Pharmacovigilance Outsourcing Market Size
| Study Period | 2019 - 2030 |
| Market Size (2025) | USD 7.92 Billion |
| Market Size (2030) | USD 16.49 Billion |
| CAGR (2025 - 2030) | 15.80% |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players*Disclaimer: Major Players sorted in no particular order |
Pharmacovigilance Outsourcing Market Analysis
The Pharmacovigilance Outsourcing Market size is estimated at USD 7.92 billion in 2025, and is expected to reach USD 16.49 billion by 2030, at a CAGR of 15.8% during the forecast period (2025-2030).
The market is driven by increased high-profile drug recalls due to safety concerns, a higher incidence of adverse drug reactions (ADRs) and drug toxicity, and the growing adoption of pharmacovigilance services. The rising incidence of adverse drug reactions and drug toxicity cases around the globe increases the demand for pharmacovigilance services for the effective reduction of these ADRs in a large population, which ultimately drives the market during the forecast period. For example, according to an article published in the International Journal of Basic and Clinical Pharmacology in March 2024, a retrospective observational study of adverse drug reactions reported in a tertiary care hospital in India over the past six years found that a total of 95 ADR reactions were reported. These adverse drug reactions were associated with a total of 108 prescribed drugs, and they were more common among females. Antimicrobials were causing the highest number of adverse reactions, with around 19.4% of ADRs caused by antimicrobial drugs, followed by antituberculosis drugs and radiocontrast with 17.59% of ADRs. Intravenous was the most common route related to the development of ADR. Hence, the increasing number of ADRs increases the demand for pharmacovigilance services to effectively monitor adverse drug reactions, which will drive the market during the forecast period. Also, the increasing number of high-profile drug recalls due to safety concerns is increasing pharmaceutical and biopharmaceutical companies' adoption of pharmacovigilance services to tackle the recall problem early and save resources, which will drive the market during the forecast period. For instance, in April 2024, Glenmark Pharmaceuticals recalled 6,528 bottles of Diltiazem hydrochloride extended-release capsules of medication used for high blood pressure treatment from the American market due to issues with dissolution specifications. In July 2023, Lupin Pharmaceuticals voluntarily recalled two lots of Tydemy (drospirenone, ethinyl estradiol, and levomefolate calcium) because of the results of a 12-month stability test. Tydemy is an oral contraceptive used to prevent pregnancy. Hence, the increasing recall of drugs raises the demand for pharmacovigilance services to identify adverse drug reactions at the initial stage and save the extra complications in large populations, which will drive the market during the forecast period. Moreover, the increasing adoption of pharmacovigilance services is expected to drive the market during the forecast period. For instance, in April 2023, PharmaLex Group planned to merge with Cpharm, a provider of pharmacovigilance services in Australia and New Zealand. The agreement will enable PharmaLex to increase the coverage of pharmacovigilance and medical services in Australia and New Zealand. Hence, such strategic activities increase the accessibility and affordability of pharmacovigilance services, which will increase the adoption and drive the market during the forecast period. In conclusion, the increasing incidence of adverse drug reactions and toxic cases and rising high-profile drug recalls increase the demand for pharmacovigilance service outsourcing and drive the market during the market. However, the lack of skilled pharmacovigilance professionals is expected to restrain the market during the forecast period.
Pharmacovigilance Outsourcing Market Trends
The Oncology Segment is Expected to Hold Significant Market Share During the Forecast Period
Pharmacovigilance in oncology refers to the specialized monitoring and assessment of safety data related to anticancer drugs and therapies. It involves the systematic collection and analysis of adverse events specific to oncology patients, identification of potential drug-related risks, and proactive risk management strategies to ensure that they are promptly addressed. The increasing prevalence of cancer cases coupled with the rising geriatric population, rising investment in the research and development of cancer drugs, and growing government initiatives to improve the lives of cancer patients are expected to drive the market during the forecast period. The growing prevalence of cancer cases, along with the increasing geriatric population, is expected to increase the demand for research activities for the development of oncology drugs, which further increases the demand for pharmacovigilance outsourcing services for the surveillance of adverse effects caused by new cancer drugs, which will drive the market during the forecast period.
