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Role of Pharmacovigilance for Drug Safety

Posted by Doctor Erick on Sep 20, 2017 12:56:40 PM

Pharmacovigilance is a vital factor to have a cohesive drug regulation system in place, in terms of tracking and assessing adverse drug reactions (ADRs). Pharmacovigilance encompasses a crucial role in the clinical research and it is showing humongous growth. Currently, the worldwide 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, according to a media statement by sbwire.com.

Growth of Pharmacovigilance
A 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, noted the statement. What is more, burgeoning public health awareness and expectation in relation to the safe use of medicines and medical interventions are some of the major factors contributing to the growth of the global pharmacovigilance market, the statement pointed out.

Future Market Insights (FMI) delivers key insights on the global pharmacovigilance market in its upcoming outlook titled “Pharmacovigilance Market: Global Industry Analysis and Opportunity Assessment, 2015 - 2020”. In terms of revenue, the global pharmacovigilance market is estimated to expand at a healthy CAGR of 14.2% through 2020. The global pharmacovigilance market was valued at $ 2,759.1 million in 2014 and is expected to reach US$ 6,104.1 million in 2020, expanding at a CAGR of 14.2% from 2015 to 2020.

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Post Marketing Surveillance Segment
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. According to the statement, the phase IV or post-marketing surveillance segment accounted for the largest share of the pharmacovigilance market in terms of revenue in 2013.

Drug Safety Monitoring and Evaluation
What with the increase in the number of safety concerns directly related to the marketed pharmaceutical products, growing need for developing systems for comparing safety profiles of similar drugs 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.

Projected Growth
Furthermore, the clinical trial phase III segment is projected to grow at the highest Compound Annual Growth Rate due to the heightened need for drug safety monitoring and evaluation in phase III before the drug manufacturer can apply for market authorization application, the statement said.

Methodologies
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. As per the statement, factors attributed to the growth of the segment are an easy simulation of realistic data sets that provide 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.

Pharmacovigilance Segments
Pertaining to the types of services, the pharmacovigilance market has been segmented into in-house and contract outsourcing, the statement said and added, “The contract outsourcing services segment accounted for the largest share in 2013. The segment is estimated to grow at the highest CAGR during the forecast period.”

Global Pharmacovigilance Market
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 ten leading causes of death in the U.S., noted the statement.

Fragmented Market
Stating that the global pharmacovigilance market is fragmented due to the presence of numerous established as well as emerging organizations, the statement goes on to add, that the top entities operating in the pharmacovigilance market includes 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.

According to FMI statement, these companies specialize in pharmacovigilance services and focus on market consolidation initiatives and analysis of their specific strengths, weaknesses, opportunities, and threats to strengthen their position in the market. The report has been concluded with strategic recommendations for players already present in the market and new players planning to enter the market, which could help them in the near future.

Topics: Drug Safety