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Table Of Content
November 2024
The global heart valve devices market size is calculated at USD 14.89 billion in 2025 and is forecasted to reach around USD 40.16 billion by 2034, accelerating at a CAGR of 11.65% from 2025 to 2034. The market sizing and forecasts are revenue-based (USD Million/Billion), with 2024 as the base year.
The global heart valve devices market size accounted for USD 13.34 billion in 2024 and is predicted to increase from USD 14.89 billion in 2025 to approximately USD 40.16 billion by 2034, expanding at a CAGR of 11.65% from 2025 to 2034. The growth of the market is driven by an increase in heart valve disease rates, growing elderly population, and high demand for minimally invasive procedures, providing safer, faster, and more effective treatments.
Artificial intelligence is set to revolutionize the heart valve devices market by enhancing the development of new devices, improving diagnostics, and enabling personalized treatment plans. New startups and existing MedTech firms are utilizing AI in the device design and planning phase, broadening the opportunity for 3D-printed heart valves that are tailor-made for specific patients and improving pre-surgical mapping. Additionally, AI is being used for robotic-assisted techniques to rationalize and reduce the risk during a complex valve replacement procedure and recover better. Companies like Edwards Lifesciences and Abbott Laboratories are incorporating AI into their newest valve systems to assist clinicians improve surgical planning. AI accelerates the development of new heart valve devices by optimizing design and predicting their performance and durability.
Heart valve devices are used to either repair or replace heart valves to restore proper blood flow through the heart. Different types of heart valve devices include mechanical valves, biological/tissue valves, transcatheter valves, and others. Valves are predominantly used for treating diseases such as valvular stenosis and valvular regurgitation. The heart valve devices market is expanding due to the increasing incidence of cardiovascular disease, the increasing aging population, and an increase in the development of new technologies related to minimally invasive procedures.
The shift toward transcatheter techniques from open-heart surgery also increased the demand for heart valves. Market growth is also aided by increased awareness of heart valve diseases, favorable reimbursement policies, and greater access to diagnosis. With manufacturers entering the market and focusing on implementing new and biocompatible solutions (including more durable devices that fit specific patient constructs), the market continues to develop over the next few years.
| Report Coverage | Details |
| Market Size by 2034 | USD 40.16 Billion |
| Market Size in 2025 | USD 14.89 Billion |
| Market Size in 2024 | USD 13.34 Billion |
| Market Growth Rate from 2025 to 2034 | CAGR of 11.65% |
| Dominating Region | North America |
| Fastest Growing Region | Asia Pacific |
| Base Year | 2024 |
| Forecast Period | 2025 to 2034 |
| Segments Covered | Type of Heart Valve, Material, Age Group, End-User, and Region |
| Regions Covered | North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
Aging Population
The heart valve devices market is primarily driven by the rapid growth in the aging population, which is at high risk for degenerative heart valve diseases like aortic stenosis and mitral regurgitation. As of 2024, the global population aged 60 years and older was over 1.6 billion - a growth from 1.5 billion in 2023, according to UN estimates. Additionally, according to the WHO, the number of people aged 80 years or older is expected to triple between 2020 and 2050 to reach 426 million.
The American Heart Association reports about 12.4% of people aged 75 and older are affected by aortic stenosis in the U.S. Furthermore, a study published in the European Heart Journal (2024) identified more than 25% of surveyed people age 60+ screened by echocardiography demonstrated undiagnosed heart valve disease. This demographic shift in the overall population sustains interest in treatment alternatives such as “Transcatheter Aortic Valve Replacement” (TAVR). With the growing acceptance of minimally invasive therapies, along with ever-increasing life expectancy, healthcare systems are witnessing increased utilization of valve replacement therapies. Currently, valve therapy volumes are increasing, especially among intermediate- and low-risk older adults.
