Pharmacovigilance Market: Growth Drivers, Challenges and Opportunities

Published: April 2024

Pharmacovigilance is defined as the science that is associated with the assessment, collection, detection, monitoring, and prevention of adverse effects of drug-related problems. Pharmacovigilance aims to bolster drug safety surveillance, efficacy of new drugs, and identification of drug abuse. In recent years, the growing prevalence of chronic diseases has surged the demand for advanced drug formulations that help patients live a quality life. However, apart from the significance offered by pharmaceutical drugs, these therapeutic drugs may also cause several side effects; some of these may be unexpected. Hence, it is essential to evaluate, identify, comprehend, and address side effects arising from drugs. Owing to the growing requirement for pharmacovigilance, the market is witnessing technological innovations, including artificial intelligence, big data analytics, cloud-based solutions, and digitized medicine. The integration of analytical technologies and big data analytics is helpful in propelling pharmacovigilance practices to mitigate the adverse impact of drugs.

Additionally, the advancements in the development of information systems and adverse drug reaction databases enabled the reporting of data with higher accuracy that researchers can utilize for clinical studies. Further, an upward shift toward the production of advanced drug formulation and mandatory stringent regulatory frameworks for drug efficacy and safety is boosting the pharmacovigilance market. Future development in this industry includes the development of algorithms for signal detection from different sources by leveraging artificial intelligence technologies to revolutionize pharmacovigilance science with intelligent signal evaluation.

Pharmacovigilance in Clinical Research

Pharmacovigilance is a crucial process in identifying the risk of therapeutic drugs that have been developed for the treatment of disease. In clinical studies of drugs, pharmacovigilance is used to determine if the significance of drugs has overshadowed the risk. If the drug is found to pose several side effects, pharmaceutical companies have to take preventive steps to improve drug efficacy and safety profile for drug approval from the regulatory authorities such as the FDA.

Before a pharma manufacturer can seek market authorization for a new treatment, it must first conduct phase I, II, and III clinical studies. In these trials, the principal investigator is the primary point of contact at the trial site. They are in charge of doing the study and reporting the results to the sponsor (the pharmaceutical leader). During clinical trials, the research team collects and analyzes data on significant adverse events (SAEs) to determine whether the medicine in issue was the cause. If they determine that the undesirable side effects were caused, they are classified as adverse drug responses (ADRs). The investigator communicates this information with the pharmaceutical firm in charge of the drug's research and development. This is evaluated by the pharmaceutical company's in-house PV team and the patient.

The pharmaceutical validation committee decides if the medicine is sufficiently safe and effective to proceed to the next stage of clinical research or to file an application with the regulatory authorities for market approval. These regulatory bodies make the ultimate decision on whether the drug's safety and effectiveness characteristics are acceptable. If licensed, the pharma manufacturer may conduct Phase IV clinical studies to gather new information about a medicine's safety profile and efficacy. These studies are important because they give data in a less controlled setting, which is reflective of how patients use therapeutic drugs.

Importance of Pharmacovigilance

Pharmacovigilance (PV) analysis undertaken during Phase I, Phase II, and Phase III clinical trials provides pharma firms with information about the medicine's safety profile. This data can be utilized for additional research and development if necessary, or it can be submitted to regulatory authorities to gain access to emerging markets. Pharmacovigilance practices in clinical research, as well as those conducted by medical professionals and consumers, provide vital information regarding the safety profile of pharmaceuticals. When a new adverse response is discovered, the side effects list on the label should be updated. Pharmacovigilance data can sometimes result in the withdrawal of medicine from the market (drug recall) due to serious adverse effects. In addition to determining the adverse impact of drugs during clinical research, the data collected from the clinical research can identify the following things:

  • Potential therapeutic drug interactions with cellular environment and other drugs 
  • Long-term risk of therapeutic drugs 
  • Risk of drugs that result due to higher doses 
  • Potential dangers that may come from drug abuse or misuse.

The benefits offered by pharmacovigilance have mandated post-marketing drug safety surveillance, specifically phase IV studies, to track the real-world effectiveness and efficacy of the drugs, as it is challenging for pharmaceutical researchers to identify all the adverse effects of therapeutic drugs on the basis of pre approval studies. Several approaches can be taken, such as drug registries, spontaneous reporting systems, and electronic health records.

Current Pharmacovigilance Market Landscape

The current pharmacovigilance market landscape features several industrial leaders and outsourcing service providers that hold the required expertise as well as technical support for determining the efficacy and safety of drugs. With increasing cases of adverse drug reactions and growing emphasis on regulatory requirements, the pharmacovigilance market is expected to grow at an exponential rate. Key players in this domain are leveraging advanced technologies to offer a cutting-edge platform that helps to deliver adverse drug reaction reports in real time. Owing to the growing demand, several pharmaceutical companies are presently outsourcing their pharmacovigilance activities to specialized service providers. The trend will continue as it enables companies to emphasize their core competencies while benefiting from dedicated pharmacovigilance professionals. Another important aspect driving pharmacovigilance market revenue growth is the increasing occurrence of adverse drug reactions. Because of significant patient variability in pharmacokinetics and pharmacodynamic, the majority of adverse medication responses result from the extension of a drug's intended pharmacologic effects.

