Global Prosthetic Heart Valve Or Artificial Heart Valve Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Type;
Transcatheter Heart Valve , Tissue Heart Valve and Mechanical Heart Valve.By Product;
Repair Products, Mitral Valve Repair Devices, and Tricuspid Valve Repair Devices.By Technology;
Biological valve and Decellularized valve.By End Use;
Hospitals, Ambulatory Surgical Centres, Speciality Clinics, and Others.By Geography;
North America, Europe, Asia Pacific, Middle East and Africa and Latin America - Report Timeline (2021 - 2031).Introduction
Global Prosthetic Heart Valve Or Artificial Heart Valve Market (USD Million), 2021 - 2031
In the year 2024, the Global Prosthetic Heart Valve Or Artificial Heart Valve Market was valued at USD 10,365.04 million. The size of this market is expected to increase to USD 22,913.81 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 12.0%.
The global prosthetic heart valve or artificial heart valve market is experiencing significant growth, driven by the increasing prevalence of cardiovascular diseases and advancements in medical technology. Prosthetic heart valves are crucial in the treatment of various heart valve disorders, including aortic stenosis and mitral regurgitation, which can lead to serious complications if left untreated. As the aging population grows and lifestyle factors contribute to the rise in cardiovascular diseases, the demand for effective heart valve replacement solutions continues to escalate. This trend is particularly pronounced in developed regions with well-established healthcare infrastructure.
Technological innovation is a key factor propelling market expansion. Advances in transcatheter heart valve replacement (TAVR) procedures have revolutionized the treatment landscape, offering minimally invasive alternatives to traditional open-heart surgery. These advancements have expanded treatment options for patients who may not be suitable candidates for surgery due to age or comorbidities. Additionally, ongoing research and development efforts are focused on enhancing the durability, biocompatibility, and performance of prosthetic heart valves to improve patient outcomes and reduce the need for repeat procedures.
Geographically, North America and Europe dominate the prosthetic heart valve market, owing to high healthcare expenditure, favorable reimbursement policies, and a large patient base. However, the Asia-Pacific region is emerging as a significant growth area, driven by increasing healthcare awareness, improving healthcare infrastructure, and a rising incidence of cardiovascular diseases. Market players are actively expanding their presence in these regions through strategic partnerships and product launches. Overall, the global prosthetic heart valve market is poised for continued growth, fueled by technological advancements, increasing demand for minimally invasive procedures, and the growing prevalence of cardiovascular diseases worldwide.
Global Prosthetic Heart Valve Or Artificial Heart Valve Market Recent Developments
- In March 2022, Edwards Lifesciences received approval from the United States Food and Drug Administration (FDA) for the MITRIS RESILIA valve. It is a tissue valve replacement specifically designed for the heart's mitral position.
- In January 2022, JenaValve Technology, Inc. entered into a strategic investment and exclusive technology licensing agreement with Peijia Medical Limited in China. According to the terms of the contract, Peijia has made a cash and equity investment in JenaValve and will continue to do so in exchange for exclusive rights to develop and market JenaValve's cutting-edge Trilogy TAVR systems in the Greater China area to treat patients with either severe symptomatic aortic regurgitation (AR) or severe symptomatic aortic stenosis.
Segment Analysis
The Global Prosthetic Heart Valve or Artificial Heart Valve Market has been segmented by type, product, technology, and end-use, each providing a comprehensive view of the evolving landscape of heart valve therapies. These segments address the diverse needs of patients suffering from heart valve diseases and the range of treatment options available. The segmentation reflects the growing demand for both advanced solutions and minimally invasive techniques in heart valve replacement and repair, offering new opportunities for market expansion.
By type, the market includes mechanical valves, biological valves, and transcatheter heart valves, each catering to different patient needs and clinical requirements. Mechanical valves, known for their durability, are typically used in younger patients who require a long-lasting solution. Biological valves, derived from animal tissues, offer a more natural function and are preferred by older patients or those who cannot tolerate long-term anticoagulation therapy. Transcatheter heart valves, the most recent innovation, allow for minimally invasive valve replacement, expanding treatment options for patients who are not candidates for traditional surgery, especially those with comorbid conditions or advanced age.
