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Newborn Metabolic Screening Market

With global rising birth, the rising prevalence of new born screening propels the overall market for new-born metabolic screening

Newborn Metabolic Screening Market Segmented By Galactosemia, Sickle Cell Disease, Cystic Fibrosis, Toxoplasmosis, Phenylketonuria (PKU), Methylmalonic Acidemia, Maple Syrup Urine Disease (MSUD), Tyrosinemia, Citrullinemia Test with Blood and Urine Sample

New-Born Metabolic Screening Market Outlook (2022-2032)

Global revenue from the new-born metabolic screening market stands at US$ 295.7 Mn in 2022 with the worldwide market estimated to surge ahead at a CAGR growth value of 8.9% to reach a valuation of around US$ 757.9 Mn by the end of 2033.

Market Size (2022)

US$ 295.7 Mn

Projected Market Value (2033)

US$ 757.9 Mn

Global Market Growth Rate (2023-2033)

8.9% CAGR

Market Share of Top 5 Countries


According to Persistence Market Research, sickle cell disease segment of the market based on tests secured a market value of US$ 96.8 Mn in 2022.

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Sales Analysis of New-Born Metabolic Screening Market from 2015 to 2022 Vs Market Outlook for 2023 to 2033

The value of the global market was approximately 50.1% of the overall ~US$ 590.0 Mn of the global metabolic testing market in 2022.

The global market recorded a historic CAGR of 8.0% in the last 7 years from 2015 to 2022.

The demand for the market is anticipated to increase due to the increased risk of sickle cell disease, maple syrup urine disease, galactosemia, phenylketonuria, and cystic fibrosis in neonates.

From a routine blood and urine test to a more thorough and complex screening system for diagnosing over 50 different disorders, new-born screening has progressed. Globally, the prevalence of new-born metabolic disorders is constantly rising.

However, these diseases go untreated in infants and endanger the child's life. To address these concerns, government and private organizations are attempting to implement metabolic screening programs.

For instance, one of the largest people-centric programs, Ayushman Bharat, was introduced in India. States and organizations are implementing various practices and innovations to address issues in the child and maternal health sector in India, as the world moves toward achieving universal health coverage and countries work toward reproductive, child, maternal, new-born, and adolescent health programmes.

The use of new-born metabolic screening tests has increased as an understanding of metabolic disorders in new-borns has grown. The ability to diagnose disease in new-borns has been made possible by the detection of new-born metabolic disease in a single cassette, which has reduced the burden of various testing on patients.

One of the main factors in increasing sales of the market is the increase in the number of new-borns. Organizations like the WHO, CDC, Healthy New-born Network, etc. are working to educate parents about potential problems and associated testing methods to stop the infant mortality numbers from rising.

Furthermore, significant complications in infants, like hearing loss, metabolic and hormonal abnormalities, and intrinsic coronary disorders are all treatable when detected early, which is projected to drive the global market for new-born screening over the upcoming years.

Additionally, the development of mass spectrometers and oximeters with increased performance is anticipated to support the market sales.

The global market is thus likely to show high growth over the coming years with a CAGR of 8.9%, and reach a global market size of around US$ 757.9 Mn by 2033.

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How Can the New-Born Metabolic Screening Market Grow?

“Rising prevalence of screening for new-born diseases like sickle cell disease and maple syrup urine disease

The rising prevalence of new-born metabolic diseases such as phenylketonuria, cystic fibrosis, toxoplasmosis, galactosemia, sickle cell disease, maple syrup urine disease, and tyrosinemia disease will increase the demand of the market in the forecasted period.

The increasing burden of new-born metabolic disease is increasing the demand for better screening options, as it causes birth defects and decreases the mortality rate. Furthermore, the development of lab-based integrated new diagnostics has a major impact on patient survival rates in addition to speeding up the diagnosis of metabolic problems. This is the key factor boosting the growth of the market.

Furthermore, new-borns are more prone to metabolic diseases and the severity is more during the neonatal period. The development of lab-based integrated new diagnostics has a major impact on patient survival rates in addition to speeding up the diagnosis of metabolic illnesses.

Due to the increased prevalence of metabolic diseases, governments are providing funding for new-born screening. Companies are focusing to enter this market to develop tests with high medical value for more personalized medicine, which might be very profitable.

The presence of benign lesions causes metabolic disease to be misdiagnosed or diagnosed too slowly, necessitating the urgent need for laboratory-based integrated tests and their swift U.S. approval, which might increase the revenues of the metabolic screening market.

This will create opportunities for the expansion of the market size over the forecast period.

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What Barriers Can Affect the Growth of the Global New-Born Metabolic Screening Market?

Challenges in under developing countries due to lack of infrastructure improvements

Lack of infrastructure improvements in the healthcare sector and a shortage of professionals with the appropriate training are the main factors impeding the growth of the global market.

For instance, new-born screening needs additional research and education because it is still not extensively used in the Asia-Pacific region. The Asia Pacific region includes developing nations with large populations and few qualified professionals. High populations, low and intermediate income levels and poor healthcare are hampering the improvement of the healthcare system in underdeveloped countries.

Furthermore, the market for new-born screening is anticipated to be constrained during the forecast period by a lack of uniformity in new-born screening policies and processes around the globe and a high rate of false positive and false negative test results. The decision-making process of healthcare practitioners is hampered by a dearth of information on the long-term effects of new disorders and a scarcity of follow-up data for screening conditions.

Additionally, the accessibility of refurbished goods such as automatic immunoassay systems and automated manual equipment is anticipated to limit this market's growth to some amount over the projected year.

A significant barrier to market growth is the high cost of automation innovation coupled with the strong competition provided by small players. Due to all these factors, under-developing countries are lacking behind in new-born metabolic screening.

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Country-wise Insights

Why is the U.S. New-Born Metabolic Screening Market Booming?

“Increasing awareness in the U.S.”

The U.S. accounted for around 83.0% market share in the North American market in 2022, and expected over the forecast period.

American programs for new-born metabolic screening are well established. The U.S. government necessitates metabolic tests for cystic fibrosis, phenylketonuria (PKU) and toxoplasmosis.

According to the CDC, millions of babies are routinely evaluated in the U.S. each year for specific metabolic problems using heel-prick blood samples. Additionally, the United States has drastically modified its metabolic screening tests and has a strong awareness of new-born metabolic issues.

For instance, according to the March of Dimes (MoD) report from 2021, every baby in the U.S. gets new-born screening before leaving the hospital, and the country screens about 4 million new-borns each year.

Will the India be a Lucrative New-Born Metabolic Screening Market?

“Implementing the new-born metabolic screening program”

The India held around 84.6% market share of the South Asia market in 2022 and market value is US$ 27.5 Mn in 2022.

One of the major obstacles to creating a sustained national newborn screening program is the absence of public health screening facilities in countries like India.

Additionally, parents' ignorance of screening programs and metabolic disorders hinders the market from growth developing. Screening initiatives require ongoing follow-ups with the impacted neonates.

The adoption rate of this screening is low among parents due to less awareness about metabolic screening. Due to all these factors, a new-born metabolic screening program is required in India. A low-cost model for conducting the program has been proposed within the country via public-private partnerships. The process was initially started by major hospitals in metropolitan cities, especially paediatric hospitals.

Furthermore, the Indian Council of Medical Research has taken the initiative, organized a task group, and sponsored a multicentre investigation to investigate the viability of new-born screening for CH (congenital hypothyroidism) and CAH (congenital adrenal hyperplasia).

How is China Emerging as a Prominent New-Born Metabolic Screening Market?

“Government programs for new-born screening in China”

China held the largest market share of about 66.6% in the East Asia market in 2022.

The country started new-born screening program in 1981. The government pays more and more attention to new-born screening. The Chinese government's program for new-born screening covers sample collection, laboratory testing, clinical diagnosis, results reporting, follow-up, and delivery.

Some tests are covered by local medical insurance plans and projects for local salvation funds, all of which have had a substantial positive impact on the growth of the Chinese market for new-born screening.

Category-wise Insights

Which Test is Largely in Focus within the Global New-Born Metabolic Screening Market?

“Rising prevalence of new-born metabolic disease like sickle cell disease”

The sickle cell disease (SCD) segment held around 32.7% share of the total newborn metabolic screening market in 2022. Red blood cells twist into a sickle shape as a result of the inherited disorder known as sickle cell disease.

Red blood cells that are affected by SCD have defective hemoglobin, which makes them sticky and hard. Based on the genes patients inherited from their parents, a person's special type of SCD is determined by such genes.

Sickle cell disease displays greater prevalence in newborns, and so, the need of screening for further disease assessment is essential. Hence, the sickle cell disease segment holds the highest share in terms of test within the global market.

Which Sample is Driving Growth of the Global Market?

“Greater accuracy in results using blood samples”

The blood sample segment held around 96.2% share of the global market in 2022. Blood sample analysis reduces the risk of a false positive result to some extent.

Furthermore, the use of dried blood spot cards by screening programmes includes more than just urine sample. False positives increase parental anxiety and incur extra costs.

In rare cases, false positives may prompt unneeded and sometimes harmful therapies for the infant. As a result, doctors prefer blood samples because they generate more precise test results.

