Structural Heart Devices Market to Grow at a Robust CAGR of 11.33% Through 2032 - Market Insights, Competitive Landscape, and Forecast | DelveInsight

The structural heart devices market is poised for significant growth through 2032, driven by the rising burden of structural heart diseases, increasing adoption of minimally invasive cardiac interventions, and continuous advancements in device technologies. Growing awareness, an aging population, and higher diagnosis rates of conditions such as aortic stenosis, mitral regurgitation, and atrial septal defects are accelerating the demand for transcatheter therapies and surgical repair systems.

Technological innovations-especially in transcatheter aortic valve replacement (TAVR), mitral valve repair/replacement (TMVR), and left atrial appendage closure (LAAC) devices-have revolutionized patient care by offering less invasive options with reduced procedural risks and shorter recovery periods. Furthermore, favorable reimbursement policies and expanding indications for transcatheter interventions continue to drive procedural volumes globally.

DelveInsight's Structural Heart Devices Market Insights report provides an in-depth analysis of the evolving landscape, highlighting emerging trends, key growth drivers and challenges, regulatory dynamics, and clinical advancements. The report also profiles leading and emerging players, mapping competitive strategies and pipeline developments to equip stakeholders with actionable insights and strategic foresight.

With increasing investments in R&D, clinical trials evaluating next-generation devices, and rising physician preference for catheter-based procedures, the structural heart devices market is expected to maintain a strong growth trajectory through 2032.

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Key Takeaways from the Structural Heart Devices Market Report
• The structural heart devices market was valued at USD 9.81 billion in 2023 and is expected to reach USD 18.67 billion by 2032, growing at a CAGR of 11.33% from 2025 to 2032.
• As per DelveInsight estimates, North America is anticipated to dominate the global Structural Heart Devices market during the forecast period.
• Notable structural heart devices companies such as Medtronic, Boston Scientific Corporation, Braile Biomedica, JOTEC GmbH, Edwards Life Sciences Corporation, Valcare Medical, W. L. Gore & Associates, Inc, Abbott, Cardiovascular Systems, Inc., XELTIS BV, JenaValve Technology, Inc, Biomerics, Lepu Medical Technology (Beijing) Co. Ltd, Livanova plc, Comed B.V., TORAY INDUSTRIES INC, Occlutech International AB, Microport Scientific Corporation, and several others are currently operating in the structural heart devices market.
• In April 2025, JenaValve Technology, Inc. announced results from an expanded cohort of 500 patients in the ALIGN-AR pivotal trial, which is assessing the Trilogy transcatheter heart valve (THV) system for treating high-risk patients with symptomatic, severe aortic regurgitation (AR).
• In April 2025, LUMA Vision Ltd. announced FDA clearance for its VERAFEYETM Visualization Platform. This catheter-based imaging system offers real-time, 360-degree visualization in two and four dimensions, enhancing precision during electrophysiology and structural heart procedures. It is also prepared for magnetic tracking and navigation of third-party catheters.
• In May 2024, 4C Medical Technologies announced that its AltaValveTM System for transcatheter mitral valve replacement received FDA Breakthrough Device Designation. The supra-annular design aims to treat both primary and secondary mitral regurgitation via transseptal access.

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Structural Heart Devices Overview
Structural heart devices are specialized medical tools used to repair or replace defective or damaged parts of the heart's anatomy without the need for open-heart surgery. These devices address a wide range of congenital and acquired structural heart conditions, such as aortic stenosis, mitral regurgitation, atrial septal defects, and patent foramen ovale. The primary goal of these devices is to restore normal heart function and improve patient outcomes, particularly in high-risk individuals who are not suitable candidates for conventional surgical procedures.

The evolution of transcatheter techniques-including Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Mitral Valve Repair (TMVR), and Left Atrial Appendage Closure (LAAC)-has transformed the treatment landscape by offering minimally invasive alternatives with shorter recovery times and reduced procedural risks. The integration of advanced imaging technologies, 3D printing, and AI-guided procedural planning is further enhancing the precision and efficacy of structural heart interventions.

Structural Heart Devices Market Insights
North America is projected to lead the global structural heart devices market, commanding the largest share throughout the forecast period. This dominance can be attributed to several pivotal factors, including the rising incidence of structural heart conditions, well-established healthcare infrastructure, the presence of key industry players, and comprehensive reimbursement frameworks.

According to the Centers for Disease Control and Prevention (CDC, 2023), approximately 40,000 babies are born each year in the United States with congenital heart defects (CHD), with nearly one in four affected by severe, life-threatening forms. Among these, ventricular septal defects are the most frequently reported.

Further, CDC statistics from 2023 show that around 2.5% of the U.S. population is affected by valvular heart diseases-conditions predominantly seen in older adults. The American Heart Association (2023) also highlights that aortic stenosis impacts roughly 20% of people over the age of 65 in the U.S., making it one of the most common and critical valvular disorders. This condition, which leads to narrowing of the aortic valve, significantly limits blood flow from the heart to the rest of the body.

The presence of industry giants like Abbott, Edwards Lifesciences Corporation, and LivaNova PLC further reinforces the U.S. market, along with a steady stream of new product launches. For example, in September 2020, the U.S. FDA expanded its approval of Edwards Lifesciences' SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Systems to include treatment of failing transcatheter or surgically implanted aortic and mitral valves in patients deemed too high-risk for open-heart surgery. These frequent approvals and stringent regulatory evaluations bolster end-user confidence and promote sustained innovation.

Consequently, the structural heart devices market in North America-particularly the U.S.-is expected to experience robust growth over the coming years.

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Structural Heart Devices Market Dynamics
According to the British Heart Foundation (2021), around 1 in every 50 births in the United Kingdom involves a congenital heart defect (CHD), translating to roughly 13 new diagnoses daily. When including late-diagnosed cases, estimates suggest that CHD may affect up to 1-2% of the UK population.

In Europe, aortic stenosis ranks as the most prevalent form of valvular heart disease, and it is the second most common valvular condition in the United States. Its prevalence increases markedly with age, affecting an estimated 0.2% of the population below 65 and 2.8% of individuals aged 75 and older.

The growing preference for minimally invasive interventions-such as transcatheter valve repair and replacement-has created a favorable environment for the structural heart devices market across Europe. These advanced procedures offer reduced surgical risks and quicker recovery, particularly benefiting elderly patients with complex comorbidities.

Nonetheless, market growth may be constrained by certain challenges. These include the increasing incidence of product recalls and the stringent regulatory requirements that manufacturers must meet to obtain device approval. These factors can delay product launches and add substantial costs to the development cycle, potentially hindering market expansion over the forecast period.

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Coverage: Global
Study Period: 2022 to 2032
Structural Heart Devices Market CAGR: ~11.33%
Key Structural Heart Devices Companies: Medtronic, Boston Scientific Corporation, Braile Biomedica, JOTEC GmbH, Edwards Life Sciences Corporation, Valcare Medical, W. L. Gore & Associates, Inc, Abbott, Cardiovascular Systems, Inc., XELTIS BV, JenaValve Technology, Inc, Biomerics, Lepu Medical Technology (Beijing) Co. Ltd, Livanova plc, Comed B.V., TORAY INDUSTRIES INC, Occlutech International AB, Microport Scientific Corporation, and others.

Structural Heart Devices Market Segmentation
Market Segmentation By Product Type: (Repair Devices [Occluders, Annuloplasty Devices, Valvuloplasty Devices, and Others] Replacement Devices [Mechanical Heart Valves and Tissue Heart Valves])
Market Segmentation By Application: Atrial Septal Defect, Aortic Valve Stenosis, Patent Foramen Ovale, Ventricular Septal Defects, Mitral Regurgitation, and others.
Market Segmentation By End User: Hospitals, Ambulatory Surgical Centers, and others.
Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of the World.

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Table of Contents
1. Structural Heart Devices Market Report Introduction
2. Structural Heart Devices Market Executive Summary
3. Competitive Landscape
4. Regulatory Analysis
5. Structural Heart Devices Market Key Factors Analysis
6. Structural Heart Devices Market Porter's Five Forces Analysis
7. Structural Heart Devices Market Layout
8. Structural Heart Devices Market Company and Product Profiles
9. KOL Views
10. Project Approach
11. About DelveInsight
12. Disclaimer & Contact Us

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This release was published on openPR.