Pharmacovigilance Market Size and Trends

The global pharmacovigilance market is estimated to be valued at USD 7.41 Bn in 2024 and is expected to reach USD 12.80 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 8.1% from 2024 to 2031.

Pharmacovigilance Market Key Factors

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Increased outsourcing of pharmacovigilance services by pharmaceutical companies, growth in clinical trials, rising drug safety concerns, and increased adverse events in reporting are some the key factors driving the market growth. With increasing pipeline drugs, it has become essential for manufacturers to closely monitor drug safety profiles in the post marketing phase through PV activities. Moreover, the development of new biological entities compared to traditional small molecule drugs has further prompted drug safety surveillance. Growing pressure from regulatory authorities on pharmaceutical players to minimize drug related risks are further expected to contribute to the market expansion over the coming years.

The rising adoption of pharmacovigilance services by pharmaceutical companies

The adoption of pharmacovigilance services by pharmaceutical companies is growing significantly due to stringent regulations regarding drug safety. Regulatory bodies like FDA and EMA are enforcing strict norms to monitor and ensure safety of drugs post marketing. This is driving pharmaceutical companies to outsource pharmacovigilance activities to specialized Clinical Research Organizations (CROs) who have expertise and infrastructure to carry out the services effectively. Outsourcing pharmacovigilance allows drug manufacturers to focus on their core competencies of drug research and development while leaving the safety monitoring activities to experienced CRO partners. This provides pharmaceutical companies access to advanced technologies, skilled workforce and a unified global approach towards safety reporting. CROs manage large medical databases, safety reporting tools and AI/ML technologies to identifying drug risks early-on. For example, CROs like IQVIA, Parexel, and Syneos Health regularly analyze Real World data from millions of patient records to pick up subtle adverse events that may have been missed in clinical trials. For instance, in September 2021, IQVIA initiated a significant partnership with NRx Pharmaceuticals to offer pharmacovigilance services and medical information in anticipation of potential regulatory measures. Additionally, a study featured in Frontiers in Drug Safety and Regulation in February 2022 underscored the rising importance of eco-pharmacovigilance in mitigating pharmaceutical pollutants' environmental impact. This trend highlights a growing market demand for pharmacovigilance services aimed at minimizing environmental pollution caused by pharmaceutical residues.

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Increasing Stringency of Regulatory Requirements

The increasing stringency of regulatory requirements across various countries is expected to drive significant growth in the global pharmacovigilance market. With new drugs entering the market at an unprecedented rate and increasing complexity of drug safety profiles, regulatory authorities have instituted more rigorous legislation and safety standards. Pharmaceutical companies are now mandated to conduct comprehensive safety profiling of drugs right from the early stages of development along with continual monitoring even post marketing. Compliance with regulatory norms has become absolutely critical for continued drug approvals and market access. The healthcare industry has also undergone intense scrutiny in the aftermath of several high-profile drug safety issues and failures. As a result, governments are now urging greater transparency and accountability from life sciences organizations in mitigating risks and ensuring patient welfare. This has prompted drug manufacturers to strengthen in-house medical surveillance and bolster outsourcing of pharmacovigilance functions to specialized service providers. The growing regulatory oversight coupled with higher compliance workload is likely to be a key driver propelling the demand for sophisticated pharmacovigilance solutions and contract research in the coming years.