Structural Heart Devices Market - By Product (Heart Valve Devices, Occluders & Delivery Systems, Annuloplasty Rings), By Procedure (Replacement, Repair), By End-use (Hospitals, ASC, Cardiac Catheterization Labs) – Global Forecast, 2024 – 2032

Structural Heart Devices Market Size

Structural Heart Devices Market size was valued at around USD 11.3 billion in 2023 and is anticipated to register a CAGR of 8.8% between 2024 and 2032. This robust market growth can be attributed to factors such as the growing burden of cardiovascular diseases globally, favorable reimbursement scenarios and the rising preference for minimally invasive procedures.
 

The primary catalyst for the growth of the market is the increasing incidence of cardiovascular diseases globally. Factors such as aging populations, lifestyle-related diseases, unhealthy diets, genetic factors, and a higher prevalence of chronic conditions like heart valve diseases, cardiomyopathy, and congenital heart diseases contribute to the high prevalence of cardiovascular diseases (CVD).
 

The aging demographic, particularly in developed regions, is prone to age-related health issues, including heart valve diseases. As the global population ages, there is a parallel increase in the prevalence of coronary heart disease (CHD). According to Centers for Disease Prevention and Control, in 2019, 7.1% of adults aged 45 to 64 years reported having CHD compared with 17.0% of adults aged 65 years and older. These statistics indicate a notable increase in the demand for structural heart devices for individuals suffering from various cardiovascular disorders.
 

Structural heart devices refer to a category of medical devices designed for the diagnosis and treatment of structural abnormalities within the heart. These devices are utilized to address congenital or acquired conditions that affect the valves, walls, chambers, or vessels of the heart.
 

Structural Heart Devices Market Trends

Technological advancements have led to the development of high-efficiency structural heart devices. These innovations enable more effective replacement and repair of procedural devices.
 

• Advancements in transcatheter approaches, such as transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (TMVR), have revolutionized structural heart interventions. These minimally invasive procedures reduce the need for open-heart surgery, offering quicker recovery times and lower procedural risks.
   
• For instance, in January 2023, the U.S. Food and Drug Administration (FDA) provided the approval to market to The Edwards Lifesciences PASCAL Precision Transcatheter Valve Repair System. TMVR procedures have been shown to reduce mitral regurgitation (MR), improve symptoms, and lower hospitalization rates in patients with moderate to severe MR who are at prohibitive or high risk of surgery.
   
• Moreover, significant advancements in transcatheter valve technologies, particularly in transcatheter tricuspid valve replacement (TTVR), are reshaping the landscape of structural heart interventions. For instance, in April 2020, Abbott announced that its TriClip transcatheter tricuspid valve repair system had received CE Mark and is now approved for use in Europe. The TriClip device functions by employing a clipping mechanism. During the procedure, a portion of the tricuspid valve leaflets is clipped together.
   

Structural Heart Devices Market Analysis

Based on product, the market is categorized into heart valve devices, annuloplasty rings, occluders & delivery systems, and other products. The heart valve devices segment accounted for the majority share and was valued at over USD 4.7 billion in revenue in 2023.
 

• Heart valve diseases such as calcific aortic valve disease and rheumatic heart disease globally, are prevalent conditions worldwide, affecting millions of individuals. For instance, according to the Centers for Disease Control and Prevention (CDC), in 2019, 2.5% of Americans were estimated to have heart valve diseases. Additionally, each year there are nearly 25,000 deaths in the U.S. due to heart valve diseases. The high incidence of these diseases necessitates the widespread adoption of heart valve devices for their management.
   
• Additionally, continuous innovation in heart valve technologies has led to the development of advanced cardiovascular devices that offer improved durability, functionality, and compatibility. Transcatheter heart valves replacement have witnessed significant technological advancements, allowing for minimally invasive procedures with enhanced outcomes.
   

Based on procedure, the structural heart devices market is segmented into replacement procedures and repair procedures. The replacement procedures segment held the leading revenue share in 2023 and is anticipated to reach USD 14.2 billion by 2032.
 

• The adoption of minimally invasive procedures, exemplified by transcatheter heart valve replacement, has significantly influenced the replacement procedures segment. Patients increasingly prefer these less invasive approaches due to shorter recovery times and reduced postoperative complications.
   
• In addition, the incorporation of robotics in cardiac surgeries, allowing surgeons precise control over surgical tools, has revolutionized replacement procedures. Robotic-assisted heart surgery enhances precision and maneuverability during interventions, influencing the preference for replacement treatments.
   
• Moreover, replacement procedures, supported by advancements in device design and procedural techniques, offer favorable clinical outcomes. The focus on improved patient safety reduced hospitalization durations, and enhanced quality of life further solidifies the dominance of the replacement procedures segment.
   

