Heart Valve Devices Market

Heart Valve Devices Market Size:

The global heart valve devices market size reached US$ 11.9 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 34.2 Billion by 2032, exhibiting a growth rate (CAGR) of 12.1% during 2024-2032. The market is experiencing steady growth driven by the increasing prevalence of valvular heart disease and the growing global aging population, which together escalate the demand for valve replacement and repair procedures and continuous technological advancements in valve design.

Heart Valve Devices Market Analysis:

• Major Market Drivers: The growing incidence of heart disease and an aging global population are the primary market drivers of the market, leading to the need for advanced therapeutic measures. Further, innovation in minimally invasive techniques and advancements in prosthetic valve technology enhance market growth, enabling patient preference and healthcare spending on a better quality of life.
• Key Market Trends: One of the major trends in the market is the shift towards the preferred use of transcatheter heart valve replacement (TAVR) procedures as less invasive compared to traditional surgery measures. Additionally, the utilization of advanced technology and materials in the manufacturing of valves, such as tissue-engineered valves and 3D printing, sets a new durability and biocompatibility standard.
• Geographical Trends: North America holds the largest market share due to its robust healthcare infrastructure, high adaptability of medical advancements, and policies on reimbursement.
• Competitive Landscape: The market is highly competitive with a few dominant players forming the market dynamics, leading to strategic alliances, mergers, and acquisitions to improve market share.
• Challenges and Opportunities: The market entails several challenges from regulatory filing requirements, to the high cost of therapies, and the extended clinical activities required for novel therapies. However, these challenges open opportunities through developing affordable valve solutions, advanced markets’ utilization, and further innovation in valve technologies and personalized medicine.

Heart Valve Devices Market Drivers:

Increasing prevalence of heart diseases

The market is majorly driven by the growing prevalence of heart diseases across the globe. For instance, the most prevalent congenital heart abnormality, bicuspid aortic valve (BAV), affects 1% to 2% of the population, according to the American Heart Association journal. This can be attributed to changing lifestyles, growing older populations, and increasing rates of obesity, hypertension, and diabetes. The most prevalent cardiac issues brought on by cardiovascular illnesses can only be treated and resolved with the usage of these devices.  The need for effective treatment options increases along with the incidence of heart disorders, which has a direct impact on the market for heart valve devices.

Growing aging population

The rapidly rising geriatric population across the globe functions as a crucial market driver for heart valve devices, as older individuals are more prone to developing valvular heart diseases. With the aging of the population, the risk for degenerative cardiovascular conditions increases, resulting in a higher prevalence of heart valve malfunctions such as stenosis or regurgitation. This demographic shift towards an older age group leads to greater demand for medical procedures, including heart valve replacement and repair, effectively addressing age-related cardiac conditions. According to data from a paper published in January 2022 under the title "Uncovering the treatable burden of severe aortic stenosis in the UK", 291,448 men and women over the age of 55 who had severe aortic stenosis in 2019 made up the 1.48% prevalence of the condition in the United Kingdom. Based on these figures, it is expected that there will be a rise in demand for prosthetic heart valves, which will fuel market expansion.

Heart Valve Devices Market Opportunities:

New improved materials for heart valves

Another transformative opportunity for the market is the availability of new and improved materials for heart valves. The application of advanced materials, such as biocompatible polymers, biological tissues, and synthetic composites, is revolutionizing heart valve technology. It enhances durability, lowers rejection rates, and better mimics natural hemodynamic flow. These advancements address previous issues like valve degeneration, thrombosis, and the requirement for lifelong anticoagulation therapy in patients with mechanical valves. For instance, Foldax Inc. signed a contract to acquire the ownership of a portfolio of patents of polymer technology from Australia's national research organization, CSIRO. The polymer technology has been integrated by Foldax into their LifePolymerTM materials platform. Testing has shown that the materials are compatible with blood, exhibiting little adhesion of proteins, cells, and calcification. Due to the remarkable durability and biocompatibility of this LifePolymer material, it may be the perfect choice for several medical devices.

Key Technological Trends & Development:

Development of novel materials for heart valve replacements

One of the most monumental technological developments in the current market is the advent of novel materials for heart valve replacements. Material science and inventive engineering have enabled the development of heart valves that are more durable, biologically safe, and functional than previous versions. The newly developed materials, including advanced polymers and bioengineered tissues, offer improved hemodynamic characteristics and reduce the risk of complications such as thrombosis and calcification. In June’2023, PECA Labs  accomplished the MASA Valve Paediatric Pulmonary Valved Conduit First-In-Human Implantation successfully in a U.S. Clinical Trial.  The MASA Valve is a polymeric valved conduit intended for use in paediatrics during pulmonary valve replacement. The U.S. Food and Drug Administration (FDA) previously granted the new polymeric valve Humanitarian Use Device (HUD) and Investigational Device Exemption (IDE) status. As part of its MASA Valve Early Feasibility Trial Study (MVEFS), the business has started enrolling participants at four trial locations in the United States.

Tissue Valves

Tissue valves are a noteworthy advancement in these devices sector, providing a natural alternative to mechanical valves. These valves are manufactured from biological materials such as bovine pericardium or porcine heart valves, designed to replicate the function of the natural human valve. They offer improved hemodynamic performance and less discomfort for patients. The development of tissue valves is characterized by enhanced durability and minimized risk of immunological rejection, thanks to advanced tissue fixation and anti-calcification processes. Often, these valves do not necessitate lifelong anticoagulation therapy, significantly enhancing patient quality of life. This innovation is in line with the shift towards less invasive procedures and plays a crucial role in broadening treatment possibilities, especially for older patients or those at increased risk of anticoagulant-related complications.

Heart Valve Devices Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on type and end-user.

