Transcatheter Heart Valve Replacement Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032

Growth Factors of Transcatheter Heart Valve Replacement Market

The global transcatheter heart valve replacement (THVR) market has experienced significant growth in recent years, driven by the increasing prevalence of cardiac valve disorders and advancements in minimally invasive surgical techniques. In 2018, the market was valued at USD 4.04 billion and is projected treach USD 10.34 billion by 2026, exhibiting a compound annual growth rate (CAGR) of 12.5% during the forecast period.

Rising Prevalence of Cardiac Valve Disorders

Valve diseases, including valve regurgitation and stenosis, have emerged as leading causes of mortality worldwide. In the United States, for instance, bicuspid aortic valve defects occur in approximately 13.7 per 1,000 individuals.

This increasing prevalence underscores the urgent need for effective treatment options, propelling the demand for transcatheter heart valve replacement procedures.

Advantages of Transcatheter Technology

Transcatheter heart valve replacement offers several benefits over traditional surgical approaches, particularly for patients at high surgical risk. The minimally invasive nature of transcatheter procedures results in reduced hospital stays, quicker recovery times, and lower complication rates. These advantages have contributed tthe growing adoption of transcatheter techniques in clinical practice.

Favorable Reimbursement Policies

Government and private reimbursement policies play a crucial role in facilitating access ttranscatheter heart valve replacement therapies. In June 2019, the Centers for Medicare & Medicaid Services (CMS) in the U.S. updated reimbursement policies for THVR, increasing the procedure volume requirements for hospitals tmaintain existing programs. Such policies are expected tdrive market growth by encouraging healthcare providers tadopt transcatheter technologies.

Product Innovations and Approvals

The THVR market has witnessed a surge in product innovations and regulatory approvals, enhancing the therapeutic options available tclinicians and patients. For example, in September 2019, Medtronic launched the Evolut PRO+, a transcatheter aortic valve replacement system in the U.S.

Similarly, in November 2019, Edwards Lifesciences received CE mark approval for the Edwards SAPIEN 3 valve, expanding its use for patients with aortic stenosis at lower risk for open-heart surgery.

Focus on Transcatheter Mitral Valve Replacement (TMVR)

Transcatheter Mitral Valve Replacement (TMVR) is emerging as a new frontier within the THVR market. The significant unmet needs of patients with mitral valve disease have prompted manufacturers tinvest in the development of TMVR products. Many of these products are currently under investigation, with clinical trials underway testablish their safety and efficacy. For instance, Shanghai NewMed Medical Co., Ltd. is conducting clinical trials for Mi-thos, a transcatheter mitral valve replacement product.

Regional Market Insights

North America dominated the global THVR market in 2018, accounting for 40.1% of the market share. This dominance is attributed tactive government support through product approvals and favorable reimbursement policies. According tthe American Heart Association, approximately 90,000 valve substitutes are implanted annually in the U.S., highlighting the substantial demand for heart valve therapies in the region.

Europe represents another significant market for transcatheter heart valve replacement, driven by the increasing prevalence of cardiac valve diseases and a shift towards minimally invasive procedures. According tthe German Heart Surgery Report, a total of 34,394 heart valve procedures were conducted in Germany in 2017, with 12,965 performed through transcatheter interventions.

In the Asia-Pacific region, the market is projected tgrow significantly due tthe rapid adoption of transcatheter valves, a rising geriatric and obese population, and strong government support. The increasing prevalence of congenital heart diseases and the demand for interventional pulmonary valve products are alscontributing tmarket expansion in this region.

Key Industry Players

The THVR market is characterized by the presence of several key players focusing on product innovation and strategic collaborations tstrengthen their market positions. Edwards Lifesciences Corporation leads the market, primarily due tthe higher sales of its SAPIEN valve range, new product approvals, and a diverse product portfolio. Abbott holds the second position, bolstered by its acquisition of St. Jude Medical, Inc., and ongoing investments in developing new products.

Future Outlook

The transcatheter heart valve replacement market is poised for continued growth, driven by technological advancements, increasing prevalence of valve diseases, and supportive reimbursement policies. The focus on developing TMVR products and expanding indications for transcatheter procedures tlower-risk patient populations are expected tcreate new opportunities for market expansion. As manufacturers continue tinnovate and collaborate, the THVR market is set tevolve, offering improved therapeutic options for patients worldwide.

ATTRIBUTE - DETAILS

Study Period - 2015-2026

Base Year - 2018

Forecast Period - 2019-2026

Historical Period - 2015-2017

Unit - Value (USD billion)

Segmentation By Product Type

• Transcatheter Aortic Valve Replacement (TAVR)
• Transcatheter Mitral Valve Replacement (TMVR)
• Transcatheter Pulmonary Valve Replacement(TPVR)

By End User

• Hospitals
• Specialty Clinics & Others

By Geography

• North America (the U.S. and Canada)
• Europe (U.K., Germany, France, Italy, Spain, Scandinavia, and the Rest of Europe)
• Asia-Pacific (Japan, China, India, Australia, Southeast Asia, and the Rest of Asia- Pacific)
• Latin America (Brazil, Mexico, and the Rest of Latin America)
• Middle East& Africa (South Africa, GCC and the Rest of Middle East & Africa)

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