Direct-to-Consumer Genetic Testing Market Size, Share & Trends Analysis Report By Product Type (Ancestry Testing, Health and Wellness Genetic Testing, Nutrigenomics Testing, Carrier Testing, Others), By Technique (Whole Genome Sequencing, Single Nucleotide Polymorphism Chips, Targeted Analysis, Others), By Sales Channel (Offline Channel, Online Channel) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Direct-to-Consumer Genetic Testing Market Insights

The global direct-to-consumer genetic testing market size was valued at USD 1,590.43 million in 2022. It is estimated to reach USD 6,686.46 million by 2031, growing at a CAGR of 17.30% during the forecast period (2023–2031).

Genetic tests marketed directly to consumers are collectively called "direct-to-consumer genetic testing" (DTC-GT). Without the aid of a healthcare provider or health insurance provider, DTC-GT tests are sold directly to the consumer. Genetic testing data can be used in various ways, each with a unique revenue model. The genomic data can be used for nutrigenomics or individual health planning, including genetic tests to identify disease risks. Customers can also obtain comprehensive genomic tests by utilizing the third party as a service platform.

Direct-to-consumer genetic testing, which gives people access to their genetic information, is also known as direct-access genetic testing, DTC genetic testing, at-home genetic testing, and home DNA testing. In-vitro diagnostics (IVDs) marketed directly to consumers without the assistance of a healthcare provider are referred to as direct-to-consumer tests, according to the U.S. Food and Drug Administration. For these tests, the consumer is typically asked to gather a sample, like a saliva or urine, and send it to the business for testing and analysis.

Highlights

• Ancestry dominates the product type segment
• Single nucleotide polymorphisms (SNPs) dominate the technology segment
• Online channel dominates the distribution channel segment
• North America is the highest shareholder in the global market

Global Direct-to-Consumer Genetic Testing Market Growth Factors

Growing Number of Direct-to-Consumer Genetic Tests

More genetic testing is now accessible than ever due to the constantly declining cost of DNA sequencing. These tests have recently become the standard of care for oncology patients and pregnant women. In 2018, Concert Genetics and the Department of Clinical Pharmacy at the University of California, San Francisco, published a study that found about 75,000 genetic tests available, with 10,000 different test types.

Furthermore, the increase in direct-to-consumer genetic testing among consumers results from sales and marketing strategies used by major market players. The major players, including 23andme, Inc. and Ancestry DNA, have access to the largest database of genetic data on humans and offer wellness, wellness risk, and genealogy reports. With a total number of cumulative genetic tests conducted in 2019 reaching more than 26 million, as per MIT Technology Review, the need to adopt automated DNA extraction is bound to increase in the coming years, thereby driving the market's growth.

Decreasing the Cost of Sequencing

Genome sequencing involves the sequencing of an individual's genome and has massive implications ranging from cancer disease screening for the identification of genetic mutations to therapeutic planning and dissemination. Since 2010, genome sequencing, particularly DNA sequencing, has become significantly faster and cheaper than ever, attributable to the advances being introduced and achieved in NGS technologies. It is anticipated that the cost of genome sequencing will ultimately drop to as low as USD 100 by 2025.

Furthering upon such advancements, service providers increasingly provide low-cost genetic testing services, initiating large-scale adoption and studies to determine their definitive role in transforming neurology care and further transforming human health. With sequencing costs decreasing even further, mutation analysis of solid tumors and hematological malignancies is expected to become a regular healthcare routine in diagnosing and planning treatment for neurological disorders, propelling the overall market growth.

Direct-to-Consumer Genetic Testing Market Restraining Factors

Genomic Data Protection

Despite the advantage of genomic data, its growing amount has significant implications for personal privacy. These implications can be attributed to the essential genomic features, such as association with traits and certain diseases, forensics identification capability, and revelation of family relationships. Moreover, direct-to-consumer genetic testing has increased the likelihood of sharing genomic data in less-regulated environments like the Internet and for-profit companies.

Growing concerns regarding data privacy threats have their basis in recent breaches. For instance, in July 2019, Vitagene, a direct-to-consumer DNA-testing service vendor, inadvertently left the data of about 3,000 consumers exposed online for several years through a misconfigured database. Therefore, growing concerns regarding data protection have restricted market growth.

Global Direct-to-Consumer Genetic Testing Market Opportunities

Massive Scope for Adoption of Genomic-Based Medicine in Emerging Nations

Globally, a high priority is placed on the accessibility of high-quality diagnostic tests, particularly molecular tests for genetic disorders. Even though biomarker-based tests have made significant advancements and have subsequently been adopted into standard healthcare practices, people in low-income countries still need access to them. This limitation may prevent them from receiving life-saving treatments, reducing the likelihood of successfully halting the spread of infectious diseases. In addition, lack of funding and an uneven distribution of diagnostic laboratories are problems in developing countries. Access could be significantly improved by using tests that can be administered without laboratory assistance.

Furthermore, the lack of quality test portfolios is mainly based on several barriers, such as lack of robustness and pricing, further accentuated by reduced performances due to environmental difficulties such as high temperatures and dust. Therefore, a lack of initiatives leads to minimum optimality in precision medicine measures. However, a majorly of the industry's key players are identifying these emerging regions as highly untapped, which makes them a perfect fit to expand their business leading to significant growth opportunities in the market in the upcoming years.

Direct-to-Consumer Genetic Testing Market Regional Analysis

North America Dominates the Global Market

The North America direct-to-consumer genetic testing market is projected to grow at a CAGR of 17.23% during the forecast period. The U.S. market largely dominates the North American direct-to-consumer genetic testing market landscape. The presence of key industry players such as Ancestry.com, 23andMe, and Family Tree DNA has acted as a significant market driver for the direct-to-consumer genetic testing market in this region. Other factors, such as funding availability, high economy, and favorable market conditions for scientific innovations, have also acted as drivers for the direct-to-consumer genetic testing market. In addition, the increasing use of personal genomics and mushrooming consumer interest in ancestry and health-based DTC-GT is another factor boosting the growth of the North American market. Another factor supporting North America's market growth is 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.

Europe is estimated to exhibit a CAGR of 16.82% over the forecast period. Europe's DTC genetic testing market has been growing since its inception. Several European countries are working persistently to enhance the adoption of immunization across Europe. Europe holds the second-largest market share in revenue in the global DTC genetic testing market, owing to increasing healthcare expenditure and a growing focus on immunizing and eradicating infectious diseases across the region. Currently, there are limited DTC genetic-testing companies in Europe. Still, at a national level, the national bioethics committees of countries such as Belgium, France, and Portugal have addressed the issue. In addition, multiple statements are made by many national organizations. The European direct-to-consumer genetic testing market holds great potential for the entry of local, new entrants that can abruptly work toward promoting and commercializing DTC genetic tests across the population. This opportunity is also supported by the funding that the DTC companies receive to carry out genetic testing and publish results through online portals. Furthermore, the U.K. and Germany act as great testing grounds after the U.S., which can help to increase the penetration of DTC-GT in Europe.

The direct-to-consumer genetic testing (DTC-GT) market in Asia-Pacific will show significant growth potential in the forthcoming period. This is due to increased healthcare awareness, a steady economy leading to higher affordability, and the implementation of improved methods of diagnosis. Additionally, it is being noted that several cutting-edge, high-quality human genome libraries generate ethnicity-specific sequences and make it possible for researchers to use genetic data to enhance precision medicine in the Asia-Pacific region. In addition, the Asia-Pacific market upholds excellent potential for new local players increasing awareness about health and lifestyle-based DTC-GT and rising online services across developing countries in the region. For instance, in November 2018, Prenetics, a Hong Kong-based biotechnology start-up, became the first home-grown company to sell genetic test kits direct to consumers that can assess the user's risk of developing eight hereditary cancers within their lifetime.

Latin America is a poorly explored region in the DTC-GT market compared to the developed regions. The adoption and growth can be significantly impacted by the emergence of cost-effective generic products by the local players in the region. Owing to the epidemiological transition being witnessed by a change in mortality and morbidity patterns, countries of Latin America are facing an increased proportion of infant mortality and morbidity due to congenital and genetic disorders. In addition, there is a rising incidence in the adult population with chronic diseases such as stroke, cancer, heart disease, and diabetes – all subgroups with significant genetic risk components. These changes in the risk factors are increasing the need for genetic services in the region.

The Rest-of-the-World consists of several other promising regions, such as the Middle East and Africa. Genetic diseases are more common in the Middle East as compared to different kinds of diseases. A significant reason is the widespread practice of consanguineous marriage in these regions. Understanding the mechanisms of many such genetic disorders would require an effective and advanced healthcare system, thereby boosting market growth. Furthermore, major African countries, such as Egypt, have primarily aligned their regulations according to the European directive, allowing for sufficient flexibility for companies trying to enter the region and fueling market expansion.

Direct-to-Consumer Genetic Testing Market Segmental Analysis

By Type

Based on type, the direct-to-consumer (DTC) genetic testing market is segmented into ancestry testing, health and wellness genetic testing, nutrigenomics testing, carrier testing, and others. The ancestry testing segment accounted for the largest direct-to-consumer (DTC) genetic testing market share and is expected to maintain strong growth with a projected CAGR of 16.68% during the forecast period. Several factors contribute to this dominant position and robust growth trajectory. One key driver is the increasing consumer interest in understanding personal and familial origins, which has been amplified by widespread marketing and advertising campaigns from leading companies in the space, such as AncestryDNA and 23andMe. These companies have made genetic testing more accessible and appealing by offering affordable, user-friendly kits that provide detailed ancestry breakdowns, connecting users with potential relatives and enabling them to explore their heritage.

Further, advancements in genetic analysis technology have improved the accuracy and depth of ancestry reports, offering consumers increasingly detailed insights, including geographic origins and ethnic composition. This technological progression, combined with a growing societal interest in genealogy and heritage, has made ancestry testing not only a tool for personal discovery but also a popular gift option, contributing to its broad consumer appeal. Additionally, privacy and data security enhancements have addressed consumer concerns, making more people comfortable with using these services. As a result, the ancestry testing segment continues to thrive, reflecting both the cultural significance of genealogy and the ongoing innovations in genetic testing technology.

By Technique

On the basis of technique, the direct-to-consumer (DTC) genetic testing market is categorised into whole genome sequencing, single nucleotide polymorphism chips, targeted analysis, and others. The whole genome sequencing segment accounted for the largest direct-to-consumer (DTC) genetic testing market share due to several compelling factors. Firstly, whole genome sequencing (WGS) provides the most comprehensive analysis of an individual's genetic makeup, offering detailed insights into all 3 billion base pairs in the human genome. This depth of information appeals to consumers who seek an extensive understanding of their genetic profile, including potential health risks, inherited traits, and ancestry. The ability to identify rare genetic variants and provide personalized health recommendations has significantly driven consumer interest in WGS.

Additionally, advancements in sequencing technologies have reduced the cost of WGS, making it more accessible to a broader audience. As prices have dropped, more consumers have been able to afford this sophisticated testing option, which was previously available only through clinical or research settings. The allure of obtaining a complete genetic blueprint, coupled with growing awareness of the benefits of personalized medicine, has further bolstered the demand for WGS in the direct-to-consumer (DTC) genetic testing market.  Moreover, companies offering WGS have effectively marketed the uniqueness and comprehensiveness of their services, positioning WGS as a premium option within the DTC genetic testing landscape. This has not only attracted health-conscious individuals but also those interested in gaining a holistic view of their genetic heritage and potential predispositions to various conditions. The convergence of these factors comprehensive data, affordability, and effective marketing—has solidified whole genome sequencing's dominance in the DTC genetic testing market.

However, the Targeted Analysis segment is expected to grow at the fastest CAGR in the direct-to-consumer (DTC) genetic testing market due to its ability to provide precise and actionable insights into specific genes or genetic regions associated with particular health conditions or traits. This focused approach is particularly appealing to consumers who are interested in obtaining targeted information about their risk for certain diseases, such as hereditary cancers or cardiovascular conditions, without the need for comprehensive genome sequencing. The growing consumer demand for personalized health insights, combined with the increasing availability of targeted genetic tests that are both affordable and easy to understand, drives this segment's rapid growth.

By Sales Channel

Based on sales channel, the direct-to-consumer (DTC) genetic testing market is divided into offline channel and online channel. The online channel segment accounted for the largest direct-to-consumer (DTC) genetic testing market share and is expected to maintain strong growth during the forecast period owing to the convenience, accessibility, and broad reach it offers to consumers. Online platforms have revolutionized the way genetic tests are marketed, purchased, and delivered, allowing consumers to order kits from the comfort of their homes and receive results directly through secure digital portals. The ease of comparing different products, reading reviews, and accessing promotional discounts online has made this channel particularly attractive. Additionally, the global shift towards digitalization, accelerated by the COVID-19 pandemic, has led to a significant increase the adoption of online channel and consumer comfort with purchasing health-related products over the internet. Companies have capitalized on this trend by enhancing their online presence, offering personalized customer experiences, and utilizing targeted digital marketing strategies to reach a wider audience, thereby driving the sustained growth of the online channel segment.

Recent Developments

• July 2022- Genetic Technologies Limited (ASX: GTG) is pleased to reveal that it has completed the acquisition of the direct-to-consumer eCommerce business and distribution rights associated with AffinityDNA.

• July 2022- 1health.io Inc., an industry-leading software company that enables diagnostic laboratories to expand their testing in the clinical and direct-to-consumer markets quickly and securely, collaborated with Apollo Health Group to bring Apollo's specialized high-performing NGS tests, like pharmacogenetics screenings (PGx) and hereditary cancer genetic screenings (CGx), to the broader clinical market.