Direct to consumer laboratory testing is also known as patient-ordered laboratory testing. A variety of tests are now available for direct to consumer testing. The growing market for direct-to-consumer laboratory testing may promote awareness of health issues and genetic diseases, which will allow patients to take a more proactive role in their healthcare. With advances in technology, the completion of the sequencing of the human genome and the pressures of the pandemic, direct to consumer lab testing is becoming increasingly popular. Still, clinical laboratories are an essential part of the health industry.  It is estimated that the vast majority of physician’s diagnoses are a result of laboratory tests.  In addition to diagnosing patients, clinical lab testing is performed to evaluate disease progression, monitor drug treatment and conditions, determine individual therapy, and several other reasons.  

Several trends are continuing to shape the direct-to-consumer laboratory testing market including the growing demand for early disease detection and diagnosis, personalized medicine, importance of disease monitoring, consumer acceptance and expanded technologies. This report, The U.S. Market for Direct-to-Consumer (DTC) Laboratory Testing, examines these and other essential market trends.

Additionally, issues and trends explored in this report include:

• Demographics and Aging Population
• Growing Incidence of Disease
• Regulatory Environment
• Consumer Driven Health Care
• Emphasis on Preventative Healthcare
• Developments in Personalized Medicine
• Mobile Devices
• Informed Consent
• Payment Structure
• Sales by Distribution Channel
• Large Diagnostic Companies and DTC
• Telehealth and DTC Testing

Leading companies profiled in the report include:

• 23andMe
• Any Lab Test Now
• Color Genomics
• Direct Laboratory Services
• EasyDNA
• Everlywell
• Laboratory Corporation of America
• MyMedLab
• Medichecks.com
• Ombre Gut Health (formerly Thryve)
• Quest Diagnostics
• Request A Test

Scope

The scope of the report is direct to consumer (DTC) laboratory testing. This does not include point of care testing or over the counter testing (i.e., pregnancy testing) because the laboratory is not needed to run the test or interpret the results. This report was assembled using both secondary and primary data.  Data from Kalorama Information's previous DTC Laboratory Testing report, in addition to company annual reports, trade publications, government and medical literature were used as a foundation for estimates and forecasts.  Interviews with executives at 8 DTC laboratory testing companies were conducted and are a key source of estimates for the market.  Kalorama Information focuses on estimates of manufacturer revenues for business planning.  The geographical scope is the United States.

The base year for data was 2021. The forecast years are 2022-2026 with compound annual growth rates (CAGRs) provided for 2021-2026 periods for each segment covered.  The forecasted market analysis for 2021-2026 was largely based on demographic trends, new developments, and innovative technology.

It is important to note that the market areas covered by this report are evolving very quickly, and that some of the company and technology information may be outdated even as the report goes to press. Kalorama is fully aware of these developments.  Even though some of the details may have changed by the time this report is published, the major themes, players and issues remain unchanged.