Which End User Aids Towards Market Growth?

“Major use in hospitals”

Hospitals held the largest share of about 45.9% with a market value of around US$ 135.7 Mn in 2022.

The significant number of neonatal metabolic screenings in hospitals segment attracts the highest proportion of end consumers. People tend to prefer hospitals for screening and detection because healthcare staff are more demanding and have professional expertise.

Hospitals offer a variety of screening tests for infants, and parents prefer hospitals because they are conveniently positioned near residential areas and have doctors available when needed. Furthermore, it is convenient for parents, resulting in the leading spot in the end user segment based on market share.

Competitive Landscape

Major producers within the market concentrate on strategic alliances, product launches, and acquisitions to increase market presence. Apart from this one of the key strategies of the manufacturers, include expansions, that is, the opening of new facilities in order to expand the screening capability of the company.

For instance:

  • For instance, on January 26, 2021, PerkinElmer joined European Alliance for new-born screening in spinal muscular atrophy.
  • For instance, In January 14, 2020, PerkinElmer provided new-born screening assay for PPMD’s New York State pilot program.

Similarly, recent developments related to companies within the new-born metabolic screening market have been tracked by the team at Persistence Market Research, which are available in the full report.

New-Born Metabolic Screening Market Scope



Forecast Period


Historical Data Available for


Market Analysis

  • USD Million for Value
  • Volume in Units

Key Countries Covered

  • U.S.
  • Canada
  • Brazil
  • Mexico
  • Argentina
  • U.K.
  • Germany
  • Italy
  • France
  • Spain
  • Russia
  • India
  • Indonesia
  • Malaysia
  • Thailand
  • China
  • Japan
  • South Korea
  • Australia
  • New Zealand
  • GCC Countries
  • Turkey
  • South Africa
  • North Africa

Key Market Segments Covered

  • Test
  • Sample
  • End User
  • Region

Key Companies Profiled

  • PerkinElmer
  • Bio-Rad Laboratories
  • Trivitron Healthcare Private Limited
  • BioMedomics, Inc.
  • Luminex Corporation
  • Synergy Medical Systems LLP
  • Agilent Technologies, Inc
  • Thermo Fisher Scientific, Inc
  • Zivak Technologies
  • Covidien Plc
  • AB Sciex LLC
  • Waters Corp.
  • Masimo Corp.
  • Natus Medical Inc.

Report Coverage

  • Market Forecast
  • Competition Intelligence
  • DROT Analysis
  • Market Dynamics and Challenges
  • Strategic Growth Initiatives

Customization & Pricing

Available upon Request

Key Segments Covered in Manufacturing of Industry Research

By Test:

  • Galactosemia
  • Sickle Cell Disease
  • Cystic Fibrosis
  • Toxoplasmosis
  • Phenylketonuria (PKU)
  • Methylmalonic Acidemia
  • Maple Syrup Urine Disease (MSUD)
  • Tyrosinemia
  • Citrullinemia
  • Medium Chain Acyl CoA Dehydrogenase (MCAD) Deficiency

By Sample:

  • Blood
  • Urine

By End User:

  • Diagnostic Laboratories
  • Specialty Clinics
  • Hospitals

By Region:

  • North America
  • Latin America
  • Europe
  • South Asia
  • East Asia
  • Oceania
  • Middle East & Africa (MEA)

- Companies Covered in This Report -

  • PerkinElmer
  • Bio-Rad Laboratories
  • Trivitron Healthcare Private Limited
  • BioMedomics, Inc.
  • Luminex Corporation
  • Synergy Medical Systems LLP
  • Agilent Technologies, Inc
  • Thermo Fisher Scientific, Inc
  • Zivak Technologies
  • Covidien Plc
  • AB Sciex LLC
  • Waters Corp.
  • Masimo Corp.
  • Natus Medical Inc.

- Frequently Asked Questions -

The global market is currently valued at around US$ 295.7 Mn in 2022.

Sales of the market are set to witness a high growth at a CAGR of 8.9% and be valued at US$ 757.9 Mn by 2033.

Demand for market increased at a 8.0% CAGR from 2015 to 2022.

The U.S., India, Brazil, China and U.K., account for the highest share of market, currently holding 53.4% market share.

The U.S. accounts for around 83.0% share of the North American market in 2022.

India accounted for around 84.6% share of the South Asia market in 2022.

Europe market is predicted to expand at 9.2% CAGR over the forecast period.

China held the largest market share of about 66.6% in the East Asia market in 2022.

The current value of the South Asia market is US$ 32.5 Mn for the year, 2022.

The U.K. market is set to expand at a CAGR growth rate of 11.8% over the forecast period.

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