Home Healthcare IT Direct-to-Consumer Genetic Testing Market Size, Share and Forecast to 2031

Direct-to-Consumer Genetic Testing Market

Direct-to-Consumer Genetic Testing Market Size, Share & Trends Analysis Report By Product Type (Ancestry, Health and Wellness, Entertainment), By Test Type (Nutrigenomics Testing, Predictive Testing, Carrier Testing, Others), By Technology (Targeted Analysis, Single Nucleotide Polymorphisms (SNPs), Whole Genome Sequencing (WGS)), By Distribution Channel (Online Channel, Over-the-Counter Channel), By Sales Channel (Institutional Sales, Retail Sales), By Sample (Saliva, Urine, Blood) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Report Code: SRHI54370DR
Study Period 2019-2031 CAGR 17.30%
Historical Period 2019-2021 Forecast Period 2023-2031
Base Year 2022 Base Year Market Size USD 1,590.43 Million
Forecast Year 2031 Forecast Year Market Size USD 6686.46 Million
Largest Market North America Fastest Growing Market Europe
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Market Overview

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

Market Dynamics

Global Direct-to-Consumer Genetic Testing Market Drivers

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.

Global Direct-to-Consumer Genetic Testing Market Restraint

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.

Regional Analysis

Based on region, the global direct-to-consumer genetic testing market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and Rest-of-the-World.

North America Dominates the Global 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 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.

Report Scope

Report Metric Details
Segmentations
By Product Type
  1. Ancestry
  2. Health and Wellness
  3. Entertainment
By Test Type
  1. Nutrigenomics Testing
  2. Predictive Testing
  3. Carrier Testing
  4. Others
By Technology
  1. Targeted Analysis
  2. Single Nucleotide Polymorphisms (SNPs)
  3. Whole Genome Sequencing (WGS)
By Distribution Channel
  1. Online Channel
  2. Over-the-Counter Channel
By Sales Channel
  1. Institutional Sales
    1. Hospitals
    2. Specialty Clinics
    3. Diagnostic Laboratories
    4. Others
  2. Retail Sales
    1. Retail Pharmacies
    2. Online Sales
By Sample
  1. Saliva
  2. Urine
  3. Blood
Company Profiles 23andme Inc. Color Genomics 24Genetics Ancestry.com LLC Easy DNA My Heritage Ltd. DNAfit others.
Geographies Covered
North America U.S. Canada
Europe U.K. Germany France Spain Italy Russia Nordic Benelux Rest of Europe
APAC China Korea Japan India Australia Taiwan South East Asia Rest of Asia-Pacific
Middle East and Africa UAE Turkey Saudi Arabia South Africa Egypt Nigeria Rest of MEA
LATAM Brazil Mexico Argentina Chile Colombia Rest of LATAM
Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends
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Segmental Analysis

The global direct-to-consumer genetic testing market is segmented by product type, technology, and distribution channel.

Based on product type, the global market is segmented into ancestry, health and wellness, and entertainment.

The ancestry segment owns the highest market share and is predicted to exhibit a CAGR of 16.68% during the forecast period. Ancestry testing, or genealogy testing, is a form of direct-to-consumer genetic testing that reveals information regarding a person's ancestry relationship, both for the paternal and maternal sides. Similarly, ancestry tests help discover the individual's ancient origin by going back hundreds of thousands of years. It helps to explore the ancestral roots—where an individual's DNA falls among several specific regional ancestry clusters.

Health and wellness-based DTC-GT helps to discover health risks associated with inherited cancers, cardiovascular diseases, and other health-related disorders that the individual may not have known about. It helps to understand how genetics can have a direct impact on health. Health and wellness-based tests help to gather information about whether the individuals carry genetic markers that could develop certain health conditions. The insights obtained from these tests' results help lower the risks associated with the diseases and optimize wellness.

Based on technology, the global market is divided into single nucleotide polymorphisms (SNPs), targeted analysis, and whole genome sequencing (WGS).

The single nucleotide polymorphisms (SNPs) segment is responsible for the largest market share and is estimated to grow at a CAGR of 17.23% over the forecast period. The expansion of consumer-based genetic panels for ancestry testing, paternity testing, and ancestry predictions has resulted in increased use of the technology, which is mainly responsible for the growth of the single nucleotide polymorphisms (SNPs) market. Additionally, SNPs can identify specific variants that have a chance of developing a disease and provide information on carrier genes and disease-prone variants. Additionally, SNPs are used for predictive models among genome-wide association study (GWAS) results from the pertinent literature, simultaneously boosting the market's growth.

The growth of the whole genome sequencing segment is majorly attributed to the increased sales and marketing of these genetic-based kits for ancestry testing and phenotypic traits and predictive testing of several genetic disorders. In addition, the decreasing cost of sequencing has also led to the development of genetic panels offering genetic analysis for several variants in a single kit. The increased product development and consumer awareness regarding genetic disorders have considerably furthered the market.

Based on the distribution channel, the global market is divided into online channels and over-the-counter (OTC) sales.

The online channel segment is responsible for the highest market share and is anticipated to exhibit a CAGR of 17.67% over the forecast period. DTC-GT companies have significant sales through online channels. Customers can purchase the necessary test from the company's website, where the products are listed for sale. Online sales have been a significant industry proponent, providing easy access and multiple options. The online sales channels segment accounts for over 70% of the sales. The enterprises are developing strategic alliances with e-commerce heavyweights. For instance, Amazon partnered with Orig3n, 23andme, Vitagene, 23andme, Ancestry, and MyHeritage to sell their DTC genetic test kits. Other than the partnerships, social media advertising is another factor contributing to the growth of sales of direct-to-consumer genetic testing through e-commerce.

DTC-GT has another distribution channel, retail sales, where the companies sell their product through retail stores and pharmacies. The sales through this channel are minimal and thus account for only 25-30% of the total sales. 23andme partnered with Walgreens, CVS Pharmacy, and Walmart for OTC sales. Similarly, many companies partner with local partners for an effective distribution channel.

Market Size By Product Type

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.

Top Key Players

23andme Inc. Color Genomics 24Genetics Ancestry.com LLC Easy DNA My Heritage Ltd. DNAfit others. Others

Frequently Asked Questions (FAQs)

What is the market size of direct-to-consumer genetic testing in 2022?
The global direct-to-consumer genetic testing market size was valued at USD 1,590.43 million in 2022.
The global direct-to-consumer genetic testing market growing at a CAGR of 17.30% from (2023–2031).
Key verticals adopting direct-to-consumer genetic testing market include: -23andme, Inc., Color Genomics, 24Genetics, Ancestry.com, LLC, Easy DNA, My Heritage Ltd., DNAfit, and others.
The massive scope for the adoption of genomic-based medicine in emerging nations is one of the key trends in the market.


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