PUBLISHER: IMARC | PRODUCT CODE: 1540794
PUBLISHER: IMARC | PRODUCT CODE: 1540794
The global pharmacovigilance market size reached US$ 7.9 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 15.9 Billion by 2032, exhibiting a growth rate (CAGR) of 7.8% during 2024-2032. The increasing prevalence of adverse drug reactions (ADRs), coupled with the launch of favorable policies by government bodies to generate awareness about the proper usage of medicines and conduct clinical trials, is primarily stimulating the pharmacovigilance market growth.
Major Market Drivers: The elevating incidences of various lifestyle diseases, including cardiac disorders, hypertension, diabetes, etc., are augmenting the usage of drugs across the globe. Consequently, there is an elevating need for pharmacovigilance (PV) to detect previously unknown adverse effects, recognize changes in the frequency or severity, assess the risks and benefits of drugs to determine required actions, etc. This, in turn, is providing significant opportunities in the pharmacovigilance market outlook.
Key Market Trends: One of the key pharmacovigilance market trends includes the development of advanced platforms to ensure automated adverse drug reactions (ADR) reporting. Furthermore, key players are also focusing on enhancing manufacturing operations and streamlining R&D activities, owing to the competitive environment. Besides this, the rising number of clinical trials is expected to fuel the pharmacovigilance market in the forecasted period.
Competitive Landscape: Some of the prominent pharmacovigilance market key players are Accenture plc, ArisGlobal LLC, BioClinica Inc. (Cinven Partners LLP), Capgemini, Cognizant, International Business Machines Corporation, ICON plc., IQVIA Inc., ITClinical, Parexel International Corporation, and Wipro Limited, among many others.
Challenges and Opportunities: According to the pharmacovigilance market analysis, some of the challenges, including stringent regulatory requirements by government bodies, the rising complexities in managing and deriving meaningful insights from a vast amount of data, and the increasing need for balancing comprehensive drug safety monitoring with the pressure to control costs, are hindering the growth of the pharmacovigilance industry across the globe. However, fostering strategic collaborations to ensure the safety of drugs and safeguard public health is expected to propel the pharmacovigilance market share in the coming years.
The Development of Continuous Technological Advancements
The increasing integration of novel technologies, such as machine learning (ML), natural language processing (NLP), artificial intelligence (AI), big data analytics, etc., is enhancing the pharmacovigilance processes. In line with this, these technologies are gaining extensive traction, as they help in identifying adverse events, risk assessments, enabling efficient signal detection, etc., which is expected to fuel the market growth over the forecasted period. For instance, Sanofi and Deloitte collaborated on ConvergeHEALTH Safety, a next-generation artificial intelligence (AI) software-as-a-service adverse events case intake platform that transformed pharmacovigilance (PV) processes and addressed some of the industry's most pressing operational safety issues. In line with this, ArisGlobal introduced the go-live of the USFDA Adverse Event Reporting System (FAERS II), an electronic safety reporting platform powered by LifeSphere MultiVigilance, which propelled the market growth. Furthermore, Saama Technologies Inc. developed the new Active Safety Analytics for Pharma (ASAP) products. ASAP is one of the first validated pharmacovigilance solutions to leverage the TreeScan methodology and the United States Food and Drug Administration's (FDA) Sentinel Common Data Model for detecting safety signals.
Stringent Regulations Implemented by Government Bodies
Government authorities across the globe are implementing strict rules in clinical trials and generating awareness regarding the proper utilization of medicines, which is stimulating the usage of pharmacovigilance services. For example, according to a study published in Frontiers in Drug Safety and Regulation, the significance of post-marketing medication evaluation is important for characterizing drug safety profiles in real-world settings. Such studies are further increasing the importance of pharmacovigilance, thereby stimulating the market growth. Moreover, Aurobindo Pharma USA reformulated Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, owing to the presence of N-Nitroso-Quinapril and Nitrosamine Drug Substance Related Impurity (NDSRI). Consequently, the inflating need for medical information among regulatory authorities is expected to fuel the market growth over the forecasted period.
