Published Year: 2021
Global Direct-to-Consumer Genetic Testing Market: Focus on Direct-to-Consumer Genetic Testing Market
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U.S. DTC Wellness Testing Industry and Technology Overview
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.
U.S. DTC Wellness Testing 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 testing 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 type 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 channel 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 type 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 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 customers 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 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.
Demand – Drivers and Limitations
Following are the demand drivers for U.S. DTC wellness testing:
• Rising Awareness and Alluring Advantages of DTC Wellness Testing
• Increasing Demand for Transparency in Testing Performanc
• Emerging Market Players Catering to DTC Concept during COVID-19
The market is expected to face some limitations, too, due to the following challenges:
• Controlled DTC Wellness Testing and Regulations in the U.S.
• Data Privacy Concerns
Analyst Thoughts
According to Nitish Kumar, Principal Analyst, BIS Research, “Direct-to-consumer tests (DTC) wellness testing helps customers to deliver a customized solution based on their test requirements. It does not involve the health care provider, and these tests generally request the consumer to collect a specimen, such as blood, saliva, or urine, and send it to the company for testing and analysis. In recent years, several companies have started selling wellness tests via online channels. Overall, these tests are supposed to guide the user towards more informed decisions about lifestyle choices.”
U.S. DTC Wellness Testing Market - A Country Analysis
Focus on Test Type, Offering, Sample Type, Distribution Channel, and Region - Analysis and Forecast, 2022-2032
Some Faq's
Frequently Asked Questions
Direct-to-consumer wellness testing industry in the U.S. includes consumer health and wellness, instigating industry stakeholders to discover new revenue streams. The rising incidence of chronic and acute diseases has led to a demand for better treatment. However, there was an impending need to identify the root cause of any disease and then treat them with the right medicine. Increasing government expenses on the building of advanced healthcare facilities in the U.S., as well as the citizenry's demand and focus on an active and nutritious lifestyle, is driving the growth of the U.S. DTC wellness testing market.
Direct-to-consumer wellness tests are moderate to high-risk medical purposes testing, which may have a higher impact on medical care. These tests are reviewed by the U.S. FDA to determine the test's validity and claims. Moreover, rising prospects in weight management programs and increasing concerns among consumers about personal physical fitness are also fuelling the U.S. DTC wellness testing market. Other factors, such as health awareness among consumers and service providers, are revamping health and wellness products to reduce sugar, cholesterol, sodium content, and saturated fat.
The U.S. DTC wellness testing has seen major development by key players operating in the market, such as business expansion, partnership, collaboration, and joint venture. According to BIS Research analysis, the majority of the companies preferred partnerships, collaborations, and joint ventures as a strategy to further increase their growth in the U.S. DTC wellness testing. Companies such as Quest Diagnostics, Laboratory Corporation of American Holdings, Everlywell, Inc., Viome Life Sciences, Inc., Modern Fertility, Cue have majorly adopted partnerships, collaborations, and joint venture strategies.
A new entrant can focus on various wellness test panels as offerings by the established players of the U.S. DTC wellness testing market.
• Extensive competitive benchmarking of the top 13 public players and three emerging companies
• Market ranking analysis based on product portfolio, recent developments, and regional spread
• Investment landscape, including product adoption scenario, funding, and patent analysis
The companies which are manufacturing wellness testing products, DTC wellness testing service providers, food and nutrition companies, health and fitness DTC companies, etc., should buy this report.
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