MediPoint: Renal Denervation - APAC Analysis and Market Forecasts - Hawaii News Now - KGMB and KHNL

MediPoint: Renal Denervation - APAC Analysis and Market Forecasts

Information contained on this page is provided by an independent third-party content provider. WorldNow and this Station make no warranties or representations in connection therewith. If you have any questions or comments about this page please contact pressreleases@worldnow.com.

SOURCE ReportBuyer

LONDON, Feb. 11, 2014 /PRNewswire/ -- Reportbuyer.com just published a new market research report:

MediPoint: Renal Denervation - APAC Analysis and Market Forecasts

MediPoint: Renal Denervation - APAC Analysis and Market Forecasts

Summary

Numerous medical device news sources and industry executives have proclaimed renal denervation to be the top medical device breakthrough of the past two years, and for good reason. Hypertension is one of the most prevalent chronic conditions worldwide, with some studies estimating that 50% of the adult population globally will have the disease in the next 20 years. With limited effectiveness from pharmacotherapy, medical device therapy has the potential for significant adoption in the treatment of resistive hypertension and uncontrolled hypertension, once efficacy and cost-effectiveness are proven. Additionally, the degree of blood pressure reduction found in long-term clinical trials from such a well-tolerated procedure has generated notable optimism about the intervention's application in other conditions where hyperactivity of the sympathetic nervous system plays a significant role, such as congestive heart failure.

The renal denervation market in the APAC will grow from essentially nothing in 2012 as the intervention was not approved for any indication in 2012. That is expected to change by the end of the forecast period. The entire market will be driven by the adoption of the intervention by resistant hypertension patients.

Scope

- An overview of hypertension, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized APAC renal denervation market revenue and future forecasts from 2009 to 2011, forecast for 7 years to 2018.
- Investigation of current and future market competition for renal denervation
- 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 renal denervation 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 APAC renal denervation market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the APAC renal denervation 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 renal denervation market landscape? Identify, understand and capitalize.

Table of Contents

1 Table of Contents 5
1.1 List of Tables 13
1.2 List of Figures 17
2 Introduction 19
2.1 Overview 19
2.2 Catalyst 20
3 Disease Overview 21
3.1 Anatomy and Physiology 21
3.2 Pathophysiology 22
3.3 Etiology 23
3.3.1 Causes 23
3.3.2 Risk Factors 26
3.4 Clinical Presentation 29
3.4.1 Symptoms 29
3.4.2 Diagnosis 29
3.4.3 Clinical Outcomes 31
3.5 Epidemiology 35
3.5.1 Resistant Hypertension 35
3.5.2 Uncontrolled Hypertension 37
3.5.3 Heart Failure 39
3.6 Economic Impact 41
3.6.1 Asia-Pacific 41
4 Marketed Products 44
4.1 Overview 44

4.2 Market Share 46
4.2.1 Japan Market Share, 2013 and 2016 46
4.2.2 India Market Share, 2013 and 2016 47
4.2.3 China Market Share, 2013 and 2016 48
4.3 Allegra Renal Denervation System (Terumo/AngioCare) 49
4.3.1 Overview 49
4.3.2 Safety and Efficacy 50
4.3.3 SWOT Analysis 51
4.4 EnligHTN Renal Denervation System (St. Jude Medical) 52
4.4.1 Overview 52
4.4.2 Safety and Efficacy 53
4.4.3 SWOT Analysis 55
4.5 OneShot Renal Denervation System (Covidien) 56
4.5.1 Overview 56
4.5.2 Safety and Efficacy 57
4.5.3 SWOT Analysis 58
4.6 Paradise Renal Denervation System (ReCor Medical) 59
4.6.1 Overview 59
4.6.2 Safety and Efficacy 60
4.6.3 SWOT Analysis 61

4.7 Symplicity Renal Denervation System (Medtronic) 62
4.7.1 Overview 62
4.7.2 Safety and Efficacy 63
4.7.3 SWOT Analysis 67
4.8 Vessix Renal Denervation System (Boston Scientific Corporation) 68
4.8.1 Overview 68
4.8.2 Safety and Efficacy 69
4.8.3 SWOT Analysis 70
5 Unmet Needs 71
5.1 Overview 71
5.1.1 Intervention to Determine Renal Denervation Efficacy 72
5.1.2 Investigation of Renal Nerve Regeneration 74
5.1.3 Ambulatory Versus Office-Based Blood Pressure Readings 75
5.1.4 Effect of Renal Denervation on Prescription Antihypertensive Medication 81
5.1.5 Expanded Indications for Renal Denervation Systems 83
5.1.6 Effect of Renal Denervation on the Adventitial Layer 86
5.1.7 Repeat Renal Denervation Procedures 89
5.1.8 Long-Term Clinical Trial Data 90
6 Pipeline Products 91
6.1 Overview 91
6.2 Beta-Cath System (Best Medical International) 91

