Prosthetic Heart Valve Market Size & Outlook, 2026-2034

Prosthetic Heart Valve Market Overview

The global prosthetic heart valve market size is estimated at USD 10.26 billion in 2025 and is projected to reach USD 21.49 billion by 2034, growing at a CAGR of 8.61% during the forecast period. Sustainable growth of the market is propelled by the accelerating clinical momentum and patient demand for curative treatments.

Key Market Trends & Insights

• North America held a dominant share of the global market, accounting for 49.52% share in 2025.
• The Asia Pacific region is growing at the fastest pace, with a CAGR of 9.90%.
• Based on Product, the transcatheter heart valve segment dominated the market in 2025 with a revenue share of 48.35%.
• Based on the Material, the biological tissue segment is expected to register the fastest CAGR growth of 9.54%.
• Based on End User, the hospitals segment dominated the market in 2025, with a revenue share of 65.02%.
• According to Straits Research, the U.S. dominated the global market, valued at USD 3.32 billion in 2024 and reaching USD 3.60 billion in 2025.

Source: Straits Research

Market Size & Forecast

• 2025 Market Size: USD 10.26 billion
• 2034 Projected Market Size: USD 21.49 billion
• CAGR (2025 to 2034): 8.61%
• Dominating Region: North America
• Fastest-Growing Region: Asia Pacific

The global market includes a range of products such as transcatheter heart valves, tissue heart valves, and mechanical heart valves, catering to patients with various valvular heart diseases, including aortic, mitral, tricuspid, and pulmonary disorders. These valves are manufactured from different materials, including metal alloys, pyrolytic carbon, biological tissue, and polymers, each selected based on durability, biocompatibility, and patient-specific requirements. The valves are implanted across multiple healthcare settings, primarily hospitals, ambulatory surgical centers, and other specialized cardiac care facilities, with the choice of setting depending on the complexity of the procedure and patient condition.

Latest Market Trends

Integration of AI-driven Real-Time Guidance in Transcatheter Aortic Valve Replacement (TAVR) Procedures

A key market trend in the prosthetic heart valve industry is the integration of AI-driven software for real-time guidance during transcatheter valve procedures. In July 2025, Caranx Medical announced FDA clearance of TAVIPILOT Soft, the commercialization of the world’s first AI software for the real-time intraoperative guidance of transcatheter heart valve implantation. This AI-powered software supports in enhancing precision and accessibility in valve positioning.

Thus, by enabling clinicians to perform complex procedures with greater accuracy, TAVIPILOT Soft expanded access to life-saving TAVR interventions, thereby enhancing the growth of the market via better patient outcomes.

Shift from Surgical (open) Valves toward Minimally Invasive and Transcatheter Approaches

The global market is witnessing a shift from traditional surgical (open) valve replacements to minimally invasive and transcatheter procedures. Recently, the FDA approved Abbott’s Tendyne Transcatheter Mitral Valve Replacement (TMVR) System for high risk patients with mitral valve disease, which highlighted the growing adoption of minimally invasive transcatheter approaches over traditional open-heart surgery.

This trend is driven by shorter recovery times, reduced procedural risks, and growing patient preference for less invasive treatments, which is accelerating the adoption of advanced transcatheter heart valve technologies globally.

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Market Driver

Increasing Awareness and Early Diagnosis

Growing awareness about valvular heart diseases and early diagnosis programs are driving the demand for prosthetic heart valves. For example, “Prevention of Rheumatic Heart Disease” initiative by WHO led to earlier detection and timely intervention for conditions, such as aortic stenosis and mitral regurgitation.

Such proactive healthcare measures enhanced patient access to valve replacement procedures, boosting the growth of the global market.

Market Restraint

Durability Concerns and Long-Term Outcomes

Durability concerns of prosthetic heart valves remains a key market restraint. Bioprosthetic (tissue) valves deteriorates and calcifies over time, limiting their lifespan, while mechanical valves require lifelong anticoagulation, increasing bleeding risk. Such uncertainty created surgeons and payers cautious, especially for younger patients, which restrains adoption of prosthetic heart valve and limits market growth.

