Direct-to-Consumer Genetic Health Testing Market to Reach $310 Million, Says Report

ROCKVILLE, Md., Jan. 15, 2018 /PRNewswire/ -- The global direct-to-consumer (DTC) genetic health testing market totaled $99 million in 2017, according to a leading biotechnology and IVD market research firm.   With average 25.6% growth, the market will grow to $310 million in 2022. Kalorama Information said growth of the direct-to-consumer genetic testing market is born out of a paradigm shift among consumers who are seeking greater control over their own healthcare. Since the 1980s, consumers have pushed for access to their laboratory tests, but it has been slow to evolve due to concerns that consumers may try to diagnose themselves without understanding how diagnoses information all fits together.  Kalorama did not include paternity testing in its number.  The finding was made in the firm's report The Market for Direct-to-Consumer Genetic Health Testing.

"Strong growth is expected through the forecast period due to easing of the regulatory process for DTC genetic tests," said Mary Ann Crandall, analyst for Kalorama Information.

With the increased use of the Internet for medical information, consumers have become medical consumers not just patients. This has created a change in the doctor/patient relationship as individuals become more knowledgeable about their own health and want more control over their personal information and treatment decisions. Consumers are more cost-conscious and the increase in high-deductible insurance plans requires that individuals ask more questions, do their own research and collaborate with their doctor about medical decisions, tests, and treatments.

The precursor to DTC testing market rests with the rise of genetic testing which began in the 1970s and has grown to include tests for cancer and other illnesses.   Ancestral testing provided clues as to what may be in the ancestral pool prompting consumers to discover more about their own predisposition for certain diseases.  The passage of the 2008 Genetic Information Nondiscrimination Act (GINA) has opened the door for consumer awareness of genetic make-up without the fear of discrimination by health insurers and employers.  Companies that provide such testing offer a broad range of services, such as predicting adverse reactions to specific medications, estimating susceptibility to various complex diseases, and diagnosing predominantly genetic disorders. 

Ethical dilemmas are also a concern for the industry. This involves the interpretation and use of the genetic test results. To address this concern, many DTC genetic testing companies have employed onsite genetic counselors.  Because this is a fledgling industry, there will be a number of growing pains before this industry is mainstream.

"However, demand by the consumer to unlock their genetic health information will likely triumph over the adversities," said Crandall.

During 2013-2015, the FDA established guidelines for DTC autosomal recessive carrier status testing. These guidelines enable companies to add autosomal recessive carrier status tests to their offerings when using FDA-approved sample collection processing devices. A milestone was achieved in this arena in April 2017, when FDA granted approval to 23andMe to market 10 genetic health risk reports. These reports only approximate genetic risk for developing a disease but do not diagnose a lifetime risk of disease.   One of the biggest issues facing the market is regulatory oversight by FDA and the establishment of guidelines. DTC genetic testing companies differ due to their specific business model, laboratory testing quality and motive of the test.  There are many reputable companies operating in this arena but there are some that do not offer quality products. This has made it hard for physicians and consumers to trust the results. 

Kalorama Information's report is based on examinations of company information, financial and medical publications and interviews with main companies in the market.  The report contains additional market sizing for regional markets and for tests by physician or consumer. 

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

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SOURCE Kalorama Information