Summary

Neonatal Toxicology Market Summary

The global neonatal toxicology market size was estimated at USD 280.92 million in 2024 and is projected to reach USD 701.32 million by 2033, growing at a CAGR of 10.73% from 2025 to 2033. This growth is attributed to the increasing incidence of maternal drug use, along with development of more sensitive and specific testing methods.

The newborn mortality is also a rising concern governing the market growth, as per WHO estimates 2.3 million children died in the first 20 days of life in 2022, with estimated 6500 newborn deaths per day, accounting to 47% of all child deaths below the age of 5 years. Furthermore, increasing government initiatives and availability of newborn screening programs are likely to drive the market over the forecast period.

The rising increase in maternal drug use during pregnancy has coincided with a surge in cases of neonatal opioid withdrawal syndrome (NOWS). This rise in maternal substance use, particularly opioids, has led to a concomitant increase in NOWS, a condition in which newborns experience withdrawal symptoms due to prenatal exposure to substances. The most commonly used substance in pregnancy is nicotine, followed by alcohol, marijuana, and cocaine. However, polysubstance use is as high as 50% in some studies. Notably, there has been five times increase in opioid use in pregnancy in the U S in recent years, coinciding with an "epidemic" of opioid prescription misuse. According to the data published by National Library of Medicine, substance abuse among pregnant women remains a pressing public health issue in the U.S, with nearly 6% using illicit drugs, over 8% drinking alcohol, and more than 16% smoking cigarettes. This has led to a staggering number of exposed offspring, with over 380,000 babies exposed to illicit substances, over 550,000 exposed to alcohol, and more than one million exposed to tobacco while in the womb.

Advanced analytical techniques have been created to identify and detect neonatal drug exposure and their metabolites in various biological samples. These biological samples have distinct windows of detection for exposure: acute exposure can be detected in matrices such as urine, blood, and oral fluid, typically within a short timeframe, while chronic exposure can be detected in matrices such as hair, meconium, or teeth, which provide a longer window of detection. Meconium analysis has gained prominence as a gold standard for drug testing in newborns that provides a longer window of detection for prenatal drug exposure compared to traditional urine or blood tests. Researchers are also exploring the potential of umbilical cord tissue analysis, which offers similar benefits to meconium testing but with easier and more standardized sample collection.

The market is further characterized by advancements in technology including mass spectrometry (MS), enzyme-based assays, and others. These technologies play a crucial role in detecting congenital or inborn abnormalities of metabolism at an early stage, preventing death, and promoting healthy development. Mass spectrometry techniques, particularly liquid chromatography-tandem mass spectrometry (LC-MS/MS), have emerged as gold standards due to their ability to detect and quantify a wide range of substances at very low concentrations. These methods allow for the simultaneous screening of multiple drugs and their metabolites, improving both the breadth and accuracy of testing.

Governments often establish regulations and guidelines that encourage or mandate drug testing for newborns in certain situations, such as when there's suspicion of maternal substance abuse during pregnancy. For instance, in the U.S., the Child Abuse Prevention and Treatment Act (CAPTA) encourages states to develop plans to address the needs of substance-exposed infants. Such initiatives across global regions is poised to drive the market in forecast period.

Global Neonatal Toxicology Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global neonatal toxicology market report on the basis of specimen, technology, drug, end use, and region:

• Specimen Outlook (Revenue, USD Million, 2021 - 2031)
• Urine
• Umbilical Cord
• Meconium
• Others
• Technology Outlook (Revenue, USD Million, 2021 - 2031)
• Mass spectroscopy
• Immunoassay
• Drug Outlook (Revenue, USD Million, 2021 - 2031)
• Cannabinoids
• Opioids
• Cocaine
• Benzodiazepines
• Amphetamines
• Other illicit drugs
• End Use Outlook (Revenue, USD Million, 2021 - 2031)
• Hospitals
• Clinical Laboratories
• Others
• Regional Outlook (Revenue in USD Million, 2021 - 2031)
• North America
o U.S.
o Canada
o Mexico
• Europe
o UK
o Germany
o France
o Italy
o Spain
o Sweden
o Denmark
o Norway
• Asia Pacific
o Japan
o China
o India
o Australia
o South Korea
o Thailand
• Latin America
o Brazil
o Argentina
• Middle East and Africa
o Saudi Arabia
o South Africa
o UAE
o Kuwait

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Table of Contents

Table of Contents

Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.2. Segment Definitions
1.2.1. Specimen
1.2.2. Technology
1.2.3. Drug
1.2.4. End User
1.2.5. Regional scope
1.2.6. Estimates and forecasts timeline.
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased database
1.4.2. GVR’s internal database
1.4.3. Secondary sources
1.4.4. Primary research
1.4.5. Details of primary research
1.5. Information or Data Analysis
1.5.1. Data analysis models
1.6. Market Formulation & Validation
1.7. Model Details
1.7.1. Commodity flow analysis (Model 1)
1.7.2. Approach 1: Commodity flow approach
1.7.3. Volume price analysis (Model 2)
1.7.4. Approach 2: Volume price analysis
1.8. List of Secondary Sources
1.9. List of Primary Sources
1.10. Objectives
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.2.1. Specimen outlook
2.2.2. Technology outlook
2.2.3. Drug outlook
2.2.4. End User outlook
2.2.5. Regional outlook
2.3. Competitive Insights
Chapter 3. Neonatal Toxicology Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent market outlook
3.1.2. Related/ancillary market outlook.
3.2. Market Dynamics
3.2.1. Market driver analysis
3.2.1.1. High prevalence of substance abuse
3.2.1.2. Stringent laws mandating alcohol and drug testing
3.2.1.3. Increasing government initiatives to monitor substance abuse
3.2.2. Market restraint analysis
3.2.2.1. Neonatal toxicology is considered a violation of privacy rights in some countries
3.3. Neonatal Toxicology Market Analysis Tools
3.3.1. Industry Analysis – Porter’s
3.3.2. PESTEL Analysis
Chapter 4. Neonatal Toxicology Market: Specimen Estimates & Trend Analysis
4.1. Specimen Market Share, 2024 & 2033
4.2. Segment Dashboard
4.3. Global Neonatal Toxicology Market by Specimen Outlook
4.4. Market Size & Forecasts and Trend Analyses, 2021 to 2033 for the following
4.4.1. Urine
4.4.1.1. Urine market estimates and forecasts 2021 to 2033 (USD Million)
4.4.2. Umbilical Cord
4.4.2.1. Umbilical cord market estimates and forecasts 2021 to 2033 (USD Million)
4.4.3. Meconium
4.4.3.1. Meconium market estimates and forecasts 2021 to 2033 (USD Million)
4.4.4. Others
4.4.4.1. Others market estimates and forecasts 2021 to 2033 (USD Million)
Chapter 5. Neonatal Toxicology Market: Technology Estimates & Trend Analysis
5.1. Technology Market Share, 2024 & 2033
5.2. Segment Dashboard
5.3. Global Neonatal Toxicology Market by Technology Outlook
5.4. Market Size & Forecasts and Trend Analyses, 2021 to 2033 for the following
5.4.1. Mass spectroscopy
5.4.1.1. Mass spectroscopy market estimates and forecasts 2021 to 2033 (USD Million)
5.4.2. Immunoassay
5.4.2.1. Immunoassay market estimates and forecasts 2021 to 2033 (USD Million)
Chapter 6. Neonatal Toxicology Market: Drug type Estimates & Trend Analysis
6.1. Drug type Market Share, 2024 & 2033
6.2. Segment Dashboard
6.3. Global Neonatal Toxicology Market by Drug type Outlook
6.4. Market Size & Forecasts and Trend Analyses, 2021 to 2033 for the following
6.4.1. Cannabinoids
6.4.1.1. Cannabinoids Market estimates and forecasts 2021 to 2033 (USD Million)
6.4.2. Opioids
6.4.2.1. Opioids Market estimates and forecasts 2021 to 2033 (USD Million)
6.4.3. Cocaine
6.4.3.1. Cocaine Market estimates and forecasts 2021 to 2033 (USD Million)
6.4.4. Benzodiazepines
6.4.4.1. Benzodiazepines market estimates and forecasts 2021 to 2033 (USD Million)
6.4.5. Amphetamines
6.4.5.1. Amphetamines Market estimates and forecasts 2021 to 2033 (USD Million)
6.4.6. Other illicit drugs
6.4.6.1. Other illicit drugs Market estimates and forecasts 2021 to 2033 (USD Million)
Chapter 7. Neonatal Toxicology Market: End User Estimates & Trend Analysis
