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MediPoint: Prosthetic Heart Valves - 5EU Analysis and Market Forecasts

Summary

The prosthetic heart valves (PHV) market in Europe is a dynamic market that is expected to grow through 2020. Recent advancements in the field of interventional cardiology have greatly improved clinical outcomes for patients. Prosthetic heart valves, including mechanical valves, tissue valves, and transcatheter valves, can be used to treat patients with valvular heart disease affecting the aortic or mitral valves. They can be delivered either via open-heart surgery or transcatheter aortic valve implantation (TAVR).

The PHV market is determined for the five major European markets (5EU): France, Germany, Italy, Spain, and the UK. The report provides insights into the competitive landscape, the marketed and pipeline products, the current and emerging players and market analysis of the different device segments within the PHV market in the 5EU. The report also provides insight into the unmet needs and an understanding of physician perceptions and decision-making process in using prosthetic heart valves. This report is built using data and information sourced from secondary sources and primary research interviews with leading Interventional Cardiologists, with in-house analysis conducted by GlobalData’s team of industry experts.

*This is an on-demand report and will be delivered within 4 working days (excluding weekends) of the purchase.

Highlights

Key Questions Answered

- What is the current and future prosthetic heart valves market outlook in the 5EU? What trends are affecting these markets?
- Which are the key, high growth markets that valve manufacturers should expand into? Which markets are growing the fastest, and what are the top-selling products in each segment?
- What are the unmet needs with PHVs currently on the market? How will emerging technologies such as repositionable and retrievable valves fulfill these unmet needs?
- What clinical factors and technical specifications influence a physician to use one type of valve over another? What is physician perception and market outlook of PHV?
- What are the challenges and complications of TAVR that have hindered widespread adoption?
- With developing the next-generation of heart valves, what aspects of the technology are device manufacturers focused on optimizing? How will new entrants impact the PHV market?

Key Benefits

“What 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. In this report you will understand the perceptions of leading Interventional Cardiologists and Cardiac Surgeons from around the world. This information is essential for all strategic decision makers in every organization allowing them to act on high quality information.

Scope

- Overview of valvular heart disease, including anatomy, epidemiology, pathophysiology, symptoms, diagnosis, and treatment guidelines and modalities.
- Annualized total PHV market revenue from 2011-2020 including adoption patterns in the 5EU.
- Key topics covered include strategic competitor assessment, market characterization, identification of unmet needs, reimbursement and regulatory considerations, and implications for the PHV market.
- Pipeline analysis: Comprehensive list of products split across different stages of development, emerging trends and valve designs in development, including investigation of delivery and deployment methods, materials and coatings used, and sizes available.
- Analysis of the current and future market competition in the 5EU PHV market. Insightful review of the key industry drivers, opportunities, barriers and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- Understand the trends shaping and driving the EU PHV market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in EU PHV market through 2018.
- Quantify candidate patient populations to better design product pricing & launch plans.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
- Perform benchmarking analysis of growth opportunities against currently marketed products.
- Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
- Take a comprehensive look at the market’s device pipeline and identify promising, paradigm-shifting products.
- Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
- What’s the next big thing in EU PHV market landscape? Identify, understand and capitalize.

