[Entangled Genetic Industry]② Korea Weeps Over Regulations... US and Japan Rapidly Growing

The Crisis of the DTC Genetic Testing Industry

Differences in Regulatory Approaches
South Korea employs positive regulation allowing only what is permitted
The US and Japan use negative regulation allowing everything except what is prohibited

While domestic direct-to-consumer (DTC) genetic testing companies continue to struggle with regulations, the DTC testing industry in major overseas countries is experiencing growth. As services from foreign companies become a reality in the domestic market, there are calls to establish policies that enable domestic companies with analytical capabilities to compete with them.

The United States accounts for more than 40% of the global DTC genetic testing market. Among local consumers, interest in preventing chronic and hereditary rare diseases and managing health is high, to the extent that DTC test kits became bestsellers during Amazon Prime Day, the largest online discount event in the U.S. It is analyzed that actress Angelina Jolie’s story, who discovered through a DTC test that she had an 87% chance of developing breast cancer and ultimately underwent a mastectomy, acted as a trigger.

The U.S. DTC genetic testing market began to grow significantly after the government’s “Precision Medicine Initiative” was launched in 2015. The concept emerged that genetic information, as well as an individual’s environment, could be considered in disease treatment and prevention. The U.S. Food and Drug Administration (FDA) approved DTC tests for 10 diseases including Parkinson’s, Alzheimer’s, and type 1 Gaucher disease in 2017, and in 2018, DTC tests for breast, ovarian, and prostate cancers also became available. However, while the FDA has relaxed regulations on DTC testing, it emphasizes that “DTC tests cannot replace health checkups or medical evaluations at hospitals.” An industry insider said, “In the U.S., they tell you not to diagnose cancer with DTC tests, but they do not regulate how much hereditary risk you have.”

There are no separate regulations for wellness items such as hair loss, diet, and skin aging. The U.S.-based leading genetic analysis company, 23andMe, provides over 400 genetic information items, including ancestry and mosquito bite frequency, for $100 to $200. This is relatively inexpensive compared to domestic DTC test fees (200,000 to 300,000 KRW), because unlike in Korea, in the U.S., consumers’ genetic data can be secondarily used by pharmaceutical companies and others.

In Japan, where biohealth industry regulations are applied on a “negative (minimal regulation)” basis, various genetic information is provided through DTC testing. Yahoo, Japan’s largest portal, promotes DTC testing online in collaboration with genetic analysis companies. Gene Quest has partnered with individual pharmacies to create a service where DTC test results assist pharmacists in medication guidance.

DTC test kits from overseas companies are also sought after by Korean consumers. A recent domestic consumer who purchased a foreign kit explained, “I found out that the health information provided is diverse, and it tells you how much hereditary risk you have for diseases like cancer and dementia.”

The domestic industry protests this as unfair competition. One official lamented, “Because the number of testable items is extremely limited, we are falling behind in competition with major overseas companies.”