Genetic testing, also called DNA testing is used to identify changes in DNA sequence and chromosome structure. The tests was available only through healthcare professionals such as doctors, nurses, and genetic counselors. However, this trend is gradually shifting towards the customer or consumer. Genetic testing is now offered directly at home, and is called Direct-to-Consumer (DTC) Genetic Testing, which bypasses the mediators or facilitators such as Physicians, Genetic Counselors, and others. The most critical thing about the genetic tests is that these tests are for disease susceptibilities only and cannot be used alone for treatment decisions or other medical interventions. In genetic testing, interpretation is important and is transferred to individual patient, who may not be trained geneticist.
Request Sample Copy of Report: https://www.coherentmarketinsights.com/insight/request-sample/1046
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. Food and Drug Administration has marked these tests as Tier-3 category test due to high chances of misinterpretation of direct-to-consumer (DTC) genetic testing. According to the U.S. FDA, Tier 3 category means that there is no clinical validity or utility of such applications in healthy individuals in the population.
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
Market Dynamics- Drivers
Easy accessibility along with increased incidences of chronic disease such as cancer, Alzheimer’s, and Parkinson’s is expected to drive growth of the market
Easy availability of these tests is the major factor expected to drive the global direct-to-consumer genetic testing devices market over the forecast period. Genetic testing requires patients or healthy individuals to visit trained medical professionals such as doctors, nurses or counselors, in order to get their test interpretations of the result. However, this process has become redundant or voluntarily since introduction of direct-to-consumer (DTC) genetic testing devices. This has significantly cut down the cost associated with testing and increasing accessibility of such tests to potential patients. Thus, it is expected to drive the global direct-to-consumer genetic testing devices market during the forecast period.
Furthermore, growing awareness regarding health, especially in developed economies such as U.S., Canada, and U.K. coupled with increasing incidences of chronic diseases such as cancer, Alzheimer’s, and Parkinson’s is expected to fuel the market growth in the near future. The reasons for this reactiveness varies with geography. For instance, in developed economies such as U.S. and Germany, geriatric population are more prone to chronic conditions, which include cancer, neurological disorders, and cardiovascular disorders. 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.
Get PDF Broacher Here: https://www.coherentmarketinsights.com/insight/request-pdf/1046
Limited accessibility to healthcare facilities, mainly in emerging economies such as Brazil, India, and China, is the major reason for low adoption of advanced technologies such as genetic tests. However, introduction of direct-to-consumer (DTC) genetic testing devices is expected to solve this problem as customers can use direct-to-consumer (DTC) genetic testing devices at their home.
Market Dynamics- Restraints
Prolonged struggle between manufacturers and regulatory bodies’ restraints growth of the 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. 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, the U.S. 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 received the first U.S. FDA approval for genetic tests for 10 diseases. The hindrance between the manufacturers and regulatory bodies restraints the market growth.
Competitive Landscape
Major companies operating in the global direct-to-consumer genetic testing devices market are 23andMe, Pathway Genomics, Color Genomics, Counsyl, Inc., deCode genetics, Inc., Map My Gene, and GenePartner.
Direct Purchase this Research Report: https://www.coherentmarketinsights.com/insight/buy-now/1046
Contact US:
Coherent Market Insights
1001 4th Ave, #3200 Seattle, WA 98154, U.S.
Email: [email protected]
United States of America: +1-206-701-6702
United Kingdom: +44-020-8133-4027
Japan: +050-5539-1737
India: +91-848-285-0837