Request for neonatal immunoassays and enzyme screening tests

ROCKVILLE, Md., March 22, 2022 (GLOBE NEWSWIRE) — Award-winning consulting firm Fact.MR’s recent report on the newborn screening market predicts an optimistic outlook, forecasting a CAGR exceeding 8% to reach a valuation of over 1 billion by 2031. Rising spending on infant care in the wake of accelerating birth rates demand for neonatal screening solutions.

The market has recorded impressive gains in the past, growing at a CAGR of less than 8% from 2016 to 2020. Stakeholders have specifically focused on the use of newborn screening consumables to predict highly accurate results and the increasing hygiene issues associated with reusable screening products.

According to the World Health Organization, the world has seen a dramatic reduction of around 60% in the under-five category, from 93 deaths per 1,000 live births in 1990 to 38 in 2019. However, the global burden of child and youth mortality remains high, with more than 7 million children, adolescents and young people aged 0-14 dying from preventable diseases. As a result, governments in key regions are spending to improve existing infant care infrastructure, which incentivizes the entry of key providers of newborn screening solutions.

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Newborn Screening Market (2031) 1 billion US dollars
Global market growth rate – 2031 8% CAGR
segments End-use industry, type and region
Report cover Revenue forecasts, competitive landscape, growth factors and trends

How is the surge in cases of childhood disorders driving demand for newborn screening?
The prevalence of childhood diseases has multiplied in recent years, resulting in a sharp increase in mortality rates. Hearing loss, metabolic and hormonal disorders are among the most common conditions affecting newborns in major regions, which are mostly treatable.

According to the Centers for Disease Control & Prevention (CDC), birth defects affect one in 33 babies, or 3% of all infants, in the United States. Additionally, the Indian Academy of Pediatrics (IAP) estimates that congenital hearing loss affects 30 out of every 100,000 children.

Consequently, the demand for effective diagnostic solutions has grown, prompting major healthcare providers to invest in advanced newborn screening approaches, generating increased demand.

Key Market Segments Covered

  • Newborn screening instruments
    • Disorder Screening Instruments
      • Fully Automated Newborn Screening Instruments
      • Other neonatal screening instruments (semi-automated instruments, shakers, incubators, etc.)
    • Hearing screening instruments
      • Newborn Screening Accessories
      • Newborn Screening Devices
    • Pulse oximeters
  • Consumables
    • Newborn screening test kits and reagents
    • Other neonatal screening consumables (columns and screening cards)

Type of test

  • Newborn Screening Tests for Dry Blood Spots
  • Newborn hearing screening tests
  • Screening tests for critical congenital heart disease (CCHD)


  • Neonatal immunoassays and enzyme screening tests
  • Tandem mass spectrometry
  • Molecular assays
  • Newborn Hearing Screening Technologies
  • Pulse oximetry
  • Other newborn screening technologies (fluorescence, gel electrophoresis, etc.)

Final user

  • Newborn screening in clinical laboratories
  • Newborn screening in hospitals

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Competitive landscape
Major newborn screening vendors depend on key expansion strategies such as expanding the product portfolio under new releases, acquiring existing manufacturers, and entering into strategic agreements and collaborations. These measures help existing suppliers secure a solid footing in the market.

  • For example, Bio-Rad Laboratories offers the VARIANTnbs automated newborn screening for sickle cell disease and other hemoglobin disorders, with fully automated analysis and advanced results reporting for maximum efficiency. It uses dried blood spot samples to provide results.
  • Recently, in May 2021, Baebies was awarded US$2.7 million in a Phase II B SBIR grant from the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) which supports the validation, clinical evaluation and the FDA. presentation of a panel of rapid tests for monitoring heparin close to the patient.

Profiled Key Companies

  • Perkin Elmer
  • Applicant A/S
  • Natus Medical Inc.
  • Bio-Rad Laboratories
  • Danaher Company
  • Medtronic Plc.
  • Chromsystems Instruments & Chemicals GmbH
  • Trivitron Health
  • Babies
  • RECIPE Chemicals + Instruments GmbH

Analysis by country of the newborn screening market
Why is the United States likely to generate significant opportunities for manufacturers of newborn screening products?
The outlook for newborn screening in the United States is expected to improve, with an expected CAGR of around 5% throughout the forecast period. The Center for Disease Control and Prevention (CDC) estimates that millions of babies are routinely screened each year.

Tests for possible diseases or conditions are widely administered via blood samples taken from a newborn’s heel for genetic, endocrine, or metabolic disorders, as well as congenital heart defects. Players such as PerkinElmer and Danaher Corporation actively provide various newborn screening solutions.

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Overview by Category of the Newborn Screening Market
Why are newborn screening consumables gaining popularity?
Based on product, demand for newborn screening consumables is poised for impressive growth, growing at a CAGR of nearly 8% through 2031. This high share is a result of rising hygiene concerns. , especially following the recent pandemic crisis.

Among all consumables, the demand for test kits and reagents is expected to remain high, owing to their ability to produce faster lead times, which aids in timely detection and diagnosis or prevention of any serious pediatric condition.

What is likely to be the dominant newborn screening technology?
Based on the technology, newborn screening by immunoassay and enzyme assay is poised to gain priority, registering a CAGR of around 7% through 2031. This technology is being widely deployed to determine various conditions in new -born.

For example, ELISA is widely deployed to screen newborns for cystic fibrosis using conventional radioimmunoassay. Similarly, monoclonal antibody immunoassay tests for the identification of hemoglobin variants are being deployed for neonatal screening.

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