United States Transcatheter Heart Valve Replacement (THVR) Devices Market to Reach USD 14.8 Billion by 2031, Driven by Rising Demand for Minimally Invasive Cardiac Treatments

Leander, Texas and TOKYO, Japan - Dec.3.2025 "Transcatheter Heart Valve Replacement (THVR) Devices Market is anticipated to grow at high CAGR during the forecast period 2024-2031."

The Transcatheter Heart Valve Replacement (THVR) Devices Market is expanding rapidly as a preferred alternative to open heart surgery for high risk and increasingly intermediate risk patients. Market growth is propelled by technological advancements in valve design and delivery systems, expanding clinical indications, strong physician adoption, and the significant unmet need within an aging global population.

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☛ Recent Industry Developments:
United States:
✅December 2025 : Edwards Lifesciences Corporation received FDA approval for its next generation balloon expandable valve with an anti calcium sensor. The $250 million rollout includes a dedicated training program for cardiac centers to adopt the smart valve technology for complex aortic regurgitation cases.

✅November 2025 : Abbott Laboratories announced the first successful U.S. implants of its novel dual chamber retrieval system for transcatheter mitral valve replacement. The procedure, part of an $80 million post market study, demonstrated a 30% reduction in procedure time.

✅October 2025 : Medtronic plc. initiated a landmark $300 million real world evidence study across 50 U.S. hospitals to evaluate the long term outcomes of its self expanding aortic valve system in low risk patient cohorts.

Global :
✅December 2025 : Boston Scientific Corporation launched its latest mechanically expandable pulmonary valve in Europe, following CE Mark approval. The launch is supported by a €120 million commercial investment targeting pediatric and adult congenital heart disease centers.

✅November 2025 : JenaValve Technology, Inc., in partnership with a Japanese conglomerate, secured $95 million to accelerate the APAC commercialization of its transcatheter aortic valve replacement system specifically designed for non-calcified aortic regurgitation.

✅October 2025 : A consortium led by MicroPort Scientific Corporation (China) and Peijia Medical (China) opened a $70 million advanced manufacturing facility in Singapore to produce next generation transcatheter valves for emerging markets in Southeast Asia and the Middle East.

☛ Core Catalysts Behind Market Growth :
The rapidly aging global population is leading to a higher prevalence of degenerative valvular heart diseases like aortic stenosis, creating a large and growing patient pool eligible for THVR procedures.

Continuous technological innovation is improving valve durability, reducing paravalvular leak, enabling easier implantation, and expanding the treatable anatomy to include mitral and tricuspid valves.

Increasing clinical evidence and guidelines supporting the safety and efficacy of THVR in intermediate and low surgical risk patients are significantly broadening the addressable market.

Growing patient preference for minimally invasive procedures due to benefits like shorter hospital stays, faster recovery, and reduced surgical trauma is driving adoption.

Expansion of healthcare infrastructure and growing physician training in emerging economies are making these advanced procedures more accessible worldwide.

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☛ Market Segmentation:
By Product :
Self Expandable Transcatheter Aortic Valves lead with 50 percent share, favored for their controlled deployment, adaptability to patient anatomy, and strong clinical data in complex cases.

Balloon Expandable Transcatheter Aortic Valves hold 40 percent share, valued for their precise placement, radial strength, and established history in treating calcified aortic stenosis.

Mechanically Expandable Transcatheter Aortic Valves capture 10 percent share, growing due to their unique ability for recapturing and repositioning during deployment, enhancing procedural safety.

By Procedure Type :
Transcatheter Aortic Valve Replacement (TAVR) dominates with 80 percent share, representing the largest and most mature segment due to standardized procedures and broad insurance coverage.

Transcatheter Mitral Valve Replacement (TMVR) accounts for 15 percent, the fastest growing segment driven by the high prevalence of mitral regurgitation and recent device approvals.

Transcatheter Pulmonary Valve Replacement (TPVR) holds 5 percent, serving the critical but niche pediatric and congenital heart disease patient population.

By Indication :
Severe Aortic Valve Stenosis is the leading indication with 75 percent share, constituting the primary driver for TAVR adoption globally.

Aortic Regurgitation represents 20 percent, an emerging high growth segment as new devices receive approval for treating non calcified valves.

Other Indications (e.g., failed surgical valves, mixed disease) account for 5 percent.

By End-users :
Hospitals are the dominant end user with 70 percent share, as they house the necessary hybrid catheterization labs, cardiac surgical backup, and multidisciplinary heart teams.

Cardiac Catheterization Laboratories account for 25 percent, increasingly performing standalone TAVR procedures in outpatient settings.

Ambulatory Surgical Centers hold 5 percent share, with gradual penetration as procedures become more streamlined and recovery times shorten.

☛ Competitive Landscape:
The global THVR devices market is characterized by intense innovation and strategic competition, dominated by a few established medtech leaders and disrupted by agile, specialized players focusing on next-generation technologies and emerging markets.

Edwards Lifesciences Corporation - Leads the market with an estimated 35% share, driven by its pioneering Sapien family of balloon expandable valves, unmatched clinical trial legacy, and deep physician loyalty in the Transcatheter Aortic Valve Replacement (TAVR) segment.

Medtronic plc. - Holds a commanding 30% market share, based on the global installed base and strong adoption of its CoreValve/Evolut portfolio of self expanding valves, supported by a robust ecosystem of delivery systems and imaging integration technologies.

Abbott Laboratories - Captures approximately 15% market share, strengthened by its MitraClip system's dominance in mitral repair and the strategic launch of its Portico and Navitor TAVR systems, positioning it across the aortic and mitral landscapes.

Boston Scientific Corporation - Commands roughly 12% of the market, leveraging its balanced Acurate Neo and Lotus valve platforms (in regions where available) and a growing pipeline in mitral and pulmonary valve replacement to secure its position.

JenaValve Technology, Inc., Meril Life Sciences, and MicroPort Scientific Corporation - Collectively hold close to 5% share, representing the innovative challenger segment. JenaValve focuses on niche indications like aortic regurgitation, while Meril and MicroPort drive volume growth through cost competitive devices in Asia-Pacific and other price sensitive emerging markets.

Other Players (Sahajanand Medical, Venus Medtech, Peijia Medical) - Account for the remaining 3%, aggressively expanding through regional approvals, local manufacturing advantages, and next-generation designs targeting specific anatomical challenges.

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☛ Regional Analysis :
North America :
North America leads the market with 45% share, driven by the high prevalence of aortic stenosis in an aging population, excellent insurance reimbursement frameworks, early adoption of advanced medical technologies, and the presence of all major market players in the U.S. and Canada.

Europe :
Europe holds a significant 35% share, supported by well established universal healthcare systems, strong clinical guidelines promoting TAVR adoption, a rapidly aging demographic, and high procedural volumes in countries like Germany, France, and Italy.

Asia Pacific :
Asia Pacific accounts for 15% share, and is the fastest growing region, fueled by its massive population base, rising healthcare expenditure, improving catheterization lab infrastructure, and growing local manufacturing of devices in China, Japan, and India.

South America :
South America holds 3% share, with growth primarily emerging from increasing physician training programs and improving hospital capabilities in major economies like Brazil, Argentina, and Chile.

Middle East & Africa :
The Middle East and Africa together account for 2% share, with demand concentrated in affluent urban centers and driven by medical tourism, government healthcare modernization initiatives in GCC countries, and key tertiary care hospitals in South Africa.

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