Newborn Screening Market Size, Share, Forecast Report 2032

GlobalNewborn Screening Market: Industry Perspective

The global newborn screening market size was worth around USD 845.31 million in 2023 and is predicted to grow to around USD 1634.27 million by 2032 with a compound annual growth rate (CAGR) of roughly 7.6% between 2024 and 2032. The report analyzes the global newborn screening market's drivers, restraints/challenges, and the effect they have on the demands during the projection period. In addition, the report explores emerging opportunities in the newborn screening industry.

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Global Newborn Screening Market: Overview

Newborn screening is a preventive pediatric screening test usually performed to diagnose any inborn abnormalities or congenital metabolism defects. Normally, newborns are more susceptible to infections, which can arise at any time, even from the first day of their lives. These newborn screening tests help physicians in the early detection of serious genetic disorders, which can result in a lifetime of disability if not treated at the right time. Newborn screening helps physicians to start the treatment from the initial stage, once the disease is diagnosed to reverse its prognosis. Early diagnosis and treatment help in the subsequent reduction of associated disabilities. These newborn programs differ from country to country, depending on the prevalence rate of different diseases and legal requirements for screening tests.

Global Newborn Screening Market: Growth Factors

The global newborn screening market is mainly driven by the growing incidences of neonatal diseases, which is leading to the high demand for newborn screening tests. Initiatives by the government in creating awareness about neonatal hereditary diseases are further boosting the newborn screening market growth globally. Technological advancements and growth in funding from government organizations are also propelling this market. Additionally, companies are also engaging in partnerships and collaborations to extend their product offerings, to increase their market shares and expand operations. These partnerships and collaborations are helping enhance the R&D capabilities for manufacturing innovative devices to meet different consumer needs. In 2015, for instance, Roche Diagnostics and Human Longevity entered into a collaboration of Roche Diagnostics' subsidiary Genentech's to conduct whole-genome sequencing on de-identified samples. The partnership helped Roche Diagnostics to discover new diagnostics and targeted therapies and analyze patient samples based on precise genetic categories. These collaborative activities are also fast-tracking drug discovery efforts, which can help detect chromosomal abnormalities in neonates and in the development of new therapies, thus further boosting the newborn screening market globally.

Key Insights

• As per the analysis shared by our research analyst, the global Newborn Screening Market is estimated to grow annually at a CAGR of around 7.6% over the forecast period (2024-2032).
• In terms of revenue, the global Newborn Screening Market size was valued at around USD 845.31 Million in 2023 and is projected to reach USD 1634.27 Million by 2032.
• Based on product, In the newborn screening market, instruments constitute the most dominant product segment. This is primarily due to the increasing demand for advanced screening technologies such as tandem mass spectrometry (MS/MS), pulse oximeters, and hearing screening instruments, which are critical for accurately detecting metabolic, hormonal, and genetic disorders in newborns. The integration of automation and high-throughput screening capabilities has further fueled the demand for these instruments across hospitals and diagnostic laboratories.
• Based on screening test, dry blood spot tests (DBS) hold the largest market share. DBS tests are preferred due to their cost-effectiveness, ease of collection and transportation, and ability to detect a wide range of conditions such as congenital hypothyroidism, phenylketonuria (PKU), and sickle cell disease. The widespread adoption of DBS as a standard testing method in national newborn screening programs significantly contributes to its dominance.
• Based on end-user, Hospitals emerge as the leading end-user segment in the newborn screening market. This dominance is driven by the fact that the majority of births occur in hospital settings where newborn screening is conducted as a routine part of postnatal care. Hospitals are equipped with advanced diagnostic infrastructure, trained personnel, and follow-up care services, making them the primary point of care for screening and early diagnosis.
• Based on region, North America dominates the global newborn screening market, attributed to its well-established healthcare infrastructure, government-mandated screening programs, high awareness among parents, and strong presence of leading market players. The United States, in particular, has implemented comprehensive newborn screening protocols across all states, driving continued growth and innovation in this region.

Global Newborn Screening Market: Report Scope

Global Newborn Screening Market: Segmentation

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The study provides a decisive view of the newborn screening market by segmenting it based on the product, screening test, end-user, and region. All the segments have been analyzed based on present and future trends and the market is estimated from 2024 to 2032.

By product, the market for newborn screening is divided into instruments and assay kits and reagents. The instruments segment is further classified into pulse oximeter, mass spectrometer, hearing screening devices, laparoscopes, retinoscopes, ultrasound machines, and others.

On the basis of screening test, the newborn screening market is fragmented into critical congenital heart disease, dry blood spot test, hearing screen, urine test, and other tests.

Based on end-user, the newborn screening market is divided into hospitals, clinics, and diagnostic centers.

The regional segment includes the current and forecast demand for North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.

Global Newborn Screening Market: Regional Analysis

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The global newborn screening market shows notable regional diversity: North America remains dominant—holding approximately 33–48% of the market in 2023—thanks to mature healthcare infrastructure, mandated national screening policies (covering metabolic, genetic, and cardiac conditions), strong government and private-sector funding, and ongoing technological innovation. Asia‑Pacific is the fastest‑growing region (CAGR ~8–9%), fueled by its large birth rate, improving healthcare systems, rising awareness, and expansive government-led screening initiatives in China, India, Japan, Australia, and Southeast Asia . Europe, Latin America, the Middle East & Africa trail in market share, but are experiencing steady growth as they strengthen screening programs, upgrade diagnostic capabilities, and adopt advanced technologies—helped by rising healthcare investments and regulatory improvements.

Global Newborn Screening Market: Competitive Analysis

Some of the major players in the global newborn screening market include:

• Bio-Rad Laboratories
• GE Healthcare
• Thermo Fisher Scientific
• Agilent Technologies
• ZenTech
• Trivitron Healthcare
• PerkinElmer
• Natus Medical
• MP Biomedicals
• Medtronic

Global Newborn Screening Market: Segmentation Analysis

The global newborn screening market is segmented as follows;

Global Newborn Screening Market: By Product

• Instruments
  • Pulse Oximeter
  • Mass Spectrometer
  • Hearing Screening Devices
  • Laparoscopes
  • Retinoscopes
  • Ultrasound Machines
  • Others
• Assay Kits and Reagents

Global Newborn Screening Market: By Screening Test

• Dry Blood Spot Test
• Critical Congenital Heart Disease (CCHD)
• Hearing Screen
• Urine Test
• Other Tests

Global Newborn Screening Market: By End-User

• Hospitals
• Clinics
• Diagnostic Centers

Global Newborn Screening Market: Regional Segment Analysis

• North America
  • The U.S.
• Europe
  • UK
  • France
  • Germany
• Asia Pacific
  • China
  • Japan
  • India
• Latin America
  • Brazil
• The Middle East and Africa