Prosthetic Heart Valve Market Summary
The global prosthetic heart valve market size was estimated at USD 9.64 billion in 2024 and is projected to reach USD 20.69 billion by 2033, growing at a CAGR of 8.7% from 2025 to 2033. Rising valvular heart diseases drive the growth of the market.
Key Market Trends & Insights
- The North America prosthetic heart valve industry dominated the global market in 2024, accounting for the largest revenue share of 48.5%.
- The U.S. prosthetic heart valve industry is anticipated to register the fastest CAGR during the forecast period.
- By valve, the transcatheter heart valves segment held the largest revenue share in 2024.
- By material, the biological tissue segment held the largest revenue share in 2024.
- By end use, the hospitals segment held the largest revenue share in 2024.
Market Size & Forecast
- 2024 Market Size: USD 9.64 Billion
- 2033 Projected Market Size: USD 20.69 Billion
- CAGR (2025-2033): 8.7%
- North America: Largest market in 2024
- Asia Pacific: Fastest growing market
According to an NCBI article published in December 2024, recent estimates indicate that approximately 54.8 million people are affected by rheumatic heart disease (RHD), with a confidence range between 43.3 and 67.6 million. In addition, non-rheumatic calcific aortic valve disease (CAVD) impacts around 13.3 million individuals, while non-rheumatic degenerative mitral valve disease (DMVD) accounts for approximately 15.5 million cases globally. These conditions are among the leading causes of structural valve deterioration, often necessitating surgical or transcatheter valve replacement. Moreover, the high and growing prevalence of both rheumatic and degenerative valve disorders across diverse age groups and regions is a key factor propelling the expansion of the market.
The rising incidence of heart valve disorders, particularly among the elderly, is a key driver for the growing adoption of prosthetic heart valve procedures, including both surgical and transcatheter approaches. Degenerative conditions such as aortic stenosis and mitral regurgitation are becoming increasingly prevalent, prompting the need for effective interventions like prosthetic valve implants. According to the CDC article published in 2024, three in four adults in the U.S. have limited awareness of heart valve disease, with particularly low recognition among those aged 65 and older, ironically, the group most at risk. Annually, more than 5 million Americans are diagnosed with heart valve disease, and the condition is responsible for over 25,000 deaths each year. These figures underscore a pressing need for improved education, early diagnosis, and expanded access to prosthetic heart valve therapies.
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Government funding and awareness campaigns fuel growth in the prosthetic heart valve industry. According to the American Heart Association, Inc., an article published in October 2024, the CDC awarded USD 8.4 million in grants to the American Heart Association to launch national campaigns focused on heart valve disease education. These initiatives will include educational outreach targeting patients, healthcare providers, and women, an underserved high-risk group. The program stems from the bipartisan CAROL Act, signed into law in December 2022, to prioritize HVD research and awareness.
There is an increasing demand for minimally invasive surgeries, including transcatheter valve replacement (TAVR), due to their shorter recovery times, reduced complication risks, and lower overall healthcare costs than traditional open-heart surgery. This shift towards non-invasive procedures is a critical factor propelling the market. In April 2024, Abbott announced FDA approval for its TriClip system, a transcatheter edge-to-edge repair technology for treating tricuspid regurgitation (TR). This first-of-its-kind device allows for less invasive treatment, improving patient outcomes without needing high-risk open-heart surgery. Clinical trials showed significant improvements in TR severity and quality of life for patients treated with TriClip.
Technological advancements in Transcatheter Heart Valves (THV) design, such as enhanced valve durability, ease of implantation, and better patient outcomes, are key drivers driving market growth. Advancements in imaging techniques and valve delivery systems also significantly improve procedural success and expand the patient pool eligible for THV procedures. In August 2024, Boston Scientific announced that its ACURATE Prime Aortic Valve System received CE mark approval. This state-of-the-art transcatheter aortic valve replacement system features a new valve size to serve patients with larger anatomies. It is indicated for individuals at low, intermediate, and high risk experiencing severe aortic stenosis. The system incorporates a self-expanding design and a refined deployment mechanism, enhancing valve positioning accuracy to improve overall patient outcomes.
Market Concentration & Characteristics
The global prosthetic heart valve industry demonstrates a strong focus on innovation, particularly with integrating digital and AI-driven technologies. For instance, in November 2024, Abbott initiated first-in-patient procedures using its investigational transcatheter aortic valve implantation (TAVI) balloon-expandable system for treating symptomatic severe aortic stenosis. This next-generation system is designed to lay the groundwork for AI-assisted, software-guided procedures. Once clinical validation and regulatory approvals are achieved, it will complement Abbott’s existing Navitor TAVI system, further expanding the company’s portfolio and enhancing procedural precision and personalization.
Key players in the prosthetic heart valve industry, including Edwards Lifesciences, Medtronic, and Abbott, actively engage in mergers and acquisitions to enrich their structural heart portfolios, support innovation, and gain geographical access. For instance, In September 2024, Edwards Lifesciences announced acquisitions of JenaValve Technology and Endotronix a combined investment of approximately USD 1.2 billion to significantly enhance its transcatheter valve and monitoring capabilities as part of its structural heart expansion strategy.
Regulatory frameworks play a key role in the prosthetic heart valve industry, ensuring patient safety and clinical efficacy. Agencies such as the U.S. FDA, European Medicines Agency (EMA), and Japan’s PMDA enforce stringent clinical trial requirements and post-market surveillance. While these rigorous standards increase time-to-market and development costs, they also maintain high quality benchmarks across devices. Recent shifts toward expedited pathways, such as the FDA’s Breakthrough Devices Program, allow faster approval for innovative heart valves, especially transcatheter options without compromising safety.
Currently, no true direct substitutes for prosthetic heart valves exist. While pharmacological therapies (e.g., anticoagulants or beta-blockers) can temporarily manage symptoms associated with valvular heart disease, they do not address the underlying mechanical dysfunction of the valve. Minimally, invasive surgical techniques and valve repair methods may be used in early stages, but they are not viable for severe stenosis or regurgitation.
Key manufacturers in the prosthetic heart valve industry, such as Edwards Lifesciences, Medtronic, and Abbott, are actively expanding their geographic footprint by targeting emerging economies with rising cardiovascular disease burdens. These companies are leveraging partnerships with regional distributors, setting up local manufacturing and training centers, and tailoring product offerings to suit regulatory and clinical preferences in Asia-Pacific, Latin America, and the Middle East.
Key Prosthetic Heart Valve Company Insights
Key prosthetic heart valve industry participants focus on devising innovative business growth strategies, such as expanding their product portfolios, partnerships and collaborations, mergers and acquisitions, and business footprints.
Key Prosthetic Heart Valve Companies:
The following are the leading companies in the prosthetic heart valve market. These companies collectively hold the largest market share and dictate industry trends.
- Edwards Lifesciences
- Medtronic plc
- Abbott Laboratories
- Boston Scientific Corp.
- CryoLife, Inc. (now Artivion)
- MicroPort Scientific Corp.
- Lepu Medical Technology(Beijing) Co., Ltd.
- Venus Medtech (Hangzhou) Inc.
- Foldax, Inc.
- Meril Life Sciences
- TTK Healthcare Limited
Recent Developments
- In May 2025, Abbott’s Tendyne transcatheter mitral valve replacement system received FDA approval to treat patients with severe mitral annular calcification (MAC) who are high-risk surgical candidates.
- In March 2025, Corcym obtained FDA clearance for its Lancelot valve, a collapsible bovine pericardium device combined with a nitinol frame, enabling simplified minimally invasive implant procedures.
- In March 2024, Medtronic announced that its Evolut FX+ transcatheter aortic valve replacement (TAVR) system had received approval from the U.S. Food and Drug Administration (FDA) to treat symptomatic severe aortic stenosis. The next-generation system includes a refined, diamond-shaped frame design, aimed at improving coronary access while continuing to deliver the reliable valve performance associated with the Evolut series.
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