Specimen Validity Testing Market Size, Share, Industry, Forecast and outlook (2024-2031)

Specimen Validity Testing Market is Segmented By Product & Services (Products, Assay Kits, Other, Reagents and Calibrators, Services ), By Type (Laboratory Testing, Rapid/POC Testing), By End-User (Drug Screening Laboratories, Pain Management Centers, other), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis,  2023-2030

Specimen Validity Testing Market Size

Specimen Validity Testing Market is growing at a CAGR of 6.3% during the forecast period (2023-2030).

The test method used to determine if a urine specimen is abnormal or tampered with is known as Specimen Validity Testing (SVT), also known as adulteration testing.

Specimen Validity Testing Market Scope

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Specimen Validity Testing Market Dynamics

The factors expected to drive the growth of the global specimen validity testing market are the growing need for drug screening and the increasing number of drug abuse cases.

The growing demand for drug screening is expected to drive market growth in the forecast period

Heroin, cocaine, marijuana, hallucinogens, inhalants, and nonmedical use of prescription psychotherapeutics are all examples of illegal drug use (stimulants, tranquilizers, and painkillers). According to the National Center for Drug Abuse Statistics, over a year, 10.1 million Americans, or 3.7 percent, misuse opioids at least once. An opioid use disorder affects 1.6 million people or 15.8% of the population. Prescription pain relievers are used by 9.7 million opioid abusers or 96.6 percent. Urine drug screening is a clinical method that can improve hospital safety, track patient compliance with treatment, diagnose drug abuse (illicit and legal), and prescription drug diversion.

Urine drug screening is a clinical tool for improving workplace safety, monitoring patient medication compliance, and detecting drug (illicit and prescription) abuse and prescription medication diversion. Because drug testing has personal, occupational, and legal ramifications, pain specialists and primary care physicians must be confident in their ability to interpret urine drug assay results to respond appropriately to improve clinical outcomes. Many companies are offering specimen validity testing. For instance, to help determine if a valid urine sample is being tested, Siemens Healthineers offers five specimen validity tests. The Atellica CH Analyzer, ADVIA Chemistry Systems, and Viva Drug Testing Systems have tests. Hence, with the growing need for drug screening, the global specimen validity testing market is expected to grow in the forecast period.

The problems associated with specimen validity testing is expected to hamper the market growth

The overpayment for specimen validity testing is expected to affect the market growth. For instance, Medicare overpaid providers for medically unnecessary specimen validity tests performed with urine drug tests. Medicare billing requirements were not followed when providers made payments for specimen validity tests. For specimen validity tests billed with urine drug tests, Medicare improperly paid $66.3 million to 4,480 clinical laboratories and physician offices. According to officials with the Centers for Medicare & Medicaid Services, medically necessary tests used to diagnose certain conditions performed on the same day as a urine drug test for a single beneficiary should be a rare occurrence (CMS). Payments for specimen validity tests billed in conjunction with urine drug tests were improperly paid because providers did not follow existing Medicare guidance. CMS's system edits were insufficient to prevent payment. CMS and most Medicare contractors issued additional guidance on specimen validity testing. Hence, the payment issues related to specimen validity testing are expected to hamper the market growth.

COVID-19 Impact Analysis

The COVID-19 pandemic has posed significant challenges to healthcare systems and public health policies worldwide. It necessitates the development of novel treatment and prevention strategies to adapt to the pandemic's impact. Multiple factors attributable to their clinical, psychological, and psychosocial conditions put people with substance use disorders (SUD) at risk for contamination. Furthermore, the social and economic changes brought on by the pandemic and the traditional challenges of treatment access and adherence will almost certainly worsen during this time, exacerbating their situation. It is well understood that the presence and severity of SUD are linked to - and can impact clinical and psychological conditions. Hence, with increasing drug abuse cases due to covid-19 impact, the demand for the specimen validity testing market is expected to grow in the forecast period.

