Increasing incidence rates of ADR (adverse drug reaction) clubbed with the introduction of stringent government policies pertaining to drug safety regulations are some key factors expected to drive the pharmacovigilance market. Pharmacovigilance is referred as an act of collection, detection, reporting and monitoring of adverse drug reaction. The global pharmacovigilance market was valued at USD 2,408.0 million in 2013 and is expected to grow at a CAGR of 12.6% during the forecast period. ADR represents a substantial burden on healthcare systems and is one of the prominent reasons of morbidity in developed countries. Approximately 5% of total hospitalizations in a year are due to ADR which makes reporting and preventing of the same a notable growth fueling factor for this market. Growing prevalence of chronic disorders coupled with rising geriatric population base has heightened the need for new drug development. With an upsurge in the drug production, regulatory authorities such as the U.S. FDA and EMEA (European Medicines Agency) have intensified drug safety regulations prior and post commercialization. Growing complexity of drug safety regulations is thus, expected to boost market growth during the forecast period. Additionally, there is an additional pressure from the regulators for electronic submission especially in European countries which would further accentuate the demand for this market in this region.
Global pharmacovigilance market, by clinical trials, 2012 – 2020 (USD Million)
Clinical Trial Insights
Pharmacovigilance market is estimated and analyzed with reference to clinical trial phase in this study including preclinical, phase I, phase II, phase III, and phase IV markets. Pharmacovigilance found the largest application in phase IV clinical trial studies in 2013. The information about hidden safety issues of drugs surfaces only after repeated usage in the real world by the large and diverse population over the period. Therefore, the data collected and assessed post phase III trial is expected to be of the highest relevance. Pharmacovigilance acts as an additional safety measure for the drug undergoing clinical trials. Phase III clinical trials market was the second largest and was valued at over USD 750.0 million in 2013.
Service Provider Insights
Service provider segments analyzed in this report include in-house and contract outsourcing. Contract outsourcing was the leading segment in 2013, accounting for over 50.0% of the market. Its large share is attributed to by the benefits attached to outsourcing such as reduction in fixed cost, risk mitigation, resource flexibility and reduction of upfront investments. Outsourcing providers render solutions such as PV audits, process design, SOP and other customized services.
North America was the largest consumer of the pharmacovigilance market in 2013. Drug safety approval regulations imposed by the U.S. FDA and other regulatory authorities coupled with increasing pressure for maintaining electronic medical records (EMR) is expected to drive regional market growth over the next six years. Additionally, the presence of high patient awareness levels and usage rates of advanced services in the region are expected to boost market growth. Europe was the second largest consumer of pharmacovigilance services in 2013. Asia Pacific pharmacovigilance market is expected to witness the fastest growth during the forecast period. Availability of large pool of educated and cost-effective labor force, the presence of favorable business environment and the implementation of government initiatives aimed at improving healthcare access are some factors accounting for its rapid growth. Statistics suggest that cost associated with clinical trials conducted in the Asia Pacific region is approximately 50% to 70% cheaper than that of trials conducted in European countries.
Major players of the pharmacovigilance market include Quintiles Transnational Corporation, Accenture Plc., Boehringer Ingelheim GmbH, Bristol-Myers Squibb, PAREXEL International Corporation, Janssen Research & Development, LLC, Pharmaceutical Product Development, Inc., United BioSource Corporation, Synowlwedge LLC, Cognizant Technology Solutions Corporation, Covance Inc. and ICON, Plc. Mergers and acquisitions, entering into strategic collaborations with contract research organizations (CRO) and providing customized services are some key sustainability strategies adopted by these market players. For example, Accenture Plc., in an attempt to expand its service base pertaining to pharmacovigilance, launched accelerated R&D services focusing on delivery of streamlined and integrated functions helpful in effective product development and entered into a partnership agreement with Oracle partner network.
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