Newborn screening market

The global newborn screening market is estimated to be valued at US$ 1,626.6 Million in 2023 and is expected to exhibit a CAGR of 10.8% during the forecast period (2023-2030).

Analysts’ Views on Global Newborn Screening Market:

The newborn screening market's growth is expected to increase over the forecast period attributable to market players increasing inorganic growth strategies, such as joining newborn screening programs by agencies. For instance, in January 2021, Revvity Inc. (PerkinElmer Inc.) a global technology provider joined the European Alliance for Newborn Screening in Spinal Muscular Atrophy, also known as the SMA NBS Alliance. This alliance brings 21 patient and research organizations focused on spinal muscular atrophy (SMA) from 20 countries across Europe. This program accelerates the identification of such children, given that early diagnosis and treatment lead to better outcomes.

Figure 1. Global Newborn Screening Share (%), By Product, 2023

Global Newborn Screening Market– Drivers

• Increasing inorganic activities, such as collaboration by market players: Increasing inorganic activities, such as collaboration by market players, are expected to propel the growth of the global newborn screening market over the forecast period. For instance, in June 2022, Revvity Inc. (PerkinElmer Inc.) collaborated with Novartis AG, a leading global medicine company, to expand newborn screening for sickle cell disease (SCD) in sub-Saharan Africa. Revvity and Novartis aim to expand advocacy efforts to educate patients, caregivers, and communities about the importance of newborn screening and early intervention with hydroxyurea (HU) and other SCD treatments.

Figure 2. Global Newborn Screening Market Share (%), By Region, 2023

Global Newborn Screening Market- Regional Analysis

• Among regions, North America is estimated to hold a dominant position in the global newborn screening market over the forecast period. North America is estimated to hold 33.5% of the market share in 2023. The global newborn screening market is expected to witness significant growth in the coming years, driven by the increasing inorganic activities such as collaboration by market players, which are contributing to the growth of the newborn screening market in the North America region. For instance, in September 2020, a group of leading rare disease-focused organizations, including the EveryLife Foundation for Rare Diseases, Orchard Therapeutics, Sarepta Therapeutics, Inc., BioMarin Pharmaceutical Inc., and Retrophin, Inc., announced a joint effort to evaluate the capacity of newborn screening in the U.S. to provide timely diagnosis of all newborns who have benefited from new treatments.

Global Newborn Screening Market– Impact of Coronavirus (COVID-19) Pandemic

• Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe, and the World Health Organization declared it a public health emergency on January 30, 2020.
• COVID-19 affected the economy in three main ways: by directly affecting the production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries, such as China, India, Saudi Arabia, the U.A.E., Egypt, and others, faced problems with the transportation of things from one place to another.
• However, the COVID-19 pandemic had a negative impact on the global newborn screening market, owing to a decrease in newborn screening procedures. According to research article published on BMJ Global Health, a ‘Global impact of COVID-19 on newborn screening programs’ by the Department of Endocrinology, University of Ljubljana, Ljubljana, Slovenia, states that most newborn screening centers responded that the pandemic created little effect (47.7%), 18.6% a moderate effect, and 12.8% a lot, while 16.3% of the centers reported no effect. COVID-19 had some effect on the newborn screening programs, and most of the screening centers encountered a wide range of issues.

Global Newborn Screening Market Segmentation:

The global newborn screening market report is segmented into product, test type, application, end user, and region.

