Direct to consumer genetic testing set for big growth despite clinical and ethical challenges

A growth projection of 25.6 percent by 2022 is expected, says new Kalorama report, and so are changes in the doctor-patient relationship.
By Mike Miliard
03:16 PM
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Direct to consumer genetic testing

As people learn more about the crucial role of genetics in health and the cost to sequence genes continues to decrease, the worldwide market for direct-to-consumer genetic tests could triple over the next five years, according to a new report from Kalorama Information.

The DTC genetic testing market was around $99 million this past years, according to the research firm, and could grow to more than $310 million in 2022.

Consumers are looking for more control over their own health and healthcare, and with the advent of affordable genetic testing there are new avenues for personalized treatment and precision medicine. Companies that can offer these testing kits stand to see big success in the years ahead, said Kalorama officials.

[Also: With precision medicine heating up, Genome Medical launches genetic services for employers]

Beyond the consumer market, rule changes also have something to do with that projected growth.

"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.

But there are complications, of course, as consumer tests come to the fore and patients arrive at their doctor appointments brandishing their own genetic data and full of questions and opinions.

The Kalorama report, The Market for Direct-to-Consumer Genetic Health Testing, comes decades after consumers first started clamoring for access to laboratory tests, officials point out, but at a time where concerns still remain that patients – and not a few physicians – don't always understand what the genetic results mean and just what to do about them.

Whether it is sequencing that can test for specific illnesses or ancestral tests that can offer valuable information about racial or ethnic predispositions, the number and variety of DTC genetic tests is increasing.

Meanwhile, Kalorama points out that the 2008 Genetic Information Nondiscrimination Act has enabled consumers to take such tests without having to be concerned that insurers and employers might discriminate based on the results.

Companies that do DTC testing offer an array of services: predicting adverse reactions to specific medications, estimating susceptibility to various complex diseases and more. The Kalorama report examines a couple dozen companies including 23andMe, DNA4Life, Natera, Veritas Genetics, LabCorp, Quest Diagnostics and others.

Quest Diagnostics and LabCorp have clear advantages due to their name recognition, a large number of locations and financial strength – but are relatively new to the DTC market. It's smaller labs that have so far been leaders in the space. Others, meanwhile, have specialized in areas like ancestral testing (23andMe) or operate regionally (Sonora Quest Laboratories).

But as consumers get more comfortable with those companies' offerings, the visits with their doctors are often getting more complex.

"With the increased use of the Internet for medical information, consumers have become medical consumers not just patients," according to Kalorama. "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."

Physicians, meanwhile, are concerned about giving patients too much access to information they may not properly understand. Even many doctors aren't well-trained in the clinical implications of genetics and genomics.  

In response to some of these ethical dilemmas about the interpretation and use of genetic test results, many testing companies have employed onsite genetic counselors to help consumers make sense of the information.

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

Twitter: @MikeMiliardHITN
Email the writer: mike.miliard@himssmedia.com