Transcatheter Pulmonary Valve Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

The report covers Transcatheter Market Trends and the Market is Segmented by Technology (Balloon-Expanded Transcatheter Valve and Self-Expanded Transcatheter Valve), Application (Pulmonary Stenosis, Pulmonary Regurgitation, Pulmonary Atresia, and Others), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The market provides the value (in USD million) for the above-mentioned segments.

Transcatheter Pulmonary Valve Market Size

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Transcatheter Pulmonary Valve Market Summary
Study Period 2019 - 2029
Base Year For Estimation 2023
CAGR 5.50 %
Fastest Growing Market Asia Pacific
Largest Market North America
Market Concentration Medium

Major Players

Transcatheter Pulmonary Valve Market Major Players

*Disclaimer: Major Players sorted in no particular order

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Transcatheter Pulmonary Valve Market Analysis

The Transcatheter Pulmonary Valve Market is expected to witness a CAGR of 5.5% over the forecast period.

The COVID-19 pandemic is an unprecedented health concern and adversely affects various surgical procedures. Due to regulatory authorities' strict guidance to prevent any non-emergent surgeries, the volume of surgeries has drastically decreased throughout the pandemic. For instance, according to the study published in October 2021, by the National Library of Medicine globally, there has been a 42.8% decrease in general surgery admissions. Thus, the reduction in surgical procedures during the COVID-19 pandemic affected the market's growth. However, the market is gradually stabilizing as COVID-19 cases are declining the number of heart procedures and operations being performed is increasing thus boosting the growth of the transcatheter pulmonary valve market. 

Certain factors that are propelling the market growth are the growing burden of congenital heart disease and the rising awareness of transcatheter pulmonary valve therapy. The rising company activities in developing and launching products as well as increasing product approvals are all expected to increase the market growth over the forecast period. For instance, According to CDC, in February 2022, congenital heart disease (CHD) affects nearly 1% of or about 40,000 births per year in the United States. Additionally, 15% of CHDs are associated with genetic conditions and about 20% to 30% of people with a CHD have other physical problems or developmental or cognitive disorders. Children with CHD are about 50% more likely to receive special education services compared to children without birth defects. Thus, an increase in the CHD burden is expected to drive the growth of the studied market. 

Additionally, the advancements in technology and increasing product approvals, along with partnerships and acquisitions by key players, are aiding the market's growth. For instance, in March 2021, Medtronic plc received U.S. FDA approval for its Harmony Transcatheter Pulmonary Valve (TPV), the first minimally invasive therapy created to treat patients with a specific type of congenital heart defect of the right ventricle (RV), one of the four chambers of the heart, which makes it difficult for blood to travel from the heart to the lungs. The Harmony TPV, which is placed inside a patient's native anatomy during a catheter-based procedure, was designated as a Breakthrough Therapy under FDA's Breakthrough Device Designation (BDD) program, an approval pathway intended to help patients receive more timely access to certain life-saving technologies. Such technological advancements are predicted to boost the transcatheter pulmonary valve demand and enhance market growth further.

Therefore, owing to the aforementioned factors, the studied market is anticipated to witness growth over the forecast period. However, the availability of alternative technologies and stringent regulations are expected to impede market growth over the forecast period.

Transcatheter Pulmonary Valve Market Trends

This section covers the major market trends shaping the Transcatheter Pulmonary Valve Market according to our research experts:

Balloon-Expanded Transcatheter Valve Segment is Expected to Witness a Significant Growth Over the Forecast Period

The Balloon-Expanded Transcatheter Valve segment is expected to witness significant growth over the forecast period owing to the factors such as its high adoption rate and rising development of new products. In addition, the growing interest of manufacturers in balloon-expanded technology and rising awareness among the population is also contributing to the growth of the studied market. The high accuracy and precision of the results using this technology are expected to increase segment growth over the forecast period. For instance, according to an article published by the Frontiers Cardiovascular Medicines journal, in March 2022, it has been observed that the burden of rheumatic heart disease (RHD) and patients with pure aortic regurgitation (AR) is increasing in emerging and industrialized countries. This increases the need to extend transcatheter treatments to patients with non-calcified regurgitant aortic valves. Thus, the demand for transcatheter in treating a patient with pulmonary valve defects, thereby propelling the market growth.

