Transcatheter Heart Valve Market size is estimated to be valued at USD 5.93 Bn in 2025 and is expected to reach USD 14.75 Bn in 2032, exhibiting a compound annual growth rate (CAGR) of13.9% from 2025 to 2032.
Increasing prevalence of aortic stenosis is expected to drive the global transcatheter heart valve market over the forecast period. For instance, in June 2021, an article published by BMJ Publishing Group Ltd, a publisher of medical journals, stated that the overall incidence rate of clinically significant aortic stenosis was 2.48 per 1000 person per year, and for moderate or severe aortic stenosis 4.05 per 1000 person per year.
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Regulatory Developments in Key Markets |
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The transcatheter heart valve pipeline includes a diverse range of devices targeting aortic, mitral, and tricuspid valve replacements across multiple clinical phases.
Several devices have CE Mark approval or FDA breakthrough designation, targeting wider patient populations and improved clinical outcomes.
The patent landscape in the transcatheter heart valve market is highly dynamic, reflecting intense innovation by leading medical device companies. Major players such as Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott hold a substantial portfolio of patents covering critical aspects including valve design, frame materials, delivery catheter technologies, and sealing mechanisms to minimize paravalvular leaks.
Recent patent filings emphasize advancements in biocompatible and durable materials aimed at extending valve lifespan, as well as innovations in repositionable and retrievable valve systems to enhance procedural safety and flexibility. Additionally, patents related to integrated imaging technologies and artificial intelligence-assisted placement are gaining prominence, aimed at improving accuracy and patient outcomes.
Geographically, patent activity is concentrated in the U.S., Europe, and select Asia-Pacific markets, aligning with major regulatory hubs and innovation centers. Emerging markets are witnessing gradual patent growth, signaling expanding research and development efforts.
Overall, the competitive patent environment underscores the market’s focus on technological differentiation and sustained product innovation, which are critical for maintaining competitive advantage and addressing unmet clinical needs.
The reimbursement landscape for transcatheter heart valve (THV) procedures such as TAVR and TMVR varies globally, significantly influencing market access and adoption.
In the United States, key procedural CPT codes include 33361–33366 for various TAVR approaches and 33418–33419 for mitral valve repairs. Coverage decisions by Medicare (CMS) have progressively expanded from high-risk patients in 2012 to include intermediate and low-risk groups by 2019. Medicare reimburses these procedures under National Coverage Determination (NCD 20.32), requiring multidisciplinary heart team evaluations.
European countries follow ICD-10-GM and OPCS-4 coding systems, with reimbursement governed by national health technology assessment bodies such as NICE (UK), G-BA (Germany), and HAS (France). These agencies assess clinical and cost-effectiveness before approving coverage.
In the Asia-Pacific region, regulatory bodies including PMDA (Japan), NMPA (China), and TGA (Australia) oversee approvals and reimbursement policies, though coverage remains limited in many emerging markets due to cost constraints.
Overall, reimbursement remains a critical market driver, with expanding coverage and favorable coding facilitating greater adoption, while cost and regulatory complexity pose challenges in certain regions.
Prescribers’ preferences in transcatheter heart valve interventions have evolved significantly, influenced by patient risk profiles, valve technology, and clinical evidence. For early-stage symptomatic aortic stenosis patients at low surgical risk, cardiologists and cardiac surgeons increasingly favor Transcatheter Aortic Valve Replacement (TAVR) as a first-line treatment, with Edwards Lifesciences’ SAPIEN 3 and Medtronic’s Evolut PRO+ series being the most commonly chosen devices.
In intermediate and high-risk patients, valve selection depends on anatomical complexity and comorbidities. For example, Edwards SAPIEN 3 Ultra is preferred for bicuspid valves, while Medtronic’s Evolut PRO+ is favored when pacemaker implantation risk is a concern. Abbott’s Portico is often chosen for severely calcified anatomies.
For valve-in-valve procedures in failed bioprosthetic valves, prescribers lean towards devices like SAPIEN 3 Ultra and JenaValve Trilogy for native aortic regurgitation.
Pharmaceutical management accompanying interventions includes dual antiplatelet therapy, anticoagulation for atrial fibrillation, and heart failure medications.
Overall, prescriber preferences reflect a balance of clinical trial data, patient-specific anatomy, and device features such as repositionability, durability, and ease of delivery.
Based on product type, the transcatheter mitral valve replacement (TMVR) segment is projected to dominate the market with a 60.0% share in 2025. This dominance is largely driven by the increasing adoption of TMVR for treating aortic stenosis and other mitral valve disorders.
