Description

The global direct-to-consumer genetic testing market is expected to grow USD 5,573.5 million by 2030 from USD 1,338.6 million in 2021, at a CAGR of 17.6% from 2022 to 2030. Direct to consumer genetic testing (DTC-GT) broadly refers to the tests marketed directly to the consumers. DTC-GT tests are sold directly to the consumer without the involvement of a healthcare professional or health insurance company. The data produced by genetic testing can have several utilizations making each a different revenue model. The genomic information can be utilized for individual health planning that includes genetic tests to identify disease risks or for nutrigenomics. The consumers can also get comprehensive genomic tests by using the third party as a service platform. Direct-to-consumer genetic testing can also be referred to as DTC genetic testing, direct-access genetic testing, at-home genetic testing, and home DNA testing, which provides access to genetic information.

The market for direct-to-consumer genetic testing has grown considerably. The awareness among consumers about DTC genetic testing is increasing, leading to the bio boom of genomic services. Another factor that has increased the interests of the consumers and the pharma giants is the production of raw genome data and interpretation services. Since the cost of genome sequencing has decreased considerably, companies providing DTC genetic tests are making biobanks of genomic data, which can be further used for developing personalized medicine and research purposes.

With the provision of raw genomic data, consumers now access information that could have been available only through medical institutions or research facilities. Direct-to-consumer genetic testing can majorly be divided into two segments: one-to-one and one-to-many. Many key players in the market offer both services. For instance, 23andme, in collaboration with GSK and Pfizer, will share the genomic data of their consumers to develop target therapeutics. Gene by Gene also offers raw genomic data to the consumers as a separate product offering. Another company that offers similar services of raw genomic data is Ancestry.com, which provides its offerings to consumers and pharmaceutical companies.

COVID-19 Impact on the Global Direct-to-Consumer Genetic Testing Market

The current global direct-to-consumer genetic testing market study comprises products and services utilized to analyze underlying genetic and protein alterations associated with genetic disorders. Since the market is primarily dominated by non-registered clinical use of products, the COVID-19 pandemic had a medium impact on the revenue generated from the market. The current market assessment has considered information provided by key opinion leaders from both supply and demand sides. 

In addition, COVID-19 has also increased the revenue generation opportunity for consumer genetic tests manufacturers. The surplus increase in nucleic acid-based testing has led to the development of self-testing COVID-19 diagnostic tests by several key players in the market. For instance, in 2020, Helix Opco LLC launched the Helix self-collection kit to detect COVID-19. Moreover, the increased focus of large biopharmaceuticals and government institutions toward population genomics due to the current COVID-19 pandemic has also increased the utilization of these tests.

Global Direct-to-Consumer Genetic Testing Market Dynamics

Drivers: Growing Number of Direct-to-Consumer Genetic Tests

The number of genetic tests has increased due to the plummeting cost of DNA sequencing. These tests have recently become the standard of care for pregnant women and oncology patients. According to a study published in 2018 by Concert Genetics and the Department of Clinical Pharmacy at the University of California San Francisco, there were approximately 75,000 genetic tests in the market, with 10,000 unique test types among them. Moreover, 14% of these tests were multigene panels, including 9,311 multianalyte assays, 85 non-invasive prenatal tests (NIPTs), 122 whole-exome sequencing tests, and 873 whole-genome sequencing tests. Between March 2014 and April 2018, nearly 14,000 tests were added, with an average rate of about 10 per day.

The rise in direct-to-consumer genetic testing among consumers is due to sales and marketing activities adopted by key players in the market. The leading players such as 23andme, Inc and Ancestry DNA have the largest database of human genetic information provided through genealogy reports, genetic health risks reports, and wellness reports.

Restraints: Uncertain Regulatory Standards for Direct-to-Consumer Genetic Tests

The global healthcare industry is suffering from increasing treatment costs due to the high disease burden. The fragmented healthcare system within the countries has led to the difference in the treatment protocols for chronic conditions, including cancer, neurological disorder, and infectious disease, which requires combinations of therapeutic regimens. Due to the difference or lack of standard treatment protocols, the actual administered treatment or the efficacy of treatment is not estimated, affecting the efficiency of the diagnostics or drugs. Moreover, the non-reproducibility of the consumer genetic tests coupled with the lack of involvement of health care professionals affects the reimbursement recommendations of the product as the payors are moving away from fee-for-service toward performance-based or value-based reimbursement strategies.

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

The availability of high-quality diagnostic tests, particularly molecular tests for genetic disorders, is prioritized worldwide. Although there have been significant strides in advancing biomarker-based tests and their consequent adoption into routine healthcare procedures, people living in low-income countries lack access. This restriction may deprive them of life-saving treatments and may reduce the opportunities for the effective prevention of onward transmission of infectious diseases. The diagnostic laboratories face poor resourcing in developing countries and are sparsely distributed. There is massive scope for improvement in access by using operable tests without laboratory support. 

Scope of the Direct-to-Consumer Genetic Testing

The study categorizes the direct-to-consumer genetic testing market based on technology, distribution channel, and product type at the regional and global levels.

