MediPoint: Cardiac Rhythm Management - APAC Analysis and Market Forecasts

Summary

Cardiac rhythm management (CRM) comprises any method of treatment aimed at regulating the heart’s rhythm, including medication, medical devices, and occasionally surgery. There can be a number of reasons why CRM is needed, all of which generally involve malfunctions of the heart’s electrical system, and are related to cardiac dyssynchrony. While medication can be effective in mild to moderate cases, patients with more severe conditions must turn to device use or surgical intervention in order to receive the therapy they require. Over the years, CRM device treatment has become less invasive, and significant advances in pacing and pulse generator technology have enabled effective long-term device therapy with limited complications.

Across the three countries included in this report, there is a marked heterogeneity in the pacemaker implantation rate per million inhabitants. Moreover, there is also a large gap among the countries in the number of pacemaker-implanting centers per million inhabitants.

Scope

- An overview of hypertension, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized APAC CRM market revenue and future forecasts from 2009 to 2011, forecast for 7 years to 2018.
- Investigation of current and future market competition for CRM
- 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.
- Analysis of unmet needs within the market and opportunities for future players.
- 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 the CRM sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL) as well as cardiologists

Reasons to buy

- Understand the trends shaping and driving APAC CRM market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in APAC CRM 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 APAC CRM market landscape? Identify, understand and capitalize.

