"Direct-To-Consumer" Genetic Testing - Market Expected to Triple in Five Years

The global direct-to-consumer (DTC) genetic health testing market totaled $99 million in 2017, according to Kalorama information's most recent report on testing driven by patients.  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. The finding was made in our report, he Market for Direct-to-Consumer Genetic Health Testing https://www.kaloramainformation.com/Direct-Consumer-Genetic-Health-Testing-11370673/.

Advances in genetic research, including the completion of the human genome project in 2003, have produced more sophisticated processes in medicine including medical testing. Gene-based testing, or DNA testing, typically involves testing for genetic disorders. The process often examines the DNA molecule itself. Other genetic tests include biochemical tests for enzymes and other proteins, and examination of fluorescent chromosomes. This area of testing includes carrier screening, preimplantation genetic diagnosis, newborn screening, presymptomatic testing, conformational diagnosis, and identity testing. Genetic testing may be used to test in medical segments such as oncology, for example, cancer tests may be accomplished by finding mutations in specific genes. By finding changes in genes called BRCA1 and BRCA2, physicians can help determine a person’s chance of developing breast or ovarian cancer.

The market generally is divided into two distinct models: Pure DTC genetic testing – a doctor’s order is not required for the consumer to order the genetic test and  Consumer initiated genetic testing ordered by a physician- a doctor’s order is required to run the test, but it can be a company staff doctor or the patient’s own doctor.

The major player in the market is 23andme.com though there are others.  Color Genomics.  The market does not include companies such as AncestryDNA, Family Tree and Heritage because they do not fit the medical mold. These companies offer genetic testing, but it is only to determine ancestry and ethnic backgrounds providing consumers with novel information about their past, but they do not purport health or medical information. It is Kalorama Information’s position that this will eventually change as the regulatory framework is stabilized and advances in genetic testing continue to shape the DTC genetic test market.  At present, there only a handful of companies that provide pure DTC genetic testing. Several of these companies are international companies and operate in countries where there is little to no restriction on DTC genetic testing. In the United States, the FDA is easing the approval process for DTC genetic tests in a new era of regulation as whole genome sequencing becomes more accessible to consumers. Europe is fragmented with some companies banning DTC genetic testing and others limiting DTC genetic testing.

Consumer initiated genetic testing does not receive the scrutiny as the pure DTC testing companies because of the involvement of a healthcare professional. There are more companies involved in the market using the consumer initiated business model.
Accuracy, safety and regulatory issues will continue to plague the industry due to a lack of knowledge by consumers and their physicians regarding genetic information. The absence of medical supervision and genetic counseling has raised concerns regarding potential misinterpretation of test results by consumers
However, DTC genetic testing may encourage consumers to take a proactive role in their healthcare by providing information about the genetic makeup of the individual. Kalorama Information believes that personalized medicine is the way of the future; genetics play a focal role in establishment of personalized treatments tailored to the patient’s unique DNA. The road to success is long and daunting but this industry is not likely to slow down anytime soon.  The 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.

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 that there may be a genetic susceptibility for in the family. 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.

Kalorama Information's report breaks out the market by patient only tests,  DTC Genetic Testing Services, by Order Origination Source, 2017 (Pure DTC, Consumer Initiated/Dr ordered) and forecasts both categories.  It also profiles companies and details the reasoning behind the market forecast

Evolution of DTC Genetic Testing

Advancements in genetic testing have provided opportunities for several companies to offer this technology to the general public at a competitive price without the consent of a physician. This led to host of companies entering the market to sell their wares. Many of these DTC genetic testing companies were not FDA approved, due to the newness of the technology. With such a valuable market, regulation by the FDA has been under scrutiny by the biotech industry, healthcare providers, and consumers. 

• The FDA ruled that in vitro genetic tests are considered medical devices and subject to FDA oversight whether they are ordered from and performed at home or performed in the healthcare setting or laboratory-developed test or LDT. These two types of tests require different levels of FDA scrutiny.
• LDTs are ordered by a physician, developed by and performed in a single laboratory and are not sold to other laboratories and not marketed to consumers. DTC tests must meet higher regulatory hurdles. They must demonstrate that they clearly and safely provide information to consumers and are not meant to diagnose diseases or risk of diseases.
• In 2010, the FDA notified Pathway Genomics and four other companies that their product was a medical device that needed FDA clearance. This disrupted the market and essentially closed it down. Only two companies remained in the DTC genetic testing market from the original testing space with very different business models. Other companies have entered the market adopting one of two business models.
• 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.

Drivers of DTC Genetic Testing

There are several trends, which continue to influence growth in the global DTC genetic testing market, including:
• Demographics remain a primary factor in growth in the health market
• Aging populations contribute to the growing concern over the delivery of health care. By 2020, 16% of the U.S. population will be over the age of 65, up from 13% in 2010.
• Globally, life expectancy is also increasing, further fueling opportunities in the market.
• Advancing technologies have led to increased use of laboratories and laboratory services online. DTC genetic testing markets rely on the expansion of digital technologies for delivery of results.
• A trend toward preventive and risk factor testing has been noted in several disciplines, particularly in the areas of oncology, endocrinology, and gynecology. Physicians and patients are taking advantage of testing for early detection and disease prevention.

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