High Costs and Regulatory Frameworks Slow Innovation and Market Access
The high cost of heart valve devices is a major factor restraining the growth of the market. The high cost of these devices limits access and deters potential buyers from undergoing surgical procedures. Stringent and lengthy regulatory approval processes for medical devices negatively impact the heart valve devices market and slow down innovation. The implementation of the Medical Device Regulation (MDR) by the European Union in 2023 increased the clinical evidence requirements and timelines to approval. The Food and Drug Administration (FDA) also added to the regulatory burden for heart valve products in the U.S. For Class III devices, including heart valves, the average premarket approval (PMA) requires 180 days to complete in 2023. Typically, fast approvals require significant investments in R&D and other processes, deterring new entrants from entering the market.
Heightened Disease Awareness is Leading to Early Diagnosis and Treatment
Heightened disease awareness surrounding valvular heart disease is creating lucrative growth opportunities for the heart valve device market. Access to diagnostics such as echocardiography is improving; with better identification, they're diagnosed earlier in their disease processes, offering patients the best chance for intervention through valve repair or valve replacement, swaying their treatment options. The U.S. Centers for Disease Control and Prevention (CDC) reported a rise in valve procedures from 25,000 in 2023 to roughly 27,500 in 2024. This increase is reflective of not only clinical advancements but also the ongoing education of patients on heart disease, increased screening frequency, and increased referrals by cardiologists.
The rising development of novel devices further creates immense opportunities in the market. In April 2024, Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the company's first-of-its-kind TriClip transcatheter edge-to-edge repair (TEER) system that's specifically designed for the treatment of tricuspid regurgitation (TR), or a leaky tricuspid valve.
(Source: https://www.prnewswire.com)
Why did the Aortic Valve Segment Dominate the Market in 2024?
The aortic valve segment dominated the heart valve devices market with the largest share in 2024 because of the high prevalence of aortic stenosis, particularly among elderly populations. Because of technological advancements in transcatheter aortic valve implantation (TAVI) in non-surgical treatment options, there has been an increase in the global uptake of TAVI procedures. In terms of aortic valve size, the 20–23 mm and 23–26 mm sizes dominate the aortic valve segment as these sizes accommodate a broad range of patients. Innovations in terms of hemodynamic performance further bolstered segmental growth.
The mitral valve segment is anticipated to grow at a significant CAGR in the coming years. The growth of the segment can be attributed to the increasing prevalence of mitral regurgitation and degenerative valve diseases. The development of minimally invasive mitral valve repair procedures and robotic-assisted surgeries are contributing to segmental expansion. Many of the valve sizes in the mitral segment, such as 26–28 mm and 29–31 mm, have been broadly applied to many of the anatomical needs of patient populations. The rising number of clinical trials and approvals for new mitral devices are likely to drive the growth of the segment.
What Made Biological Valves the Dominant Segment in the Market?
The biological valve segment dominated the market with a major share in 2024. Biological or bioprosthetic valves, which are made from either bovine or porcine tissue, are the preferred choice of surgeons or patients alike because they require less anticoagulation therapy. They are more commonly used in older patients and those with higher bleeding risk. Transcatheter Aortic Valve Implantation (TAVI) plays a significant role in the success of valve replacement procedures due to its short recovery time and improved patient outcomes. In recent years, bioprosthetic valves have become an increasingly favored option.
The mechanical valve segment is expected to expand at the fastest rate over the projected period. Mechanical valves are used for a lifetime and will last significantly longer than bioprosthetic valves, making them the preferred choice for any patient under age 50. There is growing awareness and acceptance of anticoagulation therapy; combined with improvements in biocompatibility and valve design features. Research into next-generation mechanical valves, which limit thromboembolic risk, further support segmental growth.
Why did the Adults Segment Dominate the Heart Valve Devices Market in 2024?
The adults segment dominated the market with the largest share in 2024 because valvular heart diseases are widespread among people aged 40-60, often needing intervention for valves affected by aortic stenosis or mitral regurgitation. With both surgical and minimally invasive treatment options available, treatment options for an adult patient population are better served with the recent advancements in the durability and performance of valve prostheses. Increasing lifestyle diseases and increased detection contribute to the segment’s dominance.
