The global transcatheter pulmonary valve market size was valued at USD 80.2 million in 2023, driven by the rising health awareness, increasing cases of obesity and conditions requiring transcatheter pulmonary valve replacement. The market is anticipated to grow at a CAGR of 5.8% during the forecast period 2024-2032 to reach a value of USD 133.2 million by 2032.
Congenital heart disease affecting the right ventricle outflow tract frequently necessitates surgery and a right ventricle-pulmonary artery (RV-PA) conduit at a young age. These conduits require numerous surgical revisions due to deterioration and increased pulmonary regurgitation and/or stenosis, resulting in considerable morbidity and mortality. Furthermore, unrestricted pulmonary regurgitation causes right ventricular dilation, failure, and arrhythmias.
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Bonhoeffer et al. performed the first transcatheter pulmonary valve replacement (TPVR) in 2000, and it is currently an approved treatment for severe pulmonary regurgitation/stenosis and RV-PA conduit failure. The three balloon-expandable valves utilised for malfunctioning RV-PA conduits are the Medtronic Melody valve, Edwards SAPIEN valve, and Meril Myval.
Medtronic, the world's leading medical device business, has developed various transcatheter valve therapies. Medtronic has strategically positioned itself to dominate the transcatheter pulmonary valve (TPV) industry, but an examination of the company's performance over the last five years reveals that its US revenues in this area have remained flat. This is probable because pulmonary regurgitation (PR) is frequently asymptomatic. Historically, PR has been addressed symptomatically, with valve repair or replacement used only as a last resort.
SAPIEN 3, the latest generation of balloon-expandable transcatheter heart valves, is designed to overcome certain limitations of previous generation transcatheter heart valves. It has a reduced device profile to prevent access-related vascular damage, a more accurate delivery catheter aimed at accurate implantation, and an extra outer sealing cuff to limit paravalvular leakage. Recent European and North American trials using SAPIEN 3 have demonstrated extremely low rates of vascular complications and paravalvular regurgitation, as well as lower rates of stroke and mortality, than would be expected with surgical aortic valve replacement (SAVR) in patients with moderate to high surgical risk.
Clearly, firms are striving to offer increasingly sophisticated and efficient TPVs through advancements in technology.
Numerous people with congenital heart disease have pulmonary valve issues, either since birth or following cardiac surgery. A valve replacement may be recommended in many cases. Until the previous decade, the only way to replace a damaged pulmonary valve was through open heart surgery. Because all surgically implanted valves have a limited life expectancy, patients faced many procedures to replace the pulmonary valve over the course of their lives. Percutaneous, non-surgical pulmonary valve replacement has transformed the lives of such patients.
Patients with Tetralogy of Fallot who have previously undergone surgery but now have a leaky or constricted pulmonary valve, particularly those who have previously undergone surgical replacement, may benefit from a transcatheter pulmonary valve. Others benefitting could include patients with other underlying diagnoses who also have a non-functioning surgically implanted pulmonary valve (such as a homograft or a bioprosthetic valve); these patients include those with truncus arteriosus, aortic valve disease, who have undergone a Ross procedure, and some patients with pulmonary stenosis or atresia. The goals of transcatheter pulmonary valve replacement are to replace the pulmonary valve without surgery and to minimise the number of cardiac procedures required over a patient's lifetime.
Advancements in technology that enable easier implants, growing population with obesity and conditions that may require transcatheter pulmonary valve replacement, and growing demand for less invasive procedures are expected to drive the global transcatheter pulmonary valve market. USA and Europe are expected to be key markets.
In 2021, doctors from The Department of Cardiology, PGIMER, performed a successful transcatheter pulmonary valve replacement for the first time in North India. However, transcatheter pulmonary valve replacement remains a costly alternative and in countries like India, many people might be unable to afford the treatment.
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By technology, the market is classified as follows:
By end-use, the market is segmented into:
By application, the market is divided as follows:
By raw material, the market is segmented into:
By region, the market is classified into:
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The report presents a detailed analysis of the following key players in the market, looking into their capacity, and latest developments like capacity expansions, plant turnarounds, and mergers and acquisitions:
The EMR report gives an in-depth insight into the industry by providing a SWOT analysis as well as an analysis of Porter’s Five Forces model.
|Scope of the Report||
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
|Breakup by Technology||
|Breakup by Application||
|Breakup by Region||
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*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Transcatheter Pulmonary Valve Market Overview
3.1 Transcatheter Pulmonary Valve Market Historical Value (2017-2023)
3.2 Transcatheter Pulmonary Valve Market Forecast Value (2024-2032)
4 Transcatheter Pulmonary Valve Market Landscape
4.1 Transcatheter Pulmonary Valve: Developers Landscape
4.1.1 Analysis by Year of Establishment
4.1.2 Analysis by Company Size
4.1.3 Analysis by Region
4.2 Transcatheter Pulmonary Valve: Product Landscape
4.2.1 Analysis by Type
4.2.2 Analysis by Technology
5 Transcatheter Pulmonary Valve Market Dynamics
5.1 Market Drivers and Constraints
5.2 SWOT Analysis
5.3 Porter’s Five Forces Model
5.4 Key Demand Indicators
5.5 Key Price Indicators
5.6 Industry Events, Initiatives, and Trends
5.7 Value Chain Analysis
6 Transcatheter Pulmonary Valve Market Segmentation
6.1 Transcatheter Pulmonary Valve Market by Technology
6.1.1 Market Overview
6.1.2 Balloon-Expanded Transcatheter Valve
6.1.3 Self-Expanded Transcatheter Valve
6.2 Transcatheter Pulmonary Valve Market by Application
6.2.1 Market Overview
6.2.2 Pulmonary Stenosis
6.2.3 Pulmonary Regurgitation
6.2.4 Pulmonary Atresia
6.3 Transcatheter Pulmonary Valve Market by Region
6.3.1 Market Overview
6.3.2 North America
6.3.4 Asia Pacific
6.3.5 Latin America
6.3.6 Middle East and Africa
7 North America Transcatheter Pulmonary Valve Market
7.1 Market Share by Country
7.2 United States of America
8 Europe Transcatheter Pulmonary Valve Market
8.1 Market Share by Country
8.2 United Kingdom
9 Asia Pacific Transcatheter Pulmonary Valve Market
9.1 Market Share by Country
10 Latin America Transcatheter Pulmonary Valve Market
10.1 Market Share by Country
11 Middle East and Africa Transcatheter Pulmonary Valve Market
11.1 Market Share by Country
11.2 Saudi Arabia
11.3 United Arab Emirates
11.5 South Africa
12 Regulatory Framework
12.1 Regulatory Overview
12.1.1 US FDA
12.1.2 EU EMA
12.1.3 INDIA CDSCO
12.1.4 JAPAN PMDA
13 Patent Analysis
13.1 Analysis by Type of Patent
13.2 Analysis by Publication year
13.3 Analysis by Issuing Authority
13.4 Analysis by Patent Age
13.5 Analysis by CPC Analysis
13.6 Analysis by Patent Valuation
13.7 Analysis by Key Players
14 Grants Analysis
14.1 Analysis by year
14.2 Analysis by Amount Awarded
14.3 Analysis by Issuing Authority
14.4 Analysis by Grant Application
14.5 Analysis by Funding Institute
14.6 Analysis by NIH Departments
14.7 Analysis by Recipient Organization
15 Clinical Trials Analysis
15.1 Analysis by Trial Registration Year
15.2 Analysis by Trial Status
15.3 Analysis by Trial Phase
15.4 Analysis by Therapeutic Area
15.5 Analysis by Geography
16 Funding and Investment Analysis
16.1 Analysis by Funding Instances
16.2 Analysis by Type of Funding
16.3 Analysis by Funding Amount
16.4 Analysis by Leading Players
16.5 Analysis by Leading Investors
16.6 Analysis by Geography
17 Partnership and Collaborations Analysis
