경피적 심장판막 치환술 시장 : 규모, 점유율, 동향 분석(2026-2032년)

Global Transcatheter Heart Valve Replacement Market Report to 2032

The global transcatheter heart valve replacement market was valued at $7.7 billion in 2025. It is expected to grow at a compound annual growth rate (CAGR) of 6.7%, reaching $12.1 billion by 2032.

This report covers the global market for transcatheter heart valve replacement (THVR), including artificial valves placed through minimally invasive catheter procedures for the aortic and pulmonary valves.

The analysis includes unit sales, average selling prices (ASPs), procedure numbers, market size, market shares, growth trends, market forecasts through 2032, and historical data back to 2022.

Market growth is supported by improved diagnostic capabilities, new products and delivery systems, and expanding indications for use. However, limited long-term clinical data, procedure complexity, procedural risk, and increased competition from new entrants may limit stronger market expansion.

Market Overview

The global transcatheter heart valve replacement market includes minimally invasive replacement technologies used to treat diseased aortic and pulmonary valves. These devices are delivered through catheter-based procedures, allowing selected patients to receive valve replacement without traditional open-heart surgery.

The market is primarily driven by transcatheter aortic valve replacement, which has become one of the strongest growth areas in structural heart care. Transcatheter pulmonary valve replacement is also included, although it represents a smaller portion of the total market.

As clinical evidence continues to show the safety and efficacy of TAVR across broader patient groups, indications have expanded beyond high-risk patients. Intermediate-risk, low-risk, and progressively younger patients are becoming more relevant to market growth.

This expansion is increasing the number of patients eligible for transcatheter valve procedures. At the same time, surgical aortic valve replacement volumes continue to grow in absolute terms, supported by better diagnosis rates and a larger overall treated population. Together, these trends are expected to support continued growth in aortic valve replacement procedure volumes and market value.

Market Drivers

Improved Diagnostic Capabilities

Improved diagnostic capabilities are helping expand the THVR patient population. Advances in computed tomography and magnetic resonance imaging are enabling earlier and more accurate diagnosis of heart valve defects.

In the past, many patients with heart valve disease were not diagnosed until serious symptoms appeared. Today, some valve defects are being detected during routine cardiovascular evaluations or earlier diagnostic workups.

Earlier diagnosis increases the number of patients who can be evaluated for treatment. This supports higher procedural volumes and increases demand for transcatheter heart valve replacement devices across eligible patient populations.

New Products and Technologies

New products and technologies are important drivers of the global THVR market. Multiple TAVR and TPVR devices have been released across global markets, improving treatment options for physicians and patients.

These new products include advanced valve designs, improved delivery systems, and refined placement techniques. Together, these innovations allow more patients to be treated successfully and help physicians manage more complex anatomy.

Because THVR devices carry high ASPs, increased procedure volume has a strong effect on market value. Continued product development is expected to support growth by expanding the treatable patient population and improving procedural confidence.

Expanding Indications for Use

Expanding indications for use are one of the strongest drivers of THVR growth. As clinical evidence supports broader use of TAVR, competitors are working to gain regulatory approval for moderate-risk and low-risk patients.

The expansion of indications increases the number of patients eligible for TAVR procedures. This is especially important because aortic valve disease affects a large patient population, and many patients prefer less invasive treatment options when appropriate.

Patient preference for percutaneous procedures over surgical procedures is expected to drive growth in TAVR procedural volume and unit sales. As indications continue to broaden, this trend will place upward pressure on market value over the forecast period.

Market Limiters

Lack of Clinical Data

Limited long-term clinical data remains a key limiter in the THVR market. Much of the available data on TAVR has focused on one-year follow-up periods, while longer-term outcomes and valve durability are still developing.

Some healthcare facilities and physicians may be reluctant to expand use until more long-term evidence becomes available. This is especially relevant as TAVR moves into lower-risk and younger patient populations.

For older or high-risk patients, shorter follow-up data may be sufficient to support adoption. For younger patients, however, long-term durability becomes much more important. Until more data is available, this factor may slow adoption in broader populations.

Complexity and Risk

Percutaneous aortic valve replacement remains a complex procedure. Although it is less invasive than open surgery, it still requires advanced imaging, careful patient selection, experienced operators, and strong procedural planning.

