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MediPoint: Electrophysiology - US Analysis and Market Forecasts

Summary

Still in its infancy, the electrophysiology (EP) device market has seen significant adoption; as more physicians become experienced in diagnostic and ablation techniques, increasing numbers of hospitals purchase supportive equipment, device price-points fall, and efficacy improves. This continued growth is also driven by technological advancements including the emergence of next-generation ablation technologies, improvements in catheter diagnostics, and advancements in lab systems. Further, as imaging modalities improve, patients are exposed to less radiation than ever before, which will only further drive diagnostics.

The EP market in the US continues to grow and is driven by new physician adoption, increases in patient awareness, improvements in reimbursement, and the introduction of next-generation devices. As players in the market further consolidate, as seen with Boston Scientific’s acquisition of C.R. Bard, competition continues to rise with a select number of manufacturers fighting for valuable market share.

Scope

- An overview of electrophysiology, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized US electrophysiology market revenue from 2005 to 2013, forecast for 7 years to 2020.
- Investigation of current and future market competition for electrophysiology
- 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 electrophysiology sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL)

Reasons to buy

- Understand the trends shaping and driving the US electrophysiology market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the US electrophysiology market through 2020.
- 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 the US electrophysiology market landscape? Identify, understand and capitalize.

Table Of Contents

MediPoint: Electrophysiology - US Analysis and Market Forecasts
1 Table of Contents

2 Introduction 20
2.1 Catalyst 20
2.2 Related Reports 20
3 Industry Overview 21
3.1 Introduction 21
3.2 Anatomy and Physiology 21
3.2.1 Etiology 22
3.2.2 Risk Factors 23
3.2.3 Types of Arrhythmia 24
3.3 Clinical Presentation 27
3.3.1 Symptoms 27
3.4 Diagnosis 27
3.4.1 Blood and Urine Diagnostic Procedures 28
3.4.2 Electrocardiography-Based Diagnostic Procedures 28
3.4.3 Computerized Tomographic Angiography 29
3.4.4 Electrophysiological Testing 29
3.4.5 Electromechanical Wave Imaging 30
3.4.6 Echocardiography 30
3.4.7 Tilt-Taable Testing 30
3.4.8 Diagnostic and Electrophysiological Studies 31
3.4.9 New York Heart Association Scale 31
3.4.10 American College of Cardiology Scale 31
3.5 Epidemiology 32
3.5.1 Prevalence 32
3.6 Market Segmentation 35
3.6.1 Electrophysiology Diagnostic Catheter 35
3.6.2 Electrophysiology Ablation Catheter 35
3.6.3 Electrophysiology Lab Systems 50
3.7 Treatment Costs, Pricing, and Reimbursement 50
3.7.1 Direct Costs 53
3.7.2 Indirect Costs 55
3.7.3 US Costs 57
3.7.4 Pricing of Electrophysiology Devices and Equipment 59
3.7.5 Reimbursement 60
3.8 Market Characterization 61
3.8.1 Growing Patient Population Suitable for Treatment 61
3.8.2 Increasing Prevalence of Arrhythmia with Age 62
3.8.3 Emergence of Remote Catheter Navigation and Ablation Technology 63
3.8.4 Focus on the Development of “Single Shot” Devices 66
3.8.5 Catheter Localization Aided by Novel Mapping and Visualization Techniques 67
3.8.6 Electrophysiology Market Trends in Inorganic Growth through Consolidation 68
3.8.7 Lack of Skilled and Experienced Electrophysiologists to Negatively Impact Procedure Volumes and Hinder Market Growth 68
3.8.8 Awareness and Education to Drive Earlier Intervention 69
3.9 Regulatory Issues and Recalls 70
4 Segment Analysis 71
4.1 Ablation Catheters Market Dynamics 71
4.1.1 Ablation Catheters Market Drivers 71
4.1.2 Ablation Catheters Market Barriers 88
4.2 Diagnostic Catheters Market Dynamics 99
4.2.1 Diagnostic Catheters Market Drivers 99
4.2.2 Diagnostic Catheters Market Barriers 100
4.3 Lab Systems Market Dynamics 103
4.3.1 Lab Systems Market Drivers 103
4.3.2 Lab Systems Market Barriers 105
5 Market Outlooks by Geography 107
5.1 US 107
5.1.1 Overview 107
5.1.2 Market Analysis 107
6 Strategic Competitive Assessment 116
6.1 Key Company Share 116
6.1.1 Overview 116
6.1.2 US 117
7 Current and Future Players 120
7.1 Biosense Webster 120
7.1.1 Overview 120
7.1.2 Portfolio Evaluation 120
7.1.3 Biosense Webster SWOT Analysis 121
7.2 Biotronik 124
7.2.1 Overview 124
7.2.2 Portfolio Evaluation 125
7.2.3 Biotronik SWOT Analysis 126
7.3 Boston Scientific 130
7.3.1 Overview 130
7.3.2 Boston Scientific Acquires Bard EP and Rhythmia Medical 131
7.3.3 Portfolio Evaluation 131
7.3.4 Boston Scientific SWOT Analysis 135
7.4 CardioFocus 141
7.4.1 Overview 141
7.4.2 Portfolio Evaluation 142
7.4.3 Company SWOT Analysis 143
7.5 CardioInsight 146
7.5.1 Overview 146
7.5.2 Portfolio Evaluation 146
7.5.3 CardioInsight SWOT Analysis 147
7.6 Hansen Medical 149
7.6.1 Overview 149
7.6.2 Portfolio Evaluation 149
7.6.3 Company SWOT Analysis 150
7.7 Imricor 153
7.7.1 Overview 153
7.7.2 Portfolio Evaluation 153
7.7.3 Company SWOT Analysis 153
7.8 Japan Lifeline 156
7.8.1 Overview 156
7.8.2 Portfolio Evaluation 157
7.8.3 Company SWOT Analysis 157
7.9 Magnetecs Corporation 159
7.9.1 Overview 159
7.9.2 Portfolio Evaluation 160
7.9.3 Company SWOT Analysis 161
7.10 Medtronic 163
7.10.1 Overview 163
7.10.2 Portfolio Evaluation 164
7.10.3 Company SWOT Analysis 167
7.11 MicroPort Scientific Company 170
7.11.1 Overview 170
7.11.2 Portfolio Evaluation 171
7.11.3 MicroPort Scientific SWOT Analysis 172
7.12 St. Jude Medical 174
7.12.1 Overview 174
7.12.2 Portfolio Evaluation 175
7.12.3 Company SWOT Analysis 178
7.13 Stereotaxis 181
7.13.1 Overview 181
7.13.2 Portfolio Evaluation 181
7.13.3 Commercial Positioning 182
7.13.4 Company SWOT Analysis 183
7.14 Stryker Sustainability Solutions 189
7.14.1 Overview 189
7.14.2 Portfolio Evaluation 190
7.14.3 Company SWOT Analysis 191
7.15 Topera Medical 193
7.15.1 Overview 193
7.15.2 Portfolio Evaluation 194
7.15.3 Company SWOT Analysis 195
8 Pipeline Product Assessment 198
8.1 Pipeline Assessment by Development Stage 198
8.2 Segment Analysis of Pipeline Products 199
8.2.1 Ablation Catheter Pipeline Products 199
8.2.2 Diagnostic Catheter Pipeline Products 205
8.3 Lab Systems 206
8.3.1 Integrated X-Ray and Robotic Catheter System (Hansen Medical, Philips Healthcare) 206
8.3.2 ClearTrace System (MRI Interventions) 207
8.3.3 Robotic Catheter Guidance Lab System (North Carolina State University) 207
8.3.4 Catheter Guidance Lab System (SCR) 208
9 Strategic Deals Analysis 209
9.1 Key Acquisitions 209
9.1.1 Boston Scientific Acquires C.R. Bard's Electrophysiology Business for $275m 209
9.1.2 St. Jude Medical Acquires Endosense for $161m 209
9.1.3 Boston Scientific Acquires Rhythmia Medical for $265m 210
9.2 Key Partnerships 210
9.2.1 Philips and Biosense Webster Technology Integration Agreement 210
9.2.2 Biosense Webster Technology Integration Agreement with GE Healthcare Systems and Siemens Healthcare 210
9.2.3 Abbott and St. Jude Medical Broaden Alliance in US Cardiovascular Device Market 211
10 Appendix 212
10.1 Bibliography 212
10.2 Abbreviations 223
10.3 Report Methodology 228
10.3.1 Overview 228
10.3.2 Coverage 228
10.3.3 Secondary Research 228
10.3.4 Forecasting Methodology 229
10.3.5 Primary Research - Key Opinion Leader Interviews 230
10.3.6 Expert Panel Validation 230
10.4 Physicians Included in this Study 231
10.5 About the Authors 233
10.5.1 Analysts 233
10.5.2 Global Head of Healthcare 234
10.6 About MediPoint 235
10.7 About GlobalData 235
10.8 Disclaimer 235

1.1 List of Tables

Table 1: New York Heart Association Scale 31
Table 2: American College of Cardiology Scale 32
Table 3: Prevalent Cases of Congestive Heart Failure, US, Ages ?45 Years, Men and Women (N), 2012-2019 34
Table 4: Atrial Fibrillation Treatment Goals 37
Table 5: Reasons for Lack of Consensus on Site for Ablation 42
Table 6: Techniques for Treatment of Persistent and Permanent Atrial Fibrillation 43
Table 7: Types of Atrial Fibrillation based of Triggers 45
Table 8: Characteristics of Catheter Ablation by Arrhythmia Type (%) 46
Table 9: Rates of Occurrence of Major Complications with Catheter Ablation (%), 2003-2006 47
Table 10: Catheter Ablation Success for the Treatment of Atrial Fibrillation (%), Global, 1995-2002 and 2003-2006 49
Table 11: Catheter Ablation Success by Arrhythmia Type (%), 2009 50
Table 12: Classes of Recommendations 51
Table 13: Level of Evidence 51
Table 14: Estimation of Total Incremental Health Care Costs in Patients with Atrial Fibrillation ($), US, 2008 57
Table 15: Complications Associated with Atrial Fibrillation and Their Incremental Medicare Costs, US, 2008 59
Table 16: Average Selling Price of Electrophysiology Products by Type, US, 2013 60
Table 17: Percentage of Population Age 65 and Older, US, 2005-2015 61
Table 18: Overview of the Applications, Benefits, Limitations, and Future Directions of Remote Navigation Systems in Electrophysiology 65
Table 19: Key Acquisitions in the Electrophysiology Devices Market 68
Table 20: Advantages and Disadvantages of Various Energy Sources Used for Catheter Ablation 79
Table 21: Experimental Theories of How Atrial Fibrillation Perpetuates 86
Table 22: Antiarrhythmic Drug Classification by Mode of Action 90
Table 23: Major Complications Associated with Catheter Ablation 93
Table 24: Complications Associated with Catheter Ablation 93
Table 25: Recently Approved and Investigational Antiarrhythmic Drugs Under Development 94
Table 26: Diagnosed Patient Volume by Disease Type, Diagnosed Patients (N), US, 2013 109
Table 27: Ablation Catheters Market, US, Historic Revenue ($m), 2005-2013 110
Table 28: Ablation Catheters Market, US, Forecast Revenue ($m), 2013-2020 111
Table 29: Diagnostic Catheters Market, US, Historic Revenue ($m), 2005-2013 112
Table 30: Diagnostic Catheters Market, US, Forecast Revenue ($m), 2013-2020 113
Table 31: Lab Systems Market, US, Historic Revenue ($m), 2005-2013 113
Table 32: Lab Systems Market, US, Forecast Revenue ($m), 2013-2020 114
Table 33: Company Share, US, Total Electrophysiology Market Revenue (%), 2012 118
Table 34: Company Profile - Biosense Webster 120
Table 35: Biosense Webster, Electrophysiology Devices Portfolio 121
Table 36: SWOT Analysis - Biosense Webster 121
Table 37: Company Profile - Biotronik 125
Table 38: Biotronik, Electrophysiology Devices Portfolio 126
Table 39: SWOT Analysis - Biotronik 126
Table 40: Company Profile - Boston Scientific 131
Table 41: Boston Scientific, Electrophysiology Devices Portfolio 134
Table 42: SWOT Analysis - Boston Scientific 135
Table 43: Company Profile - CardioFocus 142
Table 44: CardioFocus, Electrophysiology Devices Portfolio 143
Table 45: SWOT Analysis - CardioFocus 143
Table 46: Company Profile - CardioInsight 146
Table 47: CardioInsight, Electrophysiology Devices Portfolio 146
Table 48: SWOT Analysis - CardioInsight 147
Table 49: Company Profile - Hansen Medical 149
Table 50: Hansen Medical, Electrophysiology Devices Portfolio 150
Table 51: SWOT Analysis - Hansen Medical 150
Table 52: Company Profile - Imricor 153
Table 53: SWOT Analysis - Imricor 153
