SUSMED Research Memo (6): Domestic Market for Insomnia Disorder Treatment Apps Estimated at ¥394 Billion (FISCO)

For the domestic market, SUSMED calculated the market for Medcle by multiplying the insurance reimbursement points, patient population, single-drug treatment rate and proportion of patients with mild to moderate symptoms, arriving at ¥88.0 billion. Including potential patients, the market is estimated at ¥394.0 billion, while the SAM representing targetable demand is estimated at more than ¥42.0 billion in total. Specifically, ¥15.0 billion represents demand for switching from existing sleeping-pill treatment, and ¥27.0 billion represents demand from identifying untreated patients who are resistant to sleeping-pill treatment.

Among the main development pipeline programs, the market is estimated at ¥7.2 billion for the SMD401 exercise therapy app for breast cancer patients, ¥30.9 billion for the SMD402 program medical device for ACP, and ¥66.0 billion for the SMD201 rehabilitation app for chronic kidney disease. The DTx platform business supports the development of therapeutic apps and includes the provision of SUSMED SDS, a blockchain-based clinical trial system.

SUSMED SDS is said to provide a high level of security and resistance to data tampering while reducing the workload and costs of clinical trial monitoring. Since 2020, it has been approved as a system meeting the requirements of the GCP ministerial ordinance under the applicable legal and regulatory framework, and its adoption is reportedly advancing through joint research with healthcare institutions, academic institutions and pharmaceutical companies.

While facing the risk of research and development expenses being incurred ahead of revenue, SUSMED is exploring early monetisation through the out-licensing of pipeline programs and milestone income, in addition to revenue from Medcle sales, and is said to plan to consider financing at an appropriate time.