Genetic testing refers to medical testing that determines changes in chromosomes, genes, or proteins. Previously, these were available through healthcare personnel such as doctors, genetic counselors, and nurses. However, the trend has gradually shifted towards direct-to-consumer. As a matter of fact, genetic testing is now being offered direct to consumers, which does not require mediators such as physicians or genetic counselors. One of the most important part of these testing is that it can only be used for disease vulnerabilities and cannot be used alone for treatment decision or other medical procedures. In genetic testing, interpretation is important and is transferred to individual patient, who may not be trained geneticist.
Direct-to-Consumer (DTC) Genetic Testing provides numerous advantages to manufacturers as it provides them direct access to the customer and optimize their revenue generation. However, these tests are likely to be misinterpreted and hence the U.S. Food and Drug Administration (FDA) has categorized as ‘Tier 3’. As per the U.S. FDA, Tier 3 category refers to no clinical validity or utility of such applications in healthy individuals in the population.
Global Direct-to-Consumer Genetic Testing Devices Market Taxonomy:
Carrier Testing (Diagnosis screening)
By Type of Sample:
Market Dynamics- Drivers
Increasing cases of chronic diseases such as cancer, Parkinson’s, and Alzheimer’s combined with easy accessibility to testing is expected to drive growth of the global direct-to-consumer genetic testing devices market during the forecast period.
Previously, individuals had to visit experienced clinicians or counselors for genetic testing. However, DTC genetic testing devices have eliminated that requirement, which has further reduced the cost of testing making them accessible to potential patients.
Furthermore, growing awareness regarding health across developed economies such as the U.S., Canada, and the U.K. combined with rising cases of Parkinson’s, cancer, and Alzheimer’s is expected to support the market growth in the near future. The acceptance of these testing devices varies as per different regions. For instance, in developed countries such as Germany and the U.S., geriatric population are most susceptible to chronic diseases such as cardiovascular disorders, neurological disorders, and cancer. In 2017, the U.S. 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.
There is have limited availability of robust healthcare facilities across emerging economies including India, China, and Brazil, which has hindered their adoption. However, advent of DTC genetic testing devices can be a great solution to this problem since consumers can directly use these devices.
Market Dynamics- Restraints
Extended struggle between regulatory authorities and manufacturers is expected to restrain growth of the global direct-to-consumers genetic testing devices market during the forecast period.
Both manufacturers and regulatory authorities are key part of healthcare ecosystem. Manufacturers play an essential role in innovation, while regulatory organizations are responsible for ensuring the safety and efficacy of the product. However, lack of cooperation from regulatory authorities has led to a negative impact on growth of the market. For instance, 23andMe was established in 2006 with company selling its direct-to-consumer (DTC) genetic testing devices from 2007. In fact, in 2008, the company was even named ‘Invention of the Year’ by Time Magazine. However, in 2013, the U.S. FDA ordered 23andMe to discontinue marketing its personal genome service (PGS), as the company had received the legal regulatory approval. The company completely denied the charge and sold their products till 2015. Furthermore, in 2017, the company received the first U.S. FDA approval for genetic tests for 10 diseases. These factors are expected to hamper the market growth over the forecast period.
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.
Table of Content
Chapter 1 Industry Overview
1.3 Research Scope
1.4 Market Analysis by Regions
1.5 Direct-to-Consumer Genetic Testing Devices Market Size Analysis from 2021 to 2028
11.6 COVID-19 Outbreak: Direct-to-Consumer Genetic Testing Devices Industry Impact
Chapter 2 Global Direct-to-Consumer Genetic Testing Devices Competition by Types, Applications, and Top Regions and Countries
2.1 Global Direct-to-Consumer Genetic Testing Devices (Volume and Value) by Type
2.3 Global Direct-to-Consumer Genetic Testing Devices (Volume and Value) by Regions
Chapter 3 Production Market Analysis
3.1 Global Production Market Analysis
3.2 Regional Production Market Analysis
Chapter 4 Global Direct-to-Consumer Genetic Testing Devices Sales, Consumption, Export, Import by Regions (2016-2021)
Chapter 5 North America Direct-to-Consumer Genetic Testing Devices Market Analysis
Chapter 6 East Asia Direct-to-Consumer Genetic Testing Devices Market Analysis
Chapter 7 Europe Direct-to-Consumer Genetic Testing Devices Market Analysis
Chapter 8 South Asia Direct-to-Consumer Genetic Testing Devices Market Analysis
Chapter 9 Southeast Asia Direct-to-Consumer Genetic Testing Devices Market Analysis
Chapter 10 Middle East Direct-to-Consumer Genetic Testing Devices Market Analysis
Chapter 11 Africa Direct-to-Consumer Genetic Testing Devices Market Analysis
Chapter 12 Oceania Direct-to-Consumer Genetic Testing Devices Market Analysis
Chapter 13 South America Direct-to-Consumer Genetic Testing Devices Market Analysis
Chapter 14 Company Profiles and Key Figures in Direct-to-Consumer Genetic Testing Devices Business
Chapter 15 Global Direct-to-Consumer Genetic Testing Devices Market Forecast (2021-2027)
Chapter 16 Conclusions
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