Specimen Validity Testing Market - By Product (Product {Assay Kits, Reagents and Calibrators, Disposables}, Service), By Type (Laboratory Testing, Rapid/POC Testing), By End-use (Drug Screening Laboratories, Drug Rehabilitation Centers, Pain Management Centers) & Forecast, 2023 – 2032

Specimen Validity Testing Market Size

Specimen Validity Testing Market size was valued at around USD 2.4 billion in 2022 and is projected to reach over USD 4.7 billion by the end of 2032. This incremental growth rate is owing to increasing incidence of illicit drug abuse coupled with rising awareness regarding specimen validity testing and surging demand for rapid and point of care testing.
 

Technological advancements pertaining to specimen validity testing in urine test to analyze adulterants, substitution and dilution is expected to augment the market growth in the forecasted timeframe. Rising healthcare spending for providing better healthcare infrastructure and increasing disposable income are some of the major factors responsible for increased adoption of specimen validity testing devices and services across the world.
 

Specimen validity testing (SVT) is a process used to assess the integrity and authenticity of biological samples, typically urine, in various testing scenarios, such as drug testing. This testing is intended to verify that the submitted sample has not been adulterated, substituted, diluted, or tampered with in any way that could potentially alter the test results.
 

However, high cost of specimen validity testing can be a significant barriers and impede the market growth in the coming years. Specimen validity testing (SVT) can involve additional costs beyond the standard drug testing procedures. These test often requires specialized equipment and reagents to assess the integrity of samples accurately. These may include instruments for measuring temperature, pH, specific gravity, and specific chemical reagents for detecting adulterants or masking agents. The procurement, maintenance, and calibration of such equipment, as well as the purchase of specific reagents, can add to the overall cost of SVT. For instance, the cost of creatinine specimen validity test calibrators can range between USD 800 to USD 2,000 and may vary according to the test type. Thus, high end pricing of equipment and services can restrict their use in developing economies, thereby limiting their use up to certain extent. Hence, the aforementioned factors are expected to restrict the market growth.
 

COVID-19 Impact

The specimen validity testing industry experienced a significant decline in revenue during the first half of 2020, primarily due to the outbreak of COVID-19. The global healthcare sector, including screening laboratories and rehabilitation settings, faced numerous challenges and disruptions caused by the pandemic, leading to a negative impact on the growth of the specimen validity testing market. The initial phase of 2020 saw a proliferation of COVID-19 cases, resulting in an increased disease burden and widespread travel restrictions. Consequently, the management of specimen validity testing procedures was adversely affected, as indicated by published data. However, as the number of COVID-19 infections started to decrease and healthcare facilities gradually resumed their operations, the market gradually recovered, and the procedural volume returned to pre-pandemic levels. While the outbreak initially hampered the growth of the specimen validity testing industry, it is encouraging to observe its recovery as the pandemic situation improved.
 

Specimen Validity Testing Market Trends

The increasing incidence of illicit drug abuse is anticipated to contribute to the growth of the specimen validity testing industry. Illicit drug abuse poses significant challenges to public health and safety. For instance, according to the National Survey on Drug Use and Health (NSDUH), in 2021, 52.5 million people globally were estimated to use marijuana, a most commonly used illicit drug. In response, various industries, such as workplaces, law enforcement agencies, and drug rehabilitation programs, have increased their focus on drug testing to ensure safety, compliance, and effective treatment. This increased demand for drug testing creates a parallel need for specimen validity testing to verify the integrity of samples and prevent sample manipulation or adulteration. Additionally, factors such as rising economic conditions, regulatory landscapes, and advancements in drug testing technologies is proving beneficial for the revenue growth.  
 

Specimen Validity Testing Market Analysis

Based on product & services, the market is segmented as product and services. The product segment is further divided into assay kits, reagents and calibrators and disposables. The product dominated the specimen validity testing market in 2022 accounting for more than 67% of the total market share. This high market share is owing to several benefits offered by products in the early and accurate detection of specimen and samples. These products are designed to detect various forms of sample tampering or adulteration, such as dilution, substitution, or the addition of adulterants or masking agents. SVT products offer enhanced accuracy of drug testing and act as deterrent against sample manipulation or adulteration attempts.
 