Breakup by Type:

• Mechanical Heart Valve
• Biological Heart Valve
• Transcatheter Valve
   

Transcatheter Valve accounts for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the type. This includes mechanical heart valve, biological heart valve, and transcatheter valve. According to the report, transcatheter valve represented the largest segment.

In the market, type-based segmentation is vital for illustrating the distribution of various products and their market shares. Among these, Transcatheter Heart Valves (THVs) stand out as the largest segment, largely due to a shift in clinical practices and patient preferences. The segment's increasing prominence is due to the minimally invasive nature of THV procedures, which shorten hospital stays and recovery periods, appealing greatly to both patients and healthcare providers. THV technology is particularly aimed at high-risk patients who are not candidates for traditional surgery, providing them with a feasible and safer alternative. The adoption of THVs is escalating due to continuous technological improvements, broader indications for use, and an extensive pipeline of innovative products, all contributing to the segment's growth and its significant impact on the overall market expansion.

Breakup by End-User:

• Hospitals
• Ambulatory Surgical Centres
• Others
   

Hospitals hold the largest share of the industry

A detailed breakup and analysis of the market based on the end-user have also been provided in the report. This includes hospitals, ambulatory surgical centres, and others. According to the report, hospitals accounted for the largest market share.

End-user segmentation is fundamental in the market to identify the primary locations where the devices are utilized, with hospitals constituting the largest segment. This prominence is primarily due to hospitals offering a comprehensive and specialized approach to cardiac treatment and care, encompassing a broad spectrum of heart management services, including surgeries and various cardiac procedures. Additionally, patients place their trust in hospitals due to their use of advanced technologies and their capability to manage diverse cardiac conditions, including emergencies. Moreover, hospitals are typically the first to receive the latest advancements in heart valve technologies, making these devices integral to their treatment offerings. Consequently, the high number of procedures performed in hospitals solidifies their position as the principal end-user in the market.

Breakup by Region:

• North America
  • United States
  • Canada
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Others
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East
• Africa
   

North America leads the market, accounting for the largest heart valve devices market share

The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.

North America’s supremacy is due to its highly advanced healthcare infrastructure, substantial healthcare spending, and widespread adoption of modern medical technologies. North America's established regulatory framework accelerates the approval of new heart valve innovations, and the presence of numerous market players fosters continual technological advancements, enhancing its market share. The region's high incidence of cardiovascular diseases and an aging demographic, necessitating more cardiac care, further propels the demand for heart valve devices, thereby reinforcing North America’s leading position in the global market. The Centers for Disease Control and Prevention (CDC) states cardiovascular disease claims one life every 33 seconds in the United States. In 2021, heart disease claimed the lives of almost 695,000 Americans, accounting for 1 in 5 fatalities.

Analysis Covered Across Each Country:

• Historical, current, and future market performance
• Historical, current, and future performance of the market based on type and end-user
• Competitive landscape
• Government regulations
   

Competitive Landscape:

The market research report has provided a comprehensive analysis of the competitive landscape covering market structure, market share by key players, market player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant, among others. Detailed profiles of all major companies have also been provided. This includes business overview, product offerings, business strategies, SWOT analysis, financials, and major news and events. Some of the major market players in the heart valve devices industry include:

• Abbott
• Boston Scientific Corporation
• Lifescan
• CryoLife
• Edward Lifesciences Corporation
• Medtronic
• JenaValue Technology
• SYMETIS
• Neovasc
• Sorin Group
   

Key companies in the market are involved in a wide range of strategic actions to enhance their market position and adapt to the current industry trends. These key players are significantly investing in research and development (R&D) to develop innovative and more effective heart valve products, aiming to improve patient outcomes and expand their product ranges. They are actively engaging in acquisitions, partnerships, and joint ventures to solidify their market stance, broaden their global presence, and acquire innovative technologies. Furthermore, securing regulatory endorsements for their advanced offerings is a priority, ensuring their products comply with the rigorous safety and effectiveness standards set by healthcare authorities, thus enhancing their competitive advantage and fostering market growth.

Analysis Covered for Each Player:

• Market Share
• Business Overview
• Products Offered
• Business Strategies
• SWOT Analysis
• Major News and Events
   

Heart Valve Devices Market News:

• February 16, 2024: Abbott Laboratories' heart valve replacement device was granted approval by the U.S. Food and Drug Administration's advisory board. It is intended for patients who are at risk of problems or death after surgery.
• September 28, 2020: Boston Scientific Corporation announced that it commenced the ACURATE neo2TM Aortic Valve System's regulated rollout in Europe. With several novel characteristics, this next-generation transcatheter aortic valve implantation (TAVI) technology outperforms the original ACURATE neo-platform in terms of clinical performance.
• February 28, 2020: CryoLife acquired the CE Mark for its On-X Ascending Aortic Prosthesis (AAP), allowing the device to be distributed again inside the European Union.
   

Heart Valve Devices Market Report Scope:

Key Questions Answered in This Report:

• How has the global heart valve devices market performed so far, and how will it perform in the coming years?
• What are the drivers, restraints, and opportunities in the global heart valve devices market?
• What is the impact of each driver, restraint, and opportunity on the global heart valve devices market?
• What are the key regional markets?
• Which countries represent the most attractive heart valve devices market?
• What is the breakup of the market based on the type?
• Which is the most attractive type in the heart valve devices market?
• What is the breakup of the market based on the end-user?
• Which is the most attractive end-user in the heart valve devices market?
• What is the competitive structure of the market?
• Who are the key players/companies in the global heart valve devices market?

Key Benefits for Stakeholders:

• IMARC’s industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the heart valve devices market from 2018-2032.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the global heart valve devices market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the heart valve devices industry and its attractiveness.
• The competitive landscape allows stakeholders to understand their competitive environment and provides insight into the current positions of key players in the market.