PROSTHETIC HEART VALVE MARKET ANALYSIS

Prosthetic Heart Valve Market Size and Trends

The prosthetic heart valve market is estimated to be valued at USD 13.21 Bn in 2024 and is expected to reach USD 28.29 Bn by 2031, growing at a compound annual growth rate (CAGR) of 11.5% from 2024 to 2031.

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The market is expected to witness positive growth over the forecast period owing to the rising geriatric population worldwide coupled with the growing prevalence of cardiovascular diseases. Additionally, technological advancements in the field of heart valves such as development of transcatheter heart valves and growing preference for minimally invasive procedures are expected to drive the demand for prosthetic heart valves. However, high costs associated with prosthetic heart valve replacement procedures along with product recalls by major players may hinder the market growth to some extent. Overall, increasing investments by governments and players to enhance the healthcare infrastructure will continue aiding the expansion of the prosthetic heart valve market over the coming years.

Growing prevalence of heart valve diseases

The increasing prevalence of heart valve diseases acts as a key driver for the prosthetic heart valve market. Heart valve diseases traditionally affect elderly populations with degenerative valve disorders being the most common. However, with changing lifestyles, diseases associated with heart valves are being observed in younger populations as well. Conditions like rheumatic fever which can damage heart valves are no longer limited to developing regions. Another factor contributing to rising incidence of valve disorders is the growing epidemic of obesity and diabetes across the world. Both these conditions increase the risk of developing heart problems over the long term. As populations in developed economies continue to battle rising obesity, the burden of diabetes and other associated cardiac complications have increased. Early onset of lifestyle diseases means more people entering middle age with damaged heart valves. As populations grow older worldwide, age-related valve defects will affect a greater number of individuals.

Market Concentration and Competitive Landscape

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Technological advancements represent a key driver propelling the prosthetic heart valve market. Continuous R&D efforts are reshaping the valve replacement landscape with new materials, minimally invasive techniques and transcatheter options. Mechanical heart valves which were the standards for decades are now slowly making way for bioprosthetic or tissue valves due to their superior hemodynamic performance and patient acceptance. Engineered tissue and stent construction methods have enhanced durability of bioprostheses close to 10-15 years. Transcatheter aortic valve replacement (TAVR) procedures using catheter delivered valves have emerged as a less invasive alternative to open-heart surgeries for high-risk patient groups. TAVR systems are innovative wherein collapsed valve substitutes are delivered to the site via catheters and implanted through small incisions. Their perceived advantages over surgical valves such as quicker recovery times are increasing uptake globally. Device manufacturers are striving to develop transcatheter technologies suitable for mitral, tricuspid and pulmonary valve positions as well.

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The prosthetic heart valve market faces several challenges. Currently used mechanical valves have lifelong blood thinning medication requirements which can lead to health issues. Tissue valves have limited durability requiring reoperations. Developing biomaterial alternatives that do not require chronic anticoagulation therapy or have improved durability has been difficult. Reimbursement policies also present a challenge as not all newer valve technologies have established payment codes. The need for extensive clinical trials increases costs and time to market for innovators.

 Market Opportunities: Minimally invasive procedures are on the rise

The growing geriatric population susceptible to valvular heart disease will drive demand. Transcatheter aortic valve replacement minimally invasive procedures are on the rise allowing the treatment of inoperable patients. Newer bioprosthetic valves could provide durable alternatives to mechanical ones reducing health risks. Developing valves compatible for pediatric patients are expected to create lucrative opportunities for market development over the forecasted period.

Insights, By Valve Type: Technological Advancements Fuel the Demand for Mechanical Valves

The valve type segment includes mechanical valves, tissue valves, and transcatheter valves. The mechanical valves segment is anticipated to hold 39.7% of the market share in 2024. Several major players are consistently investing in R&D to develop newer generations of mechanical valves with improved durability and hemodynamic performance. The latest products offer minimized thrombosis risks and employ advanced materials that reduce wear and tear. Additionally, mechanical valves are highly preferred for younger patients since they last decades and eliminate reoperation risks. Recent 3D printing technologies are also enabling customized, patient-specific mechanical heart valves with minimal blood leakage. As newer technological breakthroughs enhance mechanical valves' efficacy and longevity, their adoption rates among cardiovascular specialists remain high for various severities of valvular heart disease.

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The position type segment includes aortic valve, mitral valve, and others. Aortic valve contributes the highest share of the market and is expected to hold 41.5% of the market share in 2024. Aortic stenosis carries grave mortality risks if left untreated and its prevalence increases sharply with age. Given lifestyle-related risks, rising life expectancies have meant growing incidence rates of severe aortic stenosis worldwide. At the same time, transcatheter aortic valve replacement (TAVR) procedures have revolutionized care for high-risk groups by providing a minimally-invasive alternative to conventional surgery. These factors have significantly driven the demand for aortic valve replacements, with TAVR now accounting for the majority of procedures. Additional tailwinds include favorable reimbursement policies supporting TAVR adoption and coordinated care models ensuring timely intervention.

Insights, By End User: Demand for One Day Surgical Procedures

The end user segment includes hospitals, ambulatory surgical centers, catheterization laboratory, and others. Catheterization laboratory contributes the highest share of the prosthetic heart valve market and is projected to hold 38.6% of the market share in 2024. Catheterization Laboratories contributes the highest share of the market driven by its central role in transcatheter heart procedures. Since their introduction over a decade ago, TAVR and other valve implantation techniques have transformed cardiovascular care. By avoiding the trauma of open-heart surgery, they provide treatment access for patients previously deemed inoperable. This has led to rapid capacity expansion at catheterization labs nationwide to meet the burgeoning demand. Additionally, labs benefit from strong relationships with cardiologists, cardiac surgeons and the hospital administration aiding effective coordination of heart team efforts. As transcatheter options for mitral regurgitation and other applications evolve, catheterization labs will continue promoting early intervention approaches and positively impact valve replacement market growth.

Regional Insights

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The North American region has remained the dominant market for prosthetic heart valves globally and is projected to hold 45.9% of the market share in 2024. This can be attributed to cutting-edge research and strong presence of industry leaders in the region. The U.S. in particular houses the headquarters of major players like Edwards Lifesciences, Medtronic, and Abbott that continue to invest heavily in R&D for development of innovative valve designs. Furthermore, favorable reimbursement policies for transcatheter aortic valve replacement (TAVR) procedures in the country ensure higher adoption rates of newer valve technologies.

On the pricing front, North America is able to command a small premium over other regions due to the brand reputation of valves manufactured by domestic companies. However, with rising healthcare costs, payers are pushing for more affordable options. This has led companies to rationalize portfolios by discontinuing older surgical valve models in favor of their latest transcatheter alternatives. Given the large patient pool in the US, even a small decline in average selling price can have significant impact on overall revenues for firms.

The Asia Pacific region has emerged as the fastest growing marketplace for prosthetic heart valves globally. Rapid modernization of healthcare infrastructure and increase in per capita incomes are propelling growth. Governments in various APAC countries have implemented national health insurance plans to ensure wider access to cardiac treatments. However, with a higher proportion of rheumatic heart disease cases compared to developed markets, the preference still remains for cheaper mechanical valves in this region rather than tissue/bioprosthetic alternatives.

Market Report Scope

Prosthetic Heart Valve Industry News

• In October 2023, Edwards Lifesciences Corporation, the global leader in patient-focused technologies for structural heart disease, announced that its EVOQUE tricuspid valve replacement system has acquired CE Mark for transcatheter treatment of eligible patients with tricuspid regurgitation (TR). The EVOQUE system is the world's first transcatheter valve replacement therapy to be approved by regulators for TR treatment.
• In March 2023, Abbott, a medical company, announced that the U.S. Food and Drug Administration (FDA) has approved the Epic Max stented tissue valve for the treatment of aortic regurgitation and stenosis. This device is the most recent addition to Abbott's Epic surgical valve platform, which has a decades-long track record of safety and excellent clinical outcomes, and it features an improved design to boost valve blood flow even further.
• In November 2022, Nyra Medical, Inc., a medical device company developing a revolutionary transcatheter mitral valve repair technology, announced the completion of a US$ 20 million Series A fundraising. Vensana Capital and a significant global medical device business co-led the round, with additional investors including Broadview Ventures, Epidarex Capital, and the Georgia Research Alliance Venture Fund. The proceeds from the financing will be utilized to advance Nyra Medical, Inc.’s technology through early feasibility trials.
• In September 2022, Edwards Lifesciences announced the launch of SAPIEN 3 Ultra RESILIA valve, which combines the company’s innovative RESILIA tissue technology with the industry-leading SAPIEN 3 Ultra transcatheter aortic heart valve. The rollout follows recent U.S. FDA approval.

*Definition: The prosthetic heart valve market involves the manufacturing and sales of prosthetic heart valves used to replace damaged or diseased valves in patients suffering from valve disorders. These artificial heart valves are surgically implanted to restore the heart's normal pumping function. The key types of prosthetic heart valves available are mechanical heart valves and bioprosthetic or tissue heart valves. The global prosthetic heart valve market has been growing due to the rising geriatric population suffering from valvular heart diseases.

Market Segmentation

• Position Type Insights (Revenue, USD BN, 2019 - 2031)
  • Aortic Valve
  • Mitral Valve
  • Others
•  Valve Type Insights (Revenue, USD BN, 2019 - 2031)
  • Mechanical Valves
  • Tissue Valves
  • Transcatheter Valves
• End User Insights (Revenue, USD BN, 2019 - 2031)
  • Hospitals
  • Ambulatory Surgical Centers
  • Catheterization Laboratory
  • Others
• Regional Insights (Revenue, USD BN, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Edwards Lifesciences Corporation
  • Medtronic plc.
  • Boston Scientific Corporation
  • Abbott Laboratories
  • LivaNova PLC
  • CryoLife Inc.
  • Braile Biomedica
  • Colibri Heart Valve LLC
  • JenaValve Technology Inc.
  • TTK Healthcare Limited
  • Lepu Medical Technology Co. Ltd
  • Foldax, Inc.
  • Symetis SA
  • On-X Life Technologies
  • Braile Biomedica