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U.S. Prosthetic Heart Valve Market Expected to Reach $8.9 Billion by 2033

 
2022
U.S. Prosthetic Heart Valve Market

Report Code : A27616

quote Surge in prevalence of cardiac vascular diseases, rise in geriatric population, and rise in technological advancements are the major factors which fuel the growth of the U.S. prosthetic heart valve market. quote

According to Roshan Deshmukh
Manager, Healthcare at Allied Market Research

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The U.S. prosthetic heart valve market size was valued at $3.2 billion in 2023, and is projected to reach $8.9 billion by 2033, growing at a CAGR of 10.7% from 2024 to 2033. Prosthetic heart valves are critical medical devices designed to replicate the function of natural heart valves, ensuring proper blood flow within the heart. These valves are categorized into two main types: mechanical valves, made from durable materials like metal or carbon, and bioprosthetic valves, derived from animal tissues. The market is driven by advancements in medical technology, the rising prevalence of cardiovascular diseases, and the aging population. As the demand for minimally invasive procedures grows, innovations such as transcatheter aortic valve replacement (TAVR) are also gaining prominence, further expanding the scope and significance of this market in the U.S. healthcare industry. 

The U.S. prosthetic heart valve market growth primarily driven by increase in prevalence of cardiovascular diseases, particularly valvular heart diseases, among the aging population. For instance, according to the Centers for Disease Control and Prevention, in the U.S., someone has a heart attack at every 40 seconds. In addition, the rise in aging population, the incidence of conditions such as aortic stenosis and mitral regurgitation rises, leading to a greater demand for prosthetic heart valves. Moreover, technological advancements in prosthetic heart valve design and manufacturing are also fueling U.S. prosthetic heart valve market trends. Innovations such as transcatheter heart valve replacement (TAVR) have revolutionized the treatment of patients who are at high risk for open-heart surgery. TAVR procedures offer a minimally invasive alternative to traditional surgery, reducing recovery time and improving outcomes, which has led to their growing adoption in clinical practice.

The increasing awareness and early diagnosis of valvular heart diseases further supports the growth during U.S. prosthetic heart valve market forecast period. Regulatory approvals and favorable reimbursement policies are further supporting the market's expansion. The U.S. Food and Drug Administration (FDA) has approved several new prosthetic heart valve products, which has increased the options available to patients and healthcare providers. Moreover, the inclusion of these devices in insurance coverage plans makes them more accessible to a broader patient population. 

However, factors such as high costs of prosthetic heart valve and associated risks with prosthetic heart valve procedures are expected to hinder the growth of market. Prosthetic heart valve procedures are expensive, and the costs can vary depending on several factors, such as the type of prosthetic heart valve used, the hospital where the procedure is performed, and the patient's insurance coverage. In addition to the costs, there are also risks associated with prosthetic heart valve procedures such as bleeding, infection, and complications related to anesthesia, which restrain the market U.S. U.S. prosthetic heart valve industry.

Industry Trends 

  • Centers for Medicare & Medicaid Services (CMS) issued a Medicare National Coverage Determination on May 1, 2012, which allows coverage of TAVR under Coverage with Evidence Development (CED) with certain conditions. As part of CED, they identify the Medicare approved registry and Medicare approved clinical trials which have been reviewed and determined to meet the requirements of coverage. 

Segment Highlights 

The U.S. prosthetic heart valve market size is segmented on the basis of product. On the basis of the 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 segment accounted for largest U.S. prosthetic heart valve market share in 2023 and is expected to remain dominant during forecast period owing to increase in demand for minimally invasive surgical procedures and availability of advanced transcatheter heart valve products. In addition, transcatheter heart valve offers several advantages over other heart valves thereby supporting the segment growth.

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., ShockWave Medical, Inc. are the key players operating in the U.S. prosthetic heart valve industry.

These key players adopt strategies such as product approval, agreement and others to expand the portfolio. For instance, in September 2021, Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the company's Epic Plus and Epic Plus Supra Stented Tissue Valves to improve therapy options for people with aortic or mitral valve disease. In addition, in July 2024, Edwards entered into an agreement to acquire?JenaValve Technology, a pioneer in the transcatheter treatment of aortic regurgitation (AR) , a deadly disease that impacts a significant and growing population and is largely untreated. JenaValve presented positive results of its U.S. pivotal trial for the treatment of symptomatic, severe AR in high-risk patients late last year. 

 

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quote U.S. Prosthetic Heart Valve Market by Product (Tissue Heart Valve, Mechanical Heart Valve, Transcatheter Heart Valve) , : Opportunity Analysis and Industry Forecast, 2024-2033 quote

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