Adverse drug reactions are only being reported adequately if patients are aware that they must actively participate in the diagnosing or reporting process to identify drug effects at an early stage. Introducing smartphone applications and patient-friendly technologies can help patients report ADRs more effectively. Significant expenditures in drug discovery activities, a growing trend of outsourcing pharmacovigilance, and an upsurge in chronic illness incidence are all key drivers of market revenue growth. The most common kind of heart illness, coronary heart disease, is a leading cause of mortality. As a result, increased demand for therapeutic medications for the treatment of a variety of illnesses, including cancer and diabetes, has fuelled revenue growth in many countries.

Major Drivers of the Pharmacovigilance Market

In recent years, pharmacovigilance activities to understand the potential adverse drug effects gain attention due to  the increasing awareness about safer and more effective pharmaceuticals for the treatment. Moreover, the increasing support from the government and adherence to regulatory guidelines are the key drivers of the pharmacovigilance market. The market is also driven by increasing understanding on the impact of sharing accurate information about therapeutic drugs, adverse effects, and other medication information-sharing. With accurate information and proper documentation, pharmaceutical companies will be able to get approval faster to commercialize the drugs. Furthermore, the growing trend of outsourcing of pharmacovigilance services from expert providers is accelerating the drug production on the basis of customer demand is anticipated to drive the market in the upcoming years. These service providers are increasing their products to provide clients with more sophisticated alternatives.

Notably, the American Society of Pharmacovigilance, in March 2021, initiated its national awareness campaign to encourage individuals who experienced adverse drug effects to share their stories and encourage them to follow drug safety practices in the community. As a result, such helpful measures would promote the growth of the pharmacovigilance market throughout the forecast period.

Pharmacovigilance Market Restraints

Though the pharmacovigilance market is growing at a substantial rate due to increasing awareness about drug safety standards, several factors still restrain the progress of the pharmacovigilance market. Some of the potential factors include the high cost associated with the collection of sources, including rigorous technologies and data analysis tools for the prediction of data. Pharmacovigilance activities depend on the robust data quality for accurate prediction of drug effects on humans. Ensuring accuracy and integrating data from diverse resources for comprehensive safety monitoring is challenging due to limited resources.

Additionally, meeting regulatory requirements and adhering to the evolving guidelines can be a complex and time-consuming endeavor. Pharmacovigilance services provide companies with the ability to harmonize their practices with diverse regulatory frameworks and healthcare systems to get faster approval from the FDA. Some other potential challenges witnessed by the pharmacovigilance market players are listed below.

  • Identifying the potential signals from huge amounts of data collected from different sources can be a challenging process. The difficulties may rely on distinguishing true safety concerns and managing the risk of false positives that may lead to unnecessary regulatory actions.
  • Incomplete reporting and data privacy concerns pose challenges to pharmacovigilance efforts to determine the adverse effects of drugs. There is a requirement to encourage healthcare professionals and patients to report adverse reactions and ensure efficient report systems are in place.

Growing Opportunities in Pharmacovigilance Market

Despite the challenges faced by the pharmacovigilance market leaders, the field witnesses various growth opportunities that drive growth in the upcoming years. Some of the potential growth opportunities in the pharmacovigilance market are mentioned below:

  • Technological Advancements 

The widespread adoption of various technologies, including artificial intelligence and machine learning, continues to increase, which is anticipated to drive the market in the future. These technologies ensure accurate reporting by improving data efficiency and signal detection of potential safety issues.

  • Increasing Drug Pipeline

The continuous development of advanced drug formulations to mitigate the growing risk of chronic disorders across the globe has surged the requirement for robust pharmacovigilance systems. The activities ensure the monitoring of the safety and efficacy of drugs throughout the product life cycle. Furthermore, the regulatory compliance associated with drug development necessitates pharmacovigilance activities, which is anticipated to be a major growth factor that propels the market in the future.

  • Collaborations and Partnerships

The ongoing collaborations and partnerships between key players of pharmacovigilance companies and contract research services providers are driving growth in this market. These collaborations aim to leverage the technological expertise and resources to enhance pharmacovigilance capabilities

Top Players in the Pharmacovigilance Market

It is worth noting here that several players in this domain are initiating their research efforts to deliver the best pharmacovigilance services. Some of the top players that enter into collaboration to initiate the research process are listed below.

  • Accenture
  • ArisGlobal
  • BioClinica 
  • Clinquest Group B.V. (Linical Americas)
  • Capgemini
  • Cognizant
  • ClinChoice (formerly FMD K&L)
  • IBM Corp
  • ITClinical
  • ICON plc
  • Laboratory Corporation of America Holdings
  • Parexel International
  • TAKE Solutions
  • United BioSource LLC
  • Wipro

Concluding Remarks

Pharmacovigilance data collected from clinical research is essential to determine the potential risks of medications. Considering the ongoing requirement to validate drug safety, numerous approaches have been adopted, such as drug registries, spontaneous reporting systems, and electronic health records, to ensure the safety and proficiency of drugs. In the future, the pharmacovigilance services outsourcing trend will be a significant growth driver that is anticipated to drive the market. However, the primary focus will remain on meeting the complex regulatory compliance, scalability, core competencies and efficiency of technologies adopted to perform drug safety tests. The ongoing activities and future-driven approach to improving outcomes of phase IV clinical trials will drive the pharmacovigilance market.

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