Pharmacovigilance - Global Strategic Business Report

The global market for Pharmacovigilance was estimated at US$10.8 Billion in 2024 and is projected to reach US$18.5 Billion by 2030, growing at a CAGR of 9.3% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The report includes the most recent global tariff developments and how they impact the Pharmacovigilance market.

Global Pharmacovigilance Market - Key Trends & Drivers Summarized

What Is Pharmacovigilance and Why Is It Important in Healthcare?

Pharmacovigilance refers to the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or other drug-related problems. It plays a crucial role in ensuring the safety and efficacy of pharmaceutical products throughout their lifecycle, from development to post-market surveillance. The primary goal of pharmacovigilance is to protect public health by identifying and mitigating risks associated with the use of drugs. As pharmaceutical products can have side effects that are not fully apparent during clinical trials, pharmacovigilance provides an ongoing mechanism for monitoring the safety of drugs once they are in widespread use.

Pharmacovigilance encompasses various activities, such as collecting and analyzing data from adverse drug reaction (ADR) reports, conducting risk assessments, and implementing measures to reduce harm to patients. Regulatory authorities, pharmaceutical companies, and healthcare professionals are all involved in pharmacovigilance, ensuring that any potential safety concerns related to a drug are quickly identified and addressed. As the pharmaceutical industry continues to develop new and more complex drugs, including biologics and personalized therapies, pharmacovigilance has become even more critical in maintaining drug safety and protecting patients.

How Are Technological Advancements Shaping the Pharmacovigilance Market?

Technological advancements are playing a transformative role in the pharmacovigilance market, improving the efficiency and accuracy of drug safety monitoring and enhancing the ability to identify potential risks. One of the most significant advancements in this field is the integration of artificial intelligence (AI) and machine learning (ML) into pharmacovigilance processes. AI and ML algorithms are capable of analyzing large volumes of real-world data, such as patient records, social media mentions, and electronic health records, to identify patterns that may indicate adverse drug reactions (ADRs). These technologies allow for more proactive monitoring, enabling early detection of potential safety concerns before they become widespread.

Automation is another key trend shaping the pharmacovigilance market. Automated systems can handle tasks such as data collection, report generation, and signal detection with greater speed and accuracy than traditional manual methods. For instance, robotic process automation (RPA) is being used to streamline the collection and analysis of ADR reports, improving response times and reducing human error. In addition, natural language processing (NLP) technologies are enhancing the ability to extract relevant safety information from unstructured data sources, such as clinical notes and patient reports, making it easier to identify adverse reactions that might otherwise go unnoticed.

Furthermore, the rise of cloud-based pharmacovigilance platforms is enabling greater collaboration between stakeholders, including pharmaceutical companies, regulatory authorities, and healthcare providers. These platforms offer centralized databases where ADR data can be stored, shared, and analyzed in real-time, allowing for faster decision-making and more efficient reporting. Additionally, the adoption of big data analytics is revolutionizing post-market surveillance, as companies can now analyze vast amounts of patient data to identify trends and correlations that could indicate potential safety issues.

What Are the Emerging Trends in Pharmacovigilance?

Several emerging trends are reshaping the pharmacovigilance market as the pharmaceutical industry faces evolving challenges and opportunities. One of the most significant trends is the growing focus on real-world evidence (RWE) in drug safety monitoring. RWE is derived from data collected outside of clinical trials, such as patient records, insurance claims, and registries, providing a broader understanding of how drugs perform in real-world settings. The use of RWE allows for more comprehensive safety assessments, particularly for drugs that may behave differently in diverse patient populations than they do in controlled clinical environments. As a result, pharmaceutical companies and regulators are increasingly incorporating RWE into their pharmacovigilance strategies.

Another key trend is the increased globalization of pharmacovigilance. As pharmaceutical companies expand into international markets, they must comply with the diverse regulatory requirements of different regions. This has led to greater demand for pharmacovigilance services that can operate on a global scale, ensuring that safety data is collected and reported in compliance with local regulations. Regulatory authorities in regions such as the U.S., Europe, and Asia-Pacific have developed stringent guidelines for drug safety, which require pharmaceutical companies to maintain robust pharmacovigilance systems capable of meeting these standards.

Risk management and proactive safety monitoring are also gaining importance in pharmacovigilance. Rather than reacting to adverse events after they occur, companies are increasingly adopting risk management plans (RMPs) and risk mitigation strategies to prevent potential safety issues before they arise. These approaches include pre-market risk assessments, continuous post-market surveillance, and the use of signal detection tools that identify emerging risks from data trends. Additionally, the rise of patient-centric pharmacovigilance emphasizes the importance of direct input from patients, with companies utilizing surveys, social media, and mobile health apps to collect patient-reported outcomes and experiences with medications.

What Is Driving the Growth of the Pharmacovigilance Market?

