Direct-To-Consumer (DTC) Genetic Testing - Market Insights, Competitive Landscape, and Market Forecast - 2030

Direct-To-Consumer Genetic Testing Market By Test (Ancestry Testing, Traits Testing, Nutrigenomic Testing, Prenatal Testing, And Others), Technology (Single Nucleotide Polymorphism, Genome Sequencing, And Targeted Analysis), Disribution-Channel (Online And Offline), And Geography (North America, Europe, Asia-Pacific, And Rest Of The World) is expected to grow at a steady CAGR forecast till 2030 owing to the growing incidence of genetic disorders and increasing consumer awareness and interest in personal health and genetics.

The direct-to-consumer (DTC) genetic testing market was valued at USD 1.91 billion in 2023, growing at a CAGR of 13% during the forecast period from 2024 to 2030 to reach USD 4.48 billion by 2030. The growing incidence of genetic disorders such as diabetes, cancer, and others are likely to drive the market for direct-to-consumer (DTC) genetic testing. Additionally, increasing consumer awareness and interest in personal health and genetics, and increasing number of product approvals in the domain of direct-to-consumer (DTC) genetic testing, across the globe are some of the other key factors, which are responsible for significantly boosting the market for direct-to-consumer (DTC) genetic testing globally during the forecast period from 2024 to 2030.

Direct-To-Consumer Genetic Testing Market Dynamics

According to the latest data provided by the Cancer Research UK (2021), stated that genetic specialist’s estimated that between 5 and 10 in every 100 cancers (5 to 10%) diagnosed are linked to an inherited faulty gene. These stats appeals to individuals for seeking proactive health management, especially those with a family history of cancer or other risk factors. By identifying inherited mutations associated with increased cancer risk, DTC genetic testing empowers individuals and healthcare providers to make informed decisions about preventive measures, such as increased surveillance, lifestyle modifications, or preventive surgeries thereby boosting the market of DTC genetic testing.

According to the data provided by the World Health Organization (WHO) (2024), in 2022, there were 2.3 million women diagnosed with breast cancer. Furthermore, as per the data and facts provided by the Cancer Research UK (2021), about 70% of women with a faulty BRCA1 or BRCA2 (Breast Cancer Gene) gene will develop breast cancer by age 80. Additionally, nearly 45% of females with a faulty BRCA1 gene and around 20% with a faulty BRCA2 gene will develop ovarian cancer by the same age. These statistics highlight the significant role of genetic testing, including direct-to-consumer options, in assessing inherited cancer risks and guiding personalized healthcare decisions thereby boosting the market of direct-to-consumer gene testing.
According to Food and Drug Administration (FDA), DTC GHR (direct-to-consumer genetic health risk) is listed under 21CFR866.5950 as in-vitro qualitative molecular diagnostic system which detects variants in genomic DNA isolated from human specimens. It provides users with information about their genetic risk of developing a disease, enabling informed lifestyle choices or discussions with healthcare professionals. This assessment system is designed for over-the-counter use. Thus, this FDA's regulatory framework not only enhances the credibility of DTC GHR testing but also fosters innovation in the development of new genetic tests and technologies. As more companies enter the market and expand their offerings, competition is likely to drive advancements in test accuracy and usability. Overall, the FDA's classification of DTC GHR testing as an over-the-counter diagnostic system is expected to catalyze market growth, increase consumer awareness, and ultimately improve health outcomes through proactive disease management and prevention strategies thereby boosting the market of DTC.

However, the lack of data privacy and ethical concerns and stringent regulatory concerns may result in slight obstacle to the growth of direct-to-consumer genetic testing market.

Direct-To-Consumer Genetic Testing Market Segment Analysis:

Direct-To-Consumer Genetic Testing Market by Test (Ancestry Testing, Traits Testing, Nutrigenomic Testing, Prenatal Testing, and Others), Technology (Single Nucleotide Polymorphism, Genome Sequencing, and Targeted Analysis), Distribution-channel (Online and Offline), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the technology segment of the direct-to-consumer genetic testing market, the genome sequencing category is estimated to mass a significant revenue share in the direct-to-consumer genetic testing market in 2023. Genome sequencing technology is poised to dominate the overall market of direct-to-consumer (DTC) genetic tests due to its comprehensive and personalized approach to genetic information. Unlike traditional genetic tests that focus on specific genetic markers, genome sequencing offers a comprehensive analysis of an individual's entire genetic code. This allows for a more thorough assessment of genetic predispositions to diseases, ancestry, and traits. One of the key factors driving the dominance of genome sequencing in the DTC genetic test market is its ability to provide consumers with a wealth of detailed information. This includes insights into rare genetic variants, carrier status for inherited conditions, and pharmacogenomic information that can influence responses to medications. Consumers are increasingly interested in obtaining a complete picture of their genetic health and ancestry, and genome sequencing fulfills this demand by providing a more comprehensive assessment compared to targeted genetic tests.
Therefore, according to the above-mentioned factors there will be a significant growth of the genome sequencing category, thereby driving the growth of the overall direct-to-consumer genetic testing market during the forecast period.

North America Is Expected To Dominate The Overall Direct-To-Consumer Genetic Testing Market:

North America is expected to account for the highest proportion of the direct-to-consumer genetic testing market in 2023, out of all regions. The burgeoning market for direct-to-consumer genetic testing is underpinned by a complex interplay of factors, each contributing to its rapid expansion. One of the primary drivers is the escalating incidence of genetic disorders such as cystic fibrosis, hemophilia, and Alzheimer’s disease, which has heightened public awareness of the importance of genetic insights in healthcare. This heightened awareness, coupled with a growing consumer desire for proactive health management, has fueled demand for genetic testing services. Furthermore, the landscape is being reshaped by continuous technological innovations, particularly in genetic sequencing techniques, which have made these tests more accessible and affordable to the general population.

According to recent data from the American Lung Association (2022), cystic fibrosis emerges as a hereditary condition inflicting severe harm upon the lungs, digestive system, and other bodily organs. The United States currently hosts an estimated 30,000 individuals grappling with cystic fibrosis, highlighting the significant impact of this disease within the nation. Alarmingly, the prevalence of carriers stands at approximately 1 in 30 Americans, underscoring the pervasive nature of this genetic disorder and its implications for public health.

Additionally, as per the recent data provided by Centre for Disease Control and Prevention (CDC) (2020), a staggering 5.8 million Americans were reported to be living with Alzheimer’s disease. Moreover, the CDC’s findings reveal a troubling trend: the number of individuals affected by Alzheimer’s disease doubles every five years beyond the age of 65. Looking ahead, projections suggest that by the year 2060, this number could nearly triple, reaching an estimated 14 million people grappling with the disease.

Thus, the escalating incidence of genetic disorders like cystic fibrosis, hemophilia, and Alzheimer’s disease serves as a primary driver for the burgeoning market of direct-to-consumer genetic testing. As the prevalence of these conditions continues to rise, fueled by various factors including changes in lifestyle, environmental influences, and an aging population, individuals are increasingly seeking ways to gain insights into their genetic predispositions.

Additionally, the product approval in the region has boosted the market of direct to consumer genetic testing. For instance, in July 2023 Quest Diagnostics launched its first consumer-initiated genetic test called Genetics Insights. This innovative offering examines 36 genes, unveiling potential risks for approximately 24 inheritable conditions. Covered ailments range from breast and colon cancer to various heart and blood disorders, including assessments for carrier status of cystic fibrosis, sickle cell anemia, and Tay-Sachs disease.

Thus, the above mentioned factors are expected to escalate the market of direct-to-consumer genetic testing in the region.

Direct-To-Consumer Genetic Testing Market Key Players:

Some of the key market players operating in the direct-to-consumer genetic testing market include 23andMe, Color Health, Inc., Ancestry, Easy DNA, Quest Diagnostics, 24Genetics, Full Genome Corporation, FamilyTreeDNA, Helix OpCo LLC, Genesis Healthcare, MyHeritage, Pathway genomics, Identigene, Mapmygenome, Karmagenes, and others.

