Logo

Share:

Top 5 Structural Heart Devices Companies in Global [Updated] | Global Growth Insights

The structural heart devices market in 2025 is rapidly expanding due to the rising prevalence of cardiovascular conditions and the global shift toward minimally invasive procedures. Over 12 million individuals are diagnosed with structural heart disorders each year, driving demand for devices such as transcatheter heart valves, septal occluders, and annuloplasty systems. The top five players—Medtronic, Abbott, Boston Scientific, Livanova, and Edwards Lifesciences—collectively hold over 78% of the global market share. Minimally invasive heart procedures now make up 72% of all structural heart interventions globally, showing a clear preference for patient-centric, low-recovery time therapies. The U.S. remains the global leader, contributing 48% to total procedural volume, supported by favorable reimbursement and innovation-led investment.

Structural heart devices are specialized implants and tools used to treat abnormalities in heart structure, including heart valves and septal defects. As of 2025, more than 1.5 million structural heart procedures are conducted globally, with a rising share of these performed via catheter-based approaches. Transcatheter Aortic Valve Replacement (TAVR) procedures have become standard in many markets, outpacing surgical alternatives. 72% of all structural interventions in 2025 are non-surgical, highlighting the transformation of cardiac care through innovation, safety, and efficacy

Structural Heart Devices Market size was USD 14.08 billion in 2023 and is projected to reach USD 15.6 billion in 2024, expanding to USD 35.34 billion by 2032, with a CAGR of 10.76% during the forecast period [2024-2032].

How Big is the Structural Heart Devices Industry in 2025?

In 2025, the structural heart devices industry is witnessing significant global expansion, driven by a rising burden of cardiovascular disorders and accelerating adoption of minimally invasive technologies. Globally, more than 1.5 million structural heart procedures are expected to be performed by the end of the year—marking a considerable rise from previous years. Among these, 72% of interventions are now conducted via transcatheter techniques, underscoring a shift away from open-heart surgeries and toward catheter-based approaches.

The United States remains the largest contributor, accounting for approximately 48% of the global procedure volume. This translates to more than 380,000 procedures in 2025 alone. High adoption rates are fueled by Medicare reimbursement, expanding transcatheter therapy programs, and continuous innovation in delivery systems. Institutions such as Cleveland Clinic and Mayo Clinic report record procedural volumes for Transcatheter Aortic Valve Replacement (TAVR) and Mitral Valve Repair (TMVR), with TAVR alone making up nearly 60% of all aortic interventions in the country.

Europe, holding around 28% of the market share, continues to show robust procedural uptake across Germany, France, and the U.K. Over 75% of heart valve interventions in Europe are now performed via catheter-based devices, especially in older patients and high-risk surgical candidates. Germany, in particular, leads the continent with over 95,000 structural heart procedures estimated for 2025.

The Asia Pacific region has emerged as the fastest-growing frontier, comprising nearly 18% of the global structural heart devices market. Japan leads regional innovation with a national registry that tracks over 85% of its transcatheter procedures. China and India are rapidly expanding their infrastructure—collectively accounting for over 180,000 estimated procedures this year.

Meanwhile, Latin America and the Middle East & Africa (MEA) regions contribute 3% and 2%, respectively. Brazil dominates Latin America, performing nearly 60% of the region’s procedures. In MEA, countries such as the UAE and South Africa are expanding tertiary care facilities, with a combined 30,000+ procedures expected in 2025.

Market dominance is concentrated among five key players—Medtronic, Abbott, Boston Scientific, Edwards Lifesciences, and Livanova—who together account for more than 78% of the total global procedure volume, emphasizing their technological depth, regulatory presence, and strategic collaborations.

Regional Insights – Structural Heart Devices Market

The global structural heart devices market in 2025 exhibits a highly concentrated regional landscape, with the top three regions—North America, Europe, and Asia Pacific—accounting for over 94% of the global procedural volume. Market maturity, healthcare infrastructure, regulatory clarity, and innovation pipelines are the key factors influencing regional dominance.

North America – 48% Market Share

North America continues to dominate the global market with 48% share, led primarily by the United States, where procedural volumes have exceeded 380,000 in 2025. The U.S. has become a hub for robotic-assisted TAVR, AI-integrated diagnostics, and next-generation valve platforms. Over 72% of structural heart interventions in the region are transcatheter-based, enabled by strong physician training, FDA approvals, and reimbursement systems.

