U.S. Point of Care Drug of Abuse Testing Market Size, Share & Trends Analysis Report By Product (Immunoassay Test Strips & Cassettes, Oral Fluid Testing Kits, Breath Analyzers), By Sample Type, By Technology, By End-use, And Segment Forecasts, 2025 - 2033

U.S. Point Of Care DOA Testing Market Summary

The U.S. point of care drug of abuse (DOA) testing market size was estimated at USD 370.55 million in 2024 and is projected to grow at a CAGR of 9.3% from 2025 to 2033. The market is driven by an increasing need for rapid and on-site drug testing across multiple settings. Point-of-care DOA tests, which include urine, saliva, and occasionally blood-based panels, are widely used in workplaces, emergency departments, law enforcement, rehabilitation centers, and schools. These tests offer immediate results, helping healthcare professionals and institutions make faster decisions related to patient care, compliance, and risk mitigation. Their portability and ease of use are further increasing their adoption among non-laboratory professionals, contributing to market penetration.

One of the primary market drivers is the escalating incidence of drug abuse in the U.S., particularly related to opioids, cannabis, cocaine, and amphetamines. According to the National Center for Drug Abuse Statistics, over 20 million Americans aged 12 and older had a substance use disorder in 2023. This rising trend has heightened the demand for efficient drug screening tools, particularly in emergency and occupational health settings. Additionally, increased funding from federal agencies such as SAMHSA (Substance Abuse and Mental Health Services Administration) and state-level opioid response programs has bolstered the adoption of rapid testing tools.

Mandates for pre-employment, random, and post-incident drug testing in safety-sensitive industries such as transportation, construction, and healthcare are significantly contributing to market growth. The U.S. Department of Transportation (DOT) and other regulatory bodies have stringent requirements that compel employers to implement DOA screening protocols. POC testing is especially valued in these settings for its ability to quickly identify intoxication or recent drug use, helping mitigate legal liability and ensure workforce safety.

Recent innovations have greatly improved the reliability, sensitivity, and usability of point-of-care DOA testing kits. Multiplexed test panels capable of detecting up to 12-14 drug classes simultaneously are gaining traction. Advancements in saliva-based testing and low-cutoff detection thresholds are enabling earlier and more accurate detection of drug use. Additionally, digital and connected POC devices that store results electronically and integrate with medical record systems are opening up new opportunities for remote monitoring and telehealth integration.

Market Concentration & Characteristics

The U.S. point-of-care DOA testing market is experiencing growing innovation, particularly in oral fluid and saliva-based tests, which offer rapid, non-invasive detection. Companies such as Premier Biotech and Abbott are expanding product capabilities to detect synthetic opioids and novel psychoactive substances (NPS). For instance, Quest Diagnostics launched a new NPS urine panel in December 2023 covering 88 substances, reflecting the need to adapt to emerging drug trends. Additionally, AI integration into mobile testing platforms is improving test accuracy and real-time results, especially in workplace and roadside settings.

The U.S. point of care drug of abuse (DOA) testing market has seen notable M&A activity, with companies acquiring cutting-edge technologies to expand their portfolios. For instance, in June 2024, Premier Biotech, backed by Align Capital Partners, acquired Desert Tox, a certified toxicology laboratory, to strengthen its presence in confirmatory and lab-based services. Quest Diagnostics has also been active, acquiring LifeLabs in August 2024 to expand its North American footprint, and integrating newer drug panels into its offerings. These moves reflect a competitive landscape where market players aim to consolidate capabilities and respond to shifting drug use patterns.

Regulations significantly influence the market, especially through federal mandates from agencies such as SAMHSA and the Department of Transportation (DOT), which define testing standards for workplace and forensic use. In 2024, scrutiny increased following incidents in California prisons, where a reagent switch by Quest Diagnostics led to false positives. This prompted legal challenges and calls for mandatory confirmatory testing, reinforcing the role of regulatory oversight in ensuring accuracy. Additionally, evolving cannabis laws at the state level continue to drive the adoption of roadside oral fluid tests for THC detection, such as SoToxa devices deployed in North Dakota.