There is also limited long-term data on patient outcomes and valve durability for percutaneous aortic valve replacement procedures. Until technology improves further and physicians gain more experience, procedural risk will remain an important consideration.

Physicians with less training may be unlikely to use these devices, particularly in complex cases. This can limit adoption in centers that do not yet have strong structural heart programs or sufficient procedural experience.

New Entrants

New entrants are expected to increase competition in the THVR market. Following the success of Edwards Lifesciences and Medtronic, other major competitors have taken steps to enter or expand in the market.

Abbott is one example, with its Portico(TM) and Navitor(TM) transcatheter aortic valve systems. Broader competitive participation can increase product choice and support innovation, but it may also create pricing pressure.

As the market becomes more competitive, ASPs may decline in some regions or account types. This could limit market value growth, even as procedure volumes continue to increase.

Market Coverage and Data Scope

• Quantitative coverage: Market size, market shares, procedure numbers, market forecasts, market growth rates, units sold, and average selling prices.
• Qualitative coverage: Market drivers and limiters, competitive analysis, recent mergers and acquisitions, company profiles, product portfolios, and leading competitors.
• Time frame: Base year 2025, forecasts to 2032, and historical data back to 2022.
• Market modeling: Revenue is analyzed using unit sales and ASPs, supported by procedure numbers, competitive share analysis, and forecast assumptions.
• Device scope: The report covers artificial heart valves placed through minimally invasive catheter procedures for the aortic and pulmonary valves, including transcatheter aortic valve replacement and transcatheter pulmonary valve replacement devices.

Markets Covered and Segmentation

Transcatheter Heart Valve Replacement Market

• Device type: Transcatheter aortic valve replacement and transcatheter pulmonary valve replacement.

Transcatheter aortic valve replacement devices are used to treat aortic valve disease through a catheter-based approach. TAVR is the largest and most important segment within the THVR market, supported by broad clinical adoption, expanding indications, and a large eligible patient population.

Transcatheter pulmonary valve replacement devices are used to treat pulmonary valve disease through minimally invasive catheter procedures. While smaller than the TAVR segment, TPVR remains an important part of the total THVR market.

Each segment is analyzed by market size, market shares, procedure numbers, market forecasts, market growth rates, units sold, and average selling prices.

This segmentation helps manufacturers, investors, and strategy teams understand how valve type, patient eligibility, clinical evidence, regulatory approvals, and competitive positioning are shaping the global THVR market.

Competitive Analysis

Edwards Lifesciences was the market leader in THVR devices in 2025. The company offers the SAPIEN 3(R), SAPIEN XT(R), and CENTERA(R) transcatheter valves. The SAPIEN 3(R) is used for aortic valve replacement, while the SAPIEN XT(R) is used for both aortic and pulmonary valve replacement.

Edwards Lifesciences' product lines are core devices in many regions, giving the company a strong position to maintain and grow overall market share. Its leadership is supported by established clinical use, broad physician familiarity, and a strong structural heart portfolio.

Medtronic made modest gains in the THVR device market in 2025 but remained behind Edwards Lifesciences globally. The company offers the CoreValve(TM) Evolut(TM) Pro and CoreValve(TM) Evolut(TM) R System transcatheter aortic valves.

Since Medtronic has left the ventricular assist device market, it is expected to expand its presence in the THVR segment. This may support further investment in transcatheter valve technologies and strengthen its long-term position in structural heart treatment.

Abbott was the third-leading competitor in the THVR market in 2025. The company maintains a strong TAVR portfolio through its Portico(TM) and Navitor(TM) systems, supported by the FlexNav(TM) delivery platform. In 2025, Abbott received CE Mark approval in Europe for an expanded indication of Navitor(TM) to include low- and intermediate-risk patients, strengthening its global market position.

Technology and Practice Trends

Broader TAVR Indications

TAVR indications continue to expand from high-risk patients into intermediate-risk, low-risk, and younger patient groups. This is one of the most important trends shaping the THVR market.

Broader indications are increasing the eligible patient population and driving manufacturers to pursue additional regulatory approvals.

