SEATTLE, August 02, 2021, (MEDGADGET) — Global Transcatheter Heart Valve market analysis

Overview

Transcatheter heart valve implantation is a minimally invasive operation that involves replacing weakened heart valves with bioprosthetic valves to treat VHD (valvular heart disease), such as aortic stenosis and mitral regurgitation. It’s a less invasive alternative to open heart surgery, and it’s particularly beneficial for people who are at exceptionally high risk.

Statistics

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

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Drivers

The high incidence of VHD is expected to propel the global transcatheter heart valve market forward during the forecast period. For instance, According to the report, ‘Epidemiology and Trends of Aortic Stenosis Mortality in the United States (1999-2016)’, aortic stenosis is related to a mortality rate of 106.3 per 1 million people, with non-Hispanic whites having the highest mortality rate, followed by Hispanics, and non-Hispanic blacks. Furthermore, there was a rise in age-adjusted mortality between the multiple phases, according to the report.

As a result, demand growth is projected to be supported by the growing geriatric population. According to the WHO (World Health Organization), the global geriatric population will reach 2 billion by 2050, up from 900 million in 2015.

In terms of value, North America dominated the global transcatheter heart valve market in 2019, contributing about 53.6 percent of the market share, led by Europe.

Restraints

The global transcatheter heart valve market’s growth is projected to be hampered by the high cost of transcatheter heart valves. Transcatheter aortic valve replacement (TAVR) systems cost US$ 32,000 on average, compared to US$ 4,000–US$ 7,000 for surgical aortic valve replacement (SAVR) devices.

Furthermore, TAVR is related to a number of risks and complications, including artery injury from catheter insertion, which may result in significant bleeding, valve leakage, inflammation, renal disease, heart attack, major stroke, and death during the process.

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Opportunities

Companies in the market should concentrate on developing and launching low-cost TAVR products in order to expand their market share in emerging markets like India, China, and Brazil.

Furthermore, there is growing concern regarding the risk of cerebrovascular accidents following TAVR, which are linked to a higher mortality rate. As a result, the market participants are expected to benefit from the establishment of consistent concepts and evaluations of neurological endpoints for TAVR and other cardiac therapies.

The global transcatheter heart valve market’s Transfemoral Approach segment was worth US$ 2,369.4 million in 2019 and is projected to grow at a CAGR of 14.1 percent to US$ 6,814.2 million by 2025.

Market Trends

The adoption of TAVR for the treatment of aortic stenosis is a priority for major hospitals. Chester County Hospital announced in January 2020 that TAVR will be available in a few months for appropriate patients at the hospital.

Several regulatory authorities are working to broaden the scope of transcatheter heart valve indications. The US Food and Drug Administration approved an extended designation for multiple transcatheter heart valves, including Sapien 3 Ultra, CoreValve Evolut PRO, CoreValve Evolut R, and Sapien 3, in August 2019.

Regulations:

The U.S.

• In the U.S., FDA Center for Device and Radiological Health (FDA/CDRH) is responsible for the regulation of medical devices
• TAVR is categorized by FDA/CDRH as a class III significant risk device, which requires demonstration of safety and effectiveness for approval as part of the premarket approval (PMA) process.

Competitive Landscape

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

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Key Developments

To broaden their product range, major market players are focusing on product acceptance and launch. JenaValve Technology obtained the groundbreaking drug certification from the US FDA in January 2020 for its pericardial TAVR device.

Edwards Lifesciences Corporation obtained CE Mark in November 2019 to extend the use of the Edwards SAPIEN 3 transcatheter heart valve in patients with aortic stenosis and those not eligible for open-heart surgery.

Table of Contents

1. Research Objectives and Assumptions
   • Research Objectives
   • Assumptions
   • Abbreviations
2. Market Purview
   • Report Description
     • Market Definition and Scope
   • Executive Summary
     • Market Snippet, By Product Type
     • Market Snippet, By Delivery System
     • Market Snippet, By End User
     • Market Snippet, By Region Coherent Opportunity Map (COM)
3. Market Dynamics, Regulations, and Trends Analysis
   • Market Dynamics
     • Drivers
     • Restraints
     • Market Opportunities
   • Impact Analysis
   • Key Highlights
   • Awareness Initiatives
   • PEST Analysis
   • Epidemiology
4. Global Transcatheter Heart Valve Market, By Product Type, 2019 – 2027, (US$ Mn)
   • Introduction
     • Market Share Analysis, 2019 and 2027 (%)
     • Y-o-Y Growth Analysis, 2017 – 2027
     • Segment Trends
   • TAVR
     • Introduction
     • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
   • TMVR
     • Introduction
     • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
5. Global Transcatheter Heart Valve Market, By Delivery System, 2019 – 2027, (US$ Mn)
   • Introduction
     • Market Share Analysis, 2019 and 2027 (%)
     • Y-o-Y Growth Analysis, 2017 – 2027
     • Segment Trends
   • Transfemoral Approach
     • Introduction
     • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
   • Transapical Approach
     • Introduction
     • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
   • Transaortic Approach
     • Introduction
     • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
6. Global Transcatheter Heart Valve Market, By End User, 2019 – 2027, (US$ Mn)
   • Introduction
     • Market Share Analysis, 2019 and 2027 (%)
     • Y-o-Y Growth Analysis, 2017 – 2027
     • Segment Trends
   • Hospitals
     • Introduction
     • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
   • Ambulatory Surgical Centers
     • Introduction
     • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
   • Cardiac Catheterization Laboratory
     • Introduction
     • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
7. Global Transcatheter Heart Valve Market, By Region, 2019 – 2027, (US$ Mn)
   • Introduction
     • Market Share Analysis, By Region, 2019 and 2027 (%)
     • Y-o-Y Growth Analysis, For Regions, 2017–2026
   • North America
     • Market Size and Forecast, By Product Type, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By Delivery System, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By End User, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
       • U.S.
       • Canada
   • Latin America
     • Market Size and Forecast, By Product Type, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By Delivery System, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By End User, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
       • Brazil
       • Mexico
       • Argentina
       • Rest of Latin America
   • Europe
     • Market Size and Forecast, By Product Type, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By Delivery System, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By End User, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
       • Germany
       • U.K.
       • France
       • Italy
       • Spain
       • Russia
       • Rest of Europe
   • Asia Pacific
     • Market Size and Forecast, By Product Type, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By Delivery System, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By End User, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
       • China
       • India
       • Japan
       • Australia
       • South Korea
       • ASEAN
       • Rest of APAC
   • Middle East
     • Market Size and Forecast, By Product Type, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By Delivery System, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By End User, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
       • GCC
       • Israel
       • Rest of Middle East
   • Africa
     • Market Size and Forecast, By Product Type, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By Delivery System, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By End User, 2016 – 2027, (US$ Mn)
     • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
       • South Africa
       • Central Africa
       • North Africa
8. Competitive Landscape
   • Company Profiles
9. Section
   • References
   • Research Methodology
   • About us and Sales Contact

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