구조적 심장 기기 시장 규모, 점유율, 성장, 세계 산업 분석, 지역별 인사이트 및 예측(2026-2034년)

Growth Factors of structural heart devices Market

The global structural heart devices market size was valued at USD 14.65 billion in 2025 and is projected to reach USD 15.59 billion in 2026 and USD 27.16 billion by 2034, registering a CAGR of 7.2% from 2026 to 2034. North America dominated the market with a 36.52% share in 2025, supported by the high adoption of advanced structural heart interventions and transcatheter procedures.

Structural heart devices are medical devices used in minimally invasive procedures to treat abnormalities involving the heart's chambers, walls, valves, and other structural components. Rising cases of heart failure, congenital heart defects, and heart valve disorders, along with an aging population and technological advancements, are increasing demand for these devices. The growing adoption of transcatheter therapies is also expanding treatment options for high-risk patients.

Market Definition and Scope

Structural heart devices include instruments and accessories used for heart valve replacement, valve repair, occlusion and closure procedures, and other minimally invasive interventions. The market is segmented by product, procedure type, indication, and end user. Major applications include transcatheter aortic valve replacement, transcatheter mitral valve replacement, mitral and tricuspid repair, and structural heart closure procedures.

Market Dynamics

Market Drivers

The increasing prevalence of heart disorders is a major factor supporting market growth. According to 2024 statistics cited in the report, approximately 6.7 million Americans over 20 years of age have heart failure. Growing diagnosis of congenital heart defects and valvular diseases, improved screening, and an expanding geriatric population are also increasing demand.

The adoption of minimally invasive procedures is another important driver. Shorter hospital stays, faster recovery, and growing clinical evidence for mitral and tricuspid transcatheter therapies are encouraging the use of structural heart devices.

Market Restraints

High device and procedural costs remain a significant barrier, particularly in emerging economies. Complex device designs, biocompatible materials, regulatory requirements, advanced imaging, and limited reimbursement can increase treatment expenses. The report cites an estimated USD 35,000 cost for TAVR in India, illustrating the financial challenge associated with advanced procedures.

Market Opportunities

Acquisitions, collaborations, and investments in next-generation structural heart technologies are creating new opportunities. In July 2024, Edwards Lifesciences acquired JenaValve and Endotronix to expand its structural heart portfolio. Collaboration between research institutions and medical device companies is also supporting clinical evidence generation and faster product development.

Market Challenges

Limited healthcare infrastructure, reimbursement gaps, shortages of trained specialists, and inadequate access to cardiac imaging continue to restrict adoption in developing markets. Limited access to hybrid operating rooms and catheterization laboratories and physician learning requirements for complex procedures can further slow adoption.

Market Trends

Technological advancement in next-generation transcatheter systems is a major market trend. Retrievable and repositionable valves, customized implant materials, patient-specific valve geometry, and 3D modeling are improving procedural planning and device selection.

In September 2025, Foldax, in partnership with Dolphin Life Science LLP, launched the TRIA mitral valve in India. Such developments are supporting the expansion of minimally invasive structural heart treatment options.

Segmentation Analysis

By Product

The instruments segment held the largest market share in 2025, supported by increasing demand for heart valve devices, occlusion and closure devices, and other structural heart systems. The accessories segment is projected to grow at a CAGR of 8.0% during the forecast period.

By Procedure Type

Valve replacement procedures dominated the market in 2025 and are anticipated to hold a 53.1% share in 2026. The segment includes TAVR, TMVR, and other replacement procedures. Repair procedures are expected to expand at a CAGR of 7.7%.

By Indication

Heart valve diseases dominated the market in 2025, accounting for 75.5% of the market. Rising cases of stenosis and regurgitation are supporting demand for valve repair and replacement technologies. The congenital heart defects segment is expected to grow at a CAGR of 9.2%.

By End User

Hospitals and ambulatory surgery centers dominated the market in 2025 and are expected to account for 80.5% in 2026. Specialty clinics are projected to grow at a CAGR of 8.2% during the forecast period.

Regional Insights

North America was the leading regional market, valued at USD 5.35 billion in 2025. The U.S. accounted for USD 4.98 billion, supported by a large patient population, advanced healthcare infrastructure, and high adoption of transcatheter procedures.

Europe reached USD 5.10 billion in 2025, supported by increasing adoption of minimally invasive cardiac procedures. The U.K., Germany, and France were valued at USD 0.73 billion, USD 1.29 billion, and USD 0.89 billion, respectively.

Asia Pacific reached USD 3.11 billion in 2025, with China at USD 1.06 billion and India at USD 0.36 billion. Latin America reached USD 0.63 billion, while the Middle East & Africa region recorded USD 0.23 billion for GCC markets.

Competitive Landscape

Major companies operating in the structural heart devices market include Medtronic, Boston Scientific Corporation, Abbott, Edwards Lifesciences Corporation, Genesis MedTech, Artivion, Teleflex, Corcym Group, LivaNova, and JenaValve.

Companies are focusing on product launches, acquisitions, collaborations, clinical research, and advanced technologies. In August 2025, Abbott launched the MitraClip G5 and TriClip G5 systems. In October 2025, Medtronic collaborated with DASI Simulations to expand access to AI-driven predictive modeling for TAVR procedures.

Report Coverage

The structural heart devices market report covers market size, growth trends, regional developments, competitive landscape, and key industry developments. It analyzes the market across product, procedure type, indication, and end-user segments and highlights technological developments, strategic collaborations, acquisitions, and product launches influencing market growth.

Conclusion

The global structural heart devices market is projected to increase from USD 14.65 billion in 2025 to USD 15.59 billion in 2026 and USD 27.16 billion by 2034, at a CAGR of 7.2% from 2026 to 2034. Growing heart valve disease prevalence, an aging population, increasing adoption of minimally invasive procedures, and technological advancements are expected to support market expansion. North America remains the largest regional market, while Europe and Asia Pacific continue to provide substantial opportunities through improving cardiac care infrastructure and growing adoption of transcatheter therapies.

Segmentation By Product, Procedure Type, Indication, End User, and Region

By Product

• Instruments
  • Heart Valve Devices
  • Occlusion & Closure Devices
  • Others
• Accessories

By Procedure Type

• Valve Replacement Procedures
  • Transcatheter Aortic Valve Replacement (TAVR)
  • Transcatheter Mitral Valve Replacement (TMVR)
  • Others
• Repair Procedures
  • Mitral Edge-to-Edge Repair
  • Tricuspid Edge-to-Edge Repair
  • Others
• Structural Heart Closure Procedures
  • Atrial Septal Defect closure
  • Ventricular Septal Defect closure
  • Others

By Indication

• Heart Valve Diseases
• Congenital Heart Defects
• Others

By End User

• Hospitals & ASCs
• Specialty Clinics
• Others

By Region

• North America (By Product, By Procedure Type, By Indication, By End User, and by Country)
  • U.S. (By Indication)
  • Canada (By Indication)
• Europe (By Product, By Procedure Type, By Indication, By End User, and by Country/Sub-region)
  • U.K. (By Indication)
  • Germany (By Indication)
  • France (By Indication)
  • Italy (By Indication)
  • Spain (By Indication)
  • Scandinavia (By Indication)
  • Rest of Europe (By Indication)
• Asia Pacific (By Product, By Procedure Type, By Indication, By End User, and by Country/Sub-region)
  • China (By Indication)
  • Japan (By Indication)
  • India (By Indication)
  • Australia (By Indication)
  • Southeast Asia (By Indication)
  • Rest of Asia Pacific (By Indication)
• Latin America (By Product, By Procedure Type, By Indication, By End User, and by Country/Sub-region)
  • Brazil (By Indication)
  • Mexico (By Indication)
  • Rest of Latin America (By Indication)
• Middle East & Africa (By Product, By Procedure Type, By Indication, By End User, and by Country/Sub-region)
  • GCC (By Indication)
  • South Africa (By Indication)
  • Rest of the Middle East & Africa (By Indication)

Table of Content

1. Introduction

• 1.1. Research Scope
• 1.2. Market Segmentation
• 1.3. Research Methodology

2. Executive Summary

3. Market Dynamics

• 3.1. Market Drivers
• 3.2. Market Restraints
• 3.3. Market Opportunities
• 3.4. Market Trends

4. Key Insights

• 4.1. Prevalence of Key Disorders, Key Countries/Regions, 2023/2024
• 4.2. Technological Advancements in Structural Heart Devices
• 4.3. New Product Launches, Key Players
• 4.4. Key Industry Developments - Mergers, Acquisitions & Partnerships

5. Global Structural Heart Devices Market Analysis, Insights and Forecast, 2021-2034

• 5.1. Market Analysis, Insights and Forecast - By Product
  • 5.1.1. Instruments
    • 5.1.1.1. Heart Valve Devices
    • 5.1.1.2. Occlusion & Closure Devices
    • 5.1.1.3. Others
  • 5.1.2. Accessories
• 5.2. Market Analysis, Insights and Forecast - By Procedure Type
  • 5.2.1. Valve Replacement Procedures
    • 5.2.1.1. Transcatheter Aortic Valve Replacement (TAVR)
    • 5.2.1.2. Transcatheter Mitral Valve Replacement (TMVR)
    • 5.2.1.3. Others
  • 5.2.2. Repair Procedures
    • 5.2.2.1. Mitral Edge-to-Edge Repair
    • 5.2.2.2. Tricuspid Edge-to-Edge Repair
    • 5.2.2.3. Others
  • 5.2.3. Structural Heart Closure Procedures
    • 5.2.3.1. Atrial Septal Defect closure
    • 5.2.3.2. Ventricular Septal Defect closure
    • 5.2.3.3. Others
• 5.3. Market Analysis, Insights and Forecast - By Indication
  • 5.3.1. Heart Valve Diseases
  • 5.3.2. Congenital Heart Defects
  • 5.3.3. Others
• 5.4. Market Analysis, Insights and Forecast - By End User
  • 5.4.1. Hospitals & ASCs
  • 5.4.2. Specialty Clinics
  • 5.4.3. Others
• 5.5. Market Analysis, Insights and Forecast - By Region
  • 5.5.1. North America
  • 5.5.2. Europe
  • 5.5.3. Asia Pacific
  • 5.5.4. Latin America
  • 5.5.5. Middle East & Africa

6. North America Structural Heart Devices Market Analysis, Insights and Forecast, 2021-2034

• 6.1. Market Analysis, Insights and Forecast - By Product
  • 6.1.1. Instruments
    • 6.1.1.1. Heart Valve Devices
    • 6.1.1.2. Occlusion & Closure Devices
    • 6.1.1.3. Others
  • 6.1.2. Accessories
• 6.2. Market Analysis, Insights and Forecast - By Procedure Type
  • 6.2.1. Valve Replacement Procedures
    • 6.2.1.1. Transcatheter Aortic Valve Replacement (TAVR)
    • 6.2.1.2. Transcatheter Mitral Valve Replacement (TMVR)
    • 6.2.1.3. Others
  • 6.2.2. Repair Procedures
    • 6.2.2.1. Mitral Edge-to-Edge Repair
    • 6.2.2.2. Tricuspid Edge-to-Edge Repair
    • 6.2.2.3. Others
  • 6.2.3. Structural Heart Closure Procedures
    • 6.2.3.1. Atrial Septal Defect closure
    • 6.2.3.2. Ventricular Septal Defect closure
    • 6.2.3.3. Others
• 6.3. Market Analysis, Insights and Forecast - By Indication
  • 6.3.1. Heart Valve Diseases
  • 6.3.2. Congenital Heart Defects
  • 6.3.3. Others
• 6.4. Market Analysis, Insights and Forecast - By End User
  • 6.4.1. Hospitals & ASCs
  • 6.4.2. Specialty Clinics
  • 6.4.3. Others
• 6.5. Market Analysis, Insights and Forecast - By Country
  • 6.5.1. U.S.
    • 6.5.1.1. By Indication
  • 6.5.2. Canada
    • 6.5.2.1. By Indication

7. Europe Structural Heart Devices Market Analysis, Insights and Forecast, 2021-2034

8. Asia Pacific Structural Heart Devices Market Analysis, Insights and Forecast, 2021-2034

9. Latin America Structural Heart Devices Market Analysis, Insights and Forecast, 2021-2034

10. Middle East & Africa Structural Heart Devices Market Analysis, Insights and Forecast, 2021-2034

11. Competitive Analysis

• 11.1. Global Market Share Analysis (2025)
• 11.2. Company Profiles
  • 11.2.1. Medtronic
  • 11.2.2. Boston Scientific Corporation
  • 11.2.3. Abbott
  • 11.2.4. Edwards Lifesciences Corporation
  • 11.2.5. Genesis MedTech
  • 11.2.6. Artivion, Inc.
  • 11.2.7. Teleflex Incorporated
  • 11.2.8. Corcym Group
  • 11.2.9. LivaNova PLC
  • 11.2.10. JenaValve