Drivers
Chronic Conditions:
- Increasing prevalence of chronic conditions like diabetes, cardiovascular diseases, obesity, and hypertension.
- Growing adoption of DTx due to its role in addressing co-morbidities such as depression and fatigue.
Pharma Shift Towards Personalized and Patient-Centric Approach:
- From now until the decade’s end, an event will drive digital therapeutics from being discretionary to essential.
- 1st Event – Several blockbuster drugs will lose their patent exclusivity. This shift will compel pharmaceutical companies to prioritize differentiating their products for competitive advantage and look beyond drug efficacy and effectiveness. It will lead to embracement of digital and patient-centric approaches.
Aging Population:
- The aging population in many countries is also contributing to the demand for digital therapeutics due to a decrease in healthcare professionals. For example, by 2030, it is estimated there will be a global shortage of 15 million healthcare workers. This is compounded by a rapidly aging population, disease and outbreak prevention, and other issues.
Opportunities :
Oncology
- Used to complement patients’ existing oncological care, DTx products are emerging as a valuable tool in addressing side effects such as pain, nausea, and fatigue, as well as anxiety and depression associated with cancer diagnoses.
Women’s Health
- Digital therapeutics for women covering areas such as menstrual health, sexual health, contraception, and overactive bladder, etc., present valuable opportunities.
Example of Overactive Bladder:
- There are few drug treatments available, most of which come with side effects, and overactive bladder significantly impacts quality of life. The main prescribers are gynecologists and urologists. Women, as the primary patient target group, are the main users of digital therapies. Since the cause of OAB is miscommunication between the bladder and brain, digital behavioral therapy is highly effective for this indication.
Challenges
Prescription:
- Even in countries with robust payer coverage such as Germany, uptake remains limited despite high user engagement.
- According to a 2022 DiGA report, only 4% of HCPs had prescribed digital health applications since Q4 2020.
- The main reason behind the slow adoption is a lack of trust from healthcare professionals. Clinicians point to limited information, inadequate clinical evidence, and poor alignment with conventional treatments as key reasons for not integrating DTx into their practices.
- A survey conducted in Germany in 2023 showed that over 60% of participants had never heard of digital health applications, and around 5% of DTx prescriptions were not picked up.
Reimbursement:
- Reimbursement is a major challenge that DTx companies face. If companies are not reimbursed enough for their prescription digital therapeutics, low returns could stifle innovation.
Technological:
- DTx leveraging advanced technologies such as Generative AI can adapt in real-time. Regulatory authorities might find that post-market performance monitoring and surveillance present more of a challenge than the initial process of market authorization and reimbursement.
- A significant concern is the challenges posed by digital literacy (lack of technological literacy).
Recent Developments
- On Mar 31, 2025, ATA Action, the advocacy arm of the American Telemedicine Association (ATA), announced it has acquired the Digital Therapeutics Alliance (DTA), the leading international organization focused on expanding access to digital therapeutics (DTx).
- On Feb 18, 2025, Shionogi & Co Ltd announced that it has obtained manufacturing and marketing approval in Japan for the digital therapeutic app “ENDEAVORRIDE®“. This app was developed by Akili Interactive Inc., from which Shionogi has acquired exclusive development and commercialization rights for Japan and Taiwan.
- On Aug 14, 2024, Otsuka Pharmaceutical Europe Ltd. and Otsuka Pharmaceuticals (U.K.) Ltd. announced a collaboration with Health Innovation Oxford & Thames Valley (Oxford HIN) to evaluate a new digital therapeutic (DTx), CARE for MDD, aimed at treating major depressive disorder (MDD).
- On Aug 09, 2023, Theranica announced it received expanded CE (Conformité Européenne) mark approval under MDR European regulation for Nerivio® as a dual-use therapy for both acute and preventive treatment of migraine for adults and adolescents.