Additionally, according to an article published by the Elsevier JACC: Asia journal, in September 2021, due to the increasing burden of bicuspid aortic valves in some Asian countries, the new generation balloon-expandable valve (BEV) is found to be an alternative for treating patients with aortic valve disorders. In addition, as per the same source, it has been observed that anomaly, deeply calcified, bigger annular bicuspid aortic valves (BAVs), which were deemed ineligible for transcatheter aortic valve replacement (TAVR) due to a high risk of paravalvular leak (PVL), coronary artery obstruction, permanent pacemaker implantation (PPI), and aortic rupture, might be safely treated with versatile procedures applied to balloon-expandable valve (BEV). Thus, the increasing usage of the balloon-expandable valve in treating patients with aortic regurgitation and bicuspid aortic valve disorders is expected to increase the adoption and demand for balloon-expanded transcatheter valves, thereby fueling market growth.

Thus, owing to the factors above, the studied market is expected to grow during the forecast period.

Transcatheter Pulmonary Valve Market - Total Number of Balloon-Expandable Valve Systems Clinical Trials, by Phase, Global, As of August 2022

North America is Expected to Hold a Significant Share in the Market and Expected to do Same in the Forecast Period

North America is expected to hold a significant share in the transcatheter pulmonary valve market, owing to the presence of a well-developed healthcare sector, along with the increasing prevalence of disorders such as pulmonary stenosis and regurgitation. In addition, rising awareness, growing demand for innovative heart valves, and increasing healthcare expenditure are expected to drive market growth over the forecast period. For instance, according to the Organization for Economic Co-operation and Development (OECD), in June 2022, United States healthcare spending, in 2021 was 17.8% of the total GDP of the country. Additionally, as per the data published by the Centers for Medicare & Medicaid Services, in March 2022, it has been observed that the annual growth in national health spending is expected to average 5.1% over 2021-2030. Thus, the rising health spending in the country is expected to increase company activities and government initiatives in developing efficient transcatheter pulmonary valves, thereby propelling the market growth

Furthermore, the rising burden of heart valve disorders, congenital heart disease, and aortic regurgitation among the population is expected to drive market growth over the forecast period. For instance, according to an article published by StatPearls, in April 2022, the prevalence of aortic regurgitation in the United States was between 4.9% and 10%. In addition, as per the same source, it has been observed that men (13%) are more likely to be affected by aortic regurgitation than women (8.5%). Similarly, according to the 2022 statistics published by the Centers for Disease Control and Prevention (CDC), CHD affects nearly 1% or about 40,000 births per year in the United States. Thus, the increasing prevalence of aortic regurgitation is expected to increase the demand for effective treatment which in turn is anticipated to augment the market growth over the forecast period.

Moreover, the rising company's focus on research and development activities as well as increasing product approvals in the region is expected to increase the market growth over the forecast period. For instance, in August 2021, the United States Food and Drug Administration (FDA) approved Medtronic's Evolut FX TAVR system, the newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, to enhance ease of use and provide greater precision and control throughout the symptomatic severe aortic stenosis procedure. The Evolut technology is equipped with gold markers built into the frame to provide implanters with direct visualization of depth and valve leaflet location during implant. Also, in March 2021, the United States Food and Drug Administration approved Harmony Transcatheter Pulmonary Valve (TPV) System, a non-surgical heart valve to treat pediatric and adult patients with a native or surgically repaired right ventricular outflow tract (RVOT). The device is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery.

Thus, owing to the aforementioned factors, the studied market is expected to grow in the region over the forecast period.

Transcatheter Pulmonary Valve Market - Growth Rate by Region

Transcatheter Pulmonary Valve Industry Overview

The transcatheter pulmonary valve market is moderate in nature due to the presence of companies operating globally as well as regionally. The competitive landscape includes an analysis of international and local companies that hold market shares and are well-known, including Boston Scientific Corporation, Braile Biomedica, Artivion, Inc, Inc., Edwards Lifesciences Corporation, JenaValve Technology, Inc, LivaNova PLC, Medtronic PLC, and Venus Medtech.

Transcatheter Pulmonary Valve Market Leaders

  1. Boston Scientific Corporation

  2. Braile Biomedica

  3. Medtronic PLC

  4. Edwards Lifesciences Corporation

  5. Artivion, Inc

*Disclaimer: Major Players sorted in no particular order

Transcatheter Pulmonary Valve Market Concentration
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Transcatheter Pulmonary Valve Market News

  • In December 2022, Abbott launched its latest-generation transcatheter aortic valve implantation (TAVI) system, NavitorTM, making the minimally invasive device available for people in India with severe aortic stenosis who are at high or extreme surgical risk. With the Navitor valve, the company is advancing TAVI therapies with innovations including a unique design to prevent blood leaking around the valve. 
  • In February 2022, MicroPort CardioFlow Medtech Corporation launched a prospective multicenter post-marketing clinical study on the treatment of severe aortic valve insufficiency using its VitaFlow Liberty Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty).

Transcatheter Pulmonary Valve Market Report - Table of Contents

1. INTRODUCTION

  • 1.1 Study Assumptions and Market Definition
  • 1.2 Scope of the Study

2. RESEARCH METHODOLOGY

3. EXECUTIVE SUMMARY

4. MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Growing Burden of Congenital Heart Disease
    • 4.2.2 Increasing Awareness of Transcatheter Pulmonary Valve Therapy
  • 4.3 Market Restraints
    • 4.3.1 Availability of Alternative Technologies
    • 4.3.2 Stringent Regulations
  • 4.4 Porter's Five Forces Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5. MARKET SEGMENTATION (Market Size by Value in USD million)

  • 5.1 By Technology
    • 5.1.1 Balloon-Expanded Transcatheter Valve
    • 5.1.2 Self-Expanded Transcatheter Valve
  • 5.2 By Application
    • 5.2.1 Pulmonary Stenosis
    • 5.2.2 Pulmonary Regurgitation
    • 5.2.3 Pulmonary Atresia
    • 5.2.4 Others
  • 5.3 Geography
    • 5.3.1 North America
    • 5.3.1.1 United States
    • 5.3.1.2 Canada
    • 5.3.1.3 Mexico
    • 5.3.2 Europe
    • 5.3.2.1 Germany
    • 5.3.2.2 United Kingdom
    • 5.3.2.3 France
    • 5.3.2.4 Italy
    • 5.3.2.5 Spain
    • 5.3.2.6 Rest of Europe
    • 5.3.3 Asia-Pacific
    • 5.3.3.1 China
    • 5.3.3.2 Japan
    • 5.3.3.3 India
    • 5.3.3.4 Australia
    • 5.3.3.5 South Korea
    • 5.3.3.6 Rest of Asia-Pacific
    • 5.3.4 Rest of the World

6. COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 Boston Scientific Corporation
    • 6.1.2 Braile Biomedica
    • 6.1.3 Artivion, Inc
    • 6.1.4 Edwards Lifesciences Corporation
    • 6.1.5 JenaValve Technology, Inc
    • 6.1.6 LivaNova PLC
    • 6.1.7 Medtronic PLC
    • 6.1.8 Venus Medtech
  • *List Not Exhaustive

7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies, and Recent Developments
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Transcatheter Pulmonary Valve Industry Segmentation

As per the scope of the report, transcatheter pulmonary valve is an artificial heart valve made from the jugular vein of a cow. These are delivered by the system, which is a thin, hollow, and long tube (catheter) that delivers a transcatheter pulmonary valve into the heart without open heart surgery. The Transcatheter Pulmonary Valve Market is Segmented By Technology (Balloon-Expanded Transcatheter Valve and Self-Expanded Transcatheter Valve), Application (Pulmonary Stenosis, Pulmonary Regurgitation, Pulmonary Atresia, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of World). The report offers the value (in USD million) for the above segments.

By Technology Balloon-Expanded Transcatheter Valve
Self-Expanded Transcatheter Valve
By Application Pulmonary Stenosis
Pulmonary Regurgitation
Pulmonary Atresia
Others
Geography North America United States
Canada
Mexico
Geography Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Geography Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Geography Rest of the World
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Transcatheter Pulmonary Valve Market Research FAQs

The Global Transcatheter Pulmonary Valve Market is projected to register a CAGR of 5.5% during the forecast period (2024-2029)

Boston Scientific Corporation, Braile Biomedica, Medtronic PLC, Edwards Lifesciences Corporation and Artivion, Inc are the major companies operating in the Global Transcatheter Pulmonary Valve Market.

Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).

In 2024, the North America accounts for the largest market share in Global Transcatheter Pulmonary Valve Market.

The report covers the Global Transcatheter Pulmonary Valve Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Global Transcatheter Pulmonary Valve Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.

Transcatheter Industry Report

Statistics for the 2024 Transcatheter market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Transcatheter analysis includes a market forecast outlook 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.

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Transcatheter Pulmonary Valve Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)