6.2.1 Overview 91
6.2.2 Safety and Efficacy 91
6.2.3 SWOT Analysis 92
6.3 Bullfrog MicroFusion Catheter (Mercator MedSystems) 93
6.3.1 Overview 93
6.3.2 Safety and Efficacy 94
6.3.3 SWOT Analysis 94
6.4 Chemical Denervation System (Kipprokration Hospital) 95
6.4.1 Overview 95
6.4.2 Safety and Efficacy 95
6.4.3 SWOT Analysis 96
6.5 Cryoablation System (Cryomend) 97
6.5.1 Overview 97
6.5.2 Safety and Efficacy 97
6.5.3 SWOT Analysis 97
6.6 Kona Surround Sound System (Kona Medical) 98
6.6.1 Overview 98
6.6.2 Safety and Efficacy 99
6.6.3 SWOT Analysis 100
6.7 Magnetic Nanoparticles (ApexNano) 101
6.7.1 Overview 101
6.7.2 Safety and Efficacy 101
6.7.3 SWOT Analysis 102
6.8 Perivascular Renal Denervation System (Ablative Solutions) 103
6.8.1 Overview 103
6.8.2 Safety and Efficacy 103
6.8.3 SWOT Analysis 104
6.9 Sound 360 Ultrasonic Renal Denervation System (Sound Interventions) 105
6.9.1 Overview 105
6.9.2 Safety and Efficacy 106
6.9.3 SWOT Analysis 107
6.10 Symple Surgical System (Symple Surgical) 108
6.10.1 Overview 108
6.10.2 Safety and Efficacy 108
6.10.3 SWOT Analysis 108
6.11 Tivus System (Cardiosonic) 109

6.11.1 Overview 109
6.11.2 Safety and Efficacy 110
6.11.3 SWOT Analysis 111
6.12 Celsius ThermoCool System (Cordis/Johnson & Johnson) 112
6.12.1 Overview 112
6.12.2 Safety and Efficacy 112
6.12.3 SWOT Analysis 113
6.13 Northwind Medical System (Northwind Medical) 114
6.13.1 Overview 114
6.13.2 Safety and Efficacy 114
6.13.3 SWOT Analysis 114
6.14 Verve Medical System (Verve Medical) 115
6.14.1 Overview 115
6.14.2 Safety and Efficacy 115
6.14.3 SWOT Analysis 116
7 Clinical Trial Analysis 117
7.1 Overview 117
7.2 Clinical Trial Timeline 118
7.3 Clinical Trial Results 126
7.4 Analysis of Trials to Watch 130

7.4.1 Longer Follow-Up 130
7.4.2 Uncontrolled Hypertension 130
7.4.3 Second-Generation Devices 131
7.4.4 Additional Indications 134
8 Industry Overview 135
8.1 Procedure Trends 135
8.2 Market Access 136
8.3 Reimbursement Trends 137
8.3.1 Asia-Pacific 137
8.4 Regulatory Issues/Recalls 139
8.5 Added Indications 139
8.6 Mergers and Acquisitions/Key Partnerships 142
8.6.1 Overview 142

8.6.2 Boston Scientific Acquires Vessix Vascular 143
8.6.3 Covidien Acquires Maya Medical 143
8.6.4 Medtronic Acquires Ardian 144
8.6.5 Terumo Corporation Partners With AngioCare Medical Technology 144
9 Current and Future Players 145
9.1 Trends in Corporate Strategy 145
9.2 Company Profiles 146
9.2.1 Ablative Solutions 146
9.2.2 ApexNano 149
9.2.3 Best Medical International 152
9.2.4 Boston Scientific Corporation 154
9.2.5 Cardiosonic 157
9.2.6 Covidien 160
9.2.7 Cordis Corporation and Johnson & Johnson 163
9.2.8 Cryomend 166
9.2.9 Kona Medical 169
9.2.10 Medtronic 172
9.2.11 Mercator MedSystems 175
9.2.12 Northwind Medical 178
9.2.13 ReCor Medical 180