Europe – 28% Market Share

Europe holds 28% of the total market, with Germany, France, and the United Kingdom leading in procedural density. In 2025, more than 75% of all valve replacements in Europe are performed using transcatheter techniques. Germany alone accounts for over 95,000 procedures, aided by structured national heart programs and early CE-mark access for new devices. The region emphasizes sutureless valve innovations and public reimbursement expansion.

Asia Pacific – 18% Market Share

Asia Pacific comprises 18% of the global structural heart devices market. Japan, with its aging population and robust procedural registries, leads in adoption of TAVR and TMVR. China and India are emerging as fast-growing players, collectively performing more than 180,000 procedures in 2025. Regional governments are investing in cath labs and interventional cardiology training, pushing procedural growth across Tier-1 and Tier-2 cities.

Latin America – 3% Market Share

Latin America represents a 3% share of the global market. Brazil alone accounts for 60% of all regional procedures, driven by public-private initiatives and imported device approvals. While market maturity is low compared to developed economies, cross-border partnerships and remote diagnostics are expanding accessibility.

Middle East & Africa (MEA) – 2% Market Share

MEA holds a 2% market share in 2025. The UAE and South Africa collectively contribute over 30,000 procedures, supported by hospital privatization and regional cardiac centers. The adoption of hybrid operating rooms and collaborations with multinational firms are increasing procedural volume in select urban hospitals.

Global Growth Insights unveils the top List global Structural Heart Devices Companies:

Company Headquarters 2025 Highlights Market Specialization Key Numerical Insights
Medtronic, Plc Dublin, Ireland ~580,000 implants globally TAVR, Mitral Valve Devices Strong U.S. and EU presence; expanding robotics
Abbott Laboratories Illinois, USA 250,000+ MitraClip procedures in 2025 Mitral Valve Repair, Septal Closure Devices 43% global share in mitral valve segment
Boston Scientific Corporation Massachusetts, USA 240,000+ Watchman FLX implants Left Atrial Appendage (LAA) Closure Devices 70% share in LAA closure device segment
Livanova Plc London, UK 60,000+ procedures performed in Europe Sutureless Valves, Pediatric Heart Devices Strong presence in minimally invasive solutions
Edwards Lifesciences Corp. California, USA 300,000+ Sapien 3 Ultra implants Transcatheter Aortic Valve Replacement (TAVR) 54% global share in TAVR market

Structural Heart Devices Market Trends in 2025

The structural heart devices market in 2025 is experiencing a wave of innovation and clinical adoption across all major global regions. The focus is shifting towards minimally invasive treatments, precision-guided interventions, and smart device integration. Below are the key trends reshaping the industry:

Dominance of Transcatheter Procedures

By 2025, 72% of all structural heart procedures are performed using transcatheter techniques such as TAVR, TMVR, and LAA closure. These less invasive approaches are replacing traditional open-heart surgeries due to shorter recovery times and lower complication rates.

AI and Imaging Tools Become Standard

Advanced diagnostics powered by AI are now embedded in 62% of hospitals conducting structural heart interventions. These tools support real-time image guidance, improving procedural accuracy and reducing failure rates in complex anatomical cases.

Personalized Valve Solutions Surge

Approximately 41% of procedures now utilize patient-specific anatomical data for valve sizing and deployment. The result: a 27% decrease in post-operative complications, with significantly higher device success rates.

Robotic Delivery Systems on the Rise

Robotic-assisted valve placement is gaining traction, especially in the U.S., where 22% of centers have integrated robotics into cath labs. This is enhancing precision and reducing operator fatigue during long and complex procedures.

Smart Delivery Platforms in New Devices

New-generation delivery systems with real-time positioning feedback now account for 55% of structural heart implants. These systems offer enhanced control and safety, particularly for first-time procedures and high-risk patients.

Strategic Opportunities by Region

The global structural heart devices market presents diverse regional opportunities in 2025, shaped by varying levels of healthcare maturity, regulatory frameworks, and technology adoption. North America, particularly the United States, holds a commanding 48% share of the global market, making it the most lucrative region for advanced innovations and procedural volume expansion. With more than 380,000 structural heart procedures performed in the U.S. alone in 2025, this region offers significant opportunities for device manufacturers to enhance market penetration through robotic-assisted delivery platforms and AI-powered procedural guidance. Robotic systems are now integrated into over 22% of cath labs in the country, reducing human error, improving precision, and shortening procedure durations. As hybrid operating rooms become standard in large hospitals, mid-tier institutions and community health systems remain untapped—creating an opening for scalable, cost-effective device offerings and physician training programs.

