Report Code : CVMI30620252 | Published Date : June 3, 2025
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
- Rising ACH population – >90 % of CHD infants now survive to adulthood, creating a growing re‑intervention pool.
- Avoidance of repeat sternotomy – Each surgical redo carries incremental morbidity; TPV offers a lower‑risk alternative.
- Valve technology maturation – Self‑expanding and balloon‑expandable designs cover diameters 14 – 32 mm, addressing diverse anatomies.
- Procedural cost savings – Studies show 20–30 % lower total hospital cost versus surgical valve replacement.
- Reimbursement expansion – U.S. Medicare NTAP coverage, EU DRG alignment, and Japanese NHI listing boost adoption.
Market Challenges
- Endocarditis risk – TPV bioprostheses have higher infective endocarditis incidence than surgical homografts.
- Anatomical eligibility – Up to 60 % of native RVOT anatomies still unsuitable for current devices.
- High device cost – Valves priced USD 23–35 k hinder access in low‑income regions.
- Radiation exposure – Longer fluoroscopy times vs. surgical visualization.
- Training requirements – Need for hybrid cath‑surgical skills and 3D imaging platforms.
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
- North America (41 %) – Mature reimbursement; >120 TPV centers; Harmony adoption rising.
- Europe (XX%) – Germany, UK, France drive volume; CE‑MDR approvals spur valve diversity.
- Asia‑Pacific (XX%) – Fastest CAGR 15.7 %; China and Japan ramp ACH programs.
- Latin America (XX %) – Brazil & Mexico pilot TPV within national SUS/IMSS networks.
- Middle East & Africa (XX %) – Gulf states fund ACH hubs; South Africa establishes first TPV program.
Technology & Innovation
- Large‑diameter self‑expanding nitinol frames treat native RVOT up to 34 mm.
- Polymeric & tissue‑engineered leaflets target improved durability & reduced calcification.
- 3D rotational angiography & CT overlay enhances procedural planning.
- Cerebral embolic protection trials aim to cut stroke risk.
- Next‑gen delivery catheters with steerable sheaths reduce fluoroscopy time.
Regulatory Environment
- FDA HDE & PMA pathways – Melody under HDE; Harmony received PMA (2023).
- CE‑MDR drives post‑market clinical follow‑up; 2024 approvals under new rules.
- China NMPA fast‑track for domestic TPVs addressing native RVOT.
- ISO 5840‑3:2024 sets performance testing for transcatheter pulmonary valves.
Recent Developments (Q4 2023 – Q2 2025)
- Medtronic Harmony 30 mm launched in EU & U.S. (Q4 2024).
- Edwards SAPIEN Pulmonic 35 mm began pivotal IDE cohort (Q1 2025).
- VenusP‑Valve obtained CE mark & first EU implants (Q1 2025).
- 3D‑printed patient‑specific RVOT modelling adopted by five major ACH centers (Q2 2024).
- JenaValve secured €40 m funding for Trilogy Pulmonic trial expansion (Q4 2024).
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.
Reasons To Buy

Scope

- Medtronic plc
- Edwards Lifesciences Corporation
- Boston Scientific Corporation
- Abbott Laboratories
- Artivion Inc.
- Braile Biomedica
- JenaValve Technology Inc.
- Venus Medtech (Hangzhou) Inc.
