Global Heart Valve Devices Market 2025 – 2034

Reports Description

Global Heart Valve Devices Market size was valued at USD 11,942.26 Million in 2025 and is expected to reach USD 31,553.91 Million by 2034 at a CAGR of 11.4% during the forecast period 2025 – 2034.

A heart valve device is a medical device that can change or repair damaged heart valves. The heart valve devices are used to develop, produce, and distribute the medical devices used to repair or replace the heart valves, which are required to treat conditions such as aortic stenosis and mitral regurgitation.

These devices are widely available in transcatheter aortic valve replacement (TAVR), surgical heart valves and mitral valve repair systems, hospitals, cardiac centres, and special clinics. This market includes a variety of valves, such as mechanical, biological, and transcatheter valves, designed to meet the needs of each specific patient.

The increasing prevalence of heart valve disease, mainly among the aging population, has increased the demand for heart valve equipment.  Advances in technology, especially in minimally invasive processes such as transcatheter aortic valve replacement (TAVR), have induced rapid market growth, causing these devices to be more accessible and widely used.

Heart Valve Devices Market Growth Factors

Growing Prevalence of Heart Diseases

The market is driven by the increasing proliferation of heart diseases globally. For example, according to the American Heart Association Journal, the most prevalent congenital heart abnormality, bicuspid aortic valve (BAV), affects the population of 1% to 2%.

This may be attributed to changing lifestyles, increasing chronic population, high blood pressure, increasing obesity, and increasing rate of diabetes. The most prevalent cardiovascular issues brought by cardiovascular diseases can only be treated and resolved with the use of these devices.

For instance, according to the world health organisation, in 2022, the 702,880 people died from heart disease, which is equivalent of 1 in every 5 deaths. Thus, due to growing number heart diseases the demand for effective treatment options rises along with the incidence of heart disorders, which has a direct impact on the heart valve devices market.

Increasing Aging Population

The rapidly growing geriatric population across the world acts as an important market driver for heart valves, as older individuals are more prone to the development of valvular heart diseases. With the growing population, the risk for degenerative heart conditions increases, resulting in a high proliferation of heart valve dysfunction such as regurgitation or stenosis.

This demographic change towards an old age group leads to an increasing demand for medical procedures like heart valve replacement and repair. According to a paper published under the title exposing the healing burden of severe aortic stenosis in the UK, 291,448 men and women had given people over 55 years of age to serious aortic stenosis in 2023.

Based on these figures, it is expected that the demand for prosthetic heart valves will increase, which will promote market expansion.

Heart Valve Devices Market Restraint

High cost of manufacturing heart valve devices

The high cost of manufacturing the heart valve device is a major challenge in the market. These devices need advanced materials, sophisticated manufacturing processes, and high-quality control to meet the highest standards of safety and efficacy.

For instance, heart valve devices are manufactured from materials like titanium or special polymers, that are expensive. Moreover, the accuracy required for the producer of these devices to match the exact specifications needed for each patient is high, leading to increasing technological and labour costs.

These devices have to undergo extensive tests and clinical trials before they are approved for use, which increases the total cost. All these factors contribute to the high cost of heart valve devices, causing them to become expensive for both manufacturers and patients, and all these factors hamper heart valve device market growth.

Heart Valve Devices Market Opportunities

Development of Innovative Materials for Heart Valve Replacement

The transformational opportunity for the market is the availability of new and better materials for heart valves. Applications of advanced materials, such as bio-compatible polymers, are revolutionizing organic tissues and synthetic composites, heart valve techniques. It increases durability, reduces rejection rates, and better mimic’s natural hemodynamic flow.

These progresses address previous issues such as the need for lifelong anticoagulation therapy in patients with valve degeneration, thrombosis, and mechanical valves.  For example, Foldax Inc. signed a contract to achieve the ownership of a portfolio of patents of polymer technology from Australia’s National Research Organization, CSIRO. Polymer technology is integrated into their LifePolymer content platform by Foldax.

The test has shown that the material is compatible with blood, performing little adhesion of proteins, cells, and calcification. Due to the remarkable durability of this LifePolymer material, it is the perfect choice for many medical devices.

The growing technological developments in the current market are the arrival of novel content for heart valve replacement. Material science and advanced engineering solutions have enabled the development of heart valves that are more durable, biologically safe, and functional than previous versions.

Newly developed materials, including advanced polymers and bioengineered tissues, improve hemodynamic characteristics and reduce the risk of complications such as thrombosis and calcification.  For instance, in June 2023, Peca Labs completed the MASA valve paediatric pulmonary implantation successfully in US clinical testing, which was the first-in-human implantation

Heart Valve Devices Market Challenge

The Technical Constraints of The Mechanical Valve

About two-third of both aortic and mitral valve transplants were recorded as mechanical. Recorded applications of anticoagulative agents were significantly more specific in mechanical recipients than in bioprosthetic valves. While mechanical heart valves provide better durability, one of their major restraints is the prescribed danger of thrombosis that may result in valvular dysfunction.

The most specific cause of valvular dysfunction results from the obstruction of the valve disc by the thrombus, and to some extent, the formation of the pannus. Pannus formation is characterized by fibrous tissue ingestion and the existence of endothelial and immune cells.

Additionally, the turbulence, while the pre-designed is much greater than the repetitions, is still the ability to promote thrombogenicity around the implanted heart valve. Thrombosis can also result in compliance between native tissue and transplanted materials, where the difference in mechanical compliance can lead to disturbing flow patterns like in the vascular graft.

To prevent thrombus formation, patients need to remain on a lifetime anticoagulation therapy, with excessive bleeding and lack of blood clots when needed. Anticoagulants provide complications for young women due to birth defects and additional pregnancy-related complications. These issues are constraints to the growth of the heart valve devices market.

Heart Valve Devices Market Segmentation Analysis

Based on treatment, the heart valve device market is segmented into heart valve replacement devices and heart valve repair devices. The heart valve replacement device segment dominated the market in 2024 and is expected to keep its dominance during the forecast period due to a significant increase in the count of valve replacement surgery and auxiliary health reimbursement.

Some physicians feel that transcatheter valve-in-wall devices are a better therapy for patients with tissue heart valve replacement. In addition, they indicate that valve-in-valve therapy can be used to thwart aortic valves, mitral valves, tricuspid valves, and pulmonary valves. The heart valve is advancing the growth of technological progression and the heart valve replacement device segment in replacement surgery.

Based on the End-User, the Heart valve devices market is segmented into Hospitals & Clinics, Ambulatory Surgical Centres, Cardiac Centres, and Others End-user. Among all of these, hospital segment dominated the market in 2024 and is expected to keep its dominance during the forecast period due to increased needs in a hospital due to increasing cases of repair or replacement surgery of the heart valve.

Transcatheter valves are required, such as the transcatheter mitral valve, which is required to be repaired, reducing the possibilities of hospital stay and surgical site complications. The presence of eligible physicians, proliferative counting of surgery in hospitals, government guidelines for managing heart-related diseases, and progressive infrastructure in hospitals are advancing the development of this section.

In addition, the ambulatory surgical centre segment is estimated to grow with the fastest CAGR during the forecast period, due to the increasing number of private physicians, increasing application of transcatheter valves, and unaffected patients.

Report Scope

Heart Valve Devices Market Regional Analysis

By Region, Heart valve devices market is segmented into North America, Asia Pacific, Europe, Middle East & Africa and Latin America. Among all of these, the North America region dominated the market in 2024 and is expected to keep its dominance during the forecast period due to the increasing acceptance of technically better products and methods in the North American region.

Transcatheter valves provide a proper option for traditional surgical aortic valve replacement in some paediatric patients who are sub-surgical candidates. The relatively high average selling price of heart valve devices in the region is carrying forward the growth of the market of heart valve devices in North America. In addition, the Asia-Pacific region estimates that the forecast period is the fastest CAGR rate.

This growth is due to factors such as the expanded population of the elderly in the Asia-Pacific region. Assistant reimbursement landscapes, an increase in regulatory authorities, the existence of a large target patient population, and the development of some transcatheter valves are further enhancing the market progress of heart valve equipment in the Asia-Pacific region.

Heart Valve Devices Market Recent Developments

• In May 2024, Edwards Lifesciences company announced the launch of the sapien three ultra risilia valve in Europe. The valve is a transcatheter aortic heart valve that uses the company’s state-of-the-art risilia tissue technology for extended durability. The device received the CE mark for treating patients affected by heart valve disease owing to native calcific aortic stenosis.

• In April 2024, Medtronic announced the launch of its next generation of surgical aortic tissue valves, Alas Ultra Bioprosthesis. The device has been engineered for ease of implantation, clear visibility for future valve-in-valve processes, and a convenient shape. In addition, there is a polyetheretherketone base frame to maintain frequent circulation in the valve.

• On August 27, 2024, Boston Scientific received a CE mark for its new Accurate Prime aortic valve system. This is the latest for their structural heart portfolio designed to improve their previous accurate NEO2 valves, which feature new design elements and an additional valve shape so that patients with large anatomy have better-adjusted patients with large anatomy.

List of the prominent players in the Heart Valve Devices Market:

• Medtronic plc
• Boston Scientific Corporation
• Edwards Lifesciences
• Abbott Cardiovascular
• Foldax Inc.
• Novostia SA
• Meril Life Sciences Pvt. Ltd.
• Corcym
• Anteris Technologies Ltd
• Artivion
• Thubrikar Aortic Valve Inc.
• Biosensors International Group Ltd.
• MicroPort Scientific Corporation
• Braile Biomedica
• TTK Healthcare Limited
• Colibri Heart Valve
• CryoLife Inc.
• NeoVasc
• Micro Interventional Devices Incorporated
• XELTIS
• Others

The Heart Valve Devices Market is segmented as follows:

By Product Type

• Mechanical Heart Valves
• Biological Heart Valves
• Transcatheter Heart Valves

By Treatment

• Valve Repair
• Valve Replacement

By End-User

• Hospitals & Clinics
• Ambulatory Surgical Centers
• Cardiac Centers
• Others

Regional Coverage:

North America

• U.S.
• Canada
• Mexico
• Rest of North America

Europe

• Germany
• France
• U.K.
• Russia
• Italy
• Spain
• Netherlands
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• New Zealand
• Australia
• South Korea
• Taiwan
• Rest of Asia Pacific

The Middle East & Africa

• Saudi Arabia
• UAE
• Egypt
• Kuwait
• South Africa
• Rest of the Middle East & Africa

Latin America

• Brazil
• Argentina
• Rest of Latin America