The global pharmacovigilance market size was estimated at USD 4.31 billion in 2018 and is anticipated to witness a CAGR of 13.3% over the forecast period. Increasing incidence of Adverse Drug Reactions (ADRs) is expected to accelerate the demand for Pharmacovigilance (PV) services.
Growing prevalence of chronic diseases is another major contributor for the growth of the market. Treatment of these chronic diseases require uptake of combination of drugs resulting in ADR. PV services are used to curb this problem. According to the statistics published in the Journal of American Medical Association (JAMA), in 2014, ADR was one of the leading causes of mortality in U.S., resulting in more than 100,000 deaths every year.
In addition, presence of nonprofit organization for spreading the awareness related to PV such as the International Society of Pharmacovigilance (ISoP) is expected to facilitate the adoption of PV during the forecast period as it is focusing on enhancing proper and safe usage of drugs at global level. Increasing government initiatives pertaining to adoption of PV services is anticipated to propel growth in the forthcoming years. For instance, the Patient Registries Initiative taken by European Medicines Agency (EMA) aiming at facilitating establishment of new registries and to make better use of the existing one.
Moreover, an upward shift in production of new drugs and presence of stringent government regulatory framework for drug safety is also responsible for propelling significant development of the pharmacovigilance market. 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 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.
On the basis of clinical trial phase, the market is categorized into preclinical, phase I, II, III, and IV markets. The Phase IV or the post marketing clinical trial segment led the market in 2018. PV 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. This factor can be attributed to intensive drug testing on large demographics patient base of highest relevance after commercialization of drug.
On the other hand, phase III segment is expected to witness lucrative growth. 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 commercialization of the drug. Aforementioned factors are expected to drive revenue generation in near future.
Contract outsourcing held the dominant market share in 2018 and is expected to witness 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), PV audits, and other customized services.
Dynamic growth of contract outsourcing segment can also be attributed to the rapidly emerging CROs providing end-to-end clinical trial solutions especially in the emerging economics from Asia Pacific, such as India, China, and Japan enabling resources sharing, cost efficiency, resource flexibility, and expansion of operative capabilities.
Outsourcing PV services are accompanied by benefits such as delivering services pertinent to highly complex regulatory requirements, help adding scalability to accommodate growing product portfolios, and help achieve aggressive cost targets. Contract outsourcing also helps reduce complexity of clinical trials, allows faster approval of trials, and helps effective utilization of internal resources.
In house segment is anticipated to witness moderate growth over the forecast period as a consequence of extensive R&D for development of new drugs by major pharmaceutical and biotechnological companies. This is expected to serve this industry with growth potential in the forthcoming years.
Spontaneous reporting held the largest market share in 2018, owing to wide usage in 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 predicted to be the fastest growing segment owing to its increasing application in detection of 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 segment. It serves as an active form of surveillance method which can also be used for new as well as older medicines, driving growth of this segment.
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 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 push the market further.
Electronic Health Record (her) 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 HER, 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.
As of 2018, 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 growth of the hospital segment over the forecast period. Increasing need for the identification of risk factors pertaining to ADRs is further anticipated to boost the growth of the segment in the forthcoming years.
Research organizations mainly include medicine information centers, academic research institutions, pharmacovigilance centers, and industry players. These organizations detect, investigate, evaluate patterns, report ADRs, and also investigate possible drug and food interactions.
Research organizations are 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 growth of this segment.
North America held the largest revenue share in 2018, 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. The aforementioned elements act as high growth rendering factors for the market in North America. Rising investment by major players in the development of new drugs, is also anticipated to propel the regional market. Consequentially, as a result of large production of drugs, number of clinical trials and need for post-marketing surveillance has increased thereby contributing to the overall market growth.
Asia Pacific is expected to register a lucrative CAGR of 15.1%, during the forecast period attributed to availability of a large number of 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 population are the factors driving the regional market growth.
The key players are Accenture, Clinquest Group B.V., Cognizant, Laboratory Corporation of America Holdings, IBM Corporation, ArisGlobal, ICON plc. Capgemini, ITClinical, iMEDGlobal, Foresight Group International AG, TAKE Solutions Ltd., PAREXEL International Corporation, BioClinica, Wipro Ltd., and United BioSource Corporation.
This market is experiencing a significant boost owing to 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 May 2017, Aris Global launched a new pharmacovigilance and safety platform suite called LifeSphere Safety, thus increasing its services portfolio.
Rising number of contract outsourcing providers is expected to elevate industry rivalry in near future. Owing to this fact, competitive rivalry for pharmacovigilance industry is expected to remain high in near future.
Base year for estimation
Actual estimates/Historical data
2014 - 2017
2019 - 2026
Revenue in USD Million and CAGR from 2019 to 2026
North America, Europe, Asia Pacific, Latin America, Middle East & Africa
U.S., Canada, U.K., Germany, 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 2014 to 2026. 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, 2014 - 2026)
Service Provider Outlook (Revenue, USD Million, 2014 - 2026)
Type Outlook (Revenue, USD Million, 2014 - 2026)
Intensified ADR Reporting
Targeted Spontaneous Reporting
Cohort Event Monitoring
End Use Outlook (Revenue, USD Million, 2014 - 2026)
Regional Outlook (Revenue, USD Million, 2014 - 2026)
Middle East and Africa
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