Market Opportunity

Emerging valve Replacement in Tricuspid and other Non-Aortic Positions

Emerging valve replacement in tricuspid and other non-aortic positions presents a growth opportunity in the global market. Recently, the U.S. FDA approved the Edwards Lifesciences Corporation EVOQUE Tricuspid Valve Replacement System, a catheter-delivered valve for patients with tricuspid regurgitation who remain symptomatic despite optimal medical therapy.

This development opened new growth avenues in the prosthetic heart valve market by expanding treatment options beyond the aortic position, demonstrating the market’s potential for innovation in less explored valve replacements.

Regional Analysis

The North America region dominated the market with a revenue share of 49.52% in 2025. The growth is attributed to factors such as well well-established healthcare infrastructure for cardiac care, including advanced hospitals, specialized heart centers, and skilled cardiologists. This robust infrastructure facilitated the adoption of innovative prosthetic heart valve technologies and ensures timely, high quality treatment for patients with valvular heart diseases.

The global market in U.S. is widely driven by the FDA’s expanded approval of transcatheter aortic valve replacement (TAVR) for low-risk patients. This decision opens access to a much larger population, directly boosting the market size.

Asia Pacific Market Insights

The Asia Pacific region is the fastest-growing region with a CAGR of 9.90% during the forecast timeframe, driven by local manufacturing initiatives for prosthetic heart valves, which have enhanced accessibility and affordability by reducing dependence on imports. Industrial incentives and specialized medical device parks are further promoting innovation and high-quality local production.

India continues to position itself in the global market, due to the government’s expansion of the Ayushman Bharat scheme, which covered advanced cardiac procedures including valve replacements. By improving patient access and reducing cost barriers, this policy directly boosted the market size. This unique support strengthens prosthetic heart valve market growth nationwide.

Pie Chart: Regional Market Share, 2025

Source: Straits Research

Europe Market Insights

Europe has a rapidly aging population with a high prevalence of aortic stenosis and other valvular heart diseases. Traditional open heart surgeries carry higher risks for elderly and high risk patients. As a result, the shift toward less invasive transcatheter solutions is accelerating market growth, particularly for next-generation valves that reduce recovery time, lower procedural complications, and improve quality of life.

The Prosthetic Heart Valve Market in the UK is propelling due to the National Health Service (NHS) funding expansion for minimally invasive valve replacement procedures. This public investment increased patient access and reduced waiting times, directly supporting market size. Such government-backed accessibility continued to accelerate global market growth across the UK.

Middle East and Africa Market Insights

The driving factor for the prosthetic heart valve market in the Middle East and Africa is the rising medical tourism for cardiac surgeries. Countries like the UAE, Saudi Arabia, and South Africa are emerging as regional hubs for advanced cardiac care, attracting patients from neighboring countries seeking high quality heart valve surgeries. This trend is boosting demand for advanced prosthetic heart valves and minimally invasive procedures, as hospitals invest in modern technologies and skilled cardiac specialists to cater to international patients.

The growing integration of digital imaging and 3D printing for pre-surgical planning drives the market growth. Cardiac surgeons in South Africa are increasingly using 3D printed patient specific heart valve models based on high resolution imaging (CT and MRI scans) to plan complex valve replacement procedures. This technology supported in reducing surgical risks, shortened operation times, and improved post operative outcomes. The Chris Hani Baragwanath Academic Hospital in Johannesburg implemented 3D printing for cardiac surgery planning, including prosthetic valve placements, enabling surgeons to tailor procedures to individual patients’ anatomy and thereby boosting demand for customized prosthetic valves.

Latin America Market Insights

The increasing focus on hybrid cardiac procedures combining surgical and interventional approaches, further drives the market growth. Leading cardiac centers are adopting hybrid operating rooms that allow surgeons to perform complex valve replacements using a combination of minimally invasive techniques and traditional surgery in a single procedure. This approach improves outcomes for high risk patients and drives demand for advanced prosthetic valves compatible with both surgical and transcatheter implantation.

