Newborn Screening Market Outlook 2025-2032: Growth Forecast, Key Developments, Industry Insights, Investment

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

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United States - Recent Industry Developments

✅ November 2025: The U.S. Department of Health expanded mandatory newborn screening panels to include additional rare metabolic and genetic disorders.

✅ October 2025: PerkinElmer launched an upgraded mass spectrometry platform to accelerate high-throughput newborn screening workflows.

✅ September 2025: Thermo Fisher Scientific partnered with multiple state public health labs to deploy next-generation sequencing (NGS) in newborn screening programs.

Japan - Recent Industry Developments

✅ November 2025: Japan's Ministry of Health expanded its national newborn screening program to include severe immunodeficiency and spinal muscular atrophy (SMA).

✅ October 2025: Sysmex introduced automated hematology-based screening tech to enhance accuracy and reduce sample handling time.

✅ September 2025: Collaborative studies between Japanese pediatric hospitals and diagnostic companies enabled broader adoption of tandem mass spectrometry (MS/MS).

GCC - Recent Industry Developments

✅ November 2025: Saudi Arabia advanced nationwide newborn screening digitization using centralized data management and telehealth reporting.

✅ October 2025: UAE invested in NGS-based newborn screening initiatives focusing on early detection of genetic disorders prevalent in the region.

✅ September 2025: Oman expanded public-private partnerships to strengthen access to metabolic and endocrine disorder screening across neonatal care units.

List of Top Key Player:

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

Forecast Projection:

The Global Newborn Screening Market is poised for significant growth between 2025 and 2032. In 2024, the market maintained a steady upward trajectory, and with strategic initiatives by leading players accelerating adoption, the market is expected to soar throughout the forecast period. Companies leveraging these trends are well-positioned to capture emerging opportunities and maximize revenue potential.

Recent M&A Activity

1. Dealmaking focuses on automated platforms and genomic capabilities.

2. LaCAR MDx Technologies acquired Baebies Newborn Screening Division (Mar 2025), adding unique neonatal diagnostics to LaCAR's automated screening solutions for expanded panels.​

3. Exact Sciences acquired Prevention Genetics (Jan 2022, expansions 2025) for USD 190M, enhancing hereditary cancer/newborn screening integration.

Market Intelligence Research Process:

The Global Newborn Screening Market research report by DataM Intelligence combines primary and secondary data to deliver deep, actionable insights. It examines the full spectrum of factors shaping the industry, from government regulations and market conditions to competitive dynamics, historical trends, technological breakthroughs, upcoming innovations, and potential challenges. This comprehensive analysis not only highlights growth prospects but also identifies barriers, equipping businesses to navigate market volatility and capitalize on emerging opportunities.

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Key Segments:

By Product: (Assay Kits, Instruments)

By Test Type: (Blood Test, Cardiac Test, Urine Test, Hearing Test)

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

By End-User: (Hospitals, Diagnostic Centers, Maternity & Specialty Clinics)

Growth Regional Analysis:

1. North America: Holds 48.8% market share (USD 489-970M) driven by universal mandates, NGS adoption, and launches like PerkinElmer QSight 210 MD (2025) for high-throughput quantitation.

2. Europe: Growth supported by genomic pilot programs, EMA orphan drug incentives, and screening standardization through multi-stakeholder consortia.

3. Japan: Expected to reach USD 126.7M by 2033 (8.0% CAGR) backed by KM Biologics screening expansion and Sakigake fast-track pathway for ATMPs.

4. Taiwan: 5-year spinal muscular atrophy screening program (23 cases detected among 446K newborns) and development of precision medicine hubs.

5. South Korea: Regional growth tied to APAC 10.54% CAGR (China-led) with strong policy backing for rare disease newborn screening.

Benefits of the Report:

Chapter 1 - Market Overview: Kickstarts the report with a comprehensive snapshot of the Global Newborn Screening Market, summarizing key segments by region, product type, and application. Highlights include market size, segment growth potential, and short- & long-term industry outlook.

Chapter 2 - Emerging Trends: Uncovers the game-changing trends and high-impact innovations shaping the future of the industry.

Chapter 3 - Competitive Landscape: Offers a deep dive into market competition, detailing revenue shares, strategic initiatives, and recent mergers & acquisitions.

Chapter 4 - Top Player Profiles: Features detailed company profiles, covering revenue, profit margins, product lines, and major milestones for leading market players.

Chapters 5 & 6 - Regional & Country Analysis: Breaks down revenue performance across global regions, providing insights on market sizes, opportunities, and growth prospects worldwide.

Chapter 7 - Segmentation Analysis: Explores market segmentation by type, revealing high-potential categories and guiding businesses towards lucrative areas.

Chapter 8 - Application Insights: Examines downstream markets and identifies promising sectors for expansion, showing how different applications are driving growth.

Chapter 9 - Supply Chain Mapping: Maps the entire industry supply chain, highlighting upstream and downstream activities for a holistic market perspective.

Chapter 10 - Key Takeaways: Concludes with critical insights and actionable strategies, equipping stakeholders to make informed decisions and stay ahead in the market.

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FAQ's

Q1: How fast is the Global Newborn Screening Market expected to grow in the coming years?

A: The market is forecast to expand at a robust CAGR of 10.7% between 2025 and 2032

Q2: Which regions are dominating the Global Newborn Screening Market and which are fastest-growing?

A: Key markets include North America, Europe, and Asia-Pacific, led by the U.S., Japan, China, and Germany.

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