Product segmentation within the market focuses on devices designed for specific heart valve conditions, such as repair products, mitral valve repair devices, and tricuspid valve repair devices. Repair products are essential for restoring the functionality of damaged heart valves without the need for replacement, catering to less severe valve dysfunctions. Mitral and tricuspid valve repair devices target specific valve disorders, with innovations designed to treat mitral regurgitation and tricuspid valve insufficiency, respectively. These specialized products address the need for tailored treatments that improve blood flow and overall cardiac health while minimizing the risks and invasiveness of traditional surgeries.
The market is also segmented by technology into biological and decellularized valves. Biological valves are commonly used due to their natural tissue structure, offering better compatibility and fewer complications for many patients, especially in older populations. Decellularized valves, a newer development, remove cellular material from donor or animal valves, allowing the patient’s tissue to integrate with the valve, which can lead to more durable, long-term outcomes with fewer risks of immune rejection. Lastly, end-use segmentation reveals that hospitals, ambulatory surgical centers, specialty clinics, and other healthcare settings each play critical roles in providing heart valve procedures. Hospitals continue to be the primary care centers for complex surgeries, while ambulatory surgical centers and specialty clinics focus on less invasive procedures and more specialized care, respectively, contributing to the growing trend toward outpatient and minimally invasive treatments in heart valve replacement and repair.
Global Prosthetic Heart Valve Or Artificial Heart Valve Segment Analysis
In this report, the Global Prosthetic Heart Valve Or Artificial Heart Valve Market has been segmented by Type, Product, Technology, End Use, and Geography.
Global Prosthetic Heart Valve Or Artificial Heart Valve Market, Segmentation by Type
The Global Prosthetic Heart Valve Or Artificial Heart Valve Market has been segmented by Type into Transcatheter Heart Valve, Tissue Heart Valve and Mechanical Heart Valve.
The global prosthetic heart valve or artificial heart valve market has been segmented by type into three main categories: transcatheter heart valves, tissue heart valves, and mechanical heart valves. Transcatheter heart valves represent a significant advancement in minimally invasive cardiac surgery, allowing for valve replacement without the need for open-heart surgery. This approach has gained popularity due to reduced recovery times, lower complication rates, and expanded treatment options for patients at high or intermediate surgical risk.
Tissue heart valves, also known as bioprosthetic valves, are made from biological materials such as animal tissues or human cadaveric tissues. These valves offer excellent hemodynamic performance and are associated with a lower risk of thrombosis compared to mechanical valves. Tissue valves are particularly well-suited for older patients and those who wish to avoid long-term anticoagulant therapy. However, durability remains a concern, especially in younger patients, leading to ongoing research efforts aimed at improving the longevity of tissue heart valves.
Mechanical heart valves, on the other hand, are made from synthetic materials such as titanium or carbon and are known for their durability and longevity. These valves typically require lifelong anticoagulant therapy to prevent blood clots, which can increase the risk of bleeding complications. Mechanical valves are commonly used in younger patients who require a long-lasting valve replacement solution. Despite the need for anticoagulation, mechanical valves remain a vital option for patients with certain medical conditions or lifestyle preferences, contributing to the diverse landscape of the prosthetic heart valve market.
Global Prosthetic Heart Valve Or Artificial Heart Valve Market, Segmentation by Product
The Global Prosthetic Heart Valve Or Artificial Heart Valve Market has been segmented by Product into Repair Products, Mitral Valve Repair Devices, and Tricuspid Valve Repair Devices.
Repair products form a broad category that includes devices designed to repair damaged heart valves without the need for full replacement. These products are essential in treating valve dysfunction by restoring the normal function of the heart valve, preserving the patient's native valve structure. The increasing emphasis on minimally invasive procedures and preserving natural heart tissue has fueled the demand for these products, offering patients a solution with faster recovery times and lower risks compared to traditional valve replacement.
Mitral valve repair devices are specifically designed to address issues affecting the mitral valve, such as mitral regurgitation or prolapse. These devices include annuloplasty rings, sutures, and catheters that help restore proper valve function, improve blood flow, and alleviate symptoms associated with mitral valve diseases. The mitral valve repair segment has gained significant attention due to its clinical importance and the growing number of patients requiring mitral valve interventions, especially in the aging population.
Tricuspid valve repair devices cater to conditions affecting the tricuspid valve, which is often underdiagnosed but plays a crucial role in maintaining proper blood flow in the heart. These devices are designed to repair or replace the tricuspid valve, addressing disorders like tricuspid regurgitation or stenosis. The development of specialized devices for this segment reflects the increasing recognition of the tricuspid valve's importance and the need for effective treatment options to improve patient quality of life and prevent further complications.
