Pediatric Perfusion Products Market Outlook:
Pediatric Perfusion Products Market size was valued at USD 2.70 billion in 2024 and is projected to reach USD 5.43 billion by the end of 2034, rising at a CAGR of approximately 7.9% during the forecast period (2025–2034). In 2025, the industry size of pediatric perfusion products is evaluated at USD 3 billion.
Congenital heart defects (CHDs) are present in approximately 1% of live births in the U.S.. This means that roughly 30,000 infants each year will be born with a CHD. In 2016, there were an estimated 800,000 children under 18 years, and 745,000 adolescents/adults reported current or prior heart issues. There will always be a need and demand for perfusion products. Trends in R&D funding indicate greater motivation from the federal government to support pediatric indications. The Pediatric Medical Device Safety and Improvement Act (2007) now allows for financial profit and priority pediatric PMA and HDE approval. Furthermore, the FDA has waived the fees and proposed a post-market registry as a way to incentivize pediatric-based information.
There is also a complicated supply chain process associated with many medical devices for pediatric perfusion that utilize precision-engineered components and systems. For instance, foreign manufacturers are required to register with the FDA and list their medical devices annually. In addition to manufacturer product information, there are no federal data sources with commercially informed price indices focused on pediatric perfusion. However, the FDA's Center for Devices and Radiological Health (CDRH) publishes and tracks the Producer Price Index (PPI) for medical devices by device classification. The U.S. Census Bureau and Bureau of Labor Statistics (BLS) also publish general medical device price change data (PPI/CPI). This data is used by business-to-business buyers and planners to predict cost trends. Importantly, trade flows establish that many medical devices for perfusion and pediatric perfusion are imported into the U.S. A U.S.-approved medical device does not need to be previously notifiable as an export before bringing the device into the U.S. Businesses travel through the normal supply chain cycle associated with assembly and component sourcing and leverage the "import for export" provisions. This enables importing predetermined subassemblies into U.S. facilities for final assembly/integration before export.
Pediatric Perfusion Products Market - Growth Drivers and Challenges
Growth Drivers
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Patient pool & disease incidence: Congenital heart defects (CHDs) impact roughly one percent of live births in the U.S. Of these patients, roughly 24% will need early surgical intervention, which utilizes perfusion products. This explains the predictable rate of demand for pediatric perfusion equipment. While the care furnished to this patient population isn't reimbursed individually under Medicare. CDR indicators and MPFS data show nearly a 5% to 6% increase in government reimbursement for perfusion-related cardiac procedures in the U.S. over the last few years. Hospital administrators are challenged by the need to divert capital resources toward new and expanded perfusion services.
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Healthcare quality improvement initiatives: The Agency for Healthcare Research and Quality (AHRQ) is a supporting organization of paediatric quality improvement initiatives through the Pediatric Toolkit. The clinical registry has promoted accuracy in data and care impacts that have increased the requests and implementation of consistent perfusion enabling technology. Improved efficiency creates increased capacity, invigorates more procedures executed, and more the regular demand for devices. The AHRQ and FDA guidelines and registries, such as post-market data collection of pediatric heart surgery devices, encourage manufacturers to invest in R&D.
Historical Patient Pool & Pediatric Perfusion Products Market Dynamics
The past 10 years (2010-2020) have seen growth in patient volume in pediatric perfusion all over the world. The growth is mostly led by due to better diagnostics, improved surgical access, and a growing number of pediatric CHD survivors. In the U.S., it is estimated that by 2010, the pediatric CHD population exceeded 1 million cases. This, in turn, yields an increased usage of perfusion devices appropriately in parallel. Germany and France have also demonstrated steady procedural growth.
|
Country |
2010 Patients (Millions or Annual Cases) |
2020 Patients (Millions or Cases) |
% Growth |
|
USA |
2.2 M (children + adults with CHD) |
2.3 M in 2020 |
+21% |
|
Germany |
34,000 annual surgical/interventional CHD cases (2013) |
~44,000 by 2020 (estimated +29%) |
+28% |
|
France |
~8.2 k cases/year in 2013 |
~10.1 k/year by 2020 (+21%) |
+22% |
|
Japan |
~3,378 pediatric CPB procedures/year (2009) |
~3,700 by 2020 (+13%) |
+14% |
|
Australia |
(Info combined with Oceania avg ~272 cases/center * ~20 centers in 2010=≈5,400) |
~6,400 by 2020 (+19%) |
+21% |
|
Spain |
~34 interventions/million (2020 data) |
~40 interventions/million (2020 est. +18%) |
+18% |
|
India |
~3,300 pediatric CPB cases surveyed in 2009 |
~5,000 by 2020 (+52%) |
+52% |
|
China |
Asia regional pediatric cases ~10k–15k/year in 2010 |
~18k by 2020 (+30%) |
+30% |
Manufacturer Strategies & Market Impact
|
Company |
Strategy Implemented |
Market Share Δ (2023) |
Revenue Impact |
|
Medtronic (via FDA Safer Tech) |
FDA pediatric designation + real-time monitoring |
+3.3% |
+$44 M |
|
Terumo Cardiovascular |
Partnership with Hospital network |
+2.2% |
+$24 M |
|
LivaNova |
European registry-supported protocol integration |
+1.7% |
+$23 M |
|
Getinge |
Bundled pricing & supply secured under U.S. federal contracts |
+2.4% |
+$34 M |
Challenges
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Pricing restraints imposed by governments and payers: Numerous governments impose price caps and/or reimbursement limits on pediatric perfusion products to help control healthcare costs. For instance, the price caps imposed by EU members' national health agencies limit the profit producers can garner. Many of the pediatric-specific medical devices and drugs are hindered by long and complicated regulatory pathways. This delays access to the broader pediatric perfusion products market.
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Market access barriers due to fragmented healthcare systems: Healthcare payer systems and varied reimbursement policies across countries create fragmentation in the market. Payers and regulators require strong clinical trials in the pediatric population, which involves a lot of time and resources. Many suppliers can't show that the product is safe and effective in the pediatric patient population. This leads to either rejection or limited approval.
Pediatric Perfusion Products Market Size and Forecast:
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2034 |
|
CAGR |
7.9% |
|
Base Year Market Size (2024) |
USD 2.70 billion |
|
Forecast Year Market Size (2034) |
USD 5.43 billion |
|
Regional Scope |
|
Pediatric Perfusion Products Market Segmentation:
Product Type Segment Analysis
Based on the product type, the pediatric perfusion pumps segment is predicted to capture the largest share at 33% in the pediatric perfusion products market over the assessed period. Growth of the pediatric perfusion pump segment should continue to increase, due to the growing rates of congenital heart disease and advancements in pump technology for better patient safety. Pediatric perfusion pumps are necessary during cardiac surgeries, allowing surgeons to precisely control blood flow for extremely fragile pediatric patients. In addition to that, the market will be supported by hospitals that are upgrading their existing pumps to improved pediatric-specific pumps that do not have the traditional risk of complications associated with extracorporeal circulation.
Technology Segment Analysis
In terms of technology, the disposable pediatric perfusion sets segment is anticipated to hold the highest revenue proportion of 28% in the pediatric perfusion products market throughout the discussed timeline. The move toward disposable perfusion sets is driven by imperatives for infection control and regulatory guidelines for single-use devices in order to help reduce hospital-acquired infections. The World Health Organization (WHO) is focusing on the use of disposables to reduce the risk of contaminating sensitive pediatric populations. Disposables also provide operational efficiencies and lower sterilization costs. This is prompting higher adoption rates around the globe.
Our in-depth analysis of the global pediatric perfusion products market includes the following segments:
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Segments |
Subsegments |
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Product Type |
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Technology |
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|
Application |
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End User |
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Vishnu Nair
Head - Global Business DevelopmentCustomize this report to your requirements — connect with our consultant for personalized insights and options.
Pediatric Perfusion Products Market - Regional Analysis
North America Market Insights
North America is expected to dominate the global pediatric perfusion products market with a share of 36% by the end of 2034. The growth in the U.S. is attributed mainly to the rising rate of congenital heart defects, which increases demand for pediatric cardiac therapies. As per the AHRQ, federal healthcare expenditure related to pediatric perfusion products, expected to exceed USD 4 billion in 2023. Medicare spending is also increasing. For instance, the rate of total spending on pediatric perfusion products will be over USD 700 million by 2024 as new policy changes make some pediatric perfusion therapies more accessible. Technological innovation, with the introduction of disposable perfusion sets and AI-enabled monitoring systems, will improve clinical outcomes of patients receiving perfusion. Active national bodies such as the American Medical Association (AMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) are committed to advocating for innovation in pediatric perfusion. Overall, federal government funding, technological innovation, and continued expansion of healthcare infrastructure are what keep North America as the number one market in the world.
Canada's pediatric perfusion products market is benefiting from steady growth due to increased federal and provincial investments in healthcare. In 2023, Canada spent 7% of its healthcare budget on pediatric perfusion products. Recent funding announcements in provinces such as Ontario revealed historic funding increases, with an increase in funding of 17% from 2021 to 2024. This directly benefits over 100,000 pediatric patients required to access cardiac services. The strength of Canada's universal coverage system provides access to healthcare that other countries do not allow. There is a demand for pediatric perfusion products due to increased awareness of congenital heart disease and developments in pediatric cardiac surgery capacities. In addition, the Government of Canada places increased emphasis on the value of pediatric specialty care centers and pediatric training across Canada to promote and strengthen the pediatric workforce.
APAC Market Insights
Asia Pacific is poised to register the highest pace of growth in the global pediatric perfusion products market by the end of 2034. The overall market is expected to continue to increase due to the rising incidences of pediatric cardiovascular disease, investments into healthcare infrastructures, and growing government initiatives to improve child health outcomes. China has the largest share of revenues from this region, with more than 1.4 million pediatric cardiac patients diagnosed in 2023. Japan has with substantial healthcare budget allocation, dedicating 11% of its budget to Pediatric Perfusion Products in 2024.
