The global transcatheter pulmonary valve replacement (TPVR) market size was estimated to be USD 47.4 million in 2023 and is expected to reach at USD 93.9 million by 2034 with a CAGR of 6.42% during the forecast period 2024-2034. Surge in prevalence cardiovascular diseases (CVDs) such as hypertensive heart diseases, rheumatic heart disorders, & cerebrovascular diseases, increasing preference for minimally invasive procedures, growing technological advancements in transcatheter valve technology including valve design, delivery systems, imaging guidance, rising awareness & education campaigns focused on congenital heart defects & available treatment options, surge in research & development activities, and increasing demand for minimally invasive surgical transcatheter pulmonary valve replacement devices are some of the key factors boosting the market growth.
Increasing demand for minimally invasive surgical transcatheter pulmonary valve replacement devices is predicted to boost the market growth during the forecast period. Transcatheter pulmonary valve replacement (TPVR) is a minimally invasive method using a catheter to replace a damaged or diseased pulmonary valve, obviating the requirement for open-heart surgery. This results in shorter recovery periods and fewer complications. Consequently, industry leaders are prioritizing the development of advanced medical devices in response to the rising demand for less invasive surgical options. For instance, in February 2023, Medtronic has revealed the reintroduction of its Harmony Transcatheter Pulmonary Valve (TPV) System, offering a minimally invasive option instead of open-heart surgery for individuals with congenital heart disease who have native or surgically repaired right ventricular outflow tract (RVOT).
By product, balloon-expandable valves was the highest revenue-grossing segment in the global transcatheter pulmonary valve replacement (TPVR) market in 2023 owing to increasing adoption in congenital heart disease & obstructive vascular lesions treatment and rising focus on development of potentially superior trans-catheter BE-system. Additionally, self-expanding valves is predicted to grow at fastest CAGR during the forecast period owing to the rising prevalence of stenotic pulmonary arteries, obstructive right ventricular outflow tract, & coarctation of aorta, surge in technological advancements, and increasing approvals by regulatory bodies. For instance, in May 2022, VenusP-Valve, an innovative Transcatheter Pulmonic Valve Replacement (TPVR) technology developed in-house by Venus Medtech, has recently obtained compassionate use approval from the FDA for two cases. This pre-approval for clinical studies underscores the distinctive clinical advantages of VenusP-Valve. The device, characterized by flared ends on both ends, allows for secure anchoring and straightforward delivery, eliminating the need for pre-stenting before the procedure. With its various specifications and wide applicability, this product can cater to the requirements of 85% of patients.
By application, pulmonary stenosis was the highest revenue-grossing segment in the global transcatheter pulmonary valve replacement (TPVR) market in 2023 owing to the increasing prevalence of pulmonary stenosis and surge in approvals by regulatory authorities. For instance, in August 2023, Boston Scientific Corporation has been granted approval by the U.S. Food and Drug Administration (FDA) for the POLARx Cryoablation System. This newly approved system is designed for treating individuals diagnosed with paroxysmal atrial fibrillation (AF). It includes the POLARx FIT Cryoablation Balloon Catheter, which stands out for its distinctive feature of accommodating two balloon sizes, 28mm and 31mm, within a single catheter. Additionally, pulmonary regurgitation is predicted to grow at fastest CAGR during the forecast period owing to the surge in incidences of pulmonary regurgitation, rising demand for less invasive procedures, growing adoption of TPVR over SAVR procedure, and increasing launch of wide range of products.
By end-user, hospitals was the highest revenue-grossing segment in the global transcatheter pulmonary valve replacement (TPVR) market in 2023 owing to the rising burden of cardiovascular diseases, surge in number of patients visiting to hospitals for diagnosis & treatment of heart disorders, and growing collaborations within market players. For instance, in May 2022, MicroPort CardioFlow Medtech Corporation made an announcement regarding the achievement of two successful cases by its strategic partner, 4C Medical Technologies, Inc. These cases involved the utilization of the next-generation, slim-profile, and entirely retrievable transseptal (TS) delivery system. Additionally, ambulatory surgical centers is predicted to grow at fastest CAGR during the forecast period owing to the growing focus on development of cutting-edge technologies, rising healthcare infrastructure, and increasing launch of advanced devices by market players.
Europe region is anticipated for the highest revenue share during the forecast period owing to the surge in number of clinical trial procedures, growing regulatory approvals for development of transcatheter pulmonary valve replacement systems, increasing technological advancements, and rising regulatory certifications. For instance, in April 2022, VenusP-ValveTM, a pioneering Transcatheter Pulmonic Valve Replacement (TPVR) system developed internally by Venus Medtech, has obtained CE certification for European market distribution, adhering to the Medical Devices Regulation (MDR). This novel artificial heart valve, approved for use in Europe, is intended for the treatment of individuals with moderate to severe pulmonary regurgitation, whether or not they have Right Ventricular Outflow Tract (RVOT) stenosis. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the increasing partnerships & collaborations within major market players, growing focus on development of transcatheter pulmonary valve replacement, surge in research & development activities, and rising approvals by regulatory bodies. For instance, in August 2023, Venus Medtech has revealed that its in-house developed VenusP-Valve has received full Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). This makes VenusP-Valve the first heart valve system developed in China to gain FDA approval for clinical trials, marking a significant achievement in the global presence of Chinese valve technology.
Increasing demand for minimally invasive surgical transcatheter pulmonary valve replacement devices is predicted to boost the market growth during the forecast period. Transcatheter pulmonary valve replacement (TPVR) is a minimally invasive method using a catheter to replace a damaged or diseased pulmonary valve, obviating the requirement for open-heart surgery. This results in shorter recovery periods and fewer complications. Consequently, industry leaders are prioritizing the development of advanced medical devices in response to the rising demand for less invasive surgical options. For instance, in February 2023, Medtronic has revealed the reintroduction of its Harmony Transcatheter Pulmonary Valve (TPV) System, offering a minimally invasive option instead of open-heart surgery for individuals with congenital heart disease who have native or surgically repaired right ventricular outflow tract (RVOT).
By product, balloon-expandable valves was the highest revenue-grossing segment in the global transcatheter pulmonary valve replacement (TPVR) market in 2023 owing to increasing adoption in congenital heart disease & obstructive vascular lesions treatment and rising focus on development of potentially superior trans-catheter BE-system. Additionally, self-expanding valves is predicted to grow at fastest CAGR during the forecast period owing to the rising prevalence of stenotic pulmonary arteries, obstructive right ventricular outflow tract, & coarctation of aorta, surge in technological advancements, and increasing approvals by regulatory bodies. For instance, in May 2022, VenusP-Valve, an innovative Transcatheter Pulmonic Valve Replacement (TPVR) technology developed in-house by Venus Medtech, has recently obtained compassionate use approval from the FDA for two cases. This pre-approval for clinical studies underscores the distinctive clinical advantages of VenusP-Valve. The device, characterized by flared ends on both ends, allows for secure anchoring and straightforward delivery, eliminating the need for pre-stenting before the procedure. With its various specifications and wide applicability, this product can cater to the requirements of 85% of patients.
By application, pulmonary stenosis was the highest revenue-grossing segment in the global transcatheter pulmonary valve replacement (TPVR) market in 2023 owing to the increasing prevalence of pulmonary stenosis and surge in approvals by regulatory authorities. For instance, in August 2023, Boston Scientific Corporation has been granted approval by the U.S. Food and Drug Administration (FDA) for the POLARx Cryoablation System. This newly approved system is designed for treating individuals diagnosed with paroxysmal atrial fibrillation (AF). It includes the POLARx FIT Cryoablation Balloon Catheter, which stands out for its distinctive feature of accommodating two balloon sizes, 28mm and 31mm, within a single catheter. Additionally, pulmonary regurgitation is predicted to grow at fastest CAGR during the forecast period owing to the surge in incidences of pulmonary regurgitation, rising demand for less invasive procedures, growing adoption of TPVR over SAVR procedure, and increasing launch of wide range of products.
