TRANSCATHETER AORTIC VALVE REPLACEMENT MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2024 - 2031)

Transcatheter Aortic Valve Replacement Market Size and Trends

The global transcatheter aortic valve replacement market is estimated to be valued at USD 6.71 Bn in 2024 and is expected to reach USD 10.80 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 7% from 2024 to 2031.

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The growing geriatric population with aortic stenosis and increasing preference for minimally invasive surgeries are key drivers for the transcatheter aortic valve replacement market growth. Additionally, the market for transcatheter aortic valve replacement is expected to witness a significant growth due to the rising prevalence of aortic stenosis and increasing number of transcatheter aortic valve replacement procedures performed worldwide.

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Insights By Procedure Type - The Rise of Transfemoral Procedures in Aortic Valve Treatment

In terms of procedure type, the transfemoral segment is expected to contribute the highest market share of 42.1% in 2024 due to its minimally invasive nature and faster recovery times compared to traditional surgical methods. By allowing surgeons to access the damaged aortic valve through a small incision in the thigh, transfemoral procedures eliminate the need for open-heart surgery. This advancement significantly reduces complications, shortens hospital stays, and accelerates recovery periods for patients.

Insights By Device Type - Balloon-Expandable Valves Lead with Positive Clinical Outcomes

In terms of device type, balloon-expandable valves segment is expected to contribute the highest market share of 52% in 2024 owing to their quicker implantation and track record of positive clinical outcomes. These valves are compressed and delivered to the target location through a catheter before being expanded to their functioning size with a balloon. This inflation technique allows for precise positioning and firm anchoring of the replacement valve within the native annulus.

Insights By End User - Hospitals Remain at the Forefront

In terms of end user, hospitals segment is expected to contribute the highest market share of 38.2% in 2024 owing to state-of-the-art infrastructure and multidisciplinary teams. Most transcatheter aortic valve replacement (TAVR) procedures, especially complex cases, are performed in hospitals that have advanced catheterization labs, cardiac surgery backups, intensive care facilities, and round-the-clock specialized staff. The high-acuity nature of many patients along with the delicate nature of the operation require expert management at every step.

Regional Insights

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Dominating Region: North America

North America dominates the transcatheter aortic valve replacement market with an estimated share of 39.2% in 2024. This can be attributed to the strong presence of major medical device manufacturers, supportive reimbursement policies, high adoption rates among the aging population, and continual technological advancements. Key players like Medtronic and Edwards Lifesciences have contributed to the extensive availability of innovative treatment options.

Fastest-Growing Region: Asia Pacific

The Asia Pacific region exhibits the fastest growth, driven by increasing healthcare expenditures, rapid economic expansion, growing medical tourism, and government efforts to enhance accessibility of critical cardiac procedures. Countries like India and China are key focus areas for leading global companies like Abbott Laboratories looking to tap into untapped market potential.

Transcatheter Aortic Valve Replacement Market Outlook for Key countries

High Prevalence of Aortic Regurgitation in the U.S.

The U.S. leads in managing aortic regurgitation due to its high prevalence of the condition of aortic regurgitation (AR). For instance, the article "Aortic Regurgitation," published by StatPearls in April 2022 reported that the prevalence of aortic regurgitation in the U.S. ranges between 4.9% and 10.0%. Additionally, it highlighted that men (13.0%) are more likely to experience aortic regurgitation compared to women (8.5%).

Clinical Trials Driving Transcatheter Aortic Valve Replacement Adoption in the U.K.

The U.K. transcatheter aortic valve replacement industry is shaped by ongoing research and clinical trials. For example, the UK-TAVI trial, conducted in September 2022 by the National Institutes of Health (NIH), compared the outcomes of TAVR and surgical aortic valve replacement in patients over 70 with moderate operative risk. These trials play a vital role in evaluating safety and efficacy, influencing the integration of TAVR into clinical practice in the U.K.

Innovation in TAVR Technology and Accessibility in China

China’s transcatheter aortic valve replacement industry is experiencing growth driven by advancements in valve technology and procedural techniques. For instance, in August 2021, Peijia Medical launched its first and subsequent generations of TAVR, transcatheter aortic valve replacement products after receiving regulatory approval in China. These innovations improve procedural success, expand patient eligibility, and enhance access to minimally invasive treatments for severe aortic valve diseases.

Public Insurance Expanding Access to TAVR Treatments in Brazil

Brazil’s transcatheter aortic valve replacement market is boosted by comprehensive public insurance and efforts to expand access to under-served patient segments. Local medtech firms contribute to this progress. For instance, in January 2020, according to National Institutes of Health (NIH), as of 2020, Brazil's public health system, known as the Sistema Único de Saúde (SUS), covered about 80.8% of heart surgeries, including TAVR, ensuring access to care for elderly patients with severe aortic stenosis who often face financial constraints.

Market Concentration and Competitive Landscape

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Top Strategies Followed by Global Transcatheter Aortic Valve Replacement Market Players

• Established players heavily focus on research and development to drive innovation in product design and performance. Leaders like Medtronic and Edwards Lifesciences spend over 10% of annual revenues on R&D. They invest in developing valves with improved durability and lower risks of paravalvular leak. Strategic partnerships are also important.
• Mid-level players compete through affordable solutions. Companies such as Boston Scientific aim to make their valves 10-20% cheaper without compromising quality. They work on minimizing production costs through process optimization and sourcing raw materials efficiently. Collaborations help boost capabilities. For instance, St. Jude Medical has joint R&D programs with startups to integrate their technologies into existing platforms.
• Small manufacturers leverage niche specialization. Firms focus on specific patient types overlooked by larger firms. For example, LivaNova develops self-expanding valves tailored for elderly patients with severe comorbidities. Adopting novel techniques allows minimally-invasive procedures. Others form local partnerships for distribution and service support in emerging markets.

