The global pharmacovigilance market size was estimated at USD 4.87 billion in 2019 and is anticipated to witness a CAGR of 13.2% over the forecast period. An increase in the prevalence of chronic diseases such as oncological diseases, diabetes, and cardiovascular and respiratory disorders has led to an increase in drug consumption worldwide. Thereby demand for new drug development via extensive clinical trials has increased. Pharmacovigilance is the inevitable part of drug discovery and development procedures. Increasing incidence of Adverse Drug Reactions (ADRs) is expected to accelerate the demand for these services.
The presence of a competitive environment for introducing new molecules in the market has led to a high demand for improved manufacturing operations, pharmacovigilance, clinical data management, streamlined R&D, and medical writing. Manufacturers are rapidly considering outsourcing as a viable cost curbing tool. Outsourcing helps increase internal resource flexibility, improve timelines, and gain better outcomes in the short- and long-term. It also helps achieve better pharmacovigilance through regulatory compliance, higher quality, better productivity, and improved strategic decisions.
There is an increase in the government efforts to improve management in pharmacovigilance practices. For instance, in 2018, DIA conducted a conference addressing the risk strategies and drug safety involved in pharmacovigilance, the Patient Registries Initiative taken by the European Medicines Agency (EMA) aiming at facilitating the establishment of new registries and to make better use of the existing one. Such initiatives are anticipated to propel the market growth in the forthcoming years. In addition, efforts from nonprofit organizations such as the International Society of Pharmacovigilance (ISoP) for spreading awareness regarding pharmacovigilance is expected to facilitate the adoption of the services, to encourage proper and safe usage of drugs.
Moreover, regulatory mandates on the clinical trial conduct and post-marketing vigilance are expected to spur the demand in near future. For instance, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) formulate regulatory guidelines for all phases of clinical trials. The advancements in the development of ADR databases and information systems enabled reporting accurate information, which can be further utilized by research professionals for prospective studies, thereby fueling the overall demand for pharmacovigilance.
Phase IV or the post-marketing clinical trial segment led the overall pharmacovigilance market in 2019. These solutions act as an additional safety measure for the drugs undergoing clinical trials. Phase IV is an imperative stage of clinical trials as unsuspected adverse drug reactions can be detected in this stage. Therefore, the data collected and assessed during this stage is expected to be of the highest relevance, attributed to intensive drug testing on large demographics patient base of highest relevance after commercialization of the drug.
On the other hand, the phase III segment is expected to witness lucrative growth over the forecast period. Phase III trials are done to determine and establish efficacy of drugs. These trials also provide additional information regarding possible drug interactions, drug safety and effectiveness before the commercialization of the drug. The aforementioned factors are expected to drive revenue generation in the segment over the forecast period.
Contract outsourcing held the dominant market share in 2019 and is expected to witness the fastest growth in the forthcoming years, due to the benefits associated with outsourcing such as risk mitigation, resource flexibility, reduction of upfront investments, and lowered fixed cost. Contract outsourcing organizations provide solutions such as process design Standard Operating Procedure (SOP), pharmacovigilance audits, and other customized services.
Dynamic growth of the contract outsourcing segment can also be attributed to the rapidly emerging CROs providing end-to-end clinical trial solutions especially in the emerging economies from Asia Pacific, such as India, China, and Japan enabling resources sharing, cost efficiency, resource flexibility, and expansion of operative capabilities. Outsourcing services are accompanied by benefits such as delivering services pertinent to highly complex regulatory requirements, help to add scalability to accommodate growing product portfolios and help achieve aggressive cost targets. Contract outsourcing also helps reduce the complexity of clinical trials, allows faster approval of trials, and helps effective utilization of internal resources.
The in-house segment is anticipated to witness moderate growth over the forecast period as a consequence of extensive R&D for the development of new drugs by major pharmaceutical and biotechnological companies. This is expected to drive the segment growth in the forthcoming years.
Spontaneous reporting held the largest market share in 2019, owing to wide usage in the detection of new, serious, and rare ADRs and serves as an efficient and inexpensive method. Wide usage of surveillance reports generated through this method by pharmaceutical industries and regulatory authorities is also responsible for the significant market share of spontaneous reporting.
Cohort Event Monitoring (CEM) is projected to be the fastest-growing segment over the forecast period, owing to increasing application in detection of a wide range of adverse clinical events. Conjugation of CEM with statistical tools and data mining systems such as longitudinal health records are responsible for the growing popularity of this type. It serves as an active form of surveillance method which can also be used for new as well as older medicines, driving the segment growth.
