Transcatheter Heart Valve Replacement Market

Transcatheter Heart Valve Replacement Market Outlook (2024 to 2034)

Worldwide revenue from transcatheter heart valve replacement is estimated at US$ 5.31 billion in 2024 and is projected to rise at a CAGR of 13.9% to reach US$ 19.43 billion by the end of 2034. The market for transcatheter aortic replacement has been exhibiting significant growth as heart disorders are becoming more prevalent among the population worldwide.

Transcatheter heart valve replacement offers a solution for aortic valve stenosis, a condition where the aortic valve becomes narrow and stiff. This narrowing of the aortic valve often leads to symptoms like chest pain and shortness of breath, leading individuals to seek transcatheter heart valve replacement when their symptoms become intolerable, thus fueling the expansion of the transcatheter aortic valve replacement market size.

Modern lifestyles are defined by the consumption of junk food, and this tendency has contributed to cardiovascular issues like atherosclerosis, where calcium accumulates on the aortic valve over time, causing it to stiffen and narrow. Individuals suffering from such conditions increasingly turn to transcatheter devices to address these valve obstructions, significantly boosting the demand for transcatheter heart valve replacements. Manufacturers are responding to this demand by supplying efficient, effective, and affordable transcatheter devices to meet this growing demand.

Suppliers capitalize on the needs of individuals aged 60 to 65 who are particularly vulnerable to heart diseases including aortic stenosis, collaborating with hospitals to enhance market penetration targeting. The advent of transcatheter heart valve replacement has transformed the medical landscape, overtaking traditional surgical aortic valve replacements due to its preference among both doctors and patients. This shift has fueled transcatheter aortic valve replacement market growth.

The rising prevalence of heart conditions supports the growing demand for transcatheter devices worldwide, especially among the elderly. Manufacturers predominantly utilize biological valves derived from cow or pig heart tissue to craft efficient transcatheter heart valve replacement devices, catering to patients with heart ailments. Key market players continually adapt to recent advancements, including newly developed transcatheter heart valve replacement devices, to remain competitive and contribute to the ongoing expansion of the transcatheter heart valve replacement market.

Report Attributes	Details
Transcatheter Heart Valve Replacement Market Size (2024E)	US$ 5.31 Billion
Forecasted Market Value (2034F)	US$ 19.43 Billion
Global Market Growth Rate (2024 to 2034)	13.9% CAGR
Canada Market Growth Rate (2024 to 2034)	13.5% CAGR
China Market Value (2034F)	US$ 471 Million
North America Market Share (2024E)	54.8%
East Asia Market Share (2034F)	9.1%
Key Companies Profiled	Braile Biomedica Edwards Lifesciences Corporation Cook Medical Inc. JC Medical Inc. Venus Medtech Inc. Medtronic Plc. Boston Scientific Corporation Abbott Laboratories MicroPort Scientific Corp.

Which Factors are Pushing Sales of Transcatheter Heart Valve Replacement Devices?

“Focus on Development of Second-Generation TAVR Devices for Enhanced Durability”

To prevent immune rejections in patients with severe aortic stenosis, businesses are developing second-generation TAVR devices that are more durable. Recent research has indicated that second-generation TAVR devices offer superior safety-related advantages. According to these investigations, there is a correlation between transcatheter heart valve devices and a decreased incidence of paravalvular regurgitation, valve embolization, and other bleeding incidents. While choosing between TAVR treatments, new imaging technologies are growing in popularity.

“Increasing Prevalence of Heart Diseases”

Global demand for transcatheter heart valve replacement treatment is being primarily driven by the increasing prevalence of various cardiovascular disorders, particularly valvular heart conditions like aortic stenosis. This factor significantly influences the market, given that valve replacement surgery remains the primary therapy for severe aortic stenosis.

Rising demand for minimally invasive treatments and surgeries is driven by the benefits they offer and is an important transcatheter heart valve replacement market trend. These techniques can help decrease blood loss, reduce pain and trauma, and lower the risk of infection. This leads to faster patient recovery, shorter hospital stays, and fewer visible scars, particularly in heart surgery scenarios.

Market growth is projected to continue in the coming years as more efficient and cost-effective approaches to managing the disease are emerging. Market players are investing in and enhancing their expertise to stay competitive and survive in the market.

What is Restricting Adoption of Transcatheter Heart Valve Replacement?

“High Cost of Valve Replacement Devices and Risks Associated with Treatment”

One of the primary challenges transcatheter heart valve replacement devices providers face is the high cost of these devices. Price is a significant factor influencing purchasing decisions for these devices, posing a limitation for the market due to their relatively expensive nature.

While transcatheter heart valve replacement devices are considered an alternative to open-heart aortic valve replacement, there are inherent risks associated with this treatment. These risks include blood vessel disorders, stroke, irregular heartbeat, heart attack, infection, severe bleeding, and issues related to valve positioning, such as valve migration.

Cost factor remains a crucial consideration for the viability of purchasing transcatheter heart valve replacement products, presenting a competitive barrier within the sector due to the valves' high prices. Industry players are facing this challenge as they strive to survive in the market over the long term.

