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

The U.S. DTC Genetic Testing Market was valued at $0.89 billion in 2022 and is projected to surge to $1.65 billion by 2028, growing at a CAGR of 10.86%. The modern U.S. generation is increasingly curious about their family lineage, with DNA testing emerging as the primary tool offering detailed insights into multiple generations. As per the Genetic Testing Registry in November 2022, of the 12,962 genetic tests conducted, 90% were for clinical purposes. This rise can be attributed to increasing knowledge about genetic disorders, spurring preventive testing, and a rising trend in at-home DNA ancestry testing. Significant market players like Ancestry.com dominate the ancestry domain, and the accessibility of tests has been heightened by online DTC genetic testing.

However, the market faces challenges such as stringent regulations, lack of FDA reviews for many DTC tests, ethical concerns, and quality issues that can lead to false-positive or false-negative results. Additionally, the military's post-2019 advisory against popular DTC genetic testing acts as a limitation. On the technological front, there's been a shift from single-nucleotide variation profiling to gene-specific mutation analysis and from single-nucleotide polymorphism to whole genome sequencing (WGS). However, WGS has raised concerns about privacy.

Services such as health data subscriptions, which provide detailed insights over time, are becoming a new revenue model for companies. Major players like 23andMe and Ancestry collectively occupy over 70% of the U.S. market share. Interestingly, 23andMe has been making strides and challenging Ancestry's dominance. Numerous startups are securing funding for innovative product launches focused on ancestry and carrier testing. The market saw a downturn during the COVID-19 pandemic, with reduced testing volumes in 2020-2021. However, recovery began in 2022 with predictions of regaining pre-pandemic levels by 2023-2024. Factors like renewed interest in ancestral roots, increased health awareness among the younger generation, and expecting couples have spurred the genetic tests' demand. The growing patient population with conditions like cancer and diabetes has also driven testing volume, especially during pregnancy. Launches based on WGS technology are set to reduce testing costs, further broadening market accessibility. As the dynamics of the US DTC Genetic Testing Market evolve, a comprehensive understanding of these intricacies is essential for stakeholders.

KEY HIGHLIGHTS:

• In the US, genetic tests are usually done for multipurpose, 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.