Vancouver, Sept. 04, 2023 (GLOBE NEWSWIRE) -- The worldwide market for transcatheter pulmonary valve replacement reached a value of USD 44.62 Million in 2022. As per the most recent assessment conducted by Emergen Research, it is anticipated to exhibit a Compound Annual Growth Rate (CAGR) of 6.2% throughout the projected period. This growth is attributed to several key drivers. Notably, there's an increasing incidence of cardiac ailments like Coronary Artery Disease (CAD) and heart failure. Moreover, substantial investments and financial support directed towards the development of these medical devices contribute to the market's expansion. Furthermore, the field is witnessing rapid progress in minimally invasive surgical methods, which also significantly contributes to the revenue surge in the transcatheter pulmonary valve replacement sector.
The field of Transcatheter Pulmonary Valve Replacement (TPVR) is undergoing rapid advancement. This method, characterized by its minimally invasive approach and ongoing enhancements in both effectiveness and safety, is proving to offer comparable long-term outcomes to traditional Surgical Pulmonary Valve Replacement (PVR). With the potential for repeated applications, TPVR emerges as a valuable alternative, if not a preferred choice, especially for patients who might require PVR in the future.
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Introduced two decades ago, Transcatheter Pulmonary Valve (TPV) Replacement (TPVR) has evolved into the favored approach for addressing postoperative issues such as Right Ventricular Outflow Tract (RVOT) obstruction or Pulmonary Regurgitation (PR) in patients possessing a suitable prosthetic pulmonary conduit or valve. Notably, there have been significant strides in transcatheter pulmonary valve technology over the last twenty years. Notable progress includes the use of the SAPIEN transcatheter heart valve in the pulmonary position, refinements in valve implantation techniques, and the development of self-expanding valves and prestents for treating larger-diameter native or patched right ventricular outflow tracts. More recently designed valves, including the Harmony valve, Venous P-valve, and Pulsta valve, incorporate a self-expanding mechanism to accommodate larger valves and smaller sheaths.
The market's revenue growth is propelled by the increasing prevalence of cardiac ailments and heart failure. A notable contributor to mortality is Coronary Artery Disease (CAD). Within the past 22 years, Transcatheter Pulmonary Valve Replacement (TCPVR) has become the standard of care for congenital heart disease in many major hospitals, benefiting over 7,500 individuals across the globe. Moreover, the market receives impetus from the rising number of clinical research studies and trials aimed at establishing the safety and effectiveness of such systems.
However, a significant challenge inhibiting market revenue growth is the escalating instances of product recalls by regulatory bodies. The year 2022 witnessed fluctuations in the realm of cardiac devices, marked by recall declarations and potential safety concerns. For example, on April 26, 2022, Medtronic issued a recall for the Harmony delivery catheter, a component of the Harmony Transcatheter Pulmonary Valve (TPV) system. The recall was due to the potential breakage of the bond connecting the capsule at the tip of the delivery catheter during the valve placement procedure, thereby restraining market revenue growth.
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Scope of Research
| Report Details | Outcome |
| Market size in 2022 | USD 44.62 Million |
| CAGR (2023–2032) | 6.2% |
| Revenue forecast to 2032 | USD 81.52 Million |
| Base year for estimation | 2022 |
| Historical data | 2019-2021 |
| Forecast period | 2023–2032 |
| Quantitative units | Revenue in USD Million and CAGR in % from 2023 to 2032 |
| Report coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Segments covered | Product Type, End-Use, and region |
| Regional scope | North America, Europe, Asia Pacific, Latin America, Middle East & Africa |
| Country scope | U.S., Canada, Mexico, Germany, France, U.K., Italy, Spain, Benelux, Rest of Europe, China, India, Japan, South Korea, Rest of APAC, Brazil, Rest of LATAM, Saudi Arabia, UAE, South Africa, Turkey, Rest of MEA |
| Key companies profiled | Medtronic, Abbott., Boston Scientific Corporation, Terumo Corporation, Venus Medtech (Hangzhou) Inc., Cook Medical, EDWARDS LIFESCIENCES CORPORATION, LIVANOVA, INC., Med-Zenith, and Cordis |
| Customization scope | 10 hours of free customization and expert consultation |
Major Companies and Competitive Landscape
The global transcatheter pulmonary valve replacement market is fairly fragmented, with many large and medium-sized players accounting for the majority of market revenue. Major players are deploying various strategies, entering into mergers & acquisitions, strategic agreements & contracts, developing, testing, and introducing more effective transcatheter pulmonary valve replacement solutions. Some major players included in the global transcatheter pulmonary valve replacement (TPVR) market report are:
- Medtronic
- Abbott.
