What Has Been The Evolution of the Pharmacovigilance Outsourcing Market in Recent Years?
The pharmacovigilance outsourcing market has seen considerable growth due to a variety of factors.
• Recent years have seen a rapid expansion in the size of the pharmacovigilance outsourcing market. It is set to rise from $6.16 billion in 2024 to $7.24 billion in 2025, with a compound annual growth rate (CAGR) of 17.6%.
The significant growth during the historic period is a result of amplified drug development activities, strict regulatory guidelines, an increase in reported adverse drug reactions, heightened concerns about patient safety, and a surge in outsourcing by small to medium-sized enterprises.
How Will the Pharmacovigilance Outsourcing Market?
The pharmacovigilance outsourcing market is expected to maintain its strong growth trajectory in upcoming years.
• In the coming years, it's anticipated that the pharmacovigilance outsourcing market size will experience a rapid expansion. By 2029, it's projected to attain a value of $13.73 billion, growing at a compound annual growth rate (CAGR) of 17.3%.
This expected growth over the forecast period is linked to the expansion of biologics and biosimilars, an increased engagement with personalized medicine, a surge in demand for real-world evidence, rising intricacy in drug safety profiles, and a heightened focus on patient-centric care. Key trends anticipated for the forecast period include elevated utilization of big data analytics, growth in partnerships and collaborations, embracing of cloud-supported pharmacovigilance solutions, amalgamation of pharmacovigilance with digital health platforms, and innovation in specialized pharmacovigilance services for gene therapies.
Which Factors Are Boosting Growth In The Pharmacovigilance Outsourcing Market?
The growth of the pharmacovigilance outsourcing market is likely to be fueled by the escalating number of clinical trials. Clinical trials are investigative studies designed to evaluate the safety, effectiveness, and possible side effects of new drugs, treatments, or medical devices. The increase in clinical trials can be attributed to various factors such as the growing emphasis on precision medicine, rising prevalence of chronic diseases, regulatory backing, and the internationalization of research. Outsourcing pharmacovigilance in clinical trials enhances the monitoring of drug safety by utilizing specialized knowledge and resources to improve efficiency and ensure regulatory compliance. For example, the Association of the British Pharmaceutical Industry, a British trade body, reported in November 2023 that there was a slight 4.3% increase in the initiation of industry-backed clinical trials in the UK, surging from 394 trials in 2021 to 411 in 2022. Hence, the uptick in clinical trials is bolstering the growth of the pharmacovigilance outsourcing market.
What Key Areas Define The Segmentation Of The Global Pharmacovigilance Outsourcing Market?
The pharmacovigilance outsourcingmarket covered in this report is segmented –
1) By Type: Adverse Drug Reaction Capture (ADR), Case Processing, Reporting And Submission, Report Publishing, Quality Check, Risk Management, Knowledge Management, Enabling Architecture
2) By Service Provider: Contract Research Organization, Business Processing Outsourcing
3) By End User: Pharmaceutical Industry, Research Organization, Others End Users
Subsegments:
1) Adverse Drug Reaction Capture (ADR): Automated ADR Reporting Tools, Manual ADR Reporting Solutions, ADR Data Mining Software
2) Case Processing: Case Intake and Triage Services, Medical Review and Evaluation Services, Data Entry and Management Services
3) Reporting And Submission: Regulatory Reporting Services, Submission to Health Authorities, Compliance Tracking Services
4) Report Publishing: Clinical Study Report Publishing, Safety Update Report Publishing, Final Study Report Publishing
5) Quality Check: Quality Assurance Services, Audit and Inspection Services, Compliance Monitoring Services
6) Risk Management: Risk Assessment Services, Risk Minimization Strategies, Benefit-Risk Evaluation Services
7) Knowledge Management: Data Management Solutions, Pharmacovigilance Database Management, Knowledge Sharing Platforms
8) Enabling Architecture: IT Infrastructure Solutions, Data Integration Services, Technology Platform Support
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What New Trends Are Influencing The Pharmacovigilance Outsourcing Market?
Key players in the pharmacovigilance outsourcing market are honing their focus on the creation of advanced solutions, such as the cloud-based data lake platform, to streamline pharmacovigilance case administration and the management of safety data. This is done to augment clinical research registries, while also meeting necessary regulatory standards. The cloud-based data lake platform serves as a unified storage system that can securely retain and manage voluminous raw data in its original state until it needs to be used. For instance, Thermo Fisher Scientific Inc., a leading US-based firm specializing in biotechnology and laboratory equipment, rolled out CorEvidence in December 2023. This innovation was crafted to augment clinical research registries. It does this by facilitating smooth pharmacovigilance case administration, managing multiple data sources, and perfecting the coding, categorization, and reporting of adverse events. The value of this platform lies in its ability to offer scalable, compliant, and auditable safety management, boost CorEvitas clinical research registries, and offer support throughout long-term post-authorization safety studies across a multitude of therapeutic areas.
Who Are the Key Players In The Pharmacovigilance Outsourcing Market?
Major companies operating in the pharmacovigilance outsourcing market are:
• ACCENTURE PLC
• International Business Machines Corporation (IBM)
• Tata Consultancy Services
• Capgemini SE
• Cognizant Technology Solutions Corporation
• IQVIA Holdings Inc.
• Laboratory Corporation of America Holdings (LabCorp)
• Wipro Limited
• ICON PLC
• Syneos Health
• Genpact limited
• Parexel International Corp
• Veeva Systems Inc.
• Medpace Holdings Inc.
• ProPharma Group
• Pharmalex GmbH
• PrimeVigilance Ltd.
• Global Pharma Tek
• Veristat LLC
• United BioSource LLC
• Lambda Therapeutic Research
• ArisGlobal
• Biomapas
What Is The Most Dominant Region In The Pharmacovigilance Outsourcing Market?
North America was the largest region in the pharmacovigilance outsourcing market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the pharmacovigilance outsourcing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