9.2.14 Sound Interventions 183
9.2.15 St. Jude Medical 186
9.2.16 Symple Surgical 189
9.2.17 Terumo Corporation 191
9.2.18 Verve Medical 194
10 Market Drivers and Opportunities 197
10.1 Market Drivers 197
10.1.1 Growing Global Prevalence and Cost of Hypertension 197
10.1.2 Significant and Sustained Reductions in Office-Based Blood Pressure 198
10.1.3 Growing Clinical Evidence of Efficacy in Other Indications 199
10.1.4 Potential for Outpatient Procedure 200
10.1.5 Positive Results in Moderate Hypertensive Patients 201
10.2 Market Opportunities 202

10.2.1 Expanding Indications 202
10.2.2 Competitive Cost Structure 204
10.2.3 Low-Profile Catheters 205
10.2.4 Catheters for Radial Access 208
10.2.5 Circumferential Ablation 210
10.2.6 Mapping System 211
10.2.7 Clinical Trials in Key Countries 211
10.2.8 Incorporate Renal Denervation Catheters into Sales of Other Cardiology Products 213
10.3 Market Threats 214
10.3.1 Ambulatory Blood Pressure Readings 214
10.3.2 Results of the Symplicity HTN-3 Trial 215
10.3.3 Extent of Clinical Trial Data 216

10.3.4 Radiofrequency Ablation Thermal Damage 217
10.3.5 Degree of Patient Pain 218
10.3.6 Inpatient Procedure 219
10.3.7 Carotid Baroreceptor Stimulation 220
10.3.8 External Systems 222
10.3.9 Micro-Infusion Systems 223
10.3.10 White-Coat Effect 224
10.3.11 Entrance of Cordis Into the Market 225
10.3.12 New Referral Pattern 226
11 Country Outlooks and Forecasts 227
11.1 APAC 227
11.2 Japan 228
11.3 India 229

11.4 China 230
12 Appendix 231
12.1 Bibliography 231
12.2 Abbreviations 247
12.3 Report Methodology 250
12.3.1 Overview 250
12.3.2 Coverage 250
12.3.3 Primary Research 251
12.3.4 Secondary Research 252
12.3.5 Forecasting Methodology 253
12.4 Key Opinion Leaders Included in this Study 253
12.5 About the Authors 254
12.5.1 Joseph A. Gregory, Analyst, Surgical Devices 254
12.5.2 Derek Archila, MBA, Director of Research and Analysis, Medical Devices 254
12.6 Global Head of Healthcare 255
12.6.1 Bonnie Bain, Ph.D., Global Head of Healthcare 255
12.7 About MediPoint 256
12.8 About GlobalData 256
12.9 Disclaimer 256

List of Tables

Table 1: Secondary Causes of Resistant Hypertension 23
Table 2: Risk Factors for Resistant Hypertension 26
Table 3: Medications That Can Contribute to Hypertension 27
Table 4: Nonsurgical Techniques for Treating Resistant Hypertension: Lifestyle Modifications 32
Table 5: Classes of Antihypertensive Medications 33
Table 6: Classification of the Marketed Renal Denervation Systems 44
Table 7: Product Profile - Allegra Renal Denervation System 50
Table 8: Allegra Renal Denervation System - SWOT Analysis, 2013 51
Table 9: Product Profile - EnligHTN Renal Denervation System 53
Table 10: EnligHTN Renal Denervation System - SWOT Analysis, 2013 55
Table 11: Product Profile - OneShot Renal Denervation System 57
Table 12: OneShot System - SWOT Analysis, 2013 58
Table 13: Product Profile - Paradise Renal Denervation System 60
Table 14: Paradise Renal Denervation System - SWOT Analysis, 2013 61
Table 15: Product Profile - Symplicity Renal Denervation System 63
Table 16: Efficacy Results of the Symplicity HTN-1 Clinical Trial 64
Table 17: Efficacy Results of the Symplicity HTN-2 Clinical Trial 65
Table 18: Symplicity Renal Denervation System - SWOT Analysis, 2013 67
Table 19: Product Portfolio - Vessix Renal Denervation System 69
Table 20: Vessix Renal Denervation System - SWOT Analysis, 2013 70
Table 21: Overall Unmet Needs - Current Level of Attainment and Importance 71
Table 22: Comparison of Office-Based and Ambulatory Blood Pressure Reductions in Resistant Hypertensive Patients Treated with Renal Denervation 77
Table 23: Key Renal Denervation Clinical Trials Measuring Ambulatory Blood Pressure 80
Table 24: Proportion of Patients With Changes to Their Medications in the Symplicity HTN-2 Trial 81

