신생아 스크리닝 시장 규모, 점유율, 성장 분석 : 제품별, 기술별, 검사별, 지역별 - 산업 예측(2026-2033년)

Newborn Screening Market size was valued at USD 1.34 Billion in 2024 and is poised to grow from USD 1.43 Billion in 2025 to USD 2.41 Billion by 2033, growing at a CAGR of 6.8% during the forecast period (2026-2033).

The newborn screening market is poised for significant growth driven by a rising birth rate and an increase in congenital illnesses among infants. Heightened consumer awareness and proactive government initiatives, including various programs and legislations, further contribute to this trend. Technological advancements in screening methodologies are pivotal, as the prevalence of congenital disorders in newborns underscores the necessity for comprehensive testing. It's estimated that a substantial number of neonatal deaths result from these conditions, indicating a critical need for effective screening solutions. In particular, metabolic disorders and congenital hypothyroidism exhibit considerable prevalence rates among infants. As awareness and testing capabilities expand, the favorable regulatory environment will propel the growth of the newborn screening market, creating a more robust healthcare landscape for early detection and intervention.

Top-down and bottom-up approaches were used to estimate and validate the size of the Newborn Screening market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Newborn Screening Market Segments Analysis

Global Newborn Screening Market is segmented by Product, Test, technology, end user and region. Based on Product, the market is segmented into Consumables, Instruments, Hearing screening instruments, Pulse oximeters. Based on Test, the market is segmented into Dry blood spot tests, Hearing screening tests, CCHD screening tests. Based on technology, the market is segmented into Immune assays & enzymatic assays, Tandem mass spectrometry, Molecular assays, Hearing screening technologies, Pulse oximetry, Other Technologies. Based on end user, the market is segmented into Clinical Laboratories, Hospitals. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & and Africa.

Driver of the Newborn Screening Market

The rising prevalence of congenital abnormalities has become a significant driver for the expansion of the newborn screening market. These abnormalities encompass a range of conditions, including genetic disorders, hearing impairments, and metabolic disorders. Early diagnosis of such conditions is vital, as timely intervention can considerably enhance the quality of life for affected infants and improve treatment outcomes. Advancements in medical technology, alongside a deeper understanding of the benefits of early detection, have underscored the importance of screening programs. Growing awareness and focus on congenital diseases further amplify the demand for comprehensive screening methods that identify these anomalies before symptoms manifest, ultimately aiming to safeguard newborns' long-term health.

Restraints in the Newborn Screening Market

The high costs associated with newborn screening tests create significant barriers to access, particularly in low- and middle-income countries. Many families find the expenses of complex genetic testing prohibitive, hindering their ability to obtain potentially lifesaving treatments. This financial obstacle can lead to delays in both detection and intervention, negatively impacting the health outcomes of affected neonates. Furthermore, the uneven availability of these tests highlights the need for more accessible and affordable screening initiatives, supported by networks that promote equitable diagnostic services worldwide. Fostering infant health equality is essential for improving health prospects for vulnerable populations.

Market Trends of the Newborn Screening Market

The Newborn Screening market is experiencing a notable trend towards the integration of advanced genetic testing technologies, such as whole genome sequencing (WGS) and next-generation sequencing (NGS). These innovations significantly enhance the accuracy of detecting a broader spectrum of genetic disorders, including complex and rare conditions often overlooked by traditional screening methods. As the cost of genetic testing decreases and technology becomes more accessible, comprehensive screening panels are emerging, leading to earlier and more accurate identification of genetic abnormalities. This evolution not only improves clinical outcomes but also drives the expansion of newborn screening programs, underscoring a shift toward precision medicine in neonatal care.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Driver & Opportunities
  • Restraints & Challenges
• Porters Analysis & Impact
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Technological Advancement
• Regulatory Landscape
• Patent Analysis
• Value Chain Analysis
• Case Study Analysis
• Market Attractiveness Index

Global Newborn Screening Market Size by Product & CAGR (2026-2033)

• Market Overview
• Consumables
• Instruments
• Hearing screening instruments
• Pulse oximeters

Global Newborn Screening Market Size by Test & CAGR (2026-2033)

• Market Overview
• Dry blood spot tests
• Hearing screening tests
• CCHD screening tests

Global Newborn Screening Market Size by Technology & CAGR (2026-2033)

• Market Overview
• Immune assays & enzymatic assays
• Tandem mass spectrometry
• Molecular assays
• Hearing screening technologies
• Pulse oximetry
• Other Technologies

Global Newborn Screening Market Size by End User & CAGR (2026-2033)

• Market Overview
• Clinical Laboratories
• Hospitals

Global Newborn Screening Market Size & CAGR (2026-2033)

• North America, (Product, Test, Technology, End User)
  • US
  • Canada
• Europe, (Product, Test, Technology, End User)
  • UK
  • Germany
  • Spain
  • France
  • Italy
  • Rest of Europe
• Asia-Pacific, (Product, Test, Technology, End User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia Pacific
• Latin America, (Product, Test, Technology, End User)
  • Brazil
  • Rest of Latin America
• Middle East & Africa, (Product, Test, Technology, End User)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2025
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2025
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2021-2023)

Key Company Profiles

• Masimo Corp.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Covidien Plc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• AB Sciex LLC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Natus Medical Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Agilent Technologies Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• PerkinElmer Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• GE Healthcare
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bio-Rad Laboratories Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Trivitron Healthcare
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Medtronic Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Rady Children's Institute for Genomic Medicine
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• GE Lifesciences
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Waters Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Danaher Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ZIVAK TECHNOLOGIES
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• CAMAG
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• OTODYNAMICS
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ZENTECH
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• VIVOSONIC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendation