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- Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2022-2030

The global Pharmacovigilance market size was estimated at USD 6.40 billion in 2021 and is expected to surpass around USD 14.10 billion by 2030 and poised to grow at a compound annual growth rate (CAGR) of 10.3% during the forecast period 2022 to 2030.

Key Takeaways:

• By Product Life Cycle, the U.S. Pharmacovigilance market was valued at USD 1.20 Billion in 2021 and expected to witness growth at a CAGR of 7.9% from 2022 to 2030.
• By product life cycle, phase IV held a dominant share of over 76.0% in 2021 owing to the extensive post-marketing surveillance of pharmaceuticals and an increasing number of ADR incidences in the market
• By service provider, contract outsourcing held a significant share of over 56.0% in 2021 owing to the shift in the focus of pharmaceutical companies toward outsourcing services to reduce operational cost
• Based on type, spontaneous reporting held the largest revenue share in 2021 due to its wide application in pharmacovigilance and benefits such as easy simulation of data sets for better drug comparison
• The biotechnology companies end-use segment is anticipated to exhibit a lucrative CAGR over the forecast period owing to increasing R&D for the development of novel biologics
• Asia Pacific is anticipated to register a lucrative CAGR of 10.9% over the forecast period. This is attributed to the availability of low-cost labor and the rising number of outsourcing companies in this region
• Industry participants are focusing on increasing R&D activities to develop better pharmacovigilance services. Moreover, companies are adopting strategies including new product launches, collaborations, and mergers & acquisitions to gain a competitive advantage

The increasing incidence of Adverse Drug Reactions (ADR) is a key growth factor. ADR imposes a substantial burden on healthcare systems and is one of the prominent causes of morbidity in developed countries. According to the National Center for Biotechnology Information (NCBI), approximately 5% of total hospitalizations in Europe each year are due to ADR. Pharmacovigilance services play an integral role in this clinical trial phase by assisting manufacturers in identifying adverse effects associated with the drug.

COVID-19 has undoubtedly thrown up numerous challenges as well as opportunities for pharmacovigilance service providers. Various companies are developing innovative platforms to gain a competitive edge. For instance, in December 2020, ArisGlobal and EVERSANA declared a strategic partnership to digitally transform end-to-end pharmacovigilance services globally.

The community involved in PV procedure has been quick to respond to the pandemic. Some companies are using big data analytics against COVID-19. Thus, this refers to a depth analysis of data from multiple sources. In April 2020, Saama Technologies offered its Life Science Analytics Cloud technology platform to support the consortium creation. The purpose is to fetch data from both current and future studies to slash the time required to discover a treatment by as much as 50%. Life Science Analytics Cloud is an artificial intelligence-powered platform. This represents the scope for future developments in this market.

According to the World Health Organization's (WHO) report on pharmaceutical consumption, chronic disease medications accounted for a larger proportion of the total volume of drug consumption in non-hospital setups. Hence, there has been a significant rise in the number of medicines made available to healthcare consumers. The rising demand for drugs has significantly heightened the need for the development of novel therapeutics via extensive clinical trials, which is expected to serve this market with lucrative opportunities.

Moreover, leading pharma companies in developed countries are focusing on outsourcing PV services to reduce costs and minimize operational expenses. This is anticipated to provide an opportunity to contact research organizations in developing regions to gain more revenue share. Manufacturers are now focusing on remodeling their product development processes in an attempt to cater to patient needs across the globe. These factors are anticipated to fuel the demand for pharmacovigilance services during the forecast period.

The companies operating in the market are undertaking strategic initiatives, such as collaborations with PV service providers to gain access to medical information and manage PV workflows. For instance, In October 2021, The Whiteboard, an academy for training specialists in the clinical trials and drug development field, proclaimed a partnership with OviyaMedSafe, a worldwide drug safety service and pharmacovigilance consulting corporation.

Similarly, in September 2019, Accenture collaborated with Bayer to implement the company's INTIENT Clinical platform to simplify and speed up its drug development processes, thereby widening its business. The company collaborated with BioCelebrate in the past to develop a platform for aggregating and analyzing clinical information for improving the efficiency of drug development, thus enhancing its R&D capabilities. Such initiatives help companies maintain their position and thereby support the market growth.

Report Scope of the Pharmacovigilance Market

Service Provider Insights

Contract outsourcing held the dominant revenue share of over 56.0% in 2021 and is expected to witness the fastest growth 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 76.0% share in 2021. 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.

Type Insights

Spontaneous reporting held the largest share of over 31.0% in 2021 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 26.0% in 2021. 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 36.0% in 2021. 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 2021, pharmaceuticals held the largest revenue share of over 41.0%. 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 31.0% 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 10.9% 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.

Some of the prominent players in the 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

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 2017 to 2030. For this study, Nova one advisor, Inc. has segmented the global Pharmacovigilance market

Pharmacovigilance Product Life Cycle

• Pre-clinical
• Phase I
• Phase II
• Phase III
• Phase IV

Pharmacovigilance Service Provider

• In-house
• Contract Outsourcing

Pharmacovigilance Type

• Spontaneous Reporting
• Intensified ADR Reporting
• Targeted Spontaneous Reporting
• Cohort Event Monitoring
• EHR Mining

Pharmacovigilance Process Flow

• 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

Pharmacovigilance Therapeutic Area

• Oncology
• Neurology
• Cardiology
• Respiratory Systems
• Others

Pharmacovigilance End-use

• Pharmaceuticals
• Biotechnology Companies
• Medical Device Manufacturers
• Others

By Geography

North America

• U.S.
• Canada

Europe

• Germany
• France
• United Kingdom
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Southeast Asia
• Rest of Asia Pacific

Latin America

• Brazil
• Rest of Latin America

Middle East & Africa (MEA)

• GCC
• North Africa
• South Africa
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