Pharmacovigilance Market Size, Share & Trends Analysis Report By Product Life Cycle, By Service Provider, By Type, By Therapeutic Area, By Process Flow, By End-use, And Segment Forecasts, 2020 - 2027

Report Overview

The global pharmacovigilance market size was estimated at USD 4.87 billion in 2019 is expected to expand at a compound annual growth rate (CAGR) of 13.2% from 2020 to 2027. 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. Thereby demand for new drug development via extensive clinical trials has increased. PV is the inevitable part of drug discovery and development procedures. Increasing incidence of Adverse Drug Reactions (ADRs) is expected to accelerate the demand for PV services.

The market is hammered by the appearance of the COVD-19 (coronavirus) pandemic. The evolving threat of COVID-19 infection is affecting businesses, communities, industries, and lives around the world. Safety reporting and medical monitoring are necessary as several potential therapies are being used to treat coronavirus induced infection. The medication like Remdesivir and other old drugs, such as Lopinavir/Ritonavir and hydroxychloroquine (HCQ), are being used/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.

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.

There is an increase in the government's effort to improve management in pharmacovigilance practices. For instance, in 2018, DIA conducted a conference addressing the risk strategies and drug safety involved in pharmacovigilance, the Patient Registries Initiative taken by the European Medicines Agency (EMA) aiming at facilitating the establishment of new registries and to make better use of the existing one. The initiatives like these are anticipated to propel growth in the forthcoming years. The presence of nonprofit organizations for spreading awareness related to PV such as the International Society of Pharmacovigilance (ISoP) is expected to facilitate the adoption as it is focusing on enhancing proper and safe usage of drugs at a global level.

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 accurate information, which can be further utilized by research professionals for prospective studies, thereby fueling the overall demand.

Product Life Cycle Insights

Phase IV or the post-marketing clinical trial segment led the overall pharmacovigilance market with a 75.56% revenue share in 2019. 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, attributed to intensive drug testing on large demographics patient base of highest relevance after commercialization of the drug.

On the other hand, the phase III segment is expected to witness lucrative growth over 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 drive revenue generation in the segment over the forecast period.

Service Provider Insights

Contract outsourcing held the dominant market share of 58.73% in 2019 and is expected to witness the fastest growth in the forthcoming years, due to the benefits associated with outsourcing such as risk mitigation, resource flexibility, reduction of upfront investments, and lowered fixed cost. Contract outsourcing organizations provide solutions such as process design Standard Operating Procedure (SOP), PV audits, and other customized services.

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 from the Asia Pacific, such as India, China, and Japan enabling resources sharing, cost efficiency, resource flexibility, and expansion of operative capabilities. Outsourcing PV services are accompanied by benefits such as delivering services pertinent to highly complex regulatory requirements, help to add scalability to accommodate growing product portfolios and help achieve 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 over 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.

Type Insights

Spontaneous reporting held the largest market share of 30.67% in 2019, owing to wide usage in the detection of new, serious, and rare ADRs and 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 market share of spontaneous reporting.

Cohort Event Monitoring (CEM) is projected to be the fastest-growing segment over the forecast period, owing to 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, driving the segment growth.

Targeted spontaneous reporting is anticipated to witness significant growth in the near future 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 over the forecast period.

Therapeutic Area Insights

The oncology segment held the largest market with a revenue share of around 25.7% in 2019. Monitoring the safety of cancer drugs is very important due to the associated side effects, which is propelling the demand for pharmacovigilance services. The drugs mostly have intrinsic biological toxicity and 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 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 till 2018. Constantly changing reporting systems and emerging technology in pharmacovigilance are driving the segment.

Process Flow Insights

Signal detection dominated the process flow segment with a revenue share of around 39% in 2019. Spontaneous Reporting Systems (SRSs) use the dominant source of signals through which the suspected cases get voluntarily reported by the healthcare professionals to the other regulatory bodies. Accurate signal detection depends on various factors such as knowledge of database, quality data, tools designed to summarize, visualize, and evaluate the data. Nowadays, Artificial Intelligence (AI) and big data are being used by the companies for better assessment of signals.

The case data management segment is expected to exhibit the fastest growth 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 2019, pharmaceuticals held the largest market share of around 43.28% in terms of revenue. 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 the clinical trials. For instance, Vioxx (an osteoarthritic/ acute pain medication) and Avandia (an anti-diabetic), marketed for some time before a pattern of safety problems were detected with their use. The growing need for medical information by the regulatory authorities is also anticipated to drive the growth of this segment.

Regional Insight

North America held the largest revenue share of around 34.30% in 2019, owing to the presence of key pharmaceutical and medical devices 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 the regional market. 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 14.9% during the forecast period attributed to the availability of various outsourcing organizations. Consequentially, there is improved productivity, cost efficiency, and resource sharing that is 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 driving regional growth.

Key Companies & Market Share Insights

The market is experiencing 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 in nature 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 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 of the prominent market players in the pharmacovigilance market include:

• Accenture

• Linical Accelovance

• 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

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2027. For this study, Grand View Research has segmented the global pharmacovigilance market based on the service provider, product life cycle, type, process flow, therapeutic area, end-use, and region:

• Service Provider Outlook (Revenue, USD Million, 2016 - 2027)

  • In-house

  • Contract Outsourcing

• Product Life Cycle Outlook (Revenue, USD Million, 2016 - 2027)

  • Pre-clinical

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• Type Outlook (Revenue, USD Million, 2016 - 2027)

  • Spontaneous Reporting

  • Intensified ADR Reporting

  • Targeted Spontaneous Reporting

  • Cohort Event Monitoring

  • EHR Mining

• Process Flow Outlook (Revenue, USD Million, 2016 - 2027)

  • 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, 2016 - 2027)

  • Oncology

  • Neurology

  • Cardiology

  • Respiratory Systems

  • Others

• End-use Outlook (Revenue, USD Million, 2016 - 2027)

  • Pharmaceuticals

  • Biotechnology Companies

  • Medical Device Manufacturers

  • Others

• Regional Outlook (Revenue, USD Million, 2016 - 2027)

  • North America

    • The U.S.

    • Canada

  • Europe

    • The U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

  • The Middle East and Africa

    • South Africa

  • Kingdom of Saudi Arabia