Pharmacovigilance outsourcing market is projected to record a significant growth rate over the coming years owing to the increased efficiency and economies of scale. Pharmacovigilance is the science of collecting, assessing, monitoring, evaluating, and researching data from healthcare providers as well as patients pertaining to the adverse effects of vaccines, medical devices, biological products, blood products or any other drug-related problem. It is generally concerned with two outcomes namely safety and efficacy.

The purpose of pharmacovigilance is to ascertain which adverse events cross the line of a drug’s efficacy. Citing an example, chemotherapy is generally known to cause serious side effects, but when met with cancer, the side-effects are deemed acceptable due to the procedure’s potential to cure the patient.

The key areas of pharmacovigilance are systems, operations, surveillance, and Qualified Person for Pharmacovigilance (QPPV). Pharmacovigilance outsourcing could help organizations in addressing the increased volume and complexity of regulatory requirements.

The task of outsourcing of pharmacovigilance provides a flexible solution to the ever-changing demands of running a specialist pharmacovigilance team. Duties which are supposed to be performed in-house are contracted out to a dedicated service provider, whether the duties are on project or partial, or on a full service basis.

One of the main elements for outsourcing is the acknowledgement from the pharmaceutical company of whether the services are outsourced, the duty to monitor the safety of the company products does not change and remains with them and any shortages which might occur in that monitoring also falls back on them as license holders or clinical trial sponsors.

The potential benefits of pharmacovigilance outsourcing could drive substantial benefits for the organization such as increased business model & capacity flexibility, and enhancing on demand access to unique expertise, intellectual property as well as multidisciplinary knowledge.

It also provides improved efficiencies and ROI, outsourcing also provides well-documented cost benefits, it also converts fixed resource costs into variable charges that are workload dependent. Lastly, it lessens the number of resources to manage, recruit or/and train.

The pharmacovigilance outsourcing market is segmented in terms of service and service provider.

With respect to service, the market is bifurcated into pre-marketing pharmacovigilance services, post-marketing pharmacovigilance services, and others. Among these, the pre-marketing pharmacovigilance services segment held a considerable revenue in 2019 and is expected to show around 15.5% CAGR over the forecast time period. Segment growth is attributed to increasing need for pre-marketing PV services owing to focus of companies on launch of novel drugs for chronic disease treatment.

Based on service provider, the market is divided into contract research organization (CROs) and business process outsourcing (BPOs). Among these, contract research organizations segment was valued at around $2.5 billion in 2019 owing to large number of small-size pharma companies outsourcing PV activities to CROs with an aim to reduce cost of setting up an entire pharmacovigilance unit and enable time management.