston Scientific Corporation Lotus Valve System 93
4.8 Economic Impact 93
4.8.1 Cost-Effectiveness of Pacemakers 93
4.8.2 Cost-Effectiveness of ICDs 94
4.8.3 Cost-Effectiveness of Cardiac Resynchronization Therapy 94
4.9 Market Drivers 95
4.9.1 Rapidly Increasing Patient Populations Suitable for Device Implantation to Drive Sales 95
4.9.2 Technological Advances and New Products in Pipeline to Drive Sales 101
4.9.3 Evolving Indications for Cardiac Rhythm Management Therapy 105
4.9.4 Imaging Guided Placement of Leads 108
4.9.5 Cost-Saving Benefits of Remote Home Monitoring 109
4.9.6 Growing Adoption of Device Use in Emerging Markets 111
4.9.7 Increased Primary Prevention Procedures 113
4.9.8 Increases in Implantation from Positive Clinical Trials 115
4.9.9 Antibacterial Envelopes to Reduce Rates of Complication and Increase Device Safety 116
4.9.10 Strong Portfolio of Pipeline Products from Key Players to Drive Future Growth of the Market 116
4.9.11 Leadless Technology Eliminates Lead-Related Complications 117
4.9.12 Diagnostic Rate Improvements Expected to Drive CRM Device Sales 118
4.9.13 Increased Device Implantation in Pediatrics 120
4.10 Market Barriers 121
4.10.1 US Healthcare Reform May Impact US CRM Market Growth Adversely 122
4.10.2 Increased Emphasis on Value-Based Payment Programs through Medicare and Cost-Effectiveness Research to Cause Competitive Pricing Pressure 122
4.10.3 Innovative and Next-Generation Drug Therapy May Pose a Challenge to CRM Devices in the Future 123
4.10.4 Slow Adoption of Remote Patient Monitoring Could Restrain Market Growth 123
4.10.5 Lacking Reimbursement for Costly Devices in Emerging Markets 124
4.10.6 Inconsistencies between Various Guidelines Affects Treatment 124
4.10.7 Inappropriate Shock Rates May Thwart Potential CRM Patients 125
4.10.8 Patient Education to Increase Awareness and Device Adoption 125
4.10.9 Declining Average Selling Prices to Adversely Affect CRM Product Revenues 126
5 Competitive Assessment 128
5.1 Overview 128
5.2 Global Market Share 128
5.2.1 Pacemaker and CRT-P Market Company Share Globally 128
5.2.2 ICD and CRT-D Market Company Share Globally 130
5.3 Regional Market Share 131
5.3.1 Pacemaker and CRT-P Market Company Share in the US 131
5.3.2 ICD and CRT-D Market Company Share in the US 132
5.3.3 Pacemaker and CRT-P Company Share in Europe 133
5.3.4 ICD and CRT-D Market Company Share in Europe 134
5.3.5 Pacemaker and CRT-P Market Company Share in Emerging Markets 135
5.3.6 ICD and CRT-D Market Company Share in Emerging Markets 136
5.3.7 Pacemaker and CRT-P Market Company Share in Japan 137
5.3.8 ICD and CRT-D Market Company Share in Japan 138
6 Unmet Needs 139
6.1 Overview 139
6.2 Leads and Electrode Development 139
6.2.1 MRI-Compatible Generators and Leads 140
6.2.2 Single-Lead Systems with Atrial Diagnostics 142
6.3 Power-Supplying Batteries 142
6.4 Energy-Harvesting Batteries 143
6.5 Rates of Infection 144
7 Pipeline Products 145
7.1 Overview 145
7.2 Pipeline Products by Phase in Development 145
7.3 Pacemaker and CRT-P Product Profiles 146
