Transcatheter Heart Valve Market Size, Share & Trends Analysis Report By Application (Transcatheter Aortic Valve, Transcatheter Pulmonary Valve, Transcatheter Mitral Valve), By Technology, By Region, And Segment Forecasts, 2023 - 2030

Transcatheter Heart Valve Market Trends

The global transcatheter heart valve market size was valued at USD 4.2 billion in 2022 and is anticipated to grow at a compound annual growth rate (CAGR) of 15.2% from 2023 to 2030. The key reasons attributing to the high growth include the upsurge in the prevalence of valvular heart diseases amongst the population above 65 years of age, the introduction of third-generation transcatheter heart valves, and favorable reimbursement policies in the U.S. and European Union (EU) nations. Increasing mortality due to chronic and end-stage cardiovascular diseases in the elderly population is a key concern for healthcare providers worldwide. The World Health Federation estimates that in 2021, nearly 20.5 million deaths occur worldwide due to various cardiovascular diseases. In the U.S., heart disease is a leading cause of death, accounting for approximately 928,741 deaths per year.

Transcatheter aortic valve replacement (TAVR) is a surgical heart treatment used to replace an aortic valve that has thickened and is unable to open (aortic valve stenosis) fully. The aortic valve connects the left lower heart chamber (left ventricle) to the body's major artery (aorta). Blood flow from the heart to the body is diminished if the valve does not open properly.

The rising geriatric population is a significant burden on the healthcare system. As per the UN estimates, the geriatric population in the U.S. is expected to reach over 72 million by 2022. The growth of the target population, coupled with the growing risk of end-stage cardiovascular diseases, is expected to improve the usage of these valves. Moreover, the benefits of minimally invasive surgeries and transcatheter heart valve implantation have been strongly advocated based on PARTNER I and PARTNER II clinical trials.

Furthermore, the presence of favorable reimbursement policies available to the patients in the form of government-sponsored Medicare, Medicaid plans, and individual insurance policies are expected to boost the treatment rates for aortic stenosis, mitral regurgitation, & tricuspid regurgitation, and these developments are expected to positively reinforce the market expansion over the forecast period. Medicare National Coverage Determination is one such policy issued by CMS that allows the coverage of these heart valves under Coverage with Evidence Development.

Application Insights

Based on application, the market has been segmented into transcatheter aortic valve, transcatheter pulmonary valve, and transcatheter mitral valve. The transcatheter aortic valve segment accounted for the largest market share of 84.55% in 2022 owing to the growing healthcare expenditure, increasing prevalence of chronic heart diseases, and increasing number of people with severe aortic stenosis. Moreover, technological advancements in tricuspid valve intervention development, harpoon implementation, and neochord systems are among the key factors expected to boost usage rates over the forecast period.

Additionally, various clinical trials conducted to demonstrate the significance of transcatheter aortic valve replacement therapy for treating inoperable patients with aortic stenosis or other valvular diseases have enabled faster adoption of this technology across the U.S. and EU nations. For instance, the PARTNER II clinical trial pertaining to the Edwards Sapien 3 study involving over 1000 patients at around 50 locations in Canada and the U.S. demonstrated more desirable outcomes pertaining to various primary endpoints such as stroke, mortality, and the ability to serve moderate-to-severe valve regurgitation.

The transcatheter mitral valve is expected to grow at the fastest CAGR of 21.9% during the forecast period, owing to the increasing incidences of global mitral regurgitation. Growing awareness regarding the benefits of minimally invasive heart valve surgeries and increasing demand for new treatment options for mitral regurgitation are expected to drive usage rates over the forecast period.

Mitral regurgitation is the most prevalent abnormality worldwide, affecting over 2% of the total population, and has a prevalence that increases with age. For MR patients at high risk for open cardiac surgery, TMVR is a viable therapy option. Compared to open cardiac surgery, TMVR is a less intrusive technique with a quicker recovery and decreased risk of complications. The total number of Transcatheter heart valve procedures conducted in the U.S. was 147,493 for 2022.

