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Transcatheter Heart Valve Market Outlook, 2013 - Approval of Second Generation Prosthetics and Increasing Surgeons’ Confidence and Proficiency to Drive TAVR Procedure Volumes

Summary

GBI Research’s “Transcatheter Heart Valve Market Outlook, 2013 - Approval of Second Generation Prosthetics and Increasing Surgeons’ Confidence and Proficiency to Drive TAVR Procedure Volumes” report examines the market, competitive landscape, and trends for the Transcatheter Heart Valves (THVs) market. The report provides comprehensive information on the key trends affecting these segments, and key analytical content related to market dynamics. The report also reviews the competitive landscape and provides a detailed analysis of the pipeline products for each segment, as well as details of important Mergers and Acquisitions (M&A) deals. The report has been compiled using data and information sourced from proprietary databases, primary and secondary research and in-house analysis carried out by GBI Research’s team of industry experts.

Scope

- Key geographies: the US, Canada, the UK, Germany, France, Italy, Spain, Japan, China, India, Australia and Brazil
- Information on market size and procedures for THVs.
- Annualized market revenue data, forecasts to 2017 (US, Germany, France, Italy, Spain, UK and Japan) and company share data for 2012. Market information during the historic period and company share data for 2012 is provided only for countries where THVs are available for use.
- Qualitative analysis of key trends in the THVs market
- Information on leading market players, details of the competitive landscape, and information on the leading technologies in the market

Reasons to buy

- Develop business strategies with an understanding of the trends and developments driving the global THVs market
- Design and enhance your product development, marketing, and sales strategies
- Exploit M&A opportunities by identifying the market players with the most innovative pipelines
- Develop market entry and market expansion strategies
- Identify the key players best positioned to take advantage of emerging market opportunities
- Exploit in-licensing and out-licensing opportunities by identifying the products most likely to ensure a robust return
- Identify, understand, and capitalize on the next big thing in the THVs market landscape
- Make more informed business decisions based upon insightful and in-depth analysis of the global THVs market and the factors shaping it

