FDA clearance for Otsuka’s Rejoyn app highlights rapid expansion of regulated mHealth app market: GlobalData

The COVID-19 pandemic has dramatically accelerated the development and integration of digital health technologies, including artificial intelligence (AI) and machine learning (ML) into the medical industry. For instance, Otsuka’s Rejoyn is a prescription-only app-based treatment that is designed to complement traditional medications for major depressive disorder. This digital therapeutic received 510(k) clearance from the FDA earlier this year, reflecting its validated safety and efficacy. The development highlights the rapid expansion of regulated mHealth app market, says GlobalData.

According to GlobalData forecasts, the digital health market was worth $5.9 billion in 2023.  It is expected to reach $15.4 billion by 20230, registering a compound annual growth rate (CAGR) of 13.10 per cent.

Kamilla Kan, Senior Data Scientist, Medical Devices team at GlobalData, states, “Developed in collaboration with Click Therapeutics, Rejoyn utilises an emotion-recognition feature to engage neural pathways essential for emotional processing. This innovative approach marks a significant step forward in digital therapeutics for mental health. In a pivotal six-week trial, Rejoyn demonstrated a statistically significant improvement in depression severity as measured by the Montgomery-Åsberg Depression Rating Scale.”

The rapid expansion of the regulated mHealth app market reflects a broader trend toward digital health innovation, exemplified by recent advancements such as Otsuka’s Rejoyn. According to GlobalData, following a period of steady app growth from 2015 to 2019, the market experienced a dramatic surge of over 100 per cent between 2019 and 2020.

Kan adds, “The surge highlights the accelerated adoption of mobile health solutions, driven by the need for advanced, accessible treatments. Rejoyn’s launch, integrating cognitive behavioural therapy into an app-based format, exemplifies this shift and underscores the ongoing growth in app volume, which is projected to continue at a robust pace through 2033. This trend illustrates the increasing role of digital therapeutics in enhancing patient care and adapting to evolving healthcare needs.”