Specimen Validity Testing - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts 2024 - 2029

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.

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 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.

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