The Pharmacovigilance Market, estimated at USD 8.03 Bn in 2025, is expected to exhibit a CAGR of 8.3% and reach USD 14.03 Bn by 2032.
Market expansion is fueled by growing adoption of digital healthcare solutions, rising demand for efficient data management, and continuous advancements in health IT infrastructure. Increasing integration of electronic health records (EHRs), telehealth platforms, and AI-driven analytics is enhancing patient care, operational efficiency, and decision-making. Strategic collaborations, evolving business models, and supportive regulatory frameworks are creating strong growth prospects for both emerging players and established healthcare IT providers.
Market Dynamics:
One of the major drivers propelling the growth of the global pharmacovigilance market is the growing outsourcing of pharmacovigilance services from contract research organizations owing to cost optimization and lack of in-house expertise by many pharmaceutical companies. Moreover, stringent regulations imposed by regulatory authorities regarding drug safety surveillance and risk management are further fueling the demand for pharmacovigilance services. The USFDA and EMA have made the reporting of adverse drug reactions obligatory, which has led pharmaceutical companies to invest more in pharmacovigilance and drug safety units. Additionally, the growing demand for effective case processing and sample management is encouraging pharmaceutical companies to shift to cloud-based pharmacovigilance solutions to meet regulatory compliances more efficiently.
Increasing regulatory requirements and safety guidelines from regulatory authorities is driving the market growth
Regulatory authorities across the globe are implementing new and stringent guidelines and regulations related to drug safety and risk management. For example, regulations like ICH E2E from the International Council for Harmonisation (ICH) requires timely reporting of drug safety issues during clinical trial phases. Similarly, FDA safety reporting requirements under FDA adverse event reporting system (FAERS) mandates regular collection and analysis of safety data during drug development and post marketing phases. Compliance to such regulatory policies necessitates the implementation of pharmacovigilance systems and hiring of skilled professionals by pharmaceutical companies. This factor is a major driver for the growth of global pharmacovigilance market.
Increased outsourcing of pharmacovigilance activities to CROs is propelling market expansion
Pharmaceutical and biotech companies are increasingly outsourcing their pharmacovigilance functions to specialized contract research organizations (CROs) in order to focus on their core drug development activities. CROs provide advantages like skilled workforce, advanced technology infrastructure, global regulatory expertise, and economies of scale. Moreover, the emerging trend of online healthcare records and direct drug reporting by patients is generating huge volumes of complex safety data that needs to be properly managed and interpreted. This increasing complexity of data analysis is further encouraging outsourcing to CROs and stimulating the market growth.
Shortage of trained and skilled pharmacovigilance professionals acts as a market restraint
Despite rising demand, there exists a significant shortage of qualified and experienced pharmacovigilance professionals globally. Setting up of robust pharmacovigilance operations require recruiting candidates with specialized skills and post-graduate medical training. However, qualified candidates are scarce as pharmacovigilance is a niche domain that requires skills from both medical and regulatory perspectives. This talent crunch leads to increased hiring costs and operational delays for companies entering this industry. It restricts the faster expansion of the overall market.
Budget constraints of small and mid-sized companies limits market potential
Establishing comprehensive and compliant pharmacovigilance systems involves huge capital investments for software, hardware infrastructure, hiring and training of personnel. Such steep investment requirements pose significant challenges, especially for small and mid-sized pharmaceutical firms. As the domain demands advanced technical platforms for signal detection, case processing and database management, the costs become further prohibitive for smaller players. This acts as a major restraint in tapping business opportunities from these emerging companies.
Growing prevalence of chronic diseases opens new avenues for pharmacovigilance services
Increasing global incidence of chronic, non-communicable diseases like cancer, diabetes, and cardiovascular conditions is expected to continuously drive the drug pipeline. Long term treatment of these disorders also amplifies drug safety monitoring needs across population. This growing disease burden provides scope for pharmacovigilance throughout the drug life cycle including pre-approval stages, post-marketing surveillance, and risk management. It ensures continued demand for related outsourcing services.
Emergence of e-pharmacovigilance using AI and Blockchain represents a key opportunity
Leveraging latest technologies has the potential to positively impact pharmacovigilance. Integration of AI, machine learning and neural networks allows automated parsing of huge unstructured safety data like medical records and social media. Blockchain-based platforms offer decentralized, transparent method to report and share adverse events quickly. Their application presents an opportunity to derive faster, more accurate safety signals. It also ensures standardized global data collection. Adoption of e-pharmacovigilance using digital tools can optimize processes, improve outcomes, and support market growth in the long run.
Link: https://www.coherentmarketinsights.com/market-insight/pharmacovigilance-market-1047
Key Developments
- On 6 February 2024, Mr.Robert Ball, Deputy Director of the USFDA Office of Surveillance and Epidemiology (OSE), announced at the DIA Global Pharmacovigilance and Risk Management Strategies Conference in Baltimore that the FDA is enhancing its pharmacovigilance efforts with artificial intelligence. The FDA's Information Visualization Platform (InfoViP), launched in 2022, uses AI to assist in reviewing adverse event reports, aiming to streamline the process amidst increasing annual reports exceeding 2 million. Additionally, the FDA is piloting standardized Risk Evaluation and Mitigation Strategies (REMS) data to improve accessibility and usability.
- In February 2023, Parexel International Corporation, A largest clinical research organizations introduced the Expert Series—New Medicines, Novel Insights, showcasing the latest findings from its interdisciplinary experts. The series presents in-depth analyses of trends influencing drug development, offering evidence-based guidance tailored for the biopharmaceutical sector.
- In February 2022, Cognizant, information technology services and consulting company. forged a collaboration with Medable Inc. a software company to coalesce efforts in providing clinical research solutions using Medable's software-as-a-service platform tailored for decentralized clinical trials.
- In February 2022, LINK Medical, Contract Research Organization and Regulatory service provider and Viedoc, Software company formed a partnership facilitated by Viedoc to enhance trial efficiency for LINK Medical and its clientele. This collaboration facilitates ongoing sharing of insights, requirements, and innovations, including the testing of new functionalities.
Key Players: Accenture, Cognizant Technology Solutions, Laboratory Corporation of America Holdings (LabCorp), IBM Corporation, QuintilesIMS (IQVIA), ICON plc, Capgemini, ITClinical, TAKE Solutions Ltd, BioClinica, PAREXEL International Corporation, Wipro Ltd, FMD K&L, Linical Accelovance, United BioSource Corporation (UBC), PRA Health Sciences, and ArisGlobal, Ennov Solutions Inc
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