Recent Developmental Activities In The Direct-To-Consumer Genetic Testing Market:

• In August 2021, Ancestry® entered into an agreement to acquire French Genealogy Leader Geneanet. Geneanet, a leading French genealogy company with over 30 billion records from more than 80 countries and ancestry helps customers discover new details about their family story and ancestors.
• In June 2021, Eurofins acquired DNA diagnostics center to grow genetic testing capabilities and significantly expand further into the consumer testing market.

Key Takeaways From The Direct-To-Consumer Genetic Testing Market Report Study

• Market size analysis for current direct-to-consumer genetic testing size (2023), and market forecast for 6 years (2024 to 2030)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years
• Key companies dominating the direct-to-consumer genetic testing market.
• Various opportunities available for the other competitors in the direct-to-consumer genetic testing market space.
• What are the top-performing segments in 2023? How these segments will perform in 2030?
• Which are the top-performing regions and countries in the current direct-to-consumer genetic testing market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for direct-to-consumer genetic testing market growth in the coming future?

Target Audience Who Can Be Benefited From This Direct-To-Consumer Genetic Testing Market Report Study

• Direct-to-consumer genetic testing product providers
• Research organizations and consulting companies
• Direct-to-consumer genetic testing -related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and Traders dealing in direct-to-consumer genetic testing
• Various end-users who want to know more about the direct-to-consumer genetic testing market and the latest technological developments in the direct-to-consumer genetic testing market.

Frequently Asked Questions For The Direct-To-Consumer Genetic Testing Market:

1. What are direct-to-consumer genetic testing?

Direct-to-consumer (DTC) genetic testing refers to genetic tests that are marketed directly to consumers without the involvement of healthcare providers or healthcare professionals. These tests are typically purchased online or over the counter and allow individuals to collect their own DNA samples, often through a saliva sample or cheek swab, in the comfort of their own homes. The collected samples are then sent to a laboratory for analysis.

2. What is the market for direct-to-consumer genetic testing?

The direct-to-consumer (DTC) genetic testing market was valued at USD 1.91 billion in 2023, growing at a CAGR of 13% during the forecast period from 2024 to 2030 to reach USD 4.48 billion by 2030.

3. What are the drivers for the global direct-to-consumer genetic testing market?

The demand for Direct-To-Consumer Genetic Testing is primarily being boosted by the growing incidence of genetic disorders such as diabetes, cancer, and others are likely to drive the market for direct-to-consumer (DTC) genetic testing. Additionally, increasing consumer awareness and interest in personal health and genetics, and increasing number of product approvals in the domain of direct-to-consumer (DTC) genetic testing, across the globe are some of the other key factors, which are responsible for significantly boosting the market for direct-to-consumer (DTC) genetic testing globally during the forecast period from 2024 to 2030.

4. Who are the key players operating in the global direct-to-consumer genetic testing market?

Some of the key market players operating in the direct-to-consumer genetic testing are 23andMe, Color Health, Inc., Ancestry, Easy DNA, Quest Diagnostics, 24Genetics, Full Genome Corporation, FamilyTreeDNA, Helix OpCo LLC, Genesis Healthcare, MyHeritage, Pathway genomics, Identigene, Mapmygenome, Karmagenes, and others.

5. Which region has the highest share in the global direct-to-consumer genetic testing market?

North America is expected to account for the highest proportion of the direct-to consumer genetic testing market in 2023, out of all regions. One of the primary drivers is the escalating incidence of genetic disorders such as cystic fibrosis, hemophilia, and Alzheimer’s disease, which has heightened public awareness of the importance of genetic insights in healthcare. Furthermore, continuous technological innovations, especially in the domain of genetic sequencing techniques are some of the factors influencing the growth of the direct-to consumer genetic testing market in North America.