Prosthetic Heart Valve Market

Prosthetic Heart Valves Market by Product Type (Transcatheter Heart Valves, Bioprosthetic (Tissue) Heart Valves, and Mechanical Heart Valves), Valve Position (Aortic Valve, Mitral Valve, Tricuspid Valve, and Pulmonary Valve), End-User (Hospitals, Ambulatory Surgical Centers, and Specialty Clinics), and Geography (North America, Europe, Asia-Pacific, and Rest of the World), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the rising prevalence of valvular heart diseases, rising cardiovascular risk factors, growing awareness and diagnosis rates, and increase in product development activities across the globe.

The global prosthetic heart valve market is estimated to grow at a CAGR of 11.86% during the forecast period from 2025 to 2032. The rising prevalence of valvular heart diseases such as aortic stenosis, mitral regurgitation, and congenital valve disorders, driven by aging populations and lifestyle-related risk factors like hypertension and obesity, is significantly increasing the demand for prosthetic heart valves. Growing awareness and improved diagnosis rates are enabling earlier detection and timely treatment, further driving market growth. Additionally, advancements in product development, such as transcatheter and sutureless valves, are expanding treatment options and improving patient outcomes. Collectively, these factors are fueling the global adoption of prosthetic heart valves, boosting the market's overall growth during the forecast period from 2025 to 2032.

Prosthetic Heart Valves Market Dynamics:

According to recent data provided by the Australian Bureau of Statistics (2023), in 2022, one in twenty (5.2% or 1.3 million) people had heart, stroke and vascular disease in Australia. These conditions are often caused by embolic events originating from heart valve abnormalities like atrial fibrillation or valve stenosis, underscoring the critical need for valve replacement procedures to restore proper cardiac function and prevent recurrent strokes or other heart-related problems. Prosthetic heart valves, particularly those designed for transcatheter procedures, are essential in addressing such conditions, as they reduce the risk of embolism by improving valve efficiency and preventing clot formation thereby boosting the overall market of prosthetic heart valves across the globe.

Additionally, rising cardiovascular risk factors such as hypertension, diabetes, obesity, and others are major drivers boosting the prosthetic heart valve market. These factors are closely linked to the development and progression of valvular heart diseases, including aortic stenosis, mitral regurgitation, and other structural heart issues. According to the recent data and stats provided by the World Health Organization (2024), in 2022, 1 in 8 people in the world were living with obesity i.e. about 2.5 billion adults (18 years and older) were overweight, and of these, 890 million were living with obesity. Obesity places excessive strain on the heart due to increased blood volume and cardiac output, leading to structural and functional changes in the heart, such as left ventricular hypertrophy and dilatation. Over time, these changes can result in valve dysfunction, particularly in the aortic and mitral valves, necessitating intervention.

Moreover, the rapid expansion of the strategic activities among the key market players of prosthetic heart valves is significantly boosting the overall market. For instance, in July 2022, VenusP-ValveTM, Venus Medtech’s developed innovative transcatheter pulmonic valve replacement (TPVR) system, was approved by China’s National Medical Products Administration (NMPA) for the treatment of severe pulmonary regurgitation in patients after congenital heart defects (CHD) procedure with native right ventricular outflow tract (RVOT). VenusP-Valve™ is a prosthetic heart valve designed specifically for the treatment of patients with pulmonary valve dysfunction, particularly in cases of congenital heart diseases.

Thus, the factors mentioned above are expected to boost the overall market of prosthetic heart valves across the globe during the forecast period from 2025 to 2032.

However, the presence of alternative methods such as medical therapies, catheter-based interventions, minimally invasive surgical techniques, and stringent regulatory concerns may hinder the future market of prosthetic heart valves during the forecasted period.