7.1. End User Market Share, 2024 & 2033
7.2. Segment Dashboard
7.3. Global Neonatal Toxicology Market by End User Outlook
7.4. Market Size & Forecasts and Trend Analyses, 2021 to 2033 for the following
7.4.1. Hospitals
7.4.1.1. Hospitals Market estimates and forecasts 2021 to 2033 (USD Million)
7.4.2. Clinical Laboratories
7.4.2.1. Clinical Laboratories Market estimates and forecasts 2021 to 2033 (USD Million)
7.4.3. Others
7.4.3.1. Others Market estimates and forecasts 2021 to 2033 (USD Million)
Chapter 8. Neonatal Toxicology Market: Regional Estimates & Trend Analysis
8.1. Regional Market Share Analysis, 2024 & 2033
8.2. Regional Market Dashboard
8.3. Global Regional Market Snapshot
8.4. Market Size, & Forecasts Trend Analysis, 2021 to 2033:
8.5. North America
8.5.1. North America
8.5.2. U.S.
8.5.2.1. Key country dynamics
8.5.2.2. Regulatory framework
8.5.2.3. Competitive scenario
8.5.2.4. U.S. market estimates and forecasts 2021 to 2033 (USD Million)
8.5.3. Canada
8.5.3.1. Key country dynamics
8.5.3.2. Regulatory framework
8.5.3.3. Competitive scenario
8.5.3.4. Canada market estimates and forecasts 2021 to 2033 (USD Million)
8.5.4. Mexico
8.5.4.1. Key country dynamics
8.5.4.2. Regulatory framework
8.5.4.3. Competitive scenario
8.5.4.4. Mexico market estimates and forecasts 2021 to 2033 (USD Million)
8.6. Europe
8.6.1. Europe
8.6.2. UK
8.6.2.1. Key country dynamics
8.6.2.2. Regulatory framework/ Reimbursement
8.6.2.3. Competitive scenario
8.6.2.4. UK market estimates and forecasts 2021 to 2033 (USD Million)
8.6.3. Germany
8.6.3.1. Key country dynamics
8.6.3.2. Regulatory framework/ Reimbursement
8.6.3.3. Competitive scenario
8.6.3.4. Germany market estimates and forecasts 2021 to 2033 (USD Million)
8.6.4. France
8.6.4.1. Key country dynamics
8.6.4.2. Regulatory framework/ Reimbursement
8.6.4.3. Competitive scenario
8.6.4.4. France market estimates and forecasts 2021 to 2033 (USD Million)
8.6.5. Italy
8.6.5.1. Key country dynamics
8.6.5.2. Regulatory framework/ Reimbursement
8.6.5.3. Competitive scenario
8.6.5.4. Italy market estimates and forecasts 2021 to 2033 (USD Million)
8.6.6. Spain
8.6.6.1. Key country dynamics
8.6.6.2. Regulatory framework
8.6.6.3. Competitive scenario
8.6.6.4. Spain market estimates and forecasts 2021 to 2033 (USD Million)
8.6.7. Norway
8.6.7.1. Key country dynamics
8.6.7.2. Regulatory framework
8.6.7.3. Competitive scenario
8.6.7.4. Norway market estimates and forecasts 2021 to 2033 (USD Million)
8.6.8. Sweden
8.6.8.1. Key country dynamics
8.6.8.2. Regulatory framework
8.6.8.3. Competitive scenario
8.6.8.4. Sweden market estimates and forecasts 2021 to 2033 (USD Million)
8.6.9. Denmark
8.6.9.1. Key country dynamics
8.6.9.2. Regulatory framework/ Reimbursement
8.6.9.3. Competitive scenario
8.6.9.4. Denmark market estimates and forecasts 2021 to 2033 (USD Million)
8.7. Asia Pacific
8.7.1. Asia Pacific
8.7.2. Japan
8.7.2.1. Key country dynamics
8.7.2.2. Regulatory framework/ Reimbursement
8.7.2.3. Competitive scenario
8.7.2.4. Japan market estimates and forecasts 2021 to 2033 (USD Million)
8.7.3. China
8.7.3.1. Key country dynamics
8.7.3.2. Regulatory framework/ Reimbursement
8.7.3.3. Competitive scenario
8.7.3.4. China market estimates and forecasts 2021 to 2033 (USD Million)
8.7.4. India
8.7.4.1. Key country dynamics
8.7.4.2. Regulatory framework/ Reimbursement
8.7.4.3. Competitive scenario
8.7.4.4. India market estimates and forecasts 2021 to 2033 (USD Million)
8.7.5. Australia
8.7.5.1. Key country dynamics
8.7.5.2. Regulatory framework/ Reimbursement
8.7.5.3. Competitive scenario
8.7.5.4. Australia market estimates and forecasts 2021 to 2033 (USD Million)
8.7.6. South Korea
