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.
In addition, growing 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. Furthermore, increasing number of national pharmacovigilance centers globally is playing a definitive role in augmenting public awareness about drug safety, thereby supporting the growth of the pharmacovigilance market in the next few years. However, the pharmacovigilance market is facing several hurdles and challenges to develop a better health care system. Challenges that are acting as major restraining factors for pharmacovigilance market are web-based drug information and sales, perceptions to harm and benefit, high risk associated with data security and unavailability of skilled professionals.
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. Additionally, phase III clinical trial focuses on drug safety and efficacy in diverse sub-groups, wherein the risk-benefit ratio is developed, monitored and updated accordingly. Biopharmaceutical companies are in the process of developing advanced clinical trial phases that would be more specific to drug safety. Rigorous pharmacovigilance activities are expected to be made compulsory during the commencement of various clinical trial phases that would be helpful in actively managing high-risk medicines.
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, as in this method, healthcare professionals are encouraged to report adverse reactions after which preventive measures such as adding warnings to the product labeling or recalling the product are taken. Moreover, spontaneous reporting is the most appropriate method of detecting new ADRs and generates safety signals that require further examination.
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. The major factor driving the growth of the segment is the increasing need of pharmaceutical companies to shift focus from non-core to core business activities by outsourcing their pharmacovigilance services. Moreover, outsourcing of pharmacovigilance services is aimed at minimizing operational cost and financial loss incurred from product approval delays or recalls, thereby propelling the growth of the contract outsourcing service segment.
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. Moreover, cost benefit obtained by shifting high costs of in-house pharmacovigilance activities to CROs is boosting the growth of the market in North America. However, Asia Pacific is anticipated to witness the highest growth during the forecast period.
Factors attributed to the high growth are increased demand for stringent health care regulations in Asia, presence of large patient pool and increasing volume of clinical trials being conducted in this region. According to an article published in the National Center for Biotechnology Information in 2014, serious ADRs are witnessed in 6.7% of patients in India. Additionally, demand for effective pharmacovigilance services and drug safety in increasing in the region due to large number of clinical trials and clinical research activities being carried out in various countries in Asia.
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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