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United States Prosthetic Heart Valves Market Outlook to 2021

Summary

GlobalData’s new report, "United States Prosthetic Heart Valves Market Outlook to 2021", provides key market data on the United States Prosthetic Heart Valves market. The report provides value, in millions of US dollars, volume (in units) and average price data (in US dollars), within market segments - Mechanical Heart Valves, Tissue Heart Valves and Transcatheter Heart Valves.

The report also provides company shares and distribution shares data for the market category, and global corporate-level profiles of the key market participants. Based on the availability of data for the particular category and country, information related to pipeline products, news and deals is available in the report.

The data in the report is derived from dynamic market forecast models. GlobalData uses epidemiology and capital equipment-based models to estimate and forecast the market size. The objective is to provide information that represents the most up-to-date data of the industry possible.

The epidemiology-based forecasting model makes use of epidemiology data gathered from research publications and primary interviews with physicians to establish the target patient population and treatment flow patterns for individual diseases and therapies. Using prevalence and incidence data and diagnosed and treated population, the epidemiology-based forecasting model arrives at the final numbers.

Capital equipment-based forecasting models are done based on the installed base, replacements and new sales of a specific device/equipment in healthcare facilities such as hospitals, clinics and diagnostic centers. Data for average number of units per facility is used to arrive at the installed base of the capital equipment. Sales for a particular year are arrived at by calculating the replacement units and new units (additional and first-time purchases).

Extensive interviews are conducted with key opinion leaders (KOLs), physicians and industry experts to validate the market size, company share and distribution share data and analysis.

Scope

- Market size for Prosthetic Heart Valves market segments - Mechanical Heart Valves, Tissue Heart Valves and Transcatheter Heart Valves.
- Annualized market revenues (USD million), volume (units) and average selling price ($) data for each of the market categories. Data is provided from 2007 to 2014 and forecast to 2021.
- 2014 company shares and distribution shares data for Prosthetic Heart Valves market.
- Global corporate-level profiles of key companies operating within the United States Prosthetic Heart Valves market.
- Key players covered include Edwards Lifesciences Corporation, Medtronic plc, St. Jude Medical, Inc. and Others.

Reasons to buy

- Develop business strategies by identifying the key market segments poised for strong growth in the future.
- Develop market-entry and market expansion strategies.
- Design competition strategies by identifying who-stands-where in the market.
- Develop investment strategies by identifying the key market segments expected to register strong growth in the near future.
- What are the key distribution channels and what’s the most preferred mode of product distribution - Identify, understand and capitalize.

