Pharmacovigilance Market Size By Clinical Trial Phase (Preclinical, Phase I, Phase II, Phase III, Phase IV), By Service Provider (In-house, Contract outsourcing) Industry Analysis Report, Regional Outlook (U.S., Canada, UK, Germany, Spain, Italy, France, China, Japan, India, Australia, Argentina, Brazil, Mexico, South Africa, Saudi Arabia, UAE, Qatar), Application Potential, Price Trends, Competitive Market Share & Forecast, 2016 – 2024
Published Date: December 2016 | 111 Pages | Report ID: GMI853 Report Format: PDF
Pharmacovigilance Market Size was valued at over USD 3 billion in 2015 and will exceed USD 8 billion by 2024.
U.S. Pharmacovigilance Market size, by service provider, 2012- 2024 (USD Million)
Increasing drug consumption coupled with rising chronic diseases prevalence will drive global pharmacovigilance market size. Over 6.4 billion drugs were dispensed in 2010 in the U.S alone. Rising prevalence of cardiovascular diseases, respiratory disorders, oncology and diabetes have increased global demand for medicine.
Increasing number of adverse drug reactions (ADRs) imposes a significant burden on healthcare system by extending patient morbidity under chronic condition. Adverse drug events accounted for over 5% of annual hospitalization cases. This has led to soaring demand for pharmacovigilance services, thus expanding the global pharmacovigilance market size.
Pharmacovigilance services cater to drug development activities ranging from its discovery to commercialization. Pharmaceutical companies are increasingly collaborating with BPOs and CROs to identify ways for reduction of cost and operational expenses. Outsourcing helps achieve better monitoring through regulatory compliance, higher quality, better productivity, and improved strategic outcomes, thus propelling overall pharmacovigilance market growth.
Stringent regulations regarding drug safety approvals and mandatory clinical trials management guidelines should boost adoption rate of pharmacovigilance activities. Furthermore, strict requirements for keeping electronic medical records (EMR) will fuel pharmacovigilance market trends.
Increasing patient awareness regarding drug safety and creation of WHO approved national pharmacovigilance centers worldwide will support expansion of pharmacovigilance market size. However, risks associated with data security, web-based drug sales, information about drug side effects, and dearth of skilled professionals should restrain pharmacovigilance market growth.
Pharmacovigilance Market, By Clinical Trial
Pre-Clinical trial will witness a sustainable 10.3% growth, with target market size slated to exceed USD 84 million by 2024. These studies are very critical and are mandatorily required before human clinical trials to collect safety and toxicity data in support of the new treatment.
Phase III clinical trial should grow from over USD 492 million in 2015 to over USD 1,254 million by 2024, witnessing 10.9% CAGR from 2016 to 2024, owing to growing need for drug safety monitoring and evaluate drug efficacy based on risk-benefit ratio.
Phase IV clinical trial market size was over USD 2.4 billion in 2015, growing at 10.9% from 2016 to 2024, owing to increasing drug safety concerns and growing public health awareness about adverse drug events. It aims at continuous safety surveillance through adverse event monitoring as long as a product is marketed.
Pharmacovigilance Market, By End User
Contract pharmacovigilance outsourcing market size held over 50% of revenue share in 2015, slated to exceed USD 4.8 billion by 2024. Increasing focus of pharmaceutical firms towards core business activities by outsourcing pharmacovigilance related services to specialized firms will drive segment growth. Contract outsourcing will minimize operational cost along with reduction of economic losses associated with drug approval delays and failure of clinical trials.
In-house pharmacovigilance market size was over USD 1.5 billion in 2015, with expectations to reach over USD 3 billion by 2024. Growing demand for effective data management and maintenance of clinical trial information confidentiality by major biotechnology and pharmaceutical companies will fuel business growth.
Pharmacovigilance Market, By Region
U.S. pharmacovigilance market size was valued over USD 1 billion in 2015, and predicted to witness 10.7% CAGR from 2016 to 2024 to surpass USD 2.5 billion by 2024. Rising mortality rates owing to adverse drug events and growing patient concerns pertaining to safety and efficacy of drugs will drive industry growth.
APAC pharmacovigilance market size was USD 835 million in 2015 and anticipated to exceed USD 2.4 billion by 2024. Growing demand for strict health care regulations, presence of huge patient base and increasing number of clinical trials conducted will boost regional pharmacovigilance market share.
Europe pharmacovigilance market size was valued over USD 793 million in 2015, with expectations to reach USD 1.8 billion by 2024, witnessing 9.9% CAGR from 2016 to 2024, owing to growing demand for personalized medicines and increasing level of competition from biosimilars and generics.
Competitive Market Share
Major industry players include Boehringer Ingelheim, Accenture, Bristol-Myers Squibb, Covance, ICON, PAREXEL, Quintiles, United BioSource, Synowlwedge and Cognizant Technology Solutions Corporation.
Strategic collaborations with contract research organizations (CRO), mergers and acquisitions, and providing customized services are key sustainability strategies adopted by key industry players.
Companies in developed countries usually outsource, all or partial of their pharmacovigilance services to specialized firms in developing countries, owing to their quality and cost effectiveness.
Pharmacovigilance Industry Background
Pharmacovigilance is a major segment of an effective drug regulation system for evaluating and monitoring adverse drug reactions (ADRs). As per CDC, ADRs account for over 100,000 deaths per annum and are amongst the top ten foremost causes of death in the U.S. Currently, the global network of pharmacovigilance centers, coordinated by Uppsala Monitoring Centre, are working on the international level for proper functioning of the progression of drug safety monitoring worldwide.
Preclinical and clinical trials test the potentiality of medicinal therapeutic efficacy of pharmaceutical products on animals and cells. The information about unseen safety issues of drugs is seen only after repeated practice in real world by large and varied population over the period. Therefore, the data collected and evaluated after phase III trial will be of the highest significance. It acts as an additional safety measure for the drug undergoing clinical trials.
Post marketing surveillance monitors the drug safety, efficacy and evaluates long term effects of treatment on greater number of patients for a considerable amount of time. Drug safety profile is evaluated through spontaneous adverse event monitoring in uncontrolled environment.
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