Pharmacovigilance Market, By Service Provider (In-House And Contract Outsourcing), By Clinical Trial Phase (Pre-Clinical, Phase I, Phase II, Phase III, Phase IV), By Method (Spontaneous Reporting, Intensified ADR Reporting, Targeted Spontaneous Reporting, Cohort Event Monitoring, EHR Mining), By Therapeutic Area (Oncology, Neurology, Cardiology, Respiratory Systems, Others), By End Use (Pharmaceutical Companies, Biotechnology Companies, Medical Device Manufacturers, Others),By Region (North America, Europe, Asia Pacific, Middle East &Africa, And South America) - Market Size &Forecasting (2016-2028)

The pharmacovigilance market size has been valued at USD XX million in 2020 and is expected to grow at a compound annual growth rate (CAGR) of XX% to reach USD XX million by 2028. Pharmacovigilance refers to the science and activities concerned with the understanding, assessment, detection, and prevention of adverse drug effects or any other drug-related harmful effects.

Adverse drug reaction (ADR) is an unwanted and redundant effect of a medication that occurs at the period of its clinical use. The growing number of ADRs is one of the most important problems in the pharmacovigilance field and will cause a considerable rise in the demand for clinical data management services during the forecast timeline.

The pharmacovigilance market constitutes all types of adverse events covered during clinical trials in hospitals, pharmacies, and other healthcare industry. According to the National Centre for Biotechnology Information (NCBI), the number of mortalities owing to ADRs increased more than two-fold in 2014, thereby causing surge in hospitalizations.


The key factors in accelerating the growth of the market are rising drug development rates and drug consumption, increasing incidence of adverse drug reactions along with drug toxicity, and the accelerating outsourcing pharmacovigilance services. The burden of lifestyle diseases, such as hypertension, diabetes, and cardiac disorders, has been growing due to sedentary lifestyles, changing lifestyle patterns, poor diets, and lack of physical activities. As a result, the consumption of drugs has been increasing across the world, which in turn, has increased the demand for drug monitoring. This has been promoting the growth of the global market.

The incidence of human infectious diseases is also increasing owing to factors such as pervasive poverty, varying climate, and growing urbanization. This is also causing a surge in drug consumption and is thus, fueling the drug development process. In addition, with the increasing drug consumption, the requirement for regular monitoring of drugs has increased, which is propelling the pharmacovigilance market.


The pharmacovigilance market has been segmented based on the service providers, clinical trial phase, method, therapeutic area, end-use, and region.


Based on the service provider, the global pharmacovigilance markets divided into in-house and contract outsourcing. Among these, contract outsourcing is expected to hold the largest market share and is likely to witness the fastest growth during the forecast period. This is attributed to the associated benefits of outsourcing such as resource flexibility, risk mitigation, lower fixed cost, and reduction of upfront investments.

Contract outsourcing organizations provide solutions such as process design Standard Operating Procedure (SOP), PV audits, and other customized services. Additionally, the growth of the segment is also due to the rising number of CROs that are providing end-to-end clinical trial solutions, mostly in the economies of the Asia Pacific region, such as India, China, and Japan. Contract outsourcing helps reduce the difficulty associated with clinical trials, allows faster approval of trials, and aids in the effective operation of internal resources.

The in-house segment is expected to observe moderate growth during the forecast timeline owing to extensive R&D for the development of new drugs through major biotechnological and pharmaceutical companies. Thus, the segment is projected to provide this industry with growth potential in the upcoming years.

Based on the clinical trial phase, the global pharmacovigilance markets divided into pre-clinical, phase I, phase II, phase III, and phase IV. Among these, phase Liveweight is also known as the post-marketing clinical trial segment, is likely to dominate over the forecast period. Phase IV is a vital stage in clinical trials, as unsuspected adverse drug reactions are detected in this stage. Thus, the data collected and assessed in this stage are anticipated to be of the highest significance.

It also allows exhaustive drug testing on large demographics patient base of maximum relevance after commercialization of the drug. Conversely, the phase III segment is likely to witness lucrative growth during the forecast period. Phase III trials are conducted to establish and ascertain the efficacy of drugs.

Based on the method, the global pharmacovigilance market is divided into spontaneous reporting, intensified ADR reporting, targeted spontaneous reporting, cohort event monitoring, and EHR mining. Spontaneous reporting is expected to dominate the market during the forecast period due to the wide usage in the detection of new, serious ADRs. It serves as a competent and low-cost method.

Spontaneous reporting is also widely used during the surveillance reports generated through pharmaceutical industries and regulatory authorities. However, Cohort Event Monitoring (CEM) is expected to be the fastest-growing segment during the forecast period due to its growing application in the discovery of a wide range of adverse clinical events.

Based on the therapeutic area, the global pharmacovigilance market is divided into oncology, neurology, cardiology, respiratory systems, and others. The oncology segment is likely to hold the largest market share during the forecast timeline. Observation of the safety of cancer drugs is vital owing to their associated side effects, which is boosting the demand for pharmacovigilance services. The growing incidence of cancer has resulted in rising activities in R&D and clinical research.

Based on the end-use, the global pharmacovigilance market is divided into pharmaceutical companies, biotechnology companies, medical device manufacturers, and others. The biotechnology segment is likely to observe lucrative growth in the forecast period. This can be attributed to increasing product development activities in this industry. The vital owing medical information among regulatory authorities is further likely to drive the growth of this segment.

By region, the global pharmacovigilance market is segmented as North America, Europe, Asia Pacific, Middle East & Africa, and South America. The largest share of the market will be held by North America during the forecast period. The key factors that are driving market growth in the region are the presence of key pharmaceutical and medical device players in the region and growing investment in novel drug development by major players. Additionally, the largescale production of drugs calls for a number of clinical trials. Further, the need for post-marketing surveillance will increase, which will contribute to the overall market growth.

The Asia Pacific is expected to register impressive growth during the forecast period owing to the increasing awareness among patients, growing investments, and supportive government initiatives for meeting the requirements of the population.

Recent Developments:

  • In December 2019, Accenture and UCB announced the collaboration to accelerate data processing and support for improving patient safety, thus widening their footprints in respective markets
  • In January 2019, Quanticate launched QVigilance to offer dedicated pharmacovigilance (PV) and risk management services. QVigilanceis focused on supporting small and mid-sized companies transitioning from clinical trials to post-marketing and establishing compliant PV systems
  • In January 2019, IQVIA developed a SaaS safety platform designed to reduce the cost and complexity of pharmacovigilance activities and aids companies add value back into their business

What does this Report Provide?

This report provides a detailed understanding of the global pharmacovigilance demand from a qualitative and quantitative perspective with a forecast for the next 10 years. The report also provides dynamic indicators with potential impact on the market during the forecast period and an in-depth analysis of the leading companies operating in the global pharmacovigilance market.

The major market drivers, challenges, and opportunities for the global pharmacovigilance market have also been covered in the report. This report further includes the market share of the leading companies operating in the pharmacovigilance market, along with their production capacities and the growth strategies adopted by them.

Market Segmentation:

By Service Provider

  • In-House
  • Contract Outsourcing

By Clinical Trail Phase

  • Pre-Clinical
  • Phase I
  • Phase II
  • Phase III
  • Phase IV

By Method

  • Spontaneous Reporting
  • Intensified ADR Reporting
  • Targeted Spontaneous Reporting
  • Cohort Event Monitoring
  • EHR Mining

By Therapeutic Area

  • Oncology
  • Neurology
  • Cardiology
  • Respiratory Systems
  • Others

By End-Use

  • Pharmaceuticals Companies
  • Biotechnology Companies
  • Medical Device Manufacturers
  • Others

By Region:

North America Pharmacovigilance Market

  • North America, by Country
    • US
    • Canada
    • Mexico
  • North America, by Service Provider
  • North America, by Clinical Trial Phase
  • North America, by Method
  • North America, by Therapeutic Area
  • North America, by End-User

Europe Pharmacovigilance Market

  • Europe, by Country
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Rest of Europe 
  • Europe, by Service Provider
  • Europe, by Clinical Trial Phase 
  • Europe, by Method 
  • Europe, by Therapeutic Area
  • Europe, by End-User

Asia Pacific Pharmacovigilance Market

  • Asia Pacific, by Country
    • China
    • India
    • Japan
    • South Korea
    • Australia
    • Rest of Asia Pacific 
  • Asia Pacific, by Service Provider 
  • Asia Pacific, by Clinical Trail Phase 
  • Asia Pacific, by Method 
  • Asia Pacific, by Therapeutic Area
  • Asia Pacific, by End-User

Middle East & Africa Pharmacovigilance Market

  • Middle East & Africa, by Country 
    • UAE
    • Saudi Arabia
    • Qatar
    • South Africa
    • Rest of Middle East & Africa
  • Middle East & Africa, by Service Provider 
  • Middle East & Africa, by Clinical Trial Phase 
  • Middle East & Africa, by Method 
  • Middle East & Africa, by Therapeutic Area
  • Middle East & Africa, by End-User 

South America Pharmacovigilance Market

  • South America, by Country 
    • Brazil
    • Argentina
    • Rest of South America
  • South America, by Service Provider 
  • South America, by Clinical Tail Phase 
  • South America, by Method 
  • South America, by Therapeutic Area
  • South America, by End-User 

Major Companies: In this report, the following major companies are studied: Accenture, studied: Accenture, Cognizant, Laboratory Corporation of America Holdings, IBM Corporation, ArisGlobal, ICON plc., Capgemini, ITClinical, FMD K&L, IQVIA, TAKE Solutions Ltd., PAREXEL International Corporation, BioClinica Inc., Wipro Ltd., and United BioSource Corporation.

Objectives of This Report:

  • To estimate the market size for the pharmacovigilance market on a regional and global basis.
  • To identify major segments in the pharmacovigilance market and evaluate their market shares and demand.
  • To provide a competitive scenario for the pharmacovigilance market with major developments observed by key companies in the historic years.
  • To evaluate key factors governing the dynamics of pharmacovigilance market with their potential gravity during the forecast period.
  • To evaluate the leading company-wise pricing analysis for mentioned application


This study is customized to meet your specific requirements:

  • By sub-segment
  • By client specific country, type, and application market analysis
  • Pricing analysis along with the potential list of customers
  • Product specific competitive analysis

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