Transcatheter Heart Valve Market To Generate a Significant Revenue of US$ 7,642.7 Million by 2027 | CAGR: 12.7%: Coherent Market Insights
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Transcatheter aortic valve replacement (THVR) can be defined as minimally invasive technique that is approved for patients suffering from symptomatic severe aortic stenosis or regurgitation and is usually recommended for high risk patients suffering from other chronic diseases, who needs to undergo cardiac surgery.
The global transcatheter heart valve market is estimated to surpass US$ 7,642.7 Mn in terms of value by the end of 2027
Global Transcatheter Heart Valve Market: Drivers
The global market growth is attributed to increasing demand for minimally-invasive procedures. THVR procedure aids in reducing morbidity and mortality rate, offers faster recovery time, and has less postoperative complications in comparison to conventional procedures.
Global Transcatheter Heart Valve Market: Opportunities
Moreover, favorable reimbursement policies in various economies are expected to offer lucrative growth opportunities for players in the market. For instance, in the U.S., Medicare covers reimbursement for patients, whose aortic heart valves are damaged and need replacement. Furthermore, in May 2012, the Centers for Medicare and Medicaid Services (CMS) and Food & Drug Administration (FDA) jointly approved insurance coverage for TAVR in high risk patients with severe aortic stenosis.
Global Transcatheter Heart Valve Market: Restraints
However, clinical trials for transcatheter heart valve products are time consuming and require significant capital investment. Moreover, product failure in final phases of clinical trials can lead to major losses to the company. These factors are expected to hamper growth of the global transcatheter heart valve market over the forecast period. For instance, in September 2014, MicroPort Medical (Group) Co., Ltd. submitted its transcatheter aortic valve device for FDA approval. Its results are expected to be announced by September 2021.
Among product type, TAVR segment is estimated to be valued at US$ 2,331.7 Mn in 2019 and is expected to reach US$ 6,054.9 Mn by 2027, exhibiting a CAGR of 12.7% during the forecast period. The segment growth is attributed to increasing demand for minimally-invasive procedures.
Among delivery systems, transfemoral approach segment is expected to account for major market share of 85.1% in 2019, in terms of value, followed by transapical approach segment, respectively. The market growth is attributed to increasing regulatory product approvals.
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Major players in the market are focusing on conducting clinical trials to expand their produxt portfolio. For instance, in November 2019, Meril, a company based in India, announced that its MyVal-1 transcatheter heart valve demonstrated a high procedural success rate in a one-month clinical trial for patients at intermediate or high risk for surgical aortic valve replacement.
Additionally, increasing R&D in TAVR is expected to drive growth of the market over the forecast period. For instance, in October 2019, researchers from University Heart Center Hamburg reported that implantation of the self-expanding Biovalve transcatheter heart valve for the treatment of severe aortic stenosis was safe.
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In the U.S., the premarket approval (PMA) process can be broken down into four basic stages.
- Pre-Investigational Device Exemption/Preclinical Evaluation
- IDE/Clinical Testing
- Data Review—PMA (Stage III)
- Post-market Approval (Stage IV)
The PMA process is initiated by the medical device company with a series of meetings with FDA/CDRH focused on preclinical (bench and animal) testing as well as plans for a clinical trial.
The FDA works with the sponsor to develop a plan that may include specifics regarding site/physician training, post market surveillance registries, and studies.
Global Transcatheter Heart Valve Market: Competitive Landscape
Key players operating in the global transcatheter heart valve market include Edwards Lifesciences Corporation, Medtronic, Boston Scientific Corporation, Abbott, JenaValve Technology, SYMETIS, and Braile Biomedica.
Global Transcatheter Heart Valve Market: Key Developments
- August 2019: Edwards Lifesciences announced to recall its SAPIEN 3 Ultra delivery system. The U.S. FDA identified this as a Class I recall
- August 2019: Medtronic plc received the U.S. Food and Drug Administration approval for its Evolut TAVR system for patients with symptomatic severe native aortic stenosis who are at a low risk of surgical mortality
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