Transcatheter Aortic Valve Replacement Analysis and Market Forecast - European Markets. GDME1002CFR / Published November 2012

Transcription

1 Transcatheter Aortic Valve Replacement Analysis and Market Forecast - European Markets GDME1002CFR / Published November 2012

2 Executive Summary Transcatheter Aortic Valve Replacement: Key Metrics in EU5 Device Markets Diseased population Severe, Symptomatic Population High Risk or Inoperable Population 2011 Market Sales EU5 Pipeline Assessment 2.02 million 0.28 million 0.18 million $459.8m Number of preclinical devices 7 Number of early clinical devices 4 Number of late clinical devices 3 Pericardium Tissue Valves 87% Synthetic Polymer Valves 13% Transcatheter Aortic Valve Market is forecast to Witness Significant Growth Through 2018 The Transcatheter Aortic Valve Replacement (TAVR) market is forecast to have significant growth during the forecast period. GlobalData estimates the EU5 market in 2011 was $459.8m, and it is expected to grow at a CAGR of 18.5% to reach $1,510.0m by The key drivers for the market in the forecast period are: CE Mark approval of the Portico valve in 2012 CE Mark approval of the Direct Flow valve in 2013 CE Mark approval of the Sadra Lotus valve in 2013 Key events ( ) CE Mark approval of Portico valve in 2012 CE Mark approval of Direct Flow valve in 2013 CE Mark approval of Sadra Lotus valve in 2013 CE Mark approval of Engager valve in 2014 CE Mark approval of Acurate TF valve in 2013 CE Mark approval of AorTech valve in 2015 CE Mark approval of Centera valve in 2014 CE Mark approval of Colibri valve in 2014 CE Mark approval of Vanguard valve in 2014 CE Mark approval of Trinity valve in 2015 CE Mark approval of Innovare valve in Market Sales EU5 Source: GlobalData Level of Impact $1,510.0m CE Mark approval of the Engager valve in 2014 CE Mark approval of the Acurate TF valve in 2013 CE Mark approval of the AorTech valve in 2015 CE Mark approval of the Centera valve in 2014 CE Mark approval of the Colibri valve in 2014 CE Mark approval of the Vanguard valve in 2014 CE Mark approval of the Trinity valve in 2015 CE Mark approval of Innovare valve in 2014 The major barriers for the TAVR market are: Lacking and incomplete reimbursement for TAVR procedures Slow adoption of TAVR as heart centers are trained in the procedure High cost of current devices compared to surgically implanted valve prosthetics Page 2 GDME1002CFR / Published NOV 2012

3 Executive Summary Source: GlobalData TAVR European Revenue 15% 6% 8% 18% France 54% Germany Italy Spain UK 12% 21% France 8% Germany 22% 38% 2011 Total: $460m Italy Spain UK 2018 Total: $1,510m Companies Working to Get Their Devices Approved in the TAVR Market The TAVR market has been developing quickly as a result of the Europe s rapid adoption of the procedure. Ever since the first TAVR devices received CE Mark in Europe in 2007, additional companies have been working to enter the market as well. TAVR device technology has already entered the next stage of development, with many second-generation prosthetics approved in Europe and others due to launch in Europe in the near future. In parallel development with device designs, companies are looking to further improve their delivery systems as well. Germany is leading the way with TAVR procedures, having completed over 8,000 of them during Other European countries are not far behind their German neighbors in the use of TAVR. Many countries in Europe have established reimbursement codes for the procedure, which has increased rates of adoption. GlobalData expects that most major heart centers will offer the procedure in coming years. As TAVR devices enter clinical trials in Japan, GlobalData expects rapid Japanese adoption of the technology upon its expected approval in Heart centers in Singapore have already started using TAVR devices, and Southeast Asia is expected to approve TAVR in the coming few years as well, which will trigger enormous sales growth in the region. In South America, one TAVR company has already received approval to launch their product, and adoption in the region is expected to increase as well, although at a slower rate than the US, EU or Japan. Significant Unmet Needs in TAVR Market Use of TAVR in high-risk and inoperable patients has proven effective in treating aortic valve disease; however, there is still much room for improvement. Paravalvular regurgitation and a high incidence of stroke have plagued first-generation devices, and emerging products aim to reduce these side effects while also reducing the cost of the device. Additionally, physicians have called for other device improvements, most notably repositionability and reduced delivery sheath sizes. Improvements to the device design will help TAVR be approved for moderate and low surgical risk patients by improving patient outcomes, reducing device cost, and making TAVR superior to surgical valve replacement. Page 3 GDME1002CFR / Published NOV 2012

