Drug Safety or Pharmacovigilance (PV or PhV) is a major segment in an effective drug regulation system. It deals with evaluating and monitoring Adverse Drug Reactions (ADR) to drugs before they are introduced in the market and for some time after their introduction. Annual deaths due to ADRis estimated to be over 100,000 in US and it is also one of the top 10causes of death.
Increasing drug consumption coupled with rising prevalence of chronic diseases will drive the global pharmacovigilance market size. Rising incidence of respiratory disorders, oncology, diabetes and cardiovascular ailments have increased demand for medicines. Drug safety awareness among people and WHO approved drug safety centers around the world will expand the pharmacovigilance market.
Pharmaceutical companies are increasingly collaborating with BPOs (Business Process Outsourcing) and CROs (Contract Research Organization) to identify ways to reduce operational expenses. Most companies in developed countries outsource fully or partially their pharmacovigilance activities to developing countries due to cost advantage.
US pharmacovigilance market was 1 billion USD in 2015 and is expected to exceed 2.5 billion USD by 2024. This means a growth rate of 10.7 % CAGR per year.
Drug Safety market can be categorized based on the type of clinical trials. Based on this categorization, pre-clinical trials are expected to grow at 10.3 % CAGR over the next few years. These studies are important and mandatory to collect safety and toxicity data. They are carried out before human trial is conducted. The market for Phase III trialis expected to grow at 10.9 % CAGR. This phase is mandatory for evaluating drug safety and efficacy. The Phase IV clinical trials are expected to grow at the rate of 10.9% CAGR. This phase involves continuous monitoring of adverse events after the drug is approved by regulatory authorities and introduced in the market. This phase of pharmacovigilance cycle accounted for largest share of revenue.
Based on the method of conducting pharmacovigilance, the market can be categorized into spontaneous reporting, intensified ADR reporting, targeted spontaneous reporting, cohort event monitoring, and EHR (Electronic Health Records) mining. The reason for a higher share of this segment is, it allows for easy simulation of realistic data sets for better drug evaluation and comparison. It also allows for better assessment of automatic signal generation methods. The share of spontaneous reporting category revenue was highest in 2013 and it is expected to maintain its lead in coming years. This method encourages health care professionals to report adverse reactions so that product warnings can be added to product label or the product can be recalled from the market.
Market for outsourced pharmacovigilance services will have more than 50% overall market share in the years ahead. There is increasing realization in pharma companies to concentrate on their core business activities and outsource other activities such as pharmacovigilance to specialized companies.Pharma companies benefit by outsourcing in terms of increased efficiency and reduced losses in case of delays or failures in clinical trials.
The global drug safety market is fragmented due to the presence of many reputable and emerging companies. The top companies operating in this space are BoehringerIngelheim, Accenture, Bristol-Myers Squibb, Covance, ICON, PAREXEL, Quintiles, United BioSource, Synowledge and Cognizant Technology.