경카테터 심장판막 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the transcatheter heart valve market size was valued at USD 6.51 billion in 2025 and is estimated to grow from USD 7.61 billion in 2026 to reach USD 16.62 billion by 2031, at a CAGR of 16.91% during the forecast period (2026-2031).

This report is Segmented by Product Type (Transcatheter Aortic Valve, Transcatheter Mitral Valve, and More), Valve Technology (Balloon-Expandable Valves, and More), Delivery Route (Transfemoral, Transapical, Transseptal, Transjugular), End User (Hospitals, Ascs, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Transcatheter Heart Valve Market Trends and Insights

Aging Population and Rising Severe Aortic Stenosis Burden

The transcatheter heart valve market benefits from the increasing prevalence of severe aortic stenosis in aging populations, as disease incidence rises sharply with age, driving procedural demand. Clinical discussions have progressed beyond safety, with findings from the 7-year PARTNER 3 follow-up showing no significant difference in all-cause mortality or disabling stroke between transcatheter and surgical valve replacements in low-risk patients. This supports earlier referrals, enhances physician confidence, and emphasizes timely treatment to prevent complex and costly conditions. National registry systems in countries with organized cardiac tracking further accelerate clinical adoption by providing hospitals and payers with clear outcome evidence. The market is thus supported by aging demographics and a more assured treatment pathway for severe valve diseases.

Expansion Into Lower-Risk Patient Populations

The transcatheter heart valve market is expanding as treatments extend to lower-risk groups beyond high-risk surgical candidates. A 2025 meta-analysis highlighted that younger, low-risk patients undergoing transcatheter aortic valve replacement (TAVR) achieved comparable outcomes in terms of death or disabling stroke compared to surgery, along with improvements in functional class and quality of life. The 5-year Evolut Low Risk results reported 15.5% all-cause mortality for TAVR and 16.4% for surgery, reducing resistance to broader TAVR use. This evidence not only shifts volume from surgery to catheter-based care but also broadens the patient pool, enabling earlier interventions and driving market growth.

Lifetime Management Concerns in Younger Patients

The transcatheter heart valve market faces limitations in younger patients due to unresolved lifetime management challenges after the initial implant. In 2025, the Society of Thoracic Surgeons recommended surgical aortic valve replacement as the preferred option for younger patients, especially when surgery ensures low morbidity and better planning for future interventions. This highlights concerns that patients in their mid-60s may outlive the current evidence available for many modern devices. Additionally, valve-in-valve procedures complicate coronary access and future reinterventions after the first prosthesis placement. Despite advancements, conservative heart teams are expected to prioritize age, anatomy, and long-term reintervention strategies, slowing the adoption of transcatheter heart valves among younger patients.

Other drivers and restraints analyzed in the detailed report include:

1. Next-Generation Valve Durability, Repositionability, and Coronary Access Innovation
2. Earlier Intervention Enabled by Trial Evidence and Label Expansion
3. Reimbursement and Coverage Variability Across Healthcare Systems

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

In 2025, transcatheter aortic valves held 61.67% of the transcatheter heart valve market, reflecting their strong position driven by a robust clinical history, physician familiarity, and established TAVR protocols for severe aortic stenosis. The aortic segment benefits from intense competition among leading platforms, fostering innovation and procedural confidence in advanced cardiac centers. Pulmonary and tricuspid products, though smaller in revenue, address critical patient needs previously underserved by surgical options. Edwards strengthened the tricuspid segment in March 2026 with 2-year TRISCEND II data showing sustained patient benefits and reduced mortality for the EVOQUE system, supporting broader physician adoption.

Transcatheter mitral valves are projected to grow at an 18.90% CAGR through 2031, marking a significant growth area in the transcatheter heart valve market. Abbott's FDA approval for Tendyne in May 2025 introduced a minimally invasive mitral replacement for patients lacking surgical options. Edwards followed with FDA approval for SAPIEN M3 in December 2025, offering a transseptal treatment for moderate-to-severe mitral regurgitation in non-surgical candidates.

Self-expandable valves led the market with a 63.91% share in 2025, driven by Medtronic's Evolut platform and Abbott's Navitor system. Their appeal lies in a lower crossing profile and adaptability to challenging anatomies, supported by years of operator experience. However, the focus is shifting toward long-term performance over initial convenience. Edwards reported a slight improvement in its global TAVR position in Q1 2026, partly due to discussions around Medtronic's Evolut reintervention profile.

Balloon-expandable valves are expected to grow at a 19.25% CAGR through 2031, signaling a shift in market dynamics. This growth is fueled by Edwards' SAPIEN franchise and next-generation designs mimicking native valve behavior. Anteris Technologies entered the market with DurAVR, and the FDA approved the PARADIGM global pivotal trial in November 2025. The platform addresses durability and hemodynamic concerns, driving physician preference. The market is evolving from platform familiarity to long-term valve performance and structural durability.

