Transcatheter Heart Valve Market Size, Share, Growth, Trends, and Global Industry Analysis: By Technology (Balloon-Expanded Transcatheter Valve, Self-Expanded Transcatheter Valve), By Type (Transcatheter Aortic Valves, Transcatheter Pulmonary Valves, Transcatheter Mitral Valves, and Others), By Delivery Approach (Transfemoral Approach, Transapical Approach, Transaortic Approach, and Others), By End User (Hospitals, Cardiac Centers, and Ambulatory Surgical Center), and Region Forecast 2020-2031

Transcatheter Heart Valve Market size was valued at US$ 4,858.1 million in 2024 and is projected to reach US$ 12,611.3 million by 2031 at a CAGR of 14.6% from 2025-2031. Moreover, the U.S. Transcatheter Heart Valve Market is projected to grow significantly, reaching an estimated value of US$ 3,934.7 Million by 2031.

A Transcatheter Heart Valve is a specially designed artificial heart valve that is implanted using a minimally invasive, catheter-based procedure rather than traditional open-heart surgery. It is primarily used to replace damaged or narrowed heart valves, most commonly the aortic valve, in patients with conditions like aortic stenosis or valvular heart disease.  The market is primarily driven by the rising incidence of valvular heart diseases, especially among the aging population. With a growing number of elderly individuals affected by aortic stenosis and related conditions, the demand for less invasive alternatives like TAVR is increasing. This is supported by advancements in valve technology, favourable clinical outcomes, and expanding use in lower-risk patients. A major trend shaping the market is the adoption of next-generation valve systems that offer improved precision, repositionability, and reduced complications, along with growing interest in transcatheter interventions for mitral and tricuspid valves. Technological integration, such as AI-based imaging, is further enhancing procedural outcomes.

A key opportunity lies in broadening TAVR applications to intermediate and low-risk populations, alongside the rising potential in emerging regions with evolving cardiac care infrastructure. However, the market faces restraints including high procedure and device costs, limited reimbursement in some regions, and concerns around long-term durability. Regulatory complexities and the need for specialized infrastructure also limit rapid expansion, especially in developing economies. Despite these challenges, the market holds strong promise, backed by clinical advancements, patient-centric treatment trends, and a growing global burden of cardiovascular diseases.

Facts & Figures

• Aging Population & Rising Valve Disease Prevalence: Degenerative valve conditions like aortic stenosis increase with age, boosting demand for minimally invasive TAVR procedures. For instance, according to a recently published report of the University of Oxford’s George Institute for Global Health, valvular disorders affect 2–7% of individuals over 65.
• Regulatory Expansion to Lower-Risk Patients: Regulatory bodies are approving TAVR for broader patient groups, including asymptomatic and low-risk populations, significantly enlarging the potential user base. For instance, on May?1,?2025, the FDA approved Edwards Lifesciences’ SAPIEN?3 for asymptomatic severe aortic stenosis, supported by the EARLY TAVR trial, showing a reduction from ~45% to ~27% in critical outcomes
• Technological Advancements in Valve Design: Innovations like repositionable, retrievable, and self-expanding valves improve procedure safety, efficacy, and long-term durability. For instance, the Five-year data from the Evolut Low-Risk trial (April 2025) showed self-expanding TAVR valves matched surgical outcomes, supporting their use in low-risk patients.
• Global Healthcare Infrastructure & Reimbursement Support: Supportive healthcare policies, increased infrastructure investment, and evolving reimbursement models broaden TAVR accessibility, even in emerging markets.

Key Developments

• In May 2025, the U.S. FDA cleared Edwards Lifesciences’ SAPIEN?3 TAVR system for patients with asymptomatic severe aortic stenosis, expanding its indication and opening the door to earlier intervention in less symptomatic populations.
• In May 2025, Abbott received FDA approval for its Tendyne transcatheter mitral valve replacement, the first-of-its-kind for treating high-risk patients with mitral annular calcification, marking a major step into non-aortic valve interventions.
• In March 2025, Clinical findings from over 500 patients revealed that the Trilogy transcatheter platform is safe and effective for treating aortic regurgitation, showcasing innovation outside stenosis indications.
• In March 2025, Medtronic published five-year outcomes showing its Evolut TAVR system delivers excellent durability and safety in low-risk aortic stenosis patients, bolstering confidence in long-term use.

Transcatheter Heart Valve Market Segmentation

Based on the technology, the Market is segmented into the following

• Balloon Expanded Transcatheter Valve
• Self-Expanded Transcatheter Valve

In the market, the balloon-expanded transcatheter valve segment holds the largest market share. This dominance is driven by its proven safety, precision placement, and clinical effectiveness in treating aortic stenosis, particularly in high- and intermediate-risk patients. These valves, often associated with Edwards Lifesciences' SAPIEN series, offer better hemodynamic outcomes and are widely adopted across major cardiovascular centers globally. Their favorable long-term data and physician familiarity further reinforce market preference. In contrast, the self-expanded transcatheter valve segment, while growing steadily due to flexibility and suitability for certain anatomies, currently holds a smaller share due to more variable outcomes and adoption rates.

Transcatheter Heart Valve Market Segmentation

Based on the type, the Market

• Transcatheter Aortic Valves (TAVR)
• Transcatheter Pulmonary Valves (TPV)
• Transcatheter Mitral Valves (TMVR)
• Others

Among the three types, transcatheter aortic valves (TAVR) hold the largest market share in the market. This dominance is driven by the high global prevalence of aortic stenosis, especially among the elderly, and the wide clinical acceptance of TAVR as a minimally invasive, effective alternative to open-heart surgery. Continued innovations and regulatory expansions for use in lower-risk patients have further accelerated its adoption. In contrast, Transcatheter Pulmonary Valves (TPV) hold the smallest market share due to limited indications and patient pool, primarily catering to congenital heart conditions, making it a more niche segment within this rapidly evolving market.

Based on the delivery approach

• Transfemoral Approach
• Transapical Approach
• Transaortic Approach
• Others

The transfemoral approach holds the largest market share in the market due to its minimally invasive nature, faster patient recovery, and lower complication rates. This approach accesses the heart via the femoral artery in the groin, eliminating the need for surgical incisions in the chest, making it the preferred method for most TAVR procedures globally. Its adoption is further supported by advancements in catheter technology and improved imaging guidance. In contrast, the Transaortic Approach holds the smallest share, used only in select cases where other access routes are unsuitable due to anatomical constraints.

Based on the end user, the Market is segmented into the following

• Hospitals
• Cardiac Centers
• Ambulatory Surgical Centers

Based on end user, hospitals dominate the market, holding the largest share due to their comprehensive infrastructure, availability of skilled cardiovascular surgeons, and advanced cardiac catheterization labs required for complex procedures like TAVR. Hospitals also serve as primary centers for emergency and high-risk cardiovascular cases, further boosting procedural volume. Cardiac Centers follow, offering specialized care and shorter wait times. Meanwhile, Ambulatory Surgical Centers hold a relatively smaller share, limited by infrastructure and case complexity, though their role may grow as technology enables safer outpatient transcatheter procedures.