Transcatheter Heart Valve Market Analysis

Transcatheter heart valve implantation is a minimally-invasive procedure to repair damaged heart valves with bioprosthetic valves for treatment of valvular heart disease (VHD), namely aortic stenosis and mitral regurgitation. It is an alternative approach to conventional open heart surgery and is especially recommended for extremely high risk patients.

Statistics:

The global transcatheter heart valve market is estimated to account for US$ 7,642.7 Mn in terms of value by the end of 2027.

Global Transcatheter Heart Valve Market: Drivers

Increasing prevalence of VHD is a major factor boosting growth of the global transcatheter heart valve market over the forecast period. For instance, according to the study, ‘Epidemiology and Trends of Aortic Stenosis Mortality in the United States (1999-2016)’, published in Journal of the American College of Cardiology in March 2019, aortic stenosis was associated with a mortality rate of 106.3 per 1 million persons, with highest mortality rate in non-Hispanic whites followed by Hispanics, and non-Hispanic blacks. Moreover, the study noticed increase in age-adjusted mortality between the period.

Therefore, increasing geriatric population is also expected to aid in growth of the market. For instance, according to the World Health Organization, geriatric population is expected to reach 2 billion by 2050, up from 900 million in 2015.

North America region held dominant position in the global transcatheter heart valve market in 2019, accounting for 53.6% share in terms of value, followed by Europe.

Figure 1. Global Transcatheter Heart Valve Market Share (%), by Region, 2019

Global Transcatheter Heart Valve Market: Restraints

High cost of transcatheter heart valves is expected to hinder growth of the global transcatheter heart valve market. For instance, the average cost of transcatheter aortic valve replacement (TAVR) devices is US$ 32,000 as compared to US$ 4,000–US$ 7,000 for surgical aortic valve replacement (SAVR) devices.

Moreover, TAVR is associated with some risks and complications such as artery damage due to insertion of catheter that can lead to major bleeding, valve leakage, infection, kidney failure, heart attack, major stroke, and fatality during procedure.

Global Transcatheter Heart Valve Market: Opportunities

Players in the market can focus on development and launch of affordable TAVR products in order to enhance their share in emerging market such as India, China, and Brazil.

Moreover, there is rising concern about cerebrovascular events that can occur after TAVR, which are associated with increased mortality. Therefore, development of standardized definitions and assessments of neurological endpoints for TAVR and other cardiac interventions is also expected to offer lucrative growth opportunities for players in the market.

Transfemoral Approach segment in the global transcatheter heart valve market was valued at US$ 2,369.4 Mn in 2019 and is expected to reach US$ 6,814.2 Mn by 2025 at a CAGR of 14.1% during the forecast period.

Market Trends/Key Takeaways

Major hospitals are focused on adopting TAVR for the treatment of aortic stenosis. For instance, in January 2020, Chester County Hospital announced that TAVR will be available in a couple of months at appropriate patients at the hospital.

Several regulatory bodies are focused on extending the indications of transcatheter heart valves. For instance, in August 2019, the U.S. Food and Drug Administration approved an expanded indication for several transcatheter heart valves that include, Sapien 3, Sapien 3 Ultra, CoreValve Evolut R, and CoreValve Evolut PRO for patients with severe aortic valve stenosis.

Regulations:

U.S.

• In the U.S., FDA Center for Device and Radiological Health (FDA/CDRH) is responsible for regulation of medical devices
• TAVR is categorized by FDA/CDRH as a class III significant risk device, which requires demonstration of safety and effectiveness for approval as part of the premarket approval (PMA) process.

Global Transcatheter Heart Valve Market: Competitive Landscape

Major players operating in the global transcatheter heart valve market include, Edwards Lifesciences Corporation, Medtronic, Boston Scientific Corporation, Abbott, JenaValve Technology, SYMETIS, and Braile Biomedica.

Global Transcatheter Heart Valve Market: Key Developments

Major players in the market are focused on product approval and launch to expand their product portfolio. For instance, in January 2020, JenaValve Technology received the U.S. FDA’s breakthrough device designation for its pericardial TAVR device.

In November 2019, Edwards Lifesciences Corporation received CE Mark to expand use of the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients diagnosed with aortic stenosis who are at low risk for open-heart surgery.