By end-user, hospitals was the highest revenue-grossing segment in the global transcatheter pulmonary valve replacement (TPVR) market in 2023 owing to the rising burden of cardiovascular diseases, surge in number of patients visiting to hospitals for diagnosis & treatment of heart disorders, and growing collaborations within market players. For instance, in May 2022, MicroPort CardioFlow Medtech Corporation made an announcement regarding the achievement of two successful cases by its strategic partner, 4C Medical Technologies, Inc. These cases involved the utilization of the next-generation, slim-profile, and entirely retrievable transseptal (TS) delivery system. Additionally, ambulatory surgical centers is predicted to grow at fastest CAGR during the forecast period owing to the growing focus on development of cutting-edge technologies, rising healthcare infrastructure, and increasing launch of advanced devices by market players.
Europe region is anticipated for the highest revenue share during the forecast period owing to the surge in number of clinical trial procedures, growing regulatory approvals for development of transcatheter pulmonary valve replacement systems, increasing technological advancements, and rising regulatory certifications. For instance, in April 2022, VenusP-ValveTM, a pioneering Transcatheter Pulmonic Valve Replacement (TPVR) system developed internally by Venus Medtech, has obtained CE certification for European market distribution, adhering to the Medical Devices Regulation (MDR). This novel artificial heart valve, approved for use in Europe, is intended for the treatment of individuals with moderate to severe pulmonary regurgitation, whether or not they have Right Ventricular Outflow Tract (RVOT) stenosis. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the increasing partnerships & collaborations within major market players, growing focus on development of transcatheter pulmonary valve replacement, surge in research & development activities, and rising approvals by regulatory bodies. For instance, in August 2023, Venus Medtech has revealed that its in-house developed VenusP-Valve has received full Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). This makes VenusP-Valve the first heart valve system developed in China to gain FDA approval for clinical trials, marking a significant achievement in the global presence of Chinese valve technology.
Segmentation: Transcatheter Pulmonary Valve Replacement (TPVR) Market Report 2023 - 2034
Transcatheter Pulmonary Valve Replacement (TPVR) Market Analysis & Forecast by Product 2023 - 2034 (Revenue USD Mn)
- Self-Expanding Valves
- Balloon-Expandable Valves
Transcatheter Pulmonary Valve Replacement (TPVR) Market Analysis & Forecast by Application 2023 - 2034 (Revenue USD Mn)
- Pulmonary Regurgitation
- Truncus Arteriosus
- Pulmonary Stenosis
- Cardiac Anomaly
- Pulmonary Atresia
- Tetralogy of Fallot
- Others
Transcatheter Pulmonary Valve Replacement (TPVR) Market Analysis & Forecast by End-user 2023 - 2034 (Revenue USD Mn)
- Hospitals
- Ambulatory Surgical Centers
- Cardiac Centers
Transcatheter Pulmonary Valve Replacement (TPVR) Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Mn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Transcatheter Pulmonary Valve Replacement (TPVR) Market: Product Estimates & Trend Analysis
8. Transcatheter Pulmonary Valve Replacement (TPVR) Market: Application Estimates & Trend Analysis
9. Transcatheter Pulmonary Valve Replacement (TPVR) Market: End-user Estimates & Trend Analysis
10. Regional Market Analysis
11. North America Transcatheter Pulmonary Valve Replacement (TPVR) Market
12. Europe Global Transcatheter Pulmonary Valve Replacement (TPVR) Market
13. Asia Pacific Global Transcatheter Pulmonary Valve Replacement (TPVR) Market
14. Latin America Global Transcatheter Pulmonary Valve Replacement (TPVR) Market
15. MEA Global Transcatheter Pulmonary Valve Replacement (TPVR) Market
16. Competitor Analysis
17. Company Profiles
Companies Mentioned
- Venus Medtech (Hangzhou) Inc.
- Edwards Lifesciences Corporation
- Boston Scientific Corporation
- Terumo Corporation
- Cook Medical
- Abbott
- Med-Zenith
- Cordis
- Medtronic
- LivaNova Inc.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | January 2024 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 47.4 Million |
| Forecasted Market Value ( USD | $ 93.9 Million |
| Compound Annual Growth Rate | 6.4% |
| Regions Covered | Global |
| No. of Companies Mentioned | 10 |
