Pharmacovigilance Software Market to Reach US$415.4M by 2033 at 7.4% CAGR, Led by Oracle, ArisGlobal, IQVIA; North America 40%

The pharmacovigilance software market is growing as organizations adopt digital tools to enhance drug safety monitoring and regulatory compliance”
— DataM Intelligence

LEANDER, TX, UNITED STATES, December 17, 2025 /EINPresswire.com/ -- According to DataM Intelligence, the Global Pharmacovigilance Software Market reached US$ 218.95 million in 2024 and is projected to grow to US$ 415.42 million by 2033, expanding at a CAGR of 7.4% during the forecast period 2025–2033. Market growth is driven by the increasing focus on drug safety, stringent regulatory requirements, and the rising volume of adverse event reporting associated with expanding pharmaceutical and biotechnology pipelines. As drug development becomes more complex and globalized, pharmaceutical companies and regulatory authorities are increasingly relying on advanced software solutions to ensure post-marketing surveillance and patient safety.

Pharmacovigilance software plays a critical role in monitoring medication safety after market approval by enabling efficient adverse event reporting, safety signal detection, and comprehensive data analysis. These platforms integrate data from multiple sources, provide real-time analytics to identify emerging risks, and support compliance with international regulatory standards. By streamlining drug safety workflows, pharmacovigilance software allows healthcare stakeholders to enhance patient protection while improving operational efficiency and regulatory compliance, positioning it as an essential component of modern pharmaceutical safety management.

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Key Highlights from the Report:
The pharmacovigilance software market is growing steadily due to increasing demand for efficient drug safety monitoring, adverse event reporting, and regulatory compliance solutions.

Adoption of cloud-based platforms and automation technologies, including artificial intelligence and advanced analytics, is improving signal detection, data accuracy, and operational efficiency.

Key functionalities include adverse event case management, issue tracking, drug safety audits, and integrated pharmacovigilance platforms used across the drug lifecycle.

Pharmaceutical and biotechnology companies, contract research organizations, and business process outsourcing providers are the primary end users of pharmacovigilance software.

North America leads the market supported by strong regulatory frameworks and high technology adoption, while Asia-Pacific is emerging as a high-growth region due to expanding clinical research activities.

Key Segments
By Functionality
Adverse event reporting software holds a major share as it is essential for capturing, processing, and reporting safety data in compliance with global regulatory requirements. The segment benefits from mandatory pharmacovigilance obligations and increasing post-marketing surveillance activities. Drug safety audits software is growing steadily as pharmaceutical companies focus on ensuring regulatory compliance, internal quality control, and risk management across clinical and post-approval stages. Issue tracking software is gaining traction by enabling systematic identification, monitoring, and resolution of safety signals and compliance gaps. Fully integrated software represents a fast-growing segment, driven by demand for end-to-end pharmacovigilance platforms that combine case management, signal detection, reporting, and analytics within a single system.

By Delivery Mode
On-premise delivery mode continues to hold a significant share, particularly among large pharmaceutical organizations that prioritize data control, customization, and internal IT governance. On-demand/cloud-based (SaaS) delivery mode is expanding rapidly due to its scalability, lower upfront costs, faster deployment, and ease of regulatory updates, making it attractive for both established players and emerging life sciences companies.

By End-User
Pharma and biotech companies dominate the market as they require robust pharmacovigilance systems to manage increasing drug pipelines, clinical trial activities, and post-market safety obligations. Contract research organizations (CROs) show strong growth as sponsors increasingly outsource safety monitoring and regulatory reporting functions. Business process outsourcing (BPO) firms continue to adopt advanced pharmacovigilance software to improve operational efficiency and service quality. Other pharmacovigilance service providers, including academic research institutions and independent safety consultants, contribute to market expansion through specialized safety monitoring services.

Regional Insights
• North America – 40% driven by "stringent drug safety and reporting regulations, strong presence of major pharmaceutical and biotech companies, high adoption of digital pharmacovigilance systems, and robust healthcare IT infrastructure."

• Europe – 30% supported by "comprehensive pharmacovigilance requirements under EMA and national regulators, increasing focus on drug safety and compliance, and widespread adoption of advanced software solutions by life sciences companies."

• Asia-Pacific – 20% fueled by "growing pharmaceutical and CRO sectors, increasing regulatory focus on drug safety, rising adoption of cloud-based safety databases, and expanding use of software for adverse event reporting and monitoring."

• Latin America – 6% driven by "evolving regulatory frameworks for drug safety, increasing clinical research activities, and rising adoption of digital tools for adverse event reporting and safety management."

• Middle East & Africa – 4% supported by "gradual development of healthcare and regulatory infrastructure, increasing awareness of pharmacovigilance best practices, and early adoption of safety management software by emerging pharma and health tech companies."

Key Players
Ennov | Oracle | ArisGlobal | EXTEDO | Clinevo Technologies | IQVIA | Quanticate | Cloudbyz | Flex Databases

Key Highlights
Ennov - Holds a 13.6% share, driven by its unified cloud-based pharmacovigilance suite, strong compliance capabilities, and expanding adoption across global life sciences companies.

Oracle - Holds a 19.4% share, supported by its industry-leading Argus Safety platform, advanced automation features, and deep integration with enterprise regulatory systems.

ArisGlobal - Holds a 17.2% share, backed by its LifeSphere Safety platform, AI-powered case processing, and expanding partnerships with pharmaceutical innovators.

EXTEDO - Holds an 8.7% share, fueled by its regulatory compliance expertise, robust signal management tools, and strong footprint in the EU life sciences market.

Clinevo Technologies - Holds a 6.1% share, driven by its cloud-native safety software, scalable PV solutions, and rising adoption among mid-sized pharma companies.

IQVIA - Holds a 14.9% share, supported by its advanced safety analytics, global PV outsourcing capabilities, and integrated real-world evidence ecosystem.

Quanticate - Holds a 5.3% share, recognized for its specialized PV services, case processing expertise, and strong presence in clinical research support.

Cloudbyz - Holds a 4.8% share, driven by its Salesforce-based PV platform, strong configurability, and rapid adoption in emerging biopharma.

Flex Databases - Holds a 3.1% share, supported by its modular safety systems, strong regulatory compliance, and growing customer base in clinical operations.

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Key Developments
November 2025: Leading pharmacovigilance (PV) software providers rolled out enhanced AI-driven adverse event detection modules, improving automated signal detection and reducing manual review workloads for PV teams.

October 2025: A major life sciences technology company introduced integrated PV workflows that combine safety data capture, case processing, and regulatory reporting into a unified platform, simplifying compliance for global pharmacovigilance operations.

September 2025: Health regulators and software developers jointly published updated guidelines for real-time safety surveillance, encouraging broader adoption of cloud-native PV systems to support faster, more transparent reporting.

August 2025: Strategic partnerships emerged between pharmacovigilance software vendors and clinical research organizations (CROs) to streamline adverse event management during clinical trials and post-marketing surveillance.

July 2025: Software platforms expanded support for mobile reporting tools and patient-friendly interfaces, enabling easier adverse event submission directly from patients and healthcare professionals.

June 2025: Enhancements in data interoperability modules were released, allowing pharmacovigilance systems to exchange safety data seamlessly with electronic health records (EHRs), regulatory databases, and global drug safety networks.

Frequently Asked Questions (FAQs):
How big is the global pharmacovigilance software market in terms of growth forecast?
The global pharmacovigilance software market was valued at around US$ 218.95 million in 2024 and is expected to grow steadily through the forecast period.

What is the projected CAGR for the pharmacovigilance software market?
The market is projected to grow at a CAGR of approximately 7.4% during 2025–2033.

Which region currently dominates the pharmacovigilance software market?
North America dominates the market due to strong regulatory requirements, a well-established pharmaceutical industry, and early adoption of advanced drug safety monitoring solutions.

Which deployment mode leads the pharmacovigilance software market?
The cloud-based (SaaS) deployment mode leads the market, driven by scalability, cost efficiency, and real-time safety data access.

Who are the major end users of pharmacovigilance software?
Major end users include pharmaceutical and biotechnology companies, contract research organizations (CROs), and pharmacovigilance service providers.

Conclusion:
The global pharmacovigilance software market is experiencing robust growth as healthcare stakeholders increasingly recognize the importance of monitoring drug safety throughout the product lifecycle. With expanding regulatory requirements, rising volumes of real-world safety data, and the complexity of adverse event reporting, organizations are turning to specialized software to enhance compliance, streamline case management, and improve data accuracy.

Technological advancements, including automated workflows, analytics, and integration with electronic health records, are making pharmacovigilance solutions more efficient and scalable. Although challenges such as data privacy concerns, integration with legacy systems, and high implementation costs persist, growing emphasis on patient safety, regulatory oversight, and proactive risk management is driving wider adoption. Overall, pharmacovigilance software is set to become an essential tool for life sciences companies and healthcare providers seeking to ensure drug safety, maintain compliance, and protect public health on a global scale.

Sai Kiran
DataM Intelligence 4market Research LLP
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