4 Executive Summary 35% Source: GlobalData TAVR Market by Company, % 2% 61% Edwards Lifesciences Medtronic JenaValve Symetis 2011 Total: $488m Remaining Opportunities for New Entrants Significant market opportunities still exist for novel TAVR devices in terms of superior efficacy, improved ease of use, lower adverse effects, and cost. There have been numerous design adaptations across the TAVR industry as companies look to differentiate their product from the competition. Compared to the first TAVR products approved, many second-generation devices are smaller in profile size as well as repositionable. Looking ahead, others including Direct Flow Medical and AorTech International are working to develop devices with prosthetic valve leaflets made of synthetic polymers in an attempt to improve durability and reduce the device cost. Also working towards improved durability, ValveXchange has developed a TAVR system with exchangeable leaflets that can be replaced as they wear out. In an attempt to reduce regurgitation, Boston Scientific and Symetis are both developing valves that utilize sealing membrane skirts to increase prosthetic conformance to the native valve annulus and reduce paravalvular regurgitation. Most device improvements have been related to accurate positioning of the prosthetic, secure anchoring, improved durability, ease of deployment and cost. As more companies enter the market, these points of difference between various TAVR products are likely to drive sales. Leading TAVR Companies and Future Landscape Currently, the TAVR market is dominated by two key players, both of which have had multiple device iterations and both of which are developing additional TAVR products for the market. In 2011, Edwards Lifesciences controlled roughly 61% of the global TAVR market, followed by Medtronic who had 35%. As other competitors devices enter the market, it is expected that Edwards and Medtronic will continue to see sales growth but will see a decrease in their market share. As of now, both JenaValve and Symetis have approved devices in Europe, and Braile Biomedica in Brazil, with other companies due for approval in the near term; however, Edwards is the only company with a device currently approved in the US. As new opportunities develop in Asia and South America, GlobalData believes the TAVR market will continue to grow rapidly in the near term. Additionally, several medical device giants have still not developed their own TAVR technologies, and so GlobalData expects significant merger and acquisition activity within the TAVR market. New players entering the market will combat initial challenges with physician adoption as a result of the retraining necessary for new TAVR devices; each prosthetic behaves differently. The market is still very young, though, and there is great potential for new entrants with superior efficacy, lower costs, or both. Page 4 GDME1002CFR / Published NOV 2012

5 Executive Summary Assessment of TAVR Device Features Most Desirable Features of TAVR Devices Features Most Satisfied With (Met Needs) Features Least Satisfied With (Unmet Needs) Source: GlobalData What do Physicians Think? Repositionability High durability and long device lifetime Proven safety of device Non-thrombogenic Dynamic responsiveness Valve-tissue interaction Cost of device Retrievability of device Self-repairing ability of device Physicians feel strongly that TAVR adoption will be strong in coming years. I think that most patients are probably going to go for transcatheter valves once the newer technology is available TAVR is going to explode. It s going to be THE valve platform in ten years, I mean, nobody s going to be doing open valve anymore. Key Opinion Leader, October 2012 While adoption of TAVR in the US has been slower than in Europe, many believe the approval of second generation devices will boost sales. Once the FDA approves the smaller devices, you will see a big increase in the number of implants in the US and also the number of approaches. Key Opinion Leader, October 2012 While TAVR is currently only approved for high-risk and inoperable patients, it is likely that moderate and low-risk patients will be candidates for TAVR in the future. We already, more or less, are convinced that lower risk patients may benefit from a transcatheter heart valve. So, we re already shifting to these lower risk patients. Key Opinion Leader, October 2012 But before TAVR is approved for lower risk patients, many are calling for further improvement. Limitations have to be addressed before offering TAVR to lower risk patients...so maybe in a short time, maybe five years, the surgical-risk requirement for TAVR will go down. Key Opinion Leader, November 2012 While physicians are calling for numerous device improvements, two attributes are of particular importance. The two most important things will be the development of more predictable devices with fewer complications, and the price of the valves going down. If these two things happen, the numbers will further increase. Key Opinion Leader, November 2012 From a patient standpoint, the procedure and recovery time for TAVR is much less compared with conventional surgical valve replacement. Transcatheter procedures take two hours instead of the usual four or five hours [with surgical implantation] we re shifting, and more patients that were otherwise operated on will in the future be treated with transcatheter heart valves. Key Opinion Leader, October 2012 Page 5 GDME1002CFR / Published NOV 2012