Global Prosthetic Heart Valve Or Artificial Heart Valve Market, Segmentation by Technology
The Global Prosthetic Heart Valve Or Artificial Heart Valve Market has been segmented by Technology into Biological valve and Decellularized valve.
Biological valves, which are typically derived from animal tissues such as bovine or porcine, are a widely used solution in heart valve replacement. These valves are known for their ability to closely mimic the natural function of the heart’s valves, providing an effective solution for patients suffering from valve diseases. One of the key benefits of biological valves is that they generally do not require lifelong anticoagulation therapy, a significant advantage for patients, particularly those who are elderly or have contraindications to blood thinners. Though biological valves tend to have a shorter lifespan compared to mechanical valves, technological advancements in valve preservation techniques are improving their durability, making them an increasingly viable option for many patients.
Decellularized valves represent a more advanced and innovative approach in the prosthetic heart valve market. In this technology, the cellular components are removed from donor or animal heart valves, leaving behind a protein scaffold. This scaffold is then used to create a valve that can integrate more effectively with the patient’s own tissue, reducing the risk of immune rejection and enhancing the body's natural healing process. Decellularized valves offer several benefits over traditional biological valves, including greater biocompatibility, potentially longer-lasting functionality, and reduced need for immunosuppressive treatments. They are particularly appealing to younger patients who may require longer-term solutions or those who are at higher risk of complications due to immune response.
Both biological and decellularized valves reflect the market's shift toward more personalized, durable, and less invasive solutions for heart valve replacement. As research and technological developments continue to progress, these valves are becoming central to addressing the diverse needs of patients with heart valve diseases. With the promise of improving clinical outcomes and enhancing the quality of life for patients, these technologies are poised to drive the growth of the global prosthetic heart valve market in the coming years.
Global Prosthetic Heart Valve Or Artificial Heart Valve Market, Segmentation by End Use
The Global Prosthetic Heart Valve Or Artificial Heart Valve Market has been segmented by End Use into Hospitals, Ambulatory Surgical Centres, Speciality Clinics, and Others.
Hospitals remain the largest segment in the prosthetic heart valve market, serving as the primary setting for heart valve surgeries due to their advanced infrastructure and multidisciplinary teams. Equipped with state-of-the-art technologies and specialized cardiac care units, hospitals provide comprehensive services for complex cases, including surgical valve replacements, post-operative care, and patient monitoring. They are well-suited to handle high-risk patients and those requiring extensive treatment, making them a critical component in the global heart valve market.
Ambulatory surgical centers (ASCs) are emerging as an increasingly popular choice for heart valve procedures, particularly for less invasive treatments such as transcatheter valve replacements. ASCs offer a more cost-effective and efficient environment for patients, with shorter recovery times and the benefit of being outpatient facilities. As minimally invasive techniques continue to advance, ASCs provide an appealing option for patients seeking faster procedures with fewer hospital stays, driving their growth in the market.
Specialty clinics focus on providing expert-driven, personalized care for heart valve conditions, often offering targeted treatments with a specialized approach. These clinics may cater to specific types of heart valve disorders or provide a more tailored treatment plan for individual patients. They typically attract patients who prefer more specialized care with shorter waiting times and direct access to heart valve experts, positioning them as a crucial segment in the prosthetic heart valve market.
The "others" category includes additional healthcare settings such as outpatient facilities, research institutions, and long-term care facilities, which also contribute to the delivery of prosthetic heart valve procedures. While smaller in comparison to hospitals or ASCs, these settings still play a role in providing valve replacement or repair solutions, particularly in specific regions or for patients with unique needs, further broadening the market's reach.
Global Prosthetic Heart Valve Or Artificial Heart Valve Market, Segmentation by Geography
In this report, the Global Prosthetic Heart Valve Or Artificial 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 Or Artificial Heart Valve Market Share (%), by Geographical Region, 2024
The global prosthetic heart valve or artificial heart valve market exhibits diverse geographical distribution in terms of market share. North America and Europe traditionally dominate the market, collectively accounting for a significant portion of the global market share. This dominance is attributed to factors such as well-established healthcare infrastructure, higher healthcare expenditure, and a greater prevalence of cardiovascular diseases. Within these regions, countries like the United States, Germany, and France are key contributors to market growth, driven by technological advancements, increasing awareness about cardiovascular health, and favorable reimbursement policies.