Europe, accounting for around 28% of global market share, offers another attractive landscape driven by early adoption and supportive reimbursement models. Countries like Germany, France, and the UK dominate transcatheter heart therapies, with more than 75% of procedures in Europe now performed via minimally invasive routes. A significant strategic opportunity lies in the region’s regulatory alignment—particularly under the updated Medical Device Regulation (MDR)—which has reduced the average device approval cycle by 6 to 8 months. This allows manufacturers to enter the market faster and streamline multi-country product launches. Additionally, Europe presents fertile ground for collaborative research and multi-center trials, especially in the development of next-generation TMVR (transcatheter mitral valve replacement) and tricuspid solutions for aging populations. Companies that form clinical partnerships with major academic hospitals in Europe are well-positioned to shape standards and accelerate market adoption.

Asia Pacific continues to be the fastest-growing region, capturing 18% of global procedures in 2025, with over 180,000 structural interventions estimated in markets such as Japan, China, and India. Japan leads in procedural accuracy and elderly patient care, while China and India offer massive untapped potential due to rapidly expanding cardiac infrastructure. China's government-backed investment in cardiovascular disease prevention and its growth in structural procedures at nearly twice the global rate present immense market entry opportunities for global and regional players alike. India’s shift toward public-private hospital collaborations, coupled with growth in cath lab installations in Tier 2 and Tier 3 cities, paves the way for scaled training programs and cost-sensitive device offerings. Moreover, establishing localized manufacturing in both countries can help reduce device costs by up to 25%, making care more accessible while supporting national import substitution initiatives.

Latin America, although smaller in scale, offers strategic avenues for expansion, holding about 3% of the global market. Brazil dominates this region, performing around 60% of Latin America’s structural heart procedures in 2025. The strategic opportunity here lies in the growing presence of mobile cardiac units, particularly in underserved regions of Brazil, Mexico, and Argentina. Companies can partner with NGOs and government healthcare bodies to deploy structural heart devices through mobile cath labs and telehealth-enabled follow-up systems. This decentralized model of care delivery is gaining traction and can be scaled quickly, especially when supported by local device production or streamlined import approvals.

The Middle East and Africa (MEA) region, though accounting for just 2% of global procedure volume, shows strong forward-looking potential. Countries such as the UAE and South Africa are leading regional growth, with a combined 30,000+ structural procedures expected in 2025. A key strategic advantage is the rapid privatization of tertiary hospitals and the government’s openness to foreign direct investment in cardiovascular infrastructure. Opportunities exist for companies to enter long-term contracts with new cardiac centers and supply AI-enabled imaging systems, remote consultation tools, and flexible valve technologies suited for limited-resource environments. Moreover, establishing physician training programs in collaboration with international societies could help develop local talent and expand procedural capabilities across the region.

In conclusion, while mature markets such as the U.S. and Germany offer high-value innovation pathways, emerging markets across Asia, Latin America, and MEA represent the next wave of scalable structural heart care expansion. Players who balance innovation with affordability and training will be well-positioned to lead the next phase of global growth.

Industry Insights for Investors

Over $2.5 billion in M&A recorded in structural heart space between 2024–2025 18% of new structural heart centers funded through public-private partnerships Emerging players focusing on AI-driven pre-procedural planning and valve miniaturization

Conclusion

In 2025, structural heart therapies reach new technological and clinical maturity. The U.S. remains dominant with 48% market share, but Asia Pacific is the rising frontier, doubling procedural volumes annually in several countries. The focus for top players is on robotic delivery, AI assistance, and expanding access in underserved regions. Edwards, Medtronic, and Abbott are driving global volume and innovation, contributing over 70% of all new implantations worldwide. Structural heart therapy is no longer niche—it's foundational to the future of interventional cardiology.

FAQ

Q1: What are structural heart devices?
Devices used to repair heart valve defects, septal defects, and other anatomical heart abnormalities.

Q2: Which companies are leading in 2025?
Edwards Lifesciences (~54% TAVR), Medtronic (~580K implants), Abbott Laboratories (~43% mitral valve share)

Q3: What percentage of procedures are transcatheter?
72% in 2025, indicating a strong shift from traditional surgery.

Q4: Which region leads the market?
The U.S. leads with 48% share; Europe and Asia follow.

Q5: What’s the fastest-growing device category?
Transcatheter mitral valve replacement (TMVR), growing at 35% YoY in 2025.