Specimen Validity Testing Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

The Specimen Validity Testing Market is Segmented by Drug Type (Antibacterial Drugs, Anti-fungal Drugs, Antiviral Drugs, and Others), Indication (Blood Stream Infections, Urinary Tract Infections, Surgical Site Infections, Pneumonia, and Others), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report offers the value (in USD million) for the above segments.

Specimen Validity Testing Market Size

Specimen Validity Testing Market Summary
Study Period 2019 - 2029
Base Year For Estimation 2023
Forecast Data Period 2024 - 2029
CAGR 7.40 %
Fastest Growing Market Asia Pacific
Largest Market North America

Major Players

Specimen Validity Testing Market Major Players

*Disclaimer: Major Players sorted in no particular order

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Specimen Validity Testing Market Analysis

The specimen validity testing market is expected to register a CAGR of 7.4% over the forecast period.

The COVID-19 pandemic had a significant impact on the market initially as the outbreak of COVID-19 led to vast numbers of patients, which resulted in an unprecedented demand for diagnosis. SARS-CoV-2 affects the respiratory and various body functions and dysfunctions in the body's metabolism, including altered kidney function, which is analyzed by the creatinine level in the specimen validity testing (SVT) test. For instance, a study published in the Clinical Journal of the American Society of Nephrology in April 2021 stated that proteinuria was observed to be highly frequent in patients admitted for COVID-19, and for the analysis, urine testing was carried out. However, the number of COVID-19 patients decreased gradually. But, the market is expected to experience steady growth over the forecast period. COVID-19 had a moderately positive impact on the growth of the specimen validity testing market during the pandemic. However, with the reduction in COVID-19 patients, the market is expected to grow at a normal pace.

Further, the market is expected to grow with the increasing drug screening and increasing use of illegal drugs, which leads to high demand for SVTs. Drug screening tests have been on the rise due to the increasing abuse of illegal drugs. As per the data published by the Crime Survey for England and Wales in 2022, over 3 million adults aged 16 to 59 years and 1.1 million adults aged 16 to 24 years were reported to use drugs in 2022. Further, as per the European Drug Report 2022, over 22 million adults aged 15 to 64 years were reported to use Cannabis in the European Union region in 2021. Further, the same source stated that over 1.5 million, 2.6 million, and 2 million adults of the same age group consumed cocaine, 3,4 Methylenedioxymethamphetamine (MDMA), and amphetamines in 2021. The increasing drug abuse is expected to create more demand for specimen validity testing since these tests are used to determine if the urine sample has been adulterated/diluted against drug testing. Therefore, a rise in drug abuse is expected to drive the growth of the market. Drug abuse has been increasing over the past few years. For instance, as per the data published in the European Drug Report 2022, it was mentioned that over 13 European cities were reported to have residues of drugs in Amsterdam and Antwerp in their wastewater in 2021. The same source also stated that the drug-checking services in Europe received more cannabis products for testing, which reflected an increase in product diversity and consumer uncertainty, with services in over 7 European cities in 2021. Such high substance abuse in different regions boosts the growth of the market.

Furthermore, the increasing screening drives to curb substance abuse and drug addiction are also expected to create more demand for the specimen validity test. For instance, in July 2022, the jail authorities of Punjab, India, launched a major anti-drug-trafficking and de-addiction drive in their jails, in which over 8,000 prisoners were screened in over 14 prisons and sub-jails. It was found in the screening drive that over 42% of the prisoners were drug addicts.

Therefore, owing to the aforementioned factors, including the increasing drug abuse and increasing drug screening, the studied market is anticipated to witness growth over the analysis period. However, the limited awareness of SVT and the emergence of alternative testing kits are likely to impede market growth.

Specimen Validity Testing Market Trends

The Rapid/POC Testing Segment is Expected to Witness Significant Growth Over the Forecast Period

Rapid/POC testing for SVT includes specimen validity testing of the urine sample, which analyses the urine samples for a broad spectrum of medical conditions. The analysis is carried out near the site of patient care to offer a rapid and accurate diagnosis of the disease using a urine sample. The factors such as increasing research studies that have highlighted the advantageous features of rapid SVT testing and products marketed are driving the growth of the market segment.

