MediPoint: Cardiac Rhythm Management - EU 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 five countries included in this report, there is a marked heterogeneity in the pacemaker implantation rate per million inhabitants. Nearly 80% of healthcare funding in the 5EU countries is publicly sourced and more than 70% of hospitals are in public ownership, with the states, regions or municipalities acting as major owners of hospitals. Additionally, healthcare funding provided through taxation and social health insurance of most European countries ensures that patients have access to appropriate medical treatments.

Scope

- An overview of hypertension, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized EU 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 the EU CRM market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the EU 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 EU CRM market landscape? Identify, understand and capitalize.

Table Of Contents

Table of Contents

1 Table of Contents 7
1.1 List of Tables 14
1.2 List of Figures 20
2 Introduction 22
2.1 Catalyst 22
2.2 Related Reports 23
2.3 Upcoming Related Reports 23
3 Disease Overview 24
3.1 Anatomy and Physiology 24
3.1.1 Risk Factors 25
3.1.2 Etiology 27
3.2 Pathophysiology 28
3.2.1 Cardiac Arrhythmias 28
3.3 Clinical Presentation 34
3.3.1 Symptoms 34
3.4 Diagnosis 35
3.4.1 Blood and Urine Diagnostic Procedures 35
3.4.2 Electrocardiography-Based Diagnostic Procedures 36
3.4.3 Computerized Tomographic Angiography 37
3.4.4 Electrophysiological Testing 37
3.4.5 Electromechanical Wave Imaging 37
3.4.6 Echocardiography 38
3.4.7 Tilt-Table Testing 38
3.4.8 Diagnostic and Electrophysiological Studies 38
3.4.9 New York Heart Association Scale 38
3.4.10 American College of Cardiology Scale 39
3.4.11 Level of Evidence 40
3.5 Epidemiology 41
3.5.1 Prevalence 41
4 Industry Overview 44
4.1 Overview 44
4.2 Clinical Outcomes 45
4.2.1 Pacemakers 45
4.2.2 ICDs 53
4.2.3 CRT-Ps 60
4.2.4 CRT-Ds 61
4.3 Procedure Trends 63
4.3.1 Cost Remains a Concern with Dual-Chambered Devices 63
4.3.2 Cardiac Resynchronization Therapy Increasingly Popular Around the World 67
4.3.3 Device Reuse Programs to Transform Currently Wasted Resource 68
4.3.4 Hospital Market Growth 69
4.4 Market Access 70
4.4.1 Europe 70
4.4.2 Reimbursement Trends 71
4.5 Regulatory Issues/Recalls 77
4.5.1 Medtronic Pacemakers Recalled over Failure Risk, 2009 77
4.5.2 St. Jude Riata ICD Leads Recalled, 2011 77
4.6 Mergers and Acquisitions 78
4.6.1 Boston Scientific Acquires C.R. Bard’s Electrophysiology Business 78
4.6.2 Sorin Group Closes Further Investment and Option-to-Buy in Enopace Biomedical 78
4.7 Key Partnerships 79
4.7.1 Leti Forms Partnership with Sorin, TIMA, Cedrat Technologies, Tronics and EASII IC 79
4.7.2 St. Jude Medical to Invest in Nanostim 79
4.7.3 Sorin Group Signs Supply Agreement for Boston Scientific Corporation Lotus Valve System 81
4.8 Economic Impact 82
4.8.1 Cost-Effectiveness of Pacemakers 82
4.8.2 Cost-Effectiveness of ICDs 82
4.8.3 Cost-Effectiveness of Cardiac Resynchronization Therapy 83
4.9 Market Drivers 84
4.9.1 Rapidly Increasing Patient Populations Suitable for Device Implantation to Drive Sales 84
4.9.2 Technological Advances and New Products in Pipeline to Drive Sales 90
4.9.3 Evolving Indications for Cardiac Rhythm Management Therapy 95
4.9.4 Imaging Guided Placement of Leads 98
4.9.5 Cost-Saving Benefits of Remote Home Monitoring 99
4.9.6 Increased Primary Prevention Procedures 101
4.9.7 Increases in Implantation from Positive Clinical Trials 102
4.9.8 Antibacterial Envelopes to Reduce Rates of Complication and Increase Device Safety 103
4.9.9 Strong Portfolio of Pipeline Products from Key Players to Drive Future Growth of the Market 103
4.9.10 Leadless Technology Eliminates Lead-Related Complications 104
4.9.11 Diagnostic Rate Improvements Expected to Drive CRM Device Sales 105
4.9.12 Increased Device Implantation in Pediatrics 108
