PDF Cover

Aortic Valve Replacement Devices Market

The market for Aortic Valve Replacement Devices was estimated at $8.2 billion in 2025; it is anticipated to increase to $14.0 billion by 2030, with projections indicating growth to around $23.8 billion by 2035.

Report ID:DS1801104
Author:Debadatta Patel - Senior Consultant
Published Date:
Datatree
Life Science
Medical Device
Aortic Valve Replacement Devices
Share
Report Summary
Market Data
Methodology
Table of Contents

Global Aortic Valve Replacement Devices Market Outlook

Revenue, 2025

$8.2B

Forecast, 2035

$23.8B

CAGR, 2026 - 2035

11.2%

The Aortic Valve Replacement Devices industry revenue is expected to be around $8.2 billion in 2026 and expected to showcase growth with 11.2% CAGR between 2026 and 2035. The growing importance of new aortic valve replacement technology in medical centres is demonstrated by the increasing investment being made in the development of aortic valve replacement devices. With an emphasis on structural heart devices, health systems and cardiac centres now are giving priority to the purchase of such new technology. The aortic stenosis and aortic regurgitation market is gaining ground due to the growing population of elderly, which comprises individuals with aortic stenosis and aortic regurgitation. Additionally, it is being driven by the increasing use of minimally invasive techniques known as TAVR. These cardiovascular products are increasingly seen as standard of care in the medical fields of cardiothoracic surgery and interventional cardiology, due to the fact that reimbursement frameworks are being strengthened as well as the fact that outcomes from real life are demonstrating that these products do provide superior long term clinical results.

Aortic valve replacement devices are a mix of self expanding valves, mechanical heart valves and the bioprosthetic valves, which are found in advanced surgical aortic valve replacement platforms and in systems that expand with a balloon. The majority of applications for aortic stenosis and aortic regurgitation, at 89.9%, was seen in 2025. In that year, the market for aortic valve replacement devices was dominated by the that employs a balloon to expand. This earned $5.37 billion. The success of this of valve is due to the precision and reliability of its deployment, as well as its ability to restore the body's blood flow. Advances in TAVR technology, including the expansion of the procedure into lower risk patients, increased use of imaging for precise placement and sizing of the valve, and growing demand in emerging markets are all contributing to a significant increase in the use of aortic valve replacement systems.

Aortic Valve Replacement Devices market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2025-2035
Aortic Valve Replacement Devices Market Outlook

Market Key Insights

  • The Aortic Valve Replacement Devices market is projected to grow from $8.2 billion in 2025 to $23.8 billion in 2035. This represents a CAGR of 11.2%, reflecting rising demand across Therapeutic Correction of Aortic Valve Disease, Geriatric Care, and Mitigating Rheumatic Heart Disease Impact.

  • Amongst leading manufacturers of heart valves, the competitive landscape is defined by companies such as Edwards Lifesciences Corporation, Boston Scientific Corporation and Artivion Inc.

  • The US and Germany are the largest markets in the aortic valve replacement devices sector which is expected to grow at a rate of 8.2% to 11.8% in the period 2025 to 2030.

  • The highest growth rate is expected to be experienced by emerging economies including South Africa, India and Brazil, at a compound rate of 10.8% to 14%.

  • The trend from open chest procedures to less invasive techniques, for instance minimally invasive ones, is predicted to significantly impact the growth of the global aortic valve industry which is expected to hit $1 billion by 2030.

  • The Aortic Valve Replacement Devices market is set to add $15.6 billion between 2025 and 2035, with manufacturer targeting Aortic Regurgitation & Bicuspid Aortic Valve Disease Application projected to gain a larger market share.

  • The market for devices used to replace the aortic valve is predicted to grow by 189% by 2035 over the forecast period of 2025.

aortic valve replacement devices market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032
Aortic Valve Replacement Devices - Country Share Analysis

Opportunities in the Aortic Valve Replacement Devices

Across the Asia Pacific region, networks of cardiologists are also expanding the availability of the transcatheter aortic valve replacement procedure for patients with severe aortic stenosis. Sales of balloon expandable aortic valve replacement devices are forecast to rise to $8.85 billion by 2030 from $5.37 billion in 2025, with a 10.5% CAGR from 2026. Hospitals are predicted to increasingly opt for procedures which are minimally invasive and reduce hospital stays, as part of integrated programmes covering heart disease. The reimbursement reform will help increase the use of TAVR technology in large hospitals.

Growth Opportunities in North America and Asia-Pacific

In North America the demand for aortic valve replacements is driven primarily by aortic stenosis, in which the transcatheter valve implants procedure has a well established place in the treatment protocol and preference is increasingly given to this technique over open surgery for patients who are at a higher or moderate risk of complications. Aortic regurgitation and bicuspid aortic valve disease remain significant, though lesser, indications. Key region's of focus will include developing TAVR for lower risk and younger patients who will receive long lasting bioprosthetic heart valves, improved delivery systems for minimally invasive heart operations, and new valve replacement techniques for malfunctioning existing valves. Additionally, there are opportunities in the use of imaging technology to guide heart operations to shorten the time patients spend in hospital recovering. Competing in this region is fiercely competitive, with established global businesses protecting their market share through clinical data, broad product portfolios and comprehensive cardiac catheter laboratory solutions. Those companies that are emerging in this field are instead focusing on specific indications, smaller annuluses and newer mechanical heart valves. The region has a high disease burden from cardiovascular conditions, with an aging population. This market also features well established heart treatment services, plus governments favourable payment terms for certain treatments. As well as this, There is a quick adoption of treatments which have been proven by scientific research, all factors which help to justify more expensive treatments and investment in educating doctors and demonstrating the value of treatments to the hospitals and healthcare providers which work together to treat patients.
Aortic valve replacement devices are expected to be the fastest growing sector in the Asia Pacific region, driven by demand for aortic stenosis treatment. This is partly due to a higher prevalence of bicuspid aortic valve disease and mixed valve conditions among younger populations in the region. Additionally, aortic regurgitation is an increasing concern due to a rise in echocardiographic screening tests. A company can benefit by producing cost effective and large scale aortic valve replacements, both surgical and through a catheter. These valves should be suitable for different healthcare systems, like hybrid systems that let hospitals using traditional surgical methods switch over time to minimally invasive surgery. In this industry, success will go to firms that modify manufacturing processes to accommodate different body shapes, design medical equipment with the needs of smaller stature people in mind, and work with top cardiac centres. This will create a significant obstacle to new market entrants. The region is expected to see growth in the sector as a result of an increasing number of cardiovascular disease cases, more heart specialists, better health care facilities, and greater health insurance. Government support for heart treatment equipment will make the region a more attractive option for training doctors, conducting heart disease trials and manufacturing affordable heart devices with high quality.

Market Dynamics and Supply Chain

01

Driver: Increasing Prevalence of Aortic Valve Disorders and Expansion of Minimally Invasive Procedures

The aortic valve replacement devices market is also driven by the rising prevalence of aortic valve disorders and the rapid expansion of minimally invasive procedures. Aging populations and the growing incidence of aortic stenosis and regurgitation are also increasing demand for effective valve replacement solutions. At the same time, transcatheter aortic valve replacement and other minimally invasive techniques are also gaining traction due to reduced procedural trauma, shorter hospital stays, and faster patient recovery compared to conventional open-heart surgery. This shift is also encouraging healthcare providers to invest in advanced valve replacement devices, supporting market adoption. Leading companies such as Edwards Lifesciences, Medtronic, and Boston Scientific are also focusing on developing durable and hemodynamically efficient valves suitable for catheter-based delivery, particularly for high-risk and elderly patient groups. Together, the increasing disease burden and wider adoption of minimally invasive technologies are also expanding market penetration, driving innovation, and creating growth opportunities across hospitals, cardiac specialty centers, and emerging healthcare markets.
A significant driver of the TAVR market is also the ongoing development of next-generation transcatheter and bioprosthetic valve devices. Innovations include enhanced leaflet designs for improved hemodynamics, smaller and more flexible delivery systems, and increased durability, which allow treatment of patients previously considered ineligible for valve replacement. These advancements contribute to shorter procedural times, lower complication rates, and faster patient recovery, expanding adoption in high-risk, elderly, and intermediate-risk populations. Continuous improvements in imaging compatibility, valve positioning accuracy, and long-term performance further support market growth and provide manufacturers with a strong competitive edge in the evolving structural heart devices landscape.
02