For instance, according to the American Cancer Society 2024 update, about 2 million new cancer cases are expected to be diagnosed in the United States in 2024. Also, 5,480 new cancer cases are likely to be identified in the United States daily. Thus, the high burden of cancer is expected to augment the demand for pharmacovigilance outsourcing services. Cancer therapies require adequate and quick regulatory approvals, clinical trial support, etc., which will boost market growth during the forecast period.
Also, the increasing incorporation of artificial intelligence to enable real-world data collection for oncology pharmacovigilance is expected to increase the outsourcing of pharmacovigilance services to complement the oncology clinical trials. For instance, according to an article published in Clinical Cancer Informatics in May 2024, the ubiquitous uptake of electronic health records (EHRs) in the United States, combined with advances in artificial intelligence (AI), presents new opportunities to leverage real-world data (RWD) collected as a part of routine clinical care to complement clinical trials for oncology pharmacovigilance. Hence, advanced artificial intelligence that can be utilized in pharmacovigilance services is expected to increase the adoption of these services and drive the market during the forecast period. Hence, the increasing prevalence of cancer diseases, the rising geriatric population, and the growing incorporation of artificial intelligence in pharmacovigilance services are expected to drive the market during the forecast period.
North America is Expected to Hold the Significant Market Share During the Forecast Period
The pharmacovigilance outsourcing market in North America is primarily driven by increasing adverse drug reactions and drug abuse in the region, advanced healthcare infrastructure, growing digitalization of healthcare systems, and increasing strategic activities by key players. The increasing government initiatives to reduce adverse drug reactions in the region are expected to increase the demand for pharmacovigilance services, which will drive the market during the forecast period. For instance, in the first half of 2024, the US Food and Drug Administration introduced the Emerging Drug Safety Technology Program (EDSTP), which is specifically focused on the use of artificial intelligence (AI) and other emerging technologies in pharmacovigilance (PV). This initiative solves challenges, such as timely and efficient collection, processing, and evaluation of single and aggregate patient safety data compounded by ever-increasing case volumes faced by pharmaceutical and regulatory bodies. Such initiatives will increase the adoption of pharmacovigilance outsourcing services during the forecast period. Also, increasing strategic activities such as acquisitions and collaborations by key players are expected to drive the market during the forecast period. For instance, in October 2023, IQVIA, a provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, reported a strategic collaboration with Argenx to advance treatment to patients with rare autoimmune diseases through innovative and integrated technology-enabled pharmacovigilance (PV) safety services and solutions. Also, in February 2024, Ergomed Group expanded its presence in the United States by opening a new office in Boston. Through the new office, the company will provide solutions in both rare complex diseases and oncology to the local biotechnology community. The company will provide oncology and rare and complex diseases pharmacovigilance services from this office. Hence, such strategic activities will increase the accessibility of pharmacovigilance services and drive the market during the forecast period. Hence, the increasing demand for government initiatives to increase the adoption of pharmacovigilance services and growing strategic activities, such as collaborations and expansions by key players, are expected to drive the demand for pharmacovigilance outsourcing services and boost the market in North America.
Pharmacovigilance Outsourcing Industry Overview
The pharmacovigilance outsourcing market is fragmented due to the entry of new players and an increasing number of new startups in the field. The major players in the market are adopting various strategic activities such as mergers, collaborations, and expansions to strengthen their geographical presence and expand their global customer base. Some of the key players in the market are Accenture, Qinecsa Solutions, ICON PLC, Oracle, and IQVIA Inc.
Pharmacovigilance Outsourcing Market Leaders
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Accenture
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Qinecsa Solutions
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ICON plc
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Oracle
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IQVIA Inc.
- *Disclaimer: Major Players sorted in no particular order
Pharmacovigilance Outsourcing Market News
- July 2024: Oracle reported significant updates to its Argus and Safety One Intake solutions, bolstering its pharmacovigilance portfolio with AI-powered features. These AI enhancements cater to the evolving needs of life science organizations, allowing them to navigate increasingly complex regulatory landscapes and manage rising adverse event cases efficiently.