4.10 Market Barriers 109
4.10.1 Innovative and Next-Generation Drug Therapy May Pose a Challenge to CRM Devices in the Future 110
4.10.2 Slow Adoption of Remote Patient Monitoring Could Restrain Market Growth 110
4.10.3 Inconsistencies between Various Guidelines Affects Treatment 110
4.10.4 Inappropriate Shock Rates May Thwart Potential CRM Patients 112
4.10.5 Patient Education to Increase Awareness and Device Adoption 112
4.10.6 Declining Average Selling Prices to Adversely Affect CRM Product Revenues 113
5 Competitive Assessment 115
5.1 Overview 115
5.2 Regional Market Share 115
5.2.1 Pacemaker and CRT-P Company Share in Europe 115
5.2.2 ICD and CRT-D Market Company Share in Europe 117
6 Unmet Needs 118
6.1 Overview 118
6.2 Leads and Electrode Development 118
6.2.1 MRI-Compatible Generators and Leads 119
6.2.2 Single-Lead Systems with Atrial Diagnostics 121
6.3 Power-Supplying Batteries 121
6.4 Energy-Harvesting Batteries 122
6.5 Rates of Infection 123
7 Pipeline Products 124
7.1 Overview 124
7.2 Pipeline Products by Phase in Development 124
7.3 Pacemaker and CRT-P Product Profiles 125
7.3.1 Aortic Pacemaker (Hadasit Medical Research Services and Development Ltd.) 125
7.3.2 Cardiac Energy Harvesting Pacemaker (University of Michigan) 126
7.3.3 Endurance Microgenerator (Endurance Rhythm) 126
7.3.4 Implantable Dual-Chamber Pacemaker (MicroPort Scientific) 127
7.3.5 Unconditional MRI-Compatible Implantable Pacemaker (Kenergy, Inc.) 127
7.3.6 Tissue-Engineered Autonomous Pacemaker (Duke University) 128
7.3.7 Wireless Cardiac Stimulation Device (EBR Systems, Inc.) 128
7.4 ICD and CRT-D Product Profiles 129
7.4.1 Atrial Defibrillator (SmartWave Medical Ltd.) 129
7.4.2 CardiaLen (CardiaLen, Inc.) 129
7.4.3 Chronicle (Medtronic) 130
7.5 Clinical Trials to Watch 131
7.5.1 Overview 131
7.5.2 SELECT-LV Trial of WiCS-LV System (EBR Systems, Inc.) 131
7.5.3 MultiPoint Pacing Clinical Trial of Quadra Assura CRT-D (Medtronic) 133
7.5.4 MADIT-ASIA Trial with Invive CRT-P (Boston Scientific) 134
7.5.5 MultiPoint Pacing IDE Study of Promote Quadra (St. Jude Medical) 136
7.5.6 Post Approval Study of S-ICD System (Boston Scientific) 137
7.5.7 ProMRI Study of the Evia/Entovis Pacemaker System 139
7.5.8 MIRACLE EF Clinical Study of Consulta CRT-P (Medtronic) 141
8 Current and Future Players 144
8.1 Overview 144
8.2 Trends in Corporate Strategy 144
8.3 Biotronik 145
8.3.1 Overview 145
8.3.2 Portfolio Evaluation 147
8.3.3 Commercial Positioning 158
8.3.4 Company SWOT Analysis 158
8.4 Boston Scientific 159
8.4.1 Overview 159
8.4.2 Portfolio Evaluation 161
8.4.3 Commercial Positioning 170
8.4.4 Company SWOT Analysis 171
8.5 Impulse Dynamics 172
8.5.1 Overview 172
8.5.2 Portfolio Evaluation 172
8.5.3 Commercial Positioning 173
8.5.4 Company SWOT Analysis 173
8.6 Medtronic 174
8.6.1 Overview 174
8.6.2 Portfolio Evaluation 176
8.6.3 Marketed Products 179
8.6.4 Additional Products 187
8.6.5 Commercial Positioning 189
8.6.6 Company SWOT Analysis 191
8.7 Sorin Group 191
8.7.1 Overview 191
8.7.2 Portfolio Evaluation 194
8.7.3 Marketed Products 195
8.7.4 Commercial Positioning 196
8.7.5 Company SWOT Analysis 197
8.8 St. Jude Medical 198
8.8.1 Overview 198
8.8.2 Portfolio Evaluation 199
8.8.3 Marketed Products 201
8.8.4 Commercial Positioning 214
8.8.5 Company SWOT Analysis 215
9 Market Outlooks and Forecasts 216
9.1 Market Outlooks and Forecasts by Geography 216
9.1.1 France 216
9.1.2 Germany 221
9.1.3 Italy 226
9.1.4 Spain 231
9.1.5 UK 235
10 Appendix 241
10.1 Bibliography 241
10.2 Abbreviations 254
10.3 Report Methodology 259
10.3.1 Overview 259
10.3.2 Coverage 259
10.3.3 Secondary Research 260
10.3.4 Forecasting Methodology 260
10.3.5 Primary Research - Key Opinion Leader Interviews 262
10.3.6 Expert Panel Validation 262
10.4 Physicians and Specialists Included in this Study 263
10.5 About the Authors 265
10.5.1 Analysts 265
10.5.2 Global Head of Healthcare 266
10.6 About MediPoint 267
10.7 About GlobalData 267
10.8 Disclaimer 267