- Boston Scientific Corporation
- Terumo Corporation
- Venus Medtech (Hangzhou) Inc.
- Cook Medical
- Edwards Lifesciences Corporation
- LivaNova, Inc.
- Med-Zenith
- Cordis
Strategic Development
- On 22 February 2023, Medtronic announced the reintroduction of its Harmony Transcatheter Pulmonary Valve (TPV) device, a minimally invasive alternative to open heart surgery for patients with congenital heart disease who have a native or surgically repaired Right Ventricular Outflow Tract (RVOT). Harmony TPV was developed to treat individuals with RVOT abnormalities who experience severe pulmonary valve regurgitation, according to the company.
- On 30 May 2022, VenusP-ValveTM, Venus Medtech's in-house designed breakthrough Transcatheter Pulmonic Valve Replacement (TPVR) technology, recently received FDA approval for compassionate use in two cases. The approval before formal clinical studies attests to VenusP-ValveTM's unique clinical value. VenusP-ValveTM, which has both flared ends, allows stable anchoring and simple delivery without the necessity for pre-stenting before the procedure. The product, which is available in several specifications and has broad applicability, can suit the needs of 85% of patients.
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Some Key Highlights From the Report
- The balloon-expandable valves segment accounted for largest revenue share in 2022. Balloon-expandable intravascular valves have been used successfully in adults to sustain channel walls following dilatation in coronary and peripheral circulations. In the treatment of congenital heart disease, obstructive vascular lesions that have a propensity to contract following dilatation have been treated with balloon expandable stents. Recognizing decreased need for post-implantation pacemakers in Balloon-Expandable (BE) TAVR, as well as recent developments in potentially superior leaflet resources, a trans-catheter BE-system has been designed which enables tactile, non-occlusive deployment without rapid pacing, direct attachment of both bioprosthetic and polymer leaflets onto a shape-stabilized scallop, and anchorage achieved by deformation of plastic even in the absence of calcification. The delivery device's back-flow-protected hollow balloon system, which includes a retractable balloon finder and stabilization trunks, enables gradual deployment in a beating heart. The initial balloon-expandable valves authorized were the SAPIEN Transcatheter Heart Valve (THV) developed by Edwards Lifesciences and Melody valve designed by Medtronic, which contributes to revenue growth of this segment.
- The hospitals segment is expected to register a steady revenue CAGR during the forecast period. Improved access to heart surgery education and dissemination of the most current standards and methods in cardiac care to nearby physicians and nurses are two of the key reasons patients go to hospitals. The hospital benefits from combined expertise of a multidisciplinary team that comprises neonatologists, cardiologists, cardiac surgeons, critical care specialists, anesthesiologists, and a comprehensive support staff dedicated to treating children. The use of coronary angioplasty products, Extracorporeal Membrane Oxygenation (ECMO), External Ventricular Assist Devices (EVAD) for patients, and implantable Left Ventricular Assist Devices (LVAD) are all common advanced cardiac support procedures that are frequently provided in these institutions by medical staff. These are the major factors that are contributing revenue growth of this segment.
- North America market accounted for a significantly large revenue share in 2022. This is attributed to growing number of clinical trial studies in the field of transcatheter pulmonary valve replacement, as well as rising regulatory approvals for development of transcatheter pulmonary valve replacement systems, especially in the U.S., which has resulted in continued growth of this industry. For instance, on 20 December 2021, Edwards Lifesciences announced that the U.S. Food and Drug Administration (FDA) has approved the use of the Edwards SAPIEN 3 transcatheter valve in combination with the Alterra adaptive prestent (SAPIEN 3 with Alterra) for individuals with severe pulmonary regurgitation, which has resulted in continued growth of this industry.
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Emergen Research has segmented the global transcatheter pulmonary valve replacement market on the basis of product type, end-use, and region:
- Product Type Outlook (Revenue, USD Million; 2019-2032)
- Balloon-Expandable Valves
- Self-Expanding Valves
- End-Use Outlook (Revenue, USD Million; 2019-2032)
- Hospitals
- Cardiac Centers
- Ambulatory Surgical Centers
- Regional Outlook (Revenue, USD Million; 2019-2032)
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- France
- U.K.
- Italy
- Spain
- Benelux
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Rest of LATAM
- Middle East & Africa
- Saudi Arabia
- UAE
- South Africa
- Turkey
- Rest of MEA
- North America
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