Newborn Screening Market Size, Share, Opportunities, And Trends By Technology (Immune Assays & Enzymatic Assays, Tandem Mass Spectrometry, Molecular Assays, Hearing Screening Technologies, Others), By Test (Dry Blood Spot Tests, Hearing Screening Tests, CCHD Screening Tests), By End-User (Clinical Laboratories, Hospitals), And By Geography - Forecasts From 2024 To 2029

The newborn screening industry was valued at US$1,026.817 million in 2022 and is expected to grow at a CAGR of 8.31% during the forecast period.

Newborn screening is utilized to identify various conditions that affect the child’s long-term health. A series of tests are involved in the screening technology mainly timely detection, health management, and early diagnosis to prevent overall disability. These tests detect developmental, genetic, and metabolic disorders in children. Newborn screening is performed by using a few drops of blood from the newborn’s heel and are tested for critical congenital heart defects before discharge from hospitals.

Driving factors for the newborn screening market

The newborn screening market is anticipated to grow owing to rising government initiatives and various developments in screening technology. High birth rates and an increase in the prevalence of neonatal disease are some of the other key factors influencing the growth. Furthermore, the screening of genetic disorders in developing nations like India provides significant newborn screening market growth opportunities for key players. An increase in birth rate and disposable income is also fueling the newborn screening market

Dried blood spot tests are anticipated to hold the maximum market share

Dried blood tests are predicted to dominate the newborn screening industry during the forecast period. These tests have been used for congenital metabolic diseases for over 50 years. Dried blood tests are advantageous due to ease of sample attainment by finger of heel stick, include minimal volume requirements, and are easier to transport. Leukemia, lymphomas, and autism can be detected using the dried blood test. It offers the advantage of collecting small sample volumes which are easier to transport. Therefore, the rising number of diseases in newborns is fueling the newborn screening market.

Rapidly developing pipeline of novel medicines

The pipeline of novel medicines and biologics is quickly expanding. For instance, the first gene therapy for newborn screening disorder, Zolgensma was made accessible shortly after Spinraza was approved by the FDA. This resulted in the inclusion of SMA in the NBS. Since these medicines are very uncommon, the possibility of the medications being very expensive is still a threat. For instance, Zolgensma costs around $2.2 million for a one-dose therapy. Additionally, for the creation of various newborn screening programs, the responsibilities of government, families, and healthcare professionals have been crucial. Furthermore, major newborn screening market leaders are focusing on product innovation for novel medicines.

Increasing government initiatives

Growth in government initiatives is fueling the newborn screening market growth. For instance, the World Health Organization recommended newborn screening programs to safeguard children’s health globally. Numerous policies and guidelines were taken by the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children, UK (PEACH), and many advocacy groups. Increasing funding and various conditions requiring screening are the key factors contributing to the growth of the market.

In North America, it is projected that the newborn screening market will grow steadily. 

The newborn screening market is anticipated to grow in North America during the projected period due to the increasing prevalence of congenital disorders and enforced testing in many nations. All the North American nations diligently follow the newborn screening programs. Through extensive research by the American College of Medical Genetics (ACMG) which is done under the supervision of the U.S. Department of Health and Human Services, the screening conditions are provided. Additionally, to raise awareness among parents the health departments of the United States have released free data and created websites.

Growth strategies by major market players

The newborn screening companies are focusing on growing their manufacturing facilities and are engaging in various merger and acquisition activities to strengthen their newborn screening market position. For instance, in August 2022, Perkin Elmer sold its Applied, Food, and Enterprise business to New Mountain Capital, LLC. With a total compensation of $2.45 billion. The newborn screening industry players have also been involved in various product innovations owing to the incorporation of advanced technology and meeting consumer requirements. Additionally, collaborations are being done between public and private organizations for newborn screening.

Newborn Screening Products

• Panthera PuncherTM 9, The next generation Panthera PuncherTM 9 dry sample punching tool is manufactured by PerkinElmer. PerkinElmer, a pioneer in newborn screening, has chosen the technological options and materials required to guarantee a new benchmark for punching perfection.
• EONISTM Q384, The EONISTM Q 384-well version instrument was created with a straightforward and distinctive workflow, making qPCR training and deployment simple to carry out. The EONISTM Q promises a turnaround time of under two hours and doesn't require a clean room because of the streamlined procedure.
• VARIANT NBS Newborn Screening System, The VARIANTnbs has become the de facto standard for automated newborn screening for hemoglobin abnormalities such as sickle cell anemia. For optimal effectiveness, it has completely automated analysis and cutting-edge result reporting.

Market Key Developments

• In July 2023, At the AMTZ Campus in Vishakhapatnam, India, a Centre of Excellence (CoE) with cutting-edge R&D and manufacturing capabilities was established by Triviton Healthcare.
• In June 2023, To educate the medical teams working under Rashtriya Bal Swasthya Karyakram (RBSK) and District Early Intervention Centre (DEIC) on screening for communication disorders in children, the Department of Health and Family Welfare and the All India Institute of Speech and Hearing (AIISH), based in Mysuru, have partnered to expand the Newborn Screening Programme (NBS).
• In June 2022, according to a novel program announced by Rady Children's Institute for Genomic Medicine BeginNGSTM is being used to screen newborns for roughly 400 genetic diseases for which there are known treatments using rapid whole genome sequencing.

Newborn Screening Market Scope:

Segmentation:

• By Technology
  • Immune Assays & Enzymatic Assays
  • Tandem Mass Spectrometry
  • Molecular Assays
  • Hearing Screening Technologies
  • Others
• By Test
  • Dry Blood Spot Tests
  • Hearing Screening Tests
  • CCHD Screening Tests
• By End-User
  • Clinical Laboratories
  • Hospitals
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • South America
    • Brazil
    • Argentina
    • Others
  • Europe
    • United Kingdom
    • Germany
    • France
    • Spain
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • UAE
    • Israel
    • Others
  • Asia Pacific
    • Japan
    • China
    • India
    • South Korea
    • Indonesia
    • Thailand
    • Others