The prosthetic heart valve devices and equipment market has seen considerable growth due to a variety of factors.
• The market for prosthetic heart valve devices and equipment has seen a significant expansion in size over the recent years. Its growth is projected to increase from $6.68 billion in 2024, to $7.44 billion in 2025, demonstrating a compound annual growth rate (CAGR) of 11.4%.
Factors contributing to this growth in the past include the prevalence of cardiovascular disease, an increasing elderly population, management of chronic diseases, established clinical guidelines, and ongoing research.
The prosthetic heart valve devices and equipment market is expected to maintain its strong growth trajectory in upcoming years.
• The marketplace for devices and equipment related to prosthetic heart valves is anticipated to witness substantial growth in the coming years. It is projected to expand to a worth of $10.39 billion in 2029, growing at a compound annual growth rate (CAGR) of 8.7%.
The predicted growth in this period can be associated with factors such as the integration of telehealth, worldwide access to healthcare, minimally invasive techniques, and drug-coated devices. The key trends forecasted for this period encompass the application of artificial intelligence (AI) in vascular medicine, robot-helped medical procedures, point-of-care diagnostics, and bioresorbable vascular scaffolds.
The increasing cases of valvular heart disease have necessitated the adoption of transcatheter aortic valve replacement (TAVR) operations, effectively propelling the prosthetic heart valve devices and equipment market forwards. TAVR is a minimally invasive surgery meant to treat aortic stenosis - a form of valvular heart disease that targets the heart's aortic valve. Aortic stenosis hardens the aortic valve, inhibiting the proper flow of blood, and a transcatheter valve is used to replace this faulty one through TAVR. For example, in May 2024, the Centers for Disease Control and Prevention, an agency of the U.S. government, stated that heart disease was the cause of 702,880 deaths in the United States in 2022, representing 1 of every 5 deaths. As the valvular heart diseases increase, it can be presumed that the rate of conducted TAVR procedures will also rise, boosting the demand for transcatheter valves and subsequently propelling the market in the future.
The prosthetic heart valve devices and equipment market covered in this report is segmented –
1) By Product Type: Repair Products, Mitral Valve Repair Devices, Tricuspid Valve Repair Devices
2) By Type: Transcatheter Heart Valve, Tissue Heart Valve, Mechanical Heart Valve
3) By Technology: Biological Valve, Decellularized Valve
4) By Application: Hospitals, Ambulatory Surgery Centres
Subsegments:
1) By Repair Products: Transcatheter Mitral Valve Repair (TMVR) Devices, Transcatheter Tricuspid Valve Repair (TTVR) Devices
2) By Mitral Valve Repair Devices: Mitral Valve Repair Systems (MitraClip), Mitral Valve Annuloplasty Devices, Edge-to-Edge Repair Devices
3) By Tricuspid Valve Repair Devices: Tricuspid Valve Annuloplasty Devices, Tricuspid Valve Repair Systems
Regulatory entities such as the FDA in the US and The Central Drugs Standard Control Organization (CDSCO) oversee the market for prosthetic heart valve apparatus and machinery. For example, CDSCO has issued guidelines dictating the risk levels for various medical devices, with prosthetic heart valves being classified as a class D, or high-risk, device. In the same way, manufacturers aiming to manufacture and sell prosthetic valve devices in India need to fill up forms MD-7 and MD-8 which are under the strict supervision of the Indian central government. Form MD-7 is intended for the registration of prosthetic valve makers in India while form MD-8 is used by them to avail loans.
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 2023. 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.