Global Structural Heart Devices Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Product;
Heart Valve Devices - Transcatheter Heart Valves and Surgical Heart Valves.By Component;
Replacement Procedures - TAVR Procedures & Savr Procedures, Repair Procedures - Closure Procedures, Annuloplasty, Valvuloplasty and TMVR Procedures.By Geography;
North America, Europe, Asia Pacific, Middle East and Africa and Latin America - Report Timeline (2021 - 2031).Introduction
Global Structural Heart Devices Market (USD Million), 2021 - 2031
In the year 2024, the Global Structural Heart Devices Market was valued at USD 8,488.56 million. The size of this market is expected to increase to USD 16,562.86 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 10.0%.
The global structural heart devices market is experiencing significant growth, driven primarily by the high prevalence of structural heart diseases. A substantial portion of the population in the U.S. suffers from structural heart defects, highlighting the immense potential for these devices in addressing such conditions. Structural heart disease treatments encompass a wide range of percutaneous procedures for both acquired and congenital conditions, focusing on abnormalities in cardiac chambers, proximal great vessels, and heart valves.
A favorable reimbursement scenario in the U.S. is expected to further boost market growth, making advanced procedures like Transcatheter Aortic Valve Replacement (TAVR) more affordable. With the aging population increasingly covered by Medicare and Medicaid, the financial burden of healthcare is reduced, encouraging more individuals to seek these treatments. This favorable environment also positively impacts procedures such as Left Atrial Appendage Closure (LAAC), which help in reducing the risk of stroke among patients.
Major industry players are heavily investing in research and development to maintain competitiveness and introduce effective new products. Companies like Medtronic, Boston Scientific, Abbott, and Edwards Lifesciences are at the forefront, showcasing advancements in their cardiovascular offerings. The increasing incidence of structural heart diseases, particularly congenital ones, underscores the growing demand for innovative solutions such as tissue-enhanced aortic valves for structural repair. Technological advancements have significantly improved the performance of structural heart devices, leading to better patient outcomes, higher living standards, and increased life expectancy. Minimally invasive structural heart surgeries are preferred over traditional open-heart procedures due to their reduced invasiveness and enhanced recovery times.
Global Structural Heart Devices Market Recent Developments
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In January 2024, Integer Holdings Corp. finalized a deal to acquire Pulse Technologies, a privately held contract manufacturing company that specializes in materials and coatings used to develop and manufacture medical devices to serve healthcare markets such as structural heart disease, electrophysiology, leadless pacing and neuromodulation
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In December 2023, Edwards Lifesciences announced plans to spin off its critical care unit by the end of 2024 in order to focus on its larger heart devices business. The company's leading product, the transcatheter aortic valve replacement (TAVR) device, has been encountering increasing competition from Abbott, Boston Scientific, and Medtronic. This device is utilized for minimally invasive surgery in patients with heart valve disease.
Segment Analysis
The global structural heart devices market can be segmented based on device type, procedure type, and end-user. By device type, the market includes heart valve devices, occluders and delivery systems, annuloplasty rings, and other devices. Heart valve devices, particularly transcatheter heart valves, dominate this segment due to their minimally invasive nature and the growing preference for transcatheter aortic valve replacement (TAVR) procedures. Occluders and delivery systems also hold a significant market share, driven by their effectiveness in treating conditions such as atrial septal defects and patent foramen ovale.
Procedure type segmentation highlights key treatments such as repair and replacement procedures. Repair procedures encompass treatments like annuloplasty and leaflet repair, which are essential for addressing functional and structural abnormalities in heart valves. Replacement procedures, which include transcatheter and surgical valve replacement, are witnessing substantial growth due to advancements in transcatheter technologies that offer less invasive alternatives to traditional open-heart surgery. These innovations reduce recovery times and improve patient outcomes, making them increasingly popular among both patients and healthcare providers.
End-user segmentation of the market includes hospitals, ambulatory surgical centers, and specialized cardiac centers. Hospitals represent the largest share due to their comprehensive cardiac care facilities and the availability of advanced medical equipment. Specialized cardiac centers are also significant contributors, focusing on the treatment of complex structural heart conditions with dedicated expertise and state-of-the-art technology. Ambulatory surgical centers are gaining traction as well, offering cost-effective and convenient options for less complex procedures. This diverse end-user landscape ensures broad accessibility to structural heart treatments, catering to a wide range of patient needs and contributing to the overall market growth.
