The DTC Laboratory Testing Market is projected to reach $7.92 billion by 2030, at a CAGR of 10.9% during the forecast period 2023–2030.
The growth of the direct-to-consumer laboratory testing market is driven by the increased awareness about personal health management, the benefits of DTC laboratory testing such as convenience, affordability, and accessibility, the increasing prevalence of chronic & infectious diseases, increasing healthcare costs, rising consumer awareness about ancestry/genealogy testing, and the rising elderly population. However, sample integrity and interference issues, regulatory concerns, the lack of reimbursements, and the lack of extensive test portfolios compared to conventional laboratory testing are restraining the growth of this market.
The growing adoption of telehealth, the rising popularity of DTC laboratory testing in emerging economies, and the increasing penetration of DTC pharmacogenomic testing are expected to generate growth opportunities for the players operating in this market. However, concerns regarding the security and privacy of genomic data, misinterpretation of test results, and the lack of professional medical counseling are major challenges to market growth.
Top 10 Companies Operating in DTC Laboratory Testing Market
Quest Diagnostics Incorporated (U.S.)
Incorporated in 1990 and headquartered in New Jersey, U.S., Quest Diagnostics Incorporated is engaged in providing diagnostic testing services. The company has two reportable business segments, namely, Diagnostic Information Services and Diagnostic Solutions and offers products for the direct-to-consumer laboratory testing market through the Diagnostic Information Services segment.
Quest Diagnostics has laboratories, patient service centers, offices, and other facilities around the U.S. and in selected locations outside the U.S., and more than 7,100 patient access points all over the U.S. Furthermore, the company has its laboratories in Finland, Puerto Rico, and Mexico, and provides its services in nearly 130 countries with a direct presence in Ireland, Mexico, and India.
Laboratory Corporation of America Holdings (U.S.)
Incorporated in 1995 and headquartered in North Carolina, U.S., Laboratory Corporation of America Holdings is a life sciences company. It provides important diagnostic information to hospitals, doctors, patients, pharmaceutical companies, and researchers to make confident decisions.
The company operates through two reportable business segments, namely, Labcorp Diagnostics (Dx) and Labcorp Drug Development (DD). The Labcorp Diagnostics (Dx) segment is an independent clinical laboratory business with a wide range of core testing and specialty testing conducted through an integrated network of primary and specialty laboratories across the U.S. This segment is engaged in offering products for direct-to-consumer laboratory testing through the company’s Labcorp OnDemand platform.
Furthermore, the company offers clinical diagnostic testing services only in North America, while its clinical development, central laboratory, and clinical development business support clinical activity in more than 100 countries. The company has nearly 2,000 patient service centers and over 6,000 in-office phlebotomists in customer offices and facilities throughout the U.S.
23andMe Holding Co. (U.S.)
Founded in 2006 and headquartered in California, U.S., 23andMe Holding Co. is a consumer genetics and research company. The insights from its phenotypic and genetic information database can be used to prevent, diagnose, and treat diseases.
The company offers direct-to-consumer genetic testing, which provides consumers with information about genetic health risks, traits, and ancestry. Additionally, the company has received multiple FDA authorizations for its over-the-counter carriers and health status reports. 23andMe Holding is the only company with clearance, FDA authorization or an exemption from premarket notification for all cancer predisposition, carrier status, genetic health risk and pharmacogenetics reports offered to patients. As of 31st March 2022, the company had a portfolio of over 60 health reports for customers in the U.S.
23andMe operates in two segments, namely, Consumer & Research Services and Therapeutics. It provides products for the direct-to-consumer laboratory testing market through the Consumer & Research Services segment. This segment provides personal genome services, research services and telehealth business. The Therapeutics segment provides phenotypic and genetic information by using the genetic insights database to develop novel therapies, licensing intellectual property associated with drug targets identification and expenses of candidates for therapeutic products under clinical development.
Myriad Genetics, Inc. (U.S.)
Founded in 1991 and headquartered in Utah, U.S., Myriad Genetics, Inc. is a precision medicine and genetic testing company. It provides insights that help individuals and healthcare providers to better treat, detect, and prevent disease. The company commercializes and develops genetic tests that help detect the risk of disease progression and guide treatment solutions for medical specialties.
Myriad Genetics operates in a single reporting segment. However, the company segregates its revenue as Testing Revenue and Other Revenue. The Testing Revenue includes different categories of services, including cancer, tumor profiling, pharmacogenomics, prenatal, and autoimmune.
Everlywell, Inc. (U.S.)
Founded in 2015 and headquartered in Texas, U.S., Everlywell, Inc. is a healthcare company providing at-home lab tests, supplements, virtual care, and products that support patient health & wellness. The company excels in offering affordable and convenient laboratory testing directly to customers. It also offers telehealth solutions and a wide range of at-home lab tests. For the direct-to-consumer market, the company offers testing in Nutritional Health, General Wellness, Sexual Health, Women’s Health, Men’s Health, and COVID-19 categories.
