Europe MHealth Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)

Europe MHealth Market Trends and Insights

Blood Glucose Monitors are Expected to Have the Largest Share in Device Type Segment

A blood glucose monitor is a test system for use at home or in health care settings to measure the amount of sugar (glucose) in the blood. The prevalence of diabetes is increasing among all the age groups in the European region, mostly due to an increase in the overweight and obese population, an unhealthy diet, and a lack of physical activity. These are also the major drivers propelling the growth of glucose monitors in the mhealth market over the forecast period. As per the statistics provided by the International Diabetes Federation (IDF), an estimated 59 million adults aged 20-79 years were living with diabetes in the IDF Europe Region in 2019. It has been estimated by the IDF that by the year 2045, the prevalence of Diabetes will reach up to 10.8% and the number of people having this disease would reach 81 million. Diabetes is found to be one of the leading causes of death in the European region. As the prevalence continues to increase even in the future, the demand for continuous monitoring of glucose levels in diabetic patients is also anticipated to increase in the future. The companies are using leading-edge technology to make these devices compatible with various mobile platforms to remove the extra bulk devices. For instance, in June 2021, Medtronic launched Guardian 4 continuous glucose monitor and its InPen smart insulin pen in Europe. Both devices have been approved in Europe for people with diabetes. Thus, the rise in the number of patients suffering from diabetes and technological advancements in the glucose/insulin monitoring wearable devices are expected to boost the growth of the European mHealth market.

Spain is Expected to have Significant Share in the Market Over the Forecast Period

Factors such as the initial increasing pandemic effect, research studies, increasing funding, and product launches by key market players are expected to increase the market growth. According to an article published in the European union of private hospitals in June 2021, general hospitals in Spain increased their workforce by 6% in 2020 compared to 2019, incorporating 5,000 new professionals as the hospital admission rate in the country was around 33% for the COVID-19 patients. However, the healthcare professional issues were very critical as around 26.3% of the staff was found COVID positive at a time. In November 2021, a paper named 'Hospitalization budget impact during the COVID-19 pandemic in Spain' published that the impact on the hospital's budget for the 3 months (26th February to 21st May 2020) was calculated at EUR 15,633,180, out of which the 97.4% was related to health care and hospitalization. Intensive care unit stays costs accounted for 5.3% of the total costs. Whereas the mean cost per patient was around EUR 10,744. The main costs were staffing costs (EUR 10,131 to EUR 11,357 per patient for physicians and EUR 10,274 to EUR 11,215 per patient for nurses). Hence, the impact of COVID-19 on the Spanish public health budget (12.3% of total public health expenditure) is greater than multiple sclerosis, cancer, and diabetes cost. The mhealth can decrease the cost as it does not require patients to visit until its necessary. This would free up space in the hospitals and increase productivity by decreasing the cost. Similarly, in June 2020, the Catalan Health Department launched the app, called Gestioemocional, to provide support to the patients with anxiety and stress that were triggered by the COVID-19. The app has been downloaded more than 370,000 times and has more than 200,000 users. These applications have accelerated the use of telemedicine in Spain with an increase in virtual consultation and positive impact on workflow.

Thus, due to abovementioned factors the market is expected to increase in the future.

Regulatory Landscape

In Europe, mHealth solutions that qualify as software as a medical device (SaMD) or connect to regulated devices fall under the Medical Devices Regulation (EU) 2017/745 (MDR), and in applicable cases the In vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). Developers and manufacturers are required to support conformity assessment with technical documentation, risk management, and clinical or performance evaluation aligned to the General Safety and Performance Requirements (GSPRs), which shapes how monitoring apps, connected wearables, and mobile-enabled diagnostics are designed, validated, and maintained.

Health-data interoperability and access are also being reworked through the European Health Data Space (EHDS) Regulation (EU) 2025/327, published on 5 March 2025. The program has moved into an execution phase, including establishment of the EHDS governance structure via Commission Implementing Regulation (EU) 2026/771 (adopted 7 April 2026), which set up the EHDS Board to support consistent application and technical implementation guidance for EHR-system requirements, including cross-border exchange format and interoperability obligations relevant to mHealth-integrated care pathways.

Market Opportunities and Future Outlook

EHDS implementation is creating actionable openings for mHealth vendors that can operationalize interoperability, consent, and auditability across multi-country deployments, especially when apps and remote-monitoring workflows connect to electronic health record (EHR) systems. The EHDS Board formed under Implementing Regulation (EU) 2026/771 (7 April 2026) places added emphasis on technical implementation guides and consistent application across Member States, which tends to benefit suppliers with integration tooling, data-governance capabilities, and documentation practices that fit regulated software lifecycles under MDR/IVDR.

Demand also shows up through EU-backed efforts aimed at clinical validation and data infrastructure that reduce friction for scaling AI-enabled and imaging-adjacent mHealth workflows. In May 2026, the European Commission advanced its network of AI-powered advanced screening centres, including opening a further call for expressions of interest with applications accepted until September 2026, which provides a pathway for performance assessment and real-world evidence generation alongside device and data compliance. By end-2026, Cancer Image Europe is targeting access to 60 million cancer images, supporting mobile-enabled screening pathways, patient follow-up, and clinician decision support where solutions can integrate with imaging data services and comply with evolving EU requirements for cross-border data use.