List of Tables

Table 1: New York Heart Association Scale 39
Table 2: American College of Cardiology Scale 39
Table 3: Level of Evidence 40
Table 4: Prevalent Cases of Congestive Heart Failure, EU Markets, Ages ?45 Years, Men and Women (n), 2012-2019 43
Table 5: Pacemaker Implantation Classification Guideline 47
Table 6: Patient Post-Operative Condition with ICD Implantation, 2012 54
Table 7: Level of Evidence Guidelines 58
Table 8: Single-Chamber Pacemakers versus Dual-Chamber Pacemakers, Sales Volume Comparison, by Country, 2012 64
Table 9: Single-Chamber ICDs versus Dual-Chamber ICDs, Sales Volume Comparison, by Country, 2012 65
Table 10: CRT-P versus Conventional Pacemakers, Sales Volume Comparison, by Country, 2012 67
Table 11: CRT-D versus Conventional ICD Products, Sales Volume Comparison, by Country, 2012 67
Table 12: Healthcare Expenditure by Payer (%) and Healthcare Expenditure per Capita ($), EU, 2011 71
Table 13: Percentage of Population Aged 65 Years and Older, by Country, 2005-2015 85
Table 14: Percentage of Smoking Population by Country (%), Global, 2010 86
Table 15: Percentage of Overweight and Obese Population (Aged 15 Years and Above), by Country, 2012 87
Table 16: Diabetes Prevalence Rates by Region (%), 20-79 Years, Global, 2007 and 2010 88
Table 17: Percentage of Hypertensive Population Aged 25 Years and Above (%), Global, 2010 90
Table 18: Technological Innovations, Cardiac Rhythm Management Devices 91
Table 19: Benefits of Quadripolar Lead Technology 93
Table 20: Updated Cardiac Resynchronization Therapy Guidelines 94
Table 21: Percent Primary Prevention Implantation by Country (%), ICD/CRT-D, Global, 2012 101
Table 22: Primary Prevention Cases by Country (%), ICD, EU, 2012 105
Table 23: Barriers in Access to Quality Healthcare Leading to Disparities in CRM Treatment 109
Table 24: Average Selling Price ($) Comparison, by Country, 2012 114
Table 25: Pacemaker and CRT-P Market, Europe, Revenue ($) and Company Share (%), 2012 116
Table 26: ICD and CRT-D Market, Europe, Revenue ($) and Company Share (%), 2012 117
Table 27: Product Profile - Aortic Pacemaker 125
Table 28: Product Profile - Cardiac Energy Harvesting Pacemaker 126
Table 29: Product Profile - Endurance Microgenerator 126
Table 30: Product Profile - MicroPort Pacemaker 127
Table 31: Product Profile - Kenergy Pacemaker 127
Table 32: Product Profile - Tissue-Engineered Autonomous Pacemaker 128
Table 33: Product Profile - Wireless Cardiac Stimulation Device 128
Table 34: Product Profile - Atrial Defibrillator 129
Table 35: Product Profile - CardiaLen 129
Table 36: Product Profile - Chronicle 130
Table 37: Clinical Trial for WiCS-LV System 131
Table 38: Clinical Trial for Quadra Assura CRT-D 133
Table 39: Clinical Trial for Invive CRT-P 134
Table 40: MultiPoint Pacing IDE Study for Promote Quadra 136
Table 41: Post Approval Study of S-ICD System 137
Table 42: ProMRI Study of the Evia/Entovis Pacemaker System 139
Table 43: MIRACLE EF Clinical Study of Consulta CRT-P 141
Table 44: Company Profile - Biotronik 147
Table 45: Product Profile - Cylos 990 150
Table 46: Product Profile - Effecta 151
Table 47: Product Profile - Evia/Entovis 152
Table 48: Product Profile - Estella 153
Table 49: Product Profile - Stratos 154
Table 50: Product Profile - Ilesto 7 154
Table 51: Product Profile - Lumax 157
Table 52: Biotronik SWOT Analysis, 2012 158
Table 53: Company Profile - Boston Scientific 160
Table 54: Product Profile - Advantio 163
Table 55: Product Profile - Altrua 164
Table 56: Product Profile - Cognis 165
Table 57: Product Profile - Energen 166
Table 58: Product Profile - Incepta 166
