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Transcatheter Heart Valve Market to 2017 - Improvements in Design and Technique and a Favorable Reimbursement Scenario to Contribute to Higher Procedure Volumes

Published: Jun-2013 | Format: PDF | GBI Research | Code: MRS - 1279

GBI Research’s “Transcatheter Heart Valve Market to 2017 – Improving Surgeons’ Confidence and Proficiency to Drive Growth of Routes of Access Other than Transfemoral” 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

1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 8

2 Executive Summary 10
2.1 Transcatheter Heart Valve Procedures have more than Quadrupled in Europe since 2009 10
2.2 The Global Transcatheter Heart Valve Market is Expected to Exceed $3 Billion by 2017 11
2.3 Future Events Key to Sustained Growth of Global Transcatheter Heart Valve Market 13
2.4 Edwards Lifesciences Dominated the Global Transcatheter Heart Valve Market in 2012 14
2.5 Unmet Needs Provide Scope for New Entrants in the Global Transcatheter Heart Valve Market 15

3 Introduction 15
3.1 Overview 16
3.1.1 Transcatheter Heart Valve Implantation 16
3.1.2 Routes of Access 16
3.2 GBI Research Guidance 16

4 Disease Overview and Epidemiology 17
4.1 Epidemiology 17
4.2 Market Access - Distribution and Supply Chain 19
4.2.1 Supply-side Dynamics 19
4.2.2 Demand-side Dynamics 19
4.3 Reimbursement Trends 21
4.3.1 US 21
4.3.2 Canada 22
4.3.3 Germany 22
4.3.4 France 22
4.3.5 UK 22
4.3.6 Spain 22
4.3.7 Italy 22
4.3.8 Japan 22
4.3.9 India 23
4.3.10 China 23

5 Analyst Comments 24

6 Global Transcatheter Heart Valve Market: Market Characterization 25
6.1 Global Transcatheter Heart Valve Market, Revenue ($m), 2007–2012 25
6.2 Global Transcatheter Heart Valve Market, Procedures, 2007–2012 26
6.3 Global Transcatheter Heart Valve Market, Revenue ($m), 2012–2017 27
6.4 Global Transcatheter Heart Valve Market, Procedures, 2012–2017 29
6.5 Transcatheter Heart Valves, Global, Company Shares (%), 2012–2015 30
6.6 Global Transcatheter Heart Valve Market: Key Trends 32
6.6.1 Results from Ongoing Clinical Trials will be Important for Determining the Potential of Transcatheter Aortic Heart Valve Replacement in Lower-risk Patients 32
6.6.2 Major Cardiovascular Companies are Seeking Small Companies with Transcatheter Heart Valve Replacement Technology to Strengthen their Portfolios 33
6.6.3 Second-generation Prosthetics and Simplification of Procedures to Drive Long-term Growth 35
6.6.4 High Percentage of Patients with Severe Aortic Stenosis without Treatment is Expected to Drive Future Growth of the Market 37
6.6.5 Transcatheter Valve in Valve Procedures for Degenerative Bioprosthetic Surgical Valves will Gain Adoption in Future 38
6.7 Global Transcatheter Heart Valve Market: Market Dynamics 40
6.7.1 Market Drivers 40
6.7.2 Market Restraints 44

7 Global Transcatheter Heart Valve Market: Opportunity and Risk Analysis 48

8 Global Transcatheter Heart Valve Market: Pipeline Analysis 52
8.1 Profiles of Promising Products under Clinical Development 54
8.1.1 18F Direct Flow Medical Transcatheter Aortic Valve System 54
8.1.2 22 F Percutaneous Aortic Valve System 54
8.1.3 31 Millimeter CoreValve System 55
8.1.4 Acurate TA 55
8.1.5 Acurate TF 56
8.1.6 Balloon Expandable Paniagua Heart Valve 56
8.1.7 Colibri TAVR Device 57
8.1.8 Cormove Percutaneous Aortic Valve 57
8.1.9 Edwards Centera Valve 58
8.1.10 Edwards Sapien 3 Valve 58
8.1.11 Edwards Sapien Pulmonic Transcatheter Heart Valve 59
8.1.12 Edwards Sapien XT - Ascendra 2 Delivery System 59
8.1.13 Edwards Sapien XT Valve - NovaFlex Delivery System 60
8.1.14 Engager Transcatheter Aortic Valve Implantation System 60
8.1.15 Inovare Valve 61
8.1.16 Intuity Valve System 61
8.1.17 Intuity Valve System 62
8.1.18 Lotus Aortic Valve System 62
8.1.19 Lutter Valve 63
8.1.20 Native Outflow Tract Transcatheter Pulmonary Valve 63
8.1.21 Neovasc Tiara - Transapical Version 64
8.1.22 Percutaneous Aortic Valve 64
8.1.23 PercValve 65
8.1.24 Portico Transapical Aortic Heart Valve System 65
8.1.25 Portico Transfemoral Aortic Heart Valve System 66
8.1.26 Self Expandable Paniagua Heart Valve 66
8.1.27 Transfemoral TAVR System 67
8.1.28 Percutaneous Transfemoral Transcatheter Mitral Heart Valve 67
8.1.29 Transcatheter Aortic Valve Implantation System 68
8.1.30 Transcatheter Mitral Valve 68
8.1.31 Transcatheter Mitral Valve Replacement System 69

9 Global Transcatheter Heart Valve Market: Country Analysis 70
9.1 Global Transcatheter Heart Valve Market: Cross-Country Analysis, Forecast Revenue, By Country 70
9.1.1 Transcatheter Heart Valve Market, US, Revenue ($m), 2012–2017 71
9.1.2 Transcatheter Heart Valve Market, US, Procedures, 2012–2017 73
9.1.3 Transcatheter Heart Valve Market, US, Key Company Shares (%), 2012 74
9.1.4 Transcatheter Heart Valve Market, Germany, Revenue ($m), 2007–2012 74
9.1.5 Transcatheter Heart Valve Market, Germany, Procedures, 2007–2012 75
9.1.6 Transcatheter Heart Valve Market, Germany, Revenue ($m), 2012–2017 76
9.1.7 Transcatheter Heart Valve Market, Germany, Procedures, 2012–2017 77
9.1.8 Transcatheter Heart Valve Market, Germany, Company Shares (%), 2012 78
9.1.9 Transcatheter Heart Valve Market, France, Revenue ($m), 2007–2012 79
9.1.10 Transcatheter Heart Valve Market, France, Procedures, 2007–2012 80
9.1.11 Transcatheter Heart Valve Market, France, Revenue ($m), 2012–2017 81
9.1.12 Transcatheter Heart Valve Market, France, Procedures, 2012–2017 82
9.1.13 Transcatheter Heart Valve Market, France, Company Shares (%), 2012 83
9.1.14 Transcatheter Heart Valve Market, UK, Revenue ($m), 2007–2012 84
9.1.15 Transcatheter Heart Valve Market, UK, Procedures, 2007–2012 85
9.1.16 Transcatheter Heart Valve Market, UK, Revenue ($m), 2012–2017 86
9.1.17 Transcatheter Heart Valve Market, UK, Procedures, 2012–2017 87
9.1.18 Transcatheter Heart Valve Market, UK, Company Shares (%), 2012 88
9.1.19 Transcatheter Heart Valve Market, Italy, Revenue ($m), 2007–2012 89
9.1.20 Transcatheter Heart Valve Market, Italy, Procedures, 2007–2012 90
9.1.21 Transcatheter Heart Valve Market, Italy, Revenue ($m), 2012–2017 91
9.1.22 Transcatheter Heart Valve Market, Italy, Procedures, 2012–2017 92
9.1.23 Transcatheter Heart Valve Market, Italy, Company Shares (%), 2012 93
9.1.24 Transcatheter Heart Valve Market, Spain, Revenue ($m), 2007–2012 94
9.1.25 Transcatheter Heart Valve Market, Spain, Procedures, 2007–2012 95
9.1.26 Transcatheter Heart Valve Market, Spain, Revenue ($m), 2012–2017 96
9.1.27 Transcatheter Heart Valve Market, Spain, Procedures, 2012–2017 97
9.1.28 Transcatheter Heart Valve Market, Spain, Company Shares (%), 2012 98
9.1.29 Transcatheter Heart Valve Market, Japan, Revenue ($m), 2012–2017 99
9.1.30 Transcatheter Heart Valve Market, Japan, Procedures, 2012–2017 100

10 Global Transcatheter Heart Valve Market: A Comparison of Commercially Available Transcatheter Heart Valves and Company Profiles 102
10.1 Global Transcatheter Heart Valve Market: Key Company Profiles 103
10.1.1 Edwards Lifesciences 103
10.1.2 Medtronic 107
10.1.3 JenaValve 109
10.1.4 Symetis 110
10.1.5 AorTech International plc 111
10.1.6 Boston Scientific 111
10.1.7 Bracco SpA 112
10.1.8 Braile Biomedica 112
10.1.9 Direct Flow Medical 113
10.1.10 St. Jude Medical 113
10.1.11 Transcatheter Technologies GmbH 113
10.1.12 ValveXchange 114

11 Global Transcatheter Heart Valve Market: Consolidation Landscape 115
11.1 Key Deals 2008–2012 115
11.1.1 Edwards Lifesciences’ Acquisition of Embrella Cardiovascular, 2011 115
11.1.2 Boston Scientific’s Acquisition of Sadra Medical, 2011 115
11.1.3 Bracco AMT’s Acquisition of Heart Leaflet Technologies, 2010 116
11.1.4 Medtronic’s Acquisition of CoreValve, 2009 116
11.1.5 Medtronic’s Acquisition of Ventor, 2009 117
11.1.6 Abbott Laboratories’ Acquisition of Evalve, 2009 118

12 Appendix 118
12.1 Definitions 118
12.1.1 Transcatheter Heart Valves 118
12.2 Acronyms 119
12.3 Sources 120
12.4 Research Methodology 122
12.4.1 Secondary Research 122
12.4.2 Primary Research 122
12.4.3 Models 123
12.4.4 Forecasts 123
12.4.5 Expert Panels 123
12.5 Contact Us 124
12.6 Disclaimer 124



List of Tables

Table 1: Transcatheter Heart Valve Market, Global, Revenue ($m), 2007–2012 25
Table 2: Transcatheter Heart Valve Market, Global, Procedures (‘000), 2007–2012 26
Table 3: Transcatheter Heart Valve Market, Global, Revenue Forecast ($m), 2012–2017 28
Table 4: Transcatheter Heart Valve Market, Global, Procedures Forecast, 2012–2017 29
Table 5: Transcatheter Heart Valve Market, Global, Company Shares Forecast (%), 2012–2015 30
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 39
Table 7: Transcatheter Heart Valve Market, Global, Revenue Forecast by Type of Heart Valve ($m), 2012–2017 50
Table 8: Transcatheter Heart Valve Market, Global, Pipeline Products I, 2013 53
Table 9: Transcatheter Heart Valve Market, Global, Pipeline Products II, 2013 53
Table 10: 18F Direct Flow Medical Transcatheter Aortic Valve System, Product Status, 2013 54
Table 11: 22 F Percutaneous Aortic Valve System, Product Status, 2013 55
Table 12: 31 Millimeter CoreValve System, Product Status, 2013 55
Table 13: Acurate TA, Product Status, 2013 56
Table 14: Acurate TF, Product Status, 2013 56
Table 15: Balloon Expandable Paniagua Heart Valve, Product Status, 2013 57
Table 16: Colibri TAVR Device, Product Status, 2013 57
Table 17: Cormove Percutaneous Aortic Valve, Product Status, 2013 58
Table 18: Edwards Centera Valve, Product Status, 2013 58
Table 19: Edwards Sapien 3 Valve, Product Status, 2013 59
Table 20: Edwards Sapien Pulmonic Transcatheter Heart Valve, Product Status, 2013 59
Table 21: Edwards Sapien XT - Ascendra 2 Delivery System, Product Status, 2013 60
Table 22: Edwards Sapien XT Valve - NovaFlex Delivery System, Product Status, 2013 60
Table 23: Engager Transcatheter Aortic Valve Implantation System, Product Status, 2013 61
Table 24:  Inovare Valve, Product Status, 2013 61
Table 25: Intuity Valve System, Product Status, 2013 62
Table 26: Intuity Valve System, Product Status, 2013 62
Table 27: Lotus Aortic Valve System, Product Status, 2013 63
Table 28:  Lutter Valve, Product Status, 2013 63
Table 29:  Native Outflow Tract Transcatheter Pulmonary Valve, Product Status, 2013 64
Table 30: Neovasc Tiara - Transapical Version, Product Status, 2013 64
Table 31: Percutaneous Aortic Valve, Product Status, 2013 65
Table 32: PercValve, Product Status, 2013 65
Table 33: Portico Transapical Aortic Heart Valve System, Product Status, 2013 66
Table 34: Portico Transfemoral Aortic Heart Valve System, Product Status, 2013 66
Table 35: Self Expandable Paniagua Heart Valve, Product Status, 2013 67
Table 36: Transfemoral TAVR System, Product Status, 2013 67
Table 37: Percutaneous Transfemoral Transcatheter Mitral Heart Valve, Product Status, 2013 68
Table 38: Transcatheter Aortic Valve Implantation System, Product Status, 2013 68
Table 39: Transcatheter Mitral Valve, Product Status, 2013 69
Table 40: Transcatheter Mitral Valve Replacement System, Product Status, 2013 69
Table 41: Transcatheter Heart Valve Market, Global, Cross-country Analysis, Compound Annual Growth Rate (%), 2007–2017 70
Table 42: Transcatheter Heart Valve Market, US, Revenue Forecast ($m), 2012–2017 72
Table 43: Transcatheter Heart Valve Market, US, Procedures Forecast, 2012–2017 73
Table 44: Transcatheter Heart Valve Market, Germany, Revenue ($m), 2007–2012 75
Table 45: Transcatheter Heart Valve Market, Germany, Procedures, 2007–2012 76
Table 46: Transcatheter Heart Valve Market, Germany, Revenue Forecast ($m), 2012–2017 77
Table 47: Transcatheter Heart Valve Market, Germany, Procedures Forecast, 2012–2017 78
Table 48: Transcatheter Heart Valve Market, Germany, Company Shares (%), 2012 79
Table 49: Transcatheter Heart Valve Market, France, Revenue ($m), 2007–2012 80
Table 50: Transcatheter Heart Valve Market, France, Procedures, 2007–2012 81
Table 51: Transcatheter Heart Valve Market, France, Revenue Forecast ($m), 2012–2017 82
Table 52: Transcatheter Heart Valve Market, France, Procedures Forecast, 2012–2017 83
Table 53: Transcatheter Heart Valve Market, France, Company Shares (%), 2012 84
Table 54: Transcatheter Heart Valve Market, UK, Revenue ($m), 2007–2012 85
Table 55: Transcatheter Heart Valve Market, UK, Procedures, 2007–2012 86
Table 56: Transcatheter Heart Valve Market, UK, Revenue Forecast ($m), 2012–2017 87
Table 57: Transcatheter Heart Valve Market, UK, Procedures Forecast, 2012–2017 88
Table 58: Transcatheter Heart Valve Market, UK, Company Shares (%), 2012 89
Table 59: Transcatheter Heart Valve Market, Italy, Revenue ($m), 2007–2012 90
Table 60: Transcatheter Heart Valve Market, Italy, Procedures (‘000), 2007–2012 91
Table 61: Transcatheter Heart Valve Market, Italy, Revenue Forecast ($m), 2012–2017 92
Table 62: Transcatheter Heart Valve Market, Italy, Procedures Forecast, 2012–2017 93
Table 63: Transcatheter Heart Valve Market, Italy, Company Shares (%), 2012 94
Table 64: Transcatheter Heart Valve Market, Spain, Revenue ($m), 2007–2012 95
Table 65: Transcatheter Heart Valve Market, Spain, Procedures, 2007–2012 96
Table 66: Transcatheter Heart Valve Market, Spain, Revenue Forecast ($m), 2012–2017 97
Table 67: Transcatheter Heart Valve Market, Spain, Procedures Forecast (‘000), 2012–2017 98
Table 68: Transcatheter Heart Valve Market, Spain, Company Shares (%), 2012 99
Table 69: Transcatheter Heart Valve Market, Japan, Revenue Forecast ($m), 2012–2017 100
Table 70: Transcatheter Heart Valve Market, Japan, Procedures Forecast, 2012–2017 101
Table 71: Sapien, PARTNER EU Trial, 2007 104
Table 72: Sapien, The PARTNER US TRIAL, 2007 106
Table 73: Sapien, The SOURCE Registry Trial (Cohort 1), 2009 107
Table 74: CoreValve Registry Trial, 2008 108
Table 75: JenaValve, CE Mark Study, 2010 110
Table 76: Acurate TA, First In Man Trial, 2011 111



