Pharmacovigilance Market (2025-2032)
The Pharmacovigilance Market was valued at $8.05 billion in 2024. This market is expected to reach $18.05 billion by 2032, from an estimated $8.87 billion in 2025, at a CAGR of 10.7% during the forecast period 2025-2032. Pharmacovigilance Market Size & Forecast The growth of this market is primarily
- Published
- May 2024
- Pages
- 400
- Format
- PDF + Excel
- Report ID
- MR-1211
- Base year
- 2024
- 2024 · BASELINE
- $8.05B
- 2032
- $18.05B
- CAGR 2025–2032
- 10.7%
2024 baseline · 2025–2032 forecast at 10.7% CAGR · hover a bar for the value
Key highlights
By Offering: The Services Segment to Dominate the Pharmacovigilance Market in 2025
By Drug Development Phase: The Phase IV Segment to Dominate the Pharmacovigilance Market in 2025
By Therapeutic Area: The Oncology Segment to Dominate the Pharmacovigilance Market in 2025
By End User: The Pharmaceutical & Biotechnology Companies Segment to Dominate the Pharmacovigilance Market in 2025
Report summary
| Particulars | Details |
|---|---|
| Number of Pages | 400 |
| Format | |
| Forecast Period | 2025-2032 |
| Base Year | 2024 |
| CAGR | 10.7% |
| Estimated Market Size (Value) | $18.05 Billion by 2032 |
| Segments Covered | By Offering · Software · Software, by Deployment Mode · On-premise · Cloud-based · Software, by Functionality · Issue Tracking Software · Adverse Event Reporting Software · Fully Integrated Software · Drug Safety Audit Software · Other Functionalities · Services · Services, by Service Provider · In-house · Contract Outsourcing · Services, by Type · Spontaneous Reporting · Intensified ADR Reporting · Targeted Spontaneous Reporting · Cohort Event Monitoring · EHR Mining · Other Services · Services, by Process · Core Services · Consulting Services · Services, by Process Outflow · Case Data Management · Case Logging · Case Data Analysis · Medical Review & Reporting · Signal Detection · Adverse Event Logging · Adverse Event Analysis · Adverse Event Review & Reporting · Risk Management System · Risk Evaluation System · Risk Mitigation System · (Note 1 : Other functionalities comprise reporting and analytics, case management, and signal management. · Note 2: Other services comprise case processing services, signal management services, regulatory intelligence services, and consulting services.) · By Drug Development Phase · Phase IV · Phase III · Phase II · Phase I · Preclinical Studies · By Therapeutic Area · Oncology · Cardiology/Vascular Diseases · Infectious Diseases · Immunology · Neurology · Other Therapeutic Areas · By End User · Pharmaceutical & Biotechnology Companies · Medical Device Manufacturers · Government Agencies · Other End Users · (Note: Other end users comprise CROs and BPOs.) |
| Countries Covered | North America (U.S. and Canada), Europe (Germany, France, U.K., Italy, Spain, Belgium, Netherlands, Denmark, Sweden, and Rest of Europe), Asia-Pacific (China, Japan, India, South Korea, Australia, and Rest of Asia-Pacific), Latin America (Brazil, Mexico, and Rest of Latin America), and the Middle East & Africa |
| Key Companies Profiled | IQVIA (U.S.), Cognizant Technology Solutions Corporation (U.S.), Linical Co., Ltd (U.S.), International Business Machines Corporation (U.S.), Laboratory Corporation of America Holdings (U.S.), ICON plc (Ireland), Parexel International (U.S.), Wipro Limited (India), Sanofi S.A. (France), Pharmaceutical Product Development Inc. (a subsidiary of Thermo Fisher Scientific Inc.) (U.S.), Capgemini SE (France), Syneos Health (U.S.), ArisGlobal (U.S.), Ennov (France), EXTEDO GmbH (Germany), Oracle Corporation (U.S.), Sparta Systems Inc. (U.S.), United BioSource, LLC (UBC) (U.S.), and AB Cube S.A.S. (France) |
Report overview
Segments covered: offering, phase, therapeutic area, end user. Regions: North America, Europe, Asia-Pacific, Latin America.