Table 59: Product Profile - Ingenio 167
Table 60: Product Profile - Invive 168
Table 61: Product Profile - Punctua 169
Table 62: Product Profile - S-ICD System 2.0 169
Table 63: Product Profile - Teligen 170
Table 64: Boston Scientific SWOT Analysis, 2012 171
Table 65: Company Profile - Impulse Dynamics 172
Table 66: Product Profile - Optimizer IVs 172
Table 67: Impulse Dynamics SWOT Analysis, 2012 173
Table 68: Company Profile - Medtronic 175
Table 69: Product Profile - Advisa 179
Table 70: Product Profile - Adapta 180
Table 71: Product Profile - Brava/Viva 181
Table 72: Product Profile - Consulta 182
Table 73: Product Profile - EnPulse 182
Table 74: Product Profile - EnRhythm 183
Table 75: Product Profile - Ensura MRI 183
Table 76: Product Profile - Evera 184
Table 77: Product Profile - Protecta 184
Table 78: Product Profile - Secura 185
Table 79: Product Profile - Syncra 186
Table 80: Product Profile - Revo 186
Table 81: Product Profile - Concerto 187
Table 82: Product Profile - EnTrust 188
Table 83: Product Profile - Maximo II 188
Table 84: Medtronic SWOT Analysis, 2012 191
Table 85: Company Profile - Sorin Group 193
Table 86: Product Profile - Esprit 195
Table 87: Product Profile - Paradym 195
Table 88: Product Profile - Reply 2000 196
Table 89: Sorin Group SWOT Analysis, 2012 197
Table 90: Company Profile - St. Jude Medical 198
Table 91: Product Profile - Accent 202
Table 92: Product Profile - Accent MRI 203
Table 93: Product Profile - Anthem 204
Table 94: Product Profile - Allure Quadra 205
Table 95: Product Profile - AnalyST Accel 205
Table 96: Product Profile - Assurity 206
Table 97: Product Profile - Current Accel 206
Table 98: Product Profile - Current Plus 207
Table 99: Product Profile - Ellipse 207
Table 100: Product Profile - Endurity 208
Table 101: Product Profile - Fortify Assura 208
Table 102: Product Profile - Fortify 209
Table 103: Product Profile - Microny 209
Table 104: Product Profile - Leadless Pacemaker 210
Table 105: Product Profile - Promote Plus 211
Table 106: Product Profile - Quadra Assura 212
Table 107: Product Profile - Unify Assura 212
Table 108: Product Profile - Unify Quadra 213
Table 109: Product Profile - Unify 213
Table 110: Product Profile - Zephyr 214
Table 111: St. Jude Medical SWOT Analysis, 2012 215
Table 112: France Cardiac Rhythm Management Device Implantation 218
Table 113: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, France, Revenue ($m), 2010-2020 219
Table 114: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, France, Revenue ($m), 2010-2020 220
Table 115: Germany Cardiac Rhythm Management Device Implantation 223
Table 116: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, Germany, Revenue ($m), 2010-2020 224
Table 117: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, Germany, Revenue ($m), 2010-2020 225
Table 118: Italy Cardiac Rhythm Management Device Implantation 227
Table 119: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, Italy, Revenue ($m), 2010-2020 229
Table 120: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, Italy, Revenue ($m), 2010-2020 230
Table 121: Spain Cardiac Rhythm Management Device Implantation 232
Table 122: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, Spain, Revenue ($m), 2010-2020 234
Table 123: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, Spain, Revenue ($m), 2010-2020 235
Table 124: UK Cardiac Rhythm Management Device Implantation 237
Table 125: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, UK, Revenue ($m), 2010-2020 239
Table 126: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, UK, Revenue ($m), 2010-2020 240