Restraint: High Procedural and Device Costs Limit Access in Emerging and Cost-Sensitive Markets

The high cost of aortic valve replacement devices, particularly TAVR systems and advanced bioprosthetic valves, remains a major restraint on market growth. These premium technologies require specialized infrastructure and highly trained medical personnel, prompting many healthcare systems in emerging and cost-constrained regions to delay adoption or rely on conventional surgical alternatives. Additionally, high out-of-pocket expenses for patients reduce affordability and suppress demand. As a result, revenue growth for manufacturers is constrained, and broader market penetration across price-sensitive and developing healthcare markets remains limited.
03

Opportunity: Mechanically expandable Aortic Valve Replacement Devices for younger low-risk patients in leading European centers and Rising surgical Aortic Valve Replacement Devices volumes in India’s government-funded tertiary cardiac hospitals

Researchers at a number of European cardiac care facilities are experimenting with mechanical aortic valve replacement systems. These are for people with aortic valves in need of replacement who are not only at high risk. These devices allow for precise placement and repositioning, accommodate complex valve anatomies and reduce the risk of leakage around the valve compared to earlier models of the device. The mechanically expandable valve market will see the highest growth rate with a compound annual growth rate of 14.94% to reach $1.3 billion by 2030. It was valued at $650 million in 2025. This rise in the mechanically expandable valve market can be attributed to the use of minimally invasive procedures and value based healthcare models in the leading hospitals and cardiovascular networks.
Among patients who reside in Indias rural region's and have low incomes, there is a considerable unmet demand for cost effective surgical aortic valve replacement equipment. Cardiac centres that are funded by the government are expanding the capacity in their operating theatres for the replacement of heart valves and also have installed newer models of minimally invasive valves. By 2030, the global self expandable devices market is predicted to rise from $2.21 billion to $3.84 billion at an annual growth rate of 11.7%.Increasingly Asian markets are expected to grow the most quickly in the number of procedures and in orders for this product. This is due to improving insurance cover and clinical pathways.
04

Challenge: Regulatory Hurdles and Complex Clinical Trial Requirements Delay Product Launches Globally

Stringent regulatory frameworks and extensive clinical validation demands pose ongoing challenges for aortic valve replacement device developers. Securing approvals from authorities like the FDA and EMA requires large, costly trials with long follow‑up periods, delaying time‑to‑market for new innovations. These barriers increase development costs, reduce competitive entry from smaller companies, and can restrict availability of next‑generation valves in some regions, impacting overall market dynamics and product diversity.

Supply Chain Landscape

1

Valve Materials Sourcing

W. L. Gore & AssociatesDSM BiomedicalCarpenter Technology
2

Aortic Valve Manufacturing

Edwards Lifesciences CorporationMedtronicBoston Scientific Corporation
3

Cardiac Device Distribution

Cardinal HealthOwens & MinorMedline Industries
4

Clinical End Use

Cardiac SurgeryTranscatheter Aortic Valve ReplacementAortic Valve Replacement Devices
Aortic Valve Replacement Devices - Supply Chain

Use Cases of Aortic Valve Replacement Devices in Therapeutic Correction of Disease & Geriatric Care

