Global Specimen Validity Testing Market Report 2024

The specimen validity testing market size has grown strongly in recent years. It will grow from $3.37 billion in 2023 to $3.68 billion in 2024 at a compound annual growth rate (CAGR) of 9.3%. The growth in the historic period can be attributed to increasing drug adoption, increased drug screening, stringent regulations, increased alcohol use, and integration of point-of-care testing.

The specimen validity testing market size is expected to see strong growth in the next few years. It will grow to $5.27 billion in 2028 at a compound annual growth rate (CAGR) of 9.4%. The projected growth in the forecast period can be attributed to several factors, including the increasing demand for workplace drug testing, the growing adoption of oral fluid testing methods, a rise in research and development activities, the expanding utilization of Specimen Validity Testing (SVT), and the broadening applications in pain management. Key trends expected in the forecast period encompass technological advancements, the integration of artificial intelligence for result interpretation, product innovations, increasing partnerships within the industry, and the development of portable testing devices for on-the-go monitoring.

The increasing prevalence of drug abuse is anticipated to drive the growth of the specimen validity testing (SVT) market in the future. Drug abuse involves the habitual, excessive, or inappropriate use of legal or illegal substances for non-medical purposes and is on the rise due to various interconnected factors, including opioid addiction, escalating mental health issues, limited access to treatment and support resources, and cultural influences. SVT methods are designed to detect the presence of impurities and compounds by assessing various parameters such as pH, specific gravity, creatinine content, and temperature. For example, data from the Office for Health Improvement and Disparities in October 2023 revealed an increase in adult contacts with drug and alcohol programs in the UK, totaling 0.29 million interactions from April 2021 to March 2022, up from 0.28 million the previous year. Additionally, according to the Centers for Disease Control and Prevention in May 2022, opioid overdose deaths in the USA surged by 15%, reaching 80,816 in 2021 from 70,029 in 2020. Hence, the growing incidence of drug abuse is expected to propel the growth of the specimen validity testing market.

Key players in the specimen validity testing market are focused on developing innovative products such as high-resolution urine drug testing profiles to maintain their market position. A high-resolution urine drug testing profile employs advanced analytical techniques for sophisticated testing. For instance, in July 2022, Mayo Clinic Laboratories introduced a data-driven urine drug testing (UDT) profile aimed at providing physicians with comprehensive information to manage patients addicted to common substances such as prescription opioids, alcohol, marijuana, and nicotine. This addiction medicine monitoring profile (Mayo ID ADMPU) complies with the American Society of Addiction Medicine's guidelines and offers enhanced sensitivity and specificity to detect parent drugs and metabolites from various drug classes, including opioids, benzodiazepines, stimulants, and PCP. Utilizing high-resolution, accurate mass spectrometry and targeted immunoassay testing, the profile delivers clinically relevant information for healthcare providers.

In October 2021, Mesa Laboratories Inc. acquired Agena Bioscience for $300 million, aiming to expand its presence in the clinical genomics sector by integrating Agena Bioscience's innovative molecular diagnostics tools and genetic analysis solutions into its portfolio. This strategic move enhances Mesa's capabilities in providing critical quality control solutions for the pharmaceutical, healthcare, and medical device industries. Agena Bioscience, known for its cutting-edge technologies and groundbreaking molecular genomics research, including sample validity testing, aligns well with Mesa Laboratories' objectives in advancing diagnostic solutions.

Major companies operating in the specimen validity testing market are Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Siemens Healthineers, Medline Industries Inc., Becton, Dickinson and Company, Laboratory Corporation, Quest Diagnostics Incorporated, Alere Inc., Clinical Reference Laboratory Inc., Precision Diagnostics, ACM Global Laboratories, Millennium Health, Omega Laboratories Inc., Dominion Diagnostics, CannAmm, Sciteck Inc., Starplex Scientific Inc., Vision Diagnostics Inc., Premier Biotech Inc., Alfa Scientific Designs, Express Diagnostics, American Bio Medica Corporation, Titan Biotech Ltd., SureHire, Miraclean Technology Co. Ltd.

North America was the largest region in the specimen validity testing market in 2023. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the specimen validity testing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the specimen validity testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Specimen Validity Testing (SVT) is a crucial process utilized to evaluate the integrity and authenticity of biological specimens, including urine, blood, saliva, or hair samples, collected for drug testing or clinical analysis. SVT scrutinizes diverse parameters such as pH, creatinine levels, specific gravity, and the presence of common masking agents such as oxidizing adulterants, nitrites, glutaraldehyde, and pyridinium chlorochromate.

Within the specimen validity testing market, products and services are the main offerings. Products encompass assay kits, reagents, calibrators, and disposables employed in the testing procedure to identify any adulteration, dilution, or substitution in urine samples. Various testing types include laboratory testing and rapid or point-of-care testing, catering to a range of end-users such as drug rehabilitation centers, drug screening laboratories, pain management centers, criminal justice and law enforcement agencies, among others.

The specimen validity testing market research report is one of a series of new reports that provides specimen validity testing market statistics, including the specimen validity testing industry global market size, regional shares, competitors with a specimen validity testing market share, detailed specimen validity testing market segments, market trends, and opportunities, and any further data you may need to thrive in the specimen validity testing industry. This specimen validity testing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The specimen validity testing market includes revenues earned by entities by creatinine testing, pH testing, adulterant testing, and specific gravity measurement and related specimen collection containers, urine test strips, adulterant detection kits, and temperature strips. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.


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