The U.S. DTC Wellness Testing Market is projected to reach $4,946.3 million by 2032 from $878.9 million in 2022, at a CAGR of 18.86% during the forecast period 2022-2032. The growth in the U.S. DTC wellness testing is expected to be driven by the shift of the healthcare industry in the U.S. from being physician-focused to being consumer-focused. In addition, the rise in awareness related to DTC wellness testing among consumers and growing consumer convenience are driving the demand for the U.S. DTC wellness testing market during the forecast period.

Market Lifecycle Stage

DTC wellness tests are promoted directly to consumers via commercials, televisions, and internet, thereby resulting in increased awareness related to DTC products. Consumers can get the information about the test that they have ordered through the company’s online portal without visiting any physician or through the insurance companies. Major companies such as LabCorp, Quest Diagnostics, and Everlywell, Inc. have dedicated their efforts to developing reliable consumer-facing wellness testing services.

Impact

The presence of DTC wellness testing providers in the U.S. has a major impact on the market. Companies such as Everlywell, Inc. were already gaining traction in the DTC health market with their product offerings such as at-home health and wellness products, including collection kits for infectious diseases such as syphilis, human papillomavirus, hepatitis C, HIV, and trichomoniasis. Multi-pathogen sexually transmitted infection (STI) laboratory tests based on at-home sample collection are becoming available from a number of vendors.

Impact of COVID-19

The majority of wellness testing took place in healthcare settings in the U.S. during the COVID-19 pandemic, and the DTC testing market emerged quickly with companies marketing at-home tests with the approval of U.S. FDA. These tests are regulated at both the federal and state levels. Major giants such as LabCorp and Everlywell, Inc. began marketing at-home collection kits directly to consumers during the pandemic. The healthcare professionals reviewed the tests after the consumer had initiated or completed the purchase of any wellness testing based on the requirements from the company’s website.

Companies also started marketing diagnostic and serological COVID-19 tests directly to consumers in the middle of the pandemic. The sample was collected from the patient at home or sent to the laboratory, with negligible involvement of the healthcare provider. The majority of the companies received emergency use authorization (EUA) for such testing. Furthermore, at-home tests faced several challenges as these tests raised concerns during the process of collection and analysis, as well as the shipment condition. Also, there was a risk of false-positive or false-negative results, depending on several factors, such as the use of inadequately validated assays and testing outside the diagnostic window.

Market Segmentation:

Segmentation 1: by Test Type

•   Micronutrients
•   Hormones
•   COVID-19 DTC Test
•   Food Sensitivity
•   Food Intolerance
•   Infectious Disease Tests
•   Other Test Type

Among the test type of the U.S. DTC wellness testing market, the micronutrients segment dominated in the year 2021. This is due to an increasing number of consumers undertaking vitamin tests and rising awareness among consumers related to DTC wellness testing.

Segmentation 2: by Offering Type

•   Test Panel
•   Test Strips
•   Digital Monitoring Instruments
•   Other Offering

Among the offering types of the U.S. DTC wellness testing market, the test panel segment dominated in the year 2021, owing to an increasing number of test panels by the companies in the DTC wellness testing space focused on various tests.

The technologies powering molecular diagnosis of DTC wellness testing in the U.S. are in a state of rapid evolution to aid in overcoming challenges associated with the utilization of these tests, including the improvement of clinical utility. These rapidly advancing DTC testing techniques are primed to revolutionize medical diagnostics and treatment for the better. Not only are these tests becoming more useful in a broader range of clinical paradigms among consumers at home, but they are also assisting in a more exploratory view to cater to a holistic approach toward the treatment of various chronic and acute diseases. In addition, consumers have access to various testing panels for men’s and women’s health, general wellness, food or allergen sensitivities, and women’s health test panel.

Segmentation 3: by Distribution Channel

•   Online
•   Over-the-Counter (OTC)

Among the distribution channels of the U.S. DTC wellness testing market, the online segment dominated in the year 2021. Online channels held the major share, owing to the rising internet penetration, awareness about DTC testing, and increasing number of companies involved in manufacturing kits for wellness in the U.S. The products are available to the consumer on the company’s website, from where they can purchase the required test. Online sales have been a major proponent of the industry, providing easy access and multiple options. The companies are forming strategic partnerships with e-commerce giants. For instance, in September 2021, Nordstrom collaborated with Viome Life Sciences, Inc. to embrace its wellness category under a new-brand retail partnership. The company aims to sell Viome's health intelligence test online and expand distribution in the selected stores by 2022.

Segmentation 4: by Sample Type

•   Blood
•   Urine
•   Saliva
•   Others

Among the sample types of the U.S. DTC wellness testing market, the blood segment dominated in the year 2021. The market growth of this segment can be attributed to an increase in the number of DTC wellness testing companies offering blood-based test kits, companies involved in at-home testing kits, and rising acute and chronic ailments among the U.S. population. As a result, the market for DTC wellness testing has increased and is anticipating incredible growth in the near future.

Segmentation 5: by Region

•   Southern U.S.
•   Midwest U.S.
•   Mid-Atlantic U.S.
•   West U.S.
•   Southwest U.S.
•   New England

Among the region of the U.S. DTC wellness testing market, the Southern U.S. dominated in the year 2021. The Southern U.S. consists of the states of Florida, North Carolina, Georgia, Virginia, Tennessee, Kentucky, South Carolina, Alabama, Louisiana, Arkansas, Mississippi, West Virginia, and District of Columbia. This is primarily due to the presence of market-leading service providers, such as Quest Diagnostics, Laboratory Corporation of America Holdings, Cue. and Myriad Genetics, and 23andMe, Inc., having highly functioning facilities in the state and providing DTC services at the ease of customer convenience.

Recent Developments in the U.S. DTC Wellness Testing Market

•   In March 2021, 23andMe, Inc. and VG Acquisition Corp. entered into a definitive merger agreement with 23andMe, Inc. This business combination resulted in the company being valued at approximately $3,500 million.
•   In October 2021, Everlywell, Inc. acquired Natalist, a company that offers consumers conception and pregnancy essentials. Everlywell, Inc. offers DTC wellness products such as pregnancy tests, ovulation tests, and prenatal supplements.
•   In March 2021, Everlywell, Inc. acquired PWNHealth and Home Access Health Corporation and formed the parent company Everly Health. All these companies were acquired to support more than 20 million people annually in all 50 U.S. states, Canada, and Puerto Rico.
•   In February 2022, Kindbody acquired Vios Fertility Institute, a network of fertility clinics. The acquisition helped the company to double its footprint in the U.S. to 26 clinics.
•   In March 2022, Modern Fertility (Ro) acquired Dadi, a company specialized in sperm testing, storage, and analysis. The company added $150 million funding and entered the female fertility product market.
•   In May 2021, Modern Fertility was acquired by Ro, a digital health company, and added reproductive health to its growing platform at an approximate valuation of $225 million.

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How can this report add value to an organization?

Innovation Strategy: Companies in the U.S. DTC wellness testing are involved in continuous innovation and strategy related to wellness testing. For instance, in September 2022, IHD launched two direct-to-consumer (DTC), at-home diagnostic tests, COVID-19 neutralizing antibody (CNAB) test, and an anti-mullerian hormone (AMH) test. Similarly, in January 2022, Kindbody company launched at-home new fertility test, a new line of consumer products priced at $169.0, and raised $62 million in Series C growth capital. The company has also expanded to new regions in the U.S. throughout the second half of last year.

Growth/Marketing Strategy: Companies in the DTC wellness testing market are involved in promoting wellness products as part of their marketing strategy. For instance, in October 2022, Quest Diagnostics ran the first campaign with the R/GA agency, as it pursues to be a direct-to-consumer testing agency, and with this, the company is promoting its own direct-to-consumer offerings.

Competitive Strategy: Key players in the U.S. DTC wellness testing analyzed and profiled in the study provides wellness products and services such as hormones, micronutrients, food sensitivity, and food intolerance. Moreover, a detailed competitive benchmarking of the players operating in the U.S. DTC wellness testing has been done to help the reader understand how players stack against each other, presenting a clear market landscape. Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the market.

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