Pharmacovigilance Market Listing Product Drawbacks 2025

Global Pharmacovigilance Market: Snapshot

Pharmacovigilance (PV) is a process refereeing to the detection, collection, prevention, and monitoring of negative effects that may occur because of the use of pharmaceutical products and other drugs. PV services cater to a wide range of drug related activities such as discovery of a drug to its commercialization. It also helps with the utilization of tools and software that reviews, classifies data on drugs and pharmaceutical products. There has been a soaring demand for pharmacovigilance services due factors such as rising drug consumption, growing prevalence of chronic diseases, respiratory disorders, and cancer symptoms, among others. In addition to this, a large number of adverse drug reactions (ADRs) has added a substantial burden on healthcare sector leading to the increased demand for pharmacovigilance.

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The global pharmacovigilance market is expanding at a swiftly. Many leading pharmaceutical and IT companies are strategically collaborating and actively promoting pharmacovigilance software to bolster their market contribution. There are extensive post-market controlling mechanisms set up by multiple government supervisory agencies that concentrates on safety and efficiency of the various pharmaceutical products after they are pitched in the market. The governments have also established centers to enhance the pharmacovigilance services. For instance, Indian Pharmacopoeia Commission (IPC) has aimed to assign around 40 pharmacovigilance officials across the country to coordinate with various ADR centers and strengthen reporting and monitoring of ADR activities. Increased mortality rate because of ADRs and rising awareness among patients about the safety and efficiency of the drugs are expected to be the significant driving factors for the growth of the global pharmacovigilance market.

Global Pharmacovigilance Market: Overview 

Pharmacovigilance (PV) is a scientific process pertaining to the collection, detection, monitoring, and prevention of adverse effects that may arise due to use of drugs and pharmaceutical products.

Pharmacovigilance services cater to drug development activities ranging from its discovery to commercialization and consist of tools and software that helps in reviewing, classifying, creating, and other data. PV occupies a critical role in drug regulation system that helps in comprehensive monitoring and evaluation of adverse drug reactions (ADRs). Increasing instances of ADR cause an extension of patient morbidity, increase hospitalization fees, and thus pose a significant burden on any responsive healthcare system. These factors stimulate the demand for pharmacovigilance services worldwide and contribute to the expansion of the market. Several pharmaceutical companies prefer collaborating with BPOs and contract research organizations (CROs) for pharmacovigilance services to bring down the cost and augment the operational efficiency.

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Global Pharmacovigilance Market: Trends

The global pharmacovigilance market is primarily driven by the rising incidence of ADR, soaring patient awareness regarding safety of drugs, and stringent regulations by various agencies related to drug approvals. Strict guidelines related to clinical trials of new drug therapies and mandatory requirements to keep electronic medical records (EMR) have propelled the growth of the PV market. Initiatives taken by renowned regulatory agencies, such as the FDA and European Medicines Agency (EMA), and global organizations such as the WHO have mounted pressures on several biotechnology and pharmaceutical companies to manufacture safe drugs. This is expected to stimulate the demand for pharmacovigilance.

Furthermore, the rising trend of outsourcing of PV services to BPOs and CROs has resulted in effective drug regulation system. These outsourcing entities offer pharmacovigilance services that have high regulatory compliance, enhanced productivity, and better strategic outcomes, thus boosting the global PV market. However, concerns of patient data safety, rise in web-based sale of drugs, and lack of expertise are the key factors that may impede the growth of the market to some extent. Nevertheless, the rising number of clinical trials, particularly phase 3 and phase 4 clinical trial will unlock abundant opportunities for the market players.

Global Pharmacovigilance Market: Market Potential 

The global pharmacovigilance is growing at a rapid pace. Intense post-market monitoring mechanisms set up by various government regulatory agencies increasingly focus on safety and efficacy of pharmaceutical products after they are launched in the market. This has led to a flurry of PV activities and procedures. Various coordination initiatives between national agencies, healthcare providers, and regional pharmacovigilance centers in several countries such as France, China, India, Romania, and Turkey have put the onus on pharmaceutical companies to collect and assess information relating to adverse drug effects. Subsequently, effective measures can be taken to prevent and mitigate the risks.

Furthermore, governments in various countries have created centers to expand PV services. For instance, Indian Pharmacopoeia Commission (IPC) has intended to appoint as many as 40 district product safety pharmacovigilance officials in the country; these officials will coordinate with different ADR centers to strengthen the monitoring and reporting of ADR activities. These initiatives are expected to provide a robust boost to the market across the region.

Global Pharmacovigilance Market: Regional Outlook 

The pharmacovigilance market in the U.S. held a prominent share in 2016 and the regional market is expected to rise at healthy CAGR during the forecast period. The growth is attributed to the rising mortality rates due to ADR and soaring awareness of patients on safety and efficacy of drugs. Asia Pacific is expected to expand at positive CAGR in the next five years. Growth witnessed in the region will be driven by stringent health care regulations, vast geriatric base, intense government initiatives to set up PV centers, and rising number of clinical trials conducted. 

Global Pharmacovigilance Market: Competitive Landscape 

Major technology and IT companies are actively launching pharmacovigilance software to strengthen their market shares. Pharmaceutical and life sciences companies are forming strategic collaborations with key contract research organizations (CRO) to expand their market presence in various regions. This has also enabled them to gain a better foothold in major regions by effectively positioning their services to new clients. Major players operating in this market include Accenture, Boehringer Ingelheim, Bristol-Myers Squibb, ICON, Covance, PAREXEL, Quintiles, Synowlwedge, Cognizant Technology Solutions Corporation, and United BioSource.

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