Table Of Contents

MediPoint: Prosthetic Heart Valves - 5EU Analysis and Market Forecasts
1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Anatomy
2.2 Epidemiology
2.3 Related Reports
3 Industry Overview
3.1 Overview
3.1.1 Mechanical Heart Valves
3.1.2 Tissue Heart Valves
3.1.3 Transcatheter Heart Valves
3.2 Indications
3.2.1 Valvular Stenosis
3.2.2 Valvular Regurgitation
3.3 Clinical Presentation
3.3.1 Diagnosis
3.3.2 Risk Assessment Tools
3.4 Clinical Outcomes
3.4.1 Treatment Options
3.4.2 Life Style Changes
3.4.3 Complications
3.5 Applications of Technology
3.6 Market Access
3.6.1 Purchasing Decisions
3.7 Influence of Clinical Trials
3.8 Brand Loyalty
3.9 Adoption
3.10 Regulation
3.11 Reimbursement
3.11.1 By Country
3.12 Procedure Trends
3.12.1 Overview
3.12.2 By Country
3.13 Regulatory Issues/Recalls
3.13.1 Portico TAVR Implants Halted Due to Safety Concerns
3.14 MandA, Key Partnerships
3.14.1 Licensing Agreement Between Symetis and Endoluminal Sciences
3.14.2 Manufacturing Agreement Between Sorin Group and Boston Scientific
3.15 Economic Impact
3.15.1 Indirect Costs
3.15.2 Direct Costs
4 Unmet Needs
4.1 Delivery and Implantation
4.1.1 Mechanism of Deployment
4.1.2 Anchoring
4.1.3 Retrievability
4.1.4 Repositionability
4.1.5 Artery Accessibility
4.1.6 Rapid Pacing
4.1.7 Coronary Ostia Occlusion
4.1.8 Motorized Delivery Systems
4.2 Performance
4.2.1 Durability
4.2.2 Thrombogenicity
4.2.3 Effective Orifice Area
4.2.4 Coefficient of Friction
4.3 Crimping
4.4 Stenting
4.5 Replaceable Leaflets
4.6 Embolic Protection
4.7 Pacemaker Placement
5 Market Opportunity Analysis
5.1 Overview
5.2 Emerging Markets for TAVR
5.3 Increasing Tissue Valve Lifespan
5.4 Valve-in-Valve Procedures (Re-replacement)
5.5 Transcatheter Mitral Valve Replacement
5.6 Balloon Valvuloplasty
6 Market Drivers and Barriers
6.1 Driver: Rising Disease Prevalence
6.2 Driver: Multimodality Imaging
6.3 Driver: Alternative Access Routes
6.4 Driver: Lower Risk Patient Access
6.5 Driver: Patient Demand and Awareness
6.6 Driver: Advanced Computational Tools
6.7 Driver: Rising Competition and Innovation
6.8 Barrier: High Device and Procedure Cost
6.9 Barrier: Burden of Rising Regulation
6.10 Barrier: Medical Device Excise Tax
6.11 Barrier: Proving Long-Term Efficacy
6.12 Substitute: Valve Repair
6.13 Substitute: Balloon Valvuloplasty
7 Competitive Assessment
7.1 Overview
7.2 Classification Based on Features
7.2.1 Mechanical Heart Valves
7.2.2 Tissue Heart Valves
7.2.3 Transcatheter Heart Valves
7.3 Market Dynamics Analysis
7.4 Product Profiles
7.4.1 Mechanical Heart Valves
7.4.2 Tissue Heart Valves
7.4.3 Transcatheter Heart Valves
8 Pipeline Assessment
8.1 Overview
8.2 Product Profiles
8.2.1 Cytograft Tissue Valve (Cytograft Tissue Engineering)
8.2.2 Centera Valve (Edwards Lifesciences)
8.2.3 Colibri Heart Valve (Colibri Heart Valve)
8.2.4 Cormove (Perouse Medical)
8.2.5 Endovalve (Micro Interventional Devices)
8.2.6 HLT Transcatheter Valve System (Heart Leaflet Technology)
8.2.7 Inovare Valve (Braile Biomedica)
8.2.8 Kalangos Valve (Leman Cardiovascular)
8.2.9 Tiara Valve (Neovasc)
8.2.10 Trinity Valve (Transcatheter Technologies GmbH)
8.2.11 Vanguard Exchangeable Heart Valve System (ValveXchange)
9 Clinical Trials to Watch
9.1 Overview
9.2 CoreValve Evolut R (Medtronic)
9.3 TRANSFORM Trial - Intuity Valve System (Edwards Lifesciences)
9.4 PROACT Trial - On-X Plus 1.5 Mechanical Heart Valve (On-X Life Technologies)
9.5 PARTNER II Trial - Sapien XT (Edwards Lifesciences)
9.6 PARTNER III Trial - Sapien 3 (Edwards Lifesciences)
9.7 REPRISE III IDE/PMA Trial - Lotus Valve System (Boston Scientific)
9.8 SENTINEL-H Trial - Sentinel Cerebral Protection System (Claret Medical)
10 Current and Future Players
10.1 Overview
10.2 Trends in Corporate Strategy
10.3 Company Profiles
10.3.1 AorTech International
10.3.2 Boston Scientific
10.3.3 Braile Biomedica
10.3.4 CardiAQ Valve Technologies
10.3.5 Claret Medical
10.3.6 Colibri Heart Valve
10.3.7 Cytograft Tissue Engineering
10.3.8 Direct Flow Medical
10.3.9 Edwards Lifesciences
10.3.10 Heart Leaflet Technologies
10.3.11 JenaValve Technology
10.3.12 Leman Cardiovascular
10.3.13 Micro Interventional Devices
10.3.14 Neovasc
10.3.15 On-X Life Technologies, Inc
10.3.16 Perouse Medical
10.3.17 Sorin Group
10.3.18 St Jude Medical
10.3.19 Symetis
10.3.20 Transcatheter Technologies GmbH
10.3.21 TTK Healthcare
10.3.22 ValveXchange
11 Strategic Competitive Assessment
11.1 Company Market Share
11.1.1 Overview
11.1.2 By Country
12 Market Outlooks by Market Segment
12.1 Market Segment Share
13 Market Outlooks by Geography
13.1 France
13.2 Germany
13.3 Italy
13.4 Spain
13.5 UK
14 Appendix
14.1 Bibliography
14.2 Abbreviations
14.3 Report Methodology
14.3.1 Overview
14.3.2 Coverage
14.3.3 Secondary Research
14.4 Forecasting Methodology
14.5 Physicians and Specialists Included in This Study
14.6 About the Authors
14.6.1 Analysts
14.6.2 Global Head of Healthcare
14.7 About GlobalData
14.8 Disclaimer

1.1 List of Tables
Table 1: Overview of Symptoms, Risk Factors, and Treatments
Table 2: Evolution of the Mechanical Heart Valve
Table 3: Evolution of the Tissue Heart Valve
Table 4: Comparison of Surgical and Transcatheter Procedures
Table 5: NYHA Functional Classification of Cardiac Disease Patients
Table 6: Drug Treatment Paradigm for Aortic Valve Disease
Table 7: Regulatory Differences Between the US and EU
Table 8: Forecast Indirect National Costs For Aortic Valve Disease in the EU ($bn), 2011-2020
Table 9: Minimum Arterial Diameter Required for TAVR Systems
Table 10: Global Projected Prevalence of Aortic Stenosis, 2013-2020
Table 11: Current Access Routes for Transcatheter Aortic Valve Replacement
Table 12: Mechanical Heart Valves, SWOT Analysis, 2014
Table 13: Marketed Mechanical Heart Valve Products, 2014
Table 14: Tissue Heart Valves, SWOT Analysis, 2014
Table 15: Marketed Tissue Heart Valve Products, 2014
Table 16: Transcatheter Heart Valves, SWOT Analysis, 2014
Table 17: Marketed Transcatheter Heart Valve Products, 2014
Table 18: Product Profile - Carbomedics Standard Aortic Mechanical Valve (Sorin Group)
Table 19: Carbomedics Standard Aortic Mechanical Valve, SWOT Analysis, 2014
Table 20: Product Profile - Open Pivot Mechanical Valve (Medtronic)
Table 21: Open Pivot Mechanical Valve, SWOT Analysis, 2014
Table 22: Product Profile - On-X Mechanical Heart Valve (On-X Life Technologies)
Table 23: On-X Mechanical Heart Valve, SWOT Analysis, 2014
Table 24: Product Profile - On-X Plus 1.5 Mechanical Heart Valve (On-X Life Technologies)
Table 25: On-X Plus 1.5 Mechanical Heart Valve, SWOT Analysis, 2014
Table 26: Product Profile - Regent Valve (St Jude Medical)
Table 27: Regent Valve, SWOT Analysis, 2014
Table 28: Product Profile - Carpentier-Edwards Perimount Pericardial Valve (Edwards Lifesciences)
Table 29: Carpentier-Edwards Perimount Pericardial Valve, SWOT Analysis, 2014
Table 30: Product Profile - 3f Enable Sutureless Aortic Bioprosthesis (Medtronic)
Table 31: 3f Enable Sutureless Aortic Bioprosthesis, SWOT Analysis, 2014
Table 32: Product Profile - Hancock II (Medtronic)
Table 33: Medtronic Hancock II, SWOT Analysis, 2014
Table 34: Product Profile - Mitroflow Aortic Pericardial Heart Valve (Sorin Group)
Table 35: Sorin Group Mitroflow Aortic Pericardial Heart Valve, SWOT Analysis, 2014
Table 36: Product Profile - Trifecta Heart Valve (St Jude Medical)
Table 37: St Jude Medical Trifecta Heart Valve, SWOT Analysis, 2014
Table 38: Product Profile - Acurate TA/Acurate neo (Symetis)
Table 39: Acurate TA/Acurate neo, SWOT Analysis, 2014
Table 40: Product Profile - Lotus Valve System (Boston Scientific)
Table 41: Boston Scientific Lotus Valve System, SWOT Analysis, 2014
Table 42: Product Profile - Direct Flow Medical Transcatheter Valve (Direct Flow Medical)
Table 43: Direct Flow Medical Valve, SWOT Analysis, 2014
Table 44: Product Profile - Sapien XT Valve (Edwards Lifesciences)
Table 45: Sapien XT Valve, SWOT Analysis, 2014
Table 46: Product Profile - JenaValve (JenaValve Technology)
Table 47: JenaValve, SWOT Analysis, 2014
Table 48: Product Profile - CoreValve (Medtronic)
Table 49: CoreValve, SWOT Analysis, 2014
Table 50: Product Profile - CoreValve Evolut R (Medtronic)
Table 51: CoreValve Evolut R, SWOT Analysis, 2014
Table 52: Product Profile - Portico Valve (St Jude Medical)
Table 53: Portico Valve, SWOT Analysis, 2014
Table 54: Product Profile - Cytograft Tissue Valve (Cytograft Tissue Engineering)
Table 55: Cytograft Tissue Valve, SWOT Analysis, 2014
Table 56: Product Profile - Centera Valve (Edwards Lifesciences Corporation)
Table 57: Centera Valve, SWOT Analysis, 2014
Table 58: Product Profile - Colibri Heart Valve (Colibri Heart Valve)
Table 59: Colibri Heart Valve, SWOT Analysis, 2014
Table 60: Product Profile - Cormove (Perouse Medical)
Table 61: Cormove, SWOT Analysis, 2014
Table 62: Product Profile - Endovalve (Micro Interventional Devices)
Table 63: Endovalve, SWOT Analysis, 2014
Table 64: Product Profile - HLT Transcatheter Valve System (Heart Leaflet Technology)
Table 65: HLT Transcatheter Valve System, SWOT Analysis, 2014
Table 66: Product Profile - Inovare Valve (Braile Biomedica)
Table 67: Inovare Valve, SWOT Analysis, 2014
Table 68: Product Profile - Kalangos Valve (Leman Cardiovascular)
Table 69: Kalangos Valve, SWOT Analysis, 2014
Table 70: Product Profile - Tiara Valve (Neovasc.)
Table 71: Tiara Valve, SWOT Analysis, 2014
Table 72: Product Profile - Trinity Valve (Transcatheter Technologies GmbH)
Table 73: Trinity VALVE, SWOT Analysis, 2014
Table 74: Product Profile - Vanguard Exchangeable Heart Valve System (ValveXchange)
Table 75: Vanguard Exchangeable Heart Valve System, SWOT Analysis, 2014
Table 76: AorTech International plc, Company Profile, 2014
Table 77: AorTech International, SWOT Analysis, 2014
Table 78: Boston Scientific Corporation, Company Profile, 2014
Table 79: Boston Scientific Corporation, SWOT Analysis, 2014
Table 80: Braile Biomedica, Company Profile, 2014
Table 81: Braile Biomedica, SWOT Analysis, 2014
Table 82: CardiAQ Valve Technologies, Company Profile, 2014
Table 83: CardiAQ Valve Technologies, SWOT Analysis, 2014
Table 84: Claret Medical, Inc., Company Profile, 2014
Table 85: Claret Medical, SWOT Analysis, 2014
Table 86: Colibri Heart Valve, LLC, Company Profile, 2014
Table 87: Colibri Heart Valve, SWOT Analysis, 2014
Table 88: Cytograft Tissue Engineering, Inc., Company Profile, 2014
Table 89: Cytograft Tissue Engineering, SWOT Analysis, 2014
Table 90: Direct Flow Medical, Inc., Company Profile, 2014
Table 91: Direct Flow Medical, SWOT Analysis, 2014
Table 92: Edwards Lifesciences Corporation, Company Profile, 2014
Table 93: Edwards Lifesciences, SWOT Analysis, 2014
Table 94: Heart Leaflet Technologies, Company Profile, 2014
Table 95: Heart Leaflet Technologies, SWOT Analysis, 2014
Table 96: JenaValve Technology, Company Profile, 2014
Table 97: JenaValve Technology, SWOT Analysis, 2014
Table 98: Leman Cardiovascular, Company Profile, 2014
Table 99: Leman Cardiovascular, SWOT Analysis, 2014
Table 100: Micro Interventional Devices, Inc., Company Profile, 2014
Table 101: Micro Interventional Devices, SWOT Analysis, 2014
Table 102: Neovasc, Inc., Company Profile, 2014
Table 103: Neovasc, SWOT Analysis, 2014
Table 104: On-X Life Technologies, Inc., Company Profile, 2014
Table 105: On-X Life Technologies, SWOT Analysis, 2014
Table 106: Perouse Medical, Company Profile, 2014
Table 107: Perouse Medical, SWOT Analysis, 2014
Table 108: Sorin Group, Company Profile, 2014
Table 109: Sorin Group, SWOT Analysis, 2014
Table 110: St Jude Medical, Inc., Company Profile, 2014
Table 111: St Jude Medical, Inc., SWOT Analysis, 2014
Table 112: Symetis, Company Profile, 2014
Table 113: Symetis, SWOT Analysis, 2014
Table 114: Transcatheter Technologies GmbH, Company Profile, 2014
Table 115: Transcatheter Technologies, SWOT Analysis, 2014
Table 116: TTK Healthcare, Company Profile, 2014
Table 117: TTK Healthcare, SWOT Analysis, 2014
Table 118: ValveXchange, Inc., Company Profile, 2014
Table 119: ValveXchange, SWOT Analysis, 2014
Table 120:5EU Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011-2020
Table 121:France Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011-2020
Table 122:Germany Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011-2020
Table 123:Italy Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011-2020
Table 124:Spain Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011-2020
Table 125:UK Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011-2020