Lifetime Valve Management

As TAVR expands into younger patients, lifetime valve management is becoming more important. Physicians and manufacturers must consider durability, future valve-in-valve options, and long-term treatment planning.

This trend is expected to influence next-generation device design and clinical decision-making.

Improved Delivery Systems

Delivery system improvements are helping physicians treat more complex anatomy. Better control, flexibility, and deliverability can improve procedural success and expand the types of patients who can be treated.

Abbott's FlexNav(TM) delivery platform is one example of this broader trend.

Advanced Imaging and Planning

CT and MRI are supporting better diagnosis, patient selection, and procedural planning. Imaging improvements help physicians evaluate valve anatomy and determine whether a patient is suitable for transcatheter replacement.

This supports safer procedures and more consistent outcomes.

Continued TAVR Innovation

Manufacturers are investing in next-generation transcatheter valve technologies to improve durability, reduce complications, and expand use across patient groups.

This innovation is expected to support continued market growth and competition over the forecast period.

Competitive Expansion

The THVR market is becoming more competitive as additional companies enter or expand their product lines. This may improve innovation and availability, but it can also place pressure on pricing.

Companies with strong clinical data, broad regulatory approvals, and established physician training programs are likely to remain best positioned.

Geography

This report provides global coverage across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa.

Why This Report

• How large is the global transcatheter heart valve replacement market today, and how much is it expected to grow through 2032?
• How are unit sales, procedure numbers, ASPs, and market values changing over time?
• What role does TAVR play in overall THVR market growth?
• How is transcatheter pulmonary valve replacement positioned within the broader market?
• How are improved diagnostic capabilities increasing the eligible patient population?
• How are expanded indications for use changing TAVR procedure volumes?
• What impact do low-risk, intermediate-risk, and younger patient cohorts have on future demand?
• How are long-term durability concerns shaping adoption and technology development?
• Which companies lead the global THVR market?
• How are Edwards Lifesciences, Medtronic, and Abbott positioned in the competitive landscape?

The Global Transcatheter Heart Valve Replacement Market Report from iData Research answers these questions with device-level analysis, procedure-based modeling, ASP data, company share insights, and forecasts through 2032. Use it to evaluate demand, benchmark competitors, understand transcatheter valve replacement trends, and support commercial planning in the global THVR market.

TABLE OF CONTENT

Research Methodology

• Step 1: Project Initiation & Team Selection
• Step 2: Prepare Data Systems And Perform Secondary Research
• Step 3: Preparation For Interviews & Questionnaire Design
• Step 4: Performing Primary Research
• Step 5: Research Analysis: Establishing Baseline Estimates
• Step 6: Market Forecast And Analysis
• Step 7: Identify Strategic Opportunities
• Step 8: Final Review And Market Release
• Step 9: Customer Feedback And Market Monitoring

Impact Of Global Tariffs

Transcatheter Heart Valve Replacement Market

• 10.1 Executive Summary
  • 10.1.1 Global Transcatheter Heart Valve Replacement Market Overview
  • 10.1.2 Competitive Analysis
  • 10.1.3 Procedures Included
  • 10.1.4 Markets Included
  • 10.1.5 Regions Included
• 10.2 Introduction
• 10.3 Procedure Numbers
  • 10.3.1 Total Transcatheter Heart Valve Replacement Procedures
  • 10.3.2 Transcatheter Aortic Valve Replacement Procedures
    • 10.3.2.1 TAVR With Cerebral Embolic Protection Procedures
    • 10.3.2.2 TAVR Without Cerebral Embolic Protection Procedures
  • 10.3.3 Transcatheter Pulmonary Valve Replacement Procedures
• 10.4 Market Overview
  • 10.4.1 By Segment
  • 10.4.2 By Region
• 10.5 Market Analysis And Forecast
  • 10.5.1 Total Transcatheter Heart Valve Replacement Market
  • 10.5.2 Transcatheter Aortic Valve Replacement Market
  • 10.5.3 Transcatheter Pulmonary Valve Replacement Market
• 10.6 Drivers And Limiters
  • 10.6.1 Market Drivers
  • 10.6.2 Market Limiters
• 10.7 Competitive Market Share Analysis

Appendix