Pharmacovigilance and Drug Safety Software Market Size, Share & Trends Analysis Report By Functionality (Case data collection and management, Adverse event reporting and analysis, Signal detection and other safety risk assessment), By Delivery Mode (On Premise, On Demand), By End Use (Healthcare Companies, CROs/BPOs/PV service providers, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2025-2033

Pharmacovigilance and Drug Safety Software Market Size

The global pharmacovigilance and drug safety software market size was valued at USD 205.89 million in 2024 and is projected to reach from USD 221.78 million in 2025 to USD 369.57 million by 2033, growing at a CAGR of 6.8% during the forecast period (2025-2033).

Pharmacovigilance is the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs), severe adverse events (SAEs), or severe events (SEs) through a set of activities, including data collection. Pharmacovigilance and drug safety software is generally used to identify the causes of withdrawal regarding drugs and prevent unnecessary future adverse events. It is beneficial to everyone concerned with the medical process, including consumers, prescribers, and makers, for increasing the efficacy of the pharmacovigilance process, coupled with increasing drug safety.

The purpose of pharmacovigilance is to evaluate which adverse events exceed the efficacy threshold of a drug. In other words, determining which side effects are worth the risk to patients in relation to how well they treat the disease. For instance, chemotherapy is known to cause very serious side effects, but in the face of life-threatening cancer, these side effects are deemed acceptable due to the possibility of curing the patient. However, if a drug used to treat a headache resulted in similar side effects, the risk to the patient would be deemed too high, and the potential benefit would not be sufficient to justify the risk.

Pharmacovigilance And Drug Safety Software Market Drivers

Rising prevalence of adverse drug reactions

Adverse drug reactions (ADRs) remain a challenge in contemporary healthcare, especially in light of the increasing complexity of therapeutics, the aging of the population, and the rise in the prevalence of multiple diseases. The adverse effects of a drug are an essential component of drug therapy. These reactions can result in personal injury, hospital overcrowding, and an increase in health costs, thereby placing a significant strain on national healthcare systems. 3–7% of all hospitalizations are the result of adverse drug reactions (ADRs), and 10–20% of inpatients experience drug-related adverse reactions, according to global studies. Serious ADRs were found to be the fourth to sixth leading cause of death among hospitalized patients in the United States, resulting in prolonged hospitalization and a doubling of treatment costs. Therefore, the early detection and prevention of ADRs is a goal shared by healthcare teams and patients. Therefore, rising cases of adverse drug reactions will increase the demand for the global market.

Strict regulations for drug development

Pressure from government agencies such as the European Medicines Agency and the U.S. Food and Drug Administration to adhere to safety guidelines is a factor in the growing adoption of pharmacovigilance systems. The year 2021 was marked by significant fervor, discussion, and reorganization within the relevant authorities and international bodies in charge of the surveillance of pharmaceuticals as a result of COVID-19. Throughout the year, a large number of pharmacovigilance guidelines were reviewed, approved, and released. A public consultation by European Medicine Agency (EMA) was held on the third revision of Module XVI on "Risk Minimization Measures - Selection of Tools and Effectiveness Indicators" and its addendum II on Methods for Effectiveness Evaluation.

Market Restraining Factors

Lack of awareness

Because patients are unaware of adverse events, inconsistent reporting occurs (A.E.). Usually, the patient becomes anxious and reports every symptom as an adverse event (AE). However, not all adverse events (AEs) reported are necessarily serious, which forces committees in pharmaceutical companies to make poor decisions that lead to the drug's withdrawal. Low- and middle-income countries lack the necessary software, services, and training for these specialized services. Governments and pharmaceutical companies are also not doing much to promote A.E. reporting. These problems are anticipated to limit the growth of the pharmacovigilance market in low- and middle-income countries.

Market Opportunities

Increasing government policies for pharmacovigilance

Governments worldwide are implementing policies to promote the reporting of adverse drug reactions and pharmacovigilance. The Indian Pharmacopoeia Commission, which serves as the National Coordination Center (NCC) for India's Pharmacovigilance Program, prioritizes encouraging the safe use of medications (PvPI). Currently, 179 monitoring facilities for adverse drug reactions (ADRs) report ADRs to NCC. India currently contributes 3% to the global safety database, and its completeness rating is 0.93 out of 1. In order to improve patient safety, NCC is taking a number of steps, such as building capacity for monitoring and surveillance, collaborating with other national health programs and organizations to increase ADR reporting, and making sure that PvPI serves as an essential knowledge repository for Indian regulators. For instance, the U.S. government's Open FDA initiative gives application developers and scientists access to its database through open search-based programs. Another project called Mini-Sentinel was started by the U.S. to support an active surveillance system by delivering pertinent statistical data more quickly.

Regional Insights

North America: Dominant Region With 5% Market Share

North America is the s the highest contributor to the global market and is expected to grow at a CAGR of 5% during the forecast period, following the robust research & development activities on the drugs for treating severe and chronic diseases. Moreover, the rising prevalence of chronic diseases over the last two decades has increased the demand for research & development to find a cure. The growing number of cancer cases is a dire concern in this region. For instance, more than 1.7 million new cases of cancer were registered in the U.S. in 2018, according to the National Care Institute. Whereas in Canada, it was estimated that over 206,200 new cases of cancer were registered in 2017 Canada Cancer Society.