Global Structural Heart Devices Segment Analysis
In this report, the Global Structural Heart Devices Market has been segmented by Product, Component and Geography.
Global Structural Heart Devices Market, Segmentation by Product
The Global Structural Heart Devices Market has been segmented by Product into Heart Valve Devices - Transcatheter Heart Valves and Surgical Heart Valves.
The transcatheter heart valves are innovative medical devices designed for minimally invasive procedures to treat heart valve diseases. These valves are deployed via catheter-based delivery systems, avoiding the need for open-heart surgery. Their less invasive nature makes them particularly beneficial for high-risk patients or those ineligible for traditional surgical interventions. The transcatheter heart valves segment has witnessed substantial growth due to advancements in technology, improved procedural outcomes, and increasing acceptance by healthcare professionals and patients alike.
On the other hand, surgical heart valves represent a traditional approach to treating heart valve diseases, involving open-heart surgery for valve replacement or repair. These devices are typically made from biological tissue (bioprosthetic valves) or synthetic materials (mechanical valves). While surgical heart valves have been the standard of care for decades, they are associated with greater invasiveness and longer recovery times compared to transcatheter alternatives. However, surgical heart valves remain crucial for patients with complex anatomies or specific clinical indications where transcatheter options may not be suitable. The segment continues to evolve with ongoing improvements in surgical techniques, materials, and patient outcomes.
The segmentation of the Global Structural Heart Devices Market into transcatheter and surgical heart valves reflects the diverse approaches available for managing heart valve diseases. Both categories offer unique benefits and cater to different patient populations and clinical scenarios. As technological advancements continue to drive innovation in the field of structural heart devices, the market is expected to expand further, providing patients with a wider range of treatment options and improving overall outcomes in the management of heart valve diseases.
Global Structural Heart Devices Market, Segmentation by Component
The Global Structural Heart Devices Market has been segmented by Component into Replacement Procedures - TAVR Procedures & Savr Procedures, Repair Procedures - Closure Procedures, Annuloplasty, Valvuloplasty and TMVR Procedures.
The replacement procedures consist primarily of Transcatheter Aortic Valve Replacement (TAVR) and Surgical Aortic Valve Replacement (SAVR) procedures. TAVR procedures involve the minimally invasive replacement of the aortic valve through a catheter, offering an alternative to traditional open-heart surgery. The growing preference for TAVR is fueled by its less invasive nature, shorter recovery times, and promising outcomes, particularly among high-risk patients. SAVR procedures, though more invasive, remain a crucial treatment option, especially for patients with complex anatomies or specific clinical needs.
Repair procedures in the structural heart devices market encompass a range of interventions aimed at addressing structural abnormalities within the heart. Closure procedures involve the percutaneous closure of defects such as atrial septal defects (ASD) or patent foramen ovale (PFO), reducing the risk of complications such as stroke or heart failure. Annuloplasty procedures focus on repairing or reinforcing the annulus, the ring-like structure surrounding heart valves, to restore proper valve function and prevent regurgitation. Valvuloplasty procedures are aimed at repairing or reshaping heart valves, often through balloon dilation techniques, to improve blood flow and alleviate symptoms associated with valve stenosis or insufficiency. Transcatheter Mitral Valve Replacement (TMVR) procedures represent an emerging frontier in structural heart interventions, offering minimally invasive solutions for mitral valve disorders.
Each component segment within the structural heart devices market plays a crucial role in addressing a diverse array of cardiac conditions. These procedures offer patients and healthcare providers a spectrum of treatment options, ranging from minimally invasive interventions to traditional surgical approaches. As technology continues to advance and clinical evidence accumulates, the landscape of structural heart interventions is expected to evolve, with a continued emphasis on improving patient outcomes, enhancing procedural efficiency, and expanding access to care for individuals with structural heart disease.
Global Structural Heart Devices Market, Segmentation by Geography
In this report, the Global Structural Heart Devices Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Global Structural Heart Devices Market Share (%), by Geographical Region, 2024
North America holds a significant share of the market, driven by factors such as advanced healthcare infrastructure, high healthcare expenditure, and a large patient population with structural heart diseases. The region is characterized by widespread adoption of innovative technologies and treatments, particularly in countries like the United States and Canada, leading to a robust market presence for structural heart devices.
Europe is another prominent region in the global structural heart devices market, boasting a well-established healthcare system and strong emphasis on research and development. Countries such as Germany, France, and the United Kingdom are at the forefront of technological advancements in structural heart treatments. The region benefits from a favorable reimbursement landscape and a growing aging population, which drives the demand for structural heart interventions. Increasing awareness about minimally invasive procedures and their benefits contributes to market growth across Europe.
The Asia Pacific region is witnessing rapid growth in the structural heart devices market, fueled by improving healthcare infrastructure, rising healthcare expenditure, and a growing prevalence of cardiovascular diseases. Countries like China, Japan, and India are key contributors to market expansion, supported by initiatives to enhance healthcare access and affordability. Increasing investments by major market players in the region and a shift towards minimally invasive procedures are further driving market growth in Asia Pacific. Challenges such as regulatory complexities and healthcare disparities across different countries remain, influencing market dynamics in the region.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Structural Heart Devices Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers
- High Prevalence of Heart Diseases
- Aging Population
- Congenital Heart Defects
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Percutaneous Treatments : Percutaneous treatments play a crucial role in the global structural heart devices market, offering minimally invasive alternatives to traditional surgical interventions for various structural heart conditions. These treatments involve accessing the heart through small incisions in the skin, typically using catheter-based approaches guided by advanced imaging techniques such as fluoroscopy or echocardiography. One of the most widely performed percutaneous procedures is Transcatheter Aortic Valve Replacement (TAVR), which involves implanting a prosthetic valve within the native aortic valve to treat aortic stenosis. TAVR has revolutionized the treatment of aortic valve disease, providing a less invasive option for patients deemed high-risk or inoperable for traditional open-heart surgery.
Another important percutaneous treatment modality is Left Atrial Appendage Closure (LAAC), which addresses the risk of stroke in patients with atrial fibrillation. During LAAC procedures, a device is implanted to occlude the left atrial appendage, reducing the risk of blood clots forming in this structure and potentially causing strokes. LAAC offers an alternative to long-term anticoagulant therapy, particularly for patients with contraindications to blood thinners or those at high risk of bleeding complications. The minimally invasive nature of LAAC procedures contributes to shorter hospital stays, faster recovery times, and improved patient outcomes compared to traditional surgical approaches.
In addition to TAVR and LAAC, percutaneous treatments encompass a wide range of interventions for structural heart diseases, including mitral valve repair, patent foramen ovale closure, and transcatheter mitral valve replacement. These procedures continue to evolve with advancements in technology, materials, and techniques, driving innovation in the field of structural heart devices. Percutaneous treatments offer numerous benefits over surgical approaches, including reduced morbidity and mortality, shorter recovery times, and improved quality of life for patients. As a result, they are increasingly becoming the preferred choice for both patients and clinicians, contributing to the growth of the global structural heart devices market.
Restraints
- Skilled Personnel Shortage
- Technological Limitations
- Long Approval Times
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Safety Concerns : Safety concerns are a significant consideration in the Global Structural Heart Devices Market, particularly regarding the use of transcatheter heart valves. While these devices offer less invasive treatment options compared to traditional open-heart surgery, they also pose unique challenges and potential risks. One primary concern is the risk of procedural complications, including device malpositioning, embolization, or paravalvular leak, which can lead to adverse clinical outcomes such as stroke or heart failure. Ensuring proper patient selection, meticulous procedural planning, and operator expertise are essential for minimizing these risks and ensuring patient safety.
Long-term durability and performance of structural heart devices, particularly transcatheter heart valves, remain a subject of ongoing investigation and scrutiny. Questions regarding valve durability, potential structural deterioration over time, and the need for re-intervention or valve replacement pose challenges for clinicians and patients alike. The durability of transcatheter heart valves is influenced by factors such as patient anatomy, valve design, and underlying disease pathology. Addressing these concerns requires comprehensive post-market surveillance, real-world data collection, and continuous monitoring of patient outcomes to ensure the long-term safety and efficacy of structural heart devices.
