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Newborn Screening Market Size, Share & Industry Analysis, By Product (Instruments, Kits), By Test Type (Blood Test, Hearing Test, Urine Test, Critical Congenital Heart Defect Test, Others), By Disease Indication (Congenital Heart Diseases, Genetic Disorders, Infectious Diseases, Hearing Disorders, Others), By End-user (Hospitals, Diagnostic Centers, Maternity Clinics, Others) and Regional Forecast, 2024-2032

Region : Global | Report ID: FBI101874 | Status : Ongoing



According to the WHO, an estimated 15 million babies are born preterm every year, and this number is rising at an exponential rate. Detection of the disease at the time of birth thus becomes important for ensuring the health of the baby. Newborn screening is a test or series of tests that help in identifying potentially fatal or harmful disorders, which affects the child’s long term survival and health. Newborn screening is done to detect abnormalities such as congenital heart diseases, genetic disorders, hearing impairment, neurological disorders, vision defects, and others. The emergence of new and advanced technology for newborn screening and subsequent product approvals is expected to positively impact the newborn screening industry. For example, in February 2018, Masimo received CE approval for Eve, a Critical Congenital Heart Disease (CCHD) screening application for the newborn which can be performed on Rad-97 Pulse CO-Oximeter.

Key Market Driver -

Rapid adoption of minimally and non-invasive newborn screening procedures

Key Market Restraint -

Limited availability of skilled professionals

Global newborn screening market growth is being driven by the increasing number of neonatal population, increased awareness of the separate specialty for newborns, rapid adoption of minimally and non-invasive newborn screening procedures, and favorable health reimbursement. Furthermore, the rising prevalence of congenital heart diseases and genetic disorders among newborns is anticipated to fuel the global newborn screening market. Additionally, initiatives taken by governmental and private organizations and advancement in the new technologies are also driving the growth of the global newborn screening market.  

On the counterpart, lack of knowledge among the parents about neonatal screening, limited availability of skilled professionals and lack of accuracy in some of the tests are the major factors that can hamper the growth of the global newborn screening market.

Key Players Covered:

The key companies covered in the global Newborn Screening market report include Thermo Fisher Scientific Inc., GE Healthcare, Bio Rad Laboratories, Inc., PerkinElmer Inc., ZenTech S.A., MP Biomedicals LLC, Trivitron Healthcare, Agilent Technologies, Natus Medical Incorporated, Medtronic, and others.

As per the current newborn screening market trends, congenital heart diseases among the disease indication are anticipated to hold a considerable market share in the global newborn screening market owing to the rising prevalence of congenital heart diseases. According to the Centers for Disease Control and Prevention, about 40,000 babies are born with congenital heart disease every year in the U.S., which is expected to augment the demand for newborn screening during the forecast period.

Key Insights:

  • Prevalence of congenital heart diseases and genetic diseases in newborns for key countries

  • The regulatory scenario for key countries

  • New product launch

  • Key mergers and acquisitions

Regional Analysis:

The global newborn screening market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The newborn screening market is anticipated to expand in North America during the forecast years owing to the fast adoption of non-invasive techniques for newborn screening, favorable health reimbursement, and increase in number of preterm births. According to WHO, the United States is among the top 10 countries with the greatest number of preterm births with 517,400 in 2018, which is likely to favor the expansion of newborn screening market in North America.

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Proactive government initiatives and increased government efforts to ensure child health is projected to boost the newborn screening market in Europe. Asia Pacific is anticipated to register significant growth in the global newborn screening market owing to the rising prevalence of genetic disorders and the increasing number of childbirth. In Latin America and Middle East and Africa, the evolving healthcare infrastructure, technological advancements, and increasing awareness regarding newborn screening are anticipated to fuel the newborn screening market growth during the forecast period.




By Product

  • Instruments

  • Kits

By Test Type

  • Blood Test

  • Hearing Test

  • Urine Test

  • Critical Congenital Heart Defect Test

  • Others

By Disease Indication

  • Congenital Heart Diseases

  • Genetic Disorders

  • Infectious Diseases

  • Hearing Disorders

  • Others

By End-user

  • Hospitals

  • Diagnostic Centers

  • Maternity Clinics

  • Others

By Geography

  • North America (USA and Canada)

  • Europe (UK, Germany, France, Italy, Spain, Scandinavia and Rest of Europe)

  • Asia Pacific (Japan, China, India, Australia, Southeast Asia and Rest of Asia Pacific)

  • Latin America (Brazil, Mexico and Rest of Latin America)

  • Middle East & Africa (South Africa, GCC and Rest of Middle East & Africa)

Global Newborn Screening Industry Developments

  • In February 2019, ArcherDX, Inc. announced the acquisition of Baby Genes, Inc. with the aim to expand its product portfolio with newborn screening test for spinal muscular atrophy, fragile X syndrome, and cystic fibrosis.

  • In October 2018, LifeCell International Pvt.Ltd launched RightStart, a DNA test for newborns that can detect nearly 50 medical conditions.

  • In October 2018, Labsystems Diagnostics Oy announced the launch of six new newborn screening products in order to diversify its product portfolio.

  • In February 2018, Masimo received CE approval for Eve, a Critical Congenital Heart Disease (CCHD) screening application for newborn which can be performed on Rad-97 Pulse CO-Oximeter.

  • Ongoing
  • 2023
  • 2019-2022

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