Research studies have highlighted the advantages of rapid/POC testing for SVT for testing urine sample validity, which is expected to increase its demand and boost the growth of the segment. For instance, a study published in the Annals of Clinical Biochemistry in May 2021 highlighted the key advantages of using point-of-care devices for antenatal drug screening for substance abuse by pregnant women. The study stated that point-of-care testing to detect drug use in pregnancy is affordable and convenient. Further, a study published in the Journal of Applied Laboratory Medicine in March 2022 stated that the point-of-care urine drug test devices evaluated in the study were found to have higher sensitivity and specificity as compared to the reference methods. Such studies underline the advantages of high sensitivity, specificity, and fast results of rapid/POC testing, which is expected to create high demand and drive the growth of the market.

Furthermore, there are several major players in the market that offer rapid SVT tests, which contribute to the growth of the market by addressing the need for substance abuse testing rapidly. For instance, the Alere Suite of Rapid Drug Screening Devices, iCup by Alere, and Accu-Tell Single Drug-of-Abuse Rapid Test Cassette/Strip (Urine) by AccuBioTech are some of the marketed and available rapid SVT tests in the market.

Therefore, the rapid/POC testing segment is expected to witness significant growth over the forecast period due to the abovementioned factors, including its high sensitivity and specificity and the presence of marketed rapid/POC SVT tests in the market.

Specimen Validity Testing Market: Estimates Of Drug Used By Adults Aged 15-64 years (In Million), By Type, European Union, 2021

North America is Expected to Witness Significant Growth Over the Forecast Period

North America is expected to witness significant growth in the market during the forecast period, owing to factors such as the high numbers of drug abuse, the high volume of drug screening tests performed in the region, and the key developments by the market players. For instance, as per the data published by the Substance Abuse and Mental Health Services Administration (SAMHSA) in 2021, over 61,203 people aged 12 years and above were reported to have consumed illicit drugs in the year 2021, United States. Further, according to the data published by the Canadian Mental Health Association (CMHA), it was estimated that over 21% (over 6 million Canadian individuals) of the Canadian population would meet the criteria for drug addiction in their lives.

In addition, the efforts to curb the use of illicit drugs are high in the country, which would increase awareness of drug abuse. For instance, in April 2022, a campaign was launched in Quintana Roo, Mexico, to control narcotic drug abuse in tourist destinations such as marine terminals, hotels, and airports. Further, the Canadian Centre for Substance Use and Addiction announced the launch of National Addictions Awareness Week (NAAW) in November 2023. The NAAW would highlight the solutions and address the harms caused by the abuse of drugs and alcohol. Also, in October 2021, the Centers for Disease Control and Prevention (CDC) launched its new education campaign, which focuses on preventing casualties caused by drug overdose in the United States. The campaign would raise awareness about the harmful effects of drugs, including Fentanyl, cocaine, and Naloxone.

Furthermore, the launching of more urine tests and specimen validity tests in the region is expected to boost the growth of the market. For instance, in August 2021, CompuNet Clinical Laboratories, the United States-based clinical laboratory, launched its in-house prescription drug monitoring program for urine drug testing. The Premier Health Prescription Drug Screen panel offered by the company would include testing of over 12 drugs, including specimen validity testing and confirmatory testing. The drug tests included in the panel can detect oxycodone, opiates, methadone and metabolite (EDDP), marijuana metabolite, heroin metabolites, fentanyl, cocaine metabolite, benzodiazepines, barbiturates, MDMA, and amphetamines.

Therefore, owing to the aforementioned factors, including the high numbers of drug abuse, increasing drug screening, and the recently launched specimen validity tests, the studied market is anticipated to grow further in the North American region.

Specimen Validity Testing Market - Growth Rate By Region

Specimen Validity Testing Industry Overview

The specimen validity testing market is moderately fragmented in nature due to the presence of several companies operating globally as well as regionally. The major players in the market include Abbott, Thermo Fisher Scientific, LabCorp, American Bio Medica Corporation, and Premier Biotech, Inc.

Specimen Validity Testing Market Leaders

  1. Abbott

  2. Thermo Fisher Scientific

  3. LabCorp

  4. Healgen Scientific LLC

  5. Premier Biotech, Inc.

*Disclaimer: Major Players sorted in no particular order

Specimen Validity Testing Market Concentration
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Specimen Validity Testing Market News

  • March 2023: Healgen Scientific LLC acquired the 22-acre factory and American Bio Medica corporate headquarters in New York, United States. The acquisition was part of the agreement signed between Healgen Scientific LLC and American Bio Medica Corporation in December 2022, under which Healgen Scientific would acquire American Bio Medica Corporation for USD 3 million.
  • December 2022: Omega Laboratories launched its Urine Drugs of Abuse Testing services in its state-of-the-art laboratory in Ontario, Canada.