The geriatric patients segment is expected to expand at a notable CAGR over the projected period, as life expectancy around the world increases. Geriatric people are more prone to calcific valve degeneration and stenosis, which can only be corrected with a valve replacement. The availability of less invasive solutions such as TAVI has changed the landscape for high-risk elderly patients. The availability of cardiac care in emerging economies is also expanding and improving the treatment rates for the geriatric population. Increasing demand for newer generations of heart valve devices and personalized treatment plans among geriatric people support segmental growth.
How Does the Hospitals Segment Dominate the Market?
The hospitals segment dominated the heart valve devices market in 2024 because they have the integrated infrastructure to perform complex surgical procedures and provide accompanying care, attracting more patients. Most cardiac interventions, especially open-heart procedures, happen in hospitals that have specific cardiac units. The increased patient volumes, availability of skilled staff, and reimbursement policies for hospitals sustain segment’s dominance. Rising government initiatives to improve and modernize hospital facilities further bolster the segmental growth.
The ambulatory surgical centers segment is expected to grow at the highest CAGR over the forecast period. The rising patient preference for outpatient surgeries drives the growth of the segment. As healthcare systems continue to evolve toward cost-effective and efficient care service delivery, the patient pool is likely to increase in ASCs. With shorter recovery periods and reduced hospital care costs, ASCs promote effective treatment modalities for selected patients, especially with relatively less invasive procedures such as catheter-based repairs of valves gaining acceptance.
What Made North America the Dominant Region in the Heart Valve Devices Market?
North America is a global leader in the heart valve devices market, capturing the largest share in 2024. This is because of its sophisticated healthcare system, the presence of a large number of medical device manufacturing companies, and the increased burden of cardiovascular disease. There is a high demand and acceptance of minimally invasive surgical technologies, including TAVR and TMVR. Increased awareness of structural heart diseases and reimbursement policies for surgical procedures further contributed to the region’s dominance.
The U.S. is a major player in the market within North America. This is mainly due to the increasing prevalence of heart valve diseases. In the U.S., every year, more than 5 million people are diagnosed with heart valve disease, which contributes to more than 25,000 deaths. The severity of the problem is prompting a massive push for next-generation therapies for heart valve interventions.
(Source: https://www.cdc.gov)
European Heart Valve Devices Market Trends
Europe is expected to grow at a significant rate. This is due to its robust healthcare infrastructure and the rising demand for minimally invasive cardiac procedures. An increase in the number of transcatheter aortic valve replacement (TAVR) and mitral valve interventions solidify the region’s position in the market. Supportive reimbursement policies make these devices affordable. Regional regulatory pathways relating to heart valves are becoming more aligned in the EU, enabling much clearer and less cumbersome regulatory pathways for product approvals. Germany is a major player in the market, with its strong focus on advancing cardiac care facilities and high patient volume.
(Source: https://citoday.com)
Asia Pacific Heart Valve Devices Market Trends
Asia Pacific is expected to grow at the fastest CAGR in the coming years. This is mainly due to the growing geriatric population and the increasing prevalence of cardiovascular diseases. Improved diagnostics capabilities and rising acceptance of minimally invasive procedures are driving the growth of the market. Governments of countries like India and China are providing funding for medical device manufacturers to boost domestic production, creating immense opportunities in the market. India is now becoming the center of attention with the launch of the Myval transcatheter aortic valve by Meril Life Sciences in November 2024, which is the first device of its kind to be fully developed and manufactured in India.
The growing awareness of early diagnosis of heart valve related disease increased the overall diagnostic and treatment rates. Partnerships between local hospitals and global MedTech players are supporting regional market growth. In addition, rising government initiatives to improve healthcare infrastructure and modernize existing facilities contribute to market growth.
(Source: https://www.prnewswire.com)
(Source: https://health.economictimes.indiatimes.com)
(Source: https://www.dicardiology.com)
(Source: https://www.businesswire.com)
By Type of Heart Valve
By Material
By Age Group
By End-User
By Region
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