Prosthetic Heart Valve Devices and Equipment Market Report 2025

This Prosthetic Heart Valve Devices and Equipment market report provides a comprehensive analysis of the market’s characteristics, size, and growth, including segmentation, regional and country-level breakdowns, competitive landscape, market shares, trends, and strategies. It also tracks historical and forecasted market growth across various geographies.

The prosthetic heart valve devices and equipment market size has grown rapidly in recent years. It will grow from $6.68 billion in 2024 to $7.44 billion in 2025 at a compound annual growth rate (CAGR) of 11.4%. The growth in the historic period can be attributed to cardiovascular disease prevalence, aging population, chronic disease management, clinical guidelines and research.

The prosthetic heart valve devices and equipment market size is expected to see strong growth in the next few years. It will grow to $10.39 billion in 2029 at a compound annual growth rate (CAGR) of 8.7%. The growth in the forecast period can be attributed to minimally invasive procedures, telehealth integration, global access to healthcare, drug-coated devices. Major trends in the forecast period include artificial intelligence (ai) in vascular medicine, robot-assisted interventions, point-of-care testing, bioresorbable vascular scaffolds.

The increasing prevalence of valvular heart disease has fueled the demand for transcatheter aortic valve replacement (TAVR) procedures, thereby driving the growth of the prosthetic heart valve devices and equipment market. TAVR is a minimally invasive surgical procedure used to treat aortic stenosis, a valvular heart disease that impairs the function of the heart's aortic valve. Aortic stenosis causes the aortic valve to harden, restricting proper blood flow, and TAVR replaces the malfunctioning valve with a transcatheter valve. For example, in May 2024, the Centers for Disease Control and Prevention, a US-based government agency, reported that heart disease caused 702,880 deaths in the United States in 2022, accounting for one in every five fatalities. As the incidence of valvular heart diseases continues to rise, the number of TAVR procedures is expected to grow, driving the demand for transcatheter valves and propelling the market forward.

The growing prevalence of cardiovascular disorders is anticipated to propel the prosthetic heart valve devices market. Cardiovascular disorders encompass a range of heart and blood vessel-related conditions, including coronary artery disease, heart failure, and stroke. Prosthetic heart valve devices are employed to manage cardiovascular disorders by replacing damaged valves with prosthetic heart valves. These devices contribute to improved survival rates, symptom relief, and reduced morbidity and mortality. For instance, heart valve disease, the most common type of structural heart ailment, affects approximately 2.5% of all Americans, as reported by the Cleveland Clinic in March 2022. Consequently, the increasing incidence of cardiovascular disorders is expected to drive the prosthetic heart valve devices market.

A notable trend in this market is the preference for polymer valves over traditional mechanical and bio-prosthetic valves/tissue valves. Polymer heart valves, constructed from polymeric materials, offer advantages over tissue and mechanical heart valves. Mechanical heart valves necessitate lifelong use of blood-thinning medications to prevent blood clotting, while bioprosthetic heart valves have a shorter lifespan, requiring multiple replacements and posing a risk of valve degradation. In contrast, polymeric heart valves promote better blood flow and reduce the risk of blood clot formation, thereby avoiding the disadvantages associated with tissue and mechanical valves. To leverage these benefits, various companies are investing in the development of polymeric heart valve technologies. For example, Shanghai Medics introduced a novel synthetic heart valve in July 2022. This innovative valve, created using polymer nanomaterials, exhibits an extended lifespan of 20 to 25 years.

Regulatory bodies such as the FDA in the United States and The Central Drugs Standard Control Organization (CDSCO) closely oversee the prosthetic heart valve devices and equipment market. For instance, CDSCO has issued notices classifying the risk levels of various medical devices, designating prosthetic heart valves as class D or high-risk devices. Manufacturers seeking to produce and market prosthetic valve devices in India must adhere to regulatory processes involving forms MD-7 and MD-8, which fall under the jurisdiction of the Indian central government. Form MD-7 is used for registering prosthetic valve manufacturers in India, while form MD-8 is employed by manufacturers to apply for loans.

