Prosthetic Heart Valve market size is valued at USD 10.5 billion in 2025 and is projected to reach USD 20.4 billion in 2033, at a CAGR of 8.7% from 2026 to 2033

Market Definition

The prosthetic heart valve is an artificial heart valve. It is a one-way valve implanted into a person's heart to replace a valve which is not functioning properly. Prosthetic heart valves are divided into three broad classes including mechanical heart valves, bioprosthetic tissue valves and transcatheter heart valves.

Market Dynamics

Rising prevalence of heart valve disease is driving the market demand. For instance, more than five million Americans are diagnosed with heart valve disease each year. In the United States, there were 3,046 deaths due to rheumatic valvular heart disease and 24,811 deaths due to non-rheumatic valvular heart disease in 2017. Around 25,000 die due to heart valve disease each year in the United States. Further, regulatory approvals of the advanced prosthetic heart valve is a key driving factor of the market. For instance, Medtronic plc has received CE mark and U.S. Food and Drug Administration (FDA) approval of its new Avalus pericardial aortic surgical valve for the treatment of aortic valve disease. The Avalus valve is proven surgical bioprosthetic valve concepts with added features to enhance clinical performance, helping the contemporary needs of cardiac surgeons, as well as patients for aortic valve replacement. The Avalus valve is designed for implantability, an important factor during complex cases. However, the high cost of transcatheter heart valve device and transcatheter aortic valve replacement (TAVR) procedures might hamper the market growth. For instance, the cost of transcatheter aortic valve replacement (TAVR) device is approximately US$ 32,500 as, and the average cost of TAVR surgical procedure is roughly $60,000. Moreover, increasing investments by companies for prosthetic heart valve would provide lucrative opportunities for the market in the coming years.

 

Market Segmentation

The global prosthetic heart valve market is mainly classified based on type and application. Type is further segmented into Biological/Tissue Heart Valves, Mechanical Heart Valves, and Transcatheter Heart Valves. By application, the market is divided into Hospitals and Ambulatory Surgery Centres. 

Transcatheter Heart Valves was dominating the global prosthetic heart valve market in 2019, owing to the technological development in transcatheter heart valves, the collaboration between companies to develop and market transcatheter heart valves, and commercialization of regulatory approved transcatheter heart valves. For instance, Meril has received the CE approval for its indigenously researched and manufactured TAVR technology, Myval-THV system. The approval catapults Meril Life Sciences to the select list of Global Medtech organizations that market and distribute TAVR in European Union and other international geographies. The Myval is a balloon-expandable tri-leaflet, bovine pericardium THV.

  

Regional Analysis

Based on geography, the global prosthetic heart valve market is divided into North America, Europe, Asia-Pacific, South America, and Middle East & Africa. North America is further divided in the U.S., Canada, and Mexico, whereas Europe consists of the UK, Germany, France, Italy, and Rest of Europe. Asia-Pacific is segmented into India, China, Japan, South Korea, and Rest of Asia-Pacific. The South America region includes Brazil, Argentina, and the Rest of South America, while the Middle East & Africa is categorized into GCC Countries, Egypt, South Africa, and Rest of Middle East & Africa.

North America was dominating the global prosthetic heart valve market in 2019, due to the regulatory approval of prosthetic heart valve, commercialization of technologically advanced prosthetic heart valve, rising investment by the companies and government bodies to develop prosthetic heart valve, and collaboration between companies to develop and market prosthetic heart valve. For instance, Royal DSM, a global science-based company in Nutrition, Health and Sustainable Living, collaborated with Strait Access Technologies (SAT), a medical device company focused on innovations for the heart, has developed the world’s first durable and cost-effective transcatheter replacement heart valves with polymeric leaflets.

Competitive landscape

Major players operating in the prosthetic heart valve industry include Abbott, Medtronic Plc, Edwards Lifesciences Corporation, Boston Scientific Corporation, Neovasc Inc., LivaNova Plc, Symetis SA, Cryolife, Inc., Lepu Medical Technology Co., Ltd., and Meril Life Sciences.

The commercialization of technological advanced prosthetic heart valve, the partnership between companies to develop and distribute prosthetic heart valve, rising investment for the research, develop, and market prosthetic heart valve, and regulatory approval of prosthetic heart valve are some of the strategies adopted by the major companies. For instance, on January 30, 2020, Abbott has received CE mark approval for its Tendyne Transcatheter Mitral Valve Implantation (TMVI) system and is approved for use in Europe. It is a life-changing therapy treats significant mitral regurgitation (MR) in patients requiring a heart valve replacement and provides a safe solution for MR patients.

Prosthetic Heart Valve Market Key Segments:

By Type

• Biological/Tissue Heart Valves
• Mechanical Heart Valves
• Transcatheter Heart Valves

By Application

• Hospitals
• Ambulatory Surgery Centres

Key Global Prosthetic Heart Valve Industry Players

• Abbott
• Medtronic Plc
• Edwards Lifesciences Corporation
• Boston Scientific Corporation
• Neovasc Inc.
• LivaNova Plc
• Symetis SA
• Cryolife, Inc.
• Lepu Medical Technology Co., Ltd.
• Meril Life Sciences

Report Attributes	Details
Study Period	2021-2033
Base Year	2025
Estimated Year	2026
Forecast Period	2026-2033
Historical Period	2021-2025
Growth Rate	CAGR 8.7% from 2026 to 2033
Revenue Unit	USD billion
Sales Volume Unit	Thousand Units, Kilotons, Units
Segmentation	By Type, Application, , , and Region
By Region	North America (By Type, Application, and Country) United States Canada Mexico
	Europe (By Type, Application, and Country) Germany France UK Italy Spain Russia Rest of the Europe
	Asia Pacific (By Type, Application, and Country) China Japan India South Korea Australia Southeast Asia Rest of Asia Pacific
	South America (By Type, Application, and Country) Brazil Argentina Rest of South America
	Middle East and Africa (By Type, Application, and Country) Saudi Arabia UAE South Africa Rest of Middle East and Africa

What Report Provides

• Key Company Market Share, Revenue, and Position/Ranking
• Key Market Leaders
• Full In-Depth Analysis of the Parent Industry
• Industry Statistics
• Important Changes in Market and Its Dynamics
• Segmentation Details of the Market
• Historical, On-Going, and Projected Market Analysis
• Assessment of Niche Industry Developments
• Market Share Analysis
• Key Strategies of Major Players
• Company Profiles of Key Players
• Unique Selling Prepositions of Leading Market Players
• Emerging Segments and Regional Growth Potential
• Key Strategic Recommendations
• Competitive Benchmarking
• Import Export Trade Statistics