Prompted by exponential growth, a number of BPOs and CROs from across the world are looking to foray into this market, which is likely to increase the competition in the years to come.
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Pharmacovigilance is a key component of an effective drug regulation system for monitoring and evaluating adverse drug reactions (ADRs). Pharmacovigilance activities are an important part of clinical research and are growing at a significant pace.
At present, the global network of pharmacovigilance centers, harmonized by Uppsala Monitoring Centre, are operating on the global level for appropriate functioning of the process of drug safety monitoring across the world.
Large volume of international ADR reports collected in a central database would serve as a contributing factor to the effort of national drug regulatory authorities, thus improving the safety profile of drugs that would help avoid drug related disasters.
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Based on phases of drug development, the global pharmacovigilance market has been segmented into preclinical studies, clinical trial phase I, II, III and IV or post marketing surveillance. The phase IV or post marketing surveillance segment accounted for the largest share of the pharmacovigilance market in terms of revenue in 2013.
Rise in the number of safety concerns pertaining to the marketed product, increasing need for developing systems for comparing safety profiles of similar pharmaceutical products and growth in public health awareness campaigns regarding drug safety issues among the people are the major factors attributed to the high growth of the segment. In addition, the clinical trial phase III segment is expected to grow at the highest CAGR due to the rising need for drug safety monitoring and evaluation in phase III before the drug manufacturer can apply for market authorization application.
Based on methods of performing pharmacovigilance, the market has been categorized into spontaneous reporting, intensified ADR reporting, targeted spontaneous reporting, cohort event monitoring, and EHR mining. Spontaneous reporting method was the largest segment in terms of revenue in 2013.
Factors attributed to the growth of the segment are easy simulation of realistic datasets that provides better drug evaluation and comparison, and better assessment of automatic signal generation methods proposed within pharmacovigilance. The segment is also expected to maintain its lead during the forecast period from 2014 to 2020
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Based on types of services, the pharmacovigilance market has been segmented into in-house and contract outsourcing. The contract outsourcing service segment accounted for the largest share in 2013.
The segment is estimated to grow at the highest CAGR during the forecast period.
Geographically, North America accounted for the largest share of the global pharmacovigilance market in 2013. Factors attributed to the growth of the pharmacovigilance market in North America are increasing mortality rate due to ADRs and escalating patient concerns regarding the safety and efficacy of pharmaceutical products.
According to the Centers for Disease Control and Prevention (CDC), ADRs account for more than 100,000 deaths annually and are among the top 10 leading causes of death in the U.S.
The global pharmacovigilance market is fragmented due to the presence of numerous established as well as emerging organizations. The top companies operating in the pharmacovigilance market are Cognizant Technology Solutions, Accenture plc, Bristol-Myers Squibb, Covance, Inc., Clinquest Group B.V., ICON plc, F.
Hoffmann-La Roche Ltd., inVentiv Health, Inc., GlaxoSmithKline plc, iGATE Corporation, Novartis International AG, Wipro Limited, Quintiles Transnational Holdings, Inc., Synowledge LLC, Pharmaceutical Product Development, LLC, (PPD), Sanofi, PAREXEL International Corporation, Pfizer, Inc., and iMEDGlobal Corporation.
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