Global Newborn Screening Market Size (2024 - 2029)

The newborn screening market is projected to experience significant growth over the forecast period, driven by an increase in screening programs, rising incidences of congenital diseases, and advancements in technology. The market's expansion is further supported by government initiatives mandating newborn screenings before hospital discharge. Despite the positive outlook, challenges such as inconsistent global screening policies and a high rate of false results may hinder market growth. The impact of the COVID-19 pandemic on healthcare resources has also affected newborn screening procedures, although the long-term effects on market size are still being assessed.

Market Size of Global Newborn Screening Industry

Newborn Screening Testing Market Summary
Study Period 2019 - 2029
Market Size (2024) USD 1.29 Billion
Market Size (2029) USD 1.97 Billion
CAGR (2024 - 2029) 8.90 %
Fastest Growing Market Asia Pacific
Largest Market North America
Market Concentration Medium

Major Players

Newborn Screening Testing Market Major Players

*Disclaimer: Major Players sorted in no particular order

Newborn Screening Market Analysis

The Global Newborn Screening Market size is estimated at USD 1.29 billion in 2024, and is expected to reach USD 1.97 billion by 2029, growing at a CAGR of 8.90% during the forecast period (2024-2029).

The COVID-19 pandemic affected every aspect of the healthcare system around the world due to the high influx of COVID-19 patients owing to the high infectivity rate of the SARS-COV-2 virus. The newborn screening procedures were also impacted initially due to the diversion of resources towards COVID-19 management which is anticipated to have an impact on the market. For instance, according to a research study titled 'Global impact of COVID-19 on newborn screening programs' published in March 2022, 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. Also, as per the same source, in 29 of the 38 countries that responded, COVID-19 had some effect on the newborn screening programs and most of the screening centers encountered a wide range of issues, and the majority were more negatively impacted by the pandemic's second wave. Hence, COVID-19 is expected to have a significant impact on the newborn screening market.

Factors responsible for the growth of the newborn screening market include growing newborn screening programs, rising incidences of congenital diseases, raising funding from government sectors for newborn screening, and advancements in technologies used in newborn screening. For instance, according to a research study published in April 2022, titled 'Epidemiology of Congenital Heart Disease in Jinan, China From 2005 to 2020: A Time Trend Analysis', in urban regions, the prevalence of congenital heart disease (CHD) was 4.81 per 1,000 births from 2005 to 2020, compared to 3.17 per 1,000 births in rural areas and the prevalence of CHD grew by 157.45% and 316.03%, respectively, in urban and rural areas between 2005 and 2020, according to a time trend analysis of the data. Similarly, according to the February 2022 data of the World Health Organization, an estimate, birth abnormalities are responsible for the death of about 240,000 newborns in the first 28 days of life each year across the glove and an additional 170,000 children between the ages of 1 month and 5 years die because of birth abnormalities. Hence, newborn screening becomes very important as it can provide a proper health analysis of newborns in determining various birth defects or diseases, which can be used to provide adequate medical attention to the newborn and save the life of the newborn. Thus, the demand for newborn screening is expected to increase which will fuel growth in the studied market over the forecast period.

Further, the newborn screening programs run by governments across the continent are expected to have a significant impact on the growth of the newborn screening market as several governments have made newborn screening compulsory before getting discharged from the hospital. For instance, according to the March of Dimes (MoD) report of 2021, before leaving the hospital, every baby in the United States receives newborn screening and the nation screens around 4 million newborns annually. Moreover, the technological advancement in newborn screening platforms and devices is also expected to have a significant positive impact on the newborn screening market over the forecast period. However, the lack of uniformity in newborn screening policies and procedures across the world, and a high number of false positive and false negative results from the tests are expected to restrain the newborn screening market during the forecast period.

Newborn Screening Industry Segmentation

As per the scope of this report, newborn screening is a preventive pediatric screening test conducted to diagnose congenital or inborn abnormalities of metabolism to identify the disease. The early detection and appropriate standards of diagnosis and treatment can prevent death and promote the healthy development of an infant. The newborn screening market is segmented by technology (tandem mass spectrometry, pulse oximetry, enzyme-based assays, DNA assays, and other technologies), test type (dried blood spot, hearing screening, critical congenital heart defect (CCHD), and other test types), end user (hospitals, diagnostic centers, and other end users), and geography (North America, Europe, Asia Pacific, Middle East And Africa, and South America). The Market report also covers the estimated market sizes and trends of 17 countries across major regions globally. The report offers values (in USD million) for the above segments.