- LivaNova PLC
- Xeltis AG
Global Transcatheter Pulmonary Valve (TPV) Market Report
- 1. Global Transcatheter Pulmonary Valve (TPV) Market Research Report
- 1.1 Study Objectives
- 1.2 Global Transcatheter Pulmonary Valve (TPV) Market - Overview
- 1.3 Reason to Read This Report
- 1.4 Methodology and Forecast Analysis
- 2. Global Transcatheter Pulmonary Valve (TPV) Market Research Report - Preface
- 2.1 Global Transcatheter Pulmonary Valve (TPV) Market Research Report – Detailed Scope and Definitions
- 2.1.1 By Valve Type
- 2.1.2 By Patient Group
- 2.1.3 By End User
- 2.1.4 By Region
- 2.1 Global Transcatheter Pulmonary Valve (TPV) Market Research Report – Detailed Scope and Definitions
- 3. Global Transcatheter Pulmonary Valve (TPV) Market Dynamics
- 3.1. Drivers - Macro-Economic Based, Supply Side, and Demand Side Drivers
- 3.2. Restraints – By Valve Type, By Patient Group, By End User, By Country
- 3.3. Opportunities – By Valve Type, By Patient Group, By End User, By Country
- 3.4. Trends – By Valve Type, By Patient Group, By End User, By Country
- 3.5. PEST Analysis
- 3.6. Porters Five Rule Analysis
- 3.7. Company’s Share Analysis (CSA) by Region or By Country
- 3.8. Global Transcatheter Pulmonary Valve (TPV) Market Research Report – DROTs Impact Analysis
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- 4. Global Transcatheter Pulmonary Valve (TPV) Market Research Report, Historic Data 2019 - 2023 and Forecast Analysis Data 2024 - 2031
- 4.1. Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 4.2. Annual Market Trend Assessment – Year-on-Year (YoY) Growth Analysis (%)
- 4.3. Incremental Market Value/Volume Opportunity between 2019 - 2023 and 2024 - 2031
- 4.4. Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 5. Global Transcatheter Pulmonary Valve (TPV) Market, By Valve Type, 2019 - 2023 and Forecast, 2024 - 2031 (Market Value, In USD Mn)
- 5.1 Balloon Expandable
- 5.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 5.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 5.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 5.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 5.2 Self Expanding
- 5.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 5.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 5.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 5.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 6.1 Surgically Placed Conduits
- 6.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 6.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 6.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 6.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 6.2 Native RVOT
- 6.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 6.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 6.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 6.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 7.1 Adult Congenital Heart
- 7.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 7.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 7.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 7.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 7.2 Pediatric Cardiology Hospitals
- 7.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 7.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 7.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 7.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 7.3 Academic & Research Hospitals
- 7.3.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 7.3.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 7.3.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 7.3.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8. Global Transcatheter Pulmonary Valve (TPV) Market Forecast, By Region, 2019 - 2023 and 2024 - 2031 (Market Value, In USD Mn)
- 8.1 North America
- 8.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.3.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.3.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.3.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.3.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.4.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.4.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.4.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.4.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.5.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.5.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.5.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.5.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.1 North America
- 9. North America Global Transcatheter Pulmonary Valve (TPV) Market Analysis, 2019 - 2023 and Forecast, 2024 - 2031 (Market Value, In USD Mn)
- 9.1 By Valve Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 9.1.1 Balloon Expandable
- 9.1.2 Self Expanding
- 9.2.1 Surgically Placed Conduits
- 9.2.2 Native RVOT
- 9.3.1 Adult Congenital Heart
- 9.3.2 Pediatric Cardiology Hospitals
- 9.3.3 Academic & Research Hospitals
- 9.4.1 United States
- 9.4.2 Canada
- 9.5 North America Global Transcatheter Pulmonary Valve (TPV) Market – Opportunity Analysis Index, By Valve Type, By Patient Group, By End User, and Country, 2024 - 2031
- 9.6 Regional Trends Analysis
- 9.7 North America Global Transcatheter Pulmonary Valve (TPV) Market Research Report - Company Profiles
- 9.7.1 Company 1 (United States)
- 9.7.2 Company 2 (Canada)
- 9.7.3 Company 3 (Canada)
- 10.1 By Valve Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 10.1.1 Balloon Expandable
- 10.1.2 Self Expanding
- 10.2.1 Surgically Placed Conduits
- 10.2.2 Native RVOT
- 10.3.1 Adult Congenital Heart
- 10.3.2 Pediatric Cardiology Hospitals
- 10.3.3 Academic & Research Hospitals
- 10.4.1 Germany
- 10.4.2 United Kingdom
- 10.4.3 France
- 10.4.4 Spain
- 10.4.5 Italy
- 10.4.6 Russia
- 10.4.7 Netherlands and Rest of Europe
- 10.5 Europe Global Transcatheter Pulmonary Valve (TPV) Market – Opportunity Analysis Index, By Valve Type, By Patient Group, By End User, and Country, 2024 - 2031
- 10.6 Regional Trends Analysis
- 10.7 Europe Global Transcatheter Pulmonary Valve (TPV) Market Research Report - Company Profiles
- 10.7.1 Company 1 (Germany)
- 10.7.2 Company 2 (United Kingdom)
- 10.7.3 Company 3 (United Kingdom)
- 11.1 By Valve Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 11.1.1 Balloon Expandable
- 11.1.2 Self Expanding
- 11.2.1 Surgically Placed Conduits
- 11.2.2 Native RVOT
- 11.3.1 Adult Congenital Heart
- 11.3.2 Pediatric Cardiology Hospitals
- 11.3.3 Academic & Research Hospitals
- 11.4.1 China
- 11.4.2 Japan
- 11.4.3 India
- 11.4.4 South Korea
- 11.4.5 Australia & New Zealand
- 11.4.6 ASEAN
- 11.4.7 Rest of Asia-Pacific
- 11.5 Asia-Pacific Global Transcatheter Pulmonary Valve (TPV) Market – Opportunity Analysis Index, By Valve Type, By Patient Group, By End User, and Country, 2024 - 2031
- 11.6 Regional Trends Analysis
- 11.7 Asia-Pacific Global Transcatheter Pulmonary Valve (TPV) Market Research Report - Company Profiles
- 11.7.1 Company 1 (China)
- 11.7.2 Company 2 (Japan)
- 11.7.3 Company 3 (Japan)
- 12.1 By Valve Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 12.1.1 Balloon Expandable
- 12.1.2 Self Expanding
- 12.2.1 Surgically Placed Conduits
- 12.2.2 Native RVOT
- 12.3.1 Adult Congenital Heart
- 12.3.2 Pediatric Cardiology Hospitals
- 12.3.3 Academic & Research Hospitals
- 12.4.1 Brazil
- 12.4.2 Mexico
- 12.4.3 Argentina
- 12.4.4 Peru
- 12.4.5 Colombia
- 12.4.6 Rest of Latin America
- 12.5 Latin America Global Transcatheter Pulmonary Valve (TPV) Market – Opportunity Analysis Index, By Valve Type, By Patient Group, By End User, and Country, 2024 - 2031
- 12.6 Regional Trends Analysis
- 12.7 Latin America Global Transcatheter Pulmonary Valve (TPV) Market Research Report - Company Profiles
- 12.7.1 Company 1 (Brazil)
- 12.7.2 Company 2 (Mexico)
- 12.7.3 Company 3 (Mexico)
- 13.1 By Valve Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 13.1.1 Balloon Expandable
- 13.1.2 Self Expanding
- 13.2.1 Surgically Placed Conduits
- 13.2.2 Native RVOT
- 13.3.1 Adult Congenital Heart
- 13.3.2 Pediatric Cardiology Hospitals
- 13.3.3 Academic & Research Hospitals
- 13.4.1 Saudi Arabia
- 13.4.2 UAE
- 13.4.3 South Africa
- 13.4.4 Egypt
- 13.4.5 Israel
- 13.4.6 Rest of Middle East and Africa
- 13.5 Middle East and Africa Global Transcatheter Pulmonary Valve (TPV) Market – Opportunity Analysis Index, By Valve Type, By Patient Group, By End User, and Country, 2024 - 2031
- 13.6 Regional Trends Analysis
- 13.7 Middle East and Africa Global Transcatheter Pulmonary Valve (TPV) Market Research Report - Company Profiles
- 13.7.1 Company 1 (Saudi Arabia)
- 13.7.2 Company 2 (UAE)
- 13.7.3 Company 3 (UAE)
- 14.1 Strategic Dashboard of Top Market Players
- 14.2 Company Profiles (Introduction, Financial Assessments, Portfolio of Offerings, Milestones and Achievements, Strategic Initiative, and SWOT Analysis)
- 14.2.1 Medtronic plc
- 14.2.2 Edwards Lifesciences Corporation
- 14.2.3 Boston Scientific Corporation
- 14.2.4 Abbott Laboratories
- 14.2.5 Artivion Inc.
- 14.2.6 Braile Biomedica
- 14.2.7 JenaValve Technology Inc.
- 14.2.8 Venus Medtech (Hangzhou) Inc.
- 14.2.9 LivaNova PLC
- 14.2.10 Xeltis AG
- 9.1 By Valve Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 15. Data Collection Method and Research Approach
- 16. Principal Presumptions and Acronyms