For the past four decades, pediatric congenital heart surgery has been performed using pediatric perfusion devices. In North America, over 18,000 pediatric open-heart surgeries are performed annually. Most pediatric open-heart surgeries are performed on infants younger than one-year-old. The primary cause of pediatric bypass is a congenital ventricular septal defect. Pediatric perfusion devices are mechanical circulatory support (MCS) devices used in open heart surgery to maintain blood circulation by diverting blood from the heart and lungs. As new devices and techniques are created, the market for pediatric perfusion devices is in a constant state of change. On the market for pediatric perfusion devices, it is anticipated that the development of new and improved blood pumps will meet significant unmet needs and improve the landscape of innovation in mechanical circulatory support devices. The rate of innovation in pediatric perfusion device penetration, however, varies significantly by region. The Pediatric Perfusion Committee conducted a survey that revealed that the adoption rate for recently introduced integrated arterial line filters is 23% in North America and 10% in Asia. However, the introduction of integrated line filters revealed a decline in the volume of conventional standalone arterial line filters, and it is anticipated that integrated line filters will surpass the market share of conventional standalone filters in the coming years.
The expansion of the market for pediatric perfusion devices is primarily driven by the rising prevalence of congenital heart defects and the expanding use of mechanical circulatory support devices. The expansion of the global market for pre-perfusion filters and other pediatric perfusion devices will be fuelled by research efforts and improved patient care. In addition, a number of pediatric perfusion devices for patients with complex congenital heart diseases (CHD) are being developed and are undergoing rigorous testing; it is anticipated that these devices will enter the market during the forecast period. However, the high cost of devices and the lack of pediatric perfusionists in low- to middle-income countries are expected to impede the growth of the global pediatric perfusion devices market over the forecast period.
Blood parameter monitoring or continuous in-line monitoring devices are anticipated to have the highest adoption rate across all pediatric perfusion devices. The market for pediatric perfusion devices is anticipated to be dominated by safety devices, such as bubble traps, arterial filters, and pumps, in terms of revenue. Due to the need for highly advanced infrastructure to conduct open-heart surgeries, the hospital end-user segment dominates the global pediatric perfusion devices market.
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Approximately 1% of the U.S. pediatric population is affected by congenital heart disease each year, according to the CDC. The prevalence of mild congenital heart diseases has increased over the past five years, while the prevalence of severe congenital heart diseases has remained stable. Over 20,000 pediatric open-heart operations are performed annually in the United States, according to the Cincinnati Children's hospital. North America captured the largest share of the global pediatric perfusion devices market due to the high prevalence of congenital heart diseases in the United States, the increase in the rate of congenital heart disease diagnosis, the high rate of open-heart surgery, and the well-established healthcare infrastructure.
Germany, France, and the United Kingdom dominated the market for pediatric perfusion in Europe in 2023. It is anticipated that the markets in Italy and Spain will expand significantly over the forecast period. High market shares of Germany, France, and the United Kingdom can be attributed to their highly developed healthcare industries, high rates of diagnosis and treatment of congenital heart diseases, availability of advanced instruments in hospitals, and the presence of ambulatory surgery centers.
China and Japan dominated the Asia-Pacific pediatric perfusion market in 2023. The market in India is expected to grow at a rapid rate over the next few years due to the country's large new-born population and expanding healthcare industry. During the forecast period, the pediatric perfusion market in Latin America and the Middle East & Africa is anticipated to be hampered by a lack of skilled pediatric surgeons and a lack of developed healthcare infrastructure.
On the global pediatric perfusion devices market, key players such as Medtronic Inc., Sorin Group, Terumo Corporation, BL Lifesciences, Eurosets, and Nonin Medical Inc. have been identified.