AORTIC STENOSIS MARKET ANALYSIS

The Global Aortic Stenosis Market size is expected to reach US$ 16.77 billion by 2030, from US$ 8.33 billion in 2023, at a CAGR of 10.5% during the forecast period.

The global aortic stenosis market is expected to witness significant growth over the forecast period. The rising geriatric population worldwide who are more prone to develop aortic stenosis will be a key driver. Additionally, improved diagnosis and rising awareness about the disease are also expected to contribute to market growth. One of the major challenges for the market will be the lack of approved drug therapies for aortic stenosis. Currently, valve replacement remains the primary treatment option. However, the perioperative risks associated with surgery can restrain the market to some extent. High treatment costs also poses a significant challenge, especially in developing regions. Overall, rapid rise in prevalence along with growing focus on developing innovative therapies present abundant opportunities for players in the aortic stenosis market. While developed regions will continue dominating sales, players stand to benefit immensely by targeting high-growth emerging economies.

The Global Aortic Stenosis Market is segmented by type, aortic valve types, severity, end user, and region. By type, the market is segmented into congenital aortic stenosis and acquired aortic stenosis. The acquired aortic stenosis segment accounts for the largest market share due to the advancements in treatment options. Acquired Aortic Stenosis is more common than congenital aortic stenosis, especially in older adults. It is often seen in individuals over 65 years of age.

Global Aortic Stenosis Market Regional Insights:

• North America is the largest market, accounting for 35.4% of the global market share in 2023. The high prevalence of aortic stenosis in the region, along with the availability of effective treatments, is driving the market growth.
• Europe is another key market for aortic stenosis, accounting for 28.2% of the global market in 203. This is due to the region's aging population, high prevalence of cardiovascular diseases, and advanced healthcare infrastructure.
• Asia Pacific is the third-largest market, accounting for 8% of the global market share in 2023. The growing geriatric population, rising awareness about aortic stenosis, and increasing healthcare expenditure are driving the market growth in this region.

Figure 1. Global Aortic Stenosis Market Share (%), By Region, 2023

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Global Aortic Stenosis Market Drivers:

• Aging Population: Aortic stenosis is more common among elderly individuals. With the global population aging, there is an increased prevalence of the condition, leading to a higher demand for treatment options. For instance, according to data published in January 2023, the number of people aged 65 years or older worldwide is projected to more than double, rising from 761 million in 2021 to 1.6 billion in 2050. The number of people aged 80 years or older is growing even faster.
• Technological Advancements: Advances in medical technology, such as minimally invasive procedures, transcatheter aortic valve replacement (TAVR), and other innovative treatment techniques, have expanded the treatment options available to patients. These advancements drive the growth of the aortic stenosis market.
• Increasing Awareness: Awareness campaigns and educational initiatives by healthcare organizations and advocacy groups help in early detection and diagnosis of aortic stenosis. Improved awareness results in earlier treatment and better patient outcomes.
• Rising Healthcare Expenditure: As economies grow, healthcare spending tends to increase. This enables better access to advanced treatments and therapies for aortic stenosis patients.

Global Aortic Stenosis Market Opportunities

• Transcatheter Aortic Valve Replacement (TAVR) Expansion: TAVR is a minimally invasive procedure used to treat aortic stenosis. As the technology and procedural techniques continue to advance, there is an opportunity for TAVR to become the preferred treatment option over traditional open-heart surgery. Expansion of TAVR to a broader patient population, including low-risk patients, can significantly increase its market potential.
• Increasing Research and Development Activities: Increasing research and development efforts may lead to the discovery of new treatment approaches for aortic stenosis. For instance, in March 2022, Cardiawave SA, a deeptech medical device company that has developed VALVOSOFT a revolutionary non-invasive medical device to treat aortic stenosis, the most prevalent heart valve disease in adults, announced the success of its First-In-Human I (FIH I) safety and feasibility clinical trial.
• Development of Bio-Prosthetic Heart Valves: The development of bio-prosthetic heart valves is a major innovation that can drive significant growth in the Aortic stenosis market. Current surgical options for severe symptomatic aortic stenosis include mechanical heart valves or tissue valves derived from animal tissues. However, mechanical valves require lifelong blood thinning medications which can cause bleeding risks, and tissue valves have durability issues as they wear out over time. Bio-prosthetic heart valves address some of the key limitations of existing valve replacement options. These novel valves are engineered from biomaterials to mimic the natural human tissue valve more closely while also being more durable than current tissue valves. Some bio-prosthetic valves in development are designed for viability exceeding 20 years, removing the reoperation risk that plagued previous generation tissue valves.

