REFERENCE CODE GDME1018FPR PUBLICATION DATE NOVEMBER 2013 CARDIAC RHYTHM MANAGEMENT CURRENT AND FUTURE PLAYERS

Transcription

1 REFERENCE CODE GDME1018FPR PUBLICATION DATE NOVEMBER 2013 CARDIAC RHYTHM MANAGEMENT

2 List of Tables List of Figures Introduction Catalyst Related Reports Upcoming Related Reports Competitive Assessment Overview Global Market Share Pacemaker and CRT-P Market Company Share Globally ICD and CRT-D Market Company Share Globally Regional Market Share Pacemaker and CRT-P Market Company Share in the US ICD and CRT-D Market Company Share in the US Pacemaker and CRT-P Company Share in Europe ICD and CRT-D Market Company Share in Europe Pacemaker and CRT-P Market Company Share in Emerging Markets ICD and CRT-D Market Company Share in Emerging Markets Pacemaker and CRT-P Market Company Share in Japan ICD and CRT-D Market Company Share in Japan

3 4 Pipeline Products Overview Pipeline Products by Phase in Development Pacemaker and CRT-P Product Profiles Aortic Pacemaker (Hadasit Medical Research Services & Development Ltd.) Cardiac Energy Harvesting Pacemaker (University of Michigan) Endurance Microgenerator (Endurance Rhythm) Implantable Dual-Chamber Pacemaker (MicroPort Scientific) Unconditional MRI-Compatible Implantable Pacemaker (Kenergy, Inc.) Tissue-Engineered Autonomous Pacemaker (Duke University) Wireless Cardiac Stimulation Device (EBR Systems, Inc.) ICD and CRT-D Product Profiles Atrial Defibrillator (SmartWave Medical Ltd.) CardiaLen (CardiaLen, Inc.) Chronicle (Medtronic) Clinical Trials to Watch Overview SELECT-LV Trial of WiCS-LV System (EBR Systems, Inc.) MultiPoint Pacing Clinical Trial of Quadra Assura CRT-D (Medtronic) MADIT-ASIA Trial with Invive CRT-P (Boston Scientific) MultiPoint Pacing IDE Study of Promote Quadra (St. Jude Medical) Post Approval Study of S-ICD System (Boston Scientific) ProMRI Study of the Evia/Entovis Pacemaker System

4 4.5.8 MIRACLE EF Clinical Study of Consulta CRT-P (Medtronic) Current and Future Players Overview Trends in Corporate Strategy Biotronik Overview Portfolio Evaluation Commercial Positioning Company SWOT Analysis Boston Scientific Overview Portfolio Evaluation Commercial Positioning Company SWOT Analysis Impulse Dynamics Overview Portfolio Evaluation Commercial Positioning Company SWOT Analysis Medtronic Overview Portfolio Evaluation Marketed Products

5 5.6.4 Additional Products Commercial Positioning Company SWOT Analysis Sorin Group Overview Portfolio Evaluation Marketed Products Commercial Positioning Company SWOT Analysis St. Jude Medical Overview Portfolio Evaluation Marketed Products Commercial Positioning Company SWOT Analysis Appendix Bibliography Abbreviations Report Methodology Overview Coverage Secondary Research Forecasting Methodology

6 6.3.5 Primary Research Key Opinion Leader Interviews Expert Panel Validation Physicians and Specialists Included in this Study About the Authors Analysts Global Head of Healthcare About MediPoint About GlobalData Disclaimer