Leading companies in the prosthetic heart valve devices and equipment market are focusing on the development of tricuspid valve replacement systems to meet the increasing demand for effective treatments for tricuspid valve disease, enhance patient outcomes, and minimize complications associated with conventional heart valve surgeries. Tricuspid valve replacement systems are medical devices designed to replace the tricuspid valve in the heart, which regulates blood flow between the right atrium and right ventricle. For example, in October 2023, Edwards Lifesciences, a US-based technology company, received CE Mark approval for the EVOQUE system, making it the first transcatheter valve replacement therapy globally approved for treating tricuspid regurgitation (TR). The EVOQUE valve features a self-expanding nitinol frame and tissue leaflets derived from bovine pericardial tissue. It is designed for delivery via a low-profile transfemoral 28-French system and will be available in three sizes.

Prosthetic heart valve devices and equipment are artificial valves implanted in the hearts of patients with valvular heart disease. These devices help regulate blood flow within the heart, enhancing circulation and overall heart performance. They are available in mechanical and biological forms, providing patients with options tailored to their specific medical requirements and conditions.

The primary types of prosthetic heart valve devices and equipment include transcatheter heart valves, tissue heart valves, and mechanical heart valves. Transcatheter aortic valve replacement is an invasive procedure used to replace a thickened aortic valve that does not open fully. Product types within this category encompass repair products, mitral valve repair devices, and tricuspid valve repair devices. The technologies employed in prosthetic heart valve devices and equipment involve biological valves and decellularized valves, which are utilized in various healthcare settings such as hospitals and ambulatory surgery centers.

The prosthetic heart valve devices and equipment market research report is one of a series of new reports that provides prosthetic heart valve devices and equipment market statistics, including prosthetic heart valve devices and equipment industry global market size, regional shares, competitors with a prosthetic heart valve devices and equipment market share, detailed prosthetic heart valve devices and equipment market segments, market trends and opportunities, and any further data you may need to thrive in the prosthetic heart valve devices and equipment industry. This prosthetic heart valve devices and equipment market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Major companies operating in the prosthetic heart valve devices and equipment market include Boston Scientific Corporation, Edwards Lifesciences, Medtronic PLC, LivaNova PLC, Abbott Laboratories, Jenavalve Technology Inc., Lepu Medical Technology, Cryolife Inc., Neovasc Inc., Braile Biomedica, Colibri Heart Valve, TTK Healthcare Ltd., Medical Technology Est., Micro Interventional Devices Inc., Well Health Technologies, On-X Life Technologies Inc., Meril Life Sciences Pvt. Ltd., Sorin Group, Commonwealth Edison Company, Cardiac Dimensions Inc., CardioSolutions Inc., Leman Cardiovascular, MitralSolutions Inc., Thubrikar Aortic Valve Inc., LifeNet Health Inc., Xeltis AG, Transcatheter Technologies GmbH, Venus Medtech (Hangzhou) Inc., MValve Technologies Ltd., MVRx Inc., NaviGate Cardiac Structures Inc., Pulmonx Corporation, Tendyne Holdings Inc., ValveXchange Inc., Vascutek Ltd., XpandOrtho Inc., Zhejiang A&F Medical Co. Ltd.

North America was the largest region in global prosthetic heart valve devices and equipment market in 2024. Western Europe was the second-largest region in prosthetic heart valve devices and equipment market. The regions covered in the prosthetic heart valve devices and equipment market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. The countries covered in the prosthetic heart valve devices and equipment market report are Australia, China, India, Indonesia, Japan, South Korea, Bangladesh, Thailand, Vietnam, Malaysia, Singapore, Philippines, Hong Kong, New Zealand, USA, Canada, Mexico, Brazil, Chile, Argentina, Colombia, Peru, France, Germany, UK, Austria, Belgium, Denmark, Finland, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, Russia, Czech Republic, Poland, Romania, Ukraine, Saudi Arabia, Israel, Iran, Turkey, UAE, Egypt, Nigeria, South Africa.

The prosthetic heart valve devices and equipment market consist of sales of mechanical heart valves, transcatheter heart valves, and tissue heart valves that are used for heart patients. Values in this market are factory gate values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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