However, the transcatheter mitral valve segment is expected to have the highest CAGR of 23.0% over the forecast period. The U.S. FDA approval of the transcatheter mitral repair device in October 2013 is a key driver of the growth of this segment. Growing awareness regarding the benefits of minimally invasive heart valve surgeries and increasing demand for new treatment options for mitral regurgitation are expected to drive usage rates over the forecast period.

Regional Insights

North America dominated the market and accounted for the largest revenue share of 48.4% in 2022. The major factors contributing to its high market share include the increasing investment in R&D and growing awareness about advanced transcatheter heart valve therapy. The U.S. accounts for the majority share in North America, and the U.S. FDA approval for these applications is a critical milestone for commercialization. Moreover, the robust reimbursement framework, incentives for new application development, and collaboration between various stakeholders are additional factors driving growth in this region.

Asia Pacific is expected to grow at the fastest CAGR of 17.0% during the forecast period. Japan and China are a few key hubs for the medical devices market. The growing demand for innovative heart valve therapy devices, the rapidly developing healthcare sector, the increasing geriatric population, and rising healthcare expenditure are expected to boost the transcatheter heart valve market growth. For instance, in some states of India, the presence of favorable government initiatives and reimbursement policies such as Aarogyasri, Jeevandayee Arogya Yojana, and Kalaignar insurance scheme provide coverage for transcatheter heart therapies.

Technology Insights

Based on technology, the market has been segmented into balloon-expanded transcatheter and valve, self-expanded transcatheter valve. The self-expanded transcatheter valve segment accounted for the largest market share of 66.77% in 2022. Most first- and second-generation transcatheter heart valves are based on this technology and, therefore, account for the maximum market share.

However, due to technological advancements, increasing awareness regarding the benefits of balloon-expandable valve systems, and improvements in clinical outcomes. The balloon-expanded transcatheter valve segment is expected to grow at the fastest CAGR of 15.6% during the forecast period. Valve repairs and replacements can now be done using mini-sternotomies and mini-thoracotomies due to advancements in technology and technique. Smaller incisions and longer surgical instruments are now employed to fix valve defects due to many advancements made to surgical equipment with the introduction of minimally invasive cardiac procedures. Compared to a functional incision, this enables faster wound healing, less pain, quicker recovery, and earlier hospital departure.

Key Companies & Market Share Insights

The market is oligopolistic and is dominated by Edwards Lifesciences, Medtronic, and St. Jude Medical. Application launches, approvals, strategic acquisitions, and innovations are just a few of the important business strategies market participants use to maintain and grow their global reach. Companies are actively scouting for potential start-ups and collaborating with different research centers for new application development. For instance, Edwards Lifesciences Corporation acquired CardiAQ Valve Technologies, Inc. to expand into the mitral valve replacement market.

The U.S. Food and Drug Administration approved Abbott's Epic Max stented tissue valve. The FDA in 2023 to treat patients with aortic regurgitation or stenosis. The stented tissue valve from the company is made to have good blood flow, and its low-profile frame makes it easier for patients to undergo future transcatheter procedures. It is the most recent addition to Abbott's Epic surgical valve platform and was constructed using the system for its reliability and long-term performance.

Transcatheter Heart Valve Market Report Scope

Global Transcatheter Heart Valve Market Report Segmentation

This report forecasts revenue growth at global; regional; and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study; Grand View Research has segmented the global Transcatheter heart valve market based on application; technology, and region:

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Transcatheter Aortic Valve

  • Transcatheter Pulmonary Valve

  • Transcatheter Mitral Valve

• Technology Outlook (Revenue, USD Million, 2018 - 2030)

  • Balloon Expanded Transcatheter Valve

  • Self-Expanded Transcatheter Valve

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Sweden

    • Norway

    • Denmark

  • Asia Pacific

    • China

    • Japan

    • India

    • Australia

    • Thailand

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa

    • Saudi Arabia

    • South Africa

    • UAE

    • Kuwait