The collective term for genetic tests marketed directly to consumers is "direct-to-consumer genetic testing" (DTC-GT). Without the assistance of a healthcare professional or health insurer, DTC-GT tests are sold directly to consumers. There are numerous ways to utilize genetic testing data, each with its revenue model. The genomic data can be used for nutrigenomics or individual health planning, including genetic tests to determine disease risk. Customers can also obtain comprehensive genomic tests by utilizing the third-party platform as a service. Direct-to-consumer genetic testing, which provides individuals with access to their genetic information, is also referred to as direct-access genetic testing, DTC genetic testing, at-home genetic testing, and home DNA testing.
Due to the rapidly declining cost of DNA sequencing, more genetic tests are now than ever. Recently, these tests have become the standard of care for oncology and pregnant patients. In 2018, Concert Genetics and the Department of Clinical Pharmacy at the University of California, San Francisco, published a study revealing approximately 75,000 genetic tests and 10,000 test types available. The rise in direct-to-consumer genetic testing among consumers results from the sales and marketing strategies employed by the market's major players. The major players, 23andme, Inc. and Ancestry DNA, have access to the largest database of human genetic data and provide wellness, wellness risk, and genealogy reports. According to MIT Technology Review, the cumulative number of genetic tests conducted in 2019 will exceed 26 million, increasing the demand for automated DNA extraction in the coming years and propelling the market growth.
Accessibility to high-quality diagnostic tests, particularly molecular tests for genetic disorders, is a global priority. Despite their significant advancements and subsequent adoption as standard medical procedures, people in low-income countries still require access to biomarker-based tests. This restriction may prevent them from receiving life-saving treatments, thereby decreasing the likelihood of effectively halting the spread of infectious diseases. In developing nations, inadequate funding and an uneven distribution of diagnostic laboratories are problems. Using tests that can be administered without laboratory assistance could significantly increase accessibility. The shortage of high-quality test portfolios is primarily attributable to several obstacles, such as a lack of durability and affordability, exacerbated by reduced performance due to environmental challenges, such as high temperatures and dust. Nonetheless, most of the industry's key players view these emerging regions as highly untapped, making them ideal for expanding their business and creating significant expansion opportunities in the market.
North America is the most significant global direct-to-consumer genetic testing market shareholder and is anticipated to exhibit a CAGR of 17.23% during the forecast period. The U.S. market dominates the direct-to-consumer genetic testing landscape in North America. In this region, key industry players such as Ancestry.com, 23andMe, and Family Tree DNA have been significant market drivers for direct-to-consumer genetic testing. The market for direct-to-consumer genetic testing has also been driven by factors such as the availability of funding, a robust economy, and favorable market conditions for scientific innovations. In addition, the expanding use of personal genomics and the burgeoning consumer interest in ancestry and health-based DTC-GT also contribute to expanding the North American market. Developing novel genetic tests that could predict potential allergies, different responses to medication, and associated risks of genetic diseases such as neurofibromatosis, cancer, and spinal muscular atrophy is another factor driving market growth in North America.
Europe is estimated to exhibit a CAGR of 16.82% over the forecast period. Since its inception, the DTC genetic testing market in Europe has been expanding. Several European nations are persistently working to increase vaccination rates throughout the continent. Europe holds the second-largest market share in revenue on the global market for direct-to-consumer (DTC) genetic testing due to rising healthcare expenditures and a regional emphasis on immunizing and eradicating infectious diseases. There currently needs to be more direct-to-consumer genetic testing companies in Europe. Nevertheless, national bioethics committees in countries such as Belgium, France, and Portugal have addressed the issue. In addition, numerous national organizations issue additional statements. The European market for direct-to-consumer genetic testing is ripe for local, new entrants capable of rapidly promoting and commercializing DTC genetic tests across the population. This opportunity is bolstered by the funding that direct-to-consumer companies receive to conduct genetic testing and publish results via online portals.
The key players in the global direct-to-consumer genetic testing market are 23andme, Inc., Color Genomics, 24Genetics, Ancestry.com, LLC, Easy DNA, My Heritage Ltd., DNAfit, and others.