Pharmacovigilance Market Size, Share & Trends Analysis Report By Service Provider, By Product Life Cycle, By Type, By Process Flow, By Therapeutic Area, By End-use, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global pharmacovigilance market size was valued at USD 7.80 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 10.3% from 2023 to 2030. An increase in the prevalence of chronic diseases such as oncological diseases, diabetes, and cardiovascular and respiratory disorders has led to an increase in drug consumption worldwide. Therefore, the demand for new drug development via extensive clinical trials has increased. Pharmacovigilance (PV) is an inevitable part of drug discovery and development procedures. The increasing incidence of Adverse Drug Reactions (ADRs) is expected to accelerate the demand for PV services.

The market is positively impacted by the COVD-19 pandemic. The evolving threat of COVID-19 infection is affecting businesses, communities, industries, and lives around the world. However, safety reporting and medical monitoring are necessary as several potential therapies are being used to treat the coronavirus-induced infection. Medications such as Remdesivir and other old drugs, such as Lopinavir/Ritonavir and hydroxychloroquine (HCQ), are being repurposed to treat coronavirus infection. The chances of suspected ADRs for some of these medicines have already been submitted to the individual case safety reports database named VigiBase managed by UMC. This shows the increased demand for PV services during the pandemic.

The pandemic has also resulted in the global disruption of traditional onsite clinical trials. Hence, global regulatory bodies are actively fast-tracking clinical trials for the development of innovative solutions. One such instance is Solidarity, an international clinical trial launched by the World Health Organization (WHO) to find effective treatment against COVID-19. Increasing R&D and increasing adoption of new technologies in clinical research are further contributing to the market growth. For instance, the incorporation of virtual services in the clinical trial protocol by market players such as IQVIA and PRA Health Sciences is anticipated to propel the demand in the coming years.

The presence of a competitive environment for introducing new molecules in the market has led to high demand for improved manufacturing operations, pharmacovigilance, clinical data management, streamlined R&D, and medical writing. Manufacturers are rapidly considering outsourcing as a viable cost-curbing tool. Outsourcing helps increase internal resource flexibility, improve timelines, and gain better outcomes in the short- and long-term. It also helps achieve better pharmacovigilance through regulatory compliance, higher quality, better productivity, and improved strategic decisions.

Moreover, regulatory mandates on clinical trial conduct and post-marketing vigilance are expected to spur the demand for PV services in the coming years. For instance, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) formulate regulatory guidelines for all phases of clinical trials. The advancements in the development of ADR databases and information systems enabled reporting of accurate information, which can be further utilized by research professionals for prospective studies, thereby fueling the overall demand.

Service Provider Insights

Contract outsourcing held the dominant revenue share of over 60.0% in 2022 and is expected to witness the fastest CAGR of 10.6% for 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.

The in-house segment is anticipated to witness moderate growth in the forecast period as a consequence of extensive R&D for the development of new drugs by major pharmaceutical and biotechnological companies. This is expected to serve this industry with growth potential in the forthcoming years.

Product Life Cycle Insights

The phase IV (post-marketing) segment led the overall market with over 75.8% share in 2022. 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 of 10.5% 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.

Type Insights

Spontaneous reporting held the largest share of over 30.3% in 2022 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 2021 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.

Targeted spontaneous reporting is projected to be the fastest-growing segment in the forecast period owing to rising government initiatives to incorporate reporting methodologies other than spontaneous reporting by the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Moreover, the benefits associated with targeted spontaneous reporting such as lower labor costs, greater affordability, feasibility in poor resource settings, and usage in routine monitoring are expected to further fuel the market growth.

Electronic Health Record (EHR) mining is increasingly used to identify risk factors for patients after discharge from hospitals. Electronic health records are imperative sources of medical information about clinical events in hospitals and research organizations. The benefits associated with EHR such as improved quality of care, clinical decision-making, automated access, and improvement of clinical workflow and patient management are anticipated to fuel the segment growth in the forecast period.

Therapeutic Area Insights

The oncology segment held the largest share of over 26.9% in 2022 with the anticipated to grow at the fastest CAGR of 11.1%. Monitoring the safety of cancer drugs is very important due to the associated side effects, which is, in turn, propelling the demand for pharmacovigilance services. The drugs mostly have intrinsic biological toxicity and a narrow therapeutic window, which can lead to serious adverse reactions in the body. The increasing incidence of cancer resulted in accelerated R&D and clinical research.

Pharmacovigilance helps in the early detection and spontaneous reporting of adverse drug reactions. Moreover, recent advancements in cancer treatments, such as targeted therapy, have some serious adverse effects and can compromise a patient’s quality of life. For instance, monoclonal antibodies were listed among the top 10 entries for spontaneous ADR reports with around 406,352 records from 2014 to 2018. Likewise, according to the article published by BMC informatics in 2019, in the U.S. alone, serious ADRs contributed to more than 100,000 deaths each year and emerged as a major health concern over the past decade. Constantly changing reporting systems and emerging technology in pharmacovigilance are driving the segment.

