Mobile Health (mHealth) Adverse-Event Reporting Apps Market Report 2025

The mobile health (mHealth) adverse-event reporting apps market size has grown rapidly in recent years. It will grow from $1.55 billion in 2024 to $1.84 billion in 2025 at a compound annual growth rate (CAGR) of 18.7%. Growth in the historic period was driven by regulatory initiatives for pharmacovigilance compliance, rising smartphone and internet penetration, greater patient engagement in healthcare, increasing awareness of adverse drug reactions, and expansion of digital health ecosystems.

The mobile health (mHealth) adverse-event reporting apps market size is expected to see rapid growth in the next few years. It will grow to $3.62 billion in 2029 at a compound annual growth rate (CAGR) of 18.3%. Growth in the forecast period is expected to result from integration with electronic health records (EHR/EMR), increasing adoption of remote patient monitoring, supportive government digital health initiatives, stronger focus on real-time drug safety surveillance, and growing demand for personalized and patient-centric healthcare. Primary trends anticipated for the forecast period include AI-driven adverse event detection, blockchain-enabled data security, cloud-based reporting platforms, integration with wearable devices, and use of natural language processing for patient feedback.

The growth of remote patient monitoring (RPM) is anticipated to drive the mobile health (mHealth) adverse-event reporting apps market. RPM involves using digital technologies to gather medical and health-related data from patients outside traditional healthcare settings. The rise of RPM is primarily attributed to the increasing prevalence of chronic diseases, creating a need for continuous, real-time monitoring of patients outside of hospital environments to improve health outcomes and reduce hospital visits. RPM contributes to the expansion of mHealth adverse-event reporting apps by enabling the continuous collection of patient data, which facilitates the timely tracking and reporting of adverse drug reactions or side effects through mobile platforms. For example, Vivalink, a US-based healthcare technology company, reported in August 2023 that 81% of clinicians now use RPM, a significant increase from just 20% in 2021. Additionally, 84% of RPM users plan to expand their use of this technology in 2024. As a result, the rise of remote patient monitoring is fueling the growth of mHealth adverse-event reporting apps.

Companies in the mHealth adverse-event reporting apps market are focusing on developing mobile-based communication tools to enhance the detection of adverse events and improve drug safety monitoring. These tools are digital platforms or applications that allow real-time communication, reporting, and sharing of information through smartphones or tablets. They enable seamless connectivity between patients, healthcare providers, and regulators, leading to faster decision-making and improved healthcare outcomes. For instance, Bharat Serums and Vaccines Limited (BSV), an India-based biopharmaceutical company, launched the BSV AER app in September 2023. This mobile-based communication app allows healthcare professionals, consumers, and company personnel to report potential adverse events related to BSV products via smartphones or tablets, free of charge. The app is directly linked to BSV’s pharmacovigilance system, streamlining the reporting and evaluation of adverse events to enhance patient safety through efficient management and quick responses.

In April 2022, Qinecsa Solutions, a UK-based provider of pharmacovigilance services, acquired MyMeds&Me Limited to boost its digital pharmacovigilance capabilities. The acquisition, for an undisclosed amount, integrates MyMeds&Me’s Reportum platform into Qinecsa’s services, improving real-time adverse-event reporting and patient safety monitoring. MyMeds&Me Limited is known for its mHealth solutions designed for reporting adverse events and product quality complaints.

Major players in the mobile health (mHealth) adverse-event reporting apps market are IQVIA Holdings Inc., Veeva Systems Inc., Itransition Group Inc., Bharat Serums and Vaccines Limited, ArisGlobal LLC, Saama Technologies Inc., Optimal Strategix Group Inc., OSP Labs Private Limited, K Health Inc., SafetyCall International PLLC, Medwatcher, Healthy.io Ltd., InPhase Technologies Ltd., Tiga Healthcare Technologies Inc., Qualityze Inc., iVigee Services AS, Advera Health Analytics Inc., Preventice Solutions Inc., Luscii Healthtech BV, and My Mhealth Limited.

North America was the largest region in the mobile health (mHealth) adverse event reporting apps market in 2024. The regions covered in mobile health (mHealth) adverse event reporting apps report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the mobile health (mHealth) adverse event reporting apps market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.

Mobile health (mHealth) adverse-event reporting apps are mobile-based applications that utilize smartphones or tablets to capture, record, and transmit information about negative reactions to drugs, devices, or treatments. They enable real-time safety reporting, facilitating faster communication among stakeholders. These apps enhance pharmacovigilance by streamlining data collection, improving transparency, and reducing delays in identifying potential risks.

The primary types of mHealth adverse-event reporting apps include standalone adverse-event reporting apps and integrated mHealth platforms. Standalone adverse-event reporting apps are mobile or web applications designed exclusively for reporting adverse events, allowing healthcare professionals or patients to submit information about drug reactions or medical incidents efficiently and securely. Platforms include Android, iOS, and web-based solutions, with applications in pharmacovigilance, clinical trials, patient safety monitoring, and others. Primary end users include hospitals and clinics, pharmaceutical companies, research organizations, patients, and others.

The mobile health (mHealth) adverse event reporting apps market research report is one of a series of new reports that provides mobile health (mHealth) adverse event reporting apps market statistics, including mobile health (mHealth) adverse event reporting apps industry global market size, regional shares, competitors with a mobile health (mHealth) adverse event reporting apps market share, detailed mobile health (mHealth) adverse event reporting apps market segments, market trends and opportunities, and any further data you may need to thrive in the mobile health (mHealth) adverse event reporting apps industry. The mobile health (mHealth) adverse event reporting apps market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The mobile health (mHealth) adverse event reporting apps market includes revenues earned by entities through real-time data transmission, pharmacovigilance support, analytics and reporting, and regulatory compliance. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values and are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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