Table 25: Key Clinical Trials Assessing Other Indications for Renal Denervation 84
Table 26: Vascular Adverse Events Reported in the EnligHTN-1 Clinical Trial 87
Table 27: Effects of Renal Denervation on the Renal Artery Wall 88
Table 28: Beta-Cath System - SWOT Analysis, 2013 92
Table 29: Bullfrog MicroFusion Catheter - SWOT Analysis, 2013 94
Table 30: Chemical Denervation System - SWOT Analysis, 2013 96
Table 31: Cryoablation System - SWOT Analysis, 2013 97
Table 32: Surround Sound Renal Denervation System - SWOT Analysis, 2013 100
Table 33: Magnetic Nanoparticles System - SWOT Analysis, 2013 102
Table 34: Perivascular Renal Denervation System - SWOT Analysis, 2013 104
Table 35: Sound 360 Ultrasonic Renal Denervation System - SWOT Analysis, 2013 107
Table 36: Symple Surgical Renal Denervation System - SWOT Analysis, 2013 108
Table 37: Tivus Renal Denervation System - SWOT Analysis, 2013 111
Table 38: Celsius Thermocool Renal Denervation System - SWOT Analysis, 2013 113
Table 39: Northwind Medical Renal Denervation System - SWOT Analysis, 2013 114
Table 40: Verve Medical Renal Denervation System - SWOT Analysis, 2013 116
Table 41: Comparison of Clinical Development Stages: Feasibility and Phase II Trials 118
Table 42: Comparison of Clinical Development Stages: Phase III and Phase IV Trials 122
Table 43: Efficacy Results in Renal Denervation Feasibility Trials 127
Table 44: Efficacy Results in Renal Denervation Phase II Trials 128
Table 45: Efficacy Results in Renal Denervation Company-Sponsored Registries 129
Table 46: Companies with Second-Generation Renal Denervation Systems 131
Table 47: Comparison of the Clinical Development Stages for Second-Generation Devices: Feasibility and Phase II Trials 133

Table 48: Key Indications Being Explored for Renal Denervation 140
Table 49: Aspects of Company Acquisitions in the Renal Denervation Market 142
Table 50: Company Profile - Ablative Solutions 146
Table 51: Ablative Solutions - SWOT Analysis, 2013 148
Table 52: Company Profile - ApexNano 149
Table 53: ApexNano - SWOT Analysis, 2013 151
Table 54: Company Profile - Best Medical International 152
Table 55: Best Medical International - SWOT Analysis, 2013 153
Table 56: Company Profile - Boston Scientific Corporation 154
Table 57: Boston Scientific - SWOT Analysis, 2013 156
Table 58: Company Profile - Cardiosonic 157
Table 59: CardioSonic - SWOT Analysis, 2013 159
Table 60: Company Profile - Covidien 160
Table 61: Covidien - SWOT Analysis, 2013 162
Table 62: Company Profile - Cordis Corporation 163
Table 63: Cordis Corporation - SWOT Analysis, 2013 165
Table 64: Company Profile - Cryomend 166
Table 65: Cryomend - SWOT Analysis, 2013 168
Table 66: Company Profile - Kona Medical 169

Table 67: Kona Medical - SWOT Analysis, 2013 171
Table 68: Company Profile - Medtronic 172
Table 69: Medtronic - SWOT Analysis, 2013 174
Table 70: Company Profile - Mercator MedSystems 175
Table 71: Mercator Medsystems - SWOT Analysis, 2013 177
Table 72: Company Profile - Northwind Medical 178
Table 73: Northwind Medical - SWOT Analysis, 2013 179
Table 74: Company Profile - Recor Medical 180
Table 75: ReCor Medical - SWOT Analysis, 2013 182
Table 76: Company Profile - Sound Interventions 183
Table 77: Sound Interventions - SWOT Analysis, 2013 185
Table 78: Company Portfolio - St. Jude Medical 186
Table 79: St. Jude Medical - SWOT Analysis, 2013 188
Table 80: Company Portfolio - Symple Surgical 189
Table 81: Symple Surgical - SWOT Analysis, 2013 190
Table 82: Company Profile - Terumo Corporation 192

