Newborn Screening Market Key Aspects, Trends and Growth Opportunities 2026-2033 | Major Companies - Covidien Plc., AB SCIEX, Bio Rad Laboratories, Agilent Technologies

Market Overview:

The Newborn Screening Market is expected to grow at a CAGR of 10.7% during the forecast period 2024-2031.

DataM Intelligence has published a new research report on "Newborn Screening Market Size 2026". The report explores comprehensive and insightful Information about various key factors like Regional Growth, Segmentation, CAGR, Business Revenue Status of Top Key Players and Drivers. The purpose of this report is to provide a telescopic view of the current market size by value and volume, opportunities, and development status.

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The Newborn Screening Market refers to the global industry focused on diagnostic tests and technologies used to identify serious genetic, metabolic, hormonal, and congenital disorders in infants shortly after birth. These screening programs enable early detection of conditions that may not show visible symptoms but can cause long-term health complications if untreated. The market includes testing kits, laboratory equipment, reagents, and follow-up services provided by hospitals, public health laboratories, and specialized diagnostic centers worldwide.

Recent Key Developments of United States:

✅ February 2026: Bio-Rad Laboratories introduced a multiplex assay for spinal muscular atrophy screening, mandated in additional states like California and Texas. This aligns with NIH research emphasizing gene therapy preparedness, with market projections showing accelerated growth. Healthcare providers hailed it for improving long-term patient outcomes.

✅ January 2026: Natus Medical partnered with major U.S. pediatric networks to deploy point-of-care newborn screening kits, cutting turnaround times to under 24 hours. Federal grants facilitated distribution to underserved rural areas, boosting equity in early intervention. Industry analysts noted this as a key step toward fully automated screening systems.

✅ December 2025: PerkinElmer launched an AI-powered tandem mass spectrometry device tailored for U.S. hospitals, reducing false positives by 20% in pilot programs. This development supports the HRSA's recommended uniform screening panel, addressing rising congenital disorder incidences. Adoption surged in neonatal ICUs amid holiday-season birth peaks.

✅ November 2025: The U.S. FDA approved a novel next-generation sequencing panel expanding newborn screening for rare metabolic disorders, enhancing early detection rates nationwide. This initiative, backed by CDC funding, aims to integrate genomic data into standard protocols across all 50 states. State health departments reported a 15% increase in screening compliance following the rollout.

Recent Key Developments of Japan:

✅ February 2026: IMARC Group documented the adoption of high-throughput screening tech from domestic innovators, with market size surpassing USD 70 million quarterly. Heightened focus on rare diseases like PKU spurred investments, aligning with national health reforms. Providers noted improved efficiency in tandem with rising disposable incomes.

✅ January 2026: A collaborative effort between Tokyo University and Medtronic introduced genomic newborn screening pilots using CRISPR-based detection for genetic anomalies. This innovation addresses Japan's aging population challenges by prioritizing preventive care. Industry reports highlighted its potential to reduce healthcare costs long-term.

✅ December 2025: Trivitron Healthcare Japan released a portable screening device compatible with next-gen sequencing, targeting rural clinics amid declining birth rates. Government subsidies supported its rollout, enhancing access in prefectures with high congenital risks. Early data showed faster processing, aiding timely interventions.

✅ November 2025: Japan's Ministry of Health expanded the national newborn screening program to include tandem mass spectrometry for 20+ metabolic conditions, driven by rising parental awareness. AI integration from local firms like Fujifilm improved diagnostic accuracy in urban centers. This policy shift is projected to elevate screening coverage to 99% by mid-2026.

List of the Key Players in the Newborn Screening Market:

Covidien Plc.
AB SCIEX
Bio Rad Laboratories
Agilent Technologies
Masimo Corporation
Natus Medical
Trivitron Healthcare
PerkinElmer Inc
GE Life Sciences
ZenTech S.A.

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This Report Covers:

✔ Go-to-market Strategy.

✔ Neutral perspective on the market performance.

✔Development trends, competitive landscape analysis, supply side analysis, demand side analysis, year-on-year growth, competitive benchmarking, vendor identification, and other significant analysis, as well as development status.

✔Customized regional/country reports as per request and country level analysis.

✔ Potential & niche segments and regions exhibiting promising growth covered.

✔ Analysis of Market Size (historical and forecast), Total Addressable Market (TAM), Serviceable Available Market (SAM), Serviceable Obtainable Market (SOM), Market Growth, Technological Trends, Market Share, Market Dynamics, Competitive Landscape and Major Players (Innovators, Start-ups, Laggard, and Pioneer).

Segments Covered in the Newborn Screening Market:

By Product: Assay Kits, Instruments.

By Test Type: Blood Test, Cardiac Test, Urine Test, Hearing Test, Others.

By Application: Critical congenital heart disease (CCHD), Blood Spot Test, Hearing Disability, Sickle Cell Disease, Maple Syrup Urine Disease, Thyroid Disorder, Others.

By End-User: Hospitals, Diagnostic Centers, Maternity & Specialty Clinics, Others.

Regional Analysis:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline:

Chapter 1: Introduces the report scope of the report, executive summary of different market segments (by region, product type, application, etc), including the market size of each market segment, future development potential, and so on. It offers a high-level view of the current state of the market and its likely evolution in the short to mid-term, and long term.

Chapter 2: key insights, key emerging trends, etc.

Chapter 3: Manufacturers competitive analysis, detailed analysis of Newborn Screening manufacturers competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.

Chapter 4: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product revenue, gross margin, product introduction, recent development, etc.

Chapter 5 & 6: Revenue of Newborn Screening in regional level and country level. It provides a quantitative analysis of the market size and development potential of each region and its main countries and introduces the market development, future development prospects, market space, and market size of each country in the world.

Chapter 7: Provides the analysis of various market segments by Type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.

Chapter 8: Provides the analysis of various market segments by Application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.

Chapter 9: Analysis of industrial chain, including the upstream and downstream of the industry.

Chapter 10: The main points and conclusions of the report.

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People Also Ask:

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