Table Of Contents

United States Prosthetic Heart Valves Market Outlook to 2021
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 6
2 Introduction 7
2.1 What Is This Report About? 7
2.2 Prosthetic Heart Valves Market Segmentation 7
2.3 Definitions of Markets Covered in the Report 8
3 Prosthetic Heart Valves Market, United States 9
3.1 Prosthetic Heart Valves Market, United States, Revenue ($m), 2007-2014 9
3.2 Prosthetic Heart Valves Market, United States, Revenue ($m), 2014-2021 11
3.2.1 Mechanical Heart Valves Market, United States, Revenue ($m), by Segment, 2007-2014 13
3.2.2 Tissue Heart Valves Market, United States, Revenue ($m), by Segment, 2007-2014 15
3.2.3 Transcatheter Heart Valves Market, United States, Revenue ($m), by Segment, 2007-2014 17
3.2.4 Mechanical Heart Valves Market, United States, Revenue ($m), by Segment, 2014-2021 18
3.2.5 Tissue Heart Valves Market, United States, Revenue ($m), by Segment, 2014-2021 20
3.2.6 Transcatheter Heart Valves Market, United States, Revenue ($m), by Segment, 2014-2021 22
3.3 Prosthetic Heart Valves Market, United States, Volume (Units), 2007-2014 24
3.4 Prosthetic Heart Valves Market, United States, Volume (Units), 2014-2021 26
3.4.1 Mechanical Heart Valves Market, United States, Volume (Units), by Segment, 2007-2014 28
3.4.2 Tissue Heart Valves Market, United States, Volume (Units), by Segment, 2007-2014 30
3.4.3 Transcatheter Heart Valves Market, United States, Volume (Units), by Segment, 2007-2014 32
3.4.4 Mechanical Heart Valves Market, United States, Volume (Units), by Segment, 2014-2021 33
3.4.5 Tissue Heart Valves Market, United States, Volume (Units), by Segment, 2014-2021 35
3.4.6 Transcatheter Heart Valves Market, United States, Volume (Units), by Segment, 2014-2021 37
3.5 Prosthetic Heart Valves Market, United States, Average Price ($), 2007-2021 39
3.6 Prosthetic Heart Valves Market, United States, Distribution Share by Revenue ($m), 2013-2014 41
3.7 Prosthetic Heart Valves Market, United States, Company Share by Revenue ($m), 2014 42
4 Overview of Key Companies in United States, Prosthetic Heart Valves Market 43
4.1 Edwards Lifesciences Corporation 43
4.1.1 Company Overview 43
4.2 Medtronic plc 43
4.2.1 Company Overview 43
4.3 St. Jude Medical, Inc. 43
4.3.1 Company Overview 43
4.4 Sorin S.p.A. (Inactive) 44
4.4.1 Company Overview 44
5 Prosthetic Heart Valves Market Pipeline Products 45
6 Financial Deals Landscape 46
6.1 Acquisition 46
6.1.1 CryoLife to Acquire On-X Life Technologies for USD130 Million 46
6.1.2 Abbott Labs Denies Talks to Acquire St. Jude Medical for USD25 Billion 48
6.1.3 Medtronic Acquires Twelve for up to USD458 Million 49
6.1.4 Abbott Labs Acquires Remaining Stake in Tendyne for USD250 Million 50
6.1.5 Medtronic Acquires Aptus Endosystems for USD110 Million 51
6.2 Venture Financing 52
6.2.1 Twelve Raises USD35.2 Million in Venture Financing 52
6.2.2 InterValve Secures USD3 Million from Oxford Finance 53
7 Recent Developments 54
7.1 Corporate Communications 54
7.1.1 Sep 14, 2015: Incoming St. Jude Medical President and CEO Mike Rousseau Announces Executive Leadership Team 54
7.1.2 Sep 09, 2015: St. Jude Medical Announces Leadership Transition Plan 54
7.1.3 Aug 05, 2015: St. Jude Medical Appoints David Dvorak to Its Board of Directors 56
7.1.4 Jul 30, 2015: Edwards Announces Board Change 56
7.1.5 Jun 25, 2015: Medtronic Names Geoff Martha Executive Vice President and President, Restorative Therapies Group 56
7.1.6 Feb 10, 2015: Edwards Announces Board Changes 57
7.2 Financial Announcements 58
7.2.1 Dec 18, 2015: BRILIQUE (ticagrelor) receives positive European Union CHMP opinion for extended treatment of patients with a history of heart attack 58
7.2.2 Dec 18, 2015: Sarepta Therapeutics Announces FDA Advisory Committee Meeting to Review Eteplirsen as a Treatment for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping 60
7.2.3 Oct 26, 2015: Edwards Lifesciences Reports Third Quarter Results-2015 61
7.2.4 Sep 30, 2015: MediWound Awarded BARDA Contract Valued Up to $112 Million for Development and Procurement of NexoBrid for the U.S. 63
7.2.5 Jul 28, 2015: Bio-Rad Announces U.S. FDA Pre-Market Approval for the BioPlex 2200 HIV Ag-Ab assay, a Novel Next Generation HIV Diagnostic Test 64
7.2.6 Jul 28, 2015: Edwards Lifesciences Reports Second Quarter Results 65
7.2.7 Jul 22, 2015: St. Jude Medical Reports Second Quarter 2015 Results 67
7.2.8 Jun 02, 2015: Medtronic Reports Fourth Quarter and Fiscal Year 2015 Financial Results 68
7.2.9 May 19, 2015: Medtronic Announces Preliminary Fourth Quarter and Fiscal Year 2015 Revenue Results 71
7.2.10 Apr 23, 2015: Edwards Lifesciences Reports First Quarter Results 74
7.2.11 Apr 22, 2015: St. Jude Medical Reports First Quarter 2015 Results 75
7.2.12 Feb 20, 2015: ContraVir Pharmaceuticals Provides Clinical Update on FV-100 77
7.2.13 Feb 20, 2015: St. Jude Medical Announces Increase in Quarterly Dividend 79
7.2.14 Feb 03, 2015: Edwards Lifesciences Reports Fourth Quarter And Full Year Results 79
7.2.15 Jan 28, 2015: St. Jude Medical Reports Fourth Quarter and Full-Year 2014 Results 80
7.2.16 Jan 14, 2015: St. Jude Medical Announces Preliminary Fourth Quarter Financial Results 82
7.2.17 Jan 13, 2015: European Medicines Agency Grants Positive Opinion for Orphan Drug Status for Ovarian Cancer Oncolytic Vaccine 83
7.3 Government and Public Interest 84
7.3.1 Jul 14, 2015: Malaysia, The Hub Of Medical Device Manufacturing In Asean 84
7.4 Legal And Regulatory 86
7.4.1 Nov 20, 2015: Medtronic Statement on U.S. Department of Treasury's Notice 2015-79 86
7.4.2 Oct 05, 2015: Bioprosthetic Aortic Valves: FDA Notification - Reduced Leaflet Motion 86
7.4.3 Apr 02, 2015: Medtronic To Pay $4.41 Million To Resolve Allegations That It Unlawfully Sold Medical Devices Manufactured Overseas 86
7.4.4 Feb 06, 2015: Medtronic to Pay $2.8 Million to Resolve False Claims Act Allegations Related to "SubQ Stimulation" Procedures 87
7.5 Other Significant Developments 88
7.5.1 Oct 23, 2015: Martha Marsh Appointed To Edwards Lifesciences Board Of Directors 88
7.5.2 Oct 21, 2015: St. Jude Medical Reports Third Quarter 2015 Results 89
7.5.3 May 27, 2015: Novocure Announces Commercial Launch of Optune (the NovoTTF-100A System) in Japan 90
7.5.4 Jan 12, 2015: Medtronic Awards $150,000 Locally in Health Access Grants 91
7.6 Strategy And Business Planning 92
7.6.1 Mar 02, 2015: PeaceHealth and OHSU collaborate to enhance heart and vascular surgery services 92
8 Appendix 94
8.1 Research Methodology 95
8.1.1 Coverage 95
8.1.2 Secondary Research 95
8.1.3 Primary Research 96
8.1.4 Market Modeling and Forecasting 97
8.1.5 Company Share Analysis 100
8.1.6 Distribution Share Analysis 101
8.2 Expert Panel 102
8.3 GlobalData Consulting 102
8.4 Contact Us 102
8.5 Disclaimer 102

