Global Newborn Screening Market Outlook
Revenue, 2024
$1.4B
Forecast, 2034
$3.3B
CAGR, 2025 - 2034
9.3%
The Newborn Screening industry revenue is expected to be around $1.5 billion in 2025 and expected to showcase growth with 9.3% CAGR between 2025 and 2034. The development of newborn screening as a fundamental preventive healthcare measure continues through national program growth and improved clinical guidelines and increased medical staff and parental understanding of early detection advantages. The combined revenue of hospitals and diagnostic centers reaches 78.0% of the industry total because they operate through integrated care pathways and centralized laboratory services which generate high volumes of neonatal screening tests.
The public health program of newborn screening known as neonatal screening tests newborns during their first days of life to detect severe birth defects which doctors can treat before symptoms appear. Standardized dried blood spot sampling serves as the primary method for modern program collection while screening panels check for metabolic disorders and hearing tests and critical congenital heart disease assessments run simultaneously with genetic testing for diagnosis confirmation and long term care planning. The screening market experiences changes because of three main trends which include the growth of recommended screening tests and the combination of genomic and bioinformatics technology and the use of point of care testing in maternity and neonatal intensive care units and the implementation of digital platforms which enhance follow up operations and data analysis and quality control in newborn screening networks.
Market Key Insights
The Newborn Screening market is projected to grow from $1.4 billion in 2024 to $3.3 billion in 2034. This represents a CAGR of 9.3%, reflecting rising demand across Hospital Newborn Screening, Diagnostic Center Screening, and Maternity Clinic Programs.
The market competition exists between Revvity Inc., Thermo Fisher Scientific and Bio-Rad Laboratories which operate as its leading competitors.
The Newborn Screening market depends on the United States and China as its leading customer bases which will experience growth at 6.8% to 9.8% CAGR from 2024 to 2030.
The market research predicts that India along with Brazil and Saudi Arabia will experience the most significant growth in emerging markets at a combined rate of 8.9% to 11.6% CAGR.
The Newborn Screening market will experience $225 million growth until 2030 because of the expected implementation of Data-Driven Screening Integration.
The Newborn Screening market will experience a $2.0 billion growth expansion during 2024 to 2034 because Diagnostic Centers & Maternity Clinics Application will dominate the market expansion.
With
rising incidence of inherited metabolic disorders and expanding national public health programs for universal newborn screening, and
Rapid technological adoption of high-throughput genomic sequencing platforms to enhance accuracy and speed of newborn screening, Newborn Screening market to expand 143% between 2024 and 2034.
Opportunities in the Newborn Screening
North American and European healthcare systems now use decentralized newborn screening systems which combine small medical devices with point-of-care diagnostic tools and data management systems. The combination of miniaturised tandem mass spectrometry with integrated digital reporting enables healthcare providers to make quick decisions at community clinics which lacked previous access to central laboratory services. The worldwide market for instruments will also expand from $1.01 billion during 2025 to $1.50 billion during 2030 while this product segment will achieve the highest growth rate in advanced technological primary care facilities.
Growth Opportunities in North America and Asia-Pacific
The North American region has achieved widespread newborn screening implementation which serves as a model for complete screening coverage because hospitals maintain their position as primary end users because they manage birth events and operate directly with screening facilities. The two main facilities which perform genetic testing for newborns and complex metabolic disorder screening are large diagnostic centers. The main opportunities exist in two region's which include improving tandem mass spectrometry systems and adding genomic reflex tests to current neonatal screening systems and using digital reporting systems to link heel prick test results with electronic health records for monitoring long term patient outcomes. The market competition between multinational manufacturers and reference laboratories has created an environment where companies must use service bundles and data analytics and performance based contracts to differentiate themselves instead of relying solely on their equipment. The market expansion results from strong public health screening requirements and positive insurance coverage and increasing patient demands for complete test packages which include cystic fibrosis screening tests that motivate healthcare providers to add more tests to their menus and purchase advanced testing equipment.
The Asia Pacific region experiences fast growing newborn screening services which now reach beyond major cities to serve secondary cities and rural region's thus becoming a leading expansion path for healthcare services. The public hospital sector along with rapidly expanding maternity clinics serve as essential customers because governments work to expand their neonatal screening programs through hub and spoke screening laboratories. The company has three main business opportunities which involve manufacturing tests and reagents in specific locations to lower testing expenses and establishing modular testing systems and point of care testing programs for remote region's and building alliances with health ministries and private maternity facilities to establish metabolic disorder screening and genetic testing programs for newborns. The market competition exists between worldwide brands and flexible domestic producers who fight for market share through their ability to offer affordable prices and extensive service networks and skilled workforce development. New businesses can succeed in this market by uniting affordable production with official quality recognition and dependable ongoing service delivery. The expansion of the market depends on national public health screening programs and increasing middle class knowledge about health issues and funding for maternal child health facilities and public private partnerships which work to speed up expanded panel adoption and maintain affordable universal screening for all healthcare systems.
Market Dynamics and Supply Chain
01
Driver: Rising incidence of inherited metabolic disorders and expanding national public health programs for universal newborn screening
The advancement of survival rates for premature and high risk infants has also led to doctors recording more inherited metabolic and endocrine disorders which also creates an urgent need for complete newborn screening tests. The trend also receives support from improved medical expertise and sophisticated newborn diagnosis methods and growing databases which track uncommon conditions that doctors identify during newborns initial days. Laboratories now use advanced tandem mass spectrometry systems and data analysis tools to handle expanded testing capabilities and rising numbers of daily samples. The government has also started to expand its newborn screening program through public health funding which will also provide detailed information about treatment availability. The programs now require laboratories to establish minimum disorder panels and quality standards and time limits for testing which leads to ongoing equipment improvements and staff growth. The integration of newborn screening with electronic health records and standardized reporting frameworks has also established permanent positions for this technology within maternal and child healthcare systems which will also drive sustained market expansion.
High throughput genomic sequencing has also become a revolutionary technology which provides better detection methods for diseases which standard biochemical tests cannot identify. The system enables exact variant level analysis which enhances newborn screening effectiveness for complex genetic conditions and enables healthcare providers to create individualized treatment plans. The combination of genomic information with standard genetic testing procedures enables doctors to verify positive test results at an earlier stage which shortens the diagnostic process and decreases expenses for additional tests. Public laboratories can also access new diagnostic tools because vendors create automated instruments which need minimal setup and provide specific variant databases for neonatal testing. The development of faster sequencing methods and lower costs has also made genomic newborn screening more attractive for researchers who are also testing new approaches which will also become standard medical procedures.
02
Restraint: Uneven reimbursement policies and funding gaps constrain newborn screening coverage and test menu modernization globally
The reimbursement system in high and middle income markets faces challenges because hospitals receive payment only for specific newborn screening tests while public health funding remains insufficient which prevents them from investing in expanded screening options and sophisticated genetic testing equipment. The payment system establishes fixed rates which restrict medical laboratory revenue from individual patients and prevent them from adopting new metabolic disorder and rare disease diagnostic tests when doctors want to use them. The market adoption of new medical instruments and laboratory reagents becomes delayed because vendors face this situation. The market demand for innovative tests decreases because payers implement cost reduction strategies which direct customers toward purchasing less expensive traditional tests which results in changes to market distribution and profit structures.
03
Opportunity: Rising demand for expanded metabolic and genetic newborn screening panels in Asia Pacific public hospitals and Strategic public private partnerships for rare disease newborn screening programs across Latin America and Middle East
The Asia Pacific region has expanded its neonatal screening criteria to test for metabolic disorders and inherited genetic conditions thus generating need for complete newborn screening test panels. Public hospital laboratories need specialized high volume reagents and laboratory materials which match the local disease patterns but suppliers have not only yet fully addressed this need. The Asia Pacific hospital sector will experience the highest growth in metabolic disorder testing reagents because of health programs and regional genetic testing infrastructure development investments. The worldwide reagent market will expand from $0.36 billion to $0.64 billion during 2030 with a 12.18% annual growth rate according to forecasts.
The implementation of newborn screening programs for rare diseases in Latin America and the Middle East region has created opportunities for health ministries to work with reference laboratories and biotechnology companies. The current national testing programs only check for a few conditions but next generation sequencing and advanced biochemical assays enable them to conduct more extensive testing. The regions will experience the highest expansion of genetic testing reagents and specialized confirmatory services because people become more aware of these tests while rare disease patient groups increase their support and healthcare providers receive better payment coverage.
04
Challenge: Limited laboratory capacity and specialized workforce shortages delay advanced newborn screening adoption and service expansion
The availability of funding does not only resolve the problem because numerous areas throughout the world do not only have sufficient laboratories together with necessary equipment and skilled technicians who can perform fast newborn screening tests at high volumes. The sample processing and result validation bottlenecks create delays which restrict programs from processing daily samples at full capacity and prevents them from using advanced genetic testing methods thus reducing their testing capacity and revenue potential. The existing infrastructure limitations together with workforce shortages force customers to select basic systems with reduced complexity while their purchasing activity focuses on specific reference centers which hinders the expansion of newborn screening services across different locations thus controlling the total market expansion rate.
Supply Chain Landscape
1
Dried Blood Spot
Revvity Inc.Trivitron HealthcareThermo Fisher Scientific
2
Newborn Screening Reagents
Revvity Inc.Bio-Rad LaboratoriesThermo Fisher Scientific
3
Mass Spectrometry Systems
DanaherThermo Fisher ScientificBio-Rad Laboratories
4
Clinical End Users
neonatal screening laboratoriespediatric hospitalspublic health screening programs
1
Dried Blood Spot
Revvity Inc.Trivitron HealthcareThermo Fisher Scientific
2
Newborn Screening Reagents
Revvity Inc.Bio-Rad LaboratoriesThermo Fisher Scientific
3
Mass Spectrometry Systems
DanaherThermo Fisher ScientificBio-Rad Laboratories
4
Clinical End Users
neonatal screening laboratoriespediatric hospitalspublic health screening programs
Use Cases of Newborn Screening in Hospital & Maternity Clinic Programs
Hospital Newborn Screening : The global newborn screening market depends on hospitals as its biggest customer base which brought in USD 0.70 billion during 2025 and experts predict this segment will grow at 10.4% CAGR from 2026 to 2030 because newborn screening tests will become mandatory for all newborns. Newborn screening programs at hospitals use the heel prick test to obtain dried blood spots from infants for metabolic disorder screening through high throughput testing while hearing screening and pulse oximetry run in parallel to detect critical congenital heart disease. The testing process requires centralized laboratories to operate automated instruments with specific reagents which will meet 73.8% of demand in 2025 and 26.20% of demand in 2025 respectively. The application features Revvity Inc. as a leading provider of complete reagent kits and complete analyzer systems which hospitals use for their laboratory needs. The clinical diagnostics systems from Thermo Fisher Scientific and Danaher operate at scale to handle big volumes while their middleware enables electronic medical record integration. Bio Rad Laboratories strengthens its position through its immunoassay systems and internal controls which improve test result accuracy. The company Trivitron Healthcare stands out through its affordable neonatal screening solutions and its hospital service network which targets medical facilities operating in developing countries.
Diagnostic Center Screening : Newborn screening depends on diagnostic centers to conduct advanced tests which produce USD 0.37 billion in annual revenue during 2025 while the market expects 6.42% annual growth until 2030 because healthcare organizations now focus on consolidating their complex neonatal screening operations. The facilities perform extended neonatal screening at hospitals through their use of tandem mass spectrometry systems which run expanded metabolic panels and perform genetic testing for unclear results and complete next generation sequencing for uncommon genetic conditions while maintaining strict quality assurance systems and expert laboratory staff. The company Thermo Fisher Scientific maintains its dominant market position through its high throughput mass spectrometry technology and molecular diagnostics platforms and laboratory automation software Revvity Inc. provides reference laboratories with screening panels and sample to answer workflows that they can use for their operations. Bio Rad Laboratories maintains its position as a leading company which delivers controls and calibrators and multiplex immunoassay solutions to customers. Trivitron Healthcare continues to grow its analyzer and reagent customer base throughout regional and mid sized diagnostic centers.
