U.S Direct to Consumer Laboratory Testing Market Size & Outlook, 2025-2033

U.s Direct-to-Consumer Laboratory Testing Market Size

The U.S. direct-to-consumer (DTC) laboratory testing marke size was valued at USD 1.50 billion in 2024 and is projected to reach from USD 1.67 billion in 2025 to USD 3.90 billion by 2033, growing at a CAGR of 11.2% during the forecast period (2025-2033).

The estimated market for U.S. DTC laboratory testing includes clinical and pathological testing, excluding the DTC genetic testing segment for ancestry and therapeutic testing.

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U.s Direct-to-Consumer Laboratory Testing Market Drivers

Diagnosis of a disease is the most important step in commencing the treatment for it. Diagnostics field is significantly growing and advancing technologically in the U.S. Direct-to-consumer (DTC) laboratory testing enables ordering diagnostic tests kit at home. Confidentiality and accuracy of the tests are maintained by service provider laboratories, which stands as the priority for U.S. direct to consumer laboratory testing market. Hectic work life and rising awareness regarding monitoring personal health through complete blood count (CBC) and blood glucose tests, are some of the important factors driving the U.S. direct to consumer laboratory testing market.

In the U.S., increasing prevalence of various lifestyle associated and infectious diseases such as obesity, hypertension, diabetes, Cancer, and STD is driving the demand for direct-to-consumer laboratory services for early diagnosis. Similarly, the country has a huge population suffering from various chronic diseases, which is influencing the need for regular checkup of risk of disease.  For instance, approximately every 40 seconds, an American fall prey to myocardial infarction. During 2013-2016, about 28.5 million, or 11.7%, of American adults had cholesterol issues. The direct-to-consumer laboratory is a convenient method for routine health checkup for the health-conscious population.

Countries Insights

Direct-to-consumer (DTC) laboratory offers at-home lab tests without lab visits or doctor referrals.  People in the U.S. have become very health-conscious and pay significant attention to early detection of any diseases. This has escalated the growth of direct-to-consumer (DTC) laboratories as they provide diagnostic results within 24 to 48 hours. In line with the growing demand for quick, affordable, and accurate tests, several players are active in the market and most of them are equipped with technologically advanced equipment and techniques for sample analysis. For instance, ‘ARUP Laboratories’ use advanced technology such as specimen processing workstations, interface robotic systems, automated transport system, thawing & mixing work cells, and high-speed automated sorters. Recent technological advancements in tests have made medical screening, accurate diagnosis, and monitoring more efficient. DTC laboratories offer their services through online channel.

From the last few years, the U.S. has been witnessing a considerable shift in the trend towards home-based diagnostic devices. For instance, in November 2018, Pixel by LabCorp launched a self-collected testing kit for screens for wellness, heart diseases, diabetes, and colorectal cancer. Apart from the product launch, several players active in the market are opting for different growth strategies for business expansion such as merger and acquisitions and partnership and collaboration with various organizations and leading diagnostic laboratory.

Type Insights

The market is segmented into complete blood count, cholesterol level testing, HIV testing, pregnancy testing, substance abuse testing, urinalysis, stool testing, glucose testing, and other types. Among types, complete blood count segment is expected to account for highest share. Complete blood count test is recommended for the diagnosis and monitoring of general health and wellness. In addition to this, it aids in the diagnosis of anemia and several other infectious diseases. In the U.S., increasing prevalence of infectious diseases is one of the major causes of mortality and morbidity. As per the CDC, around 3.7 million people visited hospital for primary diagnosis of infectious and parasitic diseases in 2016. Cholesterol level testing covers cholesterol, triglycerides, high-density lipoprotein, and low-density lipoprotein parameters to monitor the risk of stroke, heart attack, and peripheral artery disease. In the U.S., people are increasingly focusing on knowing their cholesterol level to understand their health status. HIV testing is used to keep tabs on the health of HIV patients and to prevent the prevalence of new infections. The increasing number of cases of HIV Infection in the U.S. is one of the major factors driving the HIV testing segment. As per the Center for Disease Control & Prevention (CDC), it was estimated that around 13% of the Americans were infected with HIV in 2016.

Pregnancy testing is witnessing a huge demand from working women for quick results and surety. Over the last few years, U.S. has been witnessing considerable rise in the unplanned pregnancy and awareness about the benefits of early detection. As per the CDC, rate of unplanned pregnancy in the U.S. is way higher than in any other developed country. In 2017, around 52% of unintended pregnancies were registered, out of which 43% resulted from inconsistent or incorrect use of contraceptives, and only 5% resulted from contraceptive failure. Substance abuse testing detects the presence of illicit drugs, prescription drugs, and alcohol. Illegal drugs consist of cocaine or heroin, and prescription medications consist of painkillers, sleeping pills, and tranquilizers. All of them can turn into addiction if overused. As per the American Addiction Center, around 21 million Americans have developed at least one addiction. Urinalysis is a diagnostic test performed to detect urinary tract infections, kidney diseases, and diabetes. It is an integral part of a routine medical exam, pregnancy test, pre-surgery preparation, and liver test. Sometimes, it is also recommended for abdominal pain, back pain, frequent or painful urination, blood in urine, and other urinary problems.

Stool testing is used for the diagnoses of certain conditions affecting the digestive tract, viral and bacterial infections, poor nutrient absorption, and cancer. Increasing prevalence of digestive diseases following the rising consumption of unhealthy food, lack of exercise, and hereditary factors are positively influencing the demand for stool analysis testing. According to the U.S. Department of Health & Human Services, around 15.3 million people were diagnosed with stomach ulcer in 2017. Similarly, around 22.4 million people visited physician for digestive problems in 2018.

List of key players in U.S Direct to Consumer Laboratory Testing Market

1. ANY LAB TEST NOW
2. DirectLabs LLC
3. EverlyWell Inc.
4. HealthCheckUSA
5. Home Access Health
6. Pixel by LabCorp (Laboratory Corporation of America Holdings)
7. Ulta Lab Tests LLC
8. MyMedLab Inc.
9. Quest Diagnostics Incorporated
10. Request A Test
11. Sonora Quest Laboratories
12. Walk-In Lab LLC.
13. WellnessFX.

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