Pharmacovigilance Market Analysis And Forecast To 2033: By Clinical Trial Phase (Preclinical, Phase I, Phase II, Phase III, and Phase IV), Service Provider (In-house and Contract Outsourcing), Type of Reporting (Spontaneous Reporting, Intensified ADR Repo

Pharmacovigilance Market Analysis And Forecast To 2033: By Clinical Trial Phase (Preclinical, Phase I, Phase II, Phase III, and Phase IV), Service Provider (In-house and Contract Outsourcing), Type of Reporting (Spontaneous Reporting, Intensified ADR Reporting, Targeted Spontaneous Reporting, Cohort Event Monitoring, and EHR Mining), End User (Pharmaceuticals, Biotechnology Companies, Medical Device Manufacturers, Others), And By Region

The global Pharmacovigilance Market was valued at 7.1 billion in 2023 and it is anticipated to grow up to USD 20.1 billion by 2033, at a CAGR of 10.9% during the forecast period.

Pharmacovigilance is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. Passive surveillance is the most common type of pharmacovigilance activity. It is important because it can identify previously unknown adverse events. However, it has some limitations, such as under-reporting and reporting bias. Active surveillance is less common, but it is useful for monitoring drugs that are used to treat rare conditions. Experimental studies are the most reliable way to assess the safety of a new medicine, but they are usually only conducted during the development and approval process. Pharmacovigilance is a complex and ever-changing field. It requires close collaboration between healthcare professionals, patients and the pharmaceutical industry.

Global Pharmacovigilance Market Scope and Report Structure

Market Trends and Drivers

The key drivers of pharmacovigilance (PV) market are the increasing number of clinical trials, the growing prevalence of chronic and life-threatening diseases, and the need for better patient safety.

The number of clinical trials has been increasing over the years as the pharmaceutical industry seeks to develop new and better treatments for various diseases. This has led to an increase in the number of patients being exposed to new drugs, which has in turn led to an increase in the need for PV.

The prevalence of chronic and life-threatening diseases is also a key driver of the PV market. As the population ages, the number of people suffering from chronic diseases such as cancer and heart disease is increasing. This is leading to a greater need for PV, as these patients are often taking multiple medications that need to be closely monitored for safety.

Finally, the need for better patient safety is also driving the PV market. In recent years, there have been a number of high-profile cases of patients being harmed by drugs that were not properly monitored. This has led to calls for better PV, which is helping to drive the market.

Market Restraints and Challenges

The key restraints and challenges in Pharmacovigilance (PV) market include the following:

• Lack of awareness of PV among patients and healthcare professionals: There is a lack of awareness of PV among patients and healthcare professionals. This is a challenge because it can lead to underreporting of adverse events and lack of data for safety monitoring.



• Lack of standardization: There is lack of standardization in PV, which is a challenge because it can lead to inconsistency in data collection and analysis.



• Limited resources: PV requires significant resources, which can be a challenge for many organizations.



• Lack of trained personnel: There is a lack of trained personnel in PV, which is a challenge because it can lead to errors in data collection and analysis.

COVID-19 Impact:

The evolving threat of COVID-19 infection adversely affected communities, industries, businesses, and lives worldwide. Medical monitoring and safety reporting are essential as several potential therapies are being used to treat a coronavirus-induced infection. For instance, an article published in September 2021 reported that the unprecedented speed with which vaccines are being developed has created new issues, such as post-authorization safety monitoring and vaccine safety communication. Comprehensive pharmacovigilance and active monitoring systems are required to quickly, effectively, and safely use novel vaccinations in varied populations. Thus, the rising incidence of adverse drug reactions and safety issues is anticipated to accelerate the demand for pharmacovigilance services amid the pandemic.

Global Pharmacovigilance Market Segmental Overview

The report analyses the global Pharmacovigilance Market based on clinical trial phases, service provider, types of reporting, end-user, and Region.

Global Pharmacovigilance Market by Clinical Trial Phase

Based on the clinical trail phases, the Pharmacovigilance market is divided into Preclinical I, phase I, phase II, phase III, phase IV. The phase IV (post-marketing) segment led the overall market with a dominant market share in 2023. These solutions act as an additional safety measure for the drugs undergoing clinical trials. Phase IV is an imperative stage of clinical trials as unsuspected adverse drug reactions can be detected in this stage. Therefore, the data collected and assessed during this stage is expected to be of the highest relevance owing to intensive drug testing on a large patient base of highest relevance after commercialization of the drug.

