Direct-To-Consumer (DTC) Genetic Testing Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2022 To 2030

The market is projected to grow at a CAGR of 19.5% during the forecast period of 2022 to 2030. Genetic testing is a type of medical test that identifies changes in chromosomes, genes, or proteins. The results of a genetic test can confirm or rule out a suspected genetic condition or help determine a person's chance of developing or passing on a genetic disorder. DTC refers to a genetic test that can be completed at home without a health care provider. After collection of the DNA sample the individual can send it to the company. They analyze it and provide a report on genetics. There are many different types of DTC tests available. They can reveal about ancestry, kinship, lifestyle factors and disease risk.

Selective Role of FDA

In general, direct-to-consumer tests for non-medical, general wellness, or low risk medical purposes are not reviewed by the FDA before they are offered. Direct-to-consumer tests for moderate to high risk medical purposes, which may have a higher impact on medical care, are generally reviewed by the FDA to determine the validity of test claims. FDA verifies that whether the test can measure accurate or reliably, whether the measurement is measured at certain health stage & finally the company's claim about the test. Also the test accuracy is measured along with descriptive recording of information. As a matter of policy, the FDA generally does not review some types of tests, called laboratory developed tests (LDTs) that are created and performed in a single laboratory, if they are offered to patients only when prescribed by a health care provider. These tests typically do not have the FDA's independent assurance of the analytical validity, clinical validity, or clear communication of test results. All direct-to-consumer test users, including health care providers and consumers, are strongly encouraged to voluntarily report problems with direct-to-consumer tests directly to the FDA through Medwatch, the FDA's voluntary reporting program.

Privacy is a concern

65% of individuals are willing to use home direct to consumer genetic testing service Privacy is one of the main concerns specifically the potential sharing of data with third parties including consumer health, pharmaceutical & insurance companies. Almost all of the respondents willing to use the service have concerns about a company owning their DNA profiles. In submitting a sample for processing, individuals provide sensitive information not only about themselves but about family members with whom they share a genetic link. Leakage of such data could negatively impact these individuals across a range of areas including employment prospects, relationships and insurance premiums. Cyber security breaches database password & server hacking, storage device theft, and human error or oversight by data custodians themselves represents a threat here.

Increase in willingness to use Direct to consumer Genetic testing

Rising public awareness and acceptance of genetic testing is steadily growing. A national survey revealed that awareness in the US grew drastically, and a social media survey found that 47% of users were familiar with the direct to consumer concept. Across many sectors there is a clear rise in customers seeking tailored products & experiences, with an increasing willingness to pay for the identification & addressing of unique needs. Customers are expressing willingness to undergo testing & pay for genetic testing services. According to a recent survey held in the U.S. 10 sample of 2,000 participants 33% of individuals stated that they would be willing to pay for & use advice provided by a direct to consumer's genetic testing company.

North America dominates the market

North America has a major market of more than 30% in Direct to consumer Genetic testing which is followed by Europe. Globally there are more than 200 companies offering DTC genetic testing services with prominent ones headquartered in North America having no clear majority of the market share held by any specific player. Products such as CentoDx Plus by Centogene AG, Ancestry kit by 23andMe and family finder test, Y-DNA and mtDNA test by GenebyGene, Ltd. are few of the products ordered through different distribution channels. Consumers are buying these services and kits to obtain information related to family lineage, disease risks and personal traits. Along with genetic testing kits, manufacturers and third parties are providing additional services pertaining to interpretation of the raw data. DTC coupled with accessibility through on-line sales channel, procurement of these services/kits has literally become hassle-free with test results delivered at consumers’ doorstep. On-line sales as a prime distribution channel expected to grow with the highest CAGR during the forecast period. North America led the DTC genetic testing market in 2017 while Asia Pacific is poised to emerge as the fastest growing region between 2018 and 2026. Availability of wide range of DTC genetic test kits through portals of manufacturers and third-party websites for the consumers to choose from is contributing to the overall remunerative growth of the DTC genetic testing market.

Key players

Key players in this segment include 23 and Me, Colour Genomics, Counsyl, Gene by Gene, Laboratory Corporation of America, MyMedLab, Mapmygenome India, Positive Bioscience, Quest Diagnostics, Request A Test, Sonora Quest Laboratories LLC, Xcode Life Sciences are some of the leading companies in the global Direct to consumer Genetic testing market.

Historical & Forecast Period

This study report represents analysis of each segment from 2020 to 2030 considering 2021 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2022 to 2030.

The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.

Research Methodology

The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation of Direct-To-Consumer (DTC) Genetic Testing market are as follows:

• Research and development budgets of manufacturers and government spending
• Revenues of key companies in the market segment
• Number of end users and consumption volume, price and value.
• Geographical revenues generate by countries considered in the report
• Micro and macro environment factors that are currently influencing the Direct-To-Consumer (DTC) Genetic Testing market and their expected impact during the forecast period.

Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.

Market Segmentation

Sales Channel

• Online Sales
• OTC Sales
• Doctor's Office

Business Model

• Genome Data Bank Material Model
• Individual Health Planning Model
• Comprehensive Genome Tests Model
• Medical Precision Tests Model
• Restricted Trait Tests Model

Key questions answered in this report

• What are the key micro and macro environmental factors that are impacting the growth of Direct-To-Consumer (DTC) Genetic Testing market?
• What are the key investment pockets with respect to product segments and geographies currently and during the forecast period?
• Estimated forecast and market projections up to 2030.
• Which segment accounts for the fastest CAGR during the forecast period?
• Which market segment holds a larger market share and why?
• Are low and middle-income economies investing in the Direct-To-Consumer (DTC) Genetic Testing market?
• Which is the largest regional market for Direct-To-Consumer (DTC) Genetic Testing market?
• What are the market trends and dynamics in emerging markets such as Asia Pacific, Latin America, and Middle East & Africa?
• Which are the key trends driving Direct-To-Consumer (DTC) Genetic Testing market growth?
• Who are the key competitors and what are their key strategies to enhance their market presence in the Direct-To-Consumer (DTC) Genetic Testing market worldwide?