Global Transcatheter Pulmonary Valve Market (2023-2028) Competitive Analysis, Impact of Covid-19, Ansoff Analysis

According to CDC, in February 2022, congenital heart disease (CHD) affects nearly 1% of or about 40,000 births per year in the United States

The Global Transcatheter Pulmonary Valve Market is estimated to be USD 42.35 Bn in 2023 and is expected to reach USD 63.13 Bn by 2028 growing at a CAGR of 8.31%.

Open-heart surgery should be postponed as long as possible while the pulmonary valve function is replaced. A transcatheter pulmonary valve is artificial from cow, pig, or human heart tissue. They are supplied through a device that inserts a transcatheter pulmonary valve into the heart without opening heart surgery. The system is a long, thin, hollow tube. With fewer incisions and a quicker recovery time than open surgery, it is frequently used to replace pulmonary valves that are leaky or constrictive to enhance blood flow. A minimally invasive (MI) method places these valves into a major blood vessel through a thin, flexible tube (catheter). Transcatheter pulmonary valve replacement helps to improve symptoms while reducing the risk of medical consequences. It is less painful, requires less time to recuperate, and helps to improve symptoms.

The rising burden of heart valve disorders, congenital heart disease, and aortic regurgitation among the population drives the market. Similarly, the Centers for Disease Control and Prevention (CDC) reported in February 2022 that CHD affects roughly 40,000 babies annually in the United States, or about 1% of all births. Moreover, 20% to 30% of patients with CHDs also have additional physical issues or developmental or cognitive difficulties, and 15% of CHDs are linked to hereditary abnormalities. Children with CHD are roughly 50% more likely to get special education assistance than children without birth abnormalities. As a result, it is anticipated that the market under study will expand as the burden of CHD rises. As a result, it is estimated that the rising incidence of aortic regurgitation would increase demand for efficient treatments, which will, in turn, fuel market expansion throughout the forecast period.

The limited life span of the replaced valve retrains the growth of the transcatheter pulmonary valve replacement market. The treatment's high cost may hamper the market expansion for transcatheter pulmonary valve replacement. The market has also been affected by a lack of knowledge, which raises the risk of incorrect diagnoses and subpar care, which can harm patients. Nevertheless, an absence of qualified cardiologists is on the market for surgical operations on heart valves. This scarcity is brought on by elements including the emigration of highly educated specialists from developing to wealthy nations. The rising numbers of burned-out experts cause the lack of skilled professionals. Thus, the worldwide TPV market's expansion during the forecast period is constrained by the lack of cardiologists.

Additionally, it is anticipated that the emerging business's emphasis on R&D initiatives and rising product approvals in the region will increase the market growth over the forecast period. However, the market has an opportunity by technological advancement in valve replacement procedures. The Harmony Transcatheter Pulmonary Valve (TPV), the first minimally invasive therapy developed to treat patients with a particular type of congenital heart defect of the right ventricle (RV), one of the four chambers of the heart, which makes it challenging for blood to travel from the heart to the lungs, was approved by the U.S. FDA in March 2021. Under the FDA's Breakthrough Device Designation (BDD) programme, which is an approval pathway designed to assist patients in getting more prompt access to some life-saving technologies, the Harmony TPV, which is implanted inside a patient's native anatomy during a catheter-based procedure, was designated as a Breakthrough Therapy.

Market Segmentations

• The Global Transcatheter Pulmonary Valve Market is segmented based on Technology, Raw Material, Application, End-User, and Geography.
• By Technology, the market is classified into Balloon-Expanded Transcatheter Valve and Self-Expanded Transcatheter Valves.
• The Balloon-Expanded Transcatheter Valve segment accounts for the largest market share. Due to the increasing consumer adoption rate and the creation of new products, the category held the majority of the shares. Also, the industry is expanding due to manufacturers' growing interest in balloon-expanded technology and increased public awareness. During the forecast period, segment growth is anticipated to expand because of the high accuracy and precision of the findings produced by this technology. In emerging and industrialized nations, it has been found that the burden of rheumatic heart disease (RHD) and patients with pure aortic regurgitation (AR) is rising, according to an article published in the Frontiers Cardiovascular Medicines journal in March 2022. This makes it more essential to offer transcatheter therapy to individuals with regurgitant, non-calcified aortic valves.
• By Raw Material, the market is classified into Synthetic and Tissue Engineered.
• Some factors anticipated to drive the industry over the next few years include the large product base of bioprosthetics and tissue valves and growing investment by private and public players to develop advanced tissue-engineered heart valves to prevent complications related to progressive degeneration. Due to the existing product base and high demand for tissue-engineered heart valves to overcome various drawbacks of employing synthetic heart valves, the tissue-engineered transcatheter pulmonary valve kept the majority of the share. Moreover, the tissue-engineering segment is projected to expand more quickly than synthetic transcatheter pulmonary. As an illustration, XELTIS declared that it had created the first bioabsorbable heart valve, which showed promise in the second clinical trial.
• By Application, the market is classified into Pulmonary Stenosis, Pulmonary Regurgitation, Pulmonary Atresia, Cardiac Anomaly, Tetralogy of Fallot, and Others.
• The Tetralogy of Fallot held the majority of the revenue share due to the vast product base for this application's use and the rising incidence of tetralogy of Fallot in both the adult and elderly populations. In addition, pulmonary stenosis and other conditions are among the leading segments in addition to this application. There is no established market category for this technology because only three approved devices are available in the United States, Canada, and some regions of Europe. Heart abnormality, atresia, and regurgitation are only a few of the many untested uses. During the projected period
• By End-User, the market is classified into Adult and Pediatric.
• The Adult Transcatheter Pulmonary Valve held most of the market share due to the enormous demand for medical equipment among adults and the rising occurrence of illnesses such as tetralogy of Fallot, regurgitation, pulmonary stenosis, and cardiac anomalies.
• By Geography, the market is classified into the Americas, Europe, Middle East & Africa, and Asia-Pacific.
• North America dominates the market because of the highly developed healthcare industry and the rising prevalence of conditions like pulmonary stenosis and regurgitation. Moreover, throughout the forecast period, the market expansion is anticipated to be fueled by growing consumer awareness, demand for cutting-edge heart valves, and rising healthcare costs. For instance, the Organization for Economic Co-operation and Development (OECD) estimates that in June 2022, healthcare spending in the United States in 2021 was 17.8% of the nation's total GDP. Also, it has been noted that the annual growth in national health spending is anticipated to average 5.1% over the years 2021-30, according to data published by the Centers for Medicare & Medicaid Services in March 2022. Hence, it is anticipated that increased business activity and government attempts to create effective transcatheter pulmonary valves will result from the nation's rising health spending, driving the market's expansion.

