PUBLISHER: The Business Research Company | PRODUCT CODE: 1957643
PUBLISHER: The Business Research Company | PRODUCT CODE: 1957643
Pharmacovigilance is the science and practice of identifying, evaluating, understanding, and mitigating side effects and other issues related to drugs or vaccines. It helps determine whether a medication's benefits outweigh its risks and continues beyond the point of drug approval.
The main types of pharmacovigilance include spontaneous reporting, intensified ADR reporting, targeted spontaneous reporting, cohort event monitoring, and EHR mining. Spontaneous reporting is a passive method that relies on individuals to voluntarily report suspected adverse drug reactions to local or national pharmacovigilance centers. Key process flows involve case data management, signal detection, and risk management systems. Service providers can be in-house or contracted for outsourcing, covering clinical trial phases such as preclinical, Phase I, Phase II, Phase III, and Phase IV. These services are utilized by hospitals, pharmaceutical companies, and other healthcare organizations.
Tariffs have moderately impacted the pharmacovigilance market by increasing the cost of imported IT infrastructure, data management software, and specialized safety monitoring tools used across global operations. These cost pressures particularly affect contract outsourcing providers and EHR mining segments, with Asia-Pacific and parts of Europe experiencing higher operational expenses due to reliance on cross-border technology services. Clinical trial phase IV activities and advanced signal detection processes are also influenced by delayed system upgrades. However, tariffs have encouraged local deployment of pharmacovigilance platforms, regional service partnerships, and investment in domestic data processing capabilities, supporting long-term market resilience.
The pharmacovigilance market research report is one of a series of new reports from The Business Research Company that provides pharmacovigilance market statistics, including pharmacovigilance industry global market size, regional shares, competitors with a pharmacovigilance market share, detailed pharmacovigilance market segments, market trends and opportunities, and any further data you may need to thrive in the pharmacovigilance industry. This pharmacovigilance market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The pharmacovigilance market size has grown rapidly in recent years. It will grow from $9.64 billion in 2025 to $10.86 billion in 2026 at a compound annual growth rate (CAGR) of 12.7%. The growth in the historic period can be attributed to increasing adverse drug reaction reporting, expansion of global pharmaceutical approvals, rising clinical trial volumes, establishment of international drug safety regulations, growth in chronic disease drug usage.
The pharmacovigilance market size is expected to see rapid growth in the next few years. It will grow to $17.41 billion in 2030 at a compound annual growth rate (CAGR) of 12.5%. The growth in the forecast period can be attributed to real-world data utilization growth, rising biologics and biosimilars approvals, increasing complexity of combination therapies, expansion of pharmacovigilance in emerging markets, growing focus on patient safety outcomes. Major trends in the forecast period include expansion of post-marketing surveillance activities, growing adoption of real-world evidence in safety monitoring, increasing regulatory scrutiny and compliance requirements, rising outsourcing of pharmacovigilance services, integration of multisource safety data platforms.
The increasing research and development (R&D) activities are expected to drive the growth of the pharmacovigilance market. By investing in R&D, pharmaceutical companies can develop new drugs with improved safety profiles. Rigorous preclinical and clinical testing during drug development enables the early identification of potential safety concerns, allowing for the implementation of effective risk mitigation strategies. Additionally, R&D supports the advancement of technologies for adverse event monitoring, data analysis, and signal detection, facilitating the timely identification of adverse drug reactions in the post-marketing phase. For instance, in 2023, according to the Office for National Statistics, a UK-based government agency, the UK government's net spending on R&D increased to £17.4 billion in 2023, up from £16.1 billion in 2022, marking an 8.2% rise. Therefore, increasing R&D activities are fueling the growth of the pharmacovigilance market.
Key companies in the pharmacovigilance market are leveraging artificial intelligence (AI) to improve operational efficiency and accuracy. AI streamlines pharmacovigilance processes, enhances data management, accelerates signal detection, and ultimately contributes to better patient safety and outcomes. For example, in August 2024, the Government of India launched the Adverse Drug Reaction Monitoring System (ADRMS) software, introduced by the Minister of Health & Family Welfare and the Minister of Chemicals and Fertilizers. This pharmacovigilance platform facilitates the collection and analysis of adverse events related to medicines and medical devices, simplifying the reporting process for healthcare professionals and consumers. ADRMS strengthens India's pharmacovigilance infrastructure by ensuring comprehensive safety data capture, enhancing regulatory compliance, and supporting the country's position in the global pharmaceutical industry.
In January 2023, AmerisourceBergen, a US-based pharmaceutical wholesale company, acquired Pharma Lex for an undisclosed amount. This acquisition expands AmerisourceBergen's capabilities in supporting pharmaceutical and biotechnology companies across the product lifecycle. Pharma Lex, a Germany-based company, provides end-to-end pharmacovigilance solutions, including systems and operations management as well as benefit-risk assessment services, enhancing the overall safety monitoring infrastructure for its clients.
Major companies operating in the pharmacovigilance market are IQVIA, Cognizant, ICON Plc, Accenture plc, PAREXEL International Corporation, United BioSource LLC, ArisGlobal, Quanticate, Wipro Limited, Linical Americas, Novotech CRO, EXTEDO, Arriello, PrimeVigilance, Axios International, C3i Solutions, Secure AI Labs, OmniSol dot Tech, Prevnos Inc., Lifescient Inc, QuintilesIMS, Labcorp Drug Development, Pharmaceutical Product Development Inc., PRA Health Sciences, Synowledge LLC, RAPAhub, illuminate health, Invenio Medical, ClinChoice Inc., Novasyte, Fortrea Holdings Inc., Syneos Health Clinical, Telerx Marketing Inc.
North America was the largest region in the pharmacovigilance market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast region. The regions covered in the pharmacovigilance market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
The countries covered in the pharmacovigilance market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The pharmacovigilance market includes revenues earned by collecting, analyzing, monitoring, and preventing adverse effects in drugs and therapies. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Pharmacovigilance Market Global Report 2026 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses pharmacovigilance market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for pharmacovigilance ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The pharmacovigilance market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
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