1.1 List of Tables
Table 1: Prosthetic Heart Valves Market, United States, Revenue ($m), USD Constant, Historic, 2007-2014 10
Table 2: Prosthetic Heart Valves Market, United States, Revenue ($m), USD Constant, Forecast, 2014-2021 12
Table 3: Mechanical Heart Valves Market, United States, Revenue ($m), USD Constant, Historic, 2007-2014 14
Table 4: Tissue Heart Valves Market, United States, Revenue ($m), USD Constant, Historic, 2007-2014 16
Table 5: Transcatheter Heart Valves Market, United States, Revenue ($m), USD Constant, Historic, 2007-2014 17
Table 6: Mechanical Heart Valves Market, United States, Revenue ($m), USD Constant, Forecast, 2014-2021 19
Table 7: Tissue Heart Valves Market, United States, Revenue ($m), USD Constant, Forecast, 2014-2021 21
Table 8: Transcatheter Heart Valves Market, United States, Revenue ($m), USD Constant, Forecast, 2014-2021 23
Table 9: Prosthetic Heart Valves Market, United States, Volume (Units), Historic, 2007-2014 25
Table 10: Prosthetic Heart Valves Market, United States, Volume (Units), Forecast, 2014-2021 27
Table 11: Mechanical Heart Valves Market, United States, Volume (Units), Historic, 2007-2014 29
Table 12: Tissue Heart Valves Market, United States, Volume (Units), Historic, 2007-2014 31
Table 13: Transcatheter Heart Valves Market, United States, Volume (Units), Historic, 2007-2014 32
Table 14: Mechanical Heart Valves Market, United States, Volume (Units), Forecast, 2014-2021 34
Table 15: Tissue Heart Valves Market, United States, Volume (Units), Forecast, 2014-2021 36
Table 16: Transcatheter Heart Valves Market, United States, Volume (Units), Forecast, 2014-2021 38
Table 17: Prosthetic Heart Valves Market, United States, Average Price ($) Historic, 2007-2014 39
Table 18: Prosthetic Heart Valves Market, United States, Average Price ($), Forecast, 2014-2021 40
Table 19: Prosthetic Heart Valves Market, United States, Distribution Share by Revenue ($m), USD Constant, 2013-2014 41
Table 20: Prosthetic Heart Valves Market, United States, Company Share by Revenue ($m), USD Constant, 2014 42
Table 21: Prosthetic Heart Valves Market Pipeline Products 45
Table 22: CryoLife to Acquire On-X Life Technologies for USD130 Million 46
Table 23: Abbott Labs Denies Talks to Acquire St. Jude Medical for USD25 Billion 48
Table 24: Medtronic Acquires Twelve for up to USD458 Million 49
Table 25: Abbott Labs Acquires Remaining Stake in Tendyne for USD250 Million 50
Table 26: Medtronic Acquires Aptus Endosystems for USD110 Million 51
Table 27: Twelve Raises USD35.2 Million in Venture Financing 52
Table 28: InterValve Secures USD3 Million from Oxford Finance 53
Table 29: Total Number of Primary Research Participants, Cardiovascular Devices Market, by Country 97