Everlywell, Inc. has a presence in 49 states in the U.S. However, it currently does not offer tests to residents of New York due to the state’s regulations around testing. The company’s partner laboratories are CLIA-certified and have both state and federal certifications.
“Meticulous Research in its latest publication on Direct-to-consumer (DTC) Laboratory Testing Market has predicted the growth of 10.9% during the forecast year 2023-2030”
DirectLabs, LLC. (U.S.)
Founded in 1993 and headquartered in Los Angeles, U.S. DirectLabs, LLC. is engaged in offering direct access laboratory testing and a wide range of health and wellness blood chemistry tests. The company aims to assist in preventing and detecting early disease by providing its customers with affordable direct-to-consumer laboratory testing services.
Furthermore, it offers services all over the U.S. except in New Jersey, New York, and Rhode Island and direct-to-consumer laboratory testing at over 3000 locations across the U.S. The company also provides test results online within 24–48 hours. Its partner laboratories are CLIA-certified and regulated by appropriate governmental agencies.
Ancestry.com, LLC (U.S.)
Founded in 1996 and headquartered in Utah, U.S., Ancestry.com, LLC is a family history and consumer genomics company. The company has built a collection of family history records and offers products and services in genomics that help people gain valuable insights about their origins. It also has a consumer DNA network of over 22 million people from over 80 countries of origin.
Ancestry.com, LLC has a wide geographic presence in over 60 countries worldwide. It has offices in San Francisco, California; Dublin, Ireland; London and Melksham, England; Sydney, Australia; Toronto, Canada; Grafing (near Munich), Germany; and Paris, France, with over 1,400 employees worldwide.
MyMedLab, Inc. (U.S.)
Founded in 1993 and headquartered in Missouri, U.S. MyMedLab, Inc. is a provider of direct-to-consumer laboratory testing services. It has a large portfolio of direct-to-consumer tests that enable consumers to make informed healthcare choices. The company offers its laboratory tests at an affordable price and gives its customers direct access to the test.
The company has partnered with Quest Diagnostics Incorporated (U.S.) for all blood draws. It also has a Personal Health Record (PHR), which contains the patients’ testing results, past orders, medications, medical conditions, and other personal health information.
ANY LAB TEST NOW (U.S.)
Founded in 1992 and headquartered in Georgia, U.S., ANY LAB TEST NOW is a direct-access lab testing franchise company engaged in providing a wide range of medical laboratory tests directly to customers. The company is affiliated with accredited laboratories throughout the U.S. and offers a wide variety of laboratory tests for general health, COVID-19, drugs & alcohol, DNA, STD, and other tests for individual consumers, businesses and government entities.
ANY LAB TEST NOW has a presence across the U.S. through its more than 210 independently owned and operated locations.
Thorne HealthTech, Inc. (U.S.)
Incorporated in 2010 and headquartered in New York, U.S., Thorne HealthTech, Inc. is a health technology company that provides a personalized testing solutions portfolio. It provides its customers, including consumers, health professionals and professional sports teams, with direct access to the company’s products through mobile, web and Amazon channels. The company operates in one reportable segment.
Thorne HealthTech, Inc. has a major presence in the U.S. and also operates in over 32 countries worldwide. The company is expected to continue to expand internationally into more regions and countries. Thorne HealthTech, Inc. also operates in the direct-to-consumer laboratory testing market through its subsidiary WellnessFX, Inc. (U.S.). WellnessFX is engaged in offering advanced blood tests directly to the consumer. Through its wide range of product portfolio, the company offers direct access to advanced biomarker tests to measure cardiovascular, metabolic, hormonal, and nutritional health.
LetsGetChecked, Inc. (U.S.)
Founded in 2015 and co-headquartered in Dublin (Ireland) and New York (U.S.), LetsGetChecked, Inc. is a healthcare solutions company that provides solutions for managing health from home through direct access diagnostic testing and virtual care. The company offers laboratory tests with at-home sample collection kits for a wide range of health conditions such as sexual health, cholesterol, thyroid, diabetes, COVID-19, and others.
The company has a geographic presence in the U.S., the U.K., and other European countries. As of 2022, the company has delivered over 10 million tests and partnered with more than 300 business clients in the U.S., the U.K., and other European Union countries.
Popular Mentions: Color Health, Inc. (U.S), Laboratoire CERBA (France), MyHeritage Ltd. (Israel), Genova Diagnostics Inc. (U.S.), Gene by Gene, Ltd. (U.S.), Metropolis Healthcare Limited (India), Vitagene (U.S.), SRL Limited (India), Hirotsu Bio Science (Japan), Ambry Genetics Corporation (U.S.), Mapmygenome India Limited (India), FamilyTreeDNA (U.S.), Genera (Brazil), Veritas Intercontinental (Spain), Medichecks.com Ltd. (U.K.), EasyDNA (U.S.) (Subsidiary of Genetic Technologies Limited (Australia), Cerascreen Biotech LLC (U.K.), and Living DNA Ltd (U.K.).
Authoritative Research on the Direct-to-consumer (DTC) Laboratory Testing Market – Global Opportunity Analysis and Industry Forecast (2023-2030)
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