The Asia-Pacific region is witnessing rapid market growth and is expected to capture a larger share of the global prosthetic heart valve market in the coming years. Factors such as the rising geriatric population, increasing healthcare expenditure, and improving healthcare infrastructure contribute to this growth. Countries like China, India, and Japan are experiencing significant market expansion, driven by initiatives to enhance healthcare accessibility and affordability, coupled with the growing adoption of advanced medical technologies.
Latin America, the Middle East, and Africa also present opportunities for market growth, albeit to a lesser extent compared to other regions. These regions are characterized by a rising prevalence of cardiovascular diseases, improving healthcare infrastructure, and increasing awareness about advanced treatment options. Market players are increasingly focusing on expanding their presence in these regions through strategic partnerships, distribution agreements, and product launches tailored to local needs. Overall, the global prosthetic heart valve market is witnessing dynamic geographical shifts, with emerging markets playing an increasingly important role in shaping its trajectory.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Prosthetic Heart Valve Or Artificial Heart Valve Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers:
- Increasing Cardiovascular Disease Prevalence
- Advancements in Medical Technology
-
Aging Population Demands - The aging population is a significant driver of growth in the global prosthetic heart valve or artificial heart valve market. As individuals age, the risk of developing heart valve diseases such as aortic stenosis and mitral regurgitation increases. With a larger portion of the global population entering older age brackets, there is a parallel rise in the incidence of these cardiovascular conditions. Consequently, there is a growing demand for prosthetic heart valves to address the needs of aging patients who require valve replacement surgeries to alleviate symptoms and improve quality of life.
The aging population's demands also fuel technological advancements in prosthetic heart valves. As patients age, there is an increasing need for durable and long-lasting heart valve replacements to accommodate their longer life expectancy and reduce the likelihood of repeat surgeries. Manufacturers are thus investing in R&D to develop innovative valve designs and materials that offer enhanced durability and biocompatibility. Additionally, the rise in aging populations has led to the development of minimally invasive procedures such as transcatheter aortic valve replacement (TAVR), which cater to older patients who may be at higher surgical risk due to age-related comorbidities.
The aging population presents opportunities for market growth beyond traditional healthcare hubs. As developing regions experience demographic shifts towards older age groups, there is a burgeoning market potential for prosthetic heart valves in these areas. Market players are increasingly focusing on expanding their presence in emerging economies, where improving healthcare infrastructure and rising healthcare spending are driving greater access to advanced medical treatments for aging populations. This demographic trend underscores the importance of addressing the unique needs of older patients in the prosthetic heart valve market and highlights opportunities for innovation and market expansion in diverse geographic regions.
Restraints:
- High Procedure and Device Costs
- Complication Risks and Reoperations
-
Regulatory Approval Hurdles - Regulatory approval hurdles pose a significant challenge in the global prosthetic heart valve or artificial heart valve market. The stringent regulatory requirements imposed by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) necessitate thorough testing and documentation of safety and efficacy before market approval can be granted. Manufacturers must navigate complex regulatory pathways, including preclinical testing, clinical trials, and post-market surveillance, which can significantly prolong the time and resources required to bring new products to market.
One of the key regulatory challenges is ensuring the safety and efficacy of prosthetic heart valves over the long term. Regulatory agencies require extensive clinical data demonstrating the durability and performance of prosthetic heart valves, particularly in high-risk patient populations. This necessitates long-term follow-up studies and post-market surveillance to monitor for adverse events and ensure ongoing safety and effectiveness. Meeting these regulatory requirements can be time-consuming and costly, delaying market entry for new products and limiting innovation in the field.
Regulatory approval hurdles can vary by region, further complicating the market landscape for prosthetic heart valves. Differences in regulatory requirements between countries and regions may necessitate additional testing and documentation to obtain market approval in multiple jurisdictions. This fragmented regulatory environment can pose challenges for manufacturers seeking to commercialize their products globally, requiring them to navigate multiple regulatory pathways simultaneously. As a result, regulatory approval hurdles remain a significant barrier to entry and expansion in the global prosthetic heart valve market, shaping the competitive landscape and influencing product development strategies.
