Press Release   -

Rising Cardiovascular Disease Burden and Technological Advancements Propel Structural Heart Devices Market Toward Strong Expansion

The global Structural Heart Devices Market is poised for robust growth, driven by advances in minimally invasive cardiac therapies, expanding indications for valvular and congenital heart disease treatment, and growing patient volumes globally. Devices such as heart valves (transcatheter and surgical), occluders and delivery systems, annuloplasty rings and accessories are transforming structural heart care. Aging populations, rising prevalence of structural heart disorders and improved healthcare infrastructure are fueling demand for such devices across hospitals, cardiac centres and ambulatory surgical settings.

Key Takeaways

1. The Structural Heart Devices Market was valued at USD 13.1 billion in 2024.
2. It is projected to reach around USD 35.65 billion by 2035, growing at a compound annual growth rate (CAGR) of 9.55% from 2025 to 2035.
3. North America currently holds the largest regional share, supported by advanced healthcare infrastructure and high uptake of minimally invasive procedures.
4. The Asia Pacific region is expected to exhibit the fastest growth over the forecast period, driven by rising cardiovascular disease burden and expanding device accessibility.
5. Innovation in device technologies (e.g., transcatheter valves, next-generation occluders, delivery systems) and expanding procedural indications are key growth enablers.
6. Challenges remain, including reimbursement uncertainty in certain markets, high procedural/device cost and competition among key players.

Key Market Trends & Insights

The market is being shaped by several notable trends: wide adoption of transcatheter therapies (especially transcatheter aortic valve replacement, TAVR) which reduce recovery time and procedural invasiveness; increased use of structural heart devices for mitral and tricuspid valve disease, beyond just aortic indications; growing penetration of these therapies in emerging economies; and rising emphasis on long-term outcomes, device durability and next-generation delivery systems. Additionally, regulatory approvals, clinical evidence expansion and device companies' investments in structural heart portfolios are accelerating market maturation.

Market Size & Forecast

According to the Vantage Market Research report, the structural heart devices market was valued at approximately USD 13.1 billion in 2024. Over the forecast period 2025 to 2035, it is projected to grow at a CAGR of 9.55% and reach approximately USD 35.65 billion by 2035. This growth reflects the increasing procedural volumes, technology advancements and rising device adoption globally.

The structural heart devices market is moderately to highly concentrated, with a few large global players commanding significant market share while numerous smaller niche competitors contribute innovation in specific device types or regional markets. Major device companies maintain strong portfolios in valves, occluders and delivery systems, benefitting from established clinical evidence, regulatory clearances and physician relationships. Key characteristics include high capital and regulatory entry barriers, long product development cycles, heavy reliance on clinical data, and a premium pricing ecosystem. Market dynamics favour companies with strong R&D, global regulatory reach and procedural adoption networks.

Product Insights

The Product segment of the Structural Heart Devices Market is categorized into Heart Valve Devices, Occluders & Delivery Systems, Annuloplasty Rings, and Other Structural Heart Devices. Heart valve devices dominate the segment, driven by the growing demand for transcatheter aortic valve replacement (TAVR) and surgical valve repair solutions. Occluders and delivery systems are experiencing rapid growth as they address congenital heart defects and improve procedural precision. Continuous innovations in material science and miniaturization enhance device safety, efficacy, and long-term durability across all product types.

Procedure Insights

The Procedure segment is divided into Repair and Replacement. Replacement procedures hold a major share due to their widespread adoption in treating severe aortic and mitral valve diseases using transcatheter and surgical methods. Repair procedures are growing rapidly as less invasive solutions gain acceptance, particularly for younger or high-risk patients. The evolution of percutaneous repair technologies, such as mitral and tricuspid valve repair systems, is reducing hospital stays and procedural risks, fueling their increasing preference across global cardiac centers.

Regional Insights

North America Structural Heart Devices Market Trends

In North America, the market leads globally thanks to extensive procedural volumes, sophisticated healthcare infrastructure and favourable reimbursement ecosystems. High uptake of TAVR and other transcatheter therapies, established physician experience and efficient device adoption contribute to a strong regional position. In the U.S., the presence of major device manufacturers and early clinical trial activity also drive innovation. As the base market matures, growth is being driven by expanded indications (e.g., mitral/tricuspid) and procedural uptick in elderly patient populations.

Europe Market Structural Heart Devices Trends

Europe presents steady growth for structural heart devices, driven by aging populations, public healthcare investment and expanding transcatheter adoption across major countries like Germany, France and the UK. Regional regulatory and reimbursement frameworks support device access, though variations exist country-to-country. European interventional cardiology and structural heart programmes are well-established, and newer procedures are gaining standing. The region also benefits from local manufacturing and clinical research hubs, which support device innovation and adoption.

Asia Pacific Structural Heart Devices Market Trends

Asia Pacific is projected to be the fastest-growing region over the forecast period. Growth is spurred by rising cardiovascular disease prevalence, expanding interventional-capable healthcare infrastructure, increasing affordability and rising middle-class access. Countries such as China, India, Japan and South Korea are expanding structural heart programmes, introducing TAVR and repair procedures more broadly. Government initiatives, medical tourism and device manufacturing growth also support regional expansion. As cost pressures ease and local device options increase, the Asia Pacific region is set to become a major growth contributor.