1.2 List of Figures
Figure 1: Hierarchy of Valvular Heart Disease
Figure 2: Operative Risk for Severe, Symptomatic Aortic Valve Disease Patients, 2009
Figure 3: France Procedure Volume Forecast by Market Segment, 2011-2020
Figure 4: France Procedure Volume Comparison by Market Segment, 2013 and 2020
Figure 5: Germany Procedure Volume Forecast by Market Segment, 2011-2020
Figure 6: Germany Procedure Volume Comparison by Market Segment, 2013 and 2020
Figure 7: Italy Procedure Volume Forecast by Market Segment, 2011-2020
Figure 8: Italy Procedure Volume Comparison by Market Segment, 2013 and 2020
Figure 9: Spain Procedure Volume Forecast by Market Segment, 2011-2020
Figure 10: Spain Procedure Volume Comparison by Market Segment, 2013 and 2020
Figure 11: UK Procedure Volume Forecast by Market Segment, 2011-2020
Figure 12: UK Procedure Volume Comparison by Market Segment, 2013 and 2020
Figure 13: EU Company Market Share for Prosthetic Heart Valves, 2012
Figure 14: France Company Market Shares for Prosthetic Heart Valves, 2012
Figure 15: Germany Company Market Shares for Prosthetic Heart Valves, 2012
Figure 16: Italy Company Market Shares for Prosthetic Heart Valves, 2012
Figure 17: Spain Company Market Shares for Prosthetic Heart Valves, 2012
Figure 18: UK Company Market Shares for Prosthetic Heart Valves, 2012
Figure 19: 5EU Market Value Forecast by Market Segment for Prosthetic Heart Valves, 2011-2020
Figure 20: France Market Value Forecast by Market Segment, $m, 2011-2020
Figure 21: France Market Value Comparison by Market Segment, 2013 and 2020
Figure 22: France Average Selling Price by Market Segment, 2011-2020
Figure 23: Germany Market Value Forecast by Market Segment, $m, 2011-2020
Figure 24: Germany Market Value Comparison by Market Segment, 2013 and 2020
Figure 25: Germany Average Selling Price by Market Segment, 2011-2020
Figure 26: Italy Market Value Forecast by Market Segment, $m, 2011-2020
Figure 27: Italy Market Value Comparison by Market Segment, 2013 and 2020
Figure 28: Italy Average Selling Price by Market Segment, 2011-2020
Figure 29: Spain Market Value Forecast by Market Segment, $m, 2011-2020
Figure 30: Spain Market Value Comparison by Market Segment, 2013 and 2020
Figure 31: Spain Average Selling Price by Market Segment, 2011-2020
Figure 32: UK Market Value Forecast by Market Segment, $m, 2011-2020
Figure 34: UK Market Value Comparison By Market Segment, 2013 and 2020
Figure 35: UK Average Selling Price by Market Segment, 2011-2020

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