U.S. Direct-to-consumer Laboratory Testing Market by Application (Genetic Testing {Ancestry, Carrier Status, Disease Risk [Cancer, Neurological, Cardiac]}, Diabetes, Thyroid, STD, Routine, CBC), Sample Type (Saliva, Urine, Blood) - Forecast to 2030

The U.S. Direct-to-Consumer Laboratory Testing Market is projected to reach $3.91 billion by 2030, at a CAGR of 10.4% from 2024 to 2030.

Direct-to-consumer or DTC tests are the ones that are self-ordered by consumers without the involvement of their healthcare providers. The sample that is collected from the consumer is processed at a laboratory, and the results are then sent directly to the consumer.

The growth of the U.S. direct-to-consumer laboratory testing market is driven by several factors, including the rising incidence of chronic diseases and sexually transmitted diseases, high disposable income, increased consumer awareness, increasing awareness about personal health management, benefits of DTC laboratory testing such as high convenience, affordability, and accessibility, increasing prevalence of chronic and infectious diseases, increasing cost of healthcare, increasing consumer awareness about ancestry/genealogy testing, rising elderly population, and the growing interest in predictive testing. Factors such as the growing adoption of telehealth, expansion in emerging economies, and increasing penetration of pharmacogenomic testing in DTC laboratory testing are a few of the opportunities that would help grow the market in the future. Patients’ genetic data privacy concerns, misinterpretation of test results, and lack of professional medical counseling could be considered challenges for the U.S. direct-to-consumer laboratory testing market. However, sample integrity and interference issues, regulatory concerns, lack of reimbursement, and the limited test portfolio compared to conventional laboratory testing restrain the growth of the market.

Inexpensive Direct-to-Consumer Laboratory Tests as Compared to Traditional Laboratory Tests

Over the last few years, consumers have been actively participating in decisions affecting their health, enabling people to be informed of their health and lead healthy lifestyles. Clinical laboratory testing is an important part of healthcare. These tests can be ordered online or bought from pharmacies without any prescription, making them easy to access for consumers. The easy accessibility and convenience of ordering the tests online also attract customers.

Direct-to-consumer laboratory testing is gaining popularity in the U.S. This is due to its several advantages over traditional laboratory testing. In the U.S., healthcare is very expensive when not reimbursed by insurance. Laboratory testing can range from USD 100 to over USD 1,000 and varies depending on the type of test and location. DTC laboratory testing offers an affordable alternative to traditional laboratory testing. DTC laboratory testing can be up to ten times less expensive than traditional testing.

Due to the significant price difference, DTC laboratory testing is accessible to people since the tests can be ordered even from an online platform. The high consumer awareness regarding their health status also supports the high adoption of DTC laboratory testing in the U.S.

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Declining Costs of Sequencing to Make DTC Genetic Testing More Accessible

Sequencing is the process of determining the nucleic acid sequence in a DNA or RNA sample. The advent of NGS has accelerated biological & medical research and discovery, allowing biologists and medical scientists to collect massive amounts of DNA sequence data rapidly and cost-effectively. Recent advancements in genomics research have substantially reduced the costs of genome sequencing procedures. In the past few years, the availability of advanced NGS technologies has lowered sequencing costs and significantly reduced the time required for DNA sequencing. According to the National Human Genome Research Institute (NHGRI), the cost of sequencing a human genome decreased from USD 29,092 in 2010 to USD 562 in 2021.

In direct-to-consumer laboratory testing, sequencing is used to conduct various types of genetic testing, such as ancestry testing, disease risk assessment testing, and carrier status testing. Cheaper genome sequencing can help reduce the cost of overall DTC genetic testing, making it more affordable and accessible.

In 2003, the human genome was sequenced for the first time, costing USD 2.7 billion. However, by 2013, the price of sequencing an average human genome had reduced to just a few thousand dollars. As of 2021, genome sequencing costs had declined to around USD 450-850. With the rising demand for sequencing services, providers are expected to further lower prices in the coming years as their sequencing costs per sample are likely to reduce. Market players are focused on launching advanced NGS products that can reduce sequencing costs. For instance, in September 2022, Illumina, Inc. (U.S.) unveiled a new line of DNA sequencing machines, which the company claims can sequence the human genome for just USD 200.

Key Findings of the U.S. Direct-to-Consumer Laboratory Testing Market Study:

The Genetic Testing Segment is Expected to Account for the Largest Share of the Market in 2024

Among all the applications, in 2024, the genetic testing segment is expected to account for the largest share of the market. DTC genetic tests are those that are provided directly to consumers without involving a healthcare provider. This testing generally offers a wide range of genetic tests that can be helpful to provide consumers with information about their ancestry, health risks, and traits. This segment is driven by factors such as increasing awareness regarding personal health management, high curiosity about self-ancestry, strong marketing strategies by the companies, rising prevalence of various genetic & chronic diseases, and high demand for personalized testing services.

The Blood Segment is Expected to Account for the Largest Share of the Market in 2024

Among sample types, in 2024, the blood segment is expected to account for the largest share of the market. The blood sample is collected from consumers to test conditions such as diabetes, routine clinical testing, thyroid function, and sexually transmitted disease testing, among others, in order to gain insight into how the organs are functioning. Blood samples are collected using a lancet or a needle that is present in the kit provided to carry out the test. This segment is driven by factors such as a large variety of available tests using blood samples. Increasing prevalence of various chronic diseases and increasing consumer awareness regarding the monitoring of chronic diseases.

Key Players

The key players profiled in the U.S. direct-to-consumer laboratory testing market report are Quest Diagnostics Incorporated (U.S.), Laboratory Corporation of America Holdings (U.S.), EverlyWell, Inc. (U.S.), DirectLabs, LLC (U.S.), Ancestry.com, LLC (U.S.), 23andMe Holding Co. (U.S.), MyMedLab, Inc. (U.S.), ANY LAB TEST NOW (U.S.), LetsGetChecked, Inc. (U.S.), and Myriad Genetics, Inc. (U.S.).

The report includes a competitive landscape based on an extensive assessment of the market based on application and sample type. The report also provides insights into the presence of major market players and their key growth strategies in the last three to four years.

Report Summary:

Scope of the Report:

U.S. Direct-to-Consumer Laboratory Testing Market, by Application

• Genetic Testing
  • Ancestry/Genealogy
  • Disease Risk Assessment
    • Cancer
    • Cardiovascular Diseases
    • Neurological Diseases
    • Other Diseases
      (Note: Disease risk assessment testing for other diseases includes celiac disease, alpha-1 antitrypsin deficiency, factor XI deficiency, glucose-6-phosphate dehydrogenase deficiency, etc.)
  • Carrier Status
  • Other Genetic Tests
    (Note: Other genetic tests primarily include direct-to-consumer genetic testing for pharmacogenomics, skin care DNA tests, and nutrigenomic testing)
• Diabetes Testing
• Routine Clinical Testing
• Thyroid Function Testing
• Sexually Transmitted Disease Testing
• Other Applications
  (Note: Other applications primarily include drug screening, infectious disease testing [Tuberculosis, Chicken pox, Measles, Mumps, Rubella, COVID, UTI], allergy testing, fertility, pregnancy, and nutritional testing.)

U.S. Direct-to-Consumer Laboratory Testing Market, by Sample Type

• Blood
• Saliva
• Urine
• Other Samples
  (Note:Other samples primarily include stool, nasopharyngeal swab, vaginal swab, buccal swab, and semen.)

Key questions answered in the report: