The global market for Post-Marketing Pharmacovigilance and Medical Information was estimated at US$6.0 Trillion in 2024 and is projected to reach US$9.6 Trillion by 2030, growing at a CAGR of 8.3% 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 Post-Marketing Pharmacovigilance and Medical Information market.
The increasing complexity of biologics, gene therapies, and personalized medicines has heightened the need for advanced pharmacovigilance strategies. Post-marketing surveillance involves spontaneous reporting systems (SRS), electronic health record (EHR) monitoring, active surveillance, and big data analytics to track real-world drug performance. Additionally, pharmaceutical companies rely on medical information (MI) services to provide accurate, evidence-based responses to healthcare professionals (HCPs), patients, and regulatory bodies, ensuring compliance and transparency in drug safety communication.
Another major advancement is the integration of real-world evidence (RWE) and electronic health records (EHRs) in post-marketing safety studies. Pharmaceutical companies and regulatory agencies are increasingly leveraging RWE analytics to assess long-term safety outcomes, off-label use risks, and drug-drug interactions in broader patient populations. These insights help in making data-driven decisions regarding drug labeling updates, market withdrawals, and risk mitigation strategies.
Cloud-based pharmacovigilance platforms and automation tools are also enhancing case management, signal detection, and regulatory reporting. Many companies are adopting cloud-based adverse event (AE) management systems, allowing for real-time adverse event reporting, automated case processing, and streamlined global safety compliance. The implementation of blockchain technology in drug safety data management is also improving data integrity, security, and traceability, ensuring tamper-proof pharmacovigilance records.
The rise of patient-centric pharmacovigilance and digital health monitoring is another major trend. With the expansion of mobile health (mHealth), wearable devices, and patient-generated health data (PGHD), drug safety monitoring is becoming more proactive and real-time. Pharmaceutical companies are increasingly using smartphone apps, wearable biosensors, and online patient registries to collect continuous safety data, allowing for early risk detection and personalized pharmacovigilance approaches.
Another key trend is the outsourcing of pharmacovigilance and medical information services to contract research organizations (CROs) and business process outsourcing (BPO) providers. The increasing volume of adverse event (AE) case reports, safety signal assessments, and regulatory filings has led many pharmaceutical companies to outsource post-marketing safety operations to specialized PV service providers and technology vendors. This outsourcing model helps reduce operational costs while ensuring regulatory compliance and data-driven decision-making.
Another key growth factor is the expansion of personalized medicine and biologics, which present unique safety challenges due to their targeted mechanisms of action and patient-specific treatment responses. The growing adoption of cell and gene therapies, immunotherapies, and precision oncology drugs has increased the demand for advanced safety surveillance models that integrate genomic and biomarker-driven pharmacovigilance data.
The increasing focus on global harmonization of drug safety regulations is also driving the market forward. Regulatory bodies are collaborating on standardized PV frameworks, digital reporting portals, and cross-border safety data sharing to improve adverse event detection and signal management. Pharmaceutical companies must comply with evolving pharmacovigilance legislation across multiple jurisdictions, driving investments in automated compliance platforms, regulatory intelligence tools, and centralized safety databases.
Additionally, the rise of pharmacovigilance in emerging markets is contributing to market expansion. Countries such as China, India, Brazil, and South Korea are strengthening their national pharmacovigilance programs, enforcing stricter post-market surveillance mandates for both locally manufactured and imported pharmaceutical products. The demand for localized PV expertise, multilingual safety reporting, and region-specific compliance solutions is creating new growth opportunities for pharmacovigilance service providers.
As post-marketing safety requirements become more stringent, pharmaceutical companies will continue to invest in AI-powered safety monitoring, digital health analytics, and patient-centric pharmacovigilance models, ensuring that drug safety remains a top priority in the evolving global healthcare landscape.
Segments: Service Type (Spontaneous Reporting Services, Intensified ADR Reporting Services, Targeted Spontaneous Reporting Services, Cohort Event Monitoring Services, EHR Mining Services); End-Use (Hospitals End-Use, Research Organizations End-Use, 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.
The analysts continuously track trade developments worldwide, drawing insights from leading global economists and over 200 industry and policy institutions, including think tanks, trade organizations, and national economic advisory bodies. This intelligence is integrated into forecasting models to provide timely, data-driven analysis of emerging risks and opportunities.
Global Post-Marketing Pharmacovigilance and Medical Information Market - Key Trends & Drivers Summarized
Why Is Post-Marketing Pharmacovigilance Essential in the Pharmaceutical Industry?