6 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction Catalyst Disease Overview Anatomy & Physiology Heart Valves Pathophysiology Heart Valve Disorders Etiology of AVD Acquired Disorders Congenital Defects Other Disorders Clinical Presentation Symptoms Diagnosis Clinical Outcomes Treatment Modalities Medication Heart Valve Repair Surgical/Intervention Strategies Surgical Heart Valve Replacement Transcatheter Heart Valve Replacement Associated Mortality Epidemiology Page 6 GDME1002CFR / Published NOV 2012

7 3.5.1 Prevalence Treatment and Mortality Economic Impact Individual Costs Industry Costs Competitive Assessment Overview Initial Devices Current Devices Competitive Assessment EU5 Marketed Products Profiles Sapien valve (Edwards Lifesciences) Sapien XT valve (Edwards Lifesciences) CoreValve (Medtronic, Inc.) Sapien vs. CoreValve Acurate TA Valve (Symetis) JenaValve (JenaValve) Portico valve (St. Jude Medical, Inc.) Unmet Needs Delivery & Implantation Repositionable Low Profile Accurate Anatomic Positioning Expansion Mechanism Rapid Pacing Motorized Delivery Systems Coronary Ostia Impairment Conformance Regurgitation Page 7 GDME1002CFR / Published NOV 2012

8 5.2.2 Sizing Effective Orifice Area Removal of Native Valve Leaflets Lifetime Durability Retrievability Pacemaker Placement (heart block) Replaceable Leaflets Materials Alternative Surfaces Endothelialization Regenerative Medicine Tailored Treatment Pre-Crimped Packaging Embolic Protection Robotic Assistance Hemodynamic Performance Pipeline Products Overview Pipeline by Phases in Development Pipeline Products Profiles Acurate TF valve (Symetis) AorTech valve (AorTech International) AorTx valve (Hansen Medical) Centera valve (Edwards Lifesciences) Colibri valve (Colibri Heart Valve) Cormove (Perouse Medical) Direct Flow valve (Direct Flow Medical) Engager valve (Medtronic, Inc.) Page 8 GDME1002CFR / Published NOV 2012

9 6.3.9 Heart Leaflet Technology (Bracco SpA) Innovare valve (Braile Biomedica) Sadra Lotus valve (Boston Scientific) Sapien 3 (Edwards Lifesciences) Trinity valve (Transcatheter Technologies GmbH) Vanguard Exchangeable Heart Valve System (ValveXchange) Clinical Trial Analysis Overview Trials to Watch Summary Industry Overview Procedure Trends EU Austerity Reimbursement Hinders Adoption Market Access Adoption of TAVR Heart Teams for Specialized Care Facilities Enabling TAVR Training and Protocols for Care Reimbursement Trends Regulatory Issues/Recalls Mergers & Acquisitions/Key Partnerships Current and Future Players Overview Trends in Corporate Strategy Company Profiles AorTech International plc Boston Scientific Bracco SpA Page 9 GDME1002CFR / Published NOV 2012

10 8.3.4 Braile Biomedica Colibri Heart Valve, LLC Direct Flow Medical Edwards Lifesciences, Inc Hansen Medical JenaValve Technology Medtronic, Inc Perouse Medical St. Jude Medical Symetis Transcatheter Technologies GmbH ValveXchange Market Drivers, Opportunities and Barriers Market Drivers Superior to Conventional Treatment New Alternative for Patients with No Options Expected Launch of CE Mark Devices Expanded Approval in US and EU Supportive Imaging Opportunities Repositionability Miniaturization of Valve Systems Single Operator Devices Lower Cost Dilation Scoring Balloon Removal of Native Valve Leaflets Temporary Aortic Valves Market Barriers Reimbursement Page 10 GDME1002CFR / Published NOV 2012

11 9.3.2 Slow Adoption Cost Substitutes Country Outlooks & Forecasts European Market Overview France France Market Analysis Germany Germany Market Analysis Italy Italy Market Analysis Spain Spain Analysis United Kingdom United Kingdom Market Analysis Appendix Abbreviations Bibliography Methodology Coverage Secondary Research Forecasting Methodology Diagnosed Aortic Valve Disease (AVD) Patients Percent Transcatheter Aortic Valve Replacement Patients Pricing Assumptions Prevalence in Surgical Risk Segments Cost of Aortic Valve Disease Physicians and Specialists Included in this Study Primary Research Page 11 GDME1002CFR / Published NOV 2012

