풍선판막성형술 시장 : 규모, 점유율, 동향 분석(2026-2032년) : MedCore

Global Balloon Valvuloplasty Market Report to 2032

The global balloon valvuloplasty market was valued at $145 million in 2025. It is expected to grow at a compound annual growth rate (CAGR) of 4.9%, reaching $202.9 million by 2032.

This report covers the global market for balloon valvuloplasty (BV) devices, including aortic, mitral, and pulmonary balloon valvuloplasty devices.

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

Market growth is supported by the expanding TAVR procedure base, improved balloon safety, and continued use of BV devices for valve preparation. However, limited clinical data and increasing adoption of self-expanding TAVR devices and direct-implant strategies are expected to limit stronger expansion.

Market Overview

The global balloon valvuloplasty market includes devices used to dilate narrowed heart valves. These products are used in aortic, mitral, and pulmonary valve procedures, either as a standalone treatment or as part of a broader transcatheter valve workflow.

Balloon valvuloplasty devices are widely used during transcatheter aortic valve replacement procedures to dilate the native aortic valve and support device delivery and expansion. This is especially relevant in cases requiring predilatation or post-dilatation.

Their use has traditionally been more common with balloon-expandable TAVR systems, where controlled valve preparation can improve procedural accuracy. As TAVR volumes rise globally, BV devices continue to benefit from their role in valve preparation.

However, the market is also being shaped by changes in TAVR practice. The increasing adoption of self-expanding TAVR devices and direct-implant strategies has reduced the need for routine balloon predilatation in some procedures. This may limit the pace of expansion for the overall BV device market.

Market Drivers

Large Potential Patient Population

The balloon valvuloplasty market is driven by the growing number of TAVR procedures performed worldwide. As TAVR volumes increase, the use of BV devices for valve preparation, predilatation, and post-dilatation is expected to support unit sales.

The expansion of TAVR indications has increased the number of patients eligible for transcatheter valve treatment. As a result, more patients are entering treatment pathways where BV devices may be used.

This creates a large potential procedural base for balloon valvuloplasty devices. Even when BV is not used in every TAVR case, the continued growth of TAVR supports demand for BV products over the forecast period.

Improved Safety

Improved safety is another important driver of the balloon valvuloplasty market. Aortic balloons are designed to inflate to predictable diameters at set pressures, helping physicians control dilation more effectively.

As the number of balloon aortic valvuloplasty procedures has increased, balloon design has evolved to improve both safety and procedural performance. These improvements help reduce risk during valve preparation and dilation.

Current-generation balloons have shifted from cylindrical shapes toward hourglass designs. This helps improve balloon positioning and stability during inflation. By maintaining shape throughout inflation, these products can reduce the likelihood of annulus rupture and support safer use.

Continued Role in TAVR Workflows

Balloon valvuloplasty devices continue to play an important role in many TAVR workflows. In cases where the native valve is heavily calcified or difficult to cross, predilatation can help prepare the valve before replacement.

BV devices may also be used after valve deployment when additional expansion or positioning support is needed. This makes them relevant in both pre-implant and post-implant steps of selected procedures.

As TAVR technology continues to expand globally, physicians will continue to use BV devices where anatomy, valve type, or procedural strategy requires controlled dilation. This supports steady demand, even as direct-implant approaches become more common.

Market Limiters

Limited Clinical Data

Limited clinical data remains a key restraint in the balloon valvuloplasty market. There is currently no randomized data available on the use of BV before transcatheter heart valve replacement procedures.

Further clinical trials are required to demonstrate whether dilating the valve before the procedure has a clear positive outcome. Without stronger evidence, some physicians may limit BV use to selected cases rather than routine TAVR preparation.

BV has also been used as a bridge to transcatheter heart valve replacement for patients who were initially too unstable. However, more clinical data is needed to define the precise role of BV in bridge therapy. Until more studies are available, the market will remain limited.

Self-Expanding TAVR Devices

The increasing use of self-expanding TAVR devices is limiting growth in the BV market. Interest is growing in performing TAVR procedures without balloon valvuloplasty to simplify workflow and avoid potential complications.

Direct-implant TAVR strategies may reduce procedure time and limit the need for additional devices. This can make them attractive for physicians and hospitals seeking procedural efficiency.

Pre-dilation with BV has not been shown to increase the incidence of complete heart block after CoreValve(TM) implantation. However, more clinical research is needed to understand the effects of TAVR without BV and which patients are suitable for this approach.

Procedure Strategy Variation

Balloon valvuloplasty use varies depending on physician preference, valve platform, patient anatomy, and procedural strategy. This creates variability in unit demand.

Some physicians may use BV routinely, while others may reserve it for heavily calcified valves, challenging anatomy, or cases where device expansion is uncertain. This limits consistent use across TAVR procedures.

As device platforms improve, some treatment teams may become more comfortable avoiding predilatation. This could reduce BV use per TAVR procedure, even while total TAVR volumes continue to increase.

Market Coverage and Data Scope

• Quantitative coverage: Market size, market shares, 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 competitive share analysis and forecast assumptions.
• Device scope: The report covers balloon valvuloplasty devices used in aortic, mitral, and pulmonary valve procedures, including devices used for valve dilation and support during transcatheter valve workflows.

Markets Covered and Segmentation

Balloon Valvuloplasty Device Market

• Device type: Aortic, mitral, and pulmonary devices.

Aortic balloon valvuloplasty devices are used to dilate the aortic valve. These products are commonly associated with TAVR workflows, where they may be used for predilatation, post-dilatation, or bridge therapy in selected patients.

Mitral balloon valvuloplasty devices are used in mitral valve procedures. These products support dilation of the mitral valve and remain important in specific clinical use cases where balloon-based treatment is appropriate.

Pulmonary balloon valvuloplasty devices are used to treat pulmonary valve narrowing. These devices support minimally invasive treatment in selected patients and are included within the broader balloon valvuloplasty market.

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

This segmentation helps manufacturers, investors, and strategy teams understand how valve type, TAVR procedure growth, product design, physician preference, and direct-implant strategies are shaping the global BV market.

Competitive Analysis

Becton Dickinson was the leading competitor in the global balloon valvuloplasty market in 2025. The company produces TRUE(R) Flow, TRUE(R) DILATION, and Vida(R) BAV products for aortic balloon valvuloplasty.

For pulmonary balloon valvuloplasty procedures, Becton Dickinson offers the Vida(TM) PTV dilation catheter. Its broad product presence across valve applications supports its leading position, and the company is expected to maintain its leading share over the coming years.

B. Braun was the second-leading competitor in the BV market in 2025. The company offers a range of balloon catheters for pulmonary, aortic, and percutaneous angioplasty procedures. Its portfolio includes the Tyshak(R) catheter line, which has an established global presence.

Although B. Braun has a strong product line, smaller local companies are becoming more popular in some regions. This is expected to contribute to a decline in B. Braun's market share over the coming years.

Toray held a notable share of the BV market in 2025, supported by its INOUE(TM) balloon platform. The INOUE(TM) balloon remains the only device indicated for mitral valve valvuloplasty in North America. Toray also launched the INOUE BALLOON A in September 2024 for aortic balloon valvuloplasty, supporting improved dilation performance and procedural reliability in aortic valve stenosis.

Technology and Practice Trends

TAVR-Linked BV Use

Balloon valvuloplasty remains closely tied to TAVR procedure growth. BV devices are used in selected TAVR cases to prepare the native valve before implantation or improve valve expansion after placement.

This connection makes TAVR procedure volume a major influence on BV demand.

Predilatation and Post-Dilatation

BV devices may be used before valve implantation for predilatation or after valve deployment for post-dilatation. These uses help physicians manage calcification, improve expansion, and support procedural accuracy.

The need for these steps varies by patient anatomy and valve platform.

Hourglass Balloon Designs

Current-generation aortic balloons have evolved from cylindrical designs toward hourglass shapes. This design supports more stable positioning during inflation.

Improved stability may reduce the risk of annulus rupture and improve procedural control.

Self-Expanding TAVR Impact

Self-expanding TAVR devices are reducing the need for routine balloon predilatation in some cases. This trend may slow BV market growth, even as TAVR volumes rise.

The impact depends on physician preference, device platform, and patient selection.

Direct-Implant Strategies

Direct implantation is becoming more common in some TAVR workflows. These strategies aim to simplify procedures by avoiding routine predilatation.

As direct implantation becomes more accepted, BV use may become more selective.

Valve-Specific Product Development

Manufacturers continue to develop products for aortic, mitral, and pulmonary applications. Valve-specific balloon designs help address different anatomy, dilation needs, and procedural requirements.

This supports continued product refinement across the BV market.

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 balloon valvuloplasty market today, and how much is it expected to grow through 2032?
• How are unit sales, ASPs, and market values changing over time?
• Which device types are included in the balloon valvuloplasty market?
• How do aortic, mitral, and pulmonary balloon valvuloplasty device segments differ?
• What role do BV devices play in TAVR procedures?
• How are predilatation and post-dilatation trends affecting product demand?
• How are improved balloon designs supporting safety and procedural control?
• What impact do self-expanding TAVR devices and direct-implant strategies have on BV use?
• Which companies lead the global balloon valvuloplasty market?
• How are Becton Dickinson, B. Braun, and Toray positioned in the competitive landscape?

The Global Balloon Valvuloplasty Market Report from iData Research answers these questions with device-level analysis, ASP data, company share insights, and forecasts through 2032. Use it to evaluate demand, benchmark competitors, understand TAVR-linked procedure trends, and support commercial planning in the global balloon valvuloplasty 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

Balloon Valvuloplasty Market

• 12.1 Executive Summary
  • 12.1.1 Global Balloon Valvuloplasty Market Overview
  • 12.1.2 Competitive Analysis
  • 12.1.3 Procedures Included
  • 12.1.4 Markets Included
  • 12.1.5 Regions Included
• 12.2 Introduction
• 12.3 Procedure Numbers
  • 12.3.1 Total Balloon Valvuloplasty Procedures
  • 12.3.2 Aortic Balloon Valvuloplasty Procedures
  • 12.3.3 Mitral Balloon Valvuloplasty Procedures
  • 12.3.4 Pulmonary Balloon Valvuloplasty Procedures
• 12.4 Market Overview
  • 12.4.1 By Segment
  • 12.4.2 By Region
• 12.5 Market Analysis And Forecast
  • 12.5.1 Total Balloon Valvuloplasty Market
  • 12.5.2 Aortic Balloon Valvuloplasty Market
  • 12.5.3 Mitral Balloon Valvuloplasty Market
  • 12.5.4 Pulmonary Balloon Valvuloplasty Market
• 12.6 Drivers And Limiters
  • 12.6.1 Market Drivers
  • 12.6.2 Market Limiters
• 12.7 Competitive Market Share Analysis

Appendix