Complete Report Scope:

• By Product Type
  • Transcatheter Aortic Valve
  • Transcatheter Mitral Valve
  • Transcatheter Tricuspid Valve
  • Transcatheter Pulmonary Valve
• By Valve Technology
  • Balloon-Expandable Valves
  • Self-Expandable Valves
  • Others
• By Delivery Route
  • Transfemoral
  • Transapical
  • Transseptal
  • Transjugular
• By End User
  • Hospitals
  • Ambulatory Surgical Centers
  • Specialty Cardiac Centers
  • Others
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

In 2025, North America accounted for 42.55% of the transcatheter heart valve market, maintaining its position as the largest regional contributor. The region benefits from mature reimbursement systems, a strong interventional cardiology base, and an extensive network of advanced cardiac centers. The U.S. remains pivotal, with coverage and registry requirements concentrating treatments within highly capable hospital systems.

Europe continues to be a stable contributor to the transcatheter heart valve market, supported by consistent reimbursement policies in Germany, France, the U.K., Italy, and Spain, along with a solid base of structural heart programs. Years of physician expertise in TAVR have ensured mature and standardized procedural pathways. Larger manufacturers hold an advantage due to their ability to manage regulatory and compliance demands effectively, ensuring supply continuity and market coverage. Despite slower growth compared to newer adoption regions, Europe remains a reliable volume base.

Asia-Pacific is projected to grow at a 19.22% CAGR through 2031, marking the fastest expansion in the transcatheter heart valve market. China's improving domestic approvals are enhancing product availability and affordability for hospitals. MicroPort's VitaFlow Liberty Flex received NMPA approval in January 2025, and Genesis MedTech's J-VALVE TF, the first transfemoral TAVR system for aortic regurgitation in China, was approved in September 2025. Japan's national health insurance supports procedural access, while South Korea is expanding structural heart capacity through a broader network of centers.

1. 4C Medical Technologies, Inc.
2. Abbott Laboratories
3. Alterra Medical, Inc.
4. Anteris Technologies Ltd.
5. Biosensors International Group, Ltd.
6. Boston Scientific
7. Braile Biomedica Industria, Comercio e Representacoes Ltda.
8. CardiaQuest, Inc.
9. Cephea Valve Technologies, Inc.
10. Edward Lifesciences
11. HighLife SAS
12. Jenavalve Technology
13. Medtronic
14. Memryx, Inc.
15. Meril Life Science
16. MicroPort
17. Navigate Medical, Inc.
18. Neovasc Inc.
19. P and F Products and Features GmbH
20. Valcare Medical Inc.
21. Venus Medtech

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET LANDSCAPE

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Aging Population and Rising Severe Aortic Stenosis Burden
  • 4.2.2 Expansion Into Lower-Risk Patient Populations
  • 4.2.3 One-Step Pathway From Diagnosis to Intervention Through Multidisciplinary Heart Teams
  • 4.2.4 Next-Generation Valve Durability, Repositionability, and Delivery Precision
  • 4.2.5 Earlier Intervention Enabled by Trial Evidence and Label Expansion
  • 4.2.6 Hospital Economics Favoring Shorter Length of Stay and Reduced Resource Intensity
• 4.3 Market Restraints
  • 4.3.1 Lifetime Management Concerns in Younger Patients
  • 4.3.2 Anatomical Complexity in Native Aortic Regurgitation, Mitral, and Tricuspid Indications
  • 4.3.3 Reimbursement and Coverage Variability Across Health Systems
  • 4.3.4 High Capital, Imaging, and Structural Heart Program Costs
• 4.4 Value/Supply Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Industry Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)

• 5.1 By Product Type
  • 5.1.1 Transcatheter Aortic Valve
  • 5.1.2 Transcatheter Mitral Valve
  • 5.1.3 Transcatheter Tricuspid Valve
  • 5.1.4 Transcatheter Pulmonary Valve
• 5.2 By Valve Technology
  • 5.2.1 Balloon-Expandable Valves
  • 5.2.2 Self-Expandable Valves
  • 5.2.3 Others
• 5.3 By Delivery Route
  • 5.3.1 Transfemoral
  • 5.3.2 Transapical
  • 5.3.3 Transseptal
  • 5.3.4 Transjugular
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Ambulatory Surgical Centers
  • 5.4.3 Specialty Cardiac Centers
  • 5.4.4 Others
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 India
    • 5.5.3.3 Japan
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 4C Medical Technologies, Inc.
  • 6.3.2 Abbott Laboratories
  • 6.3.3 Alterra Medical, Inc.
  • 6.3.4 Anteris Technologies Ltd.
  • 6.3.5 Biosensors International Group, Ltd.
  • 6.3.6 Boston Scientific Corporation
  • 6.3.7 Braile Biomedica Industria, Comercio e Representacoes Ltda.
  • 6.3.8 CardiaQuest, Inc.
  • 6.3.9 Cephea Valve Technologies, Inc.
  • 6.3.10 Edwards Lifesciences Corporation
  • 6.3.11 HighLife SAS
  • 6.3.12 JenaValve Technology, Inc.
  • 6.3.13 Medtronic plc
  • 6.3.14 Memryx, Inc.
  • 6.3.15 Meril Life Sciences Pvt. Ltd.
  • 6.3.16 MicroPort Scientific Corporation
  • 6.3.17 Navigate Medical, Inc.
  • 6.3.18 Neovasc Inc.
  • 6.3.19 P and F Products and Features GmbH
  • 6.3.20 Valcare Medical Inc.
  • 6.3.21 Venus Medtech (Hangzhou) Inc.

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment