Transcatheter Pulmonary Valve Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

Transcatheter Pulmonary Valve Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The Transcatheter Pulmonary Valve Market is expected to witness a CAGR of 5.5% over the forecast period (2022 - 2027).

The outbreak of the COVID-19 pandemic had a significant impact on the global economy and healthcare system. There was a significant decline in the revenues of major manufacturers of cardiovascular devices due to the diverted supply chain of medical devices and decline in overall sugical procedures number during the pandemic. For instance, Boston Scientific’s quarterly revenue declared that there was a 12% decline in the cardiovascular devices segment for the year 2020, whereas Medtronic announced a 33% reduction in its cardiac and vascular business sector in its 2020 quarterly financial results. Thus, the decline in key players’ segmental revenue indicates that there is a huge loss which would ultimately impact the market. Additionally, according to an article published by the Journal of American College of Cardiology, in April 2021, titled “COVID-19 in Adults With Congenital Heart Disease”, it has been observed that adults with congenital heart disease are at potentially high risk for novel coronavirus disease-19 mortality and other complications. Thus, the restrictions imposed by the government to avoid the spread of coronavirus among the population have negatively impacted the market growth. However, the releasing covid restrictions and increasing patient visits to hospitals and clinics are expected to increase the demand for diagnosis and treatment related to heart diseases, which in turn is expected to propel the transcatheter pulmonary valve market growth during the forecast period.

Certain factors that are propelling the market growth are the growing burden of congenital heart disease and the rising awareness of transcatheter pulmonary valve therapy.

The rising company activities in developing and laucnhing products as well as increasing product approvals are all expected to increase the market growth over the forecast period. For instance, in September 2020, Boston Scientific Corporation initiated the controlled launch of the ACURATE neo2 Aortic Valve System in Europe. This innovative platform for transcatheter aortic valve implantation (TAVI) uses a variety of features to outperform the clinical capabilities of the original ACURATE neo platform. It has an expanded indication for patients with aortic stenosis who are deemed suitable candidates for the therapy without specified age or risk level. Also, in September 2020, Sahajanand Medical Technology Pvt Ltd(SMT) launched the Hydra TAVR device in Central Europe. The Hydra aortic valve is a self-expanding supra-annular aortic system made of nitinol and has a mechanism for recapturing the valve after deployment. This technology allows for precise placement of the valve and also ensures orthotopic deployment.

However, the availability of alternative technologies and stringent regulations are expected to impede the market growth over the forecast period.

Key Market TrendsBalloon-Expanded Transcatheter Valve Segment Expects to Register a High CAGR in the Forecast Period

The Balloon-Expanded Transcatheter Valve segment is expected to witness significant growth over the forecast period owing to the factors such as its high adoption rate and rising development of new products. In addition, the growing interest of manufacturers in balloon expanded technology and rising awareness among the population are also contributing to the growth of the studied market.

The high accuracy and precision of the results using this technology are expected to increase the segment growth over the forecast period. For instance, according to an article published by the Frontiers Cardiovascular Medicines journal, in March 2022, titled “The Technological Basis of a Balloon-Expandable TAVR System: Non-occlusive Deployment, Anchorage in the Absence of Calcification and Polymer Leaflets”, it has been observed that the burden of rheumatic heart disease (RHD) and patients with pure aortic regurgitation (AR) is increasing in emerging and industrialized countries. This increases the need to extend transcatheter treatments to patients with non-calcified regurgitant aortic valves. Thus, the demand for transcatheter in treating a patient with pulmonary valve defects, thereby propelling the market growth.

Additionally, according to an article published by the Elsevier JACC: Asia journal, in September 2021, titled “Application of Balloon-Expandable Transcatheter Heart Valve in Bicuspid Aortic Valve”, due to the increasing burden of bicuspid aortic valve in some Asian countries, the new generation balloon-expandable valve (BEV) is found to be an alternative for treating patients with aortic valve disorders. In addition, as per the same source, it has been observed that anomaly, deeply calcified, bigger annular bicuspid aortic valves (BAVs), which were deemed ineligible for transcatheter aortic valve replacement (TAVR) due to a high risk of paravalvular leak (PVL), coronary artery obstruction, permanent pacemaker implantation (PPI), and aortic rupture, might be safely treated with versatile procedures applied to balloon-expandable valve (BEV). Thus, the increasing usage of the balloon-expandable valve in treating patients with aortic regurgitation and bicuspid aortic valve disorders is expected to increase the adoption as well as demand for balloon-expanded transcatheter valve, thereby fueling the market growth.

Thus, owing to the aforementioned factors, the studied market is expected to grow during the forecast period.

North America Dominates the Market and Expects to do Same Over the Forecast Period

North America is expected to dominate the transcatheter pulmonary valve market, owing to the presence of well-developed healthcare sector, along with the increasing prevalence of disorders such as pulmonary stenosis and regurgitation.

In addition, rising awareness, growing demand for innovative heart valves, and increasing healthcare expenditure are expected to drive market growth over the forecast period. For instance, according to the Organization for Economic Co-operation and Development (OECD), in June 2022, United States healthcare spending, in 2021 was 17.8% of the total GDP of the country. Additionally, as per the data published by the Centers for Medicare & Medicaid Services, in March 2022, titled “CMS Office of the Actuary Releases 2021-2030 Projections of National Health Expenditures”, it has been observed that the annual growth in national health spending is expected to average 5.1% over 2021-2030. In addition, the National Health Spending in 2020 was USD 4.1 trillion and it is projected to reach USD 6.8 trillion by 2030. Thus, the rising health spending in the country is expected to increase company activities and government initiatives in developing efficient transcatheter pulmonary valves, thereby propelling the market growth

Furthermore, the rising burden of heart valve disorders, congenital heart disease, and aortic regurgitation among the population is expected to drive market growth over the forecast period. For instance, according to an article published by StatPearls, in April 2022, titled “Aortic Regurgitation”, the prevalence of aortic regurgitation in the United States was between 4.9% and 10%. In addition, as per the same source, it has been observed that men (13%) are more likely to be affected by aortic regurgitation than women (8.5%). Similarly, according to the 2022 statistics published by the Centers for Disease Control and Prevention (CDC), CHD affects nearly 1% or about 40,000 births per year in the United States. Thus, the increasing prevalence of aortic regurgitation is expected to increase the demand for effective treatment which in turn is anticipated to augment the market growth over the forecast period.

Moreover, the rising company’s focus on research and development activities as well as increasing product approvals in the region is expected to increase the market growth over the forecast period. For instance, in August 2021, the United States Food and Drug Administration (FDA) approved Medtronic’s Evolut FX TAVR system, the newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, to enhance ease of use and provide greater precision and control throughout the symptomatic severe aortic stenosis procedure. The Evolut technology is equipped with gold markers built into the frame to provide implanters with direct visualization of depth and valve leaflet location during implant. Also, in March 2021, the United States Food and Drug Administration approved Harmony Transcatheter Pulmonary Valve (TPV) System, a non-surgical heart valve to treat pediatric and adult patients with a native or surgically repaired right ventricular outflow tract (RVOT). The device is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery.

Thus, owing to the aforementioned factors, the studied market is expected to grow in the region over the forecast period.

Competitive Landscape

The transcatheter pulmonary valve market is fairly consolidated with the presence of major players in the market. The companies are adopting various business strategies such as product approvals, and product launches to expand their business and offering in the transcatheter pulmonary valve market. Some of the leading players in the global market for the transcatheter pulmonary valve are Boston Scientific Corporation, Braile Biomedica, CryoLife, Inc., Edwards Lifesciences Corporation, JenaValve Technology, Inc, LivaNova PLC, Medtronic PLC, and Venus Medtech.

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