7.3.1 Aortic Pacemaker (Hadasit Medical Research Services & Development Ltd.) 146
7.3.2 Cardiac Energy Harvesting Pacemaker (University of Michigan) 147
7.3.3 Endurance Microgenerator (Endurance Rhythm) 147
7.3.4 Implantable Dual-Chamber Pacemaker (MicroPort Scientific) 148
7.3.5 Unconditional MRI-Compatible Implantable Pacemaker (Kenergy, Inc.) 148
7.3.6 Tissue-Engineered Autonomous Pacemaker (Duke University) 149
7.3.7 Wireless Cardiac Stimulation Device (EBR Systems, Inc.) 149
7.4 ICD and CRT-D Product Profiles 150
7.4.1 Atrial Defibrillator (SmartWave Medical Ltd.) 150
7.4.2 CardiaLen (CardiaLen, Inc.) 150
7.4.3 Chronicle (Medtronic) 151
7.5 Clinical Trials to Watch 152
7.5.1 Overview 152
7.5.2 SELECT-LV Trial of WiCS-LV System (EBR Systems, Inc.) 152
7.5.3 MultiPoint Pacing Clinical Trial of Quadra Assura CRT-D (Medtronic) 154
7.5.4 MADIT-ASIA Trial with Invive CRT-P (Boston Scientific) 155
7.5.5 MultiPoint Pacing IDE Study of Promote Quadra (St. Jude Medical) 157
7.5.6 Post Approval Study of S-ICD System (Boston Scientific) 158
7.5.7 ProMRI Study of the Evia/Entovis Pacemaker System 160
7.5.8 MIRACLE EF Clinical Study of Consulta CRT-P (Medtronic) 162
8 Current and Future Players 165
8.1 Overview 165
8.2 Trends in Corporate Strategy 165
8.3 Biotronik 166
8.3.1 Overview 166
8.3.2 Portfolio Evaluation 168
8.3.3 Commercial Positioning 178
8.3.4 Company SWOT Analysis 179
8.4 Boston Scientific 179
8.4.1 Overview 179
8.4.2 Portfolio Evaluation 181
8.4.3 Commercial Positioning 190
8.4.4 Company SWOT Analysis 191
8.5 Impulse Dynamics 191
8.5.1 Overview 191
8.5.2 Portfolio Evaluation 191
8.5.3 Commercial Positioning 192
8.5.4 Company SWOT Analysis 192
8.6 Medtronic 193
8.6.1 Overview 193
8.6.2 Portfolio Evaluation 195
8.6.3 Marketed Products 197
8.6.4 Additional Products 205
8.6.5 Commercial Positioning 207
8.6.6 Company SWOT Analysis 209
8.7 Sorin Group 209
8.7.1 Overview 209
8.7.2 Portfolio Evaluation 211
8.7.3 Marketed Products 212
8.7.4 Commercial Positioning 213
8.7.5 Company SWOT Analysis 214
8.8 St. Jude Medical 214
8.8.1 Overview 214
8.8.2 Portfolio Evaluation 215
8.8.3 Marketed Products 217
8.8.4 Commercial Positioning 230
8.8.5 Company SWOT Analysis 231
9 Market Outlooks and Forecasts 232
9.1 Market Outlooks and Forecasts by Market Segment 232
9.1.1 Pacemaker Market by Device Type 232
9.1.2 ICD Market by Device Type 233
9.1.3 CRT-P Market 234
9.1.4 CRT-D Market 235
9.2 Market Outlooks and Forecasts by Geography 236
9.2.1 US 236
9.2.2 France 245
9.2.3 Germany 250
9.2.4 Italy 255
9.2.5 Spain 260
9.2.6 UK 264
9.2.7 Japan 270
9.2.8 China 274
9.2.9 India 279
9.2.10 Brazil 285
10 Appendix 290
10.1 Bibliography 290
10.2 Abbreviations 303
10.3 Report Methodology 308
10.3.1 Overview 308
10.3.2 Coverage 308
10.3.3 Secondary Research 308
10.3.4 Forecasting Methodology 309
10.3.5 Primary Research – Key Opinion Leader Interviews 310
10.3.6 Expert Panel Validation 311
10.4 Physicians and Specialists Included in this Study 311
10.5 About the Authors 313
10.5.1 Analysts 313
10.5.2 Global Head of Healthcare 314
10.6 About MediPoint 315
10.7 About GlobalData 315
10.8 Disclaimer 315