Increasing FDA Approval for Transcatheter Valve to Drive the Market Growth

Published: Nov 2023

The global transcatheter pulmonary valve market is anticipated to grow at a considerable CAGR of 7.3% during the forecast period (2023-2030). Pivotal factors that are fueling the market growth includes the increasing burden of congenital heart disease along with the growing awareness of transcatheter pulmonary valve therapy. The growing company activities in developing and launching products as well as increasing product approvals are all projected to accelerate the market growth in the coming years. According to the British Heart Foundation (BHF), around 1 in 110 births globally were diagnosed with congenital heart disease, with more diagnoses later in life that's an estimated 1.2 million babies a year - an average of 3,300 per day (or a diagnosis every 26 seconds). Globally congenital heart disease is the direct cause of at least 220,000 deaths each year, the majority are before the first birthday. It estimated at least 13 million people are living with congenital heart disease around the globe, there are likely to be millions more undiagnosed. Thus, the demand for transcatheter in treating a patient with pulmonary valve defects, thereby propelling the market growth.

Browse the full report description of “Transcatheter Pulmonary Valve Market Size, Share & Trends Analysis Report by Technology (Balloon-Expanded Transcatheter Valve, and Self-Expanded Transcatheter Valve), and by Application (Cardiac Anomaly, Pulmonary Atresia, Pulmonary Stenosis, Pulmonary Regurgitation, and Others), Forecast Period (2023-2030)” at https://www.omrglobal.com/industry-reports/transcatheter-pulmonary-valve-market

Owing to such factors, the companies are primarily focusing on R&D activities as well as the increasing product approvals in the region is expected to increase market growth over the forecast period. For instance, in March 2021, Medtronic received US 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 made 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. 

Similarly, in December 2021, Edwards Lifesciences received approval from the US FDA for the use of the Edwards SAPIEN 3 transcatheter valve with the Alterra Adaptive Prestent (SAPIEN 3 with Alterra) for patients with severe pulmonary regurgitation. The Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) system combines the proven SAPIEN 3 transcatheter heart valve and The Alterra Adaptive Prestent to develop transcatheter therapy options for congenital heart valve disease patients. 

Market Coverage

The market number available for – 2022-2030

Base year- 2022

Forecast period- 2023-2030

Segment Covered- 

o By Product 

o By Application

Regions Covered-

o North America

o Europe

o Asia-Pacific

o Rest of the World

Competitive Landscape- including Boston Scientific Corp., Braile Biomedica, Medtronic PLC, Edwards Lifesciences Corp., Abott laboratories, Artivion, Inc., and others.

Key questions addressed by the report

What is the market growth rate?

Which segment and region dominate the market in the base year?

Which segment and region will project the fastest growth in the market?

Who is the leader in the market?

How players are addressing challenges to sustain growth?

Where is the investment opportunity?

Global Transcatheter Pulmonary Valve Market Report Segment

By Technology

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

By Application

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

Global Transcatheter Pulmonary Valve Market Report Segment by Region

North America

United States

Canada

Europe

UK

Germany

Italy

Spain

France

Rest of Europe 

Asia-Pacific

China

India

Japan

South Korea

Rest of Asia-Pacific 

Rest of the World

Latin America 

Middle East & Africa


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