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Prosthetic Heart Valves Market Size, Analysis, Regional Outlook, Application Development Potential, Price Trends, Competitive Market Share & Forecast, 2025 - 2034
Report ID: GMI3230
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Authors: Mariam Faizullabhoy ,
Prosthetic Heart Valves Market
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Prosthetic Heart Valves Market Size
The global prosthetic heart valves market size is expected to see strong growth in the period 2025 to 2034, recording a profitable CAGR over the forecast period. Growth is mainly driven by an increase in the number of geriatric patients, a growing incidence of cardiovascular diseases (CVDs), a global trend toward minimally invasive treatments, and accelerated technological innovation in transcatheter and tissue-engineered valve technologies.
As of 2024, cardiovascular diseases continue to be the leading cause of mortality worldwide. According to the World Heart Federation, more than 500 million people worldwide are currently living with cardiovascular diseases, which were responsible for 20.5 million deaths in 2021—nearly one-third of all global deaths. This represents a dramatic increase from estimates of 12.1 million CVD-related deaths.
It highlights the urgent need for effective heart disease treatments. Four of five deaths from these conditions occur in low- and middle-income economies, emphasizing access to effective treatment that is affordable yet high-tech across populations. In this context, prosthetic heart valves have begun to fill a special role within contemporary cardiology.
With the rise in heart valve disorders, such as aortic stenosis and mitral regurgitation, especially among the geriatric population, we observe a clear increase in the use of prosthetic heart valves. Prosthetic heart valves replace diseased natural heart valves, allowing normal blood circulation and reducing the chance of heart failure, stroke, or sudden cardiac death. Additionally, the prosthetic heart valves market is witnessing increased preference for TAVR because they are minimally invasive, have reduced hospital stay, and offer improved patient outcomes than conventional open-heart surgery.
There is a major transformation underway within the medical devices market in 2024 due to advancements in valve design, deployment approaches, and materials used. The transition towards biocompatible materials, 3D printing, and robotic-assisted approaches is fueling the development of next-generation prosthetic valves that are stronger, flexible, and safe for long-term implantable applications.
Prosthetic Heart Valves Market Trends
The prosthetic heart valves industry is experiencing various emerging trends that are redefining the industry dynamics. The most notable trend in 2024 is the application of AI and machine learning to preoperative planning and postoperative care in valve replacement surgeries. These technologies facilitate cardiologists making evidence-based decisions and tailoring therapies aligned with patient anatomies, increasing the odds of surgical success.
Additionally, there is a growing emphasis on individualized cardiac care as part of the overall individualized variadic pressures from institutions to incorporate extensive implementations of precision medicine. Companies are starting to increasingly focus on adaptive sizing and flexibility of valves for an anatomical match and reducing the chance of paravalvular leak. This is especially germane in patients with complex valvular anatomy or comorbidity.
Moreover, the trend toward increased transcatheter procedures might emerge as the most important market innovator driving innovation. These procedures (TAVR and TMVR) are becoming increasingly prevalent in part because of their growing popularity in high-risk patients who otherwise are unable to receive standard open-heart surgery. In the middle of 2024, clinical trials and approval are expected to increase as these procedures expand to intermediate and potentially low-risk patients, increasing the overall target population.
Prosthetic Heart Valves Market Analysis
The prosthetic heart valves industry from transcatheter aortic valve replacement (TAVR) segment will lead the market until 2034, posting the highest CAGR amongst product types. This minimally invasive technique for the replacement of the aortic valve is revolutionizing the treatment landscape, especially in elderly patients and comorbid patients. In 2024, the TAVR segment also gains from increased FDA indications and CE approvals, improving the procedure as never before, both safer and more accessible.
The popularity of TAVR is based on its clinical benefits, including shorter recovery time, less procedural risk, and better quality of life. In addition, innovations in delivery systems, sheath technology, and embolic protection devices are optimizing procedural safety and effectiveness. Ongoing innovation of next-generation TAVR devices with repositionable and retrievable capabilities is likely to continue to drive uptake during the forecast period.
On the disease type side, the aortic valve disease segment will continue to be the largest and the fastest-growing application segment. The growing worldwide incidence of aortic stenosis and aortic regurgitation, especially in the geriatric population, is leading to the strong demand for both mechanical and biological prosthetic valves. Research and development of aortic valve repair and replacement technologies have been aimed at prolonging the life of the valve while reducing complications like valve thrombosis and endocarditis.
Furthermore, the mitral valve replacement market is also picking up momentum. TMVR as of 2024 has several late-stage clinical trials underway, with encouraging early results. Success in these trials will likely propel commercial launches in the coming years, further diversifying and increasing the market.
North America is the biggest regional prosthetic heart valve market, and this position is expected to prevail until 2034. The excellence of the market in the region is driven by a mixture of positive reimbursement policies, sophisticated healthcare infrastructure, high incidence of cardiovascular diseases, and a fast pace of embracing state-of-the-art medical technology.
The United States is particularly seeing a boom in TAVR procedures with broader FDA approvals in low-risk patients. A growing population of geriatric individuals—projected to be over 80 million in 2050—is also largely responsible for driving demand for prosthetic heart valve treatments.
Canada is also fueling the regional development, supported by enhanced access to advanced cardiac care facilities and government initiatives encouraging minimally invasive heart procedures. Growing investments in R&D in healthcare and medical device development are motivating international players to invest in increasing the size of their operations in the region.
In addition, North American manufacturers are emphasizing collaborative strategic partnerships with academic centers and regulatory authorities to streamline product innovation and approval processes. These initiatives are geared toward minimizing the time-to-market of next-generation prosthetic valves that address the changing needs of patients and healthcare practitioners alike.
Prosthetic Heart Valves Market Share
The prosthetic heart valves industry is dominated by a few prominent global players and several new startups competing with each other to become competitive based on innovation and strategic planning. Top players in the segment are:
These firms are aggressively investing in R&D, introducing next-generation products, and entering into strategic collaborations to enhance prosthetic heart valves market positions. For example, Edwards Lifesciences continues to dominate the TAVR market with its SAPIEN valve series, while Medtronic's CoreValve Evolut platform continues to be a close competitor, with innovative features like the self-expanding mechanism and better hemodynamics.
Emerging competitors are also coming into the limelight by highlighting niche technologies like polymer-based valves, pediatric application valves, and valve-in-valve therapy systems, broadening the ambit of minimally invasive treatment offerings.
Prosthetic Heart Valves Industry News