At what pace is the pharmacovigilance outsourcing market growing, and what is its estimated value?
The pharmacovigilance outsourcing market size has grown rapidly in recent years. It will grow from $6.16 $ billion in 2024 to $7.24 $ billion in 2025 at a compound annual growth rate (CAGR) of 17.6%. The growth in the historic period can be attributed to increasing drug development activities, stringent regulatory requirements, a rising incidence of adverse drug reactions, growing patient safety concerns, and increasing outsourcing by small and mid-sized companies.
The pharmacovigilance outsourcing market size is expected to see rapid growth in the next few years. It will grow to $13.73 $ billion in 2029 at a compound annual growth rate (CAGR) of 17.3%. The growth in the forecast period can be attributed to the growth of biologics and biosimilars, the rising focus on personalized medicine, the rising demand for real-world evidence, the increasing complexity of drug safety profiles, and the growing emphasis on patient-centric care. Major trends in the forecast period include the increasing use of big data analytics, a rise in partnerships and collaborations, the adoption of cloud-based pharmacovigilance solutions, the integration of pharmacovigilance with digital health platforms, and the development of specialized pharmacovigilance services for gene therapies.
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What are the top drivers to the rising demand in the pharmacovigilance outsourcing market?
The rising number of clinical trials is expected to propel the growth of the pharmacovigilance outsourcing market going forward. Clinical trials are research studies conducted to evaluate the safety, efficacy, and potential side effects of new treatments, drugs, or medical devices. Clinical trials are rising due to several reasons, including the growing focus on precision medicine, the rising incidence of chronic diseases, regulatory support, and the globalization of research. Pharmacovigilance outsourcing in clinical trials enhances drug safety monitoring by leveraging specialized expertise and resources to ensure compliance with regulatory requirements and improve efficiency. For instance, in November 2023, according to the Association of the British Pharmaceutical Industry, a UK-based trade association, the total number of industry-sponsored clinical trials initiated in the UK increased slightly by 4.3%, rising from 394 trials in 2021 to 411 in 2022. Therefore, the rising number of clinical trials is driving the growth of the pharmacovigilance outsourcing market.
How is the pharmacovigilance outsourcing market segmented?
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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Who are the top competitors 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 significant trends should we anticipate in the pharmacovigilance outsourcing market over the forecast period?
Major companies operating in the pharmacovigilance outsourcing market are focusing on developing innovative solutions, such as a cloud-based data lake platform, to optimize pharmacovigilance case processing and safety data management processes for enhancing clinical research registries and ensuring compliance with regulatory requirements. A cloud-based data lake platform is a centralized repository that allows you to store and manage large amounts of raw data in its native format until it’s needed. For instance, in December 2023, Thermo Fisher Scientific Inc., a US-based biotechnology and laboratory equipment company, launched CorEvidence, designed to enhance clinical research registries. It is designed to streamline pharmacovigilance case processing by handling multiple data sources and optimizing the coding, classification, and reporting of adverse events. Its significance lies in providing scalable, compliant, and auditable safety management, enhancing CorEvitas clinical research registries, and supporting long-term post-authorization safety studies across multiple therapeutic areas.
Which regional trends are influencing the pharmacovigilance outsourcing market, and which area dominates the industry?
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.
What Does The Pharmacovigilance Outsourcing Market Report 2025 Offer?
The pharmacovigilance outsourcing market research report from The Business Research Company offers global market size, growth rate, regional shares, competitor analysis, detailed segments, trends, and opportunities.
Pharmacovigilance outsourcing refers to the practice of hiring external service providers to manage and conduct pharmacovigilance activities on behalf of pharmaceutical companies. These activities include detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems.
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