Post-marketing pharmacovigilance (PV) plays a critical role in ensuring drug safety and efficacy after regulatory approval, addressing potential risks, adverse events (AEs), and long-term effects of pharmaceuticals in real-world use. While clinical trials provide initial safety data, they are often limited in sample size, patient diversity, and duration, making post-market surveillance essential for detecting rare, delayed, or unforeseen adverse reactions. Regulatory agencies such as the FDA (U.S.), EMA (Europe), MHRA (UK), and PMDA (Japan) mandate ongoing drug safety monitoring, ensuring that pharmaceutical companies assess, report, and mitigate risks throughout a drug’s lifecycle.The increasing complexity of biologics, gene therapies, and personalized medicines has heightened the need for advanced pharmacovigilance strategies. Post-marketing surveillance involves spontaneous reporting systems (SRS), electronic health record (EHR) monitoring, active surveillance, and big data analytics to track real-world drug performance. Additionally, pharmaceutical companies rely on medical information (MI) services to provide accurate, evidence-based responses to healthcare professionals (HCPs), patients, and regulatory bodies, ensuring compliance and transparency in drug safety communication.
How Are Technological Advancements Enhancing Post-Marketing Pharmacovigilance?
Technological innovations such as artificial intelligence (AI), machine learning (ML), big data analytics, and natural language processing (NLP) are revolutionizing pharmacovigilance by improving the speed, accuracy, and automation of adverse event detection. AI-powered algorithms can analyze electronic medical records, social media discussions, and patient-reported outcomes to identify potential safety signals and emerging drug-related risks more efficiently than traditional manual review processes.Another major advancement is the integration of real-world evidence (RWE) and electronic health records (EHRs) in post-marketing safety studies. Pharmaceutical companies and regulatory agencies are increasingly leveraging RWE analytics to assess long-term safety outcomes, off-label use risks, and drug-drug interactions in broader patient populations. These insights help in making data-driven decisions regarding drug labeling updates, market withdrawals, and risk mitigation strategies.
Cloud-based pharmacovigilance platforms and automation tools are also enhancing case management, signal detection, and regulatory reporting. Many companies are adopting cloud-based adverse event (AE) management systems, allowing for real-time adverse event reporting, automated case processing, and streamlined global safety compliance. The implementation of blockchain technology in drug safety data management is also improving data integrity, security, and traceability, ensuring tamper-proof pharmacovigilance records.
What Are the Key Market Trends Driving the Expansion of Pharmacovigilance and Medical Information Services?
One of the most significant trends shaping the pharmacovigilance industry is the increasing regulatory scrutiny and evolving compliance requirements. Regulatory agencies worldwide are imposing stricter reporting timelines, transparency mandates, and risk minimization strategies, compelling pharmaceutical companies to adopt automated and AI-driven pharmacovigilance systems. The implementation of ICH E2E guidelines on pharmacovigilance planning and ISO IDMP (Identification of Medicinal Products) standards is further driving investments in integrated safety data management platforms.The rise of patient-centric pharmacovigilance and digital health monitoring is another major trend. With the expansion of mobile health (mHealth), wearable devices, and patient-generated health data (PGHD), drug safety monitoring is becoming more proactive and real-time. Pharmaceutical companies are increasingly using smartphone apps, wearable biosensors, and online patient registries to collect continuous safety data, allowing for early risk detection and personalized pharmacovigilance approaches.
Another key trend is the outsourcing of pharmacovigilance and medical information services to contract research organizations (CROs) and business process outsourcing (BPO) providers. The increasing volume of adverse event (AE) case reports, safety signal assessments, and regulatory filings has led many pharmaceutical companies to outsource post-marketing safety operations to specialized PV service providers and technology vendors. This outsourcing model helps reduce operational costs while ensuring regulatory compliance and data-driven decision-making.
What Factors Are Driving the Growth of the Post-Marketing Pharmacovigilance and Medical Information Market?
The growth in the post-marketing pharmacovigilance and medical information market is driven by several factors, including the increasing incidence of adverse drug reactions (ADRs), rising adoption of AI-driven safety surveillance, and the expansion of global pharmacovigilance regulations. One of the primary drivers is the rising number of newly approved drugs, biosimilars, and combination therapies, which require continuous post-market monitoring to ensure long-term safety and compliance with pharmacovigilance legislation.Another key growth factor is the expansion of personalized medicine and biologics, which present unique safety challenges due to their targeted mechanisms of action and patient-specific treatment responses. The growing adoption of cell and gene therapies, immunotherapies, and precision oncology drugs has increased the demand for advanced safety surveillance models that integrate genomic and biomarker-driven pharmacovigilance data.
The increasing focus on global harmonization of drug safety regulations is also driving the market forward. Regulatory bodies are collaborating on standardized PV frameworks, digital reporting portals, and cross-border safety data sharing to improve adverse event detection and signal management. Pharmaceutical companies must comply with evolving pharmacovigilance legislation across multiple jurisdictions, driving investments in automated compliance platforms, regulatory intelligence tools, and centralized safety databases.
Additionally, the rise of pharmacovigilance in emerging markets is contributing to market expansion. Countries such as China, India, Brazil, and South Korea are strengthening their national pharmacovigilance programs, enforcing stricter post-market surveillance mandates for both locally manufactured and imported pharmaceutical products. The demand for localized PV expertise, multilingual safety reporting, and region-specific compliance solutions is creating new growth opportunities for pharmacovigilance service providers.
