The global neonatal toxicology market size was estimated at USD 310.20 Million in 2025 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.
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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, the analyst 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
- Europe
- Asia-Pacific
- Latin America
- Middle East and Africa
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- Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
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This report addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segmental and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
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Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. Neonatal Toxicology Market Variables, Trends & Scope
Chapter 4. Neonatal Toxicology Market: Specimen Estimates & Trend Analysis
Chapter 5. Neonatal Toxicology Market: Technology Estimates & Trend Analysis
Chapter 6. Neonatal Toxicology Market: Drug type Estimates & Trend Analysis
Chapter 7. Neonatal Toxicology Market: End User Estimates & Trend Analysis
Chapter 8. Neonatal Toxicology Market: Regional Estimates & Trend Analysis
Chapter 9. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
The leading players profiled in this Neonatal Toxicology market report include:- Quest Diagnostics
- Quidel Corporation
- Bio-Rad Laboratories, Inc.
- LabCorp
- Clinical Reference Laboratory (CRL), Inc.
- Omega Laboratories, Inc.
- Cordant Health Solutions
- Agilent Technologies, Inc.
- USDTL
- Arup Consult
- Thermo Fisher Scientific, Inc.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 150 |
| Published | September 2025 |
| Forecast Period | 2025 - 2033 |
| Estimated Market Value ( USD | $ 310.2 Million |
| Forecasted Market Value ( USD | $ 701.32 Million |
| Compound Annual Growth Rate | 10.7% |
| Regions Covered | Global |
| No. of Companies Mentioned | 12 |
