Global Prosthetic Heart Valve Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• In February 2024, Edwards Lifesciences Corporation announced that its EVOQUE tricuspid valve replacement system has become the first transcatheter therapy to receive approval from the U.S. Food and Drug Administration (FDA) for treating tricuspid regurgitation (TR). The EVOQUE system is designed to enhance the health status of patients experiencing symptomatic severe TR who have not responded adequately to optimal medical therapy (OMT), and for whom tricuspid valve replacement is considered appropriate by a heart team.

• In March 2023, Abbott revealed that the U.S. Food and Drug Administration (FDA) had approved its Epic Max stented tissue valve for treating individuals with aortic regurgitation or stenosis. This device is the newest addition to Abbott's Epic surgical valve platform, which has a long-standing reputation for safety and strong clinical outcomes, featuring an optimized design to enhance valve blood flow.

The global prosthetic heart valve market is witnessing significant growth, driven by several factors including an aging population, rising prevalence of heart valve diseases, and advancements in medical technology. Prosthetic heart valves are crucial medical devices used to replace damaged or diseased heart valves, thereby restoring normal blood flow and cardiac function. With the increasing burden of cardiovascular diseases worldwide, the demand for prosthetic heart valves is expected to escalate, especially in regions with aging populations such as North America, Europe, and parts of Asia-Pacific.

In recent years, there has been a notable shift towards minimally invasive procedures for heart valve replacement, which has further fueled market expansion. Minimally invasive techniques offer advantages such as shorter recovery times, reduced hospital stays, and lower complication rates compared to traditional open-heart surgery. As a result, patients and healthcare providers are increasingly opting for these less invasive approaches, driving the adoption of prosthetic heart valves. Additionally, ongoing research and development efforts are focused on enhancing the durability, biocompatibility, and functionality of prosthetic heart valves, aiming to improve patient outcomes and quality of life.

Despite the promising growth prospects, the prosthetic heart valve market faces challenges such as stringent regulatory requirements, high costs associated with implantation procedures, and limited access to advanced healthcare facilities in developing regions. However, collaborations between industry players, healthcare institutions, and regulatory bodies are facilitating the development and commercialization of innovative prosthetic heart valve solutions. Moreover, initiatives aimed at raising awareness about heart valve diseases and expanding healthcare infrastructure in emerging markets are expected to drive market growth in the coming years. Overall, the prosthetic heart valve market presents lucrative opportunities for manufacturers and investors, with a focus on technological innovation, market expansion, and addressing unmet medical needs.

Global Prosthetic Heart Valve Segment Analysis

In this report, the Global Prosthetic Heart Valve Market has been segmented by Product, End User and Geography.

Global Prosthetic Heart Valve Market, Segmentation by Product

The Global Prosthetic Heart Valve Market has been segmented by Product into Mechanical Heart Valve, Tissue Heart Valve, Stented Tissue Heart Valve, Stentless Tissue Heart Valve and Transcatheter Heart Valve.

The global prosthetic heart valve market is witnessing significant growth, primarily driven by an aging population, increasing prevalence of cardiovascular diseases, and advancements in medical technology. Prosthetic heart valves are artificial devices implanted in patients with diseased or damaged heart valves to restore normal blood flow. These valves come in various types, with the most common being mechanical and tissue heart valves. Mechanical heart valves are durable and long-lasting but require lifelong anticoagulation therapy to prevent blood clots. On the other hand, tissue heart valves, derived from animal tissue or human tissue, offer better hemodynamic performance and eliminate the need for long-term anticoagulation therapy, making them a preferred choice for many patients.

Within the segmentation by product, stented tissue heart valves and stentless tissue heart valves are gaining traction due to their improved design and enhanced durability. Stented tissue heart valves incorporate a metal or plastic frame, or stent, which provides structural support and helps in anchoring the valve securely in place. Stentless tissue heart valves, on the other hand, offer advantages such as better hemodynamics and reduced risk of thromboembolism. Another emerging segment is transcatheter heart valves, which are minimally invasive alternatives to traditional open-heart surgery. These valves are delivered to the heart through a catheter, typically inserted through the femoral artery, offering shorter recovery times and reduced complications compared to open-heart surgery.