Table 54: Company Profile - Japan Lifeline 156
Table 55: Japan Lifeline, Electrophysiology Devices Portfolio 157
Table 56: SWOT Analysis - Japan Lifeline 157
Table 57: Company Profile - Magnetecs Corporation 160
Table 58: Magnetecs Corporation, Electrophysiology Devices Portfolio 161
Table 59: SWOT Analysis - Magnetecs Corporation 161
Table 60: Company Profile - Medtronic 164
Table 61: Medtronic, Electrophysiology Devices Portfolio, 2013 166
Table 62: SWOT Analysis - Medtronic 167
Table 63: Company Profile - MicroPort Scientific Company 171
Table 64: MicroPort Scientific, Electrophysiology Devices Portfolio 172
Table 65: SWOT Analysis - MicroPort Scientific 172
Table 66: Company Profile - St. Jude Medical 175
Table 67: St. Jude Medical, Electrophysiology Devices Portfolio 177
Table 68: SWOT Analysis - St. Jude Medical 178
Table 69: Company Profile - Stereotaxis 181
Table 70: Stereotaxis, Electrophysiology Devices Portfolio 183
Table 71: SWOT Analysis - Stereotaxis 184
Table 72: Company Profile - Stryker Sustainability Solutions 190
Table 73: Stryker Sustainability Solutions, Electrophysiology Devices Portfolio 190
Table 74: SWOT Analysis - Stryker Sustainability Solutions 191
Table 75: Company Profile - Topera Medical 194
Table 76: Topera Medical, Electrophysiology Devices Portfolio, 2013 194
Table 77: SWOT Analysis - Topera Medical 195
Table 78: Ablation Catheter Pipeline Products 198
Table 79: Diagnostic Catheter Pipeline Products 198
Table 80: Lab Systems Pipeline Products 198
Table 81: Catheter Ablation Device, Product Status 199
Table 82: Ablation Catheter Device - Transcutaneous Monitoring to Avoid Hypercapnea during Complex Catheter Ablations 200
Table 83: Apama Medical Ablation Catheter, Product Status 201
Table 84: Cooled Tip Catheter, Product Status 201
Table 85: MaPP-CS, Product Status 202
Table 86: ROF-AC, Product Status 202
Table 87: ROF-AS, Product Status 203
Table 88: Vision MR Ablation Catheter, Product Status 203
Table 89: Voyager Irrigated RFA Catheter, Product Status 204
Table 90: Navigation and Ablation Catheter, Product Status 204
Table 91: Hot Balloon Catheter, Product Status 205
Table 92: Lesion Assessment Device, Product Status 206
Table 93: Horizon MR Recording System, Product Status 206
Table 94: Integrated X-Ray and Robotic Catheter System, Product Status 207
Table 95: ClearTrace System, Product Status 207
Table 96: Robotic Catheter Guidance Lab System, Product Status 208
Table 97: Catheter Guidance Lab System, Product Status 208
Table 98: Key Acquisitions in the Electrophysiology Market 209

1.2 List of Figures
Figure 1: Types of Arrhythmia 24
Figure 2: Pulmonary Vein Ablation Procedure 39
Figure 3: Antiarrhythmic Drugs and/or Ablation for Rhythm Control in Atrial Fibrillation 52
Figure 4: Cost Comparison of Ablation versus Antiarrhythmic Drug Therapy, 2009 54
Figure 5: Breakdown of National Incremental Costs in patients with Atrial Fibrillation 58
Figure 6: Diagnosed Patient Volume by Disease Type, Diagnosed Patients (%), US, 2013 109
Figure 7: Ablation Catheters Market, US, Historic Revenue ($m), 2005-2013 110
Figure 8: Ablation Catheters Market, US, Forecast Revenue ($m), 2013-2020 111
Figure 9: Diagnostic Catheters Market, US, Historic Revenue ($m), 2005-2013 112
Figure 10: Diagnostic Catheters Market, US, Forecast Revenue ($m), 2013-2020 113
Figure 11: Lab Systems Market, US, Historic Revenue ($m), 2005-2013 114
Figure 12: Lab Systems Market, US, Forecast Revenue ($m), 2013-2020 115
Figure 13: Company Share, US, Total Electrophysiology Market Revenue (%), 2012 118

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