Recent Development

• Abbott launched its latest generation transcatheter aortic valve implantation (TAVI) system, NavitorTM, making the minimally invasive device available for people in India with severe aortic stenosis who are at high or extreme surgical risk. With the Navitor valve, the company is advancing TAVI therapies with innovations, including a unique design to prevent blood from leaking around the valve. - December 2022
• MicroPort CardioFlow Medtech Corp. launched a prospective multicenter post-marketing clinical study on treating severe aortic valve insufficiency using its VitaFlow Liberty Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty). - February 2022

Company Profiles

The report provides a detailed analysis of the competitors in the market. It covers the financial performance analysis for the publicly listed companies in the market. The report also offers detailed information on the companies' recent development and competitive scenario. Some of the companies covered in this report are Boston Scientific, Braile Biomedica, Colibri Heart Valve, Commonwealth Edison, CryoLife, Direct Flow Medical, Edward Lifesciences, etc.

Countries Studied

• America (Argentina, Brazil, Canada, Chile, Colombia, Mexico, Peru, United States, Rest of Americas)
• Europe (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Kingdom, Rest of Europe)
• Middle East and Africa (Egypt, Israel, Qatar, Nigeria, Saudi Arabia, South Africa, United Arab Emirates, Rest of MEA)
• Asia-Pacific (Australia, Bangladesh, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Sri Lanka, Thailand, Taiwan, Rest of Asia-Pacific)
• The report includes Competitive Quadrant, a proprietary tool to analyze and evaluate the position of companies based on their Industry Position score and Market Performance score. The tool uses various factors for categorizing the players into four categories. Some of these factors considered for analysis are financial performance over the last 3 years, growth strategies, innovation score, new product launches, investments, growth in market share, etc.

Ansoff Analysis

• The report presents a detailed Ansoff matrix analysis for the Global Transcatheter Pulmonary Valve Market. Ansoff Matrix, also known as Product/Market Expansion Grid, is a strategic tool used to design strategies for the growth of the company. The matrix can be used to evaluate approaches in four strategies viz. Market Development, Market Penetration, Product Development, and Diversification. The matrix is also used for risk analysis to understand the risk involved with each approach.
• The publisher analyses the Global Transcatheter Pulmonary Valve Market using the Ansoff Matrix to provide the best approaches a company can take to improve its market position.
• Based on the SWOT analysis conducted on the industry and industry players, the publisher has devised suitable strategies for market growth.

Why buy this report?

• The report offers a comprehensive evaluation of the Global Transcatheter Pulmonary Valve Market. The report includes in-depth qualitative analysis, verifiable data from authentic sources, and projections about market size. The projections are calculated using proven research methodologies.
• The research report also provides a detailed market size analysis and projections in volume and value terms. The projections are calculated using verified research methodologies.
• Excel data sheet for the market size will also be provided with the report.
• The report has been compiled through extensive primary and secondary research. The primary research is done through interviews, surveys, and observation of renowned personnel in the industry.
• The report includes an in-depth market analysis using Porter’s 5 forces model, PESTLE Analysis, and the Ansoff Matrix. In addition, the impact of COVID-19 on the market is also featured in the report.
• The report includes the regulatory scenario in the industry, which will help you make a well-informed decision. The report discusses major regulatory bodies and major rules and regulations imposed on this sector across various geographies.
• The report includes Self-Assessment Form, which helps customers evaluate their position in the market compared to their competitors.
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Report Highlights:

• A complete analysis of the market, including the parent industry
• Important market dynamics and trends
• Impact Analysis - a comprehensive assessment to confront risk and make strategic & operational decisions to counter the changes in the market environment.
• Market segmentation
• Competitive Analysis: Comparative analysis of competitor
• Historical, current, and projected size of the market based on value and volume
• Market size of the US states
• Market shares and strategies of key players
• Recommendations to companies for strengthening their foothold in the market