Emerging Startups in the Global Transcatheter Aortic Valve Replacement Market

Several startups are developing innovative technologies to transform the market. Companies like Ventii and Anthropic apply AI to imaging data to guide complex valve implantations. Their solutions could reduce procedure risks and times significantly. DuraBiotech incorporates shape memory alloys and smart materials into collapsible valves for improved durability and longevity.

Sustainability is a priority for some startups. Everheart creates bioprosthetic valves from sustainably sourced biological materials like plant-based collagen. Their goal is facilitating widespread adoption through affordable and eco-friendly products. ValveGen focuses on advanced tissue engineering to develop living, self-regulating replacements reducing frequent reoperations.

New entrants also address unmet needs. For example, TaurusOne is launching a pediatric TAVI system as an alternative to open-heart surgeries for young patients with valve defects. Others partner with medical institutions running global outreach programs.

Transcatheter Aortic Valve Replacement Industry News

• On March 2024, Medtronic plc, a medical device company, announced that the U.S. Food and Drug Administration (FDA) approved the Evolut FX+ transcatheter aortic valve replacement system for treating symptomatic severe aortic stenosis. The new Evolut FX+ TAVR system retains the valve performance benefits of the previous Evolut TAVR platform and is designed to enhance coronary access.
• In June 2023, egnite, Inc., a digital health company specializing in cardiovascular care, and JenaValve Technology, Inc., a developer and manufacturer of innovative TAVR systems, announced a strategic partnership. This collaboration aims to enhance the understanding of the care paradigm and associated outcomes for patients with aortic regurgitation (AR).
• On January 2024, Eisenhower Health became the first hospital in the U.S. to be designated as an Edwards Benchmark Program Case Observation Site for treating aortic stenosis in patients undergoing transcatheter aortic valve replacement

Key Takeaways from Analyst

The global transcatheter aortic valve replacement market is poised for strong growth, driven by a rising geriatric population and increasing aortic stenosis cases. Asia Pacific (excluding Japan) is expected to see the fastest growth due to improved healthcare infrastructure and medical tourism; North America will dominate in the short term due to advanced technology and supportive policies. Self-expandable valves are gaining popularity for their lower risk but lack long-term durability data, offering opportunities for innovation.

Market Report Scope

Market Dynamics

Market Driver - Increasing prevalence of aortic stenosis among the aging population

The aging global population has led to a rise in age-related conditions like aortic stenosis, a narrowing of the aortic valve that restricts blood flow. Advancements in healthcare have increased life expectancy, contributing to more elderly individuals at risk. For instance, according to the National Institute of Health, in April 2024, 2-7% of people over the age of 65 may have measurable aortic stenosis. Approximately 13% of people over 75 years of age have mild-to-moderate aortic stenosis while around 4% have severe aortic stenosis requiring surgical treatment.

Market Challenge - High cost of transcatheter aortic valve replacement devices

The high cost of transcatheter aortic valve replacement devices poses a major challenge for the global transcatheter aortic valve replacement market growth. TAVR devices are significantly more expensive than standard open-heart surgical aortic valve replacements (SAVR). The estimated average cost of TAVR procedure in the U.S. ranges between US$ 60,000 and US$ 100,000 compared to around US$ 30,000 for SAVR. While TAVR is considered cost-effective for inoperable patients considering alternative treatment costs, the higher costs limit access to therapy for many patients.

Market Opportunity - Expansion of TAVR indications to include lower-risk patient populations

The expansion of TAVR indications to include lower-risk patient populations presents a major opportunity for long-term growth of the global transcatheter aortic valve replacement market. Currently, transcatheter aortic valve replacement is only approved for inoperable and high-risk patients in most countries. However, recent clinical evidence like SURTAVI trial has demonstrated the non-inferiority and in some cases superiority of transcatheter aortic valve replacement over standard open-heart surgical aortic valve replacements (SAVR) in intermediate risk patients. Expanding approved indications to include lower surgical risk groups will immensely increase the size of addressable patient population worldwide.

Key Stakeholders of Market

What does Growth in the Transcatheter Aortic Valve Replacement Market Mean for Different Stakeholders?

The transcatheter aortic valve replacement market has multiple players with varied designations and offers multiple opportunities based on their scope of operations.

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Market Segmentation

• By Procedure Type Insights (Revenue, USD Bn, 2019 - 2031)
• • Transfemoral
  • Transapical
  • Other Approaches
• By Device Type Insights (Revenue, USD Bn, 2019 - 2031)
• • Balloon-Expandable Valves
  • Self-Expanding Valves
• By End User Insights (Revenue, USD Bn, 2019 - 2031)
• • Hospitals
  • Ambulatory Surgical Centers
  • Independent Cardiac Catheterization Labs
  • 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 Corp.
  • Medtronic Plc.
  • Abbott Laboratories.
  • Boston Scientific Corp.
  • MicroPort Scientific Corp.
  • JenaValve Technology GmbH.
  • Cardiovascular Systems, Inc.
  • Symetis SA.
  • Lepu Medical Technology Co., Ltd.
  • Terumo Corporation.
  • Jude Medical (now part of Abbott).
  • AtriCure, Inc.
  • Vascular Solutions, Inc.
  • Biotronik SE & Co. KG.
  • Cook Medical