The phase III segment is expected to witness lucrative growth in the forecast period. Phase III trials are done to determine and establish the efficacy of drugs. These trials also provide additional information regarding possible drug interactions, drug safety, and effectiveness before the commercialization of the drug. The aforementioned factors are expected to boost revenue generation in the segment over the forecast period.

Global Pharmacovigilance Market by Service Provide

By service provider, the industry is bifurcated into In-house, and Contract Outsourcing. Contract outsourcing held the dominant revenue share in 2023 and is expected to witness the fastest CAGR during the forecast period. This can be attributed to the benefits associated with outsourcing such as risk mitigation, resource flexibility, reduction of upfront investments, and lower fixed costs. Contract outsourcing organizations provide solutions such as process design Standard Operating Procedure (SOP), PV audits, and other customized services.

The dynamic growth of the contract outsourcing segment can also be attributed to the rapidly emerging CROs providing end-to-end clinical trial solutions, especially in the emerging economies of Asia Pacific, such as India, China, and Japan, thereby enabling resources sharing, cost efficiency, resource flexibility, and expansion of operative capabilities. Outsourcing PV services is accompanied by benefits such as delivering services pertinent to highly complex regulatory requirements, helping to add scalability to accommodate growing product portfolios, and achieving aggressive cost targets. Contract outsourcing also helps reduce the complexity of clinical trials, allows faster approval of trials, and helps effective utilization of internal resources.

Global Pharmacovigilance Market by Type of Reporting

Based on Type of Reporting, the industry is categorized into Spontaneous Reporting, Intensified ADR Reporting, Targeted Spontaneous Reporting, Cohort Event Monitoring, and EHR Mining. Spontaneous reporting held the largest share in 2023 owing to wide usage in the detection of new, serious, and rare ADRs. Moreover, this segment serves as an efficient and inexpensive method. Wide usage of surveillance reports generated through this method by pharmaceutical industries and regulatory authorities is also responsible for the significant growth of the segment.

Cohort Event Monitoring (CEM) emerged as the second-largest segment in 2023 owing to its increasing application in the detection of a wide range of adverse clinical events. Conjugation of CEM with statistical tools and data mining systems such as longitudinal health records are responsible for the growing popularity of this type. It serves as an active form of surveillance method, which can also be used for new as well as older medicines, thus driving the segment.

Global Pharmacovigilance Market by End-user

Based on end-user, the Pharmacovigilance market is divided into Pharmaceuticals, Biotechnology Companies, Medical Device Manufacturers, and Others. In 2023, pharmaceuticals held the largest revenue share. Outsourcing the pharmacovigilance process is practiced by pharma companies to avoid high upfront investments and fixed overhead costs, increase resource flexibility, and secure additional capacity. Outsourcing pharmacovigilance proves to be a cost-effective endeavor for small and medium-sized companies.

The biotechnology segment is anticipated to witness lucrative growth in the forthcoming years owing to increasing new product development activities in this sector. In recent years, drugs are being developed and consumed at increasingly high rates. The use of drugs over longer periods by a large population can lead to adverse effects not seen in clinical trials. For instance, Vioxx (an osteoarthritic/ acute pain medication) and Avandia (an anti-diabetic) were marketed for some time before a pattern of safety problems was detected with their use. The growing need for medical information among the regulatory authorities is also anticipated to drive the segment

Geographical Analysis of Global Pharmacovigilance Market

Region-wise, it is studied across North America, Europe, Asia Pacific, and the Rest of the World. North America held a major market share for pharmacovigilance in 2023 and is expected to continue its stronghold for a few more years. Since pharmacovigilance activities are being shifted to contract research organizations (CROs) due to high costs, the pharmacovigilance approach in the United States is moving from a passive to a proactive role in the healthcare system. As per the Institute of Medicine report, by Christopher Cheney, published in March 2020, nearly 98,000 Americans died annually due to medication errors. Estimates of annual patient deaths due to medication errors have since risen steadily to 440,000 lives, which makes medication errors the country's third-leading cause of death. Therefore, there is a need to modify the current protocols for quick communication between healthcare providers and the Food and Drug Administration. Since pharmacovigilance plays a vital role in drug assessment and prevention of adverse effects, the demand for such services is likely to increase in the near future.

Major Players in the Global Pharmacovigilance Market

Market players are focusing on strategic collaborations to enhance their product offerings. Some prominent participants in the global Pharmacovigilance market include

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