Newborn Screening Market

The Newborn Screening Market is valued at USD 1.3 Bn in 2026 and is projected to reach USD 1.9 Bn, growing at a CAGR of 5% by 2033.

Increasing Prevalence of Disorders in Newborns to Fuel Growth of Newborn Screening Market

Neonatal screening, also known as heel prick test, newborn screening test is a blood test done on a newborn baby to check for genetic, metabolic, blood, or other disorders that are not apparent immediately after delivery. Demand remains on an uptrend as the test results help in diagnosing rare but serious health disorders, often before there is any sign that the disorder exists. This is expected to drive the growth of global newborn screening market. Early diagnosis, and appropriate treatment can greatly reduce and often prevent the effects of the disorder for the rest of the individual's life. Unidentified, newborn will develop symptoms and could even die suddenly. While they can be offered treatment when they show symptoms, by the time symptoms appear, their growth and development may already be impaired.

While there is not one single list of newborn screening tests, some of the most sought-after tests include those for hormone (endocrine) disorders, metabolic disorders, haemoglobin (red blood cell) conditions, immune system disorders, and a few other rare but serious conditions like cystic fibrosis, Pompe disease, X-linked adrenoleukodystrophy, and spinal muscular atrophy. With sustained demand for screening of such conditions, newborn screening market is likely to remain on an upswing.

Proliferating Prevalence of Congenital Heart Abnormalities Largely Influences Newborn Screening Market Performance

The recent past has seen an increase in infant illnesses, prompting healthcare professionals to advocate for and support the need for more sophisticated screening tools. The most common neonatal diseases are hearing, metabolic and hormonal problems, and severe congenital heart disease. These conditions are curable if discovered early. The demand for newborn screening is driven by an increase in the prevalence and incidence of severe congenital heart abnormalities such as tri cuspid pulmonary atresia. Congenital cardiac abnormalities are thought to afflict 40,000 newborns annually in the United States alone, or roughly 1 percent of all births, according to the Centers for Disease Control and Prevention (CDC). One in every four newborns with CHD has critical CHD. In their first year of life, infants with severe HDs typically require surgery or other operations.

The US CDC reports that from 2015 to 2017, there were 34 neonatal disorders per 10,000 live births in the US. Each year, it's anticipated that 12,900 infants will be diagnosed with a condition. In addition, the same source notes that hearing loss (16.5 per 10,000), congenital hypothyroidism (6.0 per 10,000), sickle-cell disease (4.9 per 10,000), and cystic fibrosis are the most common conditions (1.8 per 10,000). The Indian Pediatric Academy estimates that 9 out of every 1,000 newborns are affected by congenital cardiac disease in children. More than 200,000 kids are born every year with congenital cardiac disease. Two out of every 1,000 newborns born in the US each year are thought to have critical congenital cardiac disease, according to BabysFirstTest.org, a group funded by the US Health Resources and Services Administration (HRSA).

A Sizeably Large COVID-19 Patient Pool Catalysed Newborn Screening Market Growth

Due to the enormous demand for DBS newborn screening tests brought on by the COVID-19 pandemic, new NBS tests have been developed throughout the epidemic. This has largely influenced the performance of newborn screening market. With the ability to handle up to 5,000 samples per day, PerkinElmer Inc. introduced a dry blood spot (DBS) based test for SARS-CoV-2 IgG in July 202,0 utilizing their GSP/DELFIA platform. In 32 different nations, the worldwide DBS assay, which uses PerkinElmer's GSP analyzer and the time-resolved fluorescence (TRF) of the DELFIA platform, screens more than 30% of all newborn infants.

During the predicted period, dried blood spot tests (DBS) are anticipated to maintain their dominance more than 50 years ago; DBS sampling was used to check newborns for congenital metabolic disorders. The benefits of DBS sampling include its low volume demands (about 30 to 100 L per location), the convenience of sample collection with a finger or heel stick with little training needed, and sample stability and portability. This test can identify several metabolic diseases, including autism, lymphomas, and leukemia. Dried blood spot analysis can only require a tiny, portable sample size. Thus, the increase in infant illnesses is fueling market expansion. Heel sticks or dried blood spot tests refer to the blood collection from a newborn's heel within 24-48 hours of delivery on the screening card for the diagnosis of more than 50 illnesses (DBS). These screening cards are identified by specific codes but do not include any other personal data.

Expanding Infant Population Keeps North America’s Newborn Screening Market Afloat

North America has been the largest user of newborn screening methods and the region’s newborn screening market is expected to grow at the fastest rate throughout the forecast period.  The newborn screening industry is now dominated by North America conquered industry a few more years. Congenital disorders are becoming more common, and testing is required in all 50 states, with the top significant key share in North American newborn screening market. This is due to the expanding need for sophisticated systems and the rising incidence rates of diseases in neonates. The study of diagnostic markers in blood spots collected on filter paper on an infant's second day of life is how every newborn in the United States is examined post-birth. In the United States, newborn screening programs are managed at the state level; as a result, it has been noted that several states' testing panels differ from one another. The country reported 3,613,647 new births in 2022, and the birth rate that year was 11.0 per 1,000 people, according to data from the Centers for Disease Control and Prevention. Texas Health and Human Services began newborn screening for Spinal Muscular Atrophy in June 2021. (SMA). The presence of well-developed healthcare infrastructure is also anticipated to help the US newborn screening market grow further.

Growing newborn screening programs, rising congenital illness rates, securing financing from government sectors for newborn screening, and improvements in technologies utilized in newborn screening are all contributing factors to the expansion of newborn screening market here. According to the Heart Disease and Stroke Statistical Fact Sheet 2020, congenital heart abnormalities are predicted to impact at least 40,000 infants in the United States annually. It is anticipated that about 25% (2.4 per 1,000 live births) of the affected children will need medical attention in the first year of life. As a result, the market is anticipated to develop as more newborn screening tests are used.

Global Newborn Screening Market: Competitive Landscape

LifeCell Diagnostics, based in Chennai, India, announced in November 2021 that they would be adding the innovative and sophisticated Lysosomal Screening Disorder (LSD) screening test "LSDCHECK" to their range of newborn screening tests. On the other hand, Orean, an extended neonatal genetic screening test for newborns, babies, or kids, was introduced in January 2021, according to the NIPD Genetics’ announcement.

A few of the players in the newborn screening market include:

• PerkinElmer, Inc.
• Thermo Fisher Scientific
• Abbott Laboratories
• Roche Diagnostics
• Danaher Corporation
• Bio-Rad Laboratories
• Hologic, Inc.
• GE Healthcare
• Siemens Healthineers
• Hitachi High-Tech Corporation
• QIAGEN
• BD (Becton, Dickinson and Company)
• Illumina, Inc.
• Agilent Technologies
• Fujirebio Inc.

The Global Newborn Screening Market is Segmented as Below:

By Product

• Consumables
• Instruments
• Hearing screening instruments
• Pulse oximeters

By Test

• Dry blood spot tests
• Hearing screening tests
• CCHD screening tests

By technology

• Immune assays & enzymatic assays
• Tandem mass spectrometry
• Molecular assays
• Hearing screening technologies
• Pulse oximetry
• Other Technologies (Flouroscence, gel electrophoresis, etc.)

By End-user

• Clinical Laboratories
• Hospitals

By Region

• North America
• Europe
• Asia Pacific
• LAMEA