17.1 Analysis by Partnership Instances
17.2 Analysis by Type of Partnership
17.3 Analysis by Leading Players
17.4 Analysis by Geography
18 Supplier Landscape
18.1 Boston Scientific Corporation
18.1.1 Financial Analysis
18.1.2 Product Portfolio
18.1.3 Demographic Reach and Achievements
18.1.4 Mergers and Acquisitions
18.2 Braile Biomedica
18.2.1 Financial Analysis
18.2.2 Product Portfolio
18.2.3 Demographic Reach and Achievements
18.2.4 Mergers and Acquisitions
18.3 Artivion, Inc
18.3.1 Financial Analysis
18.3.2 Product Portfolio
18.3.3 Demographic Reach and Achievements
18.3.4 Mergers and Acquisitions
18.4 Edwards Lifesciences Corporation
18.4.1 Financial Analysis
18.4.2 Product Portfolio
18.4.3 Demographic Reach and Achievements
18.4.4 Mergers and Acquisitions
18.5 JenaValve Technology, Inc
18.5.1 Financial Analysis
18.5.2 Product Portfolio
18.5.3 Demographic Reach and Achievements
18.5.4 Mergers and Acquisitions
18.6 LivaNova PLC
18.6.1 Financial Analysis
18.6.2 Product Portfolio
18.6.3 Demographic Reach and Achievements
18.6.4 Mergers and Acquisitions
18.7 Medtronic plc
18.7.1 Financial Analysis
18.7.2 Product Portfolio
18.7.3 Demographic Reach and Achievements
18.7.4 Mergers and Acquisitions
18.8 Venus Medtech
18.8.1 Financial Analysis
18.8.2 Product Portfolio
18.8.3 Demographic Reach and Achievements
18.8.4 Mergers and Acquisitions
18.9 Lepu Medical Technology
18.9.1 Financial Analysis
18.9.2 Product Portfolio
18.9.3 Demographic Reach and Achievements
18.9.4 Mergers and Acquisitions
18.10 Jude Medical Inc.
18.10.1 Financial Analysis
18.10.2 Product Portfolio
18.10.3 Demographic Reach and Achievements
18.10.4 Mergers and Acquisitions
19 Transcatheter Pulmonary Valve - Distribution Model (Additional Insight)
19.2 Potential Distributors
19.3 Key Parameters for Distribution Partner Assessment
20 Key Opinion Leaders (KOL) Insights (Additional Insight)
21 Company Competitiveness Analysis (Additional Insight)
21.1 Very Small Companies
21.2 Small Companies
21.3 Mid-Sized Companies
21.4 Large Companies
21.5 Very Large Companies
22 Payment Methods (Additional Insight)
22.1 Government Funded
22.2 Private Insurance
*Additional insights provided are customisable as per client requirements.
The global transcatheter pulmonary valve market reached a value of USD 80.2 million in 2023.
The market is anticipated to grow at a CAGR of 5.8% during the forecast period of 2024-2032 to reach a value of USD 133.2 million by 2032.
The major drivers of the market include the rising healthcare expenditure, rising health awareness, increasing cases of obesity and conditions requiring transcatheter pulmonary valve replacement, and rapid development of advanced transcatheter by major market players.
The increasing inclination towards minimally invasive treatment procedures and rapid advancements in technology enabling easier implants are expected to be the key trends guiding the growth of the industry.
The major regions in the industry are North America, Latin America, the Middle East and Africa, Europe, and the Asia Pacific.
Based on technology, the market can be segmented into balloon-expanded transcatheter valve and self-expanded transcatheter valve.
Adult and pediatric are the major end-users considered in the report.
Cardiac anomaly, pulmonary atresia, pulmonary stenosis, pulmonary regurgitation, tetralogy of fallot, and truncus arteriosus, among others are the major applications mentioned in the market report.
Synthetic and tissue engineered are the different raw materials on the basis of which the market has been bifurcated.
The major players in the industry are Boston Scientific Corporation, Direct Flow Medical, Inc., Edward Lifesciences Corporation, and Medtronic plc, among others.
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