12 11.9 Physician Survey About the Authors Analysts Global Head of Healthcare Definitions About GlobalData Contact Us Disclaimer Page 12 GDME1002CFR / Published NOV 2012

13 1.1 List of Tables Table 1: Etiology of Single Left-Side Valve Disease Table 2: Initial Presenting Symptoms of Aortic Valve Disease Table 3: Basic Frequency of Examination Table 4: Modifiers of Examination Frequency Table 5: Cardiovascular Risk Factors and Comorbidities Table 6: Investigations Performed to Diagnose AVD Table 7: Basic Principles for Management of AVD Patients Table 8: Aortic Valve Disease National Indirect and Direct Costs ($bn), Table 9: TAVR Product Approvals by Date Table 10: Assessment of TAVR Device Features Table 11: Product Profile - Sapien Table 12: Sapien SWOT Analysis, Table 13: Product Profile - Sapien XT Table 14: Sapien XT SWOT Analysis, Table 15: Product Profile - CoreValve Table 16: CoreValve SWOT Analysis, Table 17: Product Profile - Acurate TA Table 18: Acurate TA SWOT Analysis, Table 19: Product Profile - JenaValve Table 20: JenaValve SWOT Analysis, Table 21: Product Profile - Portico Table 22: Portico SWOT Analysis, Table 23: TAVR Global Product Pipeline, Table 24: Product Profile - Acurate TF Table 25: Acurate TF SWOT Analysis, Table 26: Product Profile - AorTech Table 27: AorTech SWOT Analysis, Table 28: Product Profile - AorTx Page 13 GDME1002CFR / Published NOV 2012

14 Table 29: AorTx SWOT Analysis, Table 30: Product Profile - Centera Table 31: Centera SWOT Analysis, Table 32: Product Profile - Colibri Table 33: Colibri SWOT Analysis, Table 34: Product Profile - Cormove Table 35: Cormove SWOT Analysis, Table 36: Product Profile - Direct Flow Table 37: Direct Flow SWOT Analysis, Table 38: Product Profile - Engager Table 39: Engager SWOT Analysis, Table 40: Product Profile - Heart Leaflet Technology Table 41: Heart Leaflet Technology SWOT Analysis, Table 42: Product Profile - Innovare Table 43: Innovare SWOT Analysis, Table 44: Product Profile - Sadra Lotus Table 45: Sadra Lotus SWOT Analysis, Table 46: Product Profile - Sapien Table 47: Sapien 3 SWOT Analysis, Table 48: Product Profile - Trinity Table 49: Trinity SWOT Analysis, Table 50: Product Profile - Vanguard Table 51: Vanguard SWOT Analysis, Table 52: Company Profile - AorTech International plc Table 53: AorTech International SWOT Analysis, Table 54: Company Profile - Boston Scientific Table 55: Boston Scientific SWOT Analysis, Table 56: Company Profile - Bracco SpA Table 57: Bracco SpA SWOT Analysis, Page 14 GDME1002CFR / Published NOV 2012

15 Table 58: Company Profile - Braile Biomedica Table 59: Braile Biomedica SWOT Analysis, Table 60: Company Profile - Colibri Heart Valve Table 61: Colibri Heart Valve SWOT Analysis Table 62: Company Profile - Direct Flow Medical Table 63: Direct Flow Medical SWOT Analysis, Table 64: Company Profile - Edwards Lifesciences Table 65: Edwards Lifesciences SWOT Analysis, Table 66: Company Profile - Hansen Medical Table 67: Hansen Medical SWOT Analysis, Table 68: Company Profile - JenaValve Technology Table 69: JenaValve Technology SWOT Analysis, Table 70: Company Profile - Medtronic Table 71: Medtronic SWOT Analysis, Table 72: Company Profile - Perouse Medical Table 73: Perouse Medical SWOT Analysis, Table 74: Company Profile - St. Jude Medical Table 75: St. Jude Medical SWOT Analysis, Table 76: Company Profile - Symetis Table 77: Symetis SWOT Analysis, Table 78: Company Profile - Transcatheter Technologies Table 79: Transcatheter Technologies SWOT Analysis, Table 80: Company Profile - ValveXchange Table 81: ValveXchange SWOT Analysis, Table 82: Major Events Affecting the Global TAVR Market Table 83: Sales Forecasts for TAVR in the EU5 Markets, Table 84: Sales Forecasts for TAVR in France, Table 85: Sales Forecasts for TAVR in Germany, Table 86: Sales Forecasts for TAVR in Italy, Page 15 GDME1002CFR / Published NOV 2012

