Healthcare stakeholders are intrigued by digital health and its promise for patients and providers alike. Its potential to address unmet medical needs through non-pharmacological treatments, accelerate diagnosis, personalize care, and reduce provider workload all hold appeal. Digital health companies, however, have faced significant headwinds in their commercial journey, with reduced funding inflows during the last two years and limited reimbursement of marketed products. Companies with approved products have struggled to grow revenue and expand their user base. Some have even gone bankrupt.
Despite these challenges, innovation has remained strong in 2024 and the industry has created new digital health solutions to diagnose, treat, and remotely monitor patients. AI-informed digital diagnostics and digital platforms are helping providers globally to improve health outcomes for patients by assessing and remotely monitoring patient health. Patient-focused digital therapeutics that focus on specific diseases are enabling more patients to receive treatment at home and can now access more approvals and reimbursement pathways that offer better chances for commercial success. And in the research space, biopharma companies have been using wearable sensors and digital measures in drug trials to better understand drug benefits and reduce risk. In short, digital health tools are expanding in scope and function to aid patient diagnosis, treatment, and monitoring, and now cover the full patient journey.
Over the past two years, there have been some notable evolutions in the digital space:
- 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 therapeutics are accelerating as payers recognize their clinical utility and cost savings. Of the more than 360 software-based digital therapies commercially available,140 prescription digital therapeutics are approved for patient use at home and more than 220 therapies are used within digital care or in clinics. Globally, the most progress has been seen in Germany, which has led the regulatory process and reimburses for 56 digital therapeutics (DTx), followed by the U.S. with 46 approved and the UK, where 20 DTx have been recommended for use.
- 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). This fits within a broader trend toward using AI to improve diagnostic equipment, and as of June 2024, 801 distinct AI/ML-enabled devices have received approval from the FDA.
- Digital tools such as wearables and symptom-tracking apps are being combined into broader clinical platform solutions for providers to monitor disease progression or response to therapy, detect recurrence, and even predict future health changes to triage patients in greatest need of care.
- The commercial appeal of digital health has grown as developers build solutions that bring value back to providers and integrate with health systems and embrace innovation such artificial intelligence (AI) to personalize care and reduce provider workload.
- While the overall uptake of digital health technologies is rising, over the past two years it has been relatively limited and less than required to sustain high levels of investment, leading to multiple exits and restructuring by developers. Stakeholders in the digital health ecosystem are working through regulatory and reimbursement challenges to attain sustainable investment and scaling of use that will provide maximum benefits to patients and health systems. The long-term potential for technology-supported and AI/ML-driven digital health interventions remains high despite near-term challenges.
Digital health is a complex and ever-changing space but an important one for the industry. This report from the IQVIA Institute endeavors to cover the important topics by examining trends across various segments of the digital health market, which are becoming increasingly defined. It looks closely at digital diagnostics alongside maturing therapeutic product segments such as digital therapeutics and digital care, and reviews consumer apps and non-prescription digital therapeutics that aim to reduce health symptoms. The report also covers how life sciences companies are strategically deploying wearable sensors and other patient monitoring tools in research, and explores provider-focused solutions like digital diagnostics, clinical decision support tools, remote patient monitoring tools, and patient monitoring tools in research.
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