Structural Heart Devices - Market Insights, Competitive Landscape, and Market Forecast - 2032

Structural Heart Devices Market by Product Type (Repair Devices [Occluders, Annuloplasty Devices, Valvuloplasty Devices, and Others] and Replacement Devices [Mechanical Heart Valves and Tissue Heart Valves]), Application (Atrial Septal Defect, Aortic Valve Stenosis, Patent Foramen Ovale, Ventricular Septal Defects, Mitral Regurgitation, and Others), End-User (Hospitals, Ambulatory Surgical Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the growing prevalence of structural heart disease and increasing product development and launches activities by key players.

The structural heart devices market was valued at USD 11.75 billion in 2024, growing at a CAGR of 10.08% during the forecast period from 2025 to 2032 to reach USD 25.26 billion by 2032. The growing demand for structural heart devices is primarily driven by the rising incidence of structural heart diseases, including heart valve disorders, congenital heart defects, and other related conditions. In addition, the increasing preference for minimally invasive procedures and the surge in product development and launch activities by leading market players are key factors expected to drive the positive growth of the structural heart devices market during the forecast period from 2025 to 2032.

Structural Heart Devices Market Dynamics:

According to BLISS UK (2024), over 13 million preterm births occurred globally each year, with the highest prevalence seen in sub-Saharan Africa and Southern Asia. In the United Kingdom alone, approximately 58,000 premature births were reported annually. In Australia, data from Northern Health Australia (2023) showed that one in every 12 babies is born prematurely, with the rate rising to 15% among Aboriginal babies, resulting in over 26,000 preterm births each year. Preterm birth is a leading cause of structural heart defects in newborns, which increases the demand for structural heart devices used to close holes in the heart associated with congenital heart defects, thereby driving market growth.

In addition to congenital conditions, the structural heart devices market is being propelled by the rising incidence of heart valve disease. A recent study published in Heart, Lung and Circulation (2025), in 2024, over 500,000 individuals in Australia were diagnosed with heart valve disease, while an estimated 250,000 remained undiagnosed. Similarly, data from NHS England (2025) highlights that heart valve disease affected 11.3% of individuals aged 65 and older in the UK.

The growing elderly population and increasing prevalence of valve-related disorders are significantly boosting the demand for structural heart devices such as transcatheter heart valves. This trend is further supported by a shift toward minimally invasive procedures, which offer shorter recovery times and improved patient outcomes.

Moreover, major industry players are intensifying research and development efforts to introduce advanced treatment options. For instance, in May 2025, Abbott received U.S. FDA approval for its Tendyne™ transcatheter mitral valve replacement (TMVR) system, designed to treat patients with mitral valve disease caused by severe mitral annular calcification (MAC). This breakthrough therapy is expected to enhance treatment accessibility and further stimulate growth in the structural heart devices market.

However, the frequent product failures and recalls, and stringent regulatory concerns for product approval, among others, are some of the key constraints that may limit the growth of the structural heart devices market.

Structural Heart Devices Market Segment Analysis:

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

In the product type segment of the structural heart devices market, the annuloplasty devices category is estimated to account for the largest market share in 2024. This growth is primarily driven by the rising incidence of heart valve diseases and the clinical advantages these devices offer in the treatment of structural heart defects.

Annuloplasty devices are designed to restore the native shape and size of the valve annulus, thereby improving leaflet coaptation, the ability of valve leaflets to meet and close properly. This function is especially critical in cases of annular dilation, which often leads to or worsens valvular regurgitation.

By reducing annular dilation and realigning the valve leaflets, these devices can significantly decrease regurgitation while preserving the patient's native valve function, thus helping avoid full valve replacement. This is particularly beneficial in patients with degenerative or functional mitral regurgitation, where annuloplasty rings have demonstrated excellent long-term durability and significantly lower rates of valve reoperation over time.

The segment’s growth is further fueled by technological advancements and product innovations from key market players. For example, in March 2025, Valcare Medical Inc. announced that the U.S. Food and Drug Administration (FDA) had approved its AMEND™ Trans-Septal System for an Investigational Device Exemption (IDE), allowing the initiation of an Early Feasibility Study (EFS). The AMEND™ system is a transcatheter annuloplasty device intended for the treatment of mitral insufficiency. It features a semi-rigid, closed, D-shaped ring, designed to be delivered via a trans-septal approach, offering a promising new option for patients unsuitable for traditional surgery.

With increasing clinical adoption, long-term reliability, and ongoing innovation, annuloplasty devices are well-positioned to drive substantial growth within the structural heart devices market in the coming years.

North America is expected to dominate the overall structural heart devices market:

North America is projected to hold the largest share of the structural heart devices market in 2024, driven by several key factors. This regional dominance can be attributed to the rising prevalence of structural heart conditions, including heart valve disease, congenital heart defects, and other cardiac abnormalities. Additionally, there is a shift toward minimally invasive procedures, supported by a highly advanced healthcare infrastructure and strong adoption of cutting-edge technologies. The region also benefits from a favorable regulatory environment, with frequent product approvals and new device launches by leading market players, further accelerating growth. These combined factors make North America a key region in the global structural heart devices market.

According to data from the Centers for Disease Control and Prevention (CDC, 2025), heart defects affected nearly 1% of all births in the U.S., impacting approximately 40,000 babies each year. Among these, about 1 in 4 infants is born with a critical congenital heart defect requiring intervention. Additionally, CDC data from 2024 highlights that around 1 in every 33 babies, or approximately 120,000 infants annually, are born with congenital anomalies, including structural heart defects. Therefore, the rising incidence of both congenital and acquired heart defects has significantly increased the demand for structural heart devices, which play a vital role in repairing conditions such as septal defects, valve malformations, and other anatomical abnormalities.

Furthermore, more than 5 million people in the U.S. are diagnosed with heart valve disease each year, with over 25,000 annual deaths attributed to the condition (CDC, 2025). Many of these deaths could be prevented through timely treatment using structural heart devices, such as transcatheter valves and annuloplasty systems, which offer effective, minimally invasive alternatives to open-heart surgery, particularly beneficial for elderly or high-risk patients.

Moreover, major industry players continue to innovate and expand the therapeutic landscape. For instance, in May 2025, Edwards Lifesciences announced that the U.S. FDA had approved the use of its SAPIEN 3 Transcatheter Aortic Valve Replacement (TAVR) platform for patients with severe aortic stenosis (AS) who are asymptomatic. This marks the first FDA approval for TAVR in asymptomatic patients, significantly expanding the treatment population. Such advancements, combined with the high disease burden and robust healthcare infrastructure, are key factors driving the growth of the structural heart devices market in North America.

Therefore, the combination of rising cases of structural heart disease and ongoing innovation in structural heart devices is expected to significantly propel the growth of the structural heart devices market in North America from 2025 to 2032.

Structural Heart Devices Market Key Players:

Some of the key market players operating in the structural heart devices market include 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, Meril Life Sciences, Venus Medtech (Hangzhou) Inc., and others.

Recent Developmental Activities in the Structural Heart Devices Market:

• In April 2025, Edwards Lifesciences announced that its SAPIEN M3 mitral valve replacement system received CE Mark approval. The device is approved for treating patients with moderate-to-severe or severe mitral regurgitation (MR) who are not suitable for surgery or transcatheter edge-to-edge repair (TEER). The SAPIEN M3 is the first transcatheter mitral valve replacement system approved for use through a transfemoral (through the leg) approach, offering a minimally invasive option for patients with limited treatment choices.
• In March 2025, Abbott announced new results from its TRILUMINATE™ Pivotal trial, showing that the TriClip™ TEER system provides significant and lasting improvement in tricuspid regurgitation (TR) after two years. The data also showed that TriClip reduced heart failure-related hospitalizations and improved long-term quality of life compared to standard medical therapy.
• In March 2024, Medtronic announced that the U.S. FDA approved its Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system for treating symptomatic severe aortic stenosis. The new system builds on the proven Evolut platform, offering the same valve performance benefits while being specifically designed to improve coronary access.

Key takeaways from the structural heart devices market report study

• Market size analysis for the current structural heart devices market size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the structural heart devices market.
• Various opportunities available for the other competitors in the structural heart devices market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current structural heart devices market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for the structural heart devices market growth in the future?

Target audience who can benefit from this structural heart devices market report study

• Structural heart devices product providers
• Research organizations and consulting companies
• Structural heart devices-related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in structural heart devices
• Various end-users who want to know more about the structural heart devices market and the latest technological developments in the structural heart devices market.

Frequently Asked Questions for the Structural Heart Devices Market:

1. What are structural heart devices?

• Structural heart devices are specialized tools or implants used to correct structural abnormalities of the heart, without requiring open-heart surgery in many cases. They aim to restore normal blood flow and function in patients with valvular, septal, or chamber-related heart defects.

2. What is the market for structural heart devices?

• The structural heart devices market was valued at USD 11.75 billion in 2024, growing at a CAGR of 10.08% during the forecast period from 2025 to 2032 to reach USD 25.26 billion by 2032.

3. What are the drivers for the structural heart devices market?

• The demand for structural heart devices is primarily driven by the rising incidence of structural heart diseases, including heart valve disorders, congenital heart defects, and other related conditions. In addition, the increasing preference for minimally invasive procedures and the surge in product development and launch activities by leading market players are key factors expected to drive the positive growth of the structural heart devices market during the forecast period from 2025 to 2032.

4. Who are the key players operating in the structural heart devices market?

• Some of the key market players operating in the structural heart devices market include 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, Meril Life Sciences, Venus Medtech (Hangzhou) Inc., and others.

5. Which region has the highest share in the structural heart devices market?

• North America is projected to hold the largest share of the structural heart devices market in 2024, driven by several key factors. This regional dominance can be attributed to the rising prevalence of structural heart conditions, including heart valve disease, congenital heart defects, and other cardiac abnormalities. Additionally, there is a shift toward minimally invasive procedures, supported by a highly advanced healthcare infrastructure and strong adoption of cutting-edge technologies. The region also benefits from a favorable regulatory environment, with frequent product approvals and new device launches by leading market players, further accelerating growth. These combined factors make North America a key region in the global structural heart devices market.

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