As healthcare systems continue to focus on improving patient outcomes and reducing healthcare costs, there is a growing demand for innovative prosthetic heart valve solutions. Manufacturers are investing in research and development to introduce next-generation devices with enhanced performance, durability, and compatibility. Additionally, strategic collaborations and partnerships between medical device companies and healthcare providers are facilitating the adoption of prosthetic heart valves in both developed and developing regions. With increasing awareness about the benefits of prosthetic heart valve implants and advancements in surgical techniques, the global market is expected to witness sustained growth in the coming years.

Global Prosthetic Heart Valve Market, Segmentation by End User

The Global Prosthetic Heart Valve Market has been segmented by End User into Hospitals, Ambulatory Surgical Centers, Cardiac Clinics, and Others.

The global prosthetic heart valve market is witnessing substantial growth, driven by a rising prevalence of cardiovascular diseases and an increasing aging population globally. Prosthetic heart valves are crucial in managing various heart conditions, such as valvular diseases and congenital heart defects, thereby propelling their demand. With advancements in technology, prosthetic heart valves are becoming more durable, biocompatible, and minimally invasive, further fueling market expansion.

Hospitals emerge as the dominant end user in the global prosthetic heart valve market, owing to their advanced infrastructure, skilled healthcare professionals, and comprehensive patient care services. Moreover, the high volume of surgeries performed in hospitals, coupled with the availability of advanced surgical techniques and equipment, contributes significantly to the market's growth. Ambulatory surgical centers (ASCs) are also witnessing increased adoption of prosthetic heart valves due to their advantages such as shorter hospital stays, reduced healthcare costs, and convenience for patients requiring minor surgeries.

Cardiac clinics play a crucial role in the management and treatment of cardiovascular diseases, including the implantation of prosthetic heart valves. These specialized clinics offer focused care for patients with heart conditions, providing diagnostic services, treatment options, and follow-up care. Additionally, advancements in cardiac care facilities and the availability of skilled cardiologists contribute to the growing utilization of prosthetic heart valves in cardiac clinics. Other end users, including specialty clinics and healthcare centers, are also expected to contribute to the market's growth as awareness about heart diseases and treatment options increases globally.

Global Prosthetic Heart Valve Market, Segmentation by Geography

In this report, the Global Prosthetic Heart Valve Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Prosthetic Heart Valve Market Share (%), by Geographical Region, 2024

The global prosthetic heart valve market has experienced substantial growth in recent years, driven by factors such as the increasing prevalence of cardiovascular diseases, advancements in medical technology, and growing awareness about heart valve disorders. Prosthetic heart valves are artificial devices implanted in patients with damaged or diseased heart valves to restore normal blood flow. These devices play a crucial role in managing various cardiac conditions and improving patients' quality of life.

North America and Europe are key regions in the global prosthetic heart valve market, primarily due to the presence of well-established healthcare infrastructure, high adoption rates of advanced medical technologies, and a significant prevalence of cardiovascular diseases in these regions. However, the market is witnessing rapid growth in emerging economies across Asia Pacific, Latin America, and the Middle East and Africa. Factors such as increasing healthcare expenditure, rising geriatric population, and improving access to healthcare facilities are driving market growth in these regions.

Despite the promising growth prospects, the prosthetic heart valve market faces challenges such as high treatment costs, stringent regulatory requirements, and the risk of post-implantation complications. Manufacturers are focusing on developing innovative and cost-effective solutions to address these challenges and cater to the growing demand for prosthetic heart valves worldwide. Additionally, strategic collaborations, mergers and acquisitions, and investments in research and development activities are key strategies adopted by market players to strengthen their market presence and gain a competitive edge.

This report provides an in depth analysis of various factors that impact the dynamics of Global Prosthetic Heart Valve Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers

• Aging population demand
• Technological advancements driving innovation
• Increasing prevalence of cardiovascular diseases
• Rising awareness about heart health

• Growing adoption of minimally invasive surgeries: The global prosthetic heart valve market has experienced significant growth, largely driven by the increasing prevalence of valvular heart diseases and the growing adoption of minimally invasive surgical procedures. Prosthetic heart valves are increasingly being used to replace damaged or diseased heart valves, offering patients improved quality of life and longevity. Technological advancements in prosthetic heart valve designs, such as the development of tissue and mechanical valves, have also contributed to market expansion. Moreover, rising healthcare expenditure, growing awareness about cardiovascular diseases, and the aging population are further fueling market growth. As healthcare systems worldwide prioritize less invasive procedures to reduce hospital stays and improve patient outcomes, the demand for prosthetic heart valves is expected to continue its upward trajectory.

  Invasive surgeries have revolutionized the field of cardiac interventions, including prosthetic heart valve replacement procedures. These procedures involve smaller incisions, reduced blood loss, shorter hospital stays, and quicker recovery times compared to traditional open-heart surgeries. As a result, patients benefit from less pain and scarring, lower risk of infection, and faster return to normal activities. The increasing adoption of minimally invasive techniques by healthcare providers is driving the demand for prosthetic heart valves, as they are well-suited for use in these procedures. Additionally, advancements in imaging technologies and surgical instruments have improved the accuracy and safety of minimally invasive heart valve replacement surgeries, further boosting market growth. With ongoing innovation and continued emphasis on patient-centric care, the global prosthetic heart valve market is poised for sustained expansion in the coming years.

Restraints

• High cost of prosthetic valves
• Regulatory hurdles
• Limited reimbursement policies
• Risk of post-surgery complications

• Availability of alternative treatments: The global prosthetic heart valve market has witnessed significant growth over recent years, driven by an increasing prevalence of valvular heart diseases, advancements in prosthetic heart valve technology, and a growing aging population. Prosthetic heart valves are medical devices implanted in patients with diseased or damaged heart valves to restore normal blood flow. The market encompasses both mechanical and tissue heart valves, each with its own set of advantages and considerations. Mechanical valves are durable and long-lasting but require lifelong anticoagulant therapy to prevent blood clots. Tissue valves, on the other hand, are derived from animal tissues or human cadavers and do not necessitate lifelong anticoagulation, making them a preferred choice for certain patient populations.

  While prosthetic heart valves have been the standard of care for many years, there is a growing interest in alternative treatments such as transcatheter aortic valve replacement (TAVR) and mitral valve repair techniques. TAVR is a minimally invasive procedure that involves replacing the aortic valve using a catheter-based approach, avoiding the need for open-heart surgery. This approach has gained popularity, particularly among high-risk and elderly patients who may not be suitable candidates for traditional surgical valve replacement. Similarly, advancements in mitral valve repair techniques, including percutaneous mitral valve repair with devices like the MitraClip, offer less invasive options for treating mitral regurgitation. These alternative treatments provide patients with additional options, potentially improving outcomes and quality of life while reducing the need for traditional surgical interventions.

Opportunities

• Emerging markets expansion
• Customization and personalization trends
• Development of novel materials
• Collaboration with healthcare providers

• Focus on research and development: The global prosthetic heart valve market is experiencing significant growth driven by various factors such as the increasing prevalence of valvular heart diseases, advancements in technology, and the rising aging population. Prosthetic heart valves are crucial for individuals suffering from heart valve diseases, as they help restore normal blood flow and improve overall heart function. With technological advancements, prosthetic heart valves have become more durable, biocompatible, and less invasive, leading to a surge in demand worldwide.

  Ongoing research and development activities are continually enhancing the efficacy and safety of prosthetic heart valves, leading to the introduction of innovative products in the market. Additionally, the growing adoption of minimally invasive surgical procedures is fueling market growth, as they offer benefits such as reduced hospital stays, faster recovery times, and lower healthcare costs. With increasing awareness about heart health and improved access to healthcare services in emerging economies, the prosthetic heart valve market is expected to witness sustained growth in the coming years.

Key players in Global Prosthetic Heart Valve Market include:

• Abbott Laboratories
• Boston Scientific Corporation
• Cryolife, Inc.
• Direct Flow Medical, Inc.
• Edwards Lifesciences Corporation
• Jenavalve Technology, Inc.
• Livanova Plc
• Medical Technology Est.
• Medtronic Plc
• Micro Interventional Devices, Inc

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis