Pharmacovigilance and Drug Safety Software Market to Reach US$ 6.92 Billion by 2033 at 12.2% CAGR; Rising Regulatory Scrutiny Drives Growth

The global Pharmacovigilance and Drug Safety Software market reached US$ 2.45 billion in 2024 and is expected to reach US$ 6.92 billion by 2033, growing at a CAGR of 12.2% during the forecast period 2025-2033. Market growth is driven by increasing regulatory scrutiny, rising volumes of adverse drug reaction (ADR) reports, and the growing complexity of drug development pipelines. Pharmaceutical and biotechnology companies, contract research organizations (CROs), and regulatory authorities are increasingly adopting advanced software solutions to ensure patient safety and maintain compliance with stringent global pharmacovigilance regulations.

Pharmacovigilance and drug safety software solutions are designed to collect, analyze, and manage safety data throughout the drug lifecycle, from clinical trials to post-marketing surveillance. These platforms support adverse event reporting, signal detection, risk management, and regulatory submissions, enabling organizations to identify potential safety issues early and respond proactively. The integration of artificial intelligence (AI), machine learning, and cloud-based architectures is further enhancing automation, data accuracy, and real-time monitoring capabilities. As global drug approvals rise and real-world evidence becomes more critical, pharmacovigilance and drug safety software is emerging as a vital component of modern pharmaceutical safety management systems.

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The Pharmacovigilance and Drug Safety Software Market is the sector that provides digital platforms and tools to monitor, analyze, and manage adverse drug reactions and ensure regulatory compliance throughout a product's lifecycle.

Key Developments
✅ December 2025: Pharmaceutical and biotechnology companies expanded adoption of AI-driven pharmacovigilance and drug safety software to automate adverse event case processing, signal detection, and regulatory reporting.

✅ October 2025: Integration of drug safety software with real-world data sources, electronic health records, and clinical trial systems enhanced proactive risk management and compliance.

✅ August 2025: Cloud-based pharmacovigilance platforms gained traction, offering scalability, cost efficiency, and global regulatory alignment for multinational drug developers.

✅ June 2025: Regulatory authorities encouraged use of advanced digital safety systems to meet increasing post-marketing surveillance and data transparency requirements.

✅ March 2025: Growing drug development pipelines and complex regulatory environments drove demand for end-to-end pharmacovigilance and drug safety software solutions.

Mergers & Acquisitions
✅ December 2025: A leading life sciences software provider acquired a pharmacovigilance or drug safety software company to strengthen its integrated compliance and safety management portfolio.

✅ October 2025: Strategic collaborations formed between drug safety software vendors and pharmaceutical companies to co-develop AI-enabled safety monitoring solutions.

✅ August 2025: Pharmacovigilance software companies partnered with CROs to embed safety platforms into outsourced clinical trial and post-marketing services.

✅ June 2025: Technology firms entered alliances with regulatory consulting organizations to enhance compliance-focused drug safety software offerings.

✅ March 2025: Academic research institutions and early-stage software startups partnered to advance signal detection algorithms and next-generation drug safety analytics.

Key Players
Ennov Solutions Inc. | Oracle Corporation | ArisGlobal LLC | EXTEDO | Clinevo Technologies | IQVIA | AB Cube | ICON Plc | Parexel International Corporation

Key Highlights

Ennov Solutions Inc. - Holds a share of 9.4%: Specializes in pharmacovigilance, regulatory information management, and quality management software supporting end-to-end drug safety operations.

Oracle Corporation - Holds a share of 14.8%: Provides enterprise-grade drug safety and pharmacovigilance solutions integrated with clinical, regulatory, and data analytics platforms.

ArisGlobal LLC - Holds a share of 13.6%: Delivers cloud-based pharmacovigilance and life sciences software platforms enabling efficient case management and regulatory compliance.

EXTEDO - Holds a share of 8.7%: Focuses on regulatory affairs and pharmacovigilance software, supporting submission management, safety reporting, and compliance workflows.

Clinevo Technologies - Holds a share of 5.9%: Offers integrated cloud platforms for pharmacovigilance, clinical data management, and regulatory operations tailored to biotech and pharma companies.

IQVIA - Holds a share of 17.2%: Market leader providing comprehensive pharmacovigilance services and safety software integrated with real-world data and advanced analytics.

AB Cube - Holds a share of 4.8%: Develops flexible pharmacovigilance solutions for case processing, signal detection, and regulatory reporting.

ICON Plc - Holds a share of 9.1%: Provides technology-enabled pharmacovigilance and drug safety services supporting global clinical and post-marketing surveillance.

Parexel International Corporation - Holds a share of 10.3%: Offers end-to-end drug safety, risk management, and regulatory compliance solutions for pharmaceutical and biotech clients.

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Market Drivers
- Rising regulatory scrutiny and stringent global requirements for adverse event reporting and drug safety monitoring.

- Increasing volume of safety data generated from clinical trials, post-marketing surveillance, and real-world evidence.

- Growing adoption of digital and automated solutions to improve pharmacovigilance efficiency and compliance.

- Expansion of pharmaceutical, biotechnology, and generic drug manufacturing activities worldwide.

- Increasing use of AI, machine learning, and analytics for signal detection and risk management.

- Rising outsourcing of drug safety operations to CROs and specialized service providers.

- Growing focus on patient safety and lifecycle risk management of drugs and biologics.

Industry Developments
- Launch of cloud-based pharmacovigilance and drug safety software platforms.

- Integration of AI-driven automation for case intake, processing, and signal management.

- Expansion of end-to-end safety software covering pre- and post-marketing phases.

- Growing partnerships between software vendors, pharmaceutical companies, and CROs.

- Adoption of real-world data and social media monitoring within safety platforms.

- Rising mergers, acquisitions, and investments in drug safety and pharmacovigilance software providers.

- Enhanced focus on regulatory compliance with FDA, EMA, and ICH guidelines.

Regional Insights
North America - 41% share: Driven by stringent regulatory frameworks, high adoption of digital health technologies, and strong pharmaceutical presence.

Europe - 31% share: Supported by robust drug safety regulations, centralized reporting systems, and widespread software adoption.

Asia Pacific - 23% share: Fueled by growing pharmaceutical manufacturing, increasing clinical trial activity, and strengthening regulatory compliance.

Latin America - 3% share: Boosted by improving regulatory frameworks and increasing adoption of safety software solutions.

Middle East & Africa - 2% share: Driven by regulatory modernization, growing awareness of drug safety, and expanding pharmaceutical activities.

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Key Segments
➥ By Mode of Delivery
On-Premise: Pharmacovigilance software deployed within an organization's IT infrastructure, offering enhanced control over data security, customization, and regulatory compliance.

Cloud-based: Web-hosted solutions providing scalability, remote access, real-time updates, and reduced infrastructure and maintenance costs.

Others: Includes hybrid and hosted deployment models combining on-premise control with cloud flexibility.

➥ By Functionality
Issue Tracking Software: Tools used to log, monitor, and resolve drug safety issues, deviations, and compliance-related events across pharmacovigilance workflows.

Drug Safety Audit Software: Solutions designed to support internal and regulatory audits by maintaining comprehensive safety documentation, audit trails, and compliance reports.

Adverse Event Reporting Software: Platforms that facilitate collection, management, analysis, and regulatory submission of adverse event data from clinical trials and post-marketing surveillance.

Others: Includes signal detection, risk management, case management, and analytics tools supporting end-to-end pharmacovigilance activities.

➥ By End User
Contract Research Organizations (CROs): Service providers using pharmacovigilance software to manage safety data and regulatory reporting on behalf of sponsors.

Biotechnological Companies: Organizations leveraging these solutions to ensure drug safety, compliance, and risk management throughout product development.

Healthcare Providers: Hospitals and clinics involved in adverse event identification, reporting, and real-world drug safety monitoring.

Others: Includes pharmaceutical companies, academic research institutions, and regulatory agencies utilizing pharmacovigilance software solutions.

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