Newborn screening involves testing a newborn for serious medical conditions and certain harmful or potentially fatal disorders that are not apparent at birth. These testing programs include blood tests, hearing screening, and pulse oximetry. Detecting these conditions in the early phases of infants’ lives allows health professionals to begin treatments on time to enable children to live healthy lives with normal development. Rising funding from government sectors for newborn screening, the burgeoning burden of congenital diseases, and the increasing prevalence of newborn disorders are the major factors contributing to the growing newborn screening market size. However, the lack of global uniformity in newborn screening policies and practices is the major factor hindering newborn screening market growth.
Surging Government Funding for Newborn Screening to Drive Newborn Screening Market Growth During Forecast Period
Governments of different countries are increasingly allocating funds for newborn screening programs. These programs help reduce long-term healthcare costs for children and their parents as congenital and genetic disorders could result in severe health complications and extensive medical interventions if left undetected. By identifying and addressing health issues in infancy, governments can enhance the health and well-being of their citizens. Thus, newborn screening aligns with broader public health objectives to improve overall population health and reduce the burden on healthcare systems.
Government funding promotes equity in healthcare access, ensuring that newborn screening services are available to all, regardless of socioeconomic status. This inclusivity is essential for early disease detection and intervention, as it prevents disparities in healthcare outcomes among different demographic groups. As governments continue to prioritize newborn screening through increased funding and policy support, the newborn screening market has been experiencing sustainable growth worldwide.
Newborn Screening Market: Segmental Overview
The newborn screening market is segmented on the basis of product type, technology, test type, end user, and geography. Based on technology, the market has been segmented into tandem mass spectrometry (TMS), molecular assays, immunoassays and enzymatic assays, pulse oximetry screening technology, and other technologies. In 2022, the pulse oximetry screening technology segment held the largest share of the newborn screening market. However, the immunoassays and enzymatic assays segment is anticipated to register the highest CAGR in the market during 2022–2030. Newborns with heart problems may have low blood oxygen levels. Congenital heart disease (CCHD) is one of the most common birth defects, and duct-dependent disorders are common forms of this disease. It may be detected during the prenatal and postnatal period, while it can be life-threatening if goes undiagnosed and untreated in the neonatal period or infancy. Pulse oximetry screening is used to detect critical CCHD in infants. It is a painless, noninvasive, and cost-effective method of screening infants. The pulse oximeter screening is used to determine hemoglobin percentage in the blood saturated with oxygen.
Pulse oximetry screening to detect CCHD was first studied at the beginning of the 21st century. Today, the US, UK, Canada, Norway, Sweden, and many other European countries use universal pulse oximetry screening among asymptomatic neonates for the detection of CCHD before discharge from hospitals. Routine newborn pulse oximetry screening helps in the identification of babies with CCHD that could have been missed during prenatal ultrasound and postnatal examinations. Pulse oximetry screening reduces mortality from CCHD and detects babies with other critical conditions, such as respiratory disorders and sepsis. Pulse oximetry was endorsed as a tool for critical congenital heart defect screening by the American Academy of Pediatrics and the American Heart Association in 2011. It was then added to the United States Recommended Uniform Panel.
Newborn Screening Market: Competitive Landscape and Key Developments
Medtronic Plc, LifeCell International Pvt Ltd, Zentech SA, Trivitron Healthcare, PerkinElmer Inc, Waters Corp, Bio-Rad Laboratories Inc, Masimo Corp, Natus Medical Inc, Baebies Inc, and MRC Holland BV are a few of the key companies operating in the newborn screening market. These companies focus on product innovation strategies to meet evolving customer demands, along with maintaining their brand name.
A few of the recent developments in the global newborn screening market are mentioned below:
- In November 2022, PerkinElmer Inc. received US Food and Drug Administration (FDA) authorization for the marketing of the EONIS SCID-SMA assay kit for in vitro diagnostic (IVD) use by certified laboratories for the simultaneous detection of spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns. This is the first FDA-authorized assay for SMA screening in newborns in the US and is a part of PerkinElmer’s broader EONIS Platform.
- In May 2022, Medtronic plc received US FDA granted 510(k) approval for the Nellcor OxySoft SpO2 sensor. The device is the first pulse oximetry sensor to use a silicone adhesive designed to protect fragile skin and improve repositionability and signal acquisition. This new sensor will help clinicians respond quickly with well-informed decisions for their critical care patients.