Global pharmacovigilance outsourcing Market
Pharmaceuticals

How is the Pharmacovigilance Outsourcing Market Poised for Growth: Trends and Opportunities Through 2034

Updated 2025 Market Reports Released: Trends, Forecasts to 2034 – Early Purchase Your Competitive Edge Today!

What is the Predicted Annual Growth Rate of the Pharmacovigilance Outsourcing Market Over the Coming Decade?

In recent times, the pharmacovigilance outsourcing market has seen a swift expansion. It is set to progress from $6.16 billion in 2024 to $7.24 billion in 2025, showcasing a compound annual growth rate (CAGR) of 17.6%. The historic expansion can be linked to an upsurge in drug development undertakings, stringent regulatory necessities, a heightened occurrence of detrimental drug reactions, growing concerns about patient safety, and a rise in outsourcing by small to medium-sized firms.

The section of the industry that outsources pharmacovigilance is likely to experience a swift growth spurt in the coming years, growing to $13.73 billion in 2029, with a compound annual growth rate (CAGR) of 17.3%. The predicted growth during forecasted time frame can be linked to the rise of biologics and biosimilars, the enhanced focus on custom-made medicine, the increased need for evidence derived from real-world scenarios, the rising intricacy of drug safety databases, as well as the expanded focus on care centered around the patient. Key trends anticipated during this forecast period consist of the heightened utilization of large scale data analytics, more partnerships and collaborations, the application of cloud-based pharmacovigilance solutions, the amalgamation of pharmacovigilance with digital healthcare platforms and the advancement of specific pharmacovigilance services for gene therapies.

What Major Innovations Are Driving the Accelerated Growth of the Pharmacovigilance Outsourcing Market?

The growth of the pharmacovigilance outsourcing market is predicted to surge due to the increasing number of clinical trials. These trials are research studies that test the safety, effectiveness, and possible side effects of new treatments or medical devices. An expansion in the number of clinical trials can be attributed to various factors, such as a heightened emphasis on precision medicine, the growing prevalence of chronic diseases, regulatory backing, and the internationalization of research. By employing expertise and resources in clinical trials, pharmacovigilance outsourcing enhances drugs safety monitoring, ensures regulatory compliance, and bolsters efficiency. For instance, the Association of the British Pharmaceutical Industry, a trade organization based in the UK, reported in November 2023 that the total count of industry-funded clinical trials initiated in the UK rose mildly by 4.3%, from 394 trials in 2021 to 411 in 2022. Accordingly, the surge in the number of clinical trials fuels the growth of the pharmacovigilance outsourcing market.

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What Are the Major Players Making an Impact in the Pharmacovigilance Outsourcing Market’s Growth?

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

Which Upcoming Trends Are Set to Influence the Pharmacovigilance Outsourcing Market’s Path Forward?

Leading firms in the pharmacovigilance outsourcing sector are looking to develop inventive solutions such as a cloud-based data lake platform to improve pharmacovigilance case handling and bolster safety data management systems. These solutions aim to upgrade clinical research registries and ensure regulatory compliance. A cloud-based data lake platform acts as a centralized storage system, making it easier to store and handle vast volumes of raw data in its original format until required. An example of this came in December 2023, when the biotechnology and lab equipment conglomerate, Thermo Fisher Scientific Inc., based in the USA, unveiled CorEvidence. This product promises to streamline pharmacovigilance case processing by successfully managing multiple sets of data and optimising the codification, categorisation, and submission of adverse events. The platform is vital as it offers scalabale, regulatory compliant, auditable safety management; improves the CorEvitas clinical research registries; and assist in long-term post-authorization safety studies across various therapeutic domains.

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Which Key Segments of the Pharmacovigilance Outsourcing Market Are Poised for Growth and Innovation?

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

What Regions Are Steering Growth in the Pharmacovigilance Outsourcing Sector?

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.

How Can We Define the Pharmacovigilance Outsourcing Market and Its Key Components?

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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