A South Korean stroke patient, identified as A, is regaining visual function through a novel digital therapeutic called “VIVID Brain.” Developed by Kang Dong-wha, a neurology professor at Asan Medical Center, the treatment uses virtual reality technology and a mobile app to aid patients suffering from visual cortex damage. The company reports significant improvement in vision after 12 weeks of use.
Digital therapeutics, which leverage software to prevent and manage diseases, are emerging as a third-generation treatment after chemical and biological therapies. With aging populations and chronic diseases on the rise, there is increasing demand for solutions that go beyond hospital care. A report from the Korea Health Industry Development Institute in July projected the global digital therapeutics market to grow between 16% and 31.5% annually through 2032, potentially reaching 143 trillion won ($107 billion) by then.
South Korea’s domestic digital therapeutics market is growing rapidly, expected to expand from 124.5 billion won in 2019 to 528.8 billion won by 2025—a 27.2% annual growth rate. Analysts say the country’s potential extends further into global markets, positioning it as a potential leader in the sector.
The first digital therapeutics emerged in the United States. WellDoc pioneered the field in 2010 with “Blue Star,” a mobile app for type 2 diabetes, followed by Pear Therapeutics’ 2017 FDA approval for “reSET,” an app treating substance addiction.
Despite early advancements, the U.S. market faces hurdles. Pear Therapeutics, which received the first FDA approval, filed for bankruptcy in March 2023, and Better Therapeutics, another early leader, is also undergoing bankruptcy proceedings. The U.S. market, which holds about 40% of global digital therapeutics, has yet to produce dominant players or significant success stories.
In contrast, South Korea’s digital therapeutics sector has gained momentum. The Ministry of Food and Drug Safety (MFDS) has approved four digital therapeutics, including AIMMED’s “Somzz” for insomnia, WELT’s “WELT-I,” Nunaps’ “VIVID Brain,” and Share & Service’s “EasyBreath” for respiratory rehabilitation. Three more companies, including HAII, have applied for approval this year.
As of Oct. 15, the MFDS had approved 54 clinical trial plans for digital therapeutics, including rehabilitation software, and 195 plans for software medical devices. This is a significant increase from just six trial approvals in 2018.
South Korean companies are aggressively targeting international markets. WELT, for instance, established a branch in Munich, Germany, in July to expand its cognitive behavioral therapy for insomnia in Europe. “We are accelerating global expansion while continuing to validate WELT-I’s clinical benefits,” said WELT CEO Sean Kang.
In April, South Korea marked its first technology export deal in the sector. S-Alpha Therapeutics transferred the technology for its pediatric myopia treatment “SAT-001″ to Japan’s ROHTO Pharmaceutical. SAT-001, which uses a game-based app to slow myopia progression, was the first digital therapeutic to receive clinical trial approval in South Korea.
To support its burgeoning digital therapeutics industry, South Korea’s MFDS has implemented regulatory frameworks that could set global benchmarks. In October 2022, the ministry launched the “Innovative Medical Device Integrated Review and Evaluation System,” granting innovative medical device status to products showing clinical efficacy. This status allows companies to conduct research for three to five years before undergoing the final medical technology assessment, fast-tracking their use in clinical settings.
