Recently, the National Assembly proposed a bill to support digital treatments called "third-generation treatments." As digital technologies based on artificial intelligence (AI) and big data are expected to grow, the market for "digital treatments" is expected to grow, and the intention is to promote government-level fostering and support. To this end, the bill included the definition of "brain fusion technology" related to digital treatments and government support regulations. In this regard, some campaigned against the bill, saying that if it passes, it can be used to plant chips in the human body and monitor them, and that side effects are feared like the COVID-19 vaccine. However, experts generally say that this is due to a misunderstanding of digital treatments. Hong Seok-joon, a member of the People's Power, who proposed the bill, said, "Digital treatments have the advantage of shorter development period and fewer side effects than other drugs, and the market is growing rapidly."
Digital therapy refers to the prevention, management, and treatment of diseases based on software instead of drinking pills or injections. It mainly uses smartphone apps (applications), games, VR (virtual reality), chatbots, etc., and must be approved by the Ministry of Food and Drug Safety after clinical trials like existing drugs.
On the 15th, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety designated a total of three products as innovative medical devices, including digital treatment devices to improve insomnia and software to assist in diagnosing cerebral infarction with artificial intelligence (AI). Among them, the digital treatment for insomnia has undergone confirmatory clinical trials in Korea and is undergoing item approval screening. If approved, it will be called the first digital treatment in Korea. The pharmaceutical industry expects the first digital treatment in Korea to be released in the first half of next year.
As digital treatments emerge as a new market, the merger of pharmaceutical companies and game companies to preoccupy them is becoming active. Pharmaceutical companies are competing with other companies by investing in companies that develop digital treatments for anxiety disorders to secure priority negotiation rights on sales or to jointly develop digital treatments.
According to the Ministry of Food and Drug Safety, eight companies have been approved for confirmation of digital treatments, and in the future, they will take steps such as applying for item permission after completing clinical trials. Some of them implement cognitive behavioral therapy, a standard treatment for insomnia patients, in a mobile phone app, and provide customized treatment by evaluating the patient's sleep status and environment. In addition, digital treatments for the rehabilitation of patients with chronic obstructive pulmonary disease and digital treatments that try to improve visual impairment using virtual reality are undergoing clinical trials.
In addition to insomnia, digital treatments are being commercialized in various fields such as depression, anxiety disorder, post-traumatic stress disorder (PTSD), migraines, smoking cessation, Alzheimer's, stroke, musculoskeletal pain, and obesity.
In the United States, where the FDA (US Food and Drug Administration) first approved digital treatments in 2017, research and development of digital treatments are active. Fair Seraphutics' addiction treatment app "reSET," which is considered the first digital treatment, is a method in which when a doctor prescribes an app to an alcohol or drug addiction patient, the patient downloads the app, enters whether to use drugs, and learns how to control impulses through the app. The company developed an app to treat opioid addiction, a narcotic painkiller, and an app to treat insomnia in a similar treatment method, and obtained approval from the FDA.
In 2020, Akili Interactive Lab's game "EndeavorRx" was approved by the FDA as a treatment for attention deficit hyperactivity disorder (ADHD). This is the first case in which games have been approved by the FDA as a treatment. Accordingly, the game was prescribed as a treatment for ADHD children aged 8 to 12. Digital treatments in the global market are expanding to neurodegenerative diseases, rehabilitation and physical therapy, and tumor treatment.
According to the digital therapy industry trend released by the National Center for Biotechnology Policy Research, global market analysis institutions predict that the digital therapy market, which is worth $3.83 billion (about 5 trillion won), will surge to $17.34 billion (about 22 trillion won) by 2030. Analysts say that the average annual growth rate will reach 20.5%. The number of patent applications for digital treatments also increased six-fold from 13 in 2017 to 78 in 2021. Although the U.S. currently holds more than 40 percent of the global market, experts say it should pay attention to Asian countries with high growth rates. The National Center for Biotechnology Policy said, "The growth of chronic diseases and the elderly population is a major factor in the growth of the digital treatment market in line with interest in disease prevention," adding, "Pharmaceutical companies need to integrate digital and pharmaceutical technologies through collaboration with software and advanced digital technologies."
Writer: Yeyoung Jeon
(Picture from Unsplash)
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