Table Of Contents

1 Table of Contents
1 Table of Contents 7


2 Introduction 21
2.1 Catalyst 21
2.2 Related Reports 22
2.3 Upcoming Related Reports 22
3 Disease Overview 23
3.1 Anatomy and Physiology 23
3.1.1 Risk Factors 24
3.1.2 Etiology 26
3.2 Pathophysiology 27
3.2.1 Cardiac Arrhythmias 27
3.3 Clinical Presentation 33
3.3.1 Symptoms 33
3.4 Diagnosis 34
3.4.1 Blood and Urine Diagnostic Procedures 34
3.4.2 Electrocardiography-Based Diagnostic Procedures 35
3.4.3 Computerized Tomographic Angiography 36
3.4.4 Electrophysiological Testing 36
3.4.5 Electromechanical Wave Imaging 36
3.4.6 Echocardiography 37
3.4.7 Tilt-Table Testing 37
3.4.8 Diagnostic and Electrophysiological Studies 37
3.4.9 New York Heart Association Scale 37
3.4.10 American College of Cardiology Scale 38
3.4.11 Level of Evidence 38
3.5 Epidemiology 39
3.5.1 Prevalence 39
4 Industry Overview 43
4.1 Overview 43
4.2 Clinical Outcomes 43
4.2.1 Pacemakers 43
4.2.2 ICDs 51
4.2.3 CRT-Ps 58
4.2.4 CRT-Ds 59
4.3 Procedure Trends 60
4.3.1 Single-Chamber Devices More Popular than Dual-Chamber Devices in Developing Economies 60
4.3.2 Cardiac Resynchronization Therapy Increasingly Popular Around the World 63
4.3.3 Device Reuse Programs to Transform Currently Wasted Resource 63
4.3.4 Hospital Market Growth 64
4.4 Market Access 65
4.4.1 Asia-Pacific 65
4.4.2 Reimbursement Trends 66
4.5 Regulatory Issues/Recalls 68
4.5.1 Medtronic Pacemakers Recalled over Failure Risk, 2009 68
4.5.2 St. Jude Riata ICD Leads Recalled, 2011 68
4.6 Mergers and Acquisitions 69
4.6.1 Boston Scientific Acquires C.R. Bard’s Electrophysiology Business 69
4.6.2 Sorin Group Closes Further Investment and Option-to-Buy in Enopace Biomedical 69
4.7 Key Partnerships 70
4.7.1 Leti Forms Partnership with Sorin, TIMA, Cedrat Technologies, Tronics and EASII IC 70
4.7.2 St. Jude Medical to Invest in Nanostim 70
4.7.3 Sorin Group Signs Supply Agreement for Boston Scientific Corporation Lotus Valve System 72
4.8 Economic Impact 72
4.8.1 Cost-Effectiveness of Pacemakers 72
4.8.2 Cost-Effectiveness of ICDs 73
4.8.3 Cost-Effectiveness of Cardiac Resynchronization Therapy 73
4.9 Market Drivers 74
4.9.1 Rapidly Increasing Patient Populations Suitable for Device Implantation to Drive Sales 74
4.9.2 Technological Advances and New Products in Pipeline to Drive Sales 78
4.9.3 Evolving Indications for Cardiac Rhythm Management Therapy 82
4.9.4 Imaging Guided Placement of Leads 85
4.9.5 Cost-Saving Benefits of Remote Home Monitoring 86
4.9.6 Growing Adoption of Device Use in Emerging Markets 88
4.9.7 Increased Primary Prevention Procedures 90
4.9.8 Increases in Implantation from Positive Clinical Trials 91
4.9.9 Antibacterial Envelopes to Reduce Rates of Complication and Increase Device Safety 92
4.9.10 Strong Portfolio of Pipeline Products from Key Players to Drive Future Growth of the Market 93
4.9.11 Leadless Technology Eliminates Lead-Related Complications 93
4.9.12 Diagnostic Rate Improvements Expected to Drive CRM Device Sales 94
4.9.13 Increased Device Implantation in Pediatrics 96
4.10 Market Barriers 97
4.10.1 Innovative and Next-Generation Drug Therapy May Pose a Challenge to CRM Devices in the Future 98
4.10.2 Slow Adoption of Remote Patient Monitoring Could Restrain Market Growth 98
4.10.3 Lacking Reimbursement for Costly Devices in Emerging Markets 98
4.10.4 Inconsistencies between Various Guidelines Affects Treatment 99
4.10.5 Inappropriate Shock Rates May Thwart Potential CRM Patients 100
4.10.6 Patient Education to Increase Awareness and Device Adoption 100
4.10.7 Declining Average Selling Prices to Adversely Affect CRM Product Revenues 101
5 Competitive Assessment 103
5.1 Overview 103
5.2 Regional Market Share 103
5.2.1 Pacemaker and CRT-P Market Company Share in China and India 103
5.2.2 ICD and CRT-D Market Company Share in China and India 104
5.2.3 Pacemaker and CRT-P Market Company Share in Japan 105
5.2.4 ICD and CRT-D Market Company Share in Japan 106
6 Unmet Needs 108
6.1 Overview 108
6.2 Leads and Electrode Development 108
6.2.1 MRI-Compatible Generators and Leads 109
6.2.2 Single-Lead Systems with Atrial Diagnostics 111
6.3 Power-Supplying Batteries 111
6.4 Energy-Harvesting Batteries 112
6.5 Rates of Infection 113
7 Pipeline Products 114
7.1 Overview 114
7.2 Pipeline Products by Phase in Development 114
7.3 Pacemaker and CRT-P Product Profiles 115
7.3.1 Aortic Pacemaker (Hadasit Medical Research Services and Development Ltd.) 115
7.3.2 Cardiac Energy Harvesting Pacemaker (University of Michigan) 116
7.3.3 Endurance Microgenerator (Endurance Rhythm) 116
7.3.4 Implantable Dual-Chamber Pacemaker (MicroPort Scientific) 117
7.3.5 Unconditional MRI-Compatible Implantable Pacemaker (Kenergy, Inc.) 117
7.3.6 Tissue-Engineered Autonomous Pacemaker (Duke University) 118
7.3.7 Wireless Cardiac Stimulation Device (EBR Systems, Inc.) 118
7.4 ICD and CRT-D Product Profiles 119
7.4.1 Atrial Defibrillator (SmartWave Medical Ltd.) 119
7.4.2 CardiaLen (CardiaLen, Inc.) 119
7.4.3 Chronicle (Medtronic) 120
7.5 Clinical Trials to Watch 120
7.5.1 Overview 120
7.5.2 SELECT-LV Trial of WiCS-LV System (EBR Systems, Inc.) 120
7.5.3 MultiPoint Pacing Clinical Trial of Quadra Assura CRT-D (Medtronic) 122
7.5.4 MADIT-ASIA Trial with Invive CRT-P (Boston Scientific) 123
7.5.5 MultiPoint Pacing IDE Study of Promote Quadra (St. Jude Medical) 125
7.5.6 Post Approval Study of S-ICD System (Boston Scientific) 127
7.5.7 ProMRI Study of the Evia/Entovis Pacemaker System 128
7.5.8 MIRACLE EF Clinical Study of Consulta CRT-P (Medtronic) 130
8 Current and Future Players 133
8.1 Overview 133
8.2 Trends in Corporate Strategy 133
8.3 Biotronik 134
8.3.1 Overview 134
8.3.2 Portfolio Evaluation 136
8.3.3 Commercial Positioning 146
8.3.4 Company SWOT Analysis 147
8.4 Boston Scientific 147
8.4.1 Overview 147
8.4.2 Portfolio Evaluation 149
8.4.3 Commercial Positioning 158
8.4.4 Company SWOT Analysis 159
8.5 Impulse Dynamics 159
8.5.1 Overview 159
8.5.2 Portfolio Evaluation 159
8.5.3 Commercial Positioning 160
8.5.4 Company SWOT Analysis 160
8.6 Medtronic 161
8.6.1 Overview 161
8.6.2 Portfolio Evaluation 163
8.6.3 Marketed Products 165
8.6.4 Additional Products 173
8.6.5 Commercial Positioning 175
8.6.6 Company SWOT Analysis 177
8.7 Sorin Group 177
8.7.1 Overview 177
8.7.2 Portfolio Evaluation 179
8.7.3 Marketed Products 180
8.7.4 Commercial Positioning 181
8.7.5 Company SWOT Analysis 182
8.8 St. Jude Medical 182
8.8.1 Overview 182
8.8.2 Portfolio Evaluation 183
8.8.3 Marketed Products 185
8.8.4 Commercial Positioning 198
8.8.5 Company SWOT Analysis 199
9 Market Outlooks and Forecasts 200
9.1 Market Outlooks and Forecasts by Geography 200
9.1.1 Japan 200
9.1.2 China 204
9.1.3 India 209
10 Appendix 215
10.1 Bibliography 215
10.2 Abbreviations 228
10.3 Report Methodology 233
10.3.1 Overview 233
10.3.2 Coverage 233
10.3.3 Secondary Research 233
10.3.4 Forecasting Methodology 234
10.3.5 Primary Research - Key Opinion Leader Interviews 235
10.3.6 Expert Panel Validation 236
10.4 Physicians and Specialists Included in this Study 237
10.5 About the Authors 239
10.5.1 Analysts 239
10.5.2 Global Head of Healthcare 240
10.6 About MediPoint 241
10.7 About GlobalData 241
10.8 Disclaimer 241

1.1 List of Tables
Table 1: New York Heart Association Scale 38
Table 2: American College of Cardiology Scale 38
Table 3: Level of Evidence 39
Table 4: Prevalent Cases of Congestive Heart Failure, All Markets, Ages ?45 Years, Men and Women (n), 2012-2019 42
Table 5: Pacemaker Implantation Classification Guideline 45
Table 6: Patient Post-Operative Condition with ICD Implantation, 2012 52
Table 7: Level of Evidence Guidelines 56
Table 8: Single-Chamber Pacemakers versus Dual-Chamber Pacemakers, Sales Volume Comparison, by Country, 2012 61
Table 9: Single-Chamber ICDs versus Dual-Chamber ICDs, Sales Volume Comparison, by Country, 2012 61
Table 10: CRT-P versus Conventional Pacemakers, Sales Volume Comparison, by Country, 2012 63
Table 11: CRT-D versus Conventional ICD Products, Sales Volume Comparison, by Country, 2012 63
Table 12: Percentage of Population Aged 65 Years and Older, by Country, 2005-2015 75
Table 13: Percentage of Smoking Population by Country (%), APAC, 2010 76
Table 14: Percentage of Overweight and Obese Population (Aged 15 Years and Above), by Country, 2012 76
Table 15: Percentage of Hypertensive Population Aged 25 Years and Above (%), Global, 2010 77
Table 16: Technological Innovations, Cardiac Rhythm Management Devices 78
Table 17: Benefits of Quadripolar Lead Technology 80
Table 18: Updated Cardiac Resynchronization Therapy Guidelines 81
Table 19: Emerging Market Contribution, Global, 2009-2012 90
Table 20: Percent Primary Prevention Implantation by Country (%), ICD/CRT-D, APAC, 2012 91
Table 21: Primary Prevention Cases by Country (%), ICD, APAC, 2012 95
Table 22: Barriers in Access to Quality Healthcare Leading to Disparities in CRM Treatment 97
Table 23: Average Selling Price ($) Comparison, by Country, 2012 102
Table 24: Pacemaker and CRT-P Market, Emerging Markets, Revenue ($) and Company Share (%), 2012 104
Table 25: ICD and CRT-D Market, Emerging Markets, Revenue ($) and Company Share (%), 2012 105
Table 26: Pacemaker and CRT-P Market, Japan, Revenue ($) and Company Share (%), 2012 106
Table 27: ICD and CRT-D Market, Japan, Revenue ($) and Company Share (%), 2012 107
Table 28: Product Profile - Aortic Pacemaker 115
Table 29: Product Profile - Cardiac Energy Harvesting Pacemaker 116
Table 30: Product Profile - Endurance Microgenerator 116
Table 31: Product Profile - MicroPort Pacemaker 117
Table 32: Product Profile - Kenergy Pacemaker 117
Table 33: Product Profile - Tissue-Engineered Autonomous Pacemaker 118
Table 34: Product Profile - Wireless Cardiac Stimulation Device 118
Table 35: Product Profile - Atrial Defibrillator 119
Table 36: Product Profile - CardiaLen 119
Table 37: Product Profile - Chronicle 120
Table 38: Clinical Trial for WiCS-LV System 120
Table 39: Clinical Trial for Quadra Assura CRT-D 122
Table 40: Clinical Trial for Invive CRT-P 123
Table 41: MultiPoint Pacing IDE Study for Promote Quadra 125
Table 42: Post Approval Study of S-ICD System 127
Table 43: ProMRI Study of the Evia/Entovis Pacemaker System 128
Table 44: MIRACLE EF Clinical Study of Consulta CRT-P 130
Table 45: Company Profile - Biotronik 136
Table 46: Product Profile - Cylos 990 139
Table 47: Product Profile - Effecta 140
Table 48: Product Profile - Evia/Entovis 141
Table 49: Product Profile - Estella 142
Table 50: Product Profile - Stratos 143
Table 51: Product Profile - Ilesto 7 143
Table 52: Product Profile - Lumax 146
Table 53: Biotronik SWOT Analysis, 2012 147
Table 54: Company Profile - Boston Scientific 148
Table 55: Product Profile - Advantio 151
Table 56: Product Profile - Altrua 152
Table 57: Product Profile - Cognis 153
Table 58: Product Profile - Energen 154
Table 59: Product Profile - Incepta 154
Table 60: Product Profile - Ingenio 155
Table 61: Product Profile - Invive 156
Table 62: Product Profile - Punctua 157
Table 63: Product Profile - S-ICD System 2.0 157
Table 64: Product Profile - Teligen 158
Table 65: Boston Scientific SWOT Analysis, 2012 159
Table 66: Company Profile - Impulse Dynamics 159
Table 67: Product Profile - Optimizer IVs 160
Table 68: Impulse Dynamics SWOT Analysis, 2012 160
Table 69: Company Profile - Medtronic 162
Table 70: Product Profile - Advisa 165
Table 71: Product Profile - Adapta 166
Table 72: Product Profile - Brava/Viva 167
Table 73: Product Profile - Consulta 168
Table 74: Product Profile - EnPulse 168
Table 75: Product Profile - EnRhythm 169
Table 76: Product Profile - Ensura MRI 169
Table 77: Product Profile - Evera 170
Table 78: Product Profile - Protecta 170
Table 79: Product Profile - Secura 171
Table 80: Product Profile - Syncra 172
Table 81: Product Profile - Revo 172
Table 82: Product Profile - Concerto 173
Table 83: Product Profile - EnTrust 174
Table 84: Product Profile - Maximo II 174
Table 85: Medtronic SWOT Analysis, 2012 177
Table 86: Company Profile - Sorin Group 179
Table 87: Product Profile - Esprit 180
Table 88: Product Profile - Paradym 180
Table 89: Product Profile - Reply 2000 181
Table 90: Sorin Group SWOT Analysis, 2012 182
Table 91: Company Profile - St. Jude Medical 183
Table 92: Product Profile - Accent 186
Table 93: Product Profile - Accent MRI 187
Table 94: Product Profile - Anthem 188
Table 95: Product Profile - Allure Quadra 189
Table 96: Product Profile - AnalyST Accel 189
Table 97: Product Profile - Assurity 190
Table 98: Product Profile - Current Accel 190
Table 99: Product Profile - Current Plus 191
Table 100: Product Profile - Ellipse 191
Table 101: Product Profile - Endurity 192
Table 102: Product Profile - Fortify Assura 192
Table 103: Product Profile - Fortify 193
Table 104: Product Profile - Microny 193
Table 105: Product Profile - Leadless Pacemaker 194
Table 106: Product Profile - Promote Plus 195
Table 107: Product Profile - Quadra Assura 196
Table 108: Product Profile - Unify Assura 196
Table 109: Product Profile - Unify Quadra 197
Table 110: Product Profile - Unify 197
Table 111: Product Profile - Zephyr 198
Table 112: St. Jude Medical SWOT Analysis, 2012 199
Table 113: Japan Cardiac Rhythm Management Device Implantation 201
Table 114: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, Japan, Revenue ($m), 2010-2020 202
Table 115: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, Japan, Revenue ($m), 2010-2020 203
Table 116: China Cardiac Rhythm Management Device Implantation 206
Table 117: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, China, Revenue ($m), 2010-2020 207
Table 118: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, China, Revenue ($m), 2010-2020 208
Table 119: India Cardiac Rhythm Management Device Implantation 212
Table 120: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, India, Revenue ($m), 2010-2020 213
Table 121: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, India, Revenue ($m), 2010-2020 214