Table Of Contents

Transcatheter Heart Valve Market Outlook, 2013 - Approval of Second Generation Prosthetics and Increasing Surgeons’ Confidence and Proficiency to Drive TAVR Procedure Volumes
1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 11
1.2 List of Figures 13
2 Introduction 14
2.1 Overview 14
2.1.1 Transcatheter Heart Valve Implantation 14
2.1.2 Routes of Access 14
3 Disease Overview and Epidemiology 15
3.1 Epidemiology 15
3.2 Market Access - Distribution and Supply Chain 16
3.2.1 Supply-side Dynamics 16
3.2.2 Demand-side Dynamics 16
3.3 Reimbursement Trends 17
3.3.1 US 18
3.3.2 Canada 18
3.3.3 Germany 18
3.3.4 France 18
3.3.5 UK 18
3.3.6 Spain 18
3.3.7 Italy 18
3.3.8 Japan 19
3.3.9 India 19
3.3.10 China 19
4 Analyst Comments 20
5 Global Transcatheter Heart Valve Market: Market Characterization 21
5.1 Global Transcatheter Heart Valve Market, Revenue ($m), 2007-2012 21
5.2 Global Transcatheter Heart Valve Market, Procedures, 2007-2012 22
5.3 Global Transcatheter Heart Valve Market, Revenue ($m), 2012-2017 23
5.4 Global Transcatheter Heart Valve Market, Procedures, 2012-2017 24
5.5 Transcatheter Heart Valves, Global, Company Shares (%), 2012-2015 25
5.6 Global Transcatheter Heart Valve Market: Key Trends 26
5.6.1 Results from Ongoing Clinical Trials will be Important for Determining the Potential of Transcatheter Aortic Heart Valve Replacement in Lower-risk Patients 27
5.6.2 Major Cardiovascular Companies are Seeking Small Companies with Transcatheter Heart Valve Replacement Technology to Strengthen their Portfolios 27
5.6.3 Second-generation Prosthetics and Simplification of Procedures to Drive Long-term Growth 29
5.6.4 High Percentage of Patients with Severe Aortic Stenosis without Treatment is Expected to Drive Future Growth of the Market 30
5.6.5 Transcatheter Valve in Valve Procedures for Degenerative Bioprosthetic Surgical Valves will Gain Adoption in Future 31
5.7 Global Transcatheter Heart Valve Market: Market Dynamics 33
5.7.1 Market Drivers 33
5.7.2 Market Restraints 37
6 Global Transcatheter Heart Valve Market: Opportunity and Risk Analysis 40
7 Global Transcatheter Heart Valve Market: Pipeline Analysis 43
7.1 Profiles of Promising Products under Clinical Development 46
7.1.1 18F Direct Flow Medical Transcatheter Aortic Valve System 46
7.1.2 22 F Percutaneous Aortic Valve System 46
7.1.3 31 Millimeter CoreValve System 47
7.1.4 Acurate TF 47
7.1.5 Balloon Expandable Paniagua Heart Valve 48
7.1.6 Colibri TAVR Device 48
7.1.7 Cormove Percutaneous Aortic Valve 49
7.1.8 Edwards Centera Valve 49
7.1.9 Edwards Sapien 3 Valve 50
7.1.10 Edwards Sapien Pulmonic Transcatheter Heart Valve 50
7.1.11 Edwards Sapien XT - Ascendra 2 Delivery System 51
7.1.12 Edwards Sapien XT Valve - NovaFlex Delivery System 51
7.1.13 Engager Transcatheter Aortic Valve Implantation System 52
7.1.14 Inovare Valve 52
7.1.15 Intuity Valve System 53
7.1.16 Intuity Valve System 53
7.1.17 Lotus Aortic Valve System 54
7.1.18 Lutter Valve 54
7.1.19 Native Outflow Tract Transcatheter Pulmonary Valve 55
7.1.20 Neovasc Tiara - Transapical Version 55
7.1.21 Percutaneous Aortic Valve 56
7.1.22 PercValve 56
7.1.23 Portico Transapical Aortic Heart Valve System 57
7.1.24 Portico Transfemoral Aortic Heart Valve System 57
7.1.25 Self Expandable Paniagua Heart Valve 58
7.1.26 Transfemoral TAVR System 58
7.1.27 Percutaneous Transfemoral Transcatheter Mitral Heart Valve 59
7.1.28 Transcatheter Aortic Valve Implantation System 59
7.1.29 Transcatheter Mitral Valve 60
7.1.30 Transcatheter Mitral Valve Replacement System 60
8 Global Transcatheter Heart Valve Market: Country Analysis 61
