Pediatric Perfusion Products Market Trends

Growth Drivers

• Patient pool & disease incidence: Congenital heart defects (CHDs) impact roughly one percent of live births in the U.S.  Of these patients, roughly 42 of every 10,000 children in the U.S. are born with ventricular septal defect, requiring pediatric perfusion products, as per the CDC report in October 2024. 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 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.
• 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.
• Company strategies and innovation: Major players in the pediatric perfusion products market are focusing on strategic alliances and product advancements to address the specific requirements of infant and neonatal care. Strategic partnerships with cardiac centers are facilitating access to cutting-edge technologies, while new product releases prioritize miniaturization, enhanced biocompatibility, and compatibility with real-time monitoring systems. The emphasis is on customizing pediatric physiology devices and improving clinical outcomes through innovation.

Number of Perfusionists Present for a Pediatric/Neonatal Case by Region in 2021

Source: NLM December 2022

Challenges

• 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 market.
• 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.