DIRECT TO CONSUMER GENETIC TESTING DEVICES MARKET ANALYSIS

Market Challenges And Opportunities

Prolonged struggle between manufacturers and regulatory bodies’ restraints growth of the market 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. 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.