TMVR offers a less invasive alternative to traditional surgical procedures, providing better patient outcomes and shorter recovery times, which fuels its growing preference among clinicians and patients alike. The transcatheter aortic valve replacement (TAVR) segment follows but is expected to hold a smaller share comparatively.
The delivery systems segment is segmented into transfemoral approach, transapical approach, and transaortic approach. Among these, the transfemoral approach is anticipated to dominate the market during the forecast period. Its rise in preference is attributed to the increasing prevalence of cardiac disorders and the minimally invasive nature of this approach, which reduces procedural risks and improves patient recovery.
For example, a February 2020 article by the American Heart Association noted that although transfemoral access was traditionally considered secondary for TAVR, it is increasingly becoming the preferred primary route due to technological advancements and procedural efficacy.
In terms of end users, the hospitals segment is expected to dominate the market over the forecast period. This is due to a growing number of hospital admissions for transcatheter heart valve procedures, supported by enhanced cardiac care infrastructure and skilled interventional cardiologists. Other end users include ambulatory surgical centers and cardiac catheterization laboratories, which are also witnessing growth but on a smaller scale compared to hospitals.
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North America is projected to dominate the global transcatheter heart valve market, holding an estimated 40.90% share in 2025. This leadership is primarily driven by the rising prevalence of aortic stenosis and other valvular heart diseases across the region. Increasing awareness, advancements in minimally invasive cardiac procedures, and the presence of a well-established healthcare infrastructure further bolster market growth.
For instance, a January 2025 report by Guardian News & Media Limited highlighted that approximately 300,000 people in the U.K. suffer from potentially fatal aortic valve conditions, underscoring the region’s significant disease burden and demand for innovative treatment options.
Asia Pacific is anticipated to be the fastest growing market segment for transcatheter heart valves, driven by increasing cardiovascular disease incidence, growing geriatric populations, and improving healthcare access in countries such as China, India, Japan, and South Korea.
Government initiatives to enhance cardiac care infrastructure and expanding reimbursement coverage for advanced medical devices are key factors fueling market expansion. Additionally, rising patient awareness and adoption of minimally invasive interventions contribute to the rapid uptake of transcatheter valve technologies.
The United States leads the North American market, supported by high healthcare expenditure, advanced cardiac care facilities, and early adoption of innovative transcatheter valve therapies. Strong clinical research activity and collaborations between medical device manufacturers and healthcare providers accelerate technology adoption and product launches.
China stands out in the Asia Pacific region due to its large patient pool, expanding healthcare infrastructure, and government policies aimed at improving cardiovascular devices accessibility. Increasing investments in domestic manufacturing and growing awareness about minimally invasive cardiac procedures are expected to drive significant market growth.
| Report Coverage | Details | ||
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| Base Year: | 2024 | Market Size in 2025: | USD 5.93 Bn |
| Historical Data for: | 2020 To 2024 | Forecast Period: | 2025 To 2032 |
| Forecast Period 2025 to 2032 CAGR: | 13.9% | 2032 Value Projection: | USD 14.75 Bn |
| Geographies covered: |
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| Companies covered: |
Edwards Lifesciences Corporation, Medtronic, Boston Scientific Corporation, Abbott, JenaValve Technology, SYMETIS, Braile Biomedica, CryoLife, Inc., Shockwave Medical Inc., Venus Medtech (Hangzhou) Inc. |
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Transcatheter Heart Valve is mostly used to treat aortic stenosis, which occurs mostly in geriatric population, hence, increasing awareness campaign by key market players is expected to drive the transcatheter heart valve market over the forecast period. For instance, in October 2022, according to the World Health Organization (WHO), by 2030 the share of the population aged 60 years and over will increase from 1 billion in 2020 to 1.4 billion.
In delivery systems segment, transfemoral approach hold a dominant segment in North America region due to the increasing prevalence of surgical site infection. For instance, on January 11 2023, according to report published by BioMed Central Ltd, an open access journal, stated that transfemoral approach is used mostly for transcatheter heart valve techniques.
Increasing prevalence of aortic stenosis is expected to drive the transcatheter heart valve market growth over the forecast period. For instance, in March 2022, according to Edwards Lifesciences Corporation, a medical technology company, stated that for people over the age of 75 years, the prevalence of severe aortic stenosis is 3%.
Hence, increasing awareness of transcatheter heart valve devices may help in reducing the prevalence of aortic stenosis which will then help in the growth of the transcatheter heart valve market growth over the forecast period.
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About Author
Manisha Vibhute is a consultant with over 5 years of experience in market research and consulting. With a strong understanding of market dynamics, Manisha assists clients in developing effective market access strategies. She helps medical device companies navigate pricing, reimbursement, and regulatory pathways to ensure successful product launches.
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