Opportunities:
- Emerging Market Expansion
- Minimally Invasive Procedure Innovations
-
Enhanced Durability and Biocompatibility Focus - The global prosthetic heart valve or artificial heart valve market is witnessing a significant shift towards enhanced durability and biocompatibility of valve designs. These attributes are crucial in ensuring the long-term success of valve replacement procedures and reducing the need for repeat surgeries. Manufacturers are increasingly focusing on developing prosthetic heart valves that closely mimic the natural functioning of native valves while minimizing the risk of complications such as thrombosis and tissue degradation. This emphasis on durability and biocompatibility is driven by the growing demand for improved patient outcomes and quality of life.
Technological advancements play a pivotal role in achieving enhanced durability and biocompatibility in prosthetic heart valves. Innovations in materials science, including the use of novel biocompatible materials and tissue engineering techniques, are enabling the development of valves with superior performance and longevity. These advancements aim to reduce the incidence of structural valve degeneration and valve failure, particularly in younger patient populations who may require long-term valve function. Additionally, ongoing research efforts are focused on optimizing valve design and manufacturing processes to enhance biocompatibility and reduce the risk of immune rejection or adverse reactions.
The focus on enhanced durability and biocompatibility presents significant opportunities for market growth and innovation. Manufacturers are investing in research and development to create next-generation prosthetic heart valves that offer improved clinical outcomes and patient satisfaction. By addressing unmet clinical needs and leveraging technological advancements, companies can gain a competitive edge in the market while contributing to advancements in cardiovascular care. Overall, the emphasis on durability and biocompatibility reflects a broader trend towards personalized medicine and patient-centric approaches in the treatment of cardiovascular diseases.
Competitive Landscape Analysis
Key players in Global Prosthetic Heart Valve Or Artificial Heart Valve Market include:
- Edwards Lifesciences Corporation
- Medtronic plc
- Abbott Laboratories
- Boston Scientific Corporation
- LivaNova PLC
- CryoLife Inc.
- Micro Interventional Devices Inc.
- Braile Biomédica
- JenaValve Technology, Inc.
- Colibri Heart Valve, LLC
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
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Type
- Market Snapshot, By Product
- Market Snapshot, By Technology
- Market Snapshot, By End Use
- Market Snapshot, By Region
- Global Prosthetic Heart Valve Or Artificial Heart Valve Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Increasing Cardiovascular Disease Prevalence
- Advancements in Medical Technology
- Aging Population Demands
- Restraints
- High Procedure and Device Costs
- Complication Risks and Reoperations
- Regulatory Approval Hurdles
- Opportunities
- Emerging Market Expansion
- Minimally Invasive Procedure Innovations
- Enhanced Durability and Biocompatibility Focus
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Prosthetic Heart Valve Or Artificial Heart Valve Market, By Type, 2021 - 2031 (USD Million)
- Transcatheter Heart Valve
- Tissue Heart Valve
- Mechanical Heart Valve
- Global Prosthetic Heart Valve Or Artificial Heart Valve Market, By Product, 2021 - 2031 (USD Million)
- Repair Products
- Mitral Valve Repair Devices
- Tricuspid Valve Repair Devices
- Global Prosthetic Heart Valve Or Artificial Heart Valve Market, By Technology, 2021 - 2031 (USD Million)
- Biological valve
- Decellularized valve
- Global Prosthetic Heart Valve Or Artificial Heart Valve Market, By End Use, 2021 - 2031 (USD Million)
- Hospitals, Ambulatory Surgical Centres,
- Speciality Clinics
- Others
- Global Prosthetic Heart Valve Or Artificial Heart Valve Market, By Product, 2021 - 2031 (USD Million)
- Repair Products
- Mitral Valve Repair Devices
- Tricuspid Valve Repair Devices
- Global Prosthetic Heart Valve Or Artificial Heart Valve Market, By Technology, 2021 - 2031 (USD Million)
- Biological valve
- Decellularized valve
- Global Prosthetic Heart Valve Or Artificial Heart Valve Market, By End Use, 2021 - 2031 (USD Million)
- Hospitals
- Ambulatory Surgical Centres
- Speciality Clinics
- Others
- Global Prosthetic Heart Valve Or Artificial Heart Valve Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Prosthetic Heart Valve Or Artificial Heart Valve Market, By Type, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Edwards Lifesciences Corporation
- Medtronic plc
- Abbott Laboratories
- Boston Scientific Corporation
- LivaNova PLC
- CryoLife Inc.
- Micro Interventional Devices Inc.
- Braile Biomédica
- JenaValve Technology, Inc.
- Colibri Heart Valve, LLC
- Company Profiles
- Analyst Views
- Future Outlook of the Market