8.1 Global Transcatheter Heart Valve Market: Cross-Country Analysis, Forecast Revenue, By Country 61
8.1.1 Transcatheter Heart Valve Market, US, Revenue ($m), 2012-2017 63
8.1.2 Transcatheter Heart Valve Market, US, Procedures, 2012-2017 64
8.1.3 Transcatheter Heart Valve Market, US, Key Company Shares (%), 2012 65
8.1.4 Transcatheter Heart Valve Market, Germany, Revenue ($m), 2007-2012 65
8.1.5 Transcatheter Heart Valve Market, Germany, Procedures, 2007-2012 66
8.1.6 Transcatheter Heart Valve Market, Germany, Revenue ($m), 2012-2017 67
8.1.7 Transcatheter Heart Valve Market, Germany, Procedures, 2012-2017 68
8.1.8 Transcatheter Heart Valve Market, Germany, Company Shares (%), 2012 69
8.1.9 Transcatheter Heart Valve Market, France, Revenue ($m), 2007-2012 70
8.1.10 Transcatheter Heart Valve Market, France, Procedures, 2007-2012 71
8.1.11 Transcatheter Heart Valve Market, France, Revenue ($m), 2012-2017 72
8.1.12 Transcatheter Heart Valve Market, France, Procedures, 2012-2017 73
8.1.13 Transcatheter Heart Valve Market, France, Company Shares (%), 2012 74
8.1.14 Transcatheter Heart Valve Market, UK, Revenue ($m), 2007-2012 75
8.1.15 Transcatheter Heart Valve Market, UK, Procedures, 2007-2012 76
8.1.16 Transcatheter Heart Valve Market, UK, Revenue ($m), 2012-2017 77
8.1.17 Transcatheter Heart Valve Market, UK, Procedures, 2012-2017 78
8.1.18 Transcatheter Heart Valve Market, UK, Company Shares (%), 2012 79
8.1.19 Transcatheter Heart Valve Market, Italy, Revenue ($m), 2007-2012 80
8.1.20 Transcatheter Heart Valve Market, Italy, Procedures, 2007-2012 81
8.1.21 Transcatheter Heart Valve Market, Italy, Revenue ($m), 2012-2017 82
8.1.22 Transcatheter Heart Valve Market, Italy, Procedures, 2012-2017 83
8.1.23 Transcatheter Heart Valve Market, Italy, Company Shares (%), 2012 84
8.1.24 Transcatheter Heart Valve Market, Spain, Revenue ($m), 2007-2012 85
8.1.25 Transcatheter Heart Valve Market, Spain, Procedures, 2007-2012 86
8.1.26 Transcatheter Heart Valve Market, Spain, Revenue ($m), 2012-2017 87
8.1.27 Transcatheter Heart Valve Market, Spain, Procedures, 2012-2017 88
8.1.28 Transcatheter Heart Valve Market, Spain, Company Shares (%), 2012 89
8.1.29 Transcatheter Heart Valve Market, Japan, Revenue ($m), 2012-2017 90
8.1.30 Transcatheter Heart Valve Market, Japan, Procedures, 2012-2017 91
9 Global Transcatheter Heart Valve Market: A Comparison of Commercially Available Transcatheter Heart Valves and Company Profiles 92
9.1 Global Transcatheter Heart Valve Market: Key Company Profiles 93
9.1.1 Edwards Lifesciences 93
9.1.2 Medtronic 96
9.1.3 JenaValve 98
9.1.4 Symetis 99
9.1.5 AorTech International plc 100
9.1.6 Boston Scientific 100
9.1.7 Bracco SpA 100
9.1.8 Braile Biomedica 100
9.1.9 Direct Flow Medical 101
9.1.10 St. Jude Medical 101
9.1.11 Transcatheter Technologies GmbH 101
9.1.12 ValveXchange 102
10 Global Transcatheter Heart Valve Market: Consolidation Landscape 103
10.1 Key Deals 2008-2012 103
10.1.1 Edwards Lifesciences' Acquisition of Embrella Cardiovascular, 2011 103
10.1.2 Boston Scientific's Acquisition of Sadra Medical, 2011 103
10.1.3 Bracco AMT's Acquisition of Heart Leaflet Technologies, 2010 104
10.1.4 Medtronic's Acquisition of CoreValve, 2009 104
10.1.5 Medtronic's Acquisition of Ventor, 2009 105
10.1.6 Abbott Laboratories' Acquisition of Evalve, 2009 105
11 Appendix 107
11.1 Definitions 107
11.1.1 Transcatheter Heart Valves 107
11.2 Acronyms 107
11.3 Sources 108
11.4 Research Methodology 110
11.4.1 Secondary Research 110
11.4.2 Primary Research 110
11.4.3 Models 111
11.4.4 Forecasts 111
11.4.5 Expert Panels 111
11.5 Contact Us 111
11.6 Disclaimer 111

List of Tables

Table 1: Transcatheter Heart Valve Market, Global, Revenue ($m), 2007-2012 21
Table 2: Transcatheter Heart Valve Market, Global, Procedures (‘000), 2007-2012 22
Table 3: Transcatheter Heart Valve Market, Global, Revenue Forecast ($m), 2012-2017 23
Table 4: Transcatheter Heart Valve Market, Global, Procedures Forecast (‘000), 2012-2017 24
Table 5: Transcatheter Heart Valve Market, Global, Company Shares (%), 2012-2015 25
Table 6: Transcatheter Heart Valve Market, Global, Transcatheter Aortic Valve Replacement for Degenerative Bioprosthetic Surgical Valves: Results from The Global Valve-In-Valve Registry, 2012 31
Table 7: Transcatheter Heart Valve Market, Global, Revenue Forecast by Type of Heart Valve ($m), 2012-2017 41
Table 8: Transcatheter Heart Valve Market, Global, Pipeline Products I, 2013 44
Table 9: Transcatheter Heart Valve Market, Global, Pipeline Products II, 2013 45
Table 10: 18F Direct Flow Medical Transcatheter Aortic Valve System, Product Status, 2013 46
Table 11: 22 F Percutaneous Aortic Valve System, Product Status, 2013 46
Table 12: 31 Millimeter CoreValve System, Product Status, 2013 47
Table 13: Acurate TF, Product Status, 2013 47
Table 14: Balloon Expandable Paniagua Heart Valve, Product Status, 2013 48
Table 15: Colibri TAVR Device, Product Status, 2013 48
Table 16: Cormove Percutaneous Aortic Valve, Product Status, 2013 49
Table 17: Edwards Centera Valve, Product Status, 2013 49
Table 18: Edwards Sapien 3 Valve, Product Status, 2013 50
Table 19: Edwards Sapien Pulmonic Transcatheter Heart Valve, Product Status, 2013 50
Table 20: Edwards Sapien XT - Ascendra 2 Delivery System, Product Status, 2013 51
Table 21: Edwards Sapien XT Valve - NovaFlex Delivery System, Product Status, 2013 51
Table 22: Engager Transcatheter Aortic Valve Implantation System, Product Status, 2013 52
Table 23: Inovare Valve, Product Status, 2013 52
Table 24: Intuity Valve System, Product Status, 2013 53
Table 25: Intuity Valve System, Product Status, 2013 53
Table 26: Lotus Aortic Valve System, Product Status, 2013 54
Table 27: Lutter Valve, Product Status, 2013 54
Table 28: Native Outflow Tract Transcatheter Pulmonary Valve, Product Status, 2013 55
Table 29: Neovasc Tiara - Transapical Version, Product Status, 2013 55
Table 30: Percutaneous Aortic Valve, Product Status, 2013 56
Table 31: PercValve, Product Status, 2013 56
Table 32: Portico Transapical Aortic Heart Valve System, Product Status, 2013 57
Table 33: Portico Transfemoral Aortic Heart Valve System, Product Status, 2013 57
Table 34: Self Expandable Paniagua Heart Valve, Product Status, 2013 58
Table 35: Transfemoral TAVR System, Product Status, 2013 58
Table 36: Percutaneous Transfemoral Transcatheter Mitral Heart Valve, Product Status, 2013 59
Table 37: Transcatheter Aortic Valve Implantation System, Product Status, 2013 59
Table 38: Transcatheter Mitral Valve, Product Status, 2013 60
Table 39: Transcatheter Mitral Valve Replacement System, Product Status, 2013 60
Table 40: Transcatheter Heart Valve Market, Global, Cross-country Analysis, Compound Annual Growth Rate (%), 2007-2017 61
Table 41: Transcatheter Heart Valve Market, US, Revenue Forecast ($m), 2012-2017 63
Table 42: Transcatheter Heart Valve Market, US, Procedures Forecast, 2012-2017 64
Table 43: Transcatheter Heart Valve Market, Germany, Revenue ($m), 2007-2012 65
Table 44: Transcatheter Heart Valve Market, Germany, Procedures, 2007-2012 66
Table 45: Transcatheter Heart Valve Market, Germany, Revenue Forecast ($m), 2012-2017 67
Table 46: Transcatheter Heart Valve Market, Germany, Procedures Forecast, 2012-2017 68
Table 47: Transcatheter Heart Valve Market, Germany, Company Shares (%), 2012 69
Table 48: Transcatheter Heart Valve Market, France, Revenue ($m), 2007-2012 70
Table 49: Transcatheter Heart Valve Market, France, Procedures, 2007-2012 71
Table 50: Transcatheter Heart Valve Market, France, Revenue Forecast ($m), 2012-2017 72
Table 51: Transcatheter Heart Valve Market, France, Procedures Forecast, 2012-2017 73
Table 52: Transcatheter Heart Valve Market, France, Company Shares (%), 2012 74
Table 53: Transcatheter Heart Valve Market, UK, Revenue ($m), 2007-2012 75
Table 54: Transcatheter Heart Valve Market, UK, Procedures, 2007-2012 76
Table 55: Transcatheter Heart Valve Market, UK, Revenue Forecast ($m), 2012-2017 77
Table 56: Transcatheter Heart Valve Market, UK, Procedures Forecast, 2012-2017 78
Table 57: Transcatheter Heart Valve Market, UK, Company Shares (%), 2012 79
Table 58: Transcatheter Heart Valve Market, Italy, Revenue ($m), 2007-2012 80
Table 59: Transcatheter Heart Valve Market, Italy, Procedures, 2007-2012 81
Table 60: Transcatheter Heart Valve Market, Italy, Revenue Forecast ($m), 2012-2017 82
Table 61: Transcatheter Heart Valve Market, Italy, Procedures Forecast, 2012-2017 83
Table 62: Transcatheter Heart Valve Market, Italy, Company Shares (%), 2012 84
Table 63: Transcatheter Heart Valve Market, Spain, Revenue ($m), 2007-2012 85
Table 64: Transcatheter Heart Valve Market, Spain, Procedures, 2007-2012 86
Table 65: Transcatheter Heart Valve Market, Spain, Revenue Forecast ($m), 2012-2017 87
Table 66: Transcatheter Heart Valve Market, Spain, Procedures Forecast, 2012-2017 88
Table 67: Transcatheter Heart Valve Market, Spain, Company Shares (%), 2012 89
Table 68: Transcatheter Heart Valve Market, Japan, Revenue Forecast ($m), 2012-2017 90
Table 69: Transcatheter Heart Valve Market, Japan, Procedures Forecast, 2012-2017 91
Table 70: Sapien, PARTNER EU Trial, 2007 94
Table 71: Sapien, The PARTNER US TRIAL, 2007 95
Table 72: Sapien, The SOURCE Registry Trial (Cohort 1), 2009 96
Table 73: CoreValve Registry Trial, 2008 97
Table 74: JenaValve, CE Mark Study, 2010 98
Table 75: Acurate TA, First In Man Trial, 2011 99

List of Figures

Figure 1: Transcatheter Heart Valve Market, US, Prevalence of Moderate-to-severe Valve Disease (%), 2011 15
Figure 2: Transcatheter Heart Valve Market, Global, Reimbursement Trends, 2013 17
Figure 3: Transcatheter Heart Valve Market, Global, Revenue ($m), 2007-2012 21
Figure 4: Transcatheter Heart Valve Market, Global, Procedures (‘000), 2007-2012 22
Figure 5: Transcatheter Heart Valve Market, Global, Revenue Forecast ($m), 2012-2017 23
Figure 6: Transcatheter Heart Valve Market, Global, Procedures Forecast (‘000), 2012-2017 24
Figure 7: Transcatheter Heart Valve Market, Global, Company Shares (%), 2012-2015 25
Figure 8: Transcatheter Heart Valve Market, Global, Key Trends, 2013 26
Figure 9: Transcatheter Heart Valve Market, Global, Consolidation Snap Shot, 2011 28
Figure 10: Transcatheter Heart Valve Market, Global, Advances in Technology and Procedures, 2013 29
Figure 11: Transcatheter Heart Valve Market, Global, Untreated Severe Aortic Stenosis Patients, 2011 30
Figure 12: Transcatheter Heart Valve Market, Global, Market Dynamics, 2013 33
Figure 13: Transcatheter Heart Valve Market, Global, Proportion of Population Aged 60 and Above (%), 2011-2020 36
Figure 14: Transcatheter Heart Valve Market, Global, TAVR vs. SAVR, PARTNER Cohort A Results ($), 2011 39
Figure 15: Transcatheter Heart Valve Market, Global, Opportunity and Risk Analysis, 2013 40
Figure 16: Transcatheter Heart Valve Market, Global, Revenue Forecast by Type of Heart Valve ($m), 2012-2017 41
Figure 17: Transcatheter Heart Valve Market, Global, Key Pipeline Products, 2013 43
Figure 18: Transcatheter Heart Valve Market, Global, Cross-country Analysis, Compound Annual Growth Rate (%), 2007-2017 61
Figure 19: Transcatheter Heart Valve Market, US, Revenue Forecast ($m), 2012-2017 63
Figure 20: Transcatheter Heart Valve Market, US, Procedures Forecast, 2012-2017 64
Figure 21: Transcatheter Heart Valve Market, Germany, Revenue ($m), 2007-2012 65
Figure 22: Transcatheter Heart Valve Market, Germany, Procedures, 2007-2012 66
Figure 23: Transcatheter Heart Valve Market, Germany, Revenue Forecast ($m), 2012-2017 67
Figure 24: Transcatheter Heart Valve Market, Germany, Procedures Forecast, 2012-2017 68
Figure 25: Transcatheter Heart Valve Market, Germany, Company Shares (%), 2012 69
Figure 26: Transcatheter Heart Valve Market, France, Revenue ($m), 2007-2012 70
Figure 27: Transcatheter Heart Valve Market, France, Procedures, 2007-2012 71
Figure 28: Transcatheter Heart Valve Market, France, Revenue Forecast ($m), 2012-2017 72
Figure 29: Transcatheter Heart Valve Market, France, Procedures Forecast, 2012-2017 73
Figure 30: Transcatheter Heart Valve Market, France, Company Shares (%), 2012 74
Figure 31: Transcatheter Heart Valve Market, UK, Revenue ($m), 2007-2012 75
Figure 32: Transcatheter Heart Valve Market, UK, Procedures, 2007-2012 76
Figure 33: Transcatheter Heart Valve Market, UK, Revenue Forecast ($m), 2012-2017 77
Figure 34: Transcatheter Heart Valve Market, UK, Procedures Forecast, 2012-2017 78
Figure 35: Transcatheter Heart Valve Market, UK, Company Shares (%), 2012 79
Figure 36: Transcatheter Heart Valve Market, Italy, Revenue ($m), 2007-2012 80
Figure 37: Transcatheter Heart Valve Market, Italy, Procedures, 2007-2012 81
Figure 38: Transcatheter Heart Valve Market, Italy, Revenue Forecast ($m), 2012-2017 82
Figure 39: Transcatheter Heart Valve Market, Italy, Procedures Forecast, 2012-2017 83
Figure 40: Transcatheter Heart Valve Market, Italy, Company Shares (%), 2012 84
Figure 41: Transcatheter Heart Valve Market, Spain, Revenue ($m), 2007-2012 85
Figure 42: Transcatheter Heart Valve Market, Spain, Procedures, 2007-2012 86
Figure 43: Transcatheter Heart Valve Market, Spain, Revenue Forecast ($m), 2012-2017 87
Figure 44: Transcatheter Heart Valve Market, Spain, Procedures Forecast, 2012-2017 88
Figure 45: Transcatheter Heart Valve Market, Spain, Company Shares (%), 2012 89
Figure 46: Transcatheter Heart Valve Market, Japan, Revenue Forecast ($m), 2012-2017 90
Figure 47: Transcatheter Heart Valve Market, Japan, Procedures Forecast, 2012-2017 91
Figure 48: Comparison of Commercially Available Transcatheter Heart Valves, 2013 92
Figure 49: Global Transcatheter Heart Valves Market, Product Benchmarking, 2013 92
Figure 50: Edwards Lifesciences, PARTNER Trial, Study Design, 2007 94

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