Latin America Structural Heart Devices Market Trends

Latin America is experiencing moderate yet significant growth in structural heart devices. The market is supported by increasing awareness of structural heart disease, expanding private healthcare segments and rising procedural volumes in countries like Brazil and Mexico. However, adoption is somewhat constrained by reimbursement limitations and infrastructure variability. Device manufacturers are increasingly focusing on Latin America via partnerships, local distribution networks and cost-effective devices tailored for emerging markets.

Middle East & Africa Structural Heart Devices Market Trends

The Middle East & Africa region remains nascent but shows promise in structural heart devices market growth. Key growth drivers include investment in healthcare infrastructure in Gulf Cooperation Council (GCC) countries, growth of specialized cardiac centres, rising accessibility to advanced therapies and medical tourism. Nonetheless, reimbursement challenges, lower procedure volumes, infrastructure gaps and regulatory variability limit rapid expansion. As device companies increase presence and procedures expand, gradual growth is expected.

Top Key Players Structural Heart Devices Market:

1. Medtronic plc; Braile Biomedica
2. St. Jude Medical Inc.
3. Medical Technology Est.
4. Micro Interventional Devices Inc.
5. Boston Scientific Corporation; LivaNova PLC
6. Edwards Lifesciences Corporation
7. Cryolife Inc.
8. JenaValve Technology Inc.

These companies, among others, dominate market share through innovation, global reach and procedural leadership in structural heart interventions.

Recent Developments

1. In 2024, Boston Scientific Corporation announced the acquisition of Silk Road Medical for USD 1.16 billion, bolstering its stroke-prevention and structural heart portfolio by adding transcarotid artery revascularization (TCAR) capabilities, which are synergistic with structural heart therapies.
2. In 2025, Boston Scientific reported strong second-quarter performance with its cardiovascular segment growing over 23% year-over-year, driven by structural heart and rhythm-management devices (Farapulse and WATCHMAN) and raised its full-year profit forecast accordingly.

These developments underscore increasing consolidation, pipeline expansion and procedural growth in the structural heart devices space.

Market Scope

The report from Vantage Market Research covers a global forecast period from the base year 2024 to 2035, capturing market size, revenue forecasts, CAGR, and segmentation across product types (heart valves, occluders, annuloplasty rings, accessories), procedures (replacement vs. repair), end-users (hospitals, ASCs, cardiac centres) and geographies (North America, Europe, Asia Pacific, Latin America, Middle East & Africa). It includes competitive landscape analysis, key company profiles, regional insights, market dynamics (drivers, restraints, opportunities, challenges) and strategic implications for stakeholders.

Market Dynamics

Driver:

A primary growth driver is the rising prevalence of structural heart diseases (such as aortic stenosis, mitral regurgitation, congenital defects) along with aging populations globally. This expands the patient pool requiring intervention and fuels demand for structural heart devices. At the same time, increased adoption of minimally invasive therapies (transcatheter valves, occlusion devices) offers patients lower-risk alternatives and broadens indication sets, thereby lifting procedure volumes and device demand.

Restraint:

High device and procedural costs, reimbursement variability, and infrastructure requirements hamper rapid adoption in certain markets. In emerging economies, limited specialist centres and lower awareness of structural heart interventions slow uptake. Device development and regulatory approval timelines are also long and resource‐intensive, which can restrain smaller players and slow introduction of next-generation platforms.

Opportunity:

Significant opportunities exist in emerging markets where procedural volumes are under‐penetrated, and device manufacturers are introducing cost‐effective solutions and expanding indications (e.g., mitral/tricuspid repair). The shift toward outpatient and ambulatory settings, extended device lifespans, and service models present new revenue streams. The growing use of data analytics, procedural guidance systems and next-gen delivery platforms also open opportunities for device innovation and adjacent services.

Challenges:

Challenges include maintaining competitive differentiation amid intensifying competition, demonstrating long-term clinical outcomes and device durability, and navigating complex global regulatory, reimbursement and training landscapes. Additionally, procedural complications, anatomical complexity (especially in mitral/tricuspid space), and the need for physician learning curves make adoption challenging. Ensuring global access and affordability while preserving margins remains a major strategic challenge.

Market Segmentation

1. By Product: Heart Valve Devices , Occluders & Delivery Systems, Annuloplasty Rings & Accessories, Other Structural Heart Devices
2. By Procedure: Replacement, Repair
3. By Region: North America · Europe · Asia Pacific · Latin America · Middle East & Africa

Frequently Asked Questions

1. What was the market size for the structural heart devices market in 2024?

USD 13.1 billion.

1. What is the projected market size in 2035 and the CAGR from 2025-2035?

USD 35.65 billion and CAGR of around 9.55%.

1. Which region currently dominates the market?

North America holds the largest share, driven by infrastructure, procedural volumes and device adoption.

1. Which region is expected to grow fastest?

Asia Pacific is expected to record the fastest growth over the forecast period.

1. What are the major product segments?

Heart valve devices (transcatheter and surgical), occluders & delivery systems, accessory rings/devices.

1. What end-use settings dominate?

Hospitals and cardiac centres currently dominate; ASCs and outpatient settings are emerging.

1. Which companies are leading the market?

Medtronic, Abbott Laboratories, Boston Scientific, Edwards Lifesciences, LivaNova among the primary players.