1.2 List of Figures
Figure 1: Prosthetic Heart Valves Market, United States, Revenue ($m), USD Constant, Historic, 2007-2014 9
Figure 2: Prosthetic Heart Valves Market, United States, Revenue ($m), USD Constant, Forecast, 2014-2021 11
Figure 3: Mechanical Heart Valves Market, United States, Revenue ($m), USD Constant, Historic, 2007-2014 13
Figure 4: Tissue Heart Valves Market, United States, Revenue ($m), USD Constant, Historic, 2007-2014 15
Figure 5: Transcatheter Heart Valves Market, United States, Revenue ($m), USD Constant, Historic, 2007-2014 17
Figure 6: Mechanical Heart Valves Market, United States, Revenue ($m), USD Constant, Forecast, 2014-2021 18
Figure 7: Tissue Heart Valves Market, United States, Revenue ($m), USD Constant, Forecast, 2014-2021 20
Figure 8: Transcatheter Heart Valves Market, United States, Revenue ($m), USD Constant, Forecast, 2014-2021 22
Figure 9: Prosthetic Heart Valves Market, United States, Volume (Units), Historic, 2007-2014 24
Figure 10: Prosthetic Heart Valves Market, United States, Volume (Units), Forecast, 2014-2021 26
Figure 11: Mechanical Heart Valves Market, United States, Volume (Units), Historic, 2007-2014 28
Figure 12: Tissue Heart Valves Market, United States, Volume (Units), Historic, 2007-2014 30
Figure 13: Transcatheter Heart Valves Market, United States, Volume (Units), Historic, 2007-2014 32
Figure 14: Mechanical Heart Valves Market, United States, Volume (Units), Forecast, 2014-2021 33
Figure 15: Tissue Heart Valves Market, United States, Volume (Units), Forecast, 2014-2021 35
Figure 16: Transcatheter Heart Valves Market, United States, Volume (Units), Forecast, 2014-2021 37
Figure 17: Prosthetic Heart Valves Market, United States, Company Share (%) 2014 42
Figure 18: GlobalData Epidemiology-Based Forecasting Model 99
Figure 19: GlobalData Capital Equipment-Based Forecasting Model 100
Figure 20: Primary Interviews by Participant Type (%) 101

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