- December 2023: Qinecsa Solutions, a pharmacovigilance solutions provider, reported the launch of its latest literature management solution in partnership with The Applied AI Company (AAICO). This strategic union combines Qinecsa’s medical and pharmacovigilance expertise with AAICO’s leading AI platform.
Pharmacovigilance Outsourcing Industry Segmentation
As per the scope of the report, pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem. Pharmacovigilance outsourcing (PVO) transfers the execution of drug safety functions and processes to a third-party provider. The pharmacovigilance outsourcing market is segmented into service, therapeutic area, provider, end user, and geography. By service, the market is segmented into pre-marketing services and post-marketing services. By therapeutic area, the market is segmented into neurology, cardiology, oncology, and other applications (dental and ophthalmic). By end user, the market is segmented into hospitals and other end users. By geography, the market is segmented into North America, Europe, Asia-Pacific, and Rest of the World. The market report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers values (USD) for the above segments.
| By Service | Pre-marketing Services | Clinical Pharmacovigilance Services | |
| Case Processing Services | |||
| Safety Data Management Services | |||
| Medical Review | |||
| Post-marketing Services | Knowledge Process Outsourcing Services | ||
| IT Solutions and Services | |||
| By Therapeutic Area | Neurology | ||
| Cardiology | |||
| Oncology | |||
| Others (Respiratory and Orthopedic) | |||
| By Provider | Contract Research Organizations (CROs) | ||
| Business Processing Outsourcing (BPO) | |||
| By End User | Pharmaceutical Companies | ||
| Biopharmaceutical Companies | |||
| Medical Device Companies | |||
| Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia-Pacific | China | ||
| Japan | |||
| India | |||
| Australia | |||
| South Korea | |||
| Rest of Asia-Pacific | |||
| Middle East and Africa | GCC | ||
| South Africa | |||
| Rest of Middle East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
| Pre-marketing Services | Clinical Pharmacovigilance Services |
| Case Processing Services | |
| Safety Data Management Services | |
| Medical Review | |
| Post-marketing Services | Knowledge Process Outsourcing Services |
| IT Solutions and Services |
| Neurology |
| Cardiology |
| Oncology |
| Others (Respiratory and Orthopedic) |
| Contract Research Organizations (CROs) |
| Business Processing Outsourcing (BPO) |
| Pharmaceutical Companies |
| Biopharmaceutical Companies |
| Medical Device Companies |
| North America | United States |
| Canada | |
| Mexico | |
| Europe | Germany |
| United Kingdom | |
| France | |
| Italy | |
| Spain | |
| Rest of Europe | |
| Asia-Pacific | China |
| Japan | |
| India | |
| Australia | |
| South Korea | |
| Rest of Asia-Pacific | |
| Middle East and Africa | GCC |
| South Africa | |
| Rest of Middle East and Africa | |
| South America | Brazil |
| Argentina | |
| Rest of South America |
Pharmacovigilance Outsourcing Market Research FAQs
How big is the Pharmacovigilance Outsourcing Market?
The Pharmacovigilance Outsourcing Market size is expected to reach USD 7.92 billion in 2025 and grow at a CAGR of 15.80% to reach USD 16.49 billion by 2030.
What is the current Pharmacovigilance Outsourcing Market size?
In 2025, the Pharmacovigilance Outsourcing Market size is expected to reach USD 7.92 billion.
Who are the key players in Pharmacovigilance Outsourcing Market?
Accenture, Qinecsa Solutions, ICON plc, Oracle and IQVIA Inc. are the major companies operating in the Pharmacovigilance Outsourcing Market.
Which is the fastest growing region in Pharmacovigilance Outsourcing Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Pharmacovigilance Outsourcing Market?
In 2025, the North America accounts for the largest market share in Pharmacovigilance Outsourcing Market.
What years does this Pharmacovigilance Outsourcing Market cover, and what was the market size in 2024?
In 2024, the Pharmacovigilance Outsourcing Market size was estimated at USD 6.67 billion. The report covers the Pharmacovigilance Outsourcing Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Pharmacovigilance Outsourcing Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
Pharmacovigilance Outsourcing Industry Report
Statistics for the 2025 Pharmacovigilance Outsourcing market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Pharmacovigilance Outsourcing analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