The growth in the pharmacovigilance market is driven by several factors, including increased regulatory scrutiny, the rising complexity of drug therapies, and technological innovations. One of the primary drivers is the growing number of new drug approvals, particularly in areas such as biologics, gene therapies, and personalized medicines. These therapies are often associated with complex safety profiles, requiring more intensive post-market monitoring. As pharmaceutical companies bring more innovative and personalized drugs to market, the demand for comprehensive pharmacovigilance services to ensure patient safety is expected to rise significantly. Another important factor driving market growth is the increasing regulatory requirements for drug safety. Regulatory bodies, such as the U.S. FDA and the European Medicines Agency (EMA), have implemented stringent guidelines for pharmacovigilance, requiring companies to conduct ongoing monitoring of drugs even after they receive market approval. Failure to comply with these regulations can result in significant penalties, product recalls, or damage to a company’s reputation. As a result, pharmaceutical companies are investing heavily in pharmacovigilance systems to ensure compliance and avoid regulatory risks.Technological advancements are also contributing to the growth of the pharmacovigilance market. The integration of AI, automation, and big data analytics has revolutionized the way companies approach drug safety monitoring, making it more efficient, scalable, and cost-effective. These technologies enable companies to analyze vast amounts of data in real-time, improving the speed and accuracy of safety assessments. Furthermore, the rise of cloud-based solutions and global pharmacovigilance networks has facilitated better collaboration and data sharing across the pharmaceutical industry, driving further growth in the market.

Lastly, the increasing focus on patient safety and transparency is a key growth driver. As patients become more informed about the potential risks associated with medications, pharmaceutical companies are under greater pressure to ensure that their drugs are safe and that adverse events are reported quickly and transparently. This shift toward greater accountability and patient-centric approaches is driving the demand for robust pharmacovigilance systems that can monitor drug safety and provide timely updates to regulatory authorities and healthcare providers. These factors, combined with the ongoing development of innovative therapies, are expected to continue driving growth in the pharmacovigilance market in the years to come.

SCOPE OF STUDY:

The report analyzes the Pharmacovigilance market in terms of units by the following Segments, and Geographic Regions/Countries:

• Segments: Service Provider (Contract Outsourcing, In-House); Type (Spontaneous Reporting, Intensified ADR Reporting, Targeted Spontaneous Reporting, Cohort Event Monitoring, EHR Mining); Therapeutic Area (Oncology, Neurology, Cardiology, Respiratory Systems, Other Therapeutic Areas); End-Use (Pharma Companies, Biotech Companies, Medical Device Manufacturers, Other End-Uses)
• Geographic Regions/Countries: World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Key Insights:

• Market Growth: Understand the significant growth trajectory of the Contract Outsourcing segment, which is expected to reach US$12.3 Billion by 2030 with a CAGR of a 11.2%. The In-House segment is also set to grow at 6.1% CAGR over the analysis period.
• Regional Analysis: Gain insights into the U.S. market, valued at $2.8 Billion in 2024, and China, forecasted to grow at an impressive 12.8% CAGR to reach $4.3 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.

Why You Should Buy This Report:

• Detailed Market Analysis: Access a thorough analysis of the Global Pharmacovigilance Market, covering all major geographic regions and market segments.
• Competitive Insights: Get an overview of the competitive landscape, including the market presence of major players across different geographies.
• Future Trends and Drivers: Understand the key trends and drivers shaping the future of the Global Pharmacovigilance Market.
• Actionable Insights: Benefit from actionable insights that can help you identify new revenue opportunities and make strategic business decisions.

Key Questions Answered:

• How is the Global Pharmacovigilance Market expected to evolve by 2030?
• What are the main drivers and restraints affecting the market?
• Which market segments will grow the most over the forecast period?
• How will market shares for different regions and segments change by 2030?
• Who are the leading players in the market, and what are their prospects?

Report Features:

• Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2024 to 2030.
• In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
• Company Profiles: Coverage of players such as Accenture, ArisGlobal, BioClinica Inc., Capgemini, Cognizant and more.
• Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.

Some of the 32 companies featured in this Pharmacovigilance market report include:

• Accenture
• ArisGlobal
• BioClinica Inc.
• Capgemini
• Cognizant
• FMD K&L
• IBM Corporation
• ICON Plc
• IQVIA
• ITClinical
• Laboratory Corporation of America Holdings
• Linical Accelovance
• Parexel International Corporation
• TAKE Solutions Ltd.
• United BioSource Corporation
• Wipro Ltd.

This edition integrates the latest global trade and economic shifts as of June 2025 into comprehensive market analysis. Key updates include:

• Tariff and Trade Impact: Insights into global tariff negotiations across 180+ countries, with analysis of supply chain turbulence, sourcing disruptions, and geographic realignment. Special focus on 2025 as a pivotal year for trade tensions, including updated perspectives on the Trump-era tariffs.
• Adjusted Forecasts and Analytics: Revised global and regional market forecasts through 2030, incorporating tariff effects, economic uncertainty, and structural changes in globalization. Includes segmentation by product, technology, type, material, distribution channel, application, and end-use, with historical analysis since 2015.
• Strategic Market Dynamics: Evaluation of revised market prospects, regional outlooks, and key economic indicators such as population and urbanization trends.
• Innovation & Technology Trends: Latest developments in product and process innovation, emerging technologies, and key industry drivers shaping the competitive landscape.
• Competitive Intelligence: Updated global market share estimates for 2025, competitive positioning of major players (Strong/Active/Niche/Trivial), and refined focus on leading global brands and core players.
• Expert Insight & Commentary: Strategic analysis from economists, trade experts, and domain specialists to contextualize market shifts and identify emerging opportunities.
• Complimentary Update: Buyers receive a free July 2025 update with finalized tariff impacts, new trade agreement effects, revised projections, and expanded country-level coverage.