16 Table 87: Sales Forecasts for TAVR in Spain, Table 88: Sales Forecasts for TAVR in the UK, Table 89: Physicians Surveyed, By Country Page 16 GDME1002CFR / Published NOV 2012

17 1.2 List of Figures Figure 1: Diagram of Human Heart Figure 2: Strategy for Evaluating Heart Murmurs Figure 3: General Treatment Modalities for Aortic Valve Disease Figure 4: Transcatheter Access Approaches by Frequency of Use, Europe Figure 5: Surgical Risk of Symptomatic, Severe AVD Patients, Figure 6: Prevalence of Moderate or Severe Valve Disease in EU Population Figure 7: Prevalence of AVD in Patients Figure 8: Compound Annual Growth Rate of AVD Figure 9: Breakdown of Severe AVD Patients Receiving Surgical Valve Replacement & Transcatheter Valve Replacement Figure 10:Total Costs at One Year for TAVR and SAVR as Calculated in 2011 in Europe Figure 11:Companies in TAVR Market with Approved Devices Figure 12:TAVR Device Attributes by Current Satisfaction and Importance, Figure 13:TAVR Pipeline by Stage in Clinical Development, Figure 14:TAVR Procedures Per Year Figure 15:TAVR Rate of Adoption versus Reimbursement by Country, Figure 16:Global Sales Forecast for TAVR, Figure 17:EU5 Market Sales for TAVR by Region, Figure 18:Sales for TAVR by Company, Figure 19:Sales Forecasts for TAVR in France, Figure 20:Sales Forecasts for TAVR in Germany, Figure 21:Sales Forecasts for TAVR in Italy, Figure 22:Sales Forecasts for TAVR in Spain, Figure 23:Sales Forecasts for TAVR in the UK, Page 17 GDME1002CFR / Published NOV 2012

18 Introduction 2 Introduction For patients suffering from severe aortic valve disease or valve dysfunction, percutaneous Transcatheter Aortic Valve Replacement (TAVR) enables implantation of a prosthetic heart valve within the diseased native aortic valve without the need for open heart surgery or cardiopulmonary bypass; TAVR provides a new therapeutic option for elderly patients who are considered to have high surgical risk or contraindications to open heart surgery, in addition to an alternative option for all other aortic valve disease patients. TAVR is becoming an increasingly popular alternative to open heart surgery as professional and commercial interest intensifies and effectiveness becomes proven; the percutaneous approach is less invasive and has a shorter recovery time compared with open-heart access. As approved indications for use of TAVR expand as well as more competitors enter the market, this industry will grow substantially in coming years. 2.1 Catalyst Transcatheter Aortic Valve Replacement offers a novel and groundbreaking technology for accessing the heart valves in patients who are extremely high-risk or inoperable candidates for conventional surgical valve replacement, with the expectation that this technology may be utilized in lower risk surgical candidates in the future. An estimated 55,000 patients worldwide have already undergone TAVR (Holmes et al., 2012). TAVR has been adopted in many centers in Europe, and has a huge potential for market penetration in Asia, South America, and Australia. As centers around the world improve their catheterization facilities as well as introduce training to their staff for TAVR procedures, it is expected that TAVR could be used on upwards of 10%-20% of the Aortic Valve Disease (AVD) population in coming years, and has an estimated 2018 market value of over $2 billion. This report examines procedural volumes in the US, France, Germany, Italy, Spain and the UK, as well as adoption trends in these countries for the quickly spreading TAVR procedure. With improvements in cardiac imaging and robotics, it s expected that TAVR procedures will be easier to perform in the future and have fewer associated side effects as training improves. Additionally, as TAVR is reliant on so many different types of technology, there is much room for improvement across the board in how these procedures are carried out. This report examines current unmet needs, opportunities for development and market penetration, expectations for an expanding target market, and associated complications with TAVR. This report looks at market breakdown by company, new entrants to the TAVR industry, and drivers for future growth. Page 18 GDME1002CFR / Published NOV 2012

19 Appendix 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 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. Page 167 GDME1002CFR / Published NOV 2012