Transcatheter Pulmonary Valve (TPV) Market - By Valve Type: Self Expanding, Balloon Expandable; By Patient Group: Surgically Placed Conduits, Native RVOT; By End User: Adult Congenital Centers, Pediatric Cardiology Hospitals, Academic Hospitals, By Region: North America, Europe, Asia-Pacific Latin America and Middle East & Africa
Market Overview
Transcatheter pulmonary valve (TPV) implantation is a catheter-based therapy that treats dysfunctional right-ventricular outflow tract (RVOT) conduits or native outflow tracts in patients with congenital heart disease (CHD)—particularly tetralogy of Fallot, pulmonary atresia, and truncus arteriosus—who would otherwise face repeat open-heart surgery. This minimally invasive approach delivers a bioprosthetic valve on a balloon-expandable or self-expanding stent via femoral or jugular venous access, restoring competence and reducing right-sided pressures. Advantages include shorter hospital stays, rapid recovery, lower infection risk, and cost savings compared to redo sternotomy. The increasing survival of CHD patients into adulthood, device innovations that treat larger native outflow tracts, and expanding reimbursement are driving market growth.
Market Size and Forecast
|
Year |
Market Value (USD Billion) |
Notes |
|
2019 |
0.42 |
Early adoption dominated by Medtronic Melody valve in surgically placed conduits |
|
2024 |
0.88 |
Five‑year CAGR 15.4 % (2019–2024); launch of second‑generation valves and wider regional approvals |
|
2031 |
2.05 |
Seven‑year CAGR 12.8 % (2024–2031); high‑adoption scenario USD 2.4 billion if large‑diameter native‑RVOT devices gain global clearance |
Adoption outlook – Annual TPV implant volumes are expected to rise from approximately 12,500 in 2024 to over 30,000 by 2031 as adult congenital heart (ACH) programs expand and device size ranges increase.
Primary Market Drivers
Market Challenges
Competitive Landscape
|
Company / Product |
2024 Share |
Strengths |
Recent Moves |
|
Medtronic – Melody / Harmony |
57 % |
First‑in‑class balloon & self‑expanding TPVs; >100k implants |
Harmony™ TPV 25 & 30 mm received CE‑MDR approval (Q4 2024) |
|
Edwards Lifesciences – SAPIEN Pulmonic |
24 % |
Balloon‑expandable valve adaptable to larger conduits |
FDA IDE expansion for 35 mm size (Q1 2025) |
|
Venus MedTech – VenusP‑Valve |
8 % |
Large‑diameter self‑expanding device for native RVOT |
Achieved CE mark (Q1 2025); China NMPA reimbursement inclusion |
|
JenaValve – Trilogy Pulmonic (pipeline) |
– |
Tri‑leaflet nitinol frame targeting severe regurgitation |
Initiated pivotal ALIGN‑Pulmonic trial (Q2 2024) |
|
Others (Meril, Xeltis, regional OEMs) |
11 % |
Emerging bioresorbable & polymer‑leaflet technologies |
Pre‑clinical studies on polymeric leaflet TPVs |
Detailed Market Segmentation
|
Segment |
2024 Share |
CAGR ’24–’31 |
|
By Valve Type |
||
|
Balloon‑Expandable |
XX% |
11.5 % |
|
Self‑Expanding |
XX% |
XX% |
|
By Patient Group |
||
|
Surgically Placed Conduits |
XX% |
XX% |
|
Native RVOT |
XX% |
15.4 % |
|
By End User |
||
|
Adult Congenital Heart (ACH) Centers |
51 % |
XX% |
|
Pediatric Cardiology Hospitals |
XX% |
12.1 % |
|
Academic & Research Hospitals |
XX% |
11.6 % |
Regional Analysis
Technology & Innovation
Regulatory Environment
Recent Developments (Q4 2023 – Q2 2025)
Strategic Outlook
Cardiology networks should establish ACH referral pathways to centralize TPV expertise. Manufacturers must expand size ranges and validate long-term durability to penetrate the native RVOT segment. Payers are encouraged to align DRGs to acknowledge reduced hospital stays and re-intervention costs.
Methodology
Clearview Market Insights synthesized OEM shipment data, implant registry statistics, and 82 expert interviews from 17 countries. Forecasts take into account CHD prevalence, ACH program growth, valve-in-valve cycles, and reimbursement trajectories.
About Clearview Market Insights
Clearview Market Insights delivers forward‑looking intelligence in structural heart, congenital cardiology, and catheter‑based therapies.
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