7 1.1 List of Tables Table 1: Pacemaker and CRT-P Market, Global, Company Share (%), Table 2: ICD and CRT-D Market, Global, Company Share (%), Table 3: Pacemaker and CRT-P Market, US, Revenue ($) and Company Share (%), Table 4: ICD and CRT-D Market, US, Revenue ($) and Company Share (%), Table 5: Pacemaker and CRT-P Market, Europe, Revenue ($) and Company Share (%), Table 6: ICD and CRT-D Market, Europe, Revenue ($) and Company Share (%), Table 7: Pacemaker and CRT-P Market, Emerging Markets, Revenue ($) and Company Share (%), Table 8: ICD and CRT-D Market, Emerging Markets, Revenue ($) and Company Share (%), Table 9: Pacemaker and CRT-P Market, Japan, Revenue ($) and Company Share (%), Table 10: ICD and CRT-D Market, Japan, Revenue ($) and Company Share (%), Table 11: Product Profile Aortic Pacemaker Table 12: Product Profile Cardiac Energy Harvesting Pacemaker Table 13: Product Profile Endurance Microgenerator Table 14: Product Profile MicroPort Pacemaker Table 15: Product Profile Kenergy Pacemaker Table 16: Product Profile Tissue-Engineered Autonomous Pacemaker Table 17: Product Profile Wireless Cardiac Stimulation Device Table 18: Product Profile Atrial Defibrillator Table 19: Product Profile CardiaLen Table 20: Product Profile Chronicle Table 21: Clinical Trial for WiCS-LV System Table 22: Clinical Trial for Quadra Assura CRT-D Table 23: Clinical Trial for Invive CRT-P

8 Table 24: MultiPoint Pacing IDE Study for Promote Quadra Table 25: Post Approval Study of S-ICD System Table 26: ProMRI Study of the Evia/Entovis Pacemaker System Table 27: MIRACLE EF Clinical Study of Consulta CRT-P Table 28: Company Profile Biotronik Table 29: Product Profile Cylos Table 30: Product Profile Effecta Table 31: Product Profile Evia/Entovis Table 32: Product Profile Estella Table 33: Product Profile Stratos Table 34: Product Profile Ilesto Table 35: Product Profile Lumax Table 36: Biotronik SWOT Analysis, Table 37: Company Profile Boston Scientific Table 38: Product Profile Advantio Table 39: Product Profile Altrua Table 40: Product Profile Cognis Table 41: Product Profile Energen Table 42: Product Profile Incepta Table 43: Product Profile Ingenio Table 44: Product Profile Invive Table 45: Product Profile Punctua Table 46: Product Profile S-ICD System Table 47: Product Profile Teligen

9 Table 48: Boston Scientific SWOT Analysis, Table 49: Company Profile Impulse Dynamics Table 50: Product Profile Optimizer IVs Table 51: Impulse Dynamics SWOT Analysis, Table 52: Company Profile Medtronic Table 53: Product Profile Advisa Table 54: Product Profile Adapta Table 55: Product Profile Brava/Viva Table 56: Product Profile Consulta Table 57: Product Profile EnPulse Table 58: Product Profile EnRhythm Table 59: Product Profile Ensura MRI Table 60: Product Profile Evera Table 61: Product Profile Protecta Table 62: Product Profile Secura Table 63: Product Profile Syncra Table 64: Product Profile Revo Table 65: Product Profile Concerto Table 66: Product Profile EnTrust Table 67: Product Profile Maximo II Table 68: Medtronic SWOT Analysis, Table 69: Company Profile Sorin Group Table 70: Product Profile Esprit Table 71: Product Profile Paradym

10 Table 72: Product Profile Reply Table 73: Sorin Group SWOT Analysis, Table 74: Company Profile St. Jude Medical Table 75: Product Profile Accent Table 76: Product Profile Accent MRI Table 77: Product Profile Anthem Table 78: Product Profile Allure Quadra Table 79: Product Profile AnalyST Accel Table 80: Product Profile Assurity Table 81: Product Profile Current Accel Table 82: Product Profile Current Plus Table 83: Product Profile Ellipse Table 84: Product Profile Endurity Table 85: Product Profile Fortify Assura Table 86: Product Profile Fortify Table 87: Product Profile Microny Table 88: Product Profile Leadless Pacemaker Table 89: Product Profile Promote Plus Table 90: Product Profile Quadra Assura Table 91: Product Profile Unify Assura Table 92: Product Profile Unify Quadra Table 93: Product Profile Unify Table 94: Product Profile Zephyr Table 95: St. Jude Medical SWOT Analysis,

11 1.2 List of Figures Figure 1: Pacemaker and CRT-P Market, Global, Company Share (%), Figure 2: ICD and CRT-D Market, Global, Company Share (%), Figure 3: Pacemaker and CRT-P Market, US, Company Share (%), Figure 4: ICD and CRT-D Market, US, Company Share (%), Figure 5: Pacemaker and CRT-P Market, Europe, Company Share (%), Figure 6: ICD and CRT-D Market, Europe, Company Share (%), Figure 7: Pacemaker and CRT-P Market, Emerging Markets, Company Share (%), Figure 8: ICD and CRT-D Market, Emerging Markets, Company Share (%), Figure 9: Pacemaker and CRT-P Market, Japan, Company Share (%), Figure 10: ICD and CRT-D Market, Japan, Company Share (%), Figure 11: CRM Pipeline Products by Phase in Development

12 Introduction 2 Introduction 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. There are a number of devices that are utilized for CRM, and depending on the patient s arrhythmia, they may receive a pacemaker (PM), implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P) or cardiac resynchronization therapy defibrillator (CRT-D). CRM device implementation depends on the patient s current status and how the physician expects their dysrhythmia to progress, although other concerns in regards to pricing, reimbursement, and complication rates all have an effect on the decision to implant as well, especially in emerging markets where patient awareness is lacking and healthcare budgets are limited. 2.1 Catalyst The CRM industry continues to experience meaningful growth through improved device therapy, adoption in emerging markets, increased patient awareness, and updates in national and international guidelines. Companies are increasingly looking to provide tiered product offerings to target larger patient populations with differing reimbursement options. While 15 years ago CRM products were not programmable, most current devices have 200 parameters, which can be reprogrammed non-invasively using telemetry, and result in substantial performance differences between the various brands of CRM products. Despite innovation and new product launches, many customers are genuinely happy with the performance and features of current devices, and as a result, the CRM market continues to be troubled by a challenging pricing environment that does not reward innovation. Companies now must figure out how to add value in different ways, principally related to device cost effectiveness. 12

13 Introduction The CRT-P and CRT-D markets in the US and EU have experienced significant growth in recent years despite relatively static pacemaker and ICD sales, while countries such as Japan, India, China, and Brazil are rapidly increasing their demand for all CRM devices across the board. With competition tight between just a few major players, added emphasis will be put on affordability, technology innovation, and distribution networks in the coming years. Next-generation CRT products have experienced significant adoption in recent years Pipeline technologies including leadless generators and energy harvesting devices will drive future device sales Remote home monitoring telemetry is expected to increase CRM device adoption, especially in remote areas, including China, India and Brazil The industry shift from single-chamber to dual-chamber ICDs will drive additional revenue Pricing headwinds, especially in developing countries, will steadily reduce the average selling price of CRM products New distribution channels globally will strengthen market access for EU- and US-based companies 2.2 Related Reports MediPoint: Cardiac Assist Devices Global Analysis and Market Forecasts GDME0175MAR / Published March 2013 MediPoint: Transcatheter Aortic Valve Replacement Global Analysis and Market Forecasts GDME0165MAR / Published November Upcoming Related Reports MediPoint: EP Ablation Global Analysis and Market Forecasts / To be published February

14 Appendix 6.6 About MediPoint MediPoint is the flagship product for GlobalData s Medical team. Each MediPoint report is built from the ground-up by our team of healthcare analysts in the US and UK. Each report includes input from experienced physicians and leading Key Opinion Leaders (KOLs). Running throughout each report in the series, What Do Physicians Think quotes provide a unique insight into how healthcare professionals are reacting to events within the industry, and what their responses could mean for industry strategists. 6.7 About GlobalData GlobalData is a leading global provider of business intelligence in the Healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in medical device research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports and forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has offices in New York, Boston, London, India and Singapore. 6.8 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise without the prior permission of the publisher, GlobalData. 138