Structural Heart Devices Market Set to Reach USD 20.5 Billion by 2031, Driven by Technological Breakthroughs and Surge in Minimally Invasive Procedures - Transparency Market Research

Structural heart devices market was valued at USD 11.9 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6.5%, reaching USD 20.5 billion by 2031. The development and approval of new structural heart interventions, along with increased research and development activities, are expected to fuel this growth.

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The structural heart devices market is witnessing significant expansion, driven by the increasing prevalence of structural heart diseases and the introduction of innovative medical technologies. Structural heart diseases encompass a wide range of conditions affecting the heart's valves, walls, chambers, and muscles, often requiring medical interventions such as valve repair, valve replacement, or the closure of congenital heart defects. With a growing aging population, higher awareness, and advancements in minimally invasive procedures, the demand for structural heart devices is on the rise.

Market Drivers: The Key Forces Shaping Growth

Increasing Prevalence of Structural Heart Diseases

One of the major drivers of market growth is the rising incidence of structural heart diseases, which affect millions of individuals worldwide. Conditions such as aortic valve disease, atrial septal defect, ventricular septal defect, mitral valve disease, tricuspid valve disease, and hypertrophic cardiomyopathy have been observed at high rates, particularly among newborns and the elderly. Heart valve disease alone affects approximately 2.5% of the U.S. population, with over 2 million individuals suffering from a leaky heart valve. Additionally, congenital heart defects impact around 1.4 million adults and 1 million children in the United States. These statistics highlight the urgent need for effective treatment solutions, boosting the demand for structural heart devices.

Advancements in Minimally Invasive Procedures

Traditional open-heart surgeries have long been the primary method for treating structural heart diseases. However, recent advancements in minimally invasive approaches have transformed the field, reducing recovery times, minimizing complications, and improving patient outcomes. Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Mitral Valve Repair (TMVR) are among the most significant breakthroughs, allowing patients to undergo heart valve procedures without the need for extensive surgical intervention. In October 2023, Abbott released data from its TRILUMINATE pivotal trial, confirming the effectiveness of the TriClip transcatheter edge-to-edge repair (TEER) system for treating symptomatic, severe tricuspid regurgitation. As more companies focus on the development of innovative catheter-based solutions, the structural heart devices market is expected to experience accelerated growth.

Regulatory Approvals and New Product Launches

The introduction of new structural heart devices is another major factor propelling market expansion. Regulatory approvals, particularly from agencies such as the U.S. Food and Drug Administration (FDA), are instrumental in ensuring that new technologies reach the market and improve patient outcomes. In January 2024, Occlutech, a Swedish medical device company, secured FDA approval for its ASD Occluder, designed to treat atrial septal defects (ASDs). The company also received approval for its Pistol Pusher delivery system, further expanding its product portfolio. These approvals indicate a growing trend where companies are investing heavily in research and development to introduce more efficient, safe, and effective heart devices to the market.

Regional Market Outlook: North America Leading the Way

The North American region is at the forefront of the structural heart devices market, driven by strong research and development activities, high healthcare expenditure, and an increasing number of product approvals. The region accounted for the largest market share in 2022, thanks to continuous innovations and a supportive regulatory environment. In July 2023, CardioPrecision entered the U.S. market with its advanced technology for Endoscopic Vessel Harvesting (EVH) during coronary artery bypass grafting (CABG), reinforcing the country's position as a hub for cutting-edge cardiac interventions.

Favorable reimbursement policies have also contributed to the market's expansion in North America. Government programs and private insurers are increasingly covering minimally invasive procedures, making these treatments more accessible to patients. Moreover, public awareness initiatives are playing a crucial role in educating the population about valvular heart disease and other structural heart conditions, leading to early diagnosis and timely medical intervention.

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Competitive Landscape: Key Industry Players and Developments

The structural heart devices market is highly consolidated, with a few major players dominating the industry. Leading companies are focused on developing, manufacturing, and commercializing advanced catheter-based technologies to treat various structural heart diseases. Some of the key players in the market include:

Medtronic

Abbott

Boston Scientific Corporation

Edwards Lifesciences Corporation

LivaNova plc

Lepu Medical

Micro Interventional Devices, Inc.

LifeTech Scientific Corporation

CryoLife, Inc.

These companies are engaged in strategic partnerships, mergers, acquisitions, and product innovations to strengthen their market position. In January 2024, Integer Holdings Corp. acquired Pulse Technologies, a company specializing in materials and coatings for medical devices, enabling them to expand their footprint in the structural heart disease sector. Additionally, in December 2023, Edwards Lifesciences announced its decision to spin off its critical care unit by the end of 2024 to focus on expanding its transcatheter aortic valve replacement (TAVR) business, amid rising competition from Abbott, Boston Scientific, and Medtronic.

Market Segmentation: A Closer Look at Product Categories

The structural heart devices market can be segmented based on product type, procedure, and indication.

By Product:

Biological/Tissue Valves, Transcatheter Heart Valves, Surgical Heart Valves, Mechanical Heart Valves, Annuloplasty Rings, Occluders

Accessories

By Procedure:

Replacement Procedures, Repair Procedures,

By Indication:

Valve Stenosis, Valve Regurgitation, Cardiomyopathy, Congenital Heart Defects, Other Structural Heart Conditions

Future Outlook: Where is the Market Headed?

As the global burden of structural heart diseases continues to rise, the demand for advanced, minimally invasive treatment solutions is expected to escalate. Technological innovations such as AI-driven diagnostic tools, 3D imaging, and robotic-assisted heart surgeries are likely to enhance treatment precision and patient outcomes. Additionally, biodegradable heart valves and next-generation catheter-based interventions could emerge as game-changing solutions in the industry.

Regulatory bodies, including the FDA and the European Medicines Agency (EMA), are expected to streamline approval processes, ensuring faster market entry for groundbreaking devices. Moreover, as healthcare infrastructure improves in emerging economies such as China, India, and Brazil, the adoption of structural heart devices is anticipated to surge, presenting new growth opportunities for industry players.

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The structural heart devices market is on a strong growth trajectory, fueled by rising disease prevalence, technological advancements, regulatory approvals, and strategic industry collaborations. North America remains the leading region, while Asia-Pacific is emerging as a high-growth market due to increasing healthcare investments and improved access to medical treatments. With innovations in transcatheter valve replacements, robotic-assisted surgeries, and AI-driven diagnostics, the future of the structural heart devices industry looks promising. As companies continue to push the boundaries of minimally invasive cardiovascular solutions, the market is set to revolutionize cardiac care and improve patient outcomes worldwide.

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