Heart valve disease occurs when one or more heart valves fail to open and close properly. This can affect the ability of heart to pump blood. Heart valve diseases can be congenital (at birth) or acquired later in life due to age-related changes, infections, heart attacks, calcific degeneration, heart disease or damage. There are mainly two types of problems that can disrupt blood flow through the valves, namely, regurgitation (incompetence) or stenosis (narrowing). Some valve problems are minor and do not need treatment while others might require medicines, lifestyle changes, and/or surgical procedures to repair or replace the valve. If not treated, advanced heart valve disease can cause heart failure, stroke, blood clots, or death due to sudden cardiac arrest (SCA).
Over five million people in the U.S. are diagnosed with heart valve disease each year. Heart valve repair is an effective therapy for several patients with diseased valves. In the U.S., around 100,000 heart valve surgeries are performed each year. Almost all of these surgeries are done to repair or replace the mitral or aortic valves. The heart valve devices market in this report includes heart valve replacement devices as well repairing devices. Heart valve is replaced with a prosthetic valve to treat any diseased valve that cannot be repaired. Prosthetic valves can either be mechanical (made from materials such as plastic, carbon, or metal) or biological (made from human or animal tissue).
Companies in this market are focusing on investments in R&D to launch various new and technologically advanced devices for making heart valve procedures safer and more effective, and strengthening their positions in the market. Continuous innovation has led to development of minimally invasive surgical procedures. For instance, transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve implantation (TAVI) is FDA approved and has emerged as a novel technology for people with symptomatic aortic stenosis who are considered a high risk patient for standard valve replacement surgery. Also, apart from product innovation, companies in this market are focusing on acquisitions as their key strategy to enhance their market positions. For instance, in August 2015, Medtronic signed an agreement to acquire Twelve, Inc., a privately-held developer of a transcatheter mitral valve replacement (TMVR) device for the treatment of mitral regurgitation.
The heart valve devices market is witnessing various technological advancements due to which new and innovative products are being launched in the market. This is a major factor driving the growth of the market. Aging population, significant population with structural heart disease, development and commercialization of heart valve therapies, rising advances in diagnostic technologies thereby increasing the diagnosis rates, rising awareness regarding the new treatments available in the market, increasing incidences of congenital heart defects, and other cardiovascular diseases affecting heart valves, and the advantages of minimally invasive techniques over traditional surgeries are other factors fuelling the market. However, factors such as high cost of devices and surgeries, complex regulatory procedures and varied stringency of regulatory procedures may hinder the growth of the market to some extent.
The global heart valve devices market is segmented based on type of procedure, and region. On the basis of type of procedure, the market is divided into heart valve repair devices and heart valve replacement devices. Heart valve repair devices market is subsegmented into surgical heart valve repair devices, percutaneous balloon valvuloplasty devices, and transcatheter heart valve repair devices. Heart valve replacement devices market is further segmented based on type of valve and by position. Based on the type of valve, the market is segmented into mechanical valves, tissue/bioprosthetic valves, and transcatheter heart valves/ percutaneous heart valves. Based on position, the heart valve replacement devices market is classified into mitral valve replacement devices, aortic valve replacement devices, and other position heart valve replacement devices. Based on region, the heart valve devices market is segmented into the North America, Europe, Asia, and the Rest of the World (RoW).
This report is a comprehensive study of current trends in the market, industry growth drivers, and restraints. These markets are given analysis at regional level to provide exhaustive value market analysis for the years 2013, 2014, 2015, and forecast to 2020. Each market is comprehensively analyzed at a granular level by region (North America, Europe, Asia, and Rest of the World) to provide in-depth information on the global scenario.
The major players in the heart valve devices market are Edwards Lifesciences (U.S.), Medtronic (U.S.), St. Jude Medical (U.S.), and Sorin Group (Italy). Other players include Abbott Laboratories (U.S.), Accellent Inc. (U.S.), Admedes Schuessler GmbH (Germany), AorTech International (U.K.), Arbor Surgical Technologies, Inc. (U.S.), AutoTissue GmbH (Germany), Boston Scientific (U.S.), CryoLife, Inc. (U.S.), Colibri Heart Valve, LLC (U.S.), Micro Interventional Devices, Inc. (U.S.), Neovasc, Inc. (Canada), JenaValve Technology (Germany), Leman Cardiovascular Sa (Switzerland), MiCardia Corporation (U.S.), On-X Life Technologies, Inc. (U.S.), among others.