Specimen Validity Testing Market Segment Analysis

The laboratory testing segment is expected to dominate the market growth

The key factors driving demand for this segment include the accuracy of test results and the cost-effectiveness of laboratory testing. For instance, sample tampering, substitution, and adulteration are all possibilities. When these practices occur, the specimen is deemed invalid, resulting in erroneous test results. Substitution, tampering, and adulteration techniques can be sophisticated and difficult to detect in situations where individuals attempt to evade detection of certain drug use or diversion. Drug testing continues to be hampered by using these avoidance techniques to mask controlled or illicit substances. To counter these efforts, the aforementioned entities mandate or require their certified laboratories to perform the following tests on all urine specimens submitted for drug testing creatinine, specific gravity, pH, one or more validity tests for oxidising adulterants, and additional validity tests when atypical results are found.

Screening tests (the initial tests) can detect the presence or absence of a substance or its metabolite, as well as a cross-reacting, chemically similar substance. Screening tests are usually performed in a lab or on-site (point-of-care test [POCT]) and use an immunoassay technique. Laboratory immunoassay screening tests are low-cost, simple to automate and provide quick results. Many companies offer laboratory testing, for instance, the most common way donors try to cheat a drug test is by using oxidising adulterants such as nitrites, chromates, and halogens. When a customer or Medical Review Officer requests oxidant identification for some of the most common oxidising adulterants, Quest diagnostics is one of the few laboratories that can provide it. When new adulterants become common, we monitor and adjust our testing as needed. To ensure accuracy, all "Invalid" specimens are tested twice on a different portion of the urine specimen based on analytical test results. Hence, the benefits offered by laboratories for specimen validity testing is expected to drive market growth.

Specimen Validity Testing Market Geographical Share

North America region is expected to hold the largest market share in the global specimen validity testing market

The factors influencing the specimen validity testing market are the increasing drug abuse population. For instance, in 2017, approximately 38% of adults struggled with an illicit drug use disorder. In the same year, one out of every eight adults struggled with alcohol and drug addiction. In 2017, 8.5 million adults in the United States had mental health and a substance use disorder, a condition known as co-occurring disorders. In the United States, active substance use disorders affect 22 million people. In the United States, the costs of tobacco, alcohol, illicit drugs, and prescription opioids to healthcare and society totaled more than 193 billion dollars for "illicit drugs," 78 billion dollars for prescription opioids, 250 billion dollars for alcohol use.

The government has established strict guidelines to address drug screening product adulteration, which is a major contributor to the specimen validity testing industry in North America. Another factor influencing the growth of the SVT (specimen validity testing) industry in North America is the emergence of a growing number of industries, as well as an increase in the number of pre-employment and random drug testing at work, which is fuelling the growth of the specimen validity testing market and ensuring the region's dominance. Hence, all these reasons are expected to drive the market growth in this region.

Specimen Validity Testing Market Companies and Competitive Landscape

With mergers, acquisitions, and product launches, the global specimen validity testing market is moderately competitive. Some of the key players in the market are Alere Inc., Thermo Fisher Scientific, LabCorp, American Bio Medica Corporation, Premier Biotech, Inc., Sciteck, Abbott Laboratories, Quest Laboratory Testing.

Thermo Fisher Scientific

Overview: Thermo Fisher Scientific is based in the United States that sells scientific

instruments, reagents and consumables, and software services. Waltham, Massachusetts, is

the company’s headquarters. The company was founded in 1956.

Product Portfolio: DRI General Oxidant-Detect Specimen Validity Test Calibrators with the liquid, ready-to-use this calibrator provides accuracy when testing for specimen adulterants on various general chemistry analyzers. Their product portfolio includes DRI General Oxidant-Detec Specimen Validity Test Controls, DRI Creatinine-Detect Specimen Validity Test Controls, DRI Indiko pH-Detect Specimen Validity Test.