The growth of this market is primarily driven by the rising incidence of drug toxicity, stringent regulatory frameworks, increasing pharmaceutical research spending, rising need for new drug development, and increasing focus on medical device safety. Furthermore, the introduction of technologically advanced software, growing awareness regarding adverse drug reactions, therapeutic approaches requiring a combination of drugs, and the increasing trend of outsourcing pharmacovigilance are expected to offer growth opportunities for market stakeholders.
Report infographic
Market dynamics
5 factors across 3 forcesRising Incidence of Drug Toxicity
Drug toxicity can happen as a result of the over-ingestion of medication, causing too much of the drug to be in the human body. With certain medications, drug toxicity can occur as an adverse drug reaction. ADRs can be serious, affecting patient health or even proving fatal. According to the U.S. FDA, around 6.7% of patients experience serious ADRs, with a 0.3% mortality rate. Hospitalization is also increasing due to ADRs. According to the CDC, ADRs cause around 1.3 million emergency department visits each year in the U.S., of which around 35,000 patients are hospitalized immediately after their emergency department visit.
The incidence of ADRs varies and depends on factors such as age, sex, ethnicity, existing disorders, genetic and environmental factors, administration route, treatment duration, dosage, and drug type. Moreover, increased age and polypharmacy also lead to ADRs. Pharmacovigilance is used to detect problems in medicine usage, reduce risks, and communicate observations in a disciplined way.
Stringent Regulatory Frameworks
Medical device companies, pharmaceutical companies, and Contract Research Organizations (CROs) are constantly under pressure to meet time-critical regulatory requirements using limited resources. Companies should manage and identify drug safety events before they become fatal for patients. Companies also need to maintain rigorous compliance with evolving regulations, necessitating the use of pharmacovigilance software and services.
Pharmacovigilance gathers and analyzes information about regulatory frameworks and policies, helping these companies make informed decisions about drug development and testing. Pharmacovigilance also helps in assessing the impact of regulatory changes on a company’s product portfolio. Thus, frequently changing regulatory frameworks are increasing the demand for pharmacovigilance services.
Table of contents
12 chapters · 146 sections · 400 pages · click to expandSegmental analysis
| Segment | Largest share (2025) | Fastest growth (2025–2032) |
|---|---|---|
| By Offering | Services | — |
| By Drug Development Phase | Phase IV | — |
| By Therapeutic Area | Oncology | — |
| By End User | Pharmaceutical & Biotechnology Companies | — |
By Offering
- The Services Segment to Dominate the Pharmacovigilance Market in 2025
- The services segment is expected to account for the larger share of 97.6% of the pharmacovigilance market.
- This segment is also projected to record the higher CAGR of 10.8% during the forecast period 2025–2032.
- The increasing number of molecules in clinical development and the growing importance of drug safety are driving the outsourcing of pharmacovigilance services, contributing to the segment’s large share.
- The U.S. FDA approved 55 drugs in comparison to 37 drugs in 2022 (source: U.S. FDA).
- The rising number of drug approvals drives the demand for pharmacovigilance services, supporting the growth of this segment.
By Drug Development Phase
- The Phase IV Segment to Dominate the Pharmacovigilance Market in 2025
- The phase IV segment is expected to account for the largest share of 72.5% of the pharmacovigilance market.
- Phase IV clinical trials involve larger patient populations, increasing the likelihood of rare adverse events.
- Phase IV clinical trials monitor the effectiveness and safety of drugs.
- The demand for pharmacovigilance services & software is high as the volume of data generated from real-world evidence is significant.
- During Phase IV, undetected or unsuspected ADRs can be detected due to testing being conducted on a large number of patients and over a longer observation period.
- Thus, the high complexity of Phase IV is increasing the adoption of pharmacovigilance services for the efficient management of clinical trials.
By Therapeutic Area
- The Oncology Segment to Dominate the Pharmacovigilance Market in 2025
- The oncology segment is expected to account for the largest share of the pharmacovigilance market.
- The segment’s large share is attributed to the availability of funding for oncology, life science & healthcare research, the increasing demand for personalized therapies, and high cancer incidence necessitating newer therapies to be launched in the market.
- Biopharmaceutical companies’ growing emphasis on research activities and rising government support for the development of cancer treatment are supporting the outsourcing of pharmacovigilance services.
- For instance, in February 2025, BioNTech SE (Germany) invested USD 200 million in Autolus Therapeutics (U.K.) and collaborated with the company to support the cancer therapy pipeline.