Table of Contents
1.1 Objectives of the Study
1.2 Market Definition
1.3 Market Scope
1.3.1 Markets Covered
1.3.2 Years Considered for the Study
2 Research Methodology
2.1 Market Size Estimation
2.2 Market Breakdown and Data Triangulation
2.3 Key Data From Secondary Sources
2.4 Key Data From Primary Sources
2.5 Key Industry Insights
2.6 Assumptions for the Study
3 Executive Summary
4 Premium Insights
5 Market Overview
5.2 Maket Segmentation
5.3 Market Dynamics
18.104.22.168 Technological Advancements in Heart Valve Devices
22.214.171.124 Advances in Diagnostic Technologies Increasing the Diagnosis Rates
126.96.36.199 Advantages of Minimally Invasive Procedures Over Conventional Surgeries
188.8.131.52 High Prevalence of Cardiovascular Diseases
184.108.40.206 Rising Incidences of Congenital Heart Defects (Chd)
220.127.116.11 Significant Population With Structural Heart Disease
18.104.22.168 Growing Geriatric Population
22.214.171.124 Awareness Programs and Conferences
126.96.36.199 Complex Regulatory Procedures
188.8.131.52 High Device and Procedure Cost
184.108.40.206 Robust Growth in the Transcatheter Heart Valves Market
220.127.116.11 Advances in Biodegradable Devices
18.104.22.168 Asia-Pacific Region Presents Significant Growth Opportunities
22.214.171.124 Product Approvals & Safety Concerns
126.96.36.199 Survival of Small Players and New Entrants
6 Industry Insights
6.1 Porter’s Five Forces Analysis
6.1.1 Threat of New Entrants
6.1.2 Threat of Substitutes
6.1.3 Bargaining Power of Suppliers
6.1.4 Bargaining Power of Buyers
6.1.5 Intensity of Competitive Rivalry
6.2 Burning Issues
6.3 Winning Imperatives
6.4 Regulatory Scenario
7 Heart Valve Devices Market, By Type of Procedure
7.2 Heart Valve Repair
7.2.1 Surgical Heart Valve Repair Devices
7.2.2 Percutaneous Balloon Valvuloplasty Devices
7.2.3 Transcatheter Heart Valve Repair Devices
7.3 Heart Valve Replacement
7.3.1 By Type
188.8.131.52 Mechanical Valves
184.108.40.206 Tissue/Bioprosthetic Valves
220.127.116.11 Transcatheter Heart Valves/ Percutaneous Heart Valves
7.3.2 By Position
18.104.22.168 Mitral Valve Replacement Devices
22.214.171.124 Aortic Valve Replacement Devices
126.96.36.199 Other Position Heart Valve Replacement Devices
8 Regional Analysis
8.2 North America
8.5 Rest of the World (Row)
9 Competitive Landscape
9.2 Competitive Situation and Trends
9.2.1 Partnerships, Agreements, and Collaborations
9.2.2 New Product Launches
9.2.3 Product Approvals
9.2.4 Mergers and Acquisitions
9.3 Market Share Analysis
10 Company Profiles (Business Overview, Financials, Product Offerings, Recent Developments)
10.2 Edwards Lifesciences
13.4 Sorin Group
10.5 St.Jude Medical, Inc.
10.6 Abbott Laboratories
10.7 Boston Scientific Corporation
10.8 Cryolife, Inc.
10.9 On-X Life Technologies, Inc.
10.10 Micro Interventional Devices, Inc.
11.1 Insights From Industry Experts
11.2 Discussion Guide
11.3 Other Developments, By Company, 2012–2015
11.4 Introducing RT: Real-Time Market Intelligence
11.5 Available Customizations
11.6 Related Reports