Asia-Pacific: Fastest-Growing Region With The Highest CAGR

Europe is the second leading region, and it is anticipated to grow at a CAGR of 6.2%. This can be attributed to increasing research & development activities to find a cure for several chronic diseases, including neurological disorders such as epilepsy, schizophrenia, bipolar disorders, and seizures experienced in epilepsy by pharmaceutical and biotechnology industries. For instance, over 500,000 people are living with epilepsy, with a daily incidence rate of approximately 87 people, Epilepsy Society. Moreover, rising incidences of other severe diseases, including cardiovascular diseases and arthritis, across Europe is likely to boost the demand for the global market.

Asia Pacific is witnessing significant growth in the global market on account of the rising geriatric population and increasing prevalence of chronic diseases in the region. China is experiencing swift growth in the pharmacovigilance and drug safety software market as a result of ongoing development in the pharmacovigilance, geriatric population, and prevalence of chronic diseases. For treating chronic and severe diseases such as gastrointestinal disorders, oncology, and neurology, numerous Japanese companies are investing significantly in research and development. Currently, the country has several drugs in the pipeline for treating these diseases.

The LAMEA region is emerging in the global market. This can be attributed to increasing research & development activities in the region. Moreover, the African market is struggling to pace up growth as a result of poor healthcare infrastructure and sluggish economic growth in this region. The Abu Dhabi Standard for Health Information Security and Cyber Security Standards was published by the Government of Abu Dhabi Department of Health on June 30, 2022. The Circular mandates that all medical and pharmaceutical facilities that hold a license from the DoH (the "Licensed Entities") obtain a "secure" or "safe" certificate attesting to their operation in accordance with the Standards. Licensed Entities must finish the audit process to confirm their self-certification with the Standards by December 31, 2022.

Functionality Insights

The market is bifurcated into adverse event reporting software, drug safety audits software, issue tracking software, and fully integrated software. The drug safety audits software segment is the highest contributor to the market and is expected to grow at a healthy CAGR during the forecast period, which can be attributed to its ability to monitor and track serious adverse events, serious & non-serious adverse drug reactions, and medically related product information. Moreover, the growing number of clinical trials and increasing pressure from government authorities such as the European Medicines Agency and the U.S. Food & Drug Administration (FDA) to follow and comply with safety guidelines are expected to contribute to the growing adoption of drug safety audit software. The drug safety audit software segment was valued at USD 68.36 million in 2014.

The fully integrated software segment is expected to witness a higher CAGR since the commencement of the technology. This can be attributed to its accuracy in avoiding data redundancy by eliminating errors and tracking individual case safety reports. Moreover, a rise in the demand for fully integrated software across the globe for pharmacovigilance and data safety solutions is expected to support the market growth. The fully integrated software segment was valued at USD 13.82 million in 2014 and is likely to reach USD 14.99 million by the end of 2019.

Mode of Delivery Insights

The market is bifurcated into on-premise delivery and on-demand/cloud-based (SAAS) delivery. The on-premise delivery segment is the highest contributor to the market and is expected to grow at a healthy CAGR during the forecast period as more significant pharmaceutical companies are adopting it. Installing services and solutions on computers inside an organization's walls constitutes this delivery mode. However, it can be accessed from a distance, offering the advantages of lower costs and better data security.

The on-demand/cloud-based (SAAS) delivery segment is expected to grow at a significant rate. In the upcoming years, on-demand solutions like cloud-based SaaS solutions are anticipated to grow in popularity. The segment is being driven by the growing adoption of these platforms by pharmaceutical companies and contract research organizations. The advantages of cloud-based systems include scalability, real-time data tracking, and remote access to data.

End-User Insights

The market is bifurcated into pharmaceutical and biotechnology companies, contract research organizations, business process outsourcing firms, and other pharmacovigilance service providers. The pharmaceutical and biotechnology companies segment is the highest contributor to the market and is expected to grow at a healthy CAGR during the forecast period. Pharma and biotech companies widely accept pharmacovigilance and drug safety software solutions to streamline clinical trial programs and ease the financial burden of healthcare. As a result, the segment controlled the pharmacovigilance drug safety software market in 2021. As a result of the rising trend in pharmacovigilance outsourcing, manufacturers are looking for different ways to reduce operational costs and keep costs under control by gradually moving away from being fully integrated pharmaceutical companies and toward cost-sharing arrangements with service providers. This is anticipated to accelerate the expansion of companies that conduct these tasks for pharmaceutical companies under contract.

The contact research organizations segment is expected to grow at a significant rate. Pharmacovigilance service providers offer specialized end-to-end solutions to consumers in an effort to ensure sustainability. These businesses are also implementing integrated technologies, like electronic data capture, to aggregate data from various industries and enable risk assessment.

Recent Developments

• In May 2022, APCER Life Sciences will extend Integrated Pharmacovigilance services with the Argus Cloud service of Oracle Corporation.
• In September 2022, Veeva Systems launched two new Veeva Crossix solutions to optimize omnichannel marketing.