The year 2023 marked significant transformations in the medical and pharmaceutical sectors. Despite facing resistance from the medical community, President Yoon Suk Yeol's administration declared its intention to increase the number of medical school seats starting in 2025. Additionally, 2023 witnessed the opening of the digital therapeutics market. The initiation of telemedicine this year led to an ongoing conflict between the medical community, opposing such practices, and the Ministry of Welfare, advocating for them, expected to persist into 2024. In the pharmaceutical industry, numerous domestic companies ventured into the global market. Korea Biomedical Review has compiled the 10 most noteworthy healthcare developments in 2023. -- Ed.

The year 2023 is anticipated to be marked as the period when the Korean market for digital therapeutics (DTx) saw significant expansion.

These devices are defined by the regulator as "software medical devices (SaMDs) that provide evidence-based therapeutic interventions to patients to prevent, manage, and treat medical disorders or diseases." 

Since the enactment of the Act on Nurturing Medical Devices Industry And Supporting Innovative Medical Devices in 2020, a total of 27 products have been designated as innovative medical devices. Still, none of them received official government approval until February 2023.

However, in a breakthrough development, DTx devices obtained approval in February and April, allowing their integration into clinical practice. 

AimMed's Somzz played a pivotal role in opening this new market. Somzz, a mobile app designed for insomniacs, addresses psychological, behavioral, and cognitive factors that contribute to or worsen insomnia before resorting to pharmacological treatment. AimMed explained that individuals experiencing insomnia can utilize Somzz's sleep habit education, real-time feedback, and behavioral interventions over six to nine weeks to enhance sleep efficiency and subsequently alleviate insomnia.

In April, Welt's WELT-I secured approval as the second DTx device after Somzz. Leveraging the sleep diary data inputted by individuals with insomnia, WELT-I offers personalized recommendations for optimal bedtime, behavioral interventions aimed at enhancing sleep quality, analysis of habits disrupting sleep, and relaxation therapy to alleviate tension and anxiety.

Both the first and the second DTx devices share common features, being classified as innovative medical devices with insomnia as a primary indication. 

Consequently, significant attention has been directed toward the indication for the third product. 

However, there has been no information regarding the approval of the third DTx device since April.

Nevertheless, there is a heightened pace of DTx development, following the two approvals of DTx. Until August, the Ministry of Food and Drug Safety (MFDS) has authorized a total of 47 clinical trials involving DTx devices. In tandem with this trend, the MFDS has released six guidelines for approving clinical trial plans specific to DTx devices. The ministry is actively monitoring the progress of development and making preparations for subsequent approvals.

The global market for DTx devices stands out as one of the most promising sectors for growth. This is attributable to the increased demand for telemedicine, personalized healthcare, and real-time patient monitoring, which has seen a significant uptick during the Covid-19 pandemic. Additionally, the aging population and the rising prevalence of chronic diseases further underscore the necessity for ongoing management in daily life, contributing to the positive outlook for this market.

According to Samjong KPMG's "Investment Trends and Future Strategies for Third-Generation Digital Therapeutics," released in January, the global DTx market is poised to exhibit robust growth. The forecast indicates a compound annual growth rate of 20.5 percent from 2019, with the market expected to reach $8.9 billion by 2025. Simultaneously, the Korean market for DTx devices is anticipated to experience even more accelerated growth, with a projected compound annual growth rate of 27.2 percent, leading to a value of $528.8 million in 2025, the report said.