Global Prosthetic Heart Valve Market Size, Share & Industry Trends Analysis Report By End User (Hospitals & Cardiac Centers and Ambulatory Surgical Centers), By Product (Transcatheter, Tissue, and Mechanical), By Regional Outlook and Forecast, 2022 – 2028

Global Prosthetic Heart Valve Market Size, Share & Industry Trends Analysis Report By End User (Hospitals & Cardiac Centers and Ambulatory Surgical Centers), By Product (Transcatheter, Tissue, and Mechanical), By Regional Outlook and Forecast, 2022 – 2028

The Global Prosthetic Heart Valve Market size is expected to reach $13.3 billion by 2028, rising at a market growth of 10.7% CAGR during the forecast period.

Materials like titanium and carbon are used to make mechanical heart valves. They are typically made up of two leaflets and a metal ring encircled by a knitted fabric ring that is sewed onto the heart in place of the native valve. Aortic and mitral replacement operations are available in a variety of models. Mechanical valves have the advantage of being extremely durable. These valves, on the other hand, provide a substrate on which blood clots can easily form.

An opening through which blood flows and a device that closes and opens the orifice make up artificial heart valves. Mechanical devices made of synthetic materials and biological or tissue valves made of animal or human tissue are the two forms of artificial heart valves. Biological valves are typically employed in people over the age of 65 who are unable to take anticoagulants. Mechanical valves are advised for individuals under the age of 40 who have a mechanical valve at another position, have had a stroke, or require double valve replacement. These valves necessitate the use of anti-coagulants by the patient. Mechanical valves can be classified into three categories based on how they open and close.

A revolving ball, a tilting disk, or two semispherical hinged leaflets are examples of these systems. The first is based on a ball-in-cage design, which employs a rubber ball that oscillates within a cobalt-chromium alloy metal cage. When the valve opens, blood flows between the ball and the housing through a primary and secondary orifice. A circular disk is held in place by wire-like arms that protrude into the orifice in the tilting disk valve.

The primary orifice is divided into two unequal orifices when the disk opens. A hinge mechanism connects two semicircular leaflets to the orifice enclosure in the current configuration. During the opening process, the leaflets separate, resulting in three flow zones in the center as well as on the sides.

COVID-19 Impact

During the pandemic, surgeries were delayed and production of prosthetic heart valves was also decreased or suspended due to government restrictions and limitations, causing the prosthetic heart valve market to experience a drop in the growth during the first wave of COVID-19. Coronaviruses are a wide family of SARS (severe acute respiratory syndrome) viruses that cause illnesses ranging from ordinary cold to serious respiratory illnesses. The execution of lockdown postponed the surgical operation for implanting a prosthetic heart valve as well as the manufacturing of prosthetic heart valves, resulting in gradual market disruption.

Market Growth Factors

Rising prevalence of cardiovascular diseases

With the rapidly evolving lifestyles of people across the world, the occurrence of various diseases and disorders is also rising as a result. One of the major disorders that can be caused by the changing living patterns of people is cardiovascular disease. Unhealthy food, physical inactivity, cigarette consumption, and problematic alcohol consumption are the major behavioral risk factors for heart disease and stroke. People may experience symptoms, such as high blood pressure, high blood glucose, high blood lipids, or overweight or obesity as a result of behavioral risk factors. These intermediate risk factors are detectable in primary care settings and imply a higher risk of stroke, heart attack, heart failure, and other consequences.

The rapid surge in the geriatric population

The geriatric population all over the world is significantly increasing. According to the United Nations Organization, in 2019, the world's population of people aged 65 and up totaled 703 million. In 2050, the number of geriatric people is anticipated to reach 1.5 billion. The proportion of people aged 65 and up in the global population climbed from 6% in 1990 to 9% in 2019. By 2050, that percentage is expected to climb to 16%, implying that one in every six individuals worldwide would be 65 or older. In the years 2015-2020, a 65-year-old person should expect to live an additional 17 years on average over the world.

Market Restraining Factors

Risk of valve failure

Mechanical heart valve failure occurs in various cases after the completion of an artificial heart valve transplant. Though structural damage is uncommon, infections and blood clots may necessitate the replacement of some of them. Clots can either open or seal the mechanical valve, causing stenosis, insufficiency, or a combination of the two. Some clots can break free from the prosthetic valve and move to the arteries and blood vessels that supply the heart (coronary arteries) or the brain (carotid arteries), resulting in a stroke or heart attack. Mechanical heart valves have a higher risk of thrombotic or thromboembolic consequences.

End User Outlook

Based on End User, the market is segmented into Hospitals & Cardiac Centers and Ambulatory Surgical Centers & Others. In 2021, the Hospitals & Cardiac Centers segment witnessed the largest revenue share of the prosthetic heart valve market. The rapid surge in the growth of the segment is owing to the demand for expert and professional care during valve replacement surgeries. Due to the fact that, hospitals are more advanced and comprise more devices, equipment, and resources, the growth of this segment is significantly being augmented.

Product Outlook

Based on Product, the market is segmented into Transcatheter, Tissue, and Mechanical. In 2021, the mechanical heart valve segment procured a significant revenue share of the prosthetic heart valve market. The rising growth of the segment is attributed to the robust stability and endurance of this kind of artificial heart valve. To offer mechanical stability and endurance, mechanical heart valves (MHV) are built entirely of non-biological (artificial) materials, such as pyrolytic carbon, titanium, cobalt, and polymers.

Regional Outlook

Based on Regions, the market is segmented into North America, Europe, Asia Pacific, and Latin America, Middle East & Africa. In 2021, Asia-Pacific registered a substantial revenue share of the prosthetic heart valve market. The rapidly increasing growth of the regional market is owing to the rising geriatric population of the region. Moreover, due to an increase in the prevalence of cardiac disorders, like aortic stenosis, developing healthcare infrastructure in regional countries, such as China and India, and market players' constant focus on investing in emerging markets, the healthcare industry of the region is increasingly developing.

The major strategies followed by the market participants are Acquisitions. Based on the Analysis presented in the Cardinal matrix; Abbott Laboratories is the major forerunner in the Prosthetic Heart Valve Market. Companies such as Boston Scientific Corporation, Medtronic PLC and Edwards Lifesciences Corporation are some of the key innovators in the Market.

The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Boston Scientific Corporation, Medtronic PLC, Abbott Laboratories, Meril Life Science Private Limited, Colibri Heart Valve LLC, Artivion, Inc., TTK Healthcare Limited, Edwards Lifesciences Corporation, JenaValve Technology, Inc., and Micro Interventional Devices, Inc.

Recent Strategies deployed in Prosthetic Heart Valve Market

Acquisitions and Merger:

Oct-2021: Boston Scientific took over Baylis Medical Company, a leader in the development and commercialization of innovative medical devices. With this acquisition, the company aimed to expand its electrophysiology and structural heart product offerings with the addition of radiofrequency NRG and VersaCross Transseptal Platforms along with a range of guidewires, dilators, and sheaths.

Sep-2021: Boston Scientific acquired Devoro Medical, a medical device developer. With this acquisition, the company aimed to integrate Devoro's WOLF platform into its portfolio in order to increase its efforts in ensuring the right tools for physicians to enhance procedural efficiencies. Moreover, this acquisition would also expand and complement Boston's portfolio by making it a complete range of interventional strategies for thromboemboli.

Jan-2021: Boston Scientific acquired Preventice Solutions, a leading developer of mobile health solutions and remote monitoring services. This acquisition aimed to offer a robust presence to Boston in the high-growth ambulatory electrocardiography space in order to complement the company's implantable cardiac monitor portfolio.

Jan-2021: Abbott completed its acquisition of Cephea Valve Technologies, a medical device company. This acquisition aimed to strengthen Abbott's position across structural heart therapies and complement its vision to develop comprehensive therapy for patients with mitral valve disease.

Sep-2020: CryoLife completed its acquisition of Ascyrus Medical, a medical device company. Through this acquisition, the company aimed to strengthen its position across the rapidly growing aortic repair market.

Product Launches and Product Expansions:

Nov-2020: Abbott unveiled the clip delivery system, a heart valve repair device, in India. The new device aimed to treat leaky mitral valves without conducting an open-heart surgery as it is injected into the heart through a vein in the patient's leg.

Sep-2020: Boston Scientific rolled out ACURATE neo2 in the European market. The new aortic valve system comprises a novel annular sealing technology that is designed to identify irregular and calcified anatomies while minimizing paravalvular regurgitation or leakage.
 
Approvals and Trials:

Mar-2022: Edwards Lifesciences received the US FDA approval for its MITRIS RESILIA valve. The new tissue valve replacement therapy is particularly developed for the heart's mitral position. In addition, the company's new innovative therapy offers advanced RESILIA tissue along with an anti-calcification technology in order to enable devices to be stored in dry packaging conditions.

Sep-2021: Abbott received the US FDA approval for its Epic Plus and Epic Plus Supra Stented Tissue Valves. The new tissue valves are developed to enhance therapy options for patients with mitral or aortic valve disease. In addition, these devices are built on the Epic surgical valve platform of Abbott.

May-2021: Micro Interventional Devices received the Breakthrough Device Designation approval from the US FDA for its MIA-T Percutaneous Tricuspid Annuloplasty System. This approval aimed to allow MID to interact with FDA, including sprint discussions, more timely and frequently in order to aid in data development plans as well as regular status updates through face-to-face meetings and teleconferences to accelerate the clinical trial process.

Mar-2021: Medtronic received the US FDA approval for its Harmony Transcatheter Pulmonary Valve. The new minimally invasive therapy is developed for the treatment of patients suffering from a particular type of congenital heart defect in the right ventricle.

Jan-2020: JenaValve Technologies received the breakthrough device designation approval from the US FDA for its pericardial TAVR device. With this approval, the company aimed to offer a new and enhanced version of its original and ER Mark certified JenaValve porcine root system.

Scope of the Study

Market Segments covered in the Report:

By End User

• Hospitals & Cardiac Centers
• Ambulatory Surgical Centers & Others

• Transcatheter
• Tissue
• Mechanical

• North America
• US
• Canada
• Mexico
• Rest of North America
• Europe
• Germany
• UK
• France
• Russia
• Spain
• Italy
• Rest of Europe
• Asia Pacific
• China
• Japan
• India
• South Korea
• Singapore
• Malaysia
• Rest of Asia Pacific
• LAMEA
• Brazil
• Argentina
• UAE
• Saudi Arabia
• South Africa
• Nigeria
• Rest of LAMEA

• Boston Scientific Corporation
• Medtronic PLC
• Abbott Laboratories
• Meril Life Science Private Limited
• Colibri Heart Valve LLC
• Artivion, Inc.
• TTK Healthcare Limited
• Edwards Lifesciences Corporation
• JenaValve Technology, Inc.
• Micro Interventional Devices, Inc.

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