The Rising Adoption of Pharmacovigilance Services by Pharmaceutical Companies
Pharmacovigilance services are extensively adopted by key pharmaceutical companies across the globe, owing to benefits, such as better outcomes over shorter periods and increasing internal resource flexibility. For example, according to the Vaccine Adverse Event Reporting System, 10 cases of anaphylaxis were detected after the administration of a reported 4,041,396 first doses of the Moderna COVID-19 vaccine (2.5 cases per million doses). Consequently, the growing need for pharmacovigilance services is also stimulating the market growth. In addition to this, key industry players are also entering into strategic collaborations, which will continue to propel the pharmacovigilance market over the forecasted period. For example, IQVIA entered into a strategic collaboration with NRx Pharmaceuticals to offer medical information and pharmacovigilance services in preparation for potential regulatory actions.
The Growing Number of Advanced Clinical Trial Phases
To enhance the efficacy of clinical trials, major prominent players are developing advanced clinical trials, which are stimulating the global market for pharmacovigilance. For example, Cognizant entered into a partnership with Medable Inc. to jointly deliver clinical research solutions based on Medable's software-as-a-service platform for decentralized clinical trials. In line with this, according to the pharmacovigilance market overview, Viedoc and LINK Medical entered into a partnership established by Viedoc. The collaboration was designed to enhance trial efficiency for LINK Medical and its clients. The partnership allowed for the exchange of needs, experience, ideas, etc., and the testing of new features.
IMARC Group provides an analysis of the key trends in each segment of the global pharmacovigilance market report, along with forecasts at the global, regional, and country levels from 2024-2032. Our report has categorized the market based on service provider, product life cycle, type, process flow, therapeutic area, and end use.
In-house
Contract Outsourcing
The report has provided a detailed breakup and analysis of the market based on the service provider. This includes in-house and contract outsourcing.
Pre-clinical
Phase I
Phase II
Phase III
Phase IV
A detailed breakup and analysis of the market based on the product life cycle has also been provided in the report. This includes pre-clinical, Phase I, Phase II, Phase III, and Phase IV.
Spontaneous Reporting
Intensified ADR Reporting
Targeted Spontaneous Reporting
Cohort Event Monitoring
EHR Mining
The report has provided a detailed breakup and analysis of the market based on the type. This includes spontaneous reporting, intensified ADR reporting, targeted spontaneous reporting, cohort event monitoring, and EHR Mining.
Case Data Management
Case Logging
Case Data Analysis
Medical Reviewing and Reporting
Signal Detection
Adverse Event Logging
Adverse Event Analysis
Adverse Event Review and Reporting
Risk Management System
Risk Evaluation System
Risk Mitigation System
The report has provided a detailed breakup and analysis of the market based on the process flow. This includes case data management (case logging, case data analysis, medical reviewing and reporting), signal detection (adverse event logging, adverse event analysis, and adverse event review and reporting, and risk management system (risk evaluation system and risk mitigation system).
Oncology
Neurology
Cardiology
Respiratory Systems
Others
The report has provided a detailed breakup and analysis of the market based on the therapeutic area. This includes oncology, neurology, cardiology, respiratory systems, and others.
Pharmaceuticals Companies
Biotechnology Companies
Medical Device Companies
Others
The report has provided a detailed breakup and analysis of the market based on the end-use. This includes pharmaceuticals companies, biotechnology companies, medical device companies, and others.
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa.
Accenture plc
ArisGlobal LLC
BioClinica Inc. (Cinven Partners LLP)
Capgemini
Cognizant
International Business Machines Corporation
ICON plc.
IQVIA Inc.
ITClinical
Parexel International Corporation
Wipro Limited
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
March 2024: The American Society of Pharmacovigilance (ASP), along with several partners, is focused on advancing drug safety via minimizing ADEs, the fourth leading cause of death in the United States.
February 2024: The Indian Pharmacopoeia Commission (IPC) released the Draft Pharmacovigilance Guidance Document for pharmaceutical products for its latest Version 2.0. The Commission also offered suggestions from Marketing Authorization Holders (MAHs) on the draft document.
February 2024: The US Food and Drug Administration (FDA) Office of Surveillance and Epidemiology (OSE) launched the standardization of Risk Evaluation and Mitigation Strategies (REMS) data to facilitate its use.