Austin, Texas, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Transcatheter Heart Valve Replacement Market Size & Growth Analysis:
According to SNS Insider, The Transcatheter Heart Valve Replacement Market size is estimated at USD 6.40 billion in 2025 and is projected to reach USD 19.98 billion by 2033, growing at a CAGR of 15.32% during 2026-2033.
The increasing prevalence of aortic stenosis and mitral regurgitation in the aging population is driving the market growth. The global adoption of transcatheter heart valve replacement (THVR) procedures is increasing due to the acceptance of minimally invasive alternatives to open-heart surgery, favorable insurance reimbursement policies, and rapid technological advancements.
The U.S. transcatheter heart valve replacement market is estimated at USD 2.65 billion in 2025E and is projected to reach USD 8.24 billion by 2033, growing at a CAGR of 15.24% during 2026-2033. The US is leading due to its aging population, advanced healthcare infrastructure, FDA approvals, skilled experts, and strong R&D.
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Growing Clinical Trial Evidence Supporting Safety and Long-Term Durability to Propel Market Expansion
Growing clinical trial data demonstrating the safety, effectiveness, and long-term durability of transcatheter valves is driving the global market for transcatheter heart valve replacement. Compared to standard surgery, recent multi-center studies and real-world registries consistently show reduced complication rates, increased survival, and improved quality of life. Growing scientific evidence is strengthening physician trust, expediting regulatory approvals, and promoting wider acceptance of cutting-edge transcatheter technology among various patient populations worldwide.
Post-Procedure Complications Can Hamper Market Growth Globally
Despite developments in technology, post-procedure problems continue to pose a challenge to the worldwide transcatheter heart valve replacement business. Paravalvular leaks, valve thrombosis, conduction anomalies, and long-term durability problems are risks for patients receiving TAVR. Clinicians and regulatory agencies become more cautious as a result of these safety issues, which affects adoption confidence.
Major Players Analysis Listed in the Transcatheter Heart Valve Replacement Market Report are
- Edwards Lifesciences Corporation
- Medtronic plc
- Boston Scientific Corporation
- Abbott Laboratories
- CryoLife, Inc.
- JenaValve Technology, Inc.
- Braile Biomédica
- MicroPort Scientific Corporation
- LivaNova PLC
- Terumo Corporation
- Shanghai MicroPort Medical
- ValveTech, Inc.
- CardiAQ Valve Technologies
- MedValve GmbH
- Venus Medtech
- 3f Biomedicine
- Neovasc Inc.
- Parker Hannifin
- Innovheart SAS
- Hansen Medical, Inc.
Transcatheter Heart Valve Replacement Market Report Scope
| Report Attributes | Details |
| Market Size in 2025 | USD 6.40 Billion |
| Market Size by 2033 | USD 19.98 Billion |
| CAGR | CAGR of 15.32 % From 2026 to 2033 |
| Base Year | 2025 |
| Forecast Period | 2026-2033 |
| Historical Data | 2022-2024 |
| Regional Analysis/Coverage | North America (US, Canada), Europe (Germany, UK, France, Italy, Spain, Russia, Poland, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Australia, ASEAN Countries, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Mexico, Colombia, Rest of Latin America). |
Segmentation Analysis:
By Product
Self-expandable transcatheter aortic valves led the transcatheter heart valve replacement market with a 45.70% share in 2025E due to their superior adaptability in complex anatomies, reduced risk of annular rupture, and ability for repositioning. The mechanically expanded transcatheter aortic valves are the fastest-growing segment with a CAGR of 16.33% driven by precise deployment control, reduced paravalvular leak risk, and enhanced hemodynamic performance.
By Application
The transcatheter aortic valve segment dominated the market with a 70.76% share in 2025E due to the rising elderly population, strong clinical evidence supporting TAVR, minimally invasive benefits over surgery, faster recovery times, and continuous technological advancements improving safety, durability, and patient outcomes. The transcatheter mitral valve is expected to grow fastest with a CAGR of 16.13% driven by rising mitral regurgitation prevalence, technological innovations, and expanding clinical trials.
By Technology
Self-expanded transcatheter valve led the market with a 59.83% share in 2025E due to its flexibility in complex anatomies, ability to conform to irregular annuli, and lower risk of complications. Balloon-expanded transcatheter valve is registering the fastest growth with a CAGR of 15.66% driven by precise deployment, high procedural accuracy, and strong clinical outcomes.
By End-User
The hospitals held a 65.85% share in the market in 2025E due to the availability of advanced infrastructure, skilled interventional cardiologists, comprehensive post-operative care, high procedure volumes, and established reimbursement support, making hospitals the preferred setting for transcatheter valve interventions globally. Ambulatory surgical centers are growing the fastest with a CAGR of 16.59% driven by minimally invasive procedures, shorter patient recovery times, lower costs, and increasing adoption of outpatient TAVR, expanding access beyond traditional hospital settings.
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Transcatheter Heart Valve Replacement Market Segments
By Product
- Self-Expandable Transcatheter Aortic Valves
- Balloon-Expandable Transcatheter Aortic Valves
- Mechanically Expanded Transcatheter Aortic Valves
By Application
- Transcatheter aortic valve
- Transcatheter pulmonary valve
- Transcatheter mitral valve
By Technology
- Balloon expanded transcatheter valve
- Self-expanded transcatheter valve
By End-User
- Hospitals
- Independent Cardiac Catheterization Labs
- Ambulatory Surgical Centres
Regional Insights:
North America dominates the transcatheter heart valve replacement market with a market share of 48.60% 2025E, due to advanced healthcare infrastructure, early regulatory approvals, and widespread reimbursement support.
Asia Pacific is the fastest-growing region in the transcatheter heart valve replacement market, registering a CAGR of 16.29% over the forecast period, due to rising prevalence of valvular heart diseases, an expanding elderly population, and increasing healthcare expenditure.
Recent Developments:
- In March 2025, Edwards announced positive five-year results from its RESILIA tissue-based transcatheter valve, demonstrating 92% freedom from structural valve deterioration, highlighting long-term durability and reinforcing its leadership in TAVR technologies.
- In October 2024, Medtronic received FDA approval for its Evolut FX TAVR system for low-risk patients, expanding its eligible patient pool and driving adoption in minimally invasive heart valve replacements.
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Exclusive Sections of the Report (The USPs):
- PATIENT DEMOGRAPHICS & COMORBIDITY PROFILE METRICS – helps you understand the age-wise and gender-wise distribution of THVR patients and assess procedural risk by analyzing the prevalence of comorbidities such as diabetes, hypertension, and chronic kidney disease.
- PROCEDURE PENETRATION & ELIGIBILITY CONVERSION RATES – helps you evaluate market maturity by tracking global and regional procedure volumes, hospital penetration levels, and the percentage of eligible patients who ultimately receive THVR.
- TECHNOLOGY MIX & VALVE TYPE PREFERENCE ANALYSIS – helps you gauge competitive positioning by comparing market share between balloon-expandable and self-expandable valves along with associated procedure duration differences.
- LONG-TERM VALVE DURABILITY & PERFORMANCE BENCHMARKS – helps you assess product lifecycle value by analyzing average valve longevity across different valve technologies and its impact on reintervention rates.
- CLINICAL OUTCOMES & POST-PROCEDURAL SAFETY INDICATORS – helps you quantify treatment effectiveness by evaluating short- and mid-term mortality rates, incidence of major complications such as stroke or vascular events, and readmission trends.
- HOSPITAL ADOPTION & PROCEDURAL CAPABILITY METRICS – helps you identify regional opportunity pockets by analyzing the share of hospitals equipped to perform THVR and variations in adoption across healthcare systems.
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