By Technology Outlook (Revenue, USD Million, 2017-2030)

• Single Nucleotide Polymorphism
• Targeted Analysis
• Whole Genome Sequencing

By Distribution Channel Outlook (Revenue, USD Million, 2017-2030)

• Online Channel
• OTC Channel

By Product Type Outlook (Revenue, USD Million, 2017-2030)

• Ancestry
• Health and Wellness
• Entertainment

By Region Outlook (Revenue, USD Million, 2017-2030)

• North America (US, Canada, Mexico)
• South America (Brazil, Argentina, Colombia, Peru, Rest of Latin America)
• Europe (Germany, Italy, France, UK, Spain, Poland, Russia, Slovenia, Slovakia, Hungary, Czech Republic, Belgium, the Netherlands, Norway, Sweden, Denmark, Rest of Europe)
• Asia Pacific (China, Japan, India, South Korea, Indonesia, Malaysia, Thailand, Vietnam, Myanmar, Cambodia, the Philippines, Singapore, Australia & New Zealand, Rest of Asia Pacific)
• The Middle East & Africa (Saudi Arabia, UAE, South Africa, Northern Africa, Rest of MEA)

By technology, the single nucleotide polymorphisms segment is projected to account for the largest market share

Based on technology, the global direct-to-consumer genetic testing market is divided into single nucleotide polymorphism, targeted analysis, and whole-genome sequencing. In 2021, the single nucleotide polymorphisms segment accounted for the largest market share of 52.4% in the global direct-to-consumer genetic testing market. The segment's growth is majorly attributed to the increased utilization of the technology for the development of consumer-based genetic panels for ancestry testing, paternity testing, and ancestry predictions. In addition, SNPs also offer information regarding carrier genes and identifying specific variants with the potential of developing a disease. Moreover, SNPs are also used for predictive models among genome-wide association study (GWAS) results from the relevant literature, which simultaneously bolstered the market's growth.

Asia Pacific accounts for the highest CAGR during the forecast period 

Based on the regions, the global direct-to-consumer genetic testing market has been segmented across North America, Asia-Pacific, Europe, South America, and the Middle East & Africa. Globally, Asia Pacific is projected to be the fastest-growing region with a CAGR of 18.1% during the forecast period. It is being observed that several new and advanced high-quality human genome libraries produce ethnicity-specific sequences and help enable scientists to utilize genetic information to improvise precision medicine research in the Asia-Pacific region.

As millions of people are moving from the countryside to cities across Asia, so-called "lifestyle" conditions such as heart disease and diabetes have become more commonplace as the population is inclined toward processed foods and following a sedentary lifestyle. Therefore, peering into one’s DNA can yield necessary insights into the individual's health conditions. Moreover, the rise in obesity cases across Asia-Pacific countries such as Japan and China has encouraged individuals to have a keen interest in understanding how nutrition and genes are intertwined in one's health.

Key Market Players

Every company follows its business strategy to attain the maximum market share. Currently, Myriad Genetics, Konica Minolta, Inc., 23andme, Color Health, Inc., My heritage, Atlas Biomed, Ancestry.com LL, Mapmygenome, 23mofang, EasyDNA, DNA fit, Gene by Gene, and XCode Life. are some of the leading players operating in the global direct-to-consumer genetic testing market.

Recent Developments

• In August 2020, 23andMe, Inc. received a U.S. Food and Drug Administration (FDA) 510(k) clearance for a pharmacogenetics (PGt) report for interpretive drug information for two medications, namely Clopidogrel and Citalopram.
• In June 2019, Atlas Biomed announced the launch of its DNA test and Microbiome test in Canada, following strong success in the U.K.
• In January 2021, the Australian genomics company myDNA merged with the U.S.-based consumer DNA test developer FamilyTreeDNA and its parent Gene by Gene, combining the personalized genomics pioneers.
• In December 2020, MyHeritage Ltd. announced the release of Genetic Groups. It was a major enhancement to MyHeritage DNA’s ethnicity estimates as it would accurately identify ancestral origins with an incredibly high resolution of 2100 geographic regions.

Key Issues Addressed

• What is the market size by various segmentation of the direct-to-consumer genetic testing by region and respective countries?
• What are the customer buying behavior, key takeaways, and Porter's five forces of the direct-to-consumer genetic testing market?
• What are the key opportunities and trends for manufacturers involved in the direct-to-consumer genetic testing supply chain?
• What are the market's fundamental dynamics (drivers, restraints, opportunities, and challenges)?
• What and how are regulations, schemes, patents, and policies impacting the market's growth?
• What are the upcoming technological solutions influencing market trends? How will existing companies adapt to the new change in technology?
• The market player positioning, top winning strategies by years, company product developments, and launches will be?
• How has COVID-19 impacted the demand and sales of direct-to-consumer genetic testing in the global market? Also, the expected BPS drop or rise count of the market and market predicted recovery period.
• Detailed analysis of the competitors and their latest launch, and what are the prominent startups introduced in the target market? Also, detailed company profiling of 25+ leading and prominent companies in the market.