North America Direct-to-Consumer Laboratory Testing Market Insights, 2021-2031

COVID-19 Pandemic Sparks Demand for DTC Tests

The widespread diagnostic and serological testing is emerging as one of the key measures to mitigate the COVID-19 pandemic. The increased load on healthcare systems, social distancing, and convenience needs of individuals is anticipated to boost the growth of the North America direct-to-consumer laboratory testing market.

Even though DTC (direct-to-consumer) tests have many advantages, it is also associated with significant ethical and regulatory concerns. The FDA (Food & Drug Administration) exercised its discretion not to enforce requirements for laboratories and commercial manufacturers operating without EUA (Emergency Use Authorization), as long as they provided a disclaimer that the tests are not reviewed by the FDA. This has led to concerns about the quality of many tests in the North America direct-to-consumer laboratory testing market. Eventually, the FDA has changed its approach for aligning its policy for serological tests with that for diagnostic tests. It has recommended companies to obtain EUA before marketing its at-home serological tests.

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Is DTC Testing Transforming Healthcare Landscape?

Risks and benefits of DTC tests are influencing the growth of the North America direct-to-consumer laboratory testing market. Convenience, low cost, and confidentiality advantages are bolstering market growth, whereas difficult to interpret results and risk of incorrect self-diagnosis are creating concerns amongst individuals. Nevertheless, advantages such as non-health tests and increase in number of people becoming health conscious tend to offset the disadvantages of DTC tests. The popularity of at-home DNA test kits is contributing to the growth of the North America direct-to-consumer laboratory testing market.

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Big Data Holds Potential for Analyzing New Observations through Patient Information

With the advent of point of care testing, along with self-empowerment of patients, companies in the North America direct-to-consumer laboratory testing market are capitalizing on revenue opportunities. The trend of quantitative self-movement has led to increased data collection and subsequent analysis, which may fundamentally improve the ability of individual patients to understand and predict the state of their health.

Some DTC test data can be analyzed by swarm intelligence or by Big Data analysis, which allows new observations that is not possible with previous methods of healthcare. Such findings are bolstering the growth of the North America direct-to-consumer laboratory testing market. DTC tests are helping individuals to take charge of their health.

AI and Cloud Computing Offering Smartphone-based Healthcare Services

The North America direct-to-consumer laboratory testing market is slated to clock a CAGR of 22.6% during the forecast period. Market stakeholders and telecommunication companies are anticipated to enter into collaborations to help individuals stay informed about their health status by sending lab results directly to their mobile devices.

Smartphone-based healthcare services are growing prominent in the North America direct-to-consumer laboratory testing market. The combination of artificial intelligence (AI) and cloud computing is being deployed for genetic decoding to provide services such as tailored health management. Cloud computing is helping to store and manage personal genome analysis information.

Preference for Cost Efficiency and Confidentiality in DTC Tests

Since lab tests provide critical information about a person’s health, DTC testing is meant to help patients be more directly involved in decisions about their own health. The North America direct-to-consumer laboratory testing market is expected to reach the valuation of US$ 8.86 Bn by 2031. Although DTC tests are generally not covered by insurance, the cost of a DTC test is less than the copay for a primary care visit and required laboratory charges.

On the other hand, consumers can choose which DTC testing company they want to use rather than being forced by a choice given by the insurance company. This option for best price and convenience is translating into revenue opportunities for companies in the North America direct-to-consumer laboratory testing market. Since tests for STI (Sexually Transmitted Infections) and drug screenings are highly sensitive, DTC tests are a great solution for maintaining confidentiality.

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Analysts’ Viewpoint

Labs are focusing on essential medical services such as diabetes testing and disease risk assessment testing to keep the economies running during the COVID-19 pandemic. DTC tests help to avoid time-consuming processes involved with insurance companies and primary care providers. However, in many cases, DTC testing provides individuals with raw results that are difficult to interpret. Hence, companies in the North America direct-to-consumer laboratory testing market should not only make information dissemination easy but also unlock growth opportunities with AI and cloud computing. Obtaining test results in-hand can empower consumers to create a healthy lifestyle and encourage them to seek adequate medical help.

North America Direct-to-Consumer Laboratory Testing Market: Overview

• According to Transparency Market Research’s latest research report on the direct-to-consumer laboratory testing market in North America for the historical year 2020 and the forecast period from 2021 to 2031, rise in prevalence of various lifestyle-associated  & infectious diseases and increase in geriatric population are projected to drive the direct-to-consumer laboratory testing market in North America during the forecast period
• The direct-to-consumer laboratory testing market in North America was valued at US$ 929.4 Mn in 2020 and is expected to reach US$ 8.86 Bn by 2031, expanding at a CAGR of 22.6% from 2021 to 2031. Rise in prevalence of various lifestyle-associated and infectious diseases such as cancer, diabetes, obesity, and STDs is expected to propel the market during the forecast period. The saliva segment is projected to account for 43.5% share of the market by 2031. The segment is anticipated to expand at CAGR of 22.9% from 2021 to 2031. It is projected to register market attractiveness index of 1.7 by 2031. The saliva segment’s dominance can be attributed to increase in the number of DTC testing companies offering saliva-based test kits.

High Emphasis on Patient-driven Healthcare

• Direct-to-consumer laboratory testing has affected patient care, its cost, and the role of the laboratory professional. These tests are also referred as consumer-driven testing.
• In the era of Internet and social media, consumers seek more control over their health and are willing to pay for the services. The reasons often cited for ordering DTC lab tests include convenience, preparing for a doctor visit, saving money, privacy, getting a second opinion, and obtaining tests not covered by insurance.
• Hence, surge in emphasis on patient-driven healthcare and easy access to patients as consumers through the Internet and media are expected to drive the direct-to-consumer laboratory testing market.

Surge in Demand for Early Disease Detection & Diagnosis and Personalized Medicines

• Direct-to-consumer (DTC) laboratory testing offers at-home lab tests without lab visits or doctor referrals. Presently, people have become quite health conscious and pay significant attention to the early detection of any diseases. This drives the demand for direct-to-consumer laboratory testing, as these deliver diagnostic results within 24 to 48 hours.
• In line with the rise in demand for quick, affordable, and accurate tests, several companies have considered offering actionable recommendations to complement the test results. This approach induces the customer to seek personalized services and to maximize customer satisfaction.
• In the field of personalized medicine, it is becoming increasingly evident that direct-to-consumer (DTC) testing plays an influential role in individualized healthcare
• Therefore, rise in demand for early disease detection & diagnosis and personalized medicines is expected to drive the direct-to-consumer (DTC) laboratory testing market in North America

North America Direct-to-Consumer Laboratory Testing Market: Competition Landscape

• Detailed profiles of providers of biologics contract manufacturers have been provided in the direct-to-consumer laboratory testing market report to evaluate their financials, key product offerings, recent developments, and strategies
• Key providers of biologics contract manufacturing focus on developing new technology and services related to fast and quick direct-to-consumer laboratory testing kits and platforms

North America Direct-to-Consumer Laboratory Testing Market Snapshot

North America Direct-to-Consumer Laboratory Testing Market – Segmentation

TMR’s research study assesses the direct-to-consumer laboratory testing market in North America based on sample type, test type, and end-user. The report presents extensive market dynamics and progressive trends associated with different segments and how they are influencing the direct-to-consumer laboratory testing market in North America.