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Study Period | 2019 - 2030 |
Market Size (2025) | USD 13.81 Billion |
Market Size (2030) | USD 21.48 Billion |
CAGR (2025 - 2030) | 9.24 % |
Fastest Growing Market | Asia Pacific |
Largest Market | North America |
Market Concentration | High |
Major Players![]() *Disclaimer: Major Players sorted in no particular order |
Global Structural Heart Devices Market Analysis
The Global Structural Heart Devices Market size is estimated at USD 13.81 billion in 2025, and is expected to reach USD 21.48 billion by 2030, at a CAGR of 9.24% during the forecast period (2025-2030).
Structural heart devices are medical tools designed to diagnose and treat structural problems in the heart. They address both congenital and acquired conditions affecting the heart's valves, walls, chambers, or vessels. The market for these devices is growing significantly due to the global increase in cardiovascular diseases, supportive reimbursement policies, and a rising preference for minimally invasive procedures.
The primary catalyst for the growth of the market is the increasing prevalence of heart diseases, particularly structural heart conditions such as valvular heart disease, congenital heart defects, and atrial septal defects driven by factors such as aging populations, lifestyle-related diseases, unhealthy diets, and genetic factors. For instance, according to the data published by the Centers for Disease Control and Prevention in May 2024, congenital heart defects (CHDs) affect nearly 1% of or about 40,000 births per year in the United States. According to the same source, the prevalence of some heart defects, especially mild types, is increasing yearly. Infants with critical heart defects generally need surgery or other procedures in their first year of life. Thereby creating opportunities for structural devices such as heart valves, and annuloplasty rings. Therefore, the burden of heart diseases is expected to fuel market growth during the analysis period.
Furthermore, an increasing number of clinical trials highlighting the benefits of minimally invasive mitral valve repairs for patients with advanced heart failure are set to drive market growth during the forecast period. For example, in March 2023, Abbott shared important data for MitraClip, the top treatment for people with mitral regurgitation (MR) experiencing leaky valves. These findings highlighted the device's long-term benefits for heart failure patients. The five-year results from the landmark COAPT trial confirm that MitraClip is both safe and effective. It not only reduces hospitalizations but also improves survival for heart failure patients with severe secondary (or functional) MR—a condition historically hard to manage. Such successful clinical outcomes boost healthcare providers' confidence in these devices, improve patient outcomes and quality of life, and subsequently drive the growth of the structural heart devices market.
Moreover, market players are actively engaging in product launches, acquisitions, mergers, and investments, all of which are anticipated to bolster market growth. For example, in August 2024, Edwards made a strategic move by acquiring JenaValve Technology, a frontrunner in transcatheter treatments for aortic regurgitation (AR). JenaValve's Trilogy Heart Valve System, which is currently awaiting FDA approval projected for late 2025, is poised to be a game-changer. It stands as the inaugural therapy set to receive approval for treating symptomatic, severe AR—a condition that has been predominantly overlooked and is impacting an expanding patient demographic. This acquisition not only strengthens Edwards' foothold in the structural heart domain but also broadens its horizons to encompass heart failure management solutions. Such strategic maneuvers are set to propel the market's growth trajectory in the coming years.
Therefore, owing to the above-mentioned factors, such as increasing prevalence of heart diseases, the growing number of clinical trials, and strategic initiatives by key players such as acquisitions, the market studied is expected to grow over the forecast period. However, less accessibility to new technology in emerging markets and stringent approval process for structural heart devices are the factors that are anticipated to hinder market growth.
Global Structural Heart Devices Market Trends
Heart Valve Devices Segment is Expected to Grow Over the Forecast Period
Heart valve devices are innovative medical technologies designed to replace or repair malfunctioning heart valves, which are critical for maintaining proper blood flow through the heart and preventing conditions such as heart failure and stroke. These devices include transcatheter heart valves, mechanical and biological prosthetic valves, and devices for valve repair procedures.
The increasing prevalence of valvular heart diseases combined with an aging population is driving the demand for heart valve devices. For instance, according to the article published in the Journal of the American Heart Association in April 2024, valvular heart disease (VHD) is one of the most common diseases in the United States, with an estimated prevalence of 2.5% among adults. Thus, the high prevalence of VHD necessitates innovative treatment options including transcatheter aortic valve replacement and mitral valve repair devices, thereby driving segmental growth.
Furthermore, advancements in minimally invasive techniques that provide better biocompatibility and improve patient outcomes are projected to boost the segmental growth over the forecast period. For instance, according to an article published in the Materials Today Bio Journal in October 2024 stated that polymeric heart valves offer several advantages including longer durability, better biocompatibility and reduced cost. It plays a crucial role in addressing the growing demand for effective and patient-friendly solutions in heart valve repair and replacement, potentially transforming the landscape of structural heart therapies. Such findings underscore the advantages of minimally invasive techniques, propelling their adoption and subsequently driving segmental growth.
Moreover, a surge in strategic initiatives, particularly product launches by key players, is propelling segmental growth during the forecast period. For example, in June 2024, Medtronic plc unveiled the Avalus Ultra valve. This state-of-the-art surgical aortic tissue valve is crafted for user-friendly implantation and streamlined lifetime patient management. It's a prime option for cardiac surgeons and their patients, offering a forward-compatible aortic valve solution from the outset. These product introductions not only meet pressing clinical demands but also enhance patient outcomes, fueling market expansion.
Therefore, owing to the above factors, such as high prevalence of valvular heart disease (VHD), advancements in minimally invasive techniques, and strategic initiatives by key players such as product launches, the segment is expected to register a significant growth rate during the forecast period.
![Global Structural Heart Devices Market Trends Global Structural Heart Devices Market: Prevalence Heart Failure, in Millions, United States, 2030 Vs 2040 Vs 2050](https://s3.mordorintelligence.com/structural-heart-devices-market/1736161448884-structural-heart-devices-market-Prevalence-Heart-Failure-in-Millions-United-States-2030-Vs-2040-Vs-2050.png)
North America is Expected to Hold Significant Market Share Over the Forecast Period
North America is poised to lead the market, driven by rising healthcare expenditures, heightened R&D activities associated with structural heart devices, and a growing prevalence of heart diseases, largely attributed to the region's expanding elderly population. Additionally, the region's strong inclination towards minimally invasive procedures further cements its dominant position.
Furthermore, regional government authorities are actively promoting awareness about structural heart diseases. For example, in February 2024, The National Heart, Lung, and Blood Institute launched a campaign focused on raising awareness of heart disease among women. This initiative seeks to highlight the importance of early diagnosis and available treatment options for heart diseases in the United States. These awareness efforts are expected to boost treatment adoption, subsequently driving market growth during the forecast period.
Moreover, an increasing number of product approvals for structural heart devices in Canada is expected to fuel market growth. For example, in July 2024, Edwards Lifesciences (Canada) Inc secured Health Canada's endorsement for its PASCAL Precision transcatheter valve repair system. This system is designed for the percutaneous treatment of significant, symptomatic mitral regurgitation. Such approvals introduce a more effective treatment avenue for patients with severe mitral regurgitation in Canada, subsequently propelling market growth.
Additionally, in January 2023, Abbott secured FDA approval for its Navitor transcatheter aortic valve implantation (TAVI) system. This system is designed for individuals with severe aortic stenosis, particularly those at high or extreme risk for open-heart surgery. The Navitor TAVI system enhances Abbott's extensive transcatheter structural heart portfolio, providing physicians and patients with less invasive treatment options for prevalent and serious heart conditions. Such approvals are pivotal in propelling market growth.
In summary, the growing number of awareness campaigns and the increasing number of product approvals are likely to increase the demand for structural heart devices in North America and drive the market's growth during the forecast period.
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Global Structural Heart Devices Industry Overview
The market is competitive with the significant contribution of several public and private companies operating at the global level. Many companies are now exploring collaboration opportunities in many medical tourism destinations across the emerging markets of the world. Some of the top players include Abbott, Boston Scientific Corporation, Medtronic, Lepu Medical Technology(Beijing)Co.,Ltd., and Edwards Life Sciences Corporation, among others.
Global Structural Heart Devices Market Leaders
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Boston Scientific Corporation
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Edwards Lifesciences Corporation
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Medtronic
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Lepu Medical Technology(Beijing)Co.,Ltd.
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Abbott
- *Disclaimer: Major Players sorted in no particular order
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Global Structural Heart Devices Market News
- August 2024: Boston Scientific Corporation secured the CE mark for its ACURATE Prime Aortic Valve System, marking the latest addition to its structural heart portfolio. This transcatheter aortic valve replacement (TAVR) technology enhances the clinical performance of the ACURATE neo2 platform, introducing an extra valve size to cater to patients with larger anatomies.
- March 2024: Medtronic secured FDA approval for its Evolut FX+ transcatheter aortic valve replacement (TAVR) system, targeting symptomatic severe aortic stenosis. The new Evolut FX+ TAVR system not only upholds the performance advantages of its predecessor, the legacy Evolut TAVR platform, but is also engineered to enhance coronary access.
Global Structural Heart Devices Industry Segmentation
As per the scope of the report, structural heart disease refers to defects in the heart that do not affect blood vessels. Many of these conditions are present at birth, but some can develop later in life due to infections or wear and tears. Advances in medicine have led to minimally invasive procedures, such as transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (TMVR), replacing traditional open-heart surgeries. The structural heart devices market is segmented by product, procedure, and geography. By product, the market is segmented into heart valve devices, occluders & delivery systems, annuloplasty rings, and other products. The other products segment includes surgical heart valves and transcatheter heart valves. By procedure, the market is segmented into replacement procedures and repair procedures. The report also covers the market size and forecasts for the Structural Heart Devices market in 17 countries across major regions. For each segment, the market sizing and forecasts have been done on the basis of value (USD).
By Product | Heart Valve Devices | ||
Occluders & Delivery Systems | |||
Annuloplasty Rings | |||
Other Products | |||
By Procedure | Replacement Procedures | ||
Repair Procedures | |||
Geography | North America | United States | |
Canada | |||
Mexico | |||
Europe | France | ||
Germany | |||
United Kingdom | |||
Italy | |||
Spain | |||
Rest of Europe | |||
Asia-Pacific | China | ||
Japan | |||
India | |||
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 |
Global Structural Heart Devices Market Research FAQs
How big is the Global Structural Heart Devices Market?
The Global Structural Heart Devices Market size is expected to reach USD 13.81 billion in 2025 and grow at a CAGR of 9.24% to reach USD 21.48 billion by 2030.
What is the current Global Structural Heart Devices Market size?
In 2025, the Global Structural Heart Devices Market size is expected to reach USD 13.81 billion.
Who are the key players in Global Structural Heart Devices Market?
Boston Scientific Corporation, Edwards Lifesciences Corporation, Medtronic, Lepu Medical Technology(Beijing)Co.,Ltd. and Abbott are the major companies operating in the Global Structural Heart Devices Market.
Which is the fastest growing region in Global Structural Heart Devices Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Global Structural Heart Devices Market?
In 2025, the North America accounts for the largest market share in Global Structural Heart Devices Market.
What years does this Global Structural Heart Devices Market cover, and what was the market size in 2024?
In 2024, the Global Structural Heart Devices Market size was estimated at USD 12.53 billion. The report covers the Global Structural Heart Devices Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Global Structural Heart Devices Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.