- Pharmacovigilance solutions monitor patient safety during treatment for the detection of long-term complications and adverse events, contributing to oncology drug safety.
By End User
- The pharmaceutical & biotechnology companies segment is expected to account for the largest share of the pharmacovigilance market.
- The segment’s large share is attributed to pharmaceutical & biotechnology companies’ high investments in research & development.
- For instance, global pharmaceutical R&D expenditure is expected to reach USD 213 billion in 2026 from USD 179 billion in 2020 (Source: International Federation of Pharmaceutical Manufacturers & Associations - IFPMA).
- This growing focus on R&D is supporting the development of newer therapies, driving the need for pharmacovigilance services.
Geographic analysis
North America
Largest shareIn 2025, North America is expected to account for the largest share of 44.3% of the pharmacovigilance market. North America’s large share is attributed to the presence of key market players, advanced infrastructure and resources supporting research & development, the large number of clinical trials and drug approvals, and increased reporting of adverse drug events in the region. The number of drugs in the pipeline is also increasing in North America. For instance, AbbVie Inc. (U.S.) has more than 90 indications, compounds, or devices in development, individually or in collaboration. According to Pharmaceutical Research and Manufacturers of America (U.S.), 1,600 vaccines and treatments for cancer are under development. Thus, the region’s significant drug pipeline is increasing the need for pharmacovigilance solutions for monitoring drug safety. North America to Dominate the Pharmacovigilance Market in 2025
Asia-Pacific
Fastest growthHowever, Asia-Pacific is slated to register the highest growth rate of 12.3% during the forecast period. The countries in Asia-Pacific, including China, India, and South Korea, are expected to hold significant growth opportunities for the vendors in this market. Growing cancer incidence, rising awareness about ADRs, and increasing funding and supportive initiatives for drug discovery are driving the growth of this regional market. For instance, in July 2022, the Council of Scientific and Industrial Research (CSIR) (India) invested USD 6.73 million in R&D activities for drug discovery and development. Additionally, the increasing number of clinical trials in the region is driving the growth of the pharmacovigilance market. According to the WHO, the number of clinical trials in Southeast Asia increased to 11,030 in 2022 from 9,175 in 2020.
Competitive landscape
- December 2024
Pharmaceutical Product Development, Inc., a subsidiary of Thermo Fisher Scientific Inc. (U.S.), launched CorEvidence, a patented cloud-based data lake platform for the optimization of pharmacovigilance case processing and safety data management processes.
- March 2024
ArisGlobal (U.S.) launched Intelligent Content Management for Safety. The solution can organize and store extensive documentation related to safety activities. It builds on LifeSphere’s Clinical counterpart, which supports the electronic Trial Master File (eTMF) solution.
- April 2024
PharmaLex GmbH (Germany) merged with Cpharm Pty Ltd. (Australia), a pharmacovigilance service provider, to expand its portfolio and presence in Australia and New Zealand.
- November 2022
Clinigen Group (U.S.) acquired Drug Safety Navigator Inc. (U.S.) to add pharmacovigilance services to the company’s offerings.
- IQVIA (U.S.)
- Cognizant Technology Solutions Corporation (U.S.)
- Linical Co., Ltd (U.S.)
- International Business Machines Corporation (U.S.)
- Laboratory Corporation of America Holdings (U.S.)
- ICON plc · Ireland
- Parexel International (U.S.)
- Wipro Limited · India
- Sanofi S.A. · France
- Capgemini SE · France
- Syneos Health (U.S.)
- ArisGlobal (U.S.)
- Ennov · France
- EXTEDO GmbH · Germany
- Oracle Corporation (U.S.)
- Sparta Systems Inc. (U.S.)
Frequently asked questions
The pharmacovigilance market report covers the qualitative and quantitative assessment of the pharmacovigilance market. This report provides market sizes and forecasts for pharmacovigilance market segments and subsegments by offering, drug development phase, therapeutic area, and end user at the regional and country levels. The report also provides insights on factors impacting market growth, along with a regulatory analysis and Porter’s Five Forces analysis for the pharmacovigilance market.
Cite this report
Meticulous Research. (2024). Pharmacovigilance Market - Global Opportunity Analysis and Industry Forecast (2025-2032) (Report No. MR-1211). Meticulous Market Research Pvt. Ltd. https://www.meticulousresearch.com/product/pharmacovigilance-market-5894