Process Flow Insights

Signal detection dominated the market with a revenue share of over 39.9% in 2022. Spontaneous Reporting Systems (SRSs) use the dominant source of signals through which the suspected cases get voluntarily reported by healthcare professionals to the other regulatory bodies. Accurate signal detection depends on various factors such as knowledge of the database, quality data, and tools designed to summarize, visualize, and evaluate the data. Nowadays, Artificial Intelligence (AI) and big data are being used by companies for better assessment of signals.

The case data management segment is expected to exhibit the fastest growth rate over the forecast period. The adverse event information can be generated from various modes such as post-marketing programs, clinical trials, spontaneous reports, and literature.

End-use Insights

In 2022, pharmaceuticals held the largest revenue share of over 42.0%. 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.

Regional Insights

North America held the largest revenue share of over 30.0% in 2021 owing to the presence of key pharmaceutical and medical device players, contributing to the overall revenue in this region. The rising level of drug abuse and associated adverse drug reactions is a leading cause of morbidity and death. This acts as a high growth rendering factor for the market in North America. Rising investment in novel drug development by major players is also anticipated to propel regional market growth. Consequentially, as a result of the large production of drugs, the number of clinical trials and the need for post-marketing surveillance have increased, thereby contributing to the overall growth.

Asia Pacific is expected to register a lucrative CAGR of 10.8% during the forecast period owing to the availability of various outsourcing organizations. Consequentially, improved productivity, cost efficiency, and resource sharing are anticipated to propel the regional demand for pharmacovigilance in the forthcoming years. Furthermore, increasing awareness among patients, rising investments, and supportive government initiatives for meeting the requirements of the population are the factors fueling regional growth.

Key Companies & Market Share Insights

The market is witnessing a significant boost owing to the patent expiration of branded drugs and the increasing number of new drug developments. This has attracted several local and international pharmacovigilance service providers. The presence of a competitive milieu has led to improved clinical data management and has streamlined the R&D process.

The market is competitive with key participants involved in continuous product development, collaborations, partnerships, and alliances to augment market penetration. For instance, in December 2019, Accenture and UCB announced the collaboration to accelerate data processing and help in improving patient safety, thereby widening their business in their respective markets. The rising number of Contract Research Organizations (CROs) and increased demand for outsourcing services are expected to further fuel the competition in near future. Some prominent players in the global pharmacovigilance market include:

• Accenture

• Cognizant

• Laboratory Corporation of America Holdings

• IBM Corporation

• ArisGlobal

• ICON plc.

• Capgemini

• ITClinical

• FMD K&L

• IQVIA

• TAKE Solutions Ltd.

• PAREXEL International Corporation

• BioClinica Inc.

• Wipro Ltd.

• United BioSource Corporation

Pharmacovigilance Market Report Scope

Global Pharmacovigilance Market Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2017 to 2030. For this study, Grand View Research has segmented the global pharmacovigilance market report on the basis of service provider, product life cycle, type, process flow, therapeutic area, end-use, and region:

• Service Provider Outlook (Revenue, USD Million, 2017 - 2030)

  • In-house

  • Contract Outsourcing

• Product Life Cycle Outlook (Revenue, USD Million, 2017 - 2030)

  • Pre-clinical

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• Type Outlook (Revenue, USD Million, 2017 - 2030)

  • Spontaneous Reporting

  • Intensified ADR Reporting

  • Targeted Spontaneous Reporting

  • Cohort Event Monitoring

  • EHR Mining

• Process Flow Outlook (Revenue, USD Million, 2017 - 2030)

  • Case Data Management

    • Case Logging

    • Case Data Analysis

    • Medical Reviewing & Reporting

  • Signal Detection

    • Adverse Event Logging

    • Adverse Event Analysis

    • Adverse Event Review & Reporting

  • Risk Management System

    • Risk Evaluation System

    • Risk Mitigation System

• Therapeutic Area Outlook (Revenue, USD Million, 2017 - 2030)

  • Oncology

  • Neurology

  • Cardiology

  • Respiratory Systems

  • Others

• End-use Outlook (Revenue, USD Million, 2017 - 2030)

  • Pharmaceuticals

  • Biotechnology Companies

  • Medical Device Manufacturers

  • Others

• Regional Outlook (Revenue, USD Million, 2017 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K

    • Germany

    • France

    • Italy

    • Spain

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

  • Middle East and Africa

    • South Africa

    • Kingdom of Saudi Arabia