U.S. Prosthetic Heart Valve Market Size, Share, Competitive Landscape and Trend Analysis Report, by Product, : Opportunity Analysis and Industry Forecast, 2024-2033

Key Market Dynamics 

The U.S. prosthetic heart valve market growth is predominantly driven by factors such as aging population, increasing prevalence of valvular heart diseases, advancements in technology, greater awareness and early diagnosis, a favorable regulatory and reimbursement environment, the rising demand for minimally invasive procedures, and ongoing R&D efforts. For instance, according to American College of Cardiology 2021, more than 5 million people are diagnosed with valvular heart diseases (VHD) each year in the U.S. Thus, rise in prevalence of valvular heart diseases (VHD) drives the market growth. In addition, rise in geriatric population led to rise in incidence of cardiovascular diseases, including valvular heart diseases thereby supports the market growth, Conditions such as aortic stenosis and mitral regurgitation are more common in older adults, leading to an increased demand for prosthetic heart valves. For instance, according to the Administration for Community Living (ACL) , in the U.S., Americans 65 and older numbered 57.8 million in 2022. They represented 17.3% of the population. Thus, rise in geriatric population drive the growth during U.S. prosthetic heart valve market forecast period. 

Further, the U.S. prosthetic heart valve market trends includes the growing awareness of valvular heart diseases and the importance of early diagnosis and treatment. Early diagnosis allows for timely intervention, often leading to better patient outcomes. As more healthcare providers emphasize the importance of regular cardiovascular screenings, the identification of candidates for prosthetic heart valve replacement is expected to increase, further fueling market growth. However, the high cost of devices and procedures, potential complications such as valve deterioration or thrombosis, and stringent regulatory approval processes are the factors which may restrain the U.S. prosthetic heart valve market growth. 

On the contrary, growing adoption of transcatheter aortic valve replacement (TAVR) procedures, which provide a minimally invasive alternative to open-heart surgery thereby provides market opportunity. The development of next-generation valves with enhanced durability and reduced complications presents significant market potential. Additionally, increased investment in R&D for innovative valve technologies, coupled with favorable regulatory support and reimbursement policies, can also drive market expansion. 

Market Segmentation 

The U.S. prosthetic heart valve market size is segmented on the basis of product. On the basis of product, the market is categorized into mechanical heart valve, tissue heart valve, and transcatheter heart valve. The tissue heart valve segment is further classified into stented tissue heart valve and stent less tissue heart valve. The transcatheter heart valve segment generated the largest revenue in U.S. prosthetic heart valve market share in 2023, owing to its minimally invasive nature, associated benefits, surge in cardiovascular disorders, and rise in demand of cardiac valve replacement therapy. In addition, rise in advancements in transcatheter heart valve technology, such as improved valve designs and delivery systems, have further enhanced procedural outcomes and expanded the eligible patient population. As a result, the transcatheter heart valve segment continues to lead the U.S. prosthetic heart valve industry. 

Industry Trends 

• According to Centers for Disease Control and Prevention (CDC) 2022, 40, 000 babies were born with congenital heart defect every year in the U.S. Thus, patients with congenital heart defects require surgical intervention to repair or replace the damaged valve, which creates a significant demand for prosthetic heart valves in the U.S. 

Competitive Landscape 

The key players operating in the U.S. Prosthetic heart valve market are Abbott Laboratories, Artivion, Inc, Anteris Technologies Ltd, Boston Scientific Corporation, Edward Lifesciences Corporation, JenaValve Technology, Inc., Colibri Heart Valve, Medtronic plc, Meril Life Sciences Pvt. Ltd., and ShockWave Medical, Inc. These players have adopted various developmental strategies to stay competitive in the market. For instance, in February 2024, Edwards Lifesciences Corporation announced the company’s EVOQUE tricuspid valve replacement system is the first transcatheter therapy to receive U.S. Food and Drug Administration (FDA) approval for the treatment of tricuspid regurgitation (TR) . The EVOQUE system is indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT) , for whom tricuspid valve replacement is deemed appropriate by a heart team. 

Key Benefits for Stakeholders

• Enable informed decision-making process and offer market analysis based on current market situation and estimated future trends.
• Analyze the key strategies adopted by major market players in U.S. prosthetic heart valve industry.
• Assess and rank the top factors that are expected to affect the growth of U.S. prosthetic heart valve market.
• Top Player positioning provides a clear understanding of the present position of market players.
• Detailed analysis of the U.S. prosthetic heart valve market segmentation assists to determine the prevailing market opportunities.
• Identify key investment pockets for various offerings in the market.