Newborn Screening - Market Insights, Competitive Landscape, and Market Forecast - 2030

The global newborn screening market was valued at USD 1.00 billion in 2023, growing at a CAGR of 6.03% during the forecast period from 2024 to 2030 to reach USD 1.42 billion by 2030. The demand for newborn screening is primarily being boosted by the increasing figures of newborn congenital diseases such as congenital heart defects (CHD), hypospadias, ventricular septal defect, clubfoot, down syndrome, pulmonary valve atresia and stenosis, cleft lip with cleft palate, atrioventricular septal defect, and others. Further, the rising adoption of advanced and innovative technologies, increasing government support for newborn screening and developments in screening technology, high birth rate, increasing complications in pregnancy, and increasing product launches and approval among others are thereby contributing to the overall growth of the newborn screening market during the forecast period from 2024-2030.

Newborn Screening Market Dynamics:

The newborn screening market is witnessing a growth in product demand owing to various factors, one of the key factors being the increase in the prevalence of various congenital diseases. For instance, according to World Health Organization (WHO) 2023, an estimated 6% of babies worldwide are born with a congenital disorder every year. Also, nine of ten children born with a serious congenital disorder are in low- and middle-income countries. Congenital disorders can contribute to long-term disability, which takes a significant toll on individuals, families, healthcare systems, and societies.

As per the same source, an estimated 240,000 newborns die worldwide within 28 days of birth every year due to congenital disorders. The congenital disorders can further cause 170,000 deaths of children between the ages of 1 month and 6 years. Thus, to reduce the figures of prevalence and mortality proper diagnosis and screening tests such as preconception screening, peri-conception screening, and neonatal screening should be performed by physicians from time to time as they can provide a proper health analysis of newborns in determining various birth defects or diseases. Thus, the increasing number of congenital diseases across the globe will increase the demand for newborn screening.

Government policies and programs also help to foster a favorable environment for market expansion. The WHO recommended the newborn screening program to protect children's health worldwide. The Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) of the US Department of Health and Human Services, the Japan Society of Obstetrics and Gynecology (JSOG), the United Kingdom (PEACH), and advocacy organizations like the March of Dimes have all taken various policies and initiatives under this program.

In addition, the increasing launches and approvals of various screening devices and kits will increase the demand for newborn screening in the market. For instance, in September 2020, PerkinElmer, Inc., announced that the EONIS™ screening assay for newborns that simultaneously tests for SMA (spinal muscular atrophy), SCID (severe combined immunodeficiency), and XLA (X-linked agammaglobulinemia) received CE-IVD approval. This IVD RT-PCR assay integrates into PerkinElmer’s entire newborn screening workflow to provide labs with a complete, single-source solution encompassing everything from the sample to the solution.

Therefore, the above-mentioned factors are contributing to the growth of the newborn screening market during the forecast period from 2024-2030.

However, false-positive tests, Lack of uniformity of newborn screening policies and procedures across the world, and others may restrict the newborn screening market growth.

The newborn screening market experienced significant growth during the COVID-19 pandemic. In the initial period, the market suffered a temporary setback as lockdown restrictions were enforced as a necessary step to curb the spread of COVID-19. However, the demand for newborn screening testing kits and instruments increased during the pandemic owing to the sudden increase in the number of pregnancy cases. According to UNICEF 2020, globally, an estimated 116 million babies were born under the shadow of the COVID-19 pandemic, and almost a quarter of them which is approximately 29 million were born in South Asia. Countries in South Asia with the expected highest numbers of births in the nine months since the COVID-19 pandemic declaration were India (20 million), Pakistan (5 million), Bangladesh (2.4 million), and Afghanistan (1 million). The increasing number of pregnancy cases increased the demand for newborn screening, due to which various key players in the market accelerated the manufacturing of newborn screening kits, reagents, and instruments. Henceforth, the afore-said factors propelled the demand for newborn screening during the pandemic and are estimated to grow similarly during the forecast period.

