The prosthetic heart valve market is estimated to be valued at USD 13.21 Bn in 2024, growing at a CAGR of 11.5% over the forecast period (2024 – 2031). The market is witnessing high growth owing to increasing investments in R&D for the development of innovative transcatheter heart valves with better clinical profile. Furthermore, rapid technological advancements in heart valve replacement techniques and design of prosthetic heart valves are expanding growth opportunities in the market.
Market Dynamics:
The prosthetic heart valve market is primarily driven by the growing geriatric population worldwide which increases risk of various heart valve disorders. According to a UN published in May 2021, the number of people aged 65 years or older is projected to grow dramatically from 750 million in 2020 to 1.5 billion in 2050. The rising prevalence of rheumatic heart diseases particularly in developing nations which causes damage to heart valves has augmented the demand for valve replacement surgeries. Additionally, increased life expectancy has led to a rise in the number of re-do valve replacement surgeries which require prosthetic heart valves.
Rising Prevalence of Cardiovascular Diseases
One of the key drivers for the growth of the prosthetic heart valve market is the rising prevalence of cardiovascular diseases globally. According to the World Health Organization, cardiovascular diseases are the number one cause of death globally, taking an estimated 17.9 million lives each year. Common heart conditions that often require valve replacement surgery include valvular heart disease, congenital heart disease and rheumatic heart disease. As the geriatric population increases worldwide along with lifestyle diseases like diabetes and obesity, the incidence of valvular heart problems is expected to rise significantly. This will fuel the demand for prosthetic heart valves for replacement surgeries.
Technological Advancements in Valve Design and Delivery Systems
Continuous innovations and technological advancements in valve design and delivery systems are another major factor propelling the growth of the prosthetic heart valve market. Newer valves are designed to be much more durable, effective and hemocompatible than their predecessors. Minimally invasive transcatheter aortic valve replacement (TAVR) procedures are gaining popularity as they reduce surgical risks for high-risk patients. Self-expanding and repositionable valves delivered via catheter have opened up treatment options for inoperable patients. Advancements like the development of bioprosthetic valves with induced leaflet damage and Stentless valves have further improved clinical outcomes. Such developments are expected to boost the adoption of prosthetic heart valves.
Stringent Regulatory Approval Process
The stringent regulatory approval process for new prosthetic heart valves, especially transcatheter heart valves, acts as a key restraint on the market growth. Clinical trials need to prove the safety and efficacy of novel valve designs and delivery mechanisms compared to existing standard therapies. This significantly increases the cost, time and uncertainty of the approval process. Even after approval, post-market surveillance studies and registries are mandated to monitor long-term durability and performance. Compliance with regulatory requirements across different geographies adds to the regulatory burden. Stringent rules thus delay the commercialization of novel products and technology upgrades in this market.
Reimbursement Policies of Insurers
Unfavorable reimbursement policies for costly valve replacement procedures, especially in developing nations, is another major challenge faced by market players. Transcatheter aortic valve replacement procedures require expensive valve delivery systems and catheters. Even bioprosthetic surgical heart valves have a substantial upfront cost. Lack of adequate insurance coverage and payment caps placed by some insurers restrict access to such treatments. This restraints the full potential of the market in price-sensitive regions. Though healthcare reforms are gradually expanding insurance eligibility, strict reimbursement continues to hinder the market demands to some extent in underdeveloped markets.
Usage of TAVR in Lower Risk Patients
One of the key opportunities for growth in the coming years is the increased adoption of transcatheter aortic valve replacement (TAVR) procedures for lower-risk surgical patients. Currently, TAVR is predominantly used for inoperable and high-risk patients. However, recent clinical studies have demonstrated non-inferior outcomes of TAVR compared to open-heart surgery even in intermediate-risk populations. As TAVR technologies mature further with enhanced safety profiles, guidelines are expanding to recommend their usage in lower surgical risk groups as well. This will majorly ramp up the eligible patient base driving multi-fold increase in global procedure volumes.
Emergence of New Applications
The emergence of new applications of prosthetic heart valves beyond traditional aortic and mitral valve replacements presents lucrative commercial opportunities. Areas showing promise include pulmonary and tricuspid valve replacements. Experimental usage of prosthetic valves is also underway for congenital heart defects, valve-in-valve, and left ventricular assist devices. Furthermore, innovations are being explored in regenerative technologies involving tissue-engineered heart valves and sutureless valves. Novel applications like these offer incremental growth prospects by addressing currently untapped segments of . In particular, they provide solutions for pediatric populations.
Link - https://www.coherentmarketinsights.com/market-insight/prosthetic-heart-valve-market-69
Key Development
- In October 2023, Edwards Lifesciences Corporation, a worldwide leader in patient-centric technologies for structural heart disease, declared that its EVOQUE tricuspid valve replacement system has received the CE Mark for the transcatheter treatment of eligible patients with tricuspid regurgitation (TR). This milestone makes the EVOQUE system the world's inaugural transcatheter valve replacement therapy to obtain regulatory approval for the treatment of TR.
- In March 2023, Abbott, a prominent medical company, revealed that the U.S. Food and Drug Administration (FDA) granted approval for the Epic Max stented tissue valve to address aortic regurgitation and stenosis. This device marks the latest addition to Abbott's Epic surgical valve platform, renowned for its long-standing safety record and exceptional clinical outcomes. The Epic Max features an enhanced design aimed at further enhancing valve blood flow.
- In November 2022, Nyra Medical, Inc., a medical device company pioneering a groundbreaking transcatheter mitral valve repair technology, disclosed the successful conclusion of a US$ 20 million Series A fundraising. Leading the round are Vensana Capital and a prominent global medical device business, with additional contributions from investors such as Broadview Ventures, Epidarex Capital, and the Georgia Research Alliance Venture Fund. The capital raised will be directed towards advancing Nyra's technology through early feasibility trials.
- In September 2022, unveiled the introduction of the SAPIEN 3 Ultra RESILIA valve, integrating the company’s cutting-edge RESILIA tissue technology with the highly acclaimed SAPIEN 3 Ultra transcatheter aortic heart valve. This launch comes subsequent to the recent U.S. approval, marking a significant advancement in transcatheter heart valve technology.
Key Players: Edwards Lifesciences Corporation, Medtronic plc., Boston Scientific Corporation, Abbott Laboratories, LivaNova PLC, CryoLife Inc., Braile Biomedica, Colibri Heart Valve LLC, JenaValve Technology Inc., TTK Healthcare Limited, Lepu Medical Technology Co. Ltd, Foldax, Inc., Symetis SA, On-X Life Technologies, and Braile Biomedica
