Accessing the Digital Health Application (DiGA) Market: Key Success Factors, Market Barriers and Strategies for...

Although the digital health application (DiGA) market in Germany offers great opportunities for developing powerful digital applications, it has also faced substantial challenges. DiGA are evidence-based digital interventions in Germany that have been established as reimbursable solutions. This initiative is being copied in other European countries, which have introduced similar pathways. This study systematically identifies and assesses key success factors, marketing and sales strategies and critical DiGA components affecting DiGA adoption. A mixed-methods approach was applied, combining semi-structured expert interviews (n = 32) with a quantitative survey (n = 142) among DiGA manufacturers, healthcare professionals, and industry experts. Statistical comparisons between high prescription volumes (>15 000), moderate prescription volumes (2000-15 000) and low prescription volumes (<2000) DiGA manufacturers were conducted to determine significant differences in factor scoring. The findings highlight three core drivers of DiGA success: robust clinical evidence, access to the right physicians, and awareness at the point of care. High regulatory burdens, the DiGA prescription process, and physicians' unawareness were identified as the greatest barriers to adoption. The indication-specific nature of DiGA success was evident, emphasizing the need for tailored go-to-market strategies. This study provides the first structured and data-driven analysis of DiGA commercialization success factors and major challenges. The results offer strategic guidance for manufacturers, emphasizing strategic prescriber access and regulatory adaptation as key enablers of sustainable adoption. Future research should further explore indication-specific strategies, regulatory impact assessments, and international validation to enhance DiGA scalability and integration into healthcare systems.