Newborn Screening Market Segment Analysis:

Newborn Screening by Type (Instruments and Kits), Test Type (Dried Blood Spot, Hearing Screening, Critical Congenital Heart Defect, and Others), Technology (Tandem Mass Spectrometry, Pulse Oximetry, Enzyme Based Assays, DNA Assays, and Others), End-User (Hospitals & Clinics, Diagnostic Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the test type segment of the newborn screening market, the dried blood spot category is expected to amass significant revenue share in the year 2023. This can be ascribed to the advantages and applications offered by the segment.

Heel sticks or dried blood spot tests (DBS) refer to the collection of blood from a newborn's heel within 24-48 hours of birth on the screening card for the diagnosis of more than 50 conditions. These screening cards are identified by specific codes but don't include any other personal data. The test can be used to identify many different metabolic conditions, including autism, lymphomas, leukemia, and many others. In North America, the testing card is free as part of a strategy to encourage more procedures.

Moreover, the benefits of DBS sampling include its low volume demands (roughly 30 to 100 L per spot), ease of sample collection using a finger or heel stick with little training needed, and sample stability and portability. Dried blood spot analysis has the benefit of only requiring a portable small sample size. Therefore, the prevalence of newborn diseases is driving market expansion.

The increasing strategic activities such as approvals, launches, and acquisitions related to the segment will also drive the market of dried blood spot test type segment. For instance, in July 2020, PerkinElmer Inc. launched a dry blood spot (DBS) based test for SARS-CoV-2 IgG using its GSP/DELFIA platform, enabling the processing of up to 5,000 samples per day. The DBS assay runs on PerkinElmer's GSP analyzer and, combined with the universal TRF (time-resolved fluorescence) of the DELFIA platform, screens more than 30% of all newborn babies worldwide, spanning 32 countries.

Therefore, the advantages and applications offered by dried blood spots are predicted to contribute to the increasing demand for this test type thereby driving the growth of the overall newborn screening market during the forecast period.

North America is expected to dominate the overall Newborn Screening Market:

Among all the regions, North America is estimated to account for the largest share of the global newborn screening market in the year 2023. Owing to the rising prevalence of various newborn congenital diseases such as congenital heart defects (CHD), hypospadias, ventricular septal defect, clubfoot, down syndrome, pulmonary valve atresia and stenosis, cleft lip with cleft palate, atrioventricular septal defect, and others, will increase demand of newborn screening the North America market. Also, the growing birth rate, an increasing number of pregnancy complications, and increasing government support are driving the North America newborn screening market and are expected to witness positive growth. Furthermore, high disposable income, sophisticated healthcare infrastructure, regulatory approval for new products, and high awareness also helped the market growth in this region.

The Centers for Disease Control and Prevention (CDC) 2022, it was stated that congenital heart defects (CHDs) affect about 40,000 births per year in the United States. About 1 in 4 babies with a CHD have a critical CHD. Infants with critical CHDs generally need surgery or other procedures in their first year of life. Further, the source also estimated that birth defects affect one in every 33 babies (about 3% of all babies) born in the United States each year.

The aforesaid source stated that about 1 in every 593 births per year suffers from clubfoot, 1 in every 707 births yearly suffers from Down syndrome, and 1 in every 1,687 births every year suffers from cleft palate, in the US.

Thus, the increasing number of congenital diseases in the region will increase the demand for various kits and instruments used in newborn screening, thereby driving the overall market of newborn screening in North America.

Further, in the United States, every newborn is screened post-birth, and this screening is performed by the analysis of diagnostic markers in blood spots collected on filter paper on the second day of an infant’s life. Newborn screening programs are run on a state basis within the United States; therefore, it has been observed that there is a lack of uniformity among the testing panels of many states.

Coupled with the factors mentioned above, strategic activities such as product launches and approvals, mergers, acquisitions, partnerships, and others also help in boosting regional product demand. For instance, in September 2022, PerkinElmer Inc. received the US Food and Drug Administration (FDA) authorization for the marketing of the EONIS™ SCID-SMA assay kit for in vitro diagnostic (IVD) to be used for the simultaneous detection of spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns. This is the first FDA-authorized assay for SMA screening in newborns in the United States and is part of the Company’s broader EONIS™ Platform. Thus, such strategic steps help to increase the demand for Newborn Screening, thereby driving the North America newborn screening market forward during the forecast period.

Newborn Screening Market Key Players:

Some of the key market players operating in the newborn screening market include Natus Medical Incorporated, Trivitron Healthcare, Medtronic, Bio-Rad Laboratories, Inc., PerkinElmer, GE HealthCare, Masimo, Agilent Technologies, Inc., DH Tech. Dev. Pte. Ltd., Zentech, Demant A/S, Waters Corporation, Baxter, Thermo Fisher Scientific Inc., MP BIOMEDICALS, Integrated DNA Technologies, Inc., LifeCell International Pvt. Ltd., Labsystems Diagnostics Oy, Zivak, RECIPE Chemicals + Instruments GmbH, and others.

Recent Developmental Activities in the Newborn Screening Market:

• In August 2022, Trivitron Healthcare launched a Centre of Excellence (CoE) with state-of-the-art research and development and manufacturing facilities at AMTZ Campus, Vishakhapatnam, India, for metabolomics, genomics, newborn screening, and molecular diagnostics.
• In June 2021, the Texas Health and Human Services launched newborn screening for Spinal Muscular Atrophy (SMA).

Key Takeaways from the Newborn Screening Market Report Study

Market size analysis for current newborn screening market size (2023), and market forecast for 6 years (2024-2030)

Top key product/services/technology developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years
Key companies dominating the global newborn screening market.

Various opportunities available for the other competitor in the newborn screening market space.

What are the top-performing segments in 2023? How these segments will perform in 2030.

Which are the top-performing regions and countries in the current newborn screening market scenario?

Which are the regions and countries where companies should have concentrated on opportunities for newborn screening market growth in the coming future?

Target Audience who can be benefited from this Newborn Screening Market Report Study

Newborn screening products providers

Research organizations and consulting companies

Newborn screening-related organizations, associations, forums, and other alliances

Government and corporate offices

Start-up companies, venture capitalists, and private equity firms

Distributors and Traders dealing in newborn screening

Various End-users who want to know more about the newborn screening market and the latest technological developments in the newborn screening market.

Frequently Asked Questions for the Newborn Screening Market:

1. What is newborn screening?

Newborn screening is a preventive screening test used to identify diseases by detecting congenital or inborn metabolic abnormalities. An infant's healthy development can be aided by early detection and appropriate diagnostic and therapeutic standards.

2. What is the market for global newborn screening?

The global newborn screening market was valued at USD 1.00 billion in 2023, growing at a CAGR of 6.03% during the forecast period from 2024 to 2030 to reach USD 1.42 billion by 2030.

3. What are the drivers for the global newborn screening market?

The demand for newborn screening is primarily being heightened by the increasing prevalence of various congenital diseases in newborns. In addition, the advancements in technologies used in newborn screening, increasing launches and approvals of various diagnosis kits, high birth rate, and rising funding from government sectors for newborn screening, among others are thereby contributing to the overall growth of the newborn screening market during the forecast period from 2024-2030.

4. Who are the key players operating in the global newborn screening market?

Some of the key market players operating in the newborn screening market include Natus Medical Incorporated, Trivitron Healthcare, Medtronic, Bio-Rad Laboratories, Inc., PerkinElmer, GE HealthCare, Masimo, Agilent Technologies, Inc., DH Tech. Dev. Pte. Ltd., Zentech, Demant A/S, Waters Corporation, Baxter, Thermo Fisher Scientific Inc., MP BIOMEDICALS, Integrated DNA Technologies, Inc., LifeCell International Pvt. Ltd., Labsystems Diagnostics Oy, Zivak, RECIPE Chemicals + Instruments GmbH, and others.

5. Which region has the highest share in the newborn screening market?

North America is expected to dominate the overall newborn screening market during the forecast period from 2024-2030. With factors such as the fast adoption of non-invasive techniques for newborn screening, favorable health reimbursement, and an increase in the number of preterm births, the North American newborn screening market is expected to witness positive growth. Furthermore, high disposable income, sophisticated healthcare infrastructure, regulatory approval for new devices and kits, and high awareness about congenital diseases also helped the market growth in this region.


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