Global Transcatheter Pulmonary Valve Market Report and Forecast 2024-2032

Global Transcatheter Pulmonary Valve Market Outlook

The global transcatheter pulmonary valve market size was valued at USD 84.85 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 140.94 million by 2032.

The Global Transcatheter Pulmonary Valve Market Likely to be Driven by Advancements in Technology Enabling Easier Implants, Growing Population with Obesity and Conditions Requiring Transcatheter Pulmonary Valve Replacement, and Growing Demand for Less Invasive Procedures

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.

Global Transcatheter Pulmonary Valve Market Segmentation

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By technology, the market is classified as follows:

• Balloon-Expanded Transcatheter Valve
• Self-Expanded Transcatheter Valve

By end-use, the market is segmented into:

• Adult
• Pediatric

By application, the market is divided as follows:

• Cardiac Anomaly
• Pulmonary Atresia
• Pulmonary Stenosis
• Pulmonary Regurgitation
• Tetralogy of Fallot
• Truncus Arteriosus
• Others

By raw material, the market is segmented into:

• Synthetic
• Tissue Engineered

By region, the market is classified into:

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa

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Key Industry Players in the Global Transcatheter Pulmonary Valve Market

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:

• Boston Scientific Corporation
• Direct Flow Medical, Inc.
• Edward Lifesciences Corporation
• Medtronic plc
• Others

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.

Key Highlights of the Report