Table 83: Terumo Corporation - SWOT Analysis, 2013 193
Table 84: Company Portfolio - Verve Medical 194
Table 85: Verve Medical - SWOT Analysis, 2013 196
Table 86: Worldwide Prevalence of Hypertension (Millions), 2000 and 2025 198
Table 87: Efficacy of Renal Denervation in Moderate Hypertension Patients 201
Table 88: Additional Indications for Renal Denervation 202
Table 89: Patient Exclusion Criteria for Renal Artery Stenosis in Each of the Major Clinical Investigations, 2013 206
Table 90: Advantages and Disadvantages of Carotid Baroreceptor Stimulation 222
Table 91: Renal Denervation Sales ($m) Forecast, APAC, 2010-2019 227
Table 92: Japan Renal Denervation Sales ($m) Forecast, 2010-2019 228
Table 93: India Renal Denervation Sales ($m) Forecast, 2010-2019 229
Table 94: China Renal Denervation Sales ($m) Forecast, 2010-2019 230

1.2 List of Figures
Figure 1: Treatment Paradigm for Resistant Hypertension 31
Figure 2: Composition of the Resistant Hypertension Market, APAC, 2012 36
Figure 3: Prevalence of the Renal Denervation-Eligible Resistant Hypertension Patient Population, APAC, 2010-2019 36
Figure 4: Composition of the Uncontrolled Hypertension Market, APAC, 2012 37
Figure 5: Prevalence of Uncontrolled Hypertension, APAC, 2010-2019 38
Figure 6: Prevalence of Heart Failure (Class II and III), APAC, 2010-2019 39
Figure 7: Composition of Heart Failure Patients (Class II and II), APAC, 2012 40
Figure 8: Japan Renal Denervation Market Share, 2016 46
Figure 9: India Renal Denervation Market Share, 2016 47
Figure 10: China Renal Denervation Market Share, 2016 48
Figure 11: Allegra Renal Denervation System 49
Figure 12: EnligHTN Renal Denervation System 52
Figure 13: OneShot Renal Denervation System Balloon Catheter 56
Figure 14: Paradise Renal Denervation System 59
Figure 15: Symplicity Renal Denervation System 62
Figure 16: Vessix Renal Denervation System Catheter 68
Figure 17: Bullfrog MicroFusion Catheter 93
Figure 18: Chemical Denervation System 95

Figure 19: Kona Surround Sound Renal Denervation System 98
Figure 20: Sound 360 Ultrasonic Renal Denervation System 105
Figure 21: Tivus Renal Denervation System 109
Figure 22: Tivus Renal Denervation System Catheter 110
Figure 23: Timeline of Feasibility Clinical Trials 120
Figure 24: Timeline of Phase II Clinical Trials 121
Figure 25: Timeline of Phase III Clinical Trials 124
Figure 26: Timeline of Post-Market Clinical Trials 125
Figure 27: Renal Denervation Procedure Volumes: Resistant Hypertension, APAC Region, 2010-2019 135
Figure 28: Physiological Changes Resulting from Carotid Baroreceptor Stimulation 220
Figure 29: Renal Denervation Sales ($) Forecast, APAC, 2010-2019 227
Figure 30: Japan Renal Denervation Sales ($m) Forecast, 2010-2019 228
Figure 31: India Renal Denervation Sales ($m) Forecast, 2010-2019 229
Figure 32: China Renal Denervation Sales ($m) Forecast, 2010-2019 230

Companies Mentioned

Ablative Solutions
ApexNano
Best Medical International
Boston Scientific Corporation
Cardiosonic
Covidien
Cordis Corporation and Johnson & Johnson
Cryomend
Kona Medical
Medtronic
Mercator MedSystems
Northwind Medical
ReCor Medical
Sound Interventions
St. Jude Medical
Symple Surgical
Terumo Corporation
Verve Medical

Read the full report:
MediPoint: Renal Denervation - APAC Analysis and Market Forecasts
http://www.reportbuyer.com/pharma_healthcare/drug_discovery/medipoint_renal_denervation_apac_analysis_market_forecasts.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_Discovery_and_Development

For more information:
Sarah Smith
Research Advisor at Reportbuyer.com
Email: query@reportbuyer.com  
Tel: +44 208 816 85 48
Website: www.reportbuyer.com

©2012 PR Newswire. All Rights Reserved.