At 9.6% CAGR, the North America Newborn Screening Market is Projected to be Worth US$ 1,082.30 Million by 2030, Says Business Market Insights

According to Business Market Insights research, the North America newborn screening market was valued at US$ 521.55 in 2022 and is expected to reach US$ 1,082.30 million by 2030, registering a CAGR of 9.6% from 2022 to 2030. Integration of machine learning and artificial intelligence in screening and surging government funding for newborn screening are among the critical factors attributed to the North America newborn screening market expansion.

According to a study published in The Lancet Digital Health in April 2023, a new deep-learning artificial intelligence model can help screen newborns for the retinopathy of prematureness. With the increasing availability of genetic and clinical data, machine learning algorithms have the potential to improve the accuracy and efficiency of screening processes. These algorithms can analyze vast datasets, identifying subtle patterns and associations that traditional methods may miss. By integrating machine learning into newborn screening, healthcare providers can improve the early detection of genetic disorders, leading to more timely interventions and better outcomes for infants.

As machine learning models evolve and adapt, they can contribute to the ongoing refinement and personalization of newborn screening protocols. This innovation not only benefits the health of newborns but also presents a significant growth opportunity for companies working on solutions that intersect healthcare and artificial intelligence. Additionally, machine learning can further enhance newborn screening programs by decreasing the false positive rate, raising specificity and positive predictive value, and spotting previously unidentified metabolic patterns in data. Thus, artificial intelligence and machine learning-based newborn screening are poised to become a prominent future trend in the newborn screening market.

On the contrary, lack of uniformity in newborn screening policies and practices hampers the growth North America newborn screening market.

Based on product type, the North America newborn screening market is bifurcated into reagents and assay kits, and instruments. The reagents and assay kits segment held 72.7% share of the North America newborn screening market in 2022, amassing US$ 378.99 million. It is projected to garner US$ 842.67 million by 2030 to expand at 10.5% CAGR during 2022-2030. The reagents and assay kits segment is subsegmented into DNA-based assays, and immunoassays and enzymatic assays. Instruments segment is subsegmented into newborn disorder screening instruments, pulse oximeters, newborn hearing screening instruments, and other instruments.

In terms of technology, the North America newborn screening market is categorized into tandem mass spectrometry (TMS), molecular assays, immunoassays and enzymatic assay, pulse oximetry screening technology, and other technologies. The pulse oximetry screening technology segment held 31.9% share of the North America newborn screening market in 2022, amassing US$ 166.47 million. It is projected to garner US$ 354.21 million by 2030 to expand at 9.9% CAGR during 2022-2030.

Based on test type, the North America newborn screening market is categorized into dry blood spot test, hearing screen test, critical congenital heart diseases (CCHD) test, and other test types. The dry blood spot test segment held 53.0% share of North America newborn screening market in 2022, amassing US$ 276.16 million. It is projected to garner US$ 617.87 million by 2030 to expand at 10.6% CAGR during 2022-2030.

By end user, the North America newborn screening market is segmented into hospitals and clinics and diagnostic laboratories. The hospitals and clinics segment held 65.5% share of North America newborn screening market in 2022, amassing US$ 341.54 million. It is projected to garner US$ 745.93 million by 2030 to expand at 10.3% CAGR during 2022-2030.

Based on country, the North America newborn screening market is categorized into the US, Canada, and Mexico. The US held 83.6% share of North America newborn screening market in 2022, amassing US$ 436.07 million. It is projected to garner US$ 923.19 million by 2030 to expand at 9.8% CAGR during 2022-2030.

Key players operating in the North America newborn screening market are Baebies Inc, Bio-Rad Laboratories Inc, Masimo Corp, Medtronic Plc, Natus Medical Inc, PerkinElmer Inc, and Waters Corp, among others.

- In May 2023, Masimo launched Stork, a revolutionary home baby monitoring system. This innovative system offers parents insights into their baby's health data, helping them learn more about and connect better with their baby. The Masimo Stork baby monitor system comprises several components and is available in multiple configurations. Masimo Stork Vitals+, the flagship solution, consists of a boot with a sensor, video camera, and mobile app.

- In Nov 2022, PerkinElmer Inc. received U.S. Food and Drug Administration (FDA) has 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 United States and is part of the Company's broader EONIS Platform.
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