U.S. DTC Genetic Testing Market - Focused Insights 2023-2028

MARKET INSIGHTS

The U.S. DTC (Direct-to-Consumer) Genetic Testing Market was valued at $0.89 billion in 2022 and is projected to reach $1.65 billion by 2028, registering a CAGR of 10.86%. The growing curiosity among the modern U.S. population about their family ancestry has positioned DNA testing as a primary tool for uncovering detailed multi-generational insights. According to the Genetic Testing Registry, in November 2022, 90% of the 12,962 genetic tests conducted were for clinical purposes. This surge is driven by increasing awareness of genetic disorders, the rising adoption of preventive testing, and the growing popularity of at-home DNA ancestry kits.

Leading players such as Ancestry.com and 23andMe dominate the ancestry testing segment, with online platforms enhancing accessibility to DTC genetic testing. Together, these companies hold over 70% of the U.S. market share, with 23andMe steadily gaining ground on Ancestry's longstanding dominance. Additionally, several startups are securing funding for innovative product launches in ancestry and carrier testing, further diversifying the market landscape.

However, the market faces notable challenges, including stringent regulatory requirements, ethical concerns, the absence of FDA reviews for many tests, and quality issues that can yield false-positive or false-negative results. The U.S. military's 2019 advisory against using popular DTC genetic tests adds another layer of limitation to market expansion.

Technological advancements have prompted a shift from single-nucleotide variation profiling to gene-specific mutation analysis and whole genome sequencing (WGS). While WGS improves the depth of genetic insights, it has also raised significant privacy concerns. To address these, companies are adopting new service models such as health data subscriptions, offering continuous, detailed insights over time and creating new revenue streams.

The COVID-19 pandemic caused a decline in testing volumes during 2020-2021, but the market began recovering in 2022, with expectations to return to pre-pandemic levels by 2023-2024. Factors such as renewed interest in ancestral roots, heightened health consciousness among younger demographics, and increasing demand for genetic testing among expecting couples have contributed to the market's resurgence. Moreover, the rising prevalence of chronic diseases like cancer and diabetes has driven demand for genetic testing, especially during pregnancy. The introduction of WGS-based testing is anticipated to lower costs, making genetic tests more accessible and propelling market growth further.

As the U.S. DTC Genetic Testing Market continues to evolve, understanding the market's complexities, technological advancements, and regulatory landscape will be critical for stakeholders seeking to capitalize on emerging opportunities

KEY HIGHLIGHTS:

• In the US, genetic tests are usually done for multiple purposes, as they are not mutually exclusive. The number of genetic tests is increasing over time.
• Around 90% of genetic tests carried out are for clinical purposes. Only a limited number of genetic tests are performed for research purposes. Increasing disease populations will increase the demand for DTC testing in the market as a part of preventive care.
• The increasing demand for personalized nutrition medicine is increasing the demand for DTC in the market, especially among celebrities and bodybuilders.
• At-home DNA ancestry testing provides complete information about one’s family lineage by analyzing their genetic code and by comparing it with millions of other people’s DNA. The test is usually done with a saliva sample. The current generation of the US is more curious to know about their family history. 
• 23andMe is the only US FDA that has approved DTC tests for cancer patients. The DTC test has increased the number of people undergoing cancer tests. Some of the companies are providing consultations regarding genetic testing through telehealth platforms.
• People prefer the subscription model of genetic testing in the market. The longer the subscription more detailed results for the sequences are provided. This provides more personalized solutions to the patients.