Amid the impending approval of digital therapeutics (DTx) devices in Korea, a report that examined the rapidly growing global DTx market has been presented, drawing the attention of domestic businesses.

(Credit: Getty Images)
(Credit: Getty Images)

The Korea Health Industry Development Institute (KHIDI) released the report on Monday, which analyzed DTx-related policies and industrial countries in major countries.

Digital therapeutics deliver patients evidence-based therapeutic interventions driven by high-quality software programs to treat, manage, or prevent a disease or disorder. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.

In 2010, “BlueStar,” the world's first self-care app for treating people with type 2 diabetes by WellDoc, received approval from the U.S. Food and Drug Administration (FDA).

Since then, products have been developed related to the treatment of diabetes, heart failure, asthma, COPD (chronic obstructive pulmonary disease), opioid (narcotic painkiller) use disorders, chronic insomnia, ADHD (attention deficit hyperactivity disorder), and PTSD (post-traumatic stress disorder), until 2020.

The global DTx market is growing rapidly in keeping with the development trend. In 2022, the global DTx market was $3.9 billion and was expected to grow 20 percent a year on average to $17.3 billion in 2030, according to the report.

In Korea, 25 products were being developed as of last December after winning approvals for a clinical trial from the Ministry of Food and Drug Safety.

None has received a product permit so far. However, the ministry designated three products – two digital therapy devices and one AI-based cerebral infarction diagnosis aid software late last year, causing the speculation that the first official approval of DTx was impending.

Earlier, the ministry presented guidelines on developing and commercializing DTx devices. In addition, it announced a guideline on licensing and screening AI-based medical devices in 2017 and another guideline on developing medical device industry promotion and innovative medical equipment support in 2020.

The government’s DTx-related investment is also increasing continuously. It invested 44.2 billion won ($34.9 million) into DTx-related research and development from 2015 to 2019, marking an annual increase of 25.3 percent during the period.

“Through the study of overseas examples, we could know many countries have persistently pushed to improve DTx-related systems and expanded investment,” the report said. “As DTx can replace conventional medical products, it can emerge as a new option for future healthcare for patients and medical workers.”

It said that to reinvigorate the DTx market, major governments stepped up streamlining systemic infrastructure by improving regulations and insurance coverage.

In the U.S., the FDA actively promotes regulatory overhaul to deal with DTx as a new digital health sector. Accordingly, it is establishing and operating an organization responsible for its clinical trials, licensing management, and digital health to make the most of the characteristics of digital technology. It also has prepared guidelines on cybersecurity and worked out special measures in case of emergency, such as Covid-19.

Germany introduced DTx (DiGA) under the Digital Healthcare Act (DVG) in December 2019 and included DTx in the compensatory healthcare coverage of the Public Health Insurance Association (GKV-SV).

“Concerning DTx, Korea has to solve many problems in providing insurance benefits for DTx because the country’s healthcare services and their provision methods have different characteristics,” the report said. “Due to various difficulties, including those dividing medical and non-medical services, providing telemedicine, and securing healthy data, there are limitations to developing innovative services.”

 

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