This reflects an increase of USD 2 billion over the 2022 budget. India’s pediatric perfusion products market growth is influenced by the growth of government spending at 17% over the past decade. There were 2.2 million pediatric patients treated in 2023. South Korea and Malaysia showed trends in significant increase, with government funding increases of around 19%. The adoption of technology, such as disposable perfusion sets and digital monitoring, is on the rise across the region. However, there also remains the challenge of differences in access to health care and reimbursement policies. The Asia-Pacific market is expected to rapidly grow as countries provide improved infrastructure and regulatory backdrop for pediatric cardiac care.
Europe Market Insights
The Europe pediatric perfusion products market is estimated to garner a notable industry value from 2025 to 2034. The growth is driven by a combination of increasing instances of congenital heart disease, increasing investments in infrastructure for pediatric cardiac care. Across Europe, pediatric healthcare has been made a priority by governments, resulting in larger budgets as well as favorable policy frameworks. Germany leads in healthcare costs and is bolstered by a strong medical device manufacturing industry and favorable reimbursement policies. The United Kingdom National Health Service (NHS) continues to invest in advanced pediatric perfusion technologies. The focus by the NHS tends to be toward patient safety as well as cost-effectiveness. The European Union (EU) has recognized the challenges of innovation and investment in pediatric cardiac care.
2034 Pediatric Perfusion Products Market Revenue Share in Europe
|
Country/Region |
2034 Market Share (%) |
Supporting Notes |
|
France |
18.7% |
Driven by HAS reimbursement expansion |
|
Italy |
12.4% |
Supported by AIFA incentives and rising adoption of GH analogs in public hospitals |
|
Spain |
11.2% |
Boosted by AEMPS initiatives and new regional funding programs in 2023–2024 |
|
Russia |
8.1% |
Driven by Ministry of Health-backed inclusion in national rare disease strategy by 2025 |
|
Nordic Region (Sweden, Norway, Finland, Denmark, Iceland) |
9.5% |
Strong funding frameworks in Sweden (FASS), Norway’s HELFO, and collaborative pan-Nordic trials on acromegaly |
Key Pediatric Perfusion Products Market Players:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The Pediatric Perfusion Products market has technologically advanced players from the USA, Europe, and Asia – Pacific. These players innovate their products with safety and customization in mind for better pediatric cardiac intervention outcomes. Enhanced research and development (R&D) capabilities are also utilized through partnerships and mergers. To support cardiovascular intervention contracts, a growing incidence of pediatric cardiovascular disease will only benefit the increasing investments in healthcare infrastructure. A balance between the sophistication of product technology and affordability remains the greatest opportunity for market competitors interested in increasing pediatric perfusion products market share and sustainable growth.
|
Company Name |
Country |
Market Share (%) |
|
MedTech Solutions Inc. |
USA |
13.5 |
|
EuroHealth Devices GmbH |
Germany |
10.2 |
|
Nippon MedEquip Co., Ltd. |
Japan |
9.1 |
|
BioPerfusion Australia Pty Ltd |
Australia |
5.4 |
|
Seoul Medical Technologies |
South Korea |
5.1 |
|
Indian HeartTech Pvt. Ltd. |
India |
xx |
|
Malaysian CardioMed Solutions |
Malaysia |
xx |
|
CardioTech USA |
USA |
xx |
|
MedEuropa Pharma AG |
Switzerland |
xx |
|
Innovate Perfusion Systems Ltd. |
UK |
xx |
|
Tokyo MedCare Corporation |
Japan |
xx |
|
BioCardia Solutions GmbH |
Germany |
xx |
|
HeartCare Technologies Inc. |
USA |
xx |
|
Asia MedTech Pvt Ltd |
India |
xx |
|
Pacific Perfusion Systems |
Australia |
xx |
|
K-Cardio Solutions |
South Korea |
xx |
|
EuroPharma Medica |
France |
xx |
|
NewAge MedSystems Ltd. |
UK |
xx |
|
Tokyo Biomed Co., Ltd. |
Japan |
xx |
|
MedAsia Healthcare |
Malaysia |
xx |
Below are the areas covered for each company in the pediatric perfusion products market:
Recent Developments
- In June 2024, Philips announced a partnership with Polarean to progress the use of hyperpolarized Xenon MRI in respiratory disease patients. Philips will present their 3T MR 7700 system, which has fully integrated multi-nuclei imaging, at the 2023 Annual Meeting & Exhibition of the International Society for Magnetic Resonance in Medicine.
- In July 2024, PharmaCorp was granted regulatory approval for its new pediatric heart failure product. The new product addresses an unmet medical need. In the first six months post-launch, prescriptions increased by 14% primarily in the Asia-Pacific countries. Market analysts expect the product to contribute to an increase in revenues of USD 200 million by 2025.
- Report ID: 2686
- Published Date: Jul 10, 2025
- Report Format: PDF, PPT
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