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Industry Landscape
The digital health industry is experiencing rapid growth, driven by technological advancements, increasing demand for remote care, and favorable regulatory environments, particularly in regions like Germany. Digital Therapeutics (DTx) is a key segment, gaining traction with medical device certifications and insurance reimbursement. The industry is seeing significant investment and consolidation, with traditional pharmaceutical companies acquiring digital health solutions. Focus areas include chronic disease management and personalized care.
Total Assets Under Management (AUM)
Digital Health Market Size in Germany
~€20.4 billion (2024)
(24.8% CAGR)
- Telemedicine accounts for a significant portion.
- mHealth apps are widely adopted.
- Digital therapeutics (DTx) are a rapidly growing segment, especially with new regulations.
Total Addressable Market
€43.5 billion
Market Growth Stage
Pace of Market Growth
Emerging Technologies
AI-powered Personalized Diagnostics
Utilizing artificial intelligence and machine learning to analyze diverse patient data (genomics, microbiome, lifestyle) for highly precise diagnosis and personalized treatment recommendations in gastroenterology.
Wearable Biometric Sensors
Integration of advanced wearable devices for continuous, non-invasive monitoring of physiological markers related to digestive health, providing real-time data for symptom correlation and proactive management.
Digital Twin Technology
Creation of virtual representations of an individual's gastrointestinal system and its responses to interventions, allowing for predictive modeling of treatment efficacy and personalized dietary adjustments.
Impactful Policy Frameworks
Digital Healthcare Act (DVG) - DiGA fast-track process (2019)
The Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) enacted in 2019, allows doctors to prescribe approved digital health applications (DiGAs), which are then reimbursed by statutory health insurance funds, establishing a 'fast-track' process for their approval.
This policy directly enables Cara Care's core business model in Germany, allowing its IBS therapy to be prescribed by doctors and covered by health insurers, significantly expanding its market reach and revenue streams.
Medical Device Regulation (MDR) (EU 2017/745, fully applied 2021)
The EU Medical Device Regulation (MDR) significantly tightens requirements for the safety and performance of medical devices, including software as a medical device (SaMD) like Cara Care, requiring more rigorous clinical evidence and post-market surveillance.
Cara Care's CE-certification as a Class 1 medical device under this framework reinforces its credibility and market access in Europe, but necessitates continuous adherence to stringent regulatory and quality assurance processes.
Digital Care Act (DVG) Extension (2023) / Digitale Gesundheitsanwendungen (DiGA) Guidelines Updates
While the core DVG is from 2019, subsequent legislative efforts and updates to DiGA guidelines (e.g., DiPA in 2023 for digital care applications for long-term care) continue to refine and expand the scope and conditions for reimbursement of digital health solutions in Germany.
Ongoing updates to these guidelines could affect Cara Care's eligibility for broader reimbursement categories or necessitate adjustments to its evidence generation strategies, ensuring continued alignment with evolving regulatory expectations.
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