Prosthetic Heart Valves Market Segment Analysis:

Prosthetic Heart Valves Market by Product Type (Transcatheter Heart Valves, Bioprosthetic (Tissue) Heart Valves, and Mechanical Heart Valves), Valve Position (Aortic Valve, Mitral Valve, Tricuspid Valve, and Pulmonary Valve), End-User (Hospitals, Ambulatory Surgical Centers, and Specialty Clinics), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the product type segment of the prosthetic heart valves market, the transcatheter heart valves segment is expected to hold a significant share in 2024.  Transcatheter heart valves are significantly boosting the overall prosthetic heart valve market by revolutionizing the treatment of valvular heart diseases, particularly for high-risk patients who are not suitable candidates for traditional open-heart surgery. These minimally invasive valves, exemplified by technologies such as Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Pulmonary Valve Replacement (TPVR), have emerged as game-changers, offering a safer and less invasive alternative for valve replacement. The key advantage lies in their ability to be implanted through a catheter-based approach, typically via the femoral artery, eliminating the need for sternotomy and cardiopulmonary bypass. This significantly reduces procedural risks, recovery times, and hospital stays, making it an ideal option for elderly patients or those with comorbidities such as diabetes, hypertension, or obesity.

Additionally, the growing prevalence of aortic stenosis and other valvular diseases, particularly among aging populations, has created a substantial demand for transcatheter heart valves. This demand is further fueled by increasing patient and physician awareness of minimally invasive options, supported by robust clinical evidence showcasing superior outcomes, including improved survival rates and quality of life. Furthermore, regulatory approvals for expanded indications, such as the use of TAVR in intermediate- and low-risk patients, have dramatically widened the potential patient pool. For instance, in March 2024, Medtronic plc. announced that the United States Food and Drug Administration (FDA) had approved the Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis. The latest Evolut FX+ TAVR system maintains the valve performance benefits of the legacy Evolut TAVR platform and is designed to facilitate coronary access.

Thus, the factors mentioned above are expected to boost the segment thereby boosting the overall market of prosthetic heart valves across the globe.

North America is expected to dominate the overall prosthetic heart valves market:

North America is expected to account for the highest proportion of the global prosthetic heart valves market in 2024, out of all regions. The region is anticipated to dominate the overall prosthetic heart valves market due to its advanced healthcare infrastructure, high prevalence of cardiovascular diseases, and increasing adoption of minimally invasive procedures. The region benefits from strong research and development activities, leading to innovative valve designs and materials that enhance patient outcomes. Favorable reimbursement policies, a growing geriatric population prone to valve-related disorders, and the presence of leading market players further contribute to its dominance. Additionally, rising awareness about heart valve diseases and early diagnosis through widespread screening initiatives bolsters market growth in North America.

Additionally, according to recent data from the Centers for Disease Control and Prevention (2024), approximately 4.9% of adults in the United States were diagnosed with coronary heart disease in 2022. Furthermore, by 2023, an estimated 12.1 million individuals in the United States were projected to have atrial fibrillation. Additionally, each year, over 795,000 people in the U.S. experience a stroke, with around 610,000 of these being first-time strokes. Notably, nearly 185,000 of these strokes, or about one in four, occur in individuals who have previously had a stroke.

Additionally, according to the recent data and stats provided by the Centre for Disease Control and Prevention (2024), in the United States about 38 million had diabetes. Thus, the increasing prevalence of these conditions, often fueled by aging populations, unhealthy lifestyles, and risk factors like hypertension, diabetes, and obesity, underscores the need for prosthetic heart valve interventions. These valves, including mechanical, biological, and transcatheter varieties, are crucial in restoring normal cardiac function by replacing damaged or dysfunctional native valves.

Moreover, the increasing use of prosthetic heart valves highlights the rapid adoption of technologically advanced solutions, which is expected to drive market growth. For example, in March 2023, Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the company's Epic Max stented tissue valve to treat people with aortic regurgitation or stenosis. This device is the latest addition to Abbott's Epic surgical valve platform which has a decades-long history of safety and strong clinical outcomes, with an optimized design to further improve valve blood flow. 

Thus, the above-mentioned factors are expected to escalate the market of prosthetic heart valves in the region.