Targeted spontaneous reporting is anticipated to witness significant growth in near future owing to rising government initiatives to incorporate reporting methodologies other than spontaneous reporting by the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Moreover, the benefits associated with targeted spontaneous reporting such as lower labor costs, greater affordability, feasibility in poor resource settings, and usage in routine monitoring are expected to further fuel the market growth.
Electronic Health Record (EHR) mining is increasingly used to identify risk factors for patients after discharge from hospitals. Electronic health records are imperative sources of medical information pertaining to clinical events in hospitals and research organizations. The benefits associated with EHR, such as improved quality of care, clinical decision-making, automated access, and improvement of clinical workflow and patient management are anticipated to fuel the segment over the forecast period.
In 2019, hospitals held the largest market share in terms of revenue. Hospitals serve reporter organizations, which report the ADRs occurred during a certain time frame, to regulatory authorities to ascertain the need for post-marketing surveillance. Rising incidence of ADRs and medication errors are expected to drive the segment growth over the forecast period. Increasing need for the identification of risk factors of ADRs is anticipated to further boost the segment.
Research organizations mainly include medicine information centers, academic research institutions, pharmacovigilance centers, and industry players. These organizations detect, investigate, evaluate patterns, report ADRs, and investigate possible drug and food interactions. The research organizations segment is expected to showcase lucrative growth over the forecast period owing to the rising need to investigate ADRs and to develop corrective drug treatment, give safety signals to regulatory authorities, and spread awareness amongst patient base. Growing need for medical information by the regulatory authorities is also anticipated to drive the segment growth.
North America held the largest revenue share in 2019, owing to the presence of key pharmaceutical and medical devices players, contributing to the overall revenue in this region. Rising level of drug abuse and associated adverse drug reactions is a leading cause of morbidity and death. This acts as a high growth rendering factor for the market in North America. Rising investment in novel drug development by major players is also anticipated to propel the regional market. Consequentially, as a result of large production of drugs, the number of clinical trials and need for post-marketing surveillance has increased thereby contributing to the overall growth.
Asia Pacific is expected to register a lucrative CAGR of 14.9%, during the forecast period attributed to the availability of various outsourcing organizations. Consequentially, there is improved productivity, cost efficiency, and resource sharing that is anticipated to propel the regional demand for pharmacovigilance in the forthcoming years. Furthermore, increasing awareness among patients, rising investments, and supportive government initiatives for meeting the requirements of the population are the factors driving the regional growth.
Some of the major market players are Accenture; Linical Accelovance; 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. The market is experiencing a significant boost owing to the patent expiration of branded drugs and increasing number of new drug developments. This has attracted several local and international pharmacovigilance service providers. Presence of competitive milieu has led to improved clinical data management, pharmacovigilance, and streamlined R&D process.
The market is competitive in nature with key participants involved in continuous product development, collaborations, partnerships, and alliances to augment market penetration. For instance, in December 2019, Accenture and UCB announced the collaboration to accelerate data processing and help in improving patient safety, thereby widening their business in respective markets. Rising number of Contract Research Organizations (CROs) and increased demand for outsourcing services is expected to further fuel the competition in near future.
Base year for estimation
Actual estimates/Historical data
2016 - 2018
2020 - 2027
Revenue in USD Million and CAGR from 2020 to 2027
North America, Europe, Asia Pacific, Latin America, Middle East & Africa
U.S., Canada, U.K., Germany, France, Italy, Spain, Russia, Japan, China, India, Brazil, Mexico, South Africa, and Saudi Arabia
Revenue forecast, company share, competitive landscape, growth factors and trends
15% free customization scope (equivalent to 5 analyst working days)
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This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global pharmacovigilance market report on the basis of clinical trial phase, service provider, type, end use, and region:
Clinical Trial Phase Outlook (Revenue, USD Million, 2016 - 2027)
Service Provider Outlook (Revenue, USD Million, 2016 - 2027)
Type Outlook (Revenue, USD Million, 2016 - 2027)
Intensified ADR Reporting
Targeted Spontaneous Reporting
Cohort Event Monitoring
End-use Outlook (Revenue, USD Million, 2016 - 2027)
Regional Outlook (Revenue, USD Million, 2016 - 2027)
The Middle East and Africa
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