As post-marketing safety requirements become more stringent, pharmaceutical companies will continue to invest in AI-powered safety monitoring, digital health analytics, and patient-centric pharmacovigilance models, ensuring that drug safety remains a top priority in the evolving global healthcare landscape.
Report Scope
The report analyzes the Post-Marketing Pharmacovigilance and Medical Information market, presented in terms of market value (US$ Thousand). The analysis covers the key segments and geographic regions outlined below.Segments: Service Type (Spontaneous Reporting Services, Intensified ADR Reporting Services, Targeted Spontaneous Reporting Services, Cohort Event Monitoring Services, EHR Mining Services); End-Use (Hospitals End-Use, Research Organizations End-Use, 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 Spontaneous Reporting Services segment, which is expected to reach US$4.2 Trillion by 2030 with a CAGR of a 10.1%. The Intensified ADR Reporting Services segment is also set to grow at 7.8% CAGR over the analysis period.
- Regional Analysis: Gain insights into the U.S. market, estimated at $1.6 Trillion in 2024, and China, forecasted to grow at an impressive 13.2% CAGR to reach $2.1 Trillion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.
Why You Should Buy This Report:
- Detailed Market Analysis: Access a thorough analysis of the Global Post-Marketing Pharmacovigilance and Medical Information Market, covering all major geographic regions and market segments.
- Competitive Insights: Get an overview of the competitive landscape, including the market presence of major players across different geographies.
- Future Trends and Drivers: Understand the key trends and drivers shaping the future of the Global Post-Marketing Pharmacovigilance and Medical Information Market.
- Actionable Insights: Benefit from actionable insights that can help you identify new revenue opportunities and make strategic business decisions.
Key Questions Answered:
- How is the Global Post-Marketing Pharmacovigilance and Medical Information Market expected to evolve by 2030?
- What are the main drivers and restraints affecting the market?
- Which market segments will grow the most over the forecast period?
- How will market shares for different regions and segments change by 2030?
- Who are the leading players in the market, and what are their prospects?
Report Features:
- Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ 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 4C Pharma Solutions, Accenture Plc., Allucent, APCER Life Sciences, ArisGlobal and more.
- Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.
Select Competitors (Total 42 Featured):
- 4C Pharma Solutions
- Accenture Plc.
- Allucent
- APCER Life Sciences
- ArisGlobal
- ClinChoice
- Cognizant Technology Solutions Corporation
- Ergomed Plc
- F. Hoffmann-La Roche Ltd.
- Gilead Sciences
- ICON Plc
- Indegene Limited
- IQVIA
- Labcorp Drug Development (formerly Covance)
- Med Communications, Inc.
- Parexel International Corporation
- Pharmaceutical Product Development, Inc. (PPD)
- Syneos Health
- Veristat
- Wipro Ltd.
Tariff Impact Analysis: Key Insights for 2025
Global tariff negotiations across 180+ countries are reshaping supply chains, costs, and competitiveness. This report reflects the latest developments as of April 2025 and incorporates forward-looking insights into the market outlook.The analysts continuously track trade developments worldwide, drawing insights from leading global economists and over 200 industry and policy institutions, including think tanks, trade organizations, and national economic advisory bodies. This intelligence is integrated into forecasting models to provide timely, data-driven analysis of emerging risks and opportunities.
What’s Included in This Edition:
- Tariff-adjusted market forecasts by region and segment
- Analysis of cost and supply chain implications by sourcing and trade exposure
- Strategic insights into geographic shifts
Buyers receive a free July 2025 update with:
- Finalized tariff impacts and new trade agreement effects
- Updated projections reflecting global sourcing and cost shifts
- Expanded country-specific coverage across the industry
Table of Contents
I. METHODOLOGYII. EXECUTIVE SUMMARY2. FOCUS ON SELECT PLAYERSIV. COMPETITION
1. MARKET OVERVIEW
3. MARKET TRENDS & DRIVERS
4. GLOBAL MARKET PERSPECTIVE
III. MARKET ANALYSIS
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- 4C Pharma Solutions
- Accenture Plc.
- Allucent
- APCER Life Sciences
- ArisGlobal
- ClinChoice
- Cognizant Technology Solutions Corporation
- Ergomed Plc
- F. Hoffmann-La Roche Ltd.
- Gilead Sciences
- ICON Plc
- Indegene Limited
- IQVIA
- Labcorp Drug Development (formerly Covance)
- Med Communications, Inc.
- Parexel International Corporation
- Pharmaceutical Product Development, Inc. (PPD)
- Syneos Health
- Veristat
- Wipro Ltd.
Table Information
Report Attribute | Details |
---|---|
No. of Pages | 72 |
Published | May 2025 |
Forecast Period | 2024 - 2030 |
Estimated Market Value ( USD | $ 6 Trillion |
Forecasted Market Value ( USD | $ 9.6 Trillion |
Compound Annual Growth Rate | 8.3% |
Regions Covered | Global |