1.2 List of Figures
Figure 1: Types of Arrhythmia 27
Figure 2: Generic Pacemaker Code 45
Figure 3: Guide for Pacemaker Implantation 46
Figure 4: Patient and General Population Preferences for CRM Device Reuse, US 64
Figure 5: Percentage of Hypertensive Population Aged 25 Years and Above (%), Global, 2010 77
Figure 6: Evaluating Effectiveness of Remote Home Monitoring 87
Figure 7: Emerging Market Contribution, Global, 2009-2012 89
Figure 8: Primary Prevention Cases by Country (%), ICD, APAC, 2012 94
Figure 9: Secondary Prevention Diagnosed Cases by Country (%), ICD, Global, 2012 95
Figure 10: Diagnosed VT and VF Cases Receiving ICD by Country (%), ICD, APAC, 2012 96
Figure 11: Average Selling Price ($) Comparison, by Country, 2012 101
Figure 12: Pacemaker and CRT-P Market, APAC Emerging Markets, Company Share (%), 2012 103
Figure 13: ICD and CRT-D Market, Emerging Markets, Company Share (%), 2012 104
Figure 14: Pacemaker and CRT-P Market, Japan, Company Share (%), 2012 105
Figure 15: ICD and CRT-D Market, Japan, Company Share (%), 2012 106
Figure 16: CRM Pipeline Products by Phase in Development 114
Figure 17: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, Japan, Revenue ($m), 2010-2020 202
Figure 18: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, Japan, Revenue ($m), 2010-2020 203
Figure 19: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, China, Revenue ($m), 2010-2020 207
Figure 20: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, China, Revenue ($m), 2010-2020 208
Figure 21: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, India, Revenue ($m), 2010-2020 213
Figure 22: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, India, Revenue ($m), 2010-2020 214

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