• By product, the market is segmented into instruments, assay kits and reagents. Out of which, the instruments is expected to hold a dominant position in the global newborn screening market during the forecast period, and this is attributed to increasing product launches by market players.
• By test Type, the market is segmented into dry blood spot test, cardiac test, hearing test, urine test and others. Out of which, the dry blood spot test is expected to hold a dominant position in the global newborn screening market during the forecast period and this is attributing due to increasing product launches for the screening of dry blood spot test.
• By application, the market is segmented into phenylketonuria, critical congenital cardiac disease, maple syrup urine disease, hearing disability, sickle cell disease, and others. Out of which, sickle cell disease is expected to dominate the market over the forecast period, and this is attributed to increasing product launches for screening of sickle cell disease.
• By end user, the market is segmented into hospital, maternity and specialty clinics, and diagnostic centers. Out of which, the hospital is expected to dominate the market over the forecast period, and this is attributed to increasing newborn screening in hospitals.
• Among all the segmentation, the sickle cell disease segment is expected to dominate the market over the forecast period, and this is attributed to increasing  donations to increase the capacity of newborn screening. For instance, in October 2022, Revvity Inc. (PerkinElmer Inc.) donated MigeleTM Gel Electrophoresis Systems to Ghana’s Health Services’ initiative to increase the country’s screening of newborns for sickle cell disease (SCD).

Global Newborn Screening Market- Cross Sectional Analysis:

Among application, sickle cell disease is expected to boost the newborn screening market in the North America region. For instance, in June 2022, a U.S.-based Rady Children’s Institute for Genomic Medicine (RCIGM) announced a novel program to advance and evaluate the scalability of a diagnostic and precision medicine guidance tool called BeginNGS to screen newborns for approximately 400 genetic diseases, such as sickle cell disease, that have known treatment options using rapid whole genome sequencing (rWGS).

Global Newborn Screening Market: Key Developments

• In June 2022, Novartis AG started a partnership with American Society of Hematology (ASH) to provide six additional African nations with the technology that is already being used in Ghana to document and share the diagnosis of babies with sickle cell disease. This partnership expands the current newborn screening consortium to new areas.

Global Newborn Screening Market: Key Trends

• Introduction of newborn screening with advanced technology: The Introduction of advanced newborn screening technology into the market is expected to drive the growth of the global newborn screening market over the forecast period. For instance, in February 2020, Thermo Fisher Scientific Inc. a biotechnology company launched a new next-generation sequencing (NGS)-based solution that enables reproductive health researchers to more efficiently analyze a broad range of key genetic markers with an end-to-end workflow. The Ion Torrent CarrierSeq ECS Kit for the Ion GeneStudio S5 System consolidates a multi-platform approach to expanded carrier screening (ECS) into a single solution. It expands the company's reproductive health research portfolio, which includes tools for prenatal, postnatal, in vitro fertilization, and newborn screening analysis.

Global Newborn Screening Market: Restraint

• High cost associated with newborn screening instruments: The high cost associated with newborn screening instruments is expected to hinder market growth over the forecast period. The cost of screening instruments for newborns can range anywhere from US$5,000 to US$10,000 per instrument in the usual case. Key players are focusing on developing advanced products with safety and cost-effectiveness, which is expected to drive market growth over the forecast period.

Global Newborn Screening Market - Key Players

Major players operating in the global newborn screening market include Agilent Technologies, Inc., Bio-rad laboratories, Inc., Medtronic Plc, Masimo Corporation, Natus Medical Inc., Perkin Elmer, Inc, ZenTec S.A., Trivitron Healthcare Pvt Ltd, Waters Technologies Corporation, Danaher Corporation, Baebies, Inc , Parseq Lab Co. Ltd , Chromesystem Instruments and Chemicals GmbH, and RECIPE Chemicals+ Instrument GmbH

Newborn Screening Market Detailed Segmentation:

• By Product:
  • Instruments
  • Assay Kits
  • Reagents
• By Test Type:
  • Dry Blood Spot Test
  • Cardiac Test
  • Hearing Test
  • Urine Test
  • Others
• By Application:
  • Phenylketonuria
  • Critical Congenital Cardiac Disease
  • Maple Syrup Urine Disease
  • Hearing Disability
  • Sickle Cell Disease
  • Others
• By End User:
  • Hospital
  • Maternity and Specialty Clinics
  • Diagnostic Centers
•  By Region:
  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa