Pharmacovigilance is a study of safety and efficacy of a medical product or drug. It is a science associated with the collection, detection, assessment, and prevention of adverse effects related with the medical product or drug.
The global pharmacovigilance market is estimated to account for US$ 13,284.0 Mn in terms of value by the end of 2027.
Global Pharmacovigilance Market: Drivers
Adverse drug or vaccine reactions are expected to propel growth of the global pharmacovigilance market over the forecast period. For instance, in September 2020, AstraZeneca voluntarily paused a randomized clinical trial of its coronavirus vaccine, owing to development of an unexplained illness in a volunteer.
Moreover, increasing number of clinical trials is also expected to aid in growth of the global pharmacovigilance market. For instance, according to the U.S. National Library of Medicine, the number of clinical trials conducted in the U.S. increased from 30,978 in 2018 to 32,523 in 2019.
North America held dominant position in the global pharmacovigilance market in 2019, accounting for 37.2% share in terms of value, followed by Asia Pacific and Europe, respectively.
Figure 1: Global Pharmacovigilance Market Share (%) Value, By Region, 2019
Global Pharmacovigilance Market: Restraints
Hurdles in automating pharmacovigilance are expected to hinder growth of the global pharmacovigilance market. For instance, in September 2020, Arriello, a provider of regulatory affairs & pharmacovigilance solutions and services for life sciences, reported that while the majority of organizations professed to have implemented some form of pharmacovigilance automation, or plan to do so over the next 12 months, most lack sufficient IT insight and capability to automate adverse event case intake.
Moreover, stringent and varied regulatory approval processes are also expected to limit the market growth. Regulatory bodies are increasingly scrutinizing the safety of newly launched and established drugs in the market. The U.S. FDA, in particular, has implemented new rules and regulations to curb the growing number of adverse drug reactions through amendments such as RiskMap, the Amendments Act of 2007 and the Sentinel Initiative of 2008. The FDA Amendments Act of 2007 was especially created to fund additional safety review resources within the FDA. Furthermore, safety agencies in Europe have introduced rules and regulations in the wake of adverse drug reactions. According to the EU clinical trials directive, the failure to report adverse drug reactions during clinical trials is a criminal offence.
Pharmacovigilance Market Report Coverage
||Market Size in 2019:
||US$ 5,008.2 Mn
|Historical Data for:
||2016 to 2019
||2020 to 2027
|Forecast Period 2020 to 2027 CAGR:
||2027 Value Projection:
||US$ 13,284.0 Mn
- North America: U.S., Canada
- Latin America: Brazil, Argentina, Mexico, Rest of Latin America
- Europe: Germany, U.K., France, Spain, Italy, Russia, Rest of Europe
- Asia Pacific: China, Japan, India, Australia, South Korea, ASEAN, Rest of Asia Pacific
- Middle East: GCC Countries, Israel, Rest of Middle East
- Africa: North Africa, Central Africa, South Africa
- By Type of Clinical Trial Phases: Pre-clinical Studies, Clinical Trial Phase I, Clinical Trial Phase II, Clinical Trial Phase III, Post Marketing Surveillance or Phase IV.
- By Type of Method: Spontaneous Reporting, Intensified ADR Reporting, Targeted Reporting, Cohort Event Monitoring, EHR Monitoring.
- By Type of Service Provider: In-House , Contract Outsourcing.
Accenture Plc, Bristol-Myers Squibb, Clinquest Group B.V., Cognizant Technology Solutions, Covance, Inc., GlaxoSmithKline, ICON, Plc, iGATE Corporation, Arriello, iMEDGlobal Corporation, Diamond Pharma Services, Infosys, Ergomed plc, inVentiv Health Inc., APCER Life Sciences, ArisGlobal, and Johnson and Johnson.
- Increasing prevalence of chronic diseases
- Approval and launch of new products
|Restraints & Challenges:
The global pharmacovigilance market was valued at US$ 5,008.2 Mn in 2019 and is forecast to reach a value of US$ 13,284.0 Mn by 2027 at a CAGR of 13.0% between 2020 and 2027.
Figure 2: Global Pharmacovigilance Market Value (US$ Mn), 2016 – 2027
Market Trends/Key Takeaways
Major regulatory bodies are focused on issuing guidelines regarding pharmacovigilance. For instance, in September 2020, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance detailing post-transition pharmacovigilance procedures and requirements for having a qualified person responsible for pharmacovigilance (QPPV) and a pharmacovigilance system master file (PSMF) for U.K. authorized products.
Initiatives to promote pharmacovigilance in academics is expected to propel growth of the global pharmacovigilance market. For instance, in August 2020, Parexel International collaborated with Chitkara University, India, under which, the university will offer a 2-year M.Sc Program in Pharmacovigilance & Clinical Research.
Global Pharmacovigilance Market: Competitive Landscape
Major players operating in the global pharmacovigilance market include, Accenture Plc, Bristol-Myers Squibb, Clinquest Group B.V., Cognizant Technology Solutions, Covance, Inc., GlaxoSmithKline, ICON, Plc, iGATE Corporation. Arriello, iMEDGlobal Corporation, Diamond Pharma Services, Infosys, Ergomed plc, inVentiv Health Inc., APCER Life Sciences, ArisGlobal, and Johnson and Johnson.
Global Pharmacovigilance Market: Key Developments
Major players in the global pharmacovigilance market are focused on adopting M&A strategies to enhance their market share. For instance, in January 2020, Ergomed plc acquired Ashfield Pharmacovigilance Inc., a specialist pharmacovigilance services provider based in Cary in the Research Triangle, North Carolina (U.S.) from UDG Healthcare US Holdings, Inc.
Major players in the market are focused on adopting M&A strategies to enhance their market share. For instance, in April 2020, Diamond PV Services, the pharmacovigilance division of Diamond Pharma Services, acquired PharmaCentral, a pharmacovigilance services and medical affairs business based in Dublin, Ireland.