Specimen Validity Testing Market Report - Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Drug Screening

      2. 4.2.2 Increasing Use of Illegal Drugs

    3. 4.3 Market Restraints

      1. 4.3.1 Limited Awareness for SVT and Emergence of Alternative Testing kits

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value - USD million)

    1. 5.1 By Product & Service

      1. 5.1.1 Products

        1. 5.1.1.1 Assay Kits

        2. 5.1.1.2 Reagents and Calibrators

        3. 5.1.1.3 Disposables

      2. 5.1.2 Service

    2. 5.2 By Type

      1. 5.2.1 Laboratory Testing

      2. 5.2.2 Rapid/POC Testing

    3. 5.3 By End-User

      1. 5.3.1 Drug Screening Laboratories

      2. 5.3.2 Pain Management Centers

      3. 5.3.3 Others

    4. 5.4 Geography

      1. 5.4.1 North America

        1. 5.4.1.1 United States

        2. 5.4.1.2 Canada

        3. 5.4.1.3 Mexico

      2. 5.4.2 Europe

        1. 5.4.2.1 Germany

        2. 5.4.2.2 United Kingdom

        3. 5.4.2.3 France

        4. 5.4.2.4 Italy

        5. 5.4.2.5 Spain

        6. 5.4.2.6 Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. 5.4.3.1 China

        2. 5.4.3.2 Japan

        3. 5.4.3.3 India

        4. 5.4.3.4 Australia

        5. 5.4.3.5 South Korea

        6. 5.4.3.6 Rest of Asia-Pacific

      4. 5.4.4 Middle East and Africa

        1. 5.4.4.1 GCC

        2. 5.4.4.2 South Africa

        3. 5.4.4.3 Rest of Middle East and Africa

      5. 5.4.5 South America

        1. 5.4.5.1 Brazil

        2. 5.4.5.2 Argentina

        3. 5.4.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Abbott

      2. 6.1.2 Thermo Fisher Scientific

      3. 6.1.3 LabCorp

      4. 6.1.4 Premier Biotech, Inc.

      5. 6.1.5 Sciteck, Inc.

      6. 6.1.6 Alfa Scientific Designs

      7. 6.1.7 Rochester Regional Health (ACM Global Laboratories)

      8. 6.1.8 Quest Diagnostics

      9. 6.1.9 Vision Diagnostics, Inc.,

      10. 6.1.10 Omega Laboratories

      11. 6.1.11 Nona Scientific Laboratory

      12. 6.1.12 Siemens Healthineers

      13. 6.1.13 Healgen Scientific LLC

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments
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Specimen Validity Testing Industry Segmentation

As per the scope of the report, specimen validity testing (SVT) is the screening test for urine samples to detect any adulteration, dilution, or substitution. SVT provides critical information regarding the reliability and accuracy of drug test results to clinicians, and it also validates that the urine sample tested is a valid human urine specimen. The specimen validity testing market is segmented by drug type (antibacterial drugs, anti-fungal drugs, antiviral drugs, and other drugs), indication (bloodstream infections, urinary tract infections, surgical site infections, pneumonia, and other indications), and geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD) for the above segments.

By Product & Service
Products
Assay Kits
Reagents and Calibrators
Disposables
Service
By Type
Laboratory Testing
Rapid/POC Testing
By End-User
Drug Screening Laboratories
Pain Management Centers
Others
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East and Africa
GCC
South Africa
Rest of Middle East and Africa
South America
Brazil
Argentina
Rest of South America
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Specimen Validity Testing Market Research FAQs

The Specimen Validity Testing Market is projected to register a CAGR of 7.40% during the forecast period (2024-2029)

Abbott, Thermo Fisher Scientific, LabCorp, Healgen Scientific LLC and Premier Biotech, Inc. are the major companies operating in the Specimen Validity Testing Market.

Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).

In 2024, the North America accounts for the largest market share in Specimen Validity Testing Market.

The report covers the Specimen Validity Testing Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Specimen Validity Testing Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.

Specimen Validity Testing Industry Report

Statistics for the 2024 Specimen Validity Testing market share, size and revenue growth rate, created by Mordor Intelligenceā„¢ Industry Reports. Specimen Validity Testing analysis includes a market forecast outlook to for 2024 to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.

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Specimen Validity Testing Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)