North America Newborn Screening Market Forecast to 2030

According to The Research Team’ 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.

Table 1. North America Newborn Screening Market Segmentation
Table 2. North America Newborn Screening Market, by Reagents and Assay Kits – Revenue and Forecast to 2030 (US$ Million)
Table 3. North America Newborn Screening Market, by Instruments – Revenue and Forecast to 2030 (US$ Million)
Table 4. US Newborn Screening Market, by Product Type – Revenue and Forecast to 2030 (US$ Million)
Table 5. US Newborn Screening Market, For Reagents and Assay Kits by Product Type – Revenue and Forecast to 2030 (US$ Million)
Table 6. US Newborn Screening Market, For Instruments by Product Type – Revenue and Forecast to 2030 (US$ Million)
Table 7. US Newborn Screening Market, by Technology – Revenue and Forecast to 2030 (US$ Million)
Table 8. US Newborn Screening Market, by Test Type – Revenue and Forecast to 2030 (US$ Million)
Table 9. US Newborn Screening Market, by End User – Revenue and Forecast to 2030 (US$ Million)
Table 10. Canada Newborn Screening Market, by Product Type – Revenue and Forecast to 2030 (US$ Million)
Table 11. Canada Newborn Screening Market, For Reagents and Assay Kits by Product Type – Revenue and Forecast to 2030 (US$ Million)
Table 12. Canada Newborn Screening Market, For Instruments by Product Type – Revenue and Forecast to 2030 (US$ Million)
Table 13. Canada Newborn Screening Market, by Technology – Revenue and Forecast to 2030 (US$ Million)
Table 14. Canada Newborn Screening Market, by Test Type – Revenue and Forecast to 2030 (US$ Million)
Table 15. Canada Newborn Screening Market, by End User – Revenue and Forecast to 2030 (US$ Million)
Table 16. Mexico Newborn Screening Market, by Product Type – Revenue and Forecast to 2030 (US$ Million)
Table 17. Mexico Newborn Screening Market, For Reagents and Assay Kits by Product Type – Revenue and Forecast to 2030 (US$ Million)
Table 18. Mexico Newborn Screening Market, For Instruments by Product Type – Revenue and Forecast to 2030 (US$ Million)
Table 19. Mexico Newborn Screening Market, by Technology – Revenue and Forecast to 2030 (US$ Million)
Table 20. Mexico Newborn Screening Market, by Test Type – Revenue and Forecast to 2030 (US$ Million)
Table 21. Mexico Newborn Screening Market, by End User – Revenue and Forecast to 2030 (US$ Million)
Table 22. Recent Organic Growth Strategies in Newborn Screening Market
Table 23. Recent Inorganic Growth Strategies in the Newborn Screening Market
Table 24. Glossary of Terms, Newborn Screening Market

Figure 1. North America Newborn Screening Market Segmentation, By Country
Figure 2. North America Newborn Screening Market – Key Industry Dynamics
Figure 3. Impact Analysis of Drivers and Restraints
Figure 4. North America Newborn Screening Market Revenue (US$ Mn), 2022 – 2030
Figure 5. North America Newborn Screening Market Revenue Share, by Product Type, 2022 & 2030 (%)
Figure 6. Reagents and Assay Kits: North America Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
Figure 7. Instruments: North America Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
Figure 8. North America Newborn Screening Market Revenue Share, by Technology 2022 & 2030 (%)
Figure 9. Tandem Mass Spectrometry (TMS): North America Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
Figure 10. Molecular Assays: North America Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
Figure 11. Immunoassays and Enzymatic Assays: North America Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
Figure 12. Pulse Oximetry Screening Technology: North America Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
Figure 13. Other Technologies: North America Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
Figure 14. North America Newborn Screening Market Revenue Share, by Test Type 2022 & 2030 (%)
Figure 15. Dry Blood Spot Test: North America Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
Figure 16. Hearing Screen Test: North America Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
Figure 17. Critical Congenital Heart Diseases (CCHD) Test: North America Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
Figure 18. Other Test Types: North America Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
Figure 19. North America Newborn Screening Market Revenue Share, by End User, 2022 & 2030 (%)
Figure 20. Hospitals and Clinics: North America Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
Figure 21. Diagnostic Laboratories: North America Newborn Screening Market – Revenue and Forecast to 2030 (US$ Million)
Figure 22. North America: Newborn Screening Market, by Key Country – Revenue (2022) (US$ Million)
Figure 23. North America Newborn Screening Market, By Key Countries, 2022 and 2030 (%)
Figure 24. US Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
Figure 25. Canada Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
Figure 26. Mexico Newborn Screening Market Revenue and Forecast to 2030 (US$ Mn)
Figure 27. Growth Strategies in Newborn Screening Market