Product development is centered around rapid, portable test kits and comprehensive panel options. There is a growing shift from urine to oral fluid-based tests due to convenience and lower risk of adulteration. Premier Biotech has launched a line of oral swab tests that detect multiple drug classes within minutes, aligning with the demand for on-site workplace and school testing. Furthermore, new panels are increasingly covering synthetic opioids, fentanyl analogs, and designer stimulants, reflecting the changing drug landscape in the U.S.

Regional expansion strategies have focused on penetrating underserved markets and strengthening lab networks. For example, Premier Biotech’s acquisition of Desert Tox expanded its laboratory reach in the Southwest, while Quest’s acquisition of LifeLabs provides broader access to the Canadian and northern U.S. regions. Mobile testing units and telehealth-integrated services are also helping companies enter rural and suburban areas where access to traditional lab testing is limited. These efforts are particularly crucial as employers and schools in remote areas seek reliable DOA testing solutions.

Product Insights

The immunoassay test strips and cassettes segment dominated the U.S. point of care drug of abuse (DOA) testing market with a share of 37.98% in 2024. This dominance is supported by the widespread availability, low cost, and rapid result turnaround of lateral flow-based test strips used for drug screening in clinical, workplace, and forensic settings. Recent advancements include enhanced sensitivity formats that detect a broader range of synthetic opioids and cannabinoids, with companies like Premier Biotech and OraSure Technologies introducing multi-drug panel cassettes with tamper-evident features.

The digital/portable analyzers segment in the U.S. is projected to experience the fastest CAGR over the forecast period, driven by the rising demand for connected, quantitative, and tamper-resistant drug testing tools. Key developments include the RYAN instrument, which in July 2023 became the first FDA-cleared portable analyzer to detect fentanyl at the point of care. Additionally, leading players such as Abbott and Thermo Fisher Scientific are integrating cloud-based data management and Bluetooth connectivity into analyzers for faster reporting and audit trails in occupational and emergency settings.

Sample Type Insights

The urine segment dominated the U.S. point of care drug of abuse (DOA) testing market in 2024, capturing 43.54% of the market share. Its strong position is due to its long-standing clinical acceptance, relatively wide detection windows, and suitability for multi-panel tests. Recent innovations include temperature-sensitive and adulteration-proof collection devices introduced by American Screening Corporation, which aim to improve sample integrity and compliance in workplace testing programs.

The saliva (oral fluid) segment in the U.S. point of care drug of abuse (DOA) testing market is projected to grow at a significant CAGR over the forecast period. The growth is attributed to the increasing adoption of roadside testing, law enforcement, and home-based screening. Its non-invasive nature, ease of collection, and real-time drug detection capability are driving this trend. In 2023, OraSure Technologies expanded its Intercept Oral Fluid Drug Test portfolio to include enhanced detection for cannabis and synthetic opioids, aligning with evolving drug use patterns and regulatory needs.

Technology Insights

The Lateral Flow Assay (LFA) segment dominated the U.S. point of care drug of abuse (DOA) testing market in 2024, capturing 51.59% of the market share. This growth is driven by the cost-effectiveness, rapid results, and growing sophistication of LFA platforms. Recent advances by companies such as Drägerwerk AG and Abbott have improved LFA sensitivity and shelf-life, supporting broader use in mobile health units and decentralized screening programs.

The mass spectrometry (portable or hybrid POC units) segment in the U.S. point of care drug of abuse (DOA) testing market is projected to grow at a significant CAGR over the forecast period, as newer devices offer high specificity and low detection thresholds for fentanyl and designer drugs. Firms such as Thermo Fisher Scientific and startups in precision toxicology are developing compact mass spec systems suitable for on-site law enforcement use, forensic labs, and mobile clinics, aiming to bridge the gap between rapid screening and confirmatory testing.

End-use Insights

The hospitals & emergency departments segment dominated the U.S. point of care drug of abuse (DOA) testing market with a share of 32.52% in 2024, riven by the urgent need for rapid drug screening to manage overdose cases, unconscious admissions, and drug-related trauma. The integration of DOA panels into emergency workflows and electronic health records has increased efficiency. Notably, Roche Diagnostics and Siemens Healthineers have enhanced their POC platforms with high-throughput analyzers that support toxicology panels alongside other emergency biomarkers, reinforcing hospitals’ reliance on real-time data to guide clinical decisions. 

The home care & remote users segment is expected to grow at the fastest CAGR during the forecast period, driven by the rising demand for accessible, private, and real-time drug screening solutions outside of clinical settings. Growth in this segment is supported by an increase in self-testing needs among individuals in recovery programs, adolescents under parental supervision, and remote workers. In recent developments, companies such as OraSure Technologies and Premier Biotech have introduced compact, user-friendly oral and urine drug test kits designed for at-home use, offering easy interpretation without requiring lab processing. Furthermore, integration of digital readouts and app-based result sharing is on the rise, with companies exploring telehealth-compatible platforms for remote substance use monitoring. These innovations align with broader telemedicine adoption and behavioral health trends, making home-based DOA testing a viable and expanding market channel.

Key U.S. Point of Care Drug of Abuse Testing Company Insights

Leading companies in the U.S. point-of-care drug of abuse (DOA) testing market-including Abbott Laboratories, Siemens Healthineers, Roche Diagnostics, Thermo Fisher Scientific, Bio-Rad Laboratories, bioMérieux, and Diazyme Laboratories are actively expanding their diagnostic portfolios through innovation and regulatory advancement. While these companies are primarily recognized for their contributions across various diagnostic fields, their increased focus on point-of-care testing platforms is also bolstering the DOA segment.

Recent Developments

• In July 2023, the U.S. FDA granted clearance for the first-ever point-of-care instrument to test for fentanyl, marking a major milestone in combating the opioid crisis. Developed by Shenzhen Superbio Technology Co., Ltd., the system marketed under the name RYAN is a portable immunofluorescence analyzer paired with a fentanyl urine detection kit capable of detecting fentanyl at a cutoff of 1.0 ng/mL. Distributed in the U.S. by Bioeasy USA, Inc. and Carolina Liquid Chemistries Corp., the device enables rapid, preliminary fentanyl screening at the point of care, with results requiring laboratory confirmation. This FDA clearance is expected to significantly improve the speed and accessibility of fentanyl detection in emergency settings, clinics, and addiction treatment centers across the country.

U.S. Point of Care Drug of Abuse Testing Market Report Scope

U.S. Point of Care Drug of Abuse Testing Market Report Segmentation

This report forecasts revenue growth at 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 U.S. point of care drug of abuse (DOA) testing market report based on product, sample type, technology, and end-use:

• Product Outlook (Revenue, USD Million, 2021 - 2033)

  • Immunoassay Test Strips and Cassettes

  • Oral Fluid Testing Kits

  • Breath Analyzers

  • Urine Collection Cups

  • Digital/Portable Analyzers

• Sample Type Outlook (Revenue, USD Million, 2021 - 2033)

  • Urine

  • Saliva (Oral Fluid)

  • Breath

  • Blood

  • Sweat/Hair

• Technology Outlook (Revenue, USD Million, 2021 - 2033)

  • Lateral Flow Assay (LFA)

  • Chromatographic Immunoassays

  • Enzyme-linked Immunosorbent Assay (ELISA)

  • Mass Spectrometry (Portable or Hybrid POC Units)

• End-use Outlook (Revenue, USD Million, 2021 - 2033)

  • Hospitals & Emergency Departments

  • Workplace & Occupational Health Center

  • Home Care & Remote Users

  • Others