Global Aortic Stenosis Market Trends:

• Increasing Adoption of Transcatheter Aortic Valve Replacement (TAVR): TAVR has emerged as a revolutionary treatment for aortic stenosis, especially in high-risk or inoperable patients. The procedure offers several benefits, such as reduced invasiveness, shorter hospital stays, and quicker recovery times. As technology and procedural techniques improve, TAVR has been increasingly adopted as an alternative to surgical aortic valve replacement (SAVR), driving market growth.
• Expanding Indications for TAVR: Initially, TAVR was primarily used for high-risk and inoperable patients. However, with advancements in device design and growing clinical evidence, TAVR has seen an expansion of indications to intermediate-risk and even low-risk patients. The broadening of eligible patient populations has significantly increased the potential market size for TAVR procedures.
• Growing Focus on Minimally Invasive Treatments: Minimally invasive procedures continue to gain traction in the treatment of aortic stenosis. Apart from TAVR, other minimally invasive approaches, such as balloon valvuloplasty, are being explored as potential treatment options. Patients and healthcare providers increasingly prefer these procedures due to their benefits, leading to market expansion.
• Advancements in Aortic Valve Technologies: Continuous advancements in aortic valve technologies have led to the development of new-generation devices that offer improved durability, better outcomes, and enhanced patient safety. Manufacturers are investing in research and development to create innovative devices, fostering competition in the market. For instance, in May 2022, Medtronic, a global leader in medical technology, services, and solution, announced the first patient enrollment in the EXPAND TAVR II Pivotal Trial, the first randomized clinical trial evaluating the self-expanding, supra-annular Evolut TAVR platform in patients with moderate, symptomatic aortic stenosis (AS), a population outside of current guidelines and indications for transcatheter aortic valve replacement (TAVR).

Global Aortic Stenosis Market Restraints:

• High Cost of Treatment: The high costs associated with valve replacement surgeries pose a significant restraint on the growth of the aortic stenosis market. Aortic stenosis surgery is an invasive and complex procedure that depends heavily on advanced medical technologies and highly skilled surgeons. The average cost of surgical aortic valve replacement in the U.S. ranges from US$ 150,000 to US$ 250,000 based on the hospital and location. For many patients and health insurance providers, these costs make valve replacement prohibitive.
• Availability and Awareness Barriers: In certain regions or healthcare settings, access to advanced treatments for aortic stenosis may be limited due to a lack of specialized facilities, skilled healthcare professionals, or patient awareness about available treatment options.
• Post-Surgery Complications: One of the major factors restraining the growth of Global Aortic Stenosis Market is the risk of post-surgery complications associated with the treatment procedures. The risk of complications has also increased the focus on developing minimally invasive transcatheter aortic valve replacement (TAVR) procedure. While TAVR reduces the risks associated with open-heart surgery, it also comes with its own set of risks such as paravalvular leak, pacemaker implantation, stroke, and bleeding.

Figure 2. Global Aortic Stenosis Market Share (%), By Type, 2023

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Recent Developments:

New product launches/approval:

• In January 2023, Abbott, which discovers, develops, manufactures, and sells a broad and diversified line of health care products and services., announced that the U.S. Food and Drug Administration (FDA) had approved the company's latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, to treat people with severe aortic stenosis who are at high or extreme risk for open-heart surgery. The Navitor TAVI system is the latest addition to the company's comprehensive transcatheter structural heart portfolio that offers less invasive treatment options to physicians and patients for some of the most common and serious heart diseases.
• In September 2022, Medtronic, which develops therapeutic and diagnostic medical products, announced the expanded U.S. market release of its newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut FX TAVR system. Evolut FX adds new features to the existing Evolut platform to enhance ease-of-use and predictable valve deployment for physicians.
• In September 2020, Boston Scientific Corporation, which develops, manufactures, and markets medical devices for use in various interventional medical specialties globally, announced that it had initiated a controlled launch of the ACURATE neo2 Aortic Valve System in Europe. This next-generation transcatheter aortic valve implantation (TAVI) technology is a new platform designed with a number of features to improve upon the clinical performance of the original ACURATE neo platform. Compared to the previous generation device, the ACURATE neo2 valve system also has an expanded indication for patients with aortic stenosis – with no specified age or risk level – who are considered appropriate candidates for the therapy by their heart team, including a cardiac surgeon.

Increasing Research and Development Activities:

•  On October 25, 2023, egnite, Inc., a leading cardiovascular digital health company, announced that novel research on aortic stenosis (AS) was presented by cardiologist Philippe Généreux, MD, Director of the Structural Heart Program of Morristown’s Gagnon Cardiovascular Institute, at the Transcatheter Cardiovascular Therapeutics (TCT) conference held in October 2023 at San Francisco, U.S.
• In December 2021, Aurora St. Luke’s Medical Center in Milwaukee joined a clinical trial studying a new potential replacement heart valve, continuing its long history of research into minimally invasive heart valve replacements. The study will evaluate the safety and effectiveness of Boston Scientific Corporation’s ACURATE neo2 Aortic Valve System in patients with severe symptomatic aortic stenosis who are candidates for transcatheter aortic valve replacement (TAVR).

Figure 2. Global Aortic Stenosis Market Share (%), by Type, 2023

Top Companies in Aortic Stenosis Market:

• Edwards Lifesciences Corporation
• Medtronic plc
• Abbott Laboratories
• Boston Scientific Corporation
• LivaNova PLC
• CryoLife, Inc.
• Braile Biomédica
• JenaValve Technology, Inc.
• Meril Life Sciences Pvt. Ltd.
• Micro Interventional Devices, Inc.
• egnite, Inc.

Definition: Aortic stenosis refers to the narrowing of the aortic valve opening, which limits blood flow from the heart into the aorta. There are different product types available to treat aortic stenosis depending on the severity of the condition. The main types are balloon aortic valvuloplasty (BAV) and transcatheter aortic valve replacement (TAVR).