By Technology
Tandem Mass Spectrometry
Pulse Oximetry
Enzyme Based Assays
DNA Assays
Other Technologies
By Test Type
Dried Blood Spot
Hearing Screening
Critical Congenital Heart Defect (CCHD)
Other Test Types
By End User
Hospitals
Diagnostic Centers
Other End Users
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East and Africa
GCC
South Africa
Rest of Middle East and Africa
South America
Brazil
Argentina
Rest of South America
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Global Newborn Screening Market Size Summary

The newborn screening market is poised for significant growth, driven by an increasing emphasis on early detection of congenital diseases and advancements in screening technologies. The market is expected to expand steadily over the forecast period, supported by government initiatives mandating newborn screening before hospital discharge. The COVID-19 pandemic initially disrupted screening programs, but it also spurred innovation, such as the development of dried blood spot (DBS) tests, which continue to play a crucial role in the market. These tests offer advantages like minimal sample volume and ease of transport, making them a preferred choice for screening various metabolic conditions. The rising incidence of birth defects and congenital disorders underscores the importance of newborn screening, as it facilitates timely medical intervention, potentially saving lives.

North America is anticipated to dominate the newborn screening market, largely due to its robust healthcare infrastructure, supportive government policies, and technological advancements in screening methods. The United States, in particular, is expected to hold a significant market share, driven by the high incidence of disorders in newborns and the widespread implementation of state-based screening programs. Despite the lack of uniformity in testing panels across states, the demand for advanced screening systems is on the rise. The competitive landscape of the market is characterized by the presence of major players like Agilent Technologies Inc., Natus Medical Inc., and PerkinElmer, who are actively involved in research and development to enhance screening capabilities. These factors collectively contribute to the anticipated growth and expansion of the newborn screening market over the coming years.

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Global Newborn Screening Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Rising Burden of Congenital Diseases

      2. 1.2.2 Rising Funding from Government Sectors for Newborn Screening

      3. 1.2.3 Advancements in Technologies Used in Newborn Screening

    3. 1.3 Market Restraints

      1. 1.3.1 Lack of Uniformity of Newborn Screening Policies and Procedures Across the World

      2. 1.3.2 False Positive and False Negative Results

    4. 1.4 Porter's Five Forces Analysis

      1. 1.4.1 Bargaining Power of Buyers/Consumers

      2. 1.4.2 Bargaining Power of Suppliers

      3. 1.4.3 Threat of New Entrants

      4. 1.4.4 Threat of Substitute Products

      5. 1.4.5 Intensity of Competitive Rivalry

  2. 2. MARKET SEGMENTATION

    1. 2.1 By Technology

      1. 2.1.1 Tandem Mass Spectrometry

      2. 2.1.2 Pulse Oximetry

      3. 2.1.3 Enzyme Based Assays

      4. 2.1.4 DNA Assays

      5. 2.1.5 Other Technologies

    2. 2.2 By Test Type

      1. 2.2.1 Dried Blood Spot

      2. 2.2.2 Hearing Screening

      3. 2.2.3 Critical Congenital Heart Defect (CCHD)

      4. 2.2.4 Other Test Types

    3. 2.3 By End User

      1. 2.3.1 Hospitals

      2. 2.3.2 Diagnostic Centers

      3. 2.3.3 Other End Users

    4. 2.4 Geography

      1. 2.4.1 North America

        1. 2.4.1.1 United States

        2. 2.4.1.2 Canada

        3. 2.4.1.3 Mexico

      2. 2.4.2 Europe

        1. 2.4.2.1 Germany

        2. 2.4.2.2 United Kingdom

        3. 2.4.2.3 France

        4. 2.4.2.4 Italy

        5. 2.4.2.5 Spain

        6. 2.4.2.6 Rest of Europe

      3. 2.4.3 Asia-Pacific

        1. 2.4.3.1 China

        2. 2.4.3.2 Japan

        3. 2.4.3.3 India

        4. 2.4.3.4 Australia

        5. 2.4.3.5 South Korea

        6. 2.4.3.6 Rest of Asia-Pacific

      4. 2.4.4 Middle East and Africa

        1. 2.4.4.1 GCC

        2. 2.4.4.2 South Africa

        3. 2.4.4.3 Rest of Middle East and Africa

      5. 2.4.5 South America

        1. 2.4.5.1 Brazil

        2. 2.4.5.2 Argentina

        3. 2.4.5.3 Rest of South America

Global Newborn Screening Market Size FAQs

The Global Newborn Screening Market size is expected to reach USD 1.29 billion in 2024 and grow at a CAGR of 8.90% to reach USD 1.97 billion by 2029.

In 2024, the Global Newborn Screening Market size is expected to reach USD 1.29 billion.

Newborn Screening Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)