Transcatheter Heart Valve Market Latest Technological Advancements, Scope, Applications and Competitive Outlook To 2028

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THVR (Transcatheter aortic valve replacement) is permitted for patients with symptomatic extreme aortic stenosis or regurgitation and is prescribed for high-risk patients who require heart surgery due to other chronic diseases.

Statistics

By 2027, the global transcatheter heart valve market is anticipated to have a valuation of US$ 7,642.7 million.
Drivers

During the forecast period, the global transcatheter heart valve market is expected to rise due to rising demand for minimally invasive procedures. In comparison to traditional treatments, the THVR protocol reduces morbidity and mortality, has a shorter turnaround time, and has less postoperative complications.

Competitive Landscape

Key companies contributing in the global transcatheter heart valve market are Boston Scientific Corporation, JenaValve Technology, Edwards Lifesciences Corporation, Braile Biomedica, Medtronic, SYMETIS, and Abbott.

Opportunities

Various countries' favourable rebate programmes are projected to provide attractive growth prospects for market players. In the U.S., Medicare reimburses patients whose aortic heart valves are weakened and need to be replaced. The FDA (Food and Drug Administration) and the CMS (Centers for Medicare and Medicaid Services) collectively approved TAVR coverage in high-risk patients with serious aortic stenosis in May 2012.

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Restraints

Clinical trials for transcatheter heart valve devices will take a long time and cost a lot of money. Failure of a product in the final stages of clinical trials will result in significant financial losses for the firm. As a result, the global transcatheter heart valve market is expected to decline. MicroPort Medical (Group) Co., Ltd applied its transcatheter aortic valve system for FDA approval in September 2014. The findings are scheduled to be released in September 2021.

Key Takeaways

The TAVR segment of the global transcatheter heart valve market was estimated at US$ 2,331.7 Mn in 2019 and is projected to rise at a CAGR of 12.7 percent to US$ 6,054.9 Mn by 2027, with a CAGR of 12.7 percent. Growing demand for minimally invasive procedures is expected to drive segment growth over the forecasted period.

In terms of value, the Transfemoral Approach segment dominated the global transcatheter heart valve market in 2019, contributing about 85.1 percent of the market share, led by Transapical Approach. Rising product approvals are expected to fuel segment growth over the forecast period.

Market Trends

Clinical trials are a priority for the market's major players as they seek to broaden their product range. Meril, an Indian firm, announced in November 2019 that its MyVal-1 transcatheter heart valve had a high procedural success rate in a one-month clinical trial for patients at moderate to high risk for surgical aortic valve replacement.

Increased R&D in TAVR is expected to help the market expand. In October 2019, researchers from the University Heart Center Hamburg announced that the self-expanding Biovalve transcatheter heart valve was healthy when used to treat serious aortic stenosis.

Regulations

In the U.S., the premarket approval (PMA) process can be segmented into four basic categories,

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.

Key Developments

August 2019: Edwards Lifesciences announced to recall the SAPIEN 3 Ultra distribution system. The U.S. FDA described this as a Class I recall.

Medtronic plc was awarded the U.S. Patent and Trademark Office (USPTO) in August 2019. The Evolut TAVR device has received FDA clearance for patients with symptomatic extreme native aortic stenosis who are at a low risk of surgical mortality.

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Table of Content

1. Overview and Scope

1.1. Research goal & scope

1.2. Research assumptions

1.3. Research methodology

1.3.1. Primary data sources

1.3.2. Secondary data sources

1.4. Key takeaway

1.5. Stakeholders

2. Executive Summary

2.1. Market definition

2.2. Market segmentation

3. Transcatheter Heart Valve Market Insights

3.1. Transcatheter Heart Valve - Industry snapshot

3.1.1. Leading Companies

3.1.2. Key Companies to Watch

3.2. Transcatheter Heart Valve - Ecosystem analysis

3.2.1. Market overview

3.2.2. Commercial Landscape

3.3. Transcatheter Heart Valve Market Dynamics

3.3.1. Market Forces

3.3.1.1. Market Driver Analysis

3.3.1.2. Market Restraint/Challenges analysis

3.3.1.3. Market Opportunity Analysis

3.4. Industry analysis Porter's five forces

3.4.1. Bargaining power of supplier

3.4.2. Bargaining power of the buyer

3.4.3. Threat of substitute

3.4.4. The threat of new entrant

3.4.5. Degree of competition

3.5. Market PEST Analysis

3.6. Market Value Chain Analysis

3.7. Industry Trends

3.8. Competitive Ranking Analysis

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