1.2 List of Figures
Figure 1: Types of Arrhythmia 28
Figure 2: Generic Pacemaker Code 46
Figure 3: Guide for Pacemaker Implantation 48
Figure 4: Percent Dual-Chamber Pacemakers, by Country, 2010, 2013, 2020 63
Figure 5: Dual-Chamber ICDs (%), by Country, 2009, 2013, 2020 65
Figure 6: Patient and General Population Preferences for CRM Device Reuse, US 68
Figure 7: Percentage of Population Aged 65 Years and Above, by Country, 2005-2015 85
Figure 8: Diabetes Prevalence Rates, 20-79 Years, by Region, 2007-2010 88
Figure 9: Percentage of Hypertensive Population Aged 25 Years and Above (%), Global, 2010 89
Figure 10: Evaluating Effectiveness of Remote Home Monitoring 100
Figure 11: Secondary Prevention Diagnosed Cases by Country (%), ICD, EU, 2012 106
Figure 12: Diagnosed VT and VF Cases Receiving ICD by Country (%), ICD, EU, 2012 107
Figure 13: Average Selling Price ($) Comparison, by Country, EU, 2012 113
Figure 14: Pacemaker and CRT-P Market, Europe, Company Share (%), 2012 115
Figure 15: ICD and CRT-D Market, Europe, Company Share (%), 2012 117
Figure 16: CRM Pipeline Products by Phase in Development 124
Figure 17: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, France, Revenue ($m), 2010-2020 219
Figure 18: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, France, Revenue ($m), 2010-2020 220
Figure 19: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, Germany, Revenue ($m), 2010-2020 224
Figure 20: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, Germany, Revenue ($m), 2010-2020 225
Figure 21: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, Italy, Revenue ($m), 2010-2020 229
Figure 22: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, Italy, Revenue ($m), 2010-2020 230
Figure 23: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, Spain, Revenue ($m), 2010-2020 233
Figure 24: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, Spain, Revenue ($m), 2010-2020 234
Figure 25: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, UK, Revenue ($m), 2010-2020 239
Figure 26: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, UK, Revenue ($m), 2010-2020 240



Companies Mentioned

Biotronik
Boston Scientific
Impulse Dynamics
Medtronic
Sorin Group
St. Jude Medical

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