The market is projected to grow at a CAGR of 19.5% during the forecast period of 2023 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.
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.
65% of individuals are willing to use, home Direct to consumer genetic testing service is reported. 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.
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 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 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 2022 to 2032 considering 2023 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2024 to 2032.
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:
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.
| ATTRIBUTE | DETAILS |
|---|---|
| Research Period | 2022-2032 |
| Base Year | 2023 |
| Forecast Period | 2024-2032 |
| Historical Year | 2022 |
| Unit | USD Million |
| Segmentation | |
Sales Channel
| |
Business Model
| |
|
Region Segment (2022-2032; US$ Million)
|
Key questions answered in this report