Based on type, the market is segmented as laboratory testing and rapid/POC testing. The laboratory testing segment dominated the specimen validity testing market in 2022 accounting for more than 60% of the total market share. This high market share is owing to several clinical benefits offered by laboratory testing for the detection of samples and specimen. These laboratories are equipped with technological advanced devices and equipment along with highly qualified and well-trained staff. Additionally, laboratory testing provides a comprehensive analysis of biological samples to assess their integrity and authenticity. This comprehensive analysis helps in identifying any abnormalities or inconsistencies in the samples, ensuring accurate and reliable drug test results. Moreover, increased accuracy and reliability, expert interpretation, and consultation along with research and development activities is expected to augment the market growth in the estimated timeframe.
 

Based on end-use, the specimen validity testing market is segmented as drug screening laboratories, drug rehabilitation centers, pain management centers and others. The drug screening laboratories held the highest market share in 2022 and is projected to grow at 6.5% CAGR from 2023-2032. This high market share is owing to the availability of advanced detection and screening equipment and services to assist a wide customer base. Enhanced operability and accessibility to comprehensive range of tests incorporating identification of illicit drug use is expected to drive the market growth. Increasing prevalence of adulteration and alteration with urine sample for testing is expected to boost the industry growth. Thus, accessibility to better analysis coupled with highly advance and accurate testing products will boost product adoption rate in drug screening laboratories, thereby propelling the segmental revenue.
 

U.S. specimen validity testing market with a majority industry share in 2022 and is predicted to reach around USD 1.9 billion by 2032. This market share is attributable to numerous variables including the presence of key business players, an increase in the number of illicit drug use, and rising awareness regarding the specimen validity testing among others. Furthermore, the rising prevalence of prescription diversion, a growing population of drug abusers, and the implementation of stringent regulations modulating drug screening are projected to boost market expansion in the region. However, venturing government funding availability, increased initiatives to boost drug screening, and the societal effect of drug addiction are expected to accelerate product adoption rates, hence quickening corporate growth. Thus, the aforementioned factors is expected to drive the regional revenue share positively.
 

Specimen Validity Testing Market Share

Some of the major players operating in the specimen validity testing market are

• Abbott Laboratories
• ACM Global Laboratories
• Alfa Scientific Designs, Inc.
• American Bio Medica Corporation
• Danaher Corporation
• Express Diagnostics
• GenomeWeb LLC.
• Genway Biotech, Inc.
• LabCorp
• Premier Biotech, Inc.
• Quest Diagnostics Incorporated.
• Sciteck, Inc.
• SureHire
• Thermo Fisher Scientific Inc.

These leading market players are implementing advanced technologies to cater to the large unmet needs of the consumers. These players focus on strategic partnerships, new product launch & commercialization for market expansion. Furthermore, these players are heavily investing in research that allows them to introduce innovative products and garner maximum revenue in the market.
 

Specimen Validity Testing Industry News:

• In April 2020, Nona Scientific announced the launch of NonaClear 2.0, an advance specimen validity testing product. This test can accurately detect synthetic urine, as well as multiple methods of subversion. This innovative product launch helped the company to increase their product portfolio and enhance their business revenue.
   
• In June 2018, ACM Global Laboratories announced the acquisition of ABS Laboratories, a manufacturer and provider of medical devices including specimen validity testing equipment. This acquisition helped the company to increase their market presence and enhance their customer base.
   

Specimen validity testing market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032, for the following segments:

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By Product & Services

• Product 
• Assay Kits
• Reagents and Calibrators
• Disposables

• Service

By Type

• Laboratory Testing
• Rapid/POC Testing

By End-use

• Drug Screening Laboratories
• Drug Rehabilitation Centers
• Pain Management Centers
• Others

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Poland
  • Sweden
  • The Netherlands
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Indonesia
  • Thailand
  • Philippines
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Colombia
  • Chile
  • Peru
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Israel
  • Egypt
  • Turkey