List of Figures

Figure 1: Transcatheter Heart Valve Market, Global, Procedures Forecast (%), 2012–2017 10
Figure 2: Transcatheter Heart Valve Market, Global, Revenue Forecast ($m), 2012–2017 11
Figure 3: Transcatheter Heart Valve Market, Global, Heat Map, Likelihood of Events and Revenue Impact, 2013–2017 13
Figure 4: Transcatheter Heart Valve Market, Global, Key Attributes, 2013 15
Figure 5: Transcatheter Heart Valve Market, US, Prevalence of Moderate-to-severe Valve Disease (%), 2011 17
Figure 6: Transcatheter Heart Valve Market, Global, Reimbursement Trends, 2013 21
Figure 7: Transcatheter Heart Valve Market, Global, Revenue ($m), 2007–2012 25
Figure 8: Transcatheter Heart Valve Market, Global, Procedures, 2007–2012 26
Figure 9: Transcatheter Heart Valve Market, Global, Revenue Forecast ($m), 2012–2017 27
Figure 10: Transcatheter Heart Valve Market, Global, Procedures Forecast, 2012–2017 29
Figure 11: Transcatheter Heart Valve Market, Global, Company Shares Forecast (%), 2012–2015 30
Figure 12: Transcatheter Heart Valve Market, Global, Key Trends, 2013 32
Figure 13: Transcatheter Heart Valve Market, Global, Consolidation Snap Shot, 2011 34
Figure 14: Transcatheter Heart Valve Market, Global, Advances in Technology and Procedures, 2013 36
Figure 15: Transcatheter Heart Valve Market, Global, Untreated Severe Aortic Stenosis Patients, 2011 37
Figure 16: Transcatheter Heart Valve Market, Global, Market Dynamics, 2013 40
Figure 17: Transcatheter Heart Valve Market, Global, Proportion of Population Aged 60 and Above (%), 2011–2020 44
Figure 18: Transcatheter Heart Valve Market, Global, TAVR vs. SAVR, PARTNER Cohort A Results ($), 2011 48
Figure 19: Transcatheter Heart Valve Market, Global, Opportunity and Risk Analysis, 2013 49
Figure 20: Transcatheter Heart Valve Market, Global, Revenue Forecast by Type of Heart Valve ($m), 2012–2017 50
Figure 21: Transcatheter Heart Valve Market, Global, Key Pipeline Products, 2013 52
Figure 22: Transcatheter Heart Valve Market, Global, Cross-country Analysis, Compound Annual Growth Rate (%), 2007–2017 70
Figure 23: Transcatheter Heart Valve Market, US, Revenue Forecast ($m), 2012–2017 72
Figure 24: Transcatheter Heart Valve Market, US, Procedures Forecast, 2012–2017 73
Figure 25: Transcatheter Heart Valve Market, Germany, Revenue ($m), 2007–2012 75
Figure 26: Transcatheter Heart Valve Market, Germany, Procedures, 2007–2012 76
Figure 27: Transcatheter Heart Valve Market, Germany, Revenue Forecast ($m), 2012–2017 77
Figure 28: Transcatheter Heart Valve Market, Germany, Procedures Forecast, 2012–2017 78
Figure 29: Transcatheter Heart Valve Market, Germany, Company Shares (%), 2012 79
Figure 30: Transcatheter Heart Valve Market, France, Revenue ($m), 2007–2012 80
Figure 31: Transcatheter Heart Valve Market, France, Procedures, 2007–2012 81
Figure 32: Transcatheter Heart Valve Market, France, Revenue Forecast ($m), 2012–2017 82
Figure 33: Transcatheter Heart Valve Market, France, Procedures Forecast, 2012–2017 83
Figure 34: Transcatheter Heart Valve Market, France, Company Shares (%), 2012 84
Figure 35: Transcatheter Heart Valve Market, UK, Revenue ($m), 2007–2012 85
Figure 36: Transcatheter Heart Valve Market, UK, Procedures, 2007–2012 86
Figure 37: Transcatheter Heart Valve Market, UK, Revenue Forecast ($m), 2012–2017 87
Figure 38: Transcatheter Heart Valve Market, UK, Procedures Forecast, 2012–2017 88
Figure 39: Transcatheter Heart Valve Market, UK, Company Shares (%), 2012 89
Figure 40: Transcatheter Heart Valve Market, Italy, Revenue ($m), 2007–2012 90
Figure 41: Transcatheter Heart Valve Market, Italy, Procedures, 2007–2012 91
Figure 42: Transcatheter Heart Valve Market, Italy, Revenue Forecast ($m), 2012–2017 92
Figure 43: Transcatheter Heart Valve Market, Italy, Procedures Forecast, 2012–2017 93
Figure 44: Transcatheter Heart Valve Market, Italy, Company Shares (%), 2012 94
Figure 45: Transcatheter Heart Valve Market, Spain, Revenue ($m), 2007–2012 95
Figure 46: Transcatheter Heart Valve Market, Spain, Procedures (‘000), 2007–2012 96
Figure 47: Transcatheter Heart Valve Market, Spain, Revenue Forecast ($m), 2012–2017 97
Figure 48: Transcatheter Heart Valve Market, Spain, Procedures Forecast (‘000), 2012–2017 98
Figure 49: Transcatheter Heart Valve Market, Spain, Company Shares (%), 2012 99
Figure 50: Transcatheter Heart Valve Market, Japan, Revenue Forecast ($m), 2012–2017 100
Figure 51: Transcatheter Heart Valve Market, Japan, Procedures Forecast, 2012–2017 101
Figure 52: Comparison of Commercially Available Transcatheter Heart Valves, 2013 102
Figure 53: Global Transcatheter Heart Valves Market, Product Benchmarking, 2013 102
Figure 54: Edwards Lifesciences, PARTNER Trial, Study Design, 2007 105

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