8.7.6.1. Key country dynamics
8.7.6.2. Regulatory framework/ Reimbursement
8.7.6.3. Competitive scenario
8.7.6.4. South Korea market estimates and forecasts 2021 to 2033 (USD Million)
8.7.7. Thailand
8.7.7.1. Key country dynamics
8.7.7.2. Regulatory framework/ Reimbursement
8.7.7.3. Competitive scenario
8.7.7.4. Thailand market estimates and forecasts 2021 to 2033 (USD Million)
8.8. Latin America
8.8.1. Latin America
8.8.2. Brazil
8.8.2.1. Key country dynamics
8.8.2.2. Regulatory framework
8.8.2.3. Competitive scenario
8.8.2.4. Brazil market estimates and forecasts 2021 to 2033 (USD Million)
8.8.3. Argentina
8.8.3.1. Key country dynamics
8.8.3.2. Regulatory framework/ Reimbursement
8.8.3.3. Competitive scenario
8.8.3.4. Argentina market estimates and forecasts 2021 to 2033 (USD Million)
8.9. MEA
8.9.1. MEA
8.9.2. South Africa
8.9.2.1. Key country dynamics
8.9.2.2. Regulatory framework/ Reimbursement
8.9.2.3. Competitive scenario
8.9.2.4. South Africa market estimates and forecasts 2021 to 2033 (USD Million)
8.9.3. Saudi Arabia
8.9.3.1. Key country dynamics
8.9.3.2. Regulatory framework/ Reimbursement
8.9.3.3. Competitive scenario
8.9.3.4. Saudi Arabia market estimates and forecasts 2021 to 2033 (USD Million)
8.9.4. UAE
8.9.4.1. Key country dynamics
8.9.4.2. Regulatory framework/ Reimbursement
8.9.4.3. Competitive scenario
8.9.4.4. UAE market estimates and forecasts 2021 to 2033 (USD Million)
8.9.5. Kuwait
8.9.5.1. Key country dynamics
8.9.5.2. Regulatory framework
8.9.5.3. Competitive scenario
8.9.5.4. Kuwait market estimates and forecasts 2021 to 2033 (USD Million)
Chapter 9. Competitive Landscape
9.1. Recent Developments & Impact Analysis, By Key Market Participants
9.2. Company/Competition Categorization
9.3. Vendor Landscape
9.3.1. List of key distributors and channel partners
9.3.2. Key customers
9.3.3. Key company market share analysis, 2023
9.3.4. Quest Diagnostics Incorporated
9.3.4.1. Company overview
9.3.4.2. Financial performance
9.3.4.3. Others benchmarking
9.3.4.4. Strategic initiatives
9.3.5. USDTL
9.3.5.1. Company overview
9.3.5.2. Financial performance
9.3.5.3. Others benchmarking
9.3.5.4. Strategic initiatives
9.3.6. Quidel Corporation
9.3.6.1. Company overview
9.3.6.2. Financial performance
9.3.6.3. Others benchmarking
9.3.6.4. Strategic initiatives
9.3.7. Thermo Fisher Scientific, Inc.
9.3.7.1. Company overview
9.3.7.2. Financial performance
9.3.7.3. Others benchmarking
9.3.7.4. Strategic initiatives
9.3.8. Omega Laboratories, Inc.
9.3.8.1. Company overview
9.3.8.2. Financial performance
9.3.8.3. Others benchmarking
9.3.8.4. Strategic initiatives
9.3.9. Bio-Rad Laboratories, Inc.
9.3.9.1. Company overview
9.3.9.2. Financial performance
9.3.9.3. Others benchmarking
9.3.9.4. Strategic initiatives
9.3.10. Agilent Technologies, Inc.
9.3.10.1. Company overview
9.3.10.2. Financial performance
9.3.10.3. Others benchmarking
9.3.10.4. Strategic initiatives
9.3.11. Laboratory Corporation of America Holdings
9.3.11.1. Company overview
9.3.11.2. Financial performance
9.3.11.3. Others benchmarking
9.3.11.4. Strategic initiatives
9.3.12. Clinical Reference Laboratory, Inc.
9.3.12.1. Company overview
9.3.12.2. Financial performance
9.3.12.3. Others benchmarking
9.3.12.4. Strategic initiatives
9.3.13. Cordant Health Solutions
9.3.13.1. Company overview
9.3.13.2. Financial performance
9.3.13.3. Others benchmarking
9.3.13.4. Strategic initiatives
9.3.14. Arup Consult
9.3.14.1. Company overview
9.3.14.2. Financial performance
9.3.14.3. Others benchmarking
9.3.14.4. Strategic initiatives
9.3.15. Cordant Health Solutions
9.3.15.1. Company overview
9.3.15.2. Financial performance
9.3.15.3. Others benchmarking
9.3.15.4. Strategic initiatives