The adoption of structural heart devices, especially transcatheter heart valves, has led to the need for specialized training and credentialing programs for healthcare professionals. Performing transcatheter procedures requires a high level of technical skill and proficiency in navigating complex cardiac anatomy and deploying intricate device systems. Safety concerns arise when procedures are performed by inexperienced operators or in facilities with limited resources and infrastructure. Standardizing training protocols, establishing quality assurance measures, and promoting collaboration between multidisciplinary teams are essential strategies for enhancing patient safety and optimizing outcomes in the Global Structural Heart Devices Market.
Opportunities
- Emerging Markets
- Government Initiatives
- Patient Awareness
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Minimally Invasive Procedures : Minimally invasive procedures have revolutionized the global structural heart devices market, offering patients effective treatment options with reduced risk and quicker recovery times compared to traditional open-heart surgeries. These procedures involve accessing the heart through small incisions or catheters, rather than through large surgical openings, leading to less trauma to the body and decreased post-operative complications. One of the key minimally invasive procedures in the market is Transcatheter Aortic Valve Replacement (TAVR), which has gained widespread acceptance due to its ability to treat aortic valve stenosis without the need for open-heart surgery. TAVR procedures are performed by threading a replacement valve through a catheter, typically inserted through the femoral artery, and deploying it within the native aortic valve, offering a less invasive alternative for patients who are at high risk for surgical valve replacement.
Another significant minimally invasive procedure is Left Atrial Appendage Closure (LAAC), which is used to reduce the risk of stroke in patients with atrial fibrillation. LAAC involves sealing off the left atrial appendage, where blood clots often form in patients with atrial fibrillation, using a device delivered via catheter. This procedure has become increasingly popular as an alternative to long-term anticoagulation therapy, particularly in patients who are at high risk of bleeding complications. Advancements in imaging technologies and catheter-based techniques have further improved the safety and efficacy of LAAC procedures, driving their adoption in the structural heart devices market.
Minimally invasive procedures are also expanding beyond traditional valve interventions to include treatments for structural heart defects such as atrial septal defects (ASDs) and patent foramen ovale (PFO). Percutaneous closure devices, delivered via catheter, are increasingly used to seal these defects, offering patients a less invasive alternative to surgical repair. As technologies continue to evolve and procedural techniques become more refined, minimally invasive procedures are expected to play an increasingly prominent role in the treatment of structural heart diseases, driving growth and innovation in the global structural heart devices market.
Competitive Landscape Analysis
Key players in Global Structural Heart Devices Market include:
- Boston Scientific Corporation
- Medtronic
- Edwards Lifesciences Corporation
- Abbott Laboratories
- ST. JUDE MEDICAL
- Biomerics
- Comed BV
- LivaNova PLC
- JenaValve Technology, Inc.
- CardioKinetix
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Product
- Market Snapshot, By Component
- Market Snapshot, By Region
- Global Structural Heart Devices Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- High Prevalence of Heart Diseases
- Aging Population
- Congenital Heart Defects
- Percutaneous Treatments
- Restraints
- Skilled Personnel Shortage
- Technological Limitations
- Long Approval Times
- Safety Concerns
- Opportunities
- Emerging Markets
- Government Initiatives
- Patient Awareness
- Minimally Invasive Procedures
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Structural Heart Devices Market, By Product, 2021 - 2031 (USD Million)
- Heart Valve Devices
- Transcatheter Heart Valves
- Surgical Heart Valves
- Heart Valve Devices
- Global Structural Heart Devices Market, By Component, 2021 - 2031 (USD Million)
- Replacement Procedures
- TAVR Procedures
- Savr Procedures
- Repair Procedures
- Closure Procedures
- Annuloplasty
- Valvuloplasty
- TMVR Procedures
- Replacement Procedures
- Global Structural Heart Devices Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia/New Zealand
- South Korea
- ASEAN
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Structural Heart Devices Market, By Product, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Boston Scientific Corporation
- Medtronic
- Edwards Lifesciences Corporation
- Abbott Laboratories
- ST. JUDE MEDICAL
- Biomerics
- Comed BV
- LivaNova PLC
- JenaValve Technology, Inc.
- CardioKinetix
- Company Profiles
- Analyst Views
- Future Outlook of the Market