Based on end-use, the structural heart devices market is categorized into hospitals, ambulatory surgical centre, cardiac catheterization labs, and other end-users. The hospital's segment accounted for the majority of revenue share and was valued at around USD 4.8 billion revenue in 2023.
 

• Hospitals serve as comprehensive healthcare institutions equipped with specialized interventions such as transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (TMVR), which require specialized equipment and expertise. Hospitals, particularly those with specialized cardiac care units and interventional cardiology departments, are equipped to perform these procedures.
   
• For instance, as per the article published by Cardiac Interventions Today, in 2019, about half of structural heart clinics were located in hospitals. The availability of effective and advanced cardiac prosthetic devices in hospital settings enables healthcare providers to offer innovative solutions for complex heart conditions, ultimately enhancing patient care and well-being.
   
• Additionally, the growing population and the increasing burden of disease results in a high load of patients. Hospitals, as the primary centers for cardiovascular care, handle a large volume of patients with structural heart diseases, making them the primary end-users of structural heart devices.
   

North America structural heart devices market accounted for USD 3.8 billion in revenue in 2023 and is predicted to witness substantial market progress. This substantial market growth is attributed to a combination of factors that contribute to the region's robust market position.
 

• North America boasts a sophisticated healthcare infrastructure, coupled with high healthcare expenditure, fostering a conducive environment for the adoption of advanced medical technologies. Additionally, the region exhibits a strong focus on research and development, driving technological advancements in the field of structural heart devices.
   
• Furthermore, government authorities in the region are taking initiatives to spread awareness about structural heart diseases. For instance, the South Asian Heart Health Awareness and Research Act was initiated by the government to raise awareness and comprehension of heart diseases, especially within the South Asian community in the U.S. This act includes the heart health promotion grants, establishment of a clearinghouse and web portal, support for heart health promotion activities and many of such actions to increase the awareness about the available treatment options in the region.
   

Structural Heart Devices Market Share

The structural heart devices industry is competitive in nature, with various large multinationals and small and mid-sized companies competing in the industry. The development and launch of novel advanced products with improved efficiency and cost-effectiveness is among a key market strategy for structural heart devices manufacturers. Some of the leading industry players including Abbott Laboratories, Boston Scientific Corporation, Inc., Medtronic plc, Lepu Medical Technology (Beijing) Co., Ltd., and Edwards Lifesciences Corporation., Ltd, among others have a substantial presence in the market.
 

Structural Heart Devices Market Companies

Some of the eminent market participants operating in the structural heart devices industry include:

• Abbott Laboratories
• AtriCure, Inc.
• Biomerics, LLC
• Boston Scientific Corporation
• Braile Biomedica
• Cryolife Inc.
• Edwards Lifesciences Corporation
• JenaValve Technology, Inc.
• Lepu Medical Technology (Beijing) Co., Ltd.
• LivaNova PLC
• Medtronic plc
• NuMed Inc.
   

Structural Heart Devices Industry News:

• In October 2021, Abbott announced the U.S. Food and Drug Administration (FDA) approval of two key minimally invasive devices, the Amplatzer Amulet Left Atrial Appendage (LAA) Occluder and Portico with FlexNav transcatheter aortic valve replacement (TAVR) system. Amulet device help prevent blood clots and reduce stroke risk in people with atrial fibrillation (AFib). Portico device help open a narrowed aortic valve in people with aortic stenosis. This approval helped the company solidify its structural heart portfolio in the U.S.
   
• In September 2022, Medtronic 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. This product launch helped the company to increase business revenue and acquiring enhanced customer base.
   

Structural heart devices market research report includes an in-depth coverage of the industry with estimates & forecasts in terms of revenue in USD Million from 2018 - 2032 for the following segments:

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Market, By Product

• Heart valve devices
  • Surgical heart valves
  • Transcatheter heart valves 
• Annuloplasty rings
• Occluders & delivery systems
• Other products

Market, By Procedure

• Replacement procedures
  • Surgical aortic valve replacement (SAVR)                   
  • Transcatheter aortic valve replacement (TAVR)                     
  • Transcatheter mitral valve replacement (TMVR)                     
  • Other replacement procedures 
• Repair procedures   
  • Left atrial appendage closure (LAAC)      
  • Transcatheter mitral valve repair (TMVr)                     
  • Transcatheter tricuspid valve repair (TTVr)                           
  • Valvuloplasty                    
  • Other repair procedures

Market, By End-use

• Hospitals
• Ambulatory surgical centers         
• Cardiac catheterization labs
• Other end-users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East and Africa