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Direct-to-Consumer Genetic Testing Devices Market to Witness Huge Growth by Key Players 23andMe, Pathway Genomics, Color Genomics, Counsyl, Inc., deCode genetics, Inc., Map My Gene

03-06-2019 05:49 AM CET | Advertising, Media Consulting, Marketing Research

Press release from: Coherent Market Insights

Direct-to-Consumer Genetic Testing Devices

Direct-to-Consumer Genetic Testing Devices

Direct-to-Consumer (DTC) Genetic Testing is advantageous for manufacturers as it gives direct access to them to appeal to the customer and maximize their revenue. However, this testing provides easy access to the customer while chances of misinterpretation are really high.

The U.S. FDA has kept these tests in “Tier 3” category due to high chances of misinterpretation of direct-to-consumer (DTC) genetic testing. According to FDA, Tier 3 category means that there is no clinical validity or utility of such applications in healthy individuals in the population.

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For instance, 23andMe was started in 2006 and the company started selling its direct-to-consumer (DTC) genetic testing devices in 2007 and was even named ‘Invention of the Year’ by Time magazine in 2008. However, in 2013, FDA ordered 23andMe to discontinue marketing its personal genome service (PGS), as the company had not obtained the legal regulatory approval. The company completely denied the charge and sold their products till 2015. In 2017, the company got first FDA approval for genetic tests for 10 diseases. The hindrance between the manufacturers and regulatory bodies restraints the market growth.

Manufacturers and regulatory bodies are the essential parts of healthcare ecosystem and cooperation between them is must for any development. Manufacturers drive innovation whereas regulatory authorities insures safety and efficacy of the product or process. However, the direct-to-consumer genetic testing devices market has seen very little cooperation.

In 2017, FDA approved direct-to-consumer (DTC) genetic testing for 10 diseases, including Alzheimer’s and Parkinson’s. This has further certified direct-to-consumer (DTC) genetic testing devices for these conditions, which in turn, is expected to increase the use of direct-to-consumer (DTC) genetic tests among patients suffering from the medical conditions.

Increasing awareness about health, especially in developed economies such as U.S., Canada, and U.K. among others, and increasing incidences of chronic diseases such as cancer, Alzheimer’s, and Parkinson’s is majorly contributing to growth of the market. The reasons for this reactiveness varies with geography. For instance, in developed economies such as U.S. and Germany, aging population are more prone to chronic conditions, which include cancer, neurological disorders, and cardiovascular disorders.

Key players operating in the global direct-to-consumer genetic testing devices market include 23andMe, Pathway Genomics, Color Genomics, Counsyl, Inc., deCode genetics, Inc., Map My Gene, and GenePartner.

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Global Direct-to-Consumer Genetic Testing Devices Market Taxonomy:

By Application:

Health Testing
Carrier Testing (Diagnosis screening)
Nutrigenetic Testing
Ancestry
Relationship Testing
Talent Testing
Matchmaking
Others
By Type of Sample:

Saliva
Blood
Others

About Coherent Market Insights:

Coherent Market Insights is a prominent market research and consulting firm offering action-ready syndicated research reports, custom market analysis, consulting services, and competitive analysis through various recommendations related to emerging market trends, technologies, and potential absolute dollar opportunity.

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