Country-wise Evaluation

Heart diseases are becoming common among the population across the world in countries including Canada, the United States, Mexico, China, and South Korea. Fact.MR, a leading market intelligence company, states that the South Korean market is projected to expand at a CAGR of 14.7% from 2024 to 2034.

What Attracting Transcatheter Valve Replacement Device Manufacturers to the United States?

“Advanced Medical Infrastructure and Increasing Prevalence of Cardiovascular Disorders”

Attribute	United States
Market Value (2024E)	US$ 2.66 Billion
Growth Rate (2024 to 2034)	14.1% CAGR
Projected Value (2034F)	US$ 9.97 Billion

Heart disease is one of the leading causes of deaths in the United States. Approval from the Food and Drug Administration (FDA) enhances access to TAVR devices for patients. Preference for minimally invasive solutions leads to faster recovery. Transcatheter heart valve replacement devices are included in reimbursement schemes. The well-established healthcare infrastructure in the country helps minimize complications.

• According to research conducted by the American College of Cardiology, valvular heart disorders are rather common among Americans. According to the research, each year over 5 million Americans receive a diagnosis of one of these illnesses. This figure comprises 1.5 million Americans with aortic stenosis, and the approximately 500,000 Americans with severe aortic stenosis represent approximately 33% of the total instances of aortic stenosis in the United States.

What are the Opportunities for Transcatheter Valve Replacement Device Suppliers in China?

“Increasing Elderly Population Susceptible to Cardiovascular Diseases”

Attribute	China
Market Value (2024E)	US$ 112 Million
Growth Rate (2024 to 2034)	15.4% CAGR
Projected Value (2034F)	US$ 471 Million

Transcatheter heart valve replacement devices primarily serve individuals aged 60 and above, who are at higher risk of cardiovascular diseases and depend on these tools for optimal heart function. China has the world's second-largest population, including a substantial elderly demographic. The nation presents lucrative opportunities for transcatheter heart valve replacement device suppliers to expand their presence and distribute their products. This expansion contributes to China’s leading transcatheter heart valve replacement market share in East Asia.

Category-wise Insights

Demand for transcatheter mitral valve replacement (TMVR) devices is projected to increase at a CAGR of 14.5% from 2024 to 2034. TMVR is being adopted as a less invasive alternative to open-heart surgery for addressing mitral valve stenosis. This has led to an increasing demand for TMVR in the market.

Which Delivery System is Widely Preferred by Healthcare Providers?

“Effectiveness of Transfemoral Delivery Systems in Reducing Chest Pain and Shortness of Breath”

Attribute	Transfemoral
Segment Value (2024E)	US$ 4.66 Billion
Growth Rate (2024 to 2034)	14% CAGR
Projected Value (2034F)	US$ 17.23 Billion

Transfemoral delivery systems, occupying a significant transcatheter heart valve replacement market share, have become more popular in recent years due to their multifaceted advantages, including the option for a fully percutaneous procedure. This attracts patients as it is performed under mild anesthesia and can help in reducing symptoms such as chest pain, shortness of breath, and other symptoms of aortic valve stenosis.

Which End User Accounts for a Significant Share of the Market?

“Hospitals Account for High Market Share Due to Their Capacity for Complex Interventions”

Attribute	Hospitals
Segment Value (2024E)	US$ 4.5 Billion
Growth Rate (2024 to 2034)	13.9% CAGR
Projected Value (2034F)	US$ 16.48 Billion

Hospitals play a significant role compared to ambulatory settings due to their diverse departments and a large number of collaborating doctors. This results in higher demand for transcatheter heart valve replacement devices within hospitals than in other medical facilities. Market players establish yearly contracts with hospitals to ensure priority access for transcatheter heart valve replacements. Moreover, the presence of comprehensive medical infrastructure and hospitals’ capacity for complex interventions are factors influencing market growth.

Market Rivalry

Key players in the transcatheter heart valve replacement market such as Braile Biomedica, Edwards Lifesciences Corporation, and Cook Medical Inc. are focusing on mergers and acquisitions to establish themselves in the market. Companies are also investing in strategic relationships with rivals in other areas. They are adapting themselves to the evolving transcatheter heart valve replacement market trends such as heart attack diagnostics and heart monitoring devices.

• Following FDA clearance, Edwards Lifesciences introduced the Sapien 3 Ultra Resilia Valve in September 2022, making it the first dry-storage transcatheter heart valve made available in the United States.
• The Evolut PRO TAVR System was approved by Medtronic in January 2022 for use in treating severe aortic stenosis in China. As China's population ages, this problem is projected to worsen.

Key Segments of Transcatheter Heart Valve Replacement Market Research

• By Product :

  • Transcatheter Aortic Valve Replacement (TAVR)
    • Self-expandable Transcatheter Aortic Valves
    • Balloon-Expandable Transcatheter Aortic Valves
    • Mechanically Expanded Transcatheter Aortic Valves
  • Transcatheter Mitral Valve Repair

• By Indication :

  • Severe Aortic Valve Stenosis
  • Valve-in-Valve Procedures (Failed Bioprosthesis)
  • Aortic Regurgitation

• By End User :

  • Hospitals
  • Independent Cardiac Catheterization Labs
  • Ambulatory Surgical Centers

• By Region :

  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia & Oceania
  • Middle East & Africa