Pharmaceuticals

Pharmacovigilance Outsourcing Market Insights: In-Depth Look at Growth Trends, Market Size, and Opportunities for 2025-2034

2025 Market Reports Update: Market Size Forecasts to 2034, Key Trends, Leading Players, and Top Regions – Get Ahead of the Competition Today!

What External and Internal Drivers Are Contributing to the Growth of thePharmacovigilance Outsourcing Market?

The growth of clinical trials is expected to drive the growth of the pharmacovigilance outsourcing market. Clinical trials evaluate the safety and effectiveness of new drugs, treatments, or medical devices. The increase in clinical trials is attributed to the focus on precision medicine, rising chronic disease rates, regulatory support, and global research expansion. Outsourcing pharmacovigilance in clinical trials improves drug safety monitoring by utilizing specialized expertise to ensure regulatory compliance and enhance efficiency. For instance, the Association of the British Pharmaceutical Industry noted a 4.3% increase in the number of clinical trials in the UK from 394 in 2021 to 411 in 2022. Hence, the rising number of clinical trials contributes to the growth of the pharmacovigilance outsourcing market.

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#How Does the ProjectedPharmacovigilance Outsourcing Market Growth Compare Over the Forecast Period?

The pharmacovigilance outsourcing market size has grown from $6.16 billion in 2024 to $7.24 billion in 2025, with a CAGR of 17.6%. Growth is due to increasing drug development, stringent regulatory requirements, the rise in adverse drug reactions, patient safety concerns, and outsourcing by smaller companies.

The pharmacovigilance outsourcing market is expected to grow to $13.73 billion by 2029, at a CAGR of 17.3%. This growth is attributed to the expansion of biologics and biosimilars, the focus on personalized medicine, the demand for real-world evidence, more complex drug safety profiles, and a greater emphasis on patient-centric care. Key trends include big data analytics, partnerships, cloud-based pharmacovigilance solutions, integration with digital health platforms, and specialized services for gene therapies.

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Which Upcoming Market Trends and Innovations Are Set to Influence thePharmacovigilance Outsourcing Market’s Path Forward?

Companies in the pharmacovigilance outsourcing market are focusing on developing solutions like cloud-based data lake platforms to improve pharmacovigilance case processing and safety data management in clinical research registries while ensuring regulatory compliance. For instance, in December 2023, Thermo Fisher Scientific Inc. introduced CorEvidence, a cloud-based platform that enhances pharmacovigilance processes by handling various data sources and optimizing the classification and reporting of adverse events. It supports scalable, compliant, and auditable safety management, thus improving clinical research registries and facilitating post-authorization safety studies.

Who Are the Dominant Market Players Pushing the Boundaries of thePharmacovigilance 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

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What Are the Core Segments of the Pharmacovigilance Outsourcing Market, and How Do They Contribute to Growth?

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 Regions Are Dominating the Pharmacovigilance Outsourcing Market Growth?

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.

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