Maternity Clinic Programs : Newborn screening programs now use maternity clinics as their primary distribution channel which generated USD 0.22 billion in revenue during 2025 and will continue to grow at 10.6% CAGR from 2026 to 2030 because hospitals now send newborns home earlier while using community based neonatal care services. The care teams at maternity clinics start early neonatal screening at the bedside by performing point of care tests for jaundice and hearing screening and pulse oximetry while they schedule prompt dried blood spot card collection for partner hospital or diagnostic center laboratory testing of complete metabolic and endocrine panels. The application requires Revvity Inc. and Trivitron Healthcare to provide user friendly sample collection kits and compact analyzers and training programs which match the needs of maternity staff. The system enables clinics to connect with centralized laboratories through Thermo Fisher Scientific and Danaher which provide data integration and remote result review capabilities. Bio Rad Laboratories provides reagents and controls which enable standardized neonatal screening results throughout different care settings.
Recent Developments
Newborn screening programs have expanded their testing scope at a fast pace because scientists have made progress in genomic sequencing and biomarker research. The combination of public health programs and growing knowledge about early disease detection has led to faster implementation of new screening tests for newborns throughout medical facilities and laboratory centers. The market shows a major trend which combines digital health platforms with laboratory automation systems to achieve faster results and enhanced data analysis and better follow up treatment methods.
March 2024 : The acquisition of Abcam by Danaher brought new high quality antibody and reagent products which will enhance immunoassay and tandem mass spectrometry workflows for biochemical assays that need higher sensitivity in newborn screening and neonatal screening programs.
October 2023 : The company Thermo Fisher Scientific has reached a final agreement to purchase Olink which specializes in proteomics to enhance its biomarker discovery operations and genomic testing partnership capabilities for developing advanced panels to identify rare diseases in newborns across the globe.
May 2023 : The company launched Revvity as the new life sciences division of PerkinElmer which concentrated on clinical diagnostics and newborn screening platforms that unite genetic testing systems with automated laboratory systems to support public health organizations in their efforts to add new conditions to their screening programs and enhance infant health results.
Impact of Industry Transitions on the Newborn Screening Market
As a core segment of the Medical Device industry,
the Newborn Screening market develops in line with broader industry shifts.
Over recent years, transitions such as Data Driven Screening Integration and Genomics Enabled Care Pathways have redefined priorities
across the Medical Device sector,
influencing how the Newborn Screening market evolves in terms of demand, applications and competitive dynamics.
These transitions highlight the structural changes shaping long-term growth opportunities.
01
Data Driven Screening Integration
The Newborn Screening market is poised for a significant transformation, projected to grow by $225 million by 2030, driven by the shift from manual, siloed workflows to integrated digital systems. This transition enables healthcare facilities to connect laboratory information systems with electronic health records and digital health platforms, facilitating instant result reporting and automated patient recall procedures. As a result, healthcare professionals can make quicker, data informed decisions while enhancing population health analytics and reducing participant attrition in public health programs. To support this evolution, the industry must adopt secure data exchange systems and scalable cloud infrastructures, positioning itself for a more efficient and effective approach to managing metabolic disorders and improving patient outcomes.
02
Genomics Enabled Care Pathways
The second essential transition involved newborn screening which evolved from performing basic biochemical tests into performing complete genetic assessments and genomics based medical treatment protocols. New protocols now use specific test panels which some research studies apply for whole exome sequencing to identify uncommon diseases before standard newborn screening methods can detect them. The development of cancer genetics has created the foundation for precision medicine approaches which help doctors predict patient outcomes and monitor their condition and provide guidance to family members. Pharmaceutical and biotech companies achieve faster patient identification for clinical trials through this system which enables payers and policymakers to assess the extended financial benefits of preventing costly intensive care hospitalizations and starting treatments at an earlier stage.