Therapeutic Correction of Aortic Valve Disease : In the therapeutic correction of aortic valve disease, aortic valve replacement devices such as transcatheter aortic valve replacement (TAVR) systems and surgical bioprosthetic valves are predominantly used to restore normal blood flow and relieve symptoms of stenosis or regurgitation. TAVR systems are increasingly preferred for high‑ and intermediate‑risk patients due to their minimally invasive delivery via catheterization, reducing procedural trauma and recovery time. Leading players Edwards Lifesciences, Medtronic, and Boston Scientific offer advanced TAVR platforms with proven durability and hemodynamic performance. Their strengths lie in robust clinical evidence, widespread adoption in cardiac centers, and strong innovation pipelines. These systems help clinicians deliver effective therapeutic correction while enhancing patient outcomes and expanding treatment candidacy for individuals previously ineligible for open‑heart surgery.
Geriatric Care : Aortic valve replacement devices play a critical role in geriatric care due to the high prevalence of aortic stenosis in older populations. TAVR devices, especially self‑expanding and balloon expandable valves, are widely deployed in elderly patients who may not tolerate conventional surgery. Manufacturers like Edwards Lifesciences and Medtronic lead this segment with patient‑specific sizing and low profile designs that improve procedural safety and shorten hospital stays. Their devices support improved quality of life, reduced procedural risk, and faster rehabilitation for aging patients, reinforcing strong market positions in age‑focused cardiovascular care.
Mitigating Rheumatic Heart Disease Impact : In regions affected by rheumatic heart disease, especially in low‑ and middle‑income countries, surgical bioprosthetic valves and TAVR systems are used to address rheumatic aortic valve damage, providing durable functional replacement. Bioprosthetic valves from St. Jude Medical (Abbott), Sorin (LivaNova), and Carpentier‑Edwards are favored for their long‑term performance and reduced need for long‑term anticoagulation. TAVR devices are also increasingly introduced where infrastructure permits less invasive interventions. Leading global players expand access through partnerships, training programs, and tiered pricing, helping mitigate the burden of rheumatic complications and improving outcomes in vulnerable populations.

Recent Developments

Recent developments in the TAVR market highlight a shift toward next-generation transcatheter valves, improved delivery systems, and patient-specific sizing to enhance procedural safety and outcomes. Key trends include the expansion of TAVR into low- and intermediate-risk populations and increasing adoption in geriatric care. Leading players like Edwards Lifesciences and Medtronic are driving innovation with durable, minimally invasive valves that reduce hospital stays and support rapid recovery, reinforcing TAVR’s role as a standard treatment for aortic stenosis.

March 2025 : Medtronic reported five‑year clinical outcomes from the Evolut Low Risk Trial, showing durable performance and safety of its Evolut transcatheter aortic valve replacement system in low‑risk aortic stenosis patients. 
July 2024 : JenaValve Technology Inc. received CE Mark approval in Europe for a transcatheter aortic valve system specifically targeting aortic regurgitation, offering a differentiated treatment option for this condition.
July 2024 : Edwards Lifesciences completed its acquisition of JC Medical (including J‑Valve technology) and Endotronix, expanding its structural heart portfolio and reinforcing innovation in TAVR and associated therapies.

Impact of Industry Transitions on the Aortic Valve Replacement Devices Market

As a core segment of the Medical Device industry, the Aortic Valve Replacement Devices market develops in line with broader industry shifts. Over recent years, transitions such as Shift to Minimally Invasive Procedures and Rising Demand for Transcatheter Aortic Valve Replacement have redefined priorities across the Medical Device sector, influencing how the Aortic Valve Replacement Devices market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Shift to Minimally Invasive Procedures

With more hospitals and heart centres choosing minimally invasive techniques for surgeries there is an acceleration of the trend in this industry. The technology offers patients less pain and a shorter hospital stay when compared with open heart surgery. This trend is greatly affecting the market for aortic valve replacement equipment. The market for aortic valve replacement devices will be driven forward by the swift adoption of minimally invasive cardiac surgery techniques such as TAVR. This will enhance the market size by $1 billion by 2030 and make it the main growth driver for the structural heart segment. Companies that focus on making valve systems smaller and easier to deliver, plus catheter based systems that deliver valves, will gain more market share, increase their pricing power and have a greater rate of innovation in heart valve products.
02

Rising Demand for Transcatheter Aortic Valve Replacement

The Transcatheter Aortic Valve Replacement market is witnessing significant growth due to increasing acceptance of minimally invasive valve implants over traditional open-heart surgery. TAVR procedures are especially favored for high-risk and elderly patients, as they reduce recovery time, hospital stays, and procedural complications. This shift has driven hospitals and cardiac specialty centers to invest in advanced catheterization labs, imaging equipment, and procedural support tools, creating downstream opportunities for medical device suppliers. Leading players like Edwards Lifesciences, Medtronic, and Boston Scientific are expanding product portfolios with next-generation TAVR devices featuring improved durability and smaller delivery systems. The rise of TAVR has also influenced related sectors such as interventional cardiology, perioperative care, and hospital infrastructure upgrades, promoting wider adoption of minimally invasive therapies, improving patient outcomes, and stimulating innovation in complementary devices like catheters, guidewires, and imaging platforms across the cardiovascular ecosystem.