Key Findings:

• The number of digital health apps stands at 337,000, with disease-specific apps that bring more value to health systems growing in number and their focus expanding beyond mental health and chronic diseases to encompass other conditions.
• Approval and reimbursement of digital tools is accelerating as payers recognize clinical utility and cost savings; of the more than 360 software-based digital therapies commercially available,140 prescription digital therapeutics (TX) are approved for patient use at home and over 220 therapies are used within digital care or in clinics.
• Sensor-based digital biomarkers that track patient health using wearables now monitor patients in care and research, and the first digital endpoints have been approved by regulators in the U.S. and Europe.
• More than 103 digital diagnostics for disease assessment are now commercially available and used to evaluate disease risk, accelerate diagnosis and monitor patient health; many of these are enabled by artificial intelligence and machine learning (AI/ML).

Other Findings:

Exhibit 2: Segments of digital health and their use by stakeholder

• Although the rise of mobile health has been driven by the creation and use of consumer-facing digital apps for wellness and self-care, other segments now serve healthcare providers directly.
• These include a growing number of tools that aid clinical decision-making such as “clinical decision support tools” that providers use as apps on their smartphones or are embedded within clinical workflow, mobile software-based medical devices that process signals from sensors to assess disease, and software platforms for clinical care or research.
• Notable among these are a growing number of algorithm-, model- and AI-based digital diagnostics (Dx) that analyze data from biometric sensors to help clinicians detect and characterize disease.

Exhibit 14: Digital therapeutics, digital care programs and other tools commercially available or in development in 2024

• To treat specific diseases or conditions, patients may now be prescribed a digital therapeutic — health software that delivers a medical intervention — or they may be referred to digital care (DC) providers that use digital tools to enhance their treatment, prevention, or disease management programs.
• The availability of these therapeutic solutions has notably grown since 2021 with a five-fold increase in the number of commercially available prescription digital therapeutics and the number of marketed digital care programs almost doubling.
• Some evidence-based self-care support apps have also been validated through clinical studies to have positive health impacts and reduce the symptoms of disease and are available as non-prescription digital therapeutics (NDTs) or used within health programs.

Exhibit 19: Prescription digital therapeutic market authorizations since May 2021

• Since May 2021, at least 94 PDTs gained new approvals and/or market access globally, including 51 in Germany alone.
• However, among these, five products that were provisionally listed on the DiGA directory in Germany have since lost their temporary reimbursement status and two others are no longer available due to company bankruptcies.
• The result has been 87 net new product additions: 46 in Germany and 41 elsewhere.

Exhibit 30: Digital tools supporting disease assessment and diagnosis

• A wide range of digital tools now support health assessment across the entire patient journey, simplifying and accelerating diagnosis.
• They help individuals identify potential causes of symptoms they may be experiencing, aid in triage, disease screening and diagnosis, and enable providers to monitor a patient’s disease progression or response to therapy.
• While most of these tools analyze data from sensor-based devices that gather digital measures associated with the presence of a disease, others conduct digital performance assessments or analyze patient-reported data or big data to yield clues to a patient’s health status.

Exhibit 34: Patient facing mobile apps and sensors for remote patient monitoring

• Tools for remote patient monitoring (RPM), also known as telemonitoring and digital nursing in some countries, are now being used to improve patient care in healthcare settings and in clinical trials.
• They use a range of methods such as tracking physiologic or behavioral data from sensors and collecting electronic patient reported outcomes (ePROs) via apps, and sometimes provide additional alerts and risk analysis to aid in population management, chronic condition management and enable personalized care.
• While some remote monitoring tools transmit raw data to a healthcare professional for their analysis and interpretation — and may therefore be exempt from regulatory approvals — digital solutions in this category have increasingly added sophisticated analytic and predictive capabilities and are being approved as devices.

Exhibit 37: Number of monthly prescriptions for pharmacy-dispensed digital therapeutics written in the United States

• Many digital product developers that entered the U.S. market early have faced commercial challenges, failing to earn enough money from their initial go-to-market strategy, and some are no longer in business today.
• Prescription DTx products that launched early into the U.S. market faced sluggish adoption or reimbursement, and one product, EndeavorRx aims to shift to OTC distribution to enable broader consumer-driven adoption.
• While little prescription volume is now flowing through this channel, new DTx are now emerging that may fare better in the marketplace, including Luminopia, Leva Pelvic Health System, SleepioRx and, more recently, Rejoyn was launched to treat Major Depressive Disorder (MDD).