Prosthetic Heart Valves Market Key Players:

Some of the key market players operating in the prosthetic heart valves market include Medtronic plc., Abott., Edwards Lifesciences Corp., Corcym Srl, Boston Scientific Corporation, LivaNova PLC., Lepu Medical Technology Co., Ltd., CryoLife, Inc., Symetis SA, Jenavalve Technology, Inc., Braile Biomédica, Labcor Laboratorios Ltd., ShockWave Medical, Inc., Meril Life Sciences, TTK Healthcare Limited, and others.

Recent Developmental Activities in the Prosthetic Heart Valves Market:

• In February 2024, Edwards Lifesciences Corporation introduced the EVOQUE tricuspid valve replacement system as the first transcatheter therapy approved by the U.S. Food and Drug Administration (FDA) for treating tricuspid regurgitation (TR).
• In March 2022, Edwards Lifesciences announced that it received approval from the U.S. Food and Drug Administration (FDA) for the MITRIS RESILIA valve, a tissue valve replacement specifically designed for the heart's mitral position.

Key Takeaways from the Prosthetic Heart Valves Market Report Study

• Market size analysis for current prosthetic heart valves market size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the prosthetic heart valves market.
• Various opportunities available for the other competitors in the prosthetic heart valves market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current prosthetic heart valves market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for prosthetic heart valve market growth in the coming future?

Target Audience Who Can Benefit from this Prosthetic Heart Valves Market Report Study

• Prosthetic heart valve product providers
• Research organizations and consulting companies
• Prosthetic heart valves related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in prosthetic heart valves
• Various end-users who want to know more about the prosthetic heart valves market and the latest technological developments in the prosthetic heart valves market. 

Frequently Asked Questions for the Prosthetic Heart Valves Market:

1. What are prosthetic heart valves?

• Prosthetic heart valves are medical devices designed to replace damaged or diseased heart valves, restoring normal blood flow through the heart. They can be mechanical (made of durable materials like titanium or carbon) or biological (made from animal or human tissue) and are used in conditions like valve stenosis or regurgitation.

2. What is the market for prosthetic heart valves?

• The global prosthetic heart valve market is estimated to grow at a CAGR of 11.86% during the forecast period from 2025 to 2032.

3. What are the drivers for the prosthetic heart valve market?

• The rising prevalence of valvular heart diseases such as aortic stenosis, mitral regurgitation, and congenital valve disorders, driven by aging populations and lifestyle-related risk factors like hypertension and obesity, is significantly increasing the demand for prosthetic heart valves. Growing awareness and improved diagnosis rates are enabling earlier detection and timely treatment, further driving market growth. Additionally, advancements in product development, such as transcatheter and sutureless valves, are expanding treatment options and improving patient outcomes. Collectively, these factors are fueling the global adoption of prosthetic heart valves, boosting the market's overall growth during the forecast period from 2025 to 2032.

4. Who are the key players operating in the prosthetic heart valves market?

• Some of the key market players operating in the prosthetic heart valves are Medtronic plc., Abott., Edwards Lifesciences Corp., Corcym Srl, Boston Scientific Corporation, LivaNova PLC., Lepu Medical Technology Co., Ltd., CryoLife, Inc., Symetis SA, Jenavalve Technology, Inc., Braile Biomédica, Labcor Laboratorios Ltd., ShockWave Medical, Inc., Meril Life Sciences, TTK Healthcare Limited, and others.

5. Which region has the highest share in the prosthetic heart valves market?

• North America is expected to account for the highest proportion of the prosthetic heart valves market in 2024, out of all regions. The region is anticipated to dominate the overall prosthetic heart valves market due to its advanced healthcare infrastructure, high prevalence of cardiovascular diseases, and increasing adoption of minimally invasive procedures. The region benefits from strong research and development activities, leading to innovative valve designs and materials that enhance patient outcomes. Favorable reimbursement policies, a growing geriatric population prone to valve-related disorders, and the presence of leading market players further contribute to its dominance. Additionally, rising awareness about heart valve diseases and early diagnosis through widespread screening initiatives bolsters market growth in North America.