Increasing adoption of remote patient monitoring and tele cardiology for post operative care, drives the market growth. Hospitals and clinics are implementing digital platforms to monitor patients after valve replacement surgeries, allowing timely detection of complications and reducing hospital readmissions. This trend encouraged surgeons to adopt advanced prosthetic valves with longer durability and compatibility with remote monitoring devices, improving patient outcomes and confidence in surgical interventions. Hospital Italiano de Buenos Aires integrated tele cardiology programs for post operative valve patients, supporting the use of next-generation prosthetic heart valves while enhancing follow up care.

Product Insights

The transcatheter heart valve segment dominated the market in 2025 with a revenue share of 48.35%. The growth is attributed to the technological advancements in transcatheter valve design, shorter recovery times, and reduced procedural risks compared to traditional surgical valve replacement.

Mechanical Heart Valve segment is anticipated to register the fastest CAGR of 9.25%, owing to its exceptional durability, often lasting 20 years or more. This makes them particularly suitable for younger patients who require a long-term solution. In addition, they are also more cost-efficient over the long term due to their durability, reducing the need for repeated surgeries or valve replacements.

Source: Straits Research

Material Insights

The biological tissue segment is anticipated to grow at a CAGR of 9.54% during 2026 - 2034. This growth is attributed to the increasing preference for biocompatible and durable valve materials, as well as rising adoption of minimally invasive procedures using biological tissue valves.

Pyrolytic carbon dominated the market in 2025, with a revenue share of 32.21%, owing to its excellent biocompatibility, which minimizes adverse immune responses and reduces the risk of complications such as hemolysis. This property ensures that the valve functions safely, making it suitable for lifelong implantation in patients.

End-User Insights

The hospitals segment dominated the market in 2025, with a revenue share of 65.02%. The growth is attributed to the availability of advanced surgical facilities, higher patient inflow for cardiac procedures, and the preference for hospitals as primary centers for complex prosthetic heart valve implantation and postoperative care. Additionally, hospitals offer access to multidisciplinary care teams, and innovative diagnostic and monitoring equipment, ensuring better patient outcomes. The presence of specialized cardiac units, comprehensive pre and post-operative services, and the ability to handle high risk or complicated cases further reinforce hospitals as the preferred choice for prosthetic heart valve procedures.

The ambulatory surgical centers (ASCs) is anticipated to register the fastest CAGR during the forecast period, owing to the increasing adoption of minimally invasive transcatheter valve replacement procedures and the growing preference for outpatient procedures, which require shorter recovery times and lower costs.

Competitive Landscape

The global market is moderately fragmented with a few major players dominating, such as Edwards Lifesciences Corporation, Medtronic, Boston Scientific Corporation, and Others, while several regional and emerging companies contribute to competition.

Abbott: An emerging market player

Abbott is an emerging player in the prosthetic heart valve market, focused on advancing minimally invasive transcatheter valve technologies with enhanced precision, expanded indications, and global accessibility.

• In May 2025, Abbott’s Tendyne transcatheter mitral valve system gained FDA approval for high-risk patients with severe mitral annular calcification (MAC).

List of key players in Prosthetic Heart Valve Market

1. Edwards Lifesciences Corporation
2. Medtronic
3. Boston Scientific Corporation
4. Abbott
5. Artivion, Inc
6. MicroPort Scientific Corporation
7. Lepu Medical Technology (Beijing)Co., Ltd.
8. Venus Medtech (Hangzhou) Inc.
9. Foldax
10. Meril Life Sciences
11. TTK
12. LivaNova PLC
13. JenaValve
14. Braile Biomédica
15. Xeltis
16. 4C Medical Technologies, Inc.
17. Caranx Medical
18. Corcym Group
19. Colibri Heart Valve
20. Xeltis
21. Others

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Strategic Initiatives

• May 2025: Edwards Lifesciences Corporation announced the U.S. FDA approval of its transcatheter aortic valve replacement therapy, the SAPIEN 3 platform for severe aortic stenosis patients without symptoms.
• May 2024: 4C Medical Technologies, Inc. was granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its AltaValve System, a transcatheter mitral valve replacement (TMVR) device.
• February 2024: Edwards Lifesciences Corporation announced the U.S. FDA approval of EVOQUE Tricuspid Valve Replacement System, an artificial heart valve, implanted by using a delivery catheter without the need for open heart surgery.