Pharmacovigilance Market Report 2025 (Global Edition)

Global Pharmacovigilance Market Report 2025 Market Size Split by Type (Intensified adverse drug reaction reporting Cohort event monitoring, Spontaneous reporting, Electronic health record mining, Targ...

Pharmacovigilance Market Report Description

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Impact of Tariff Trumph on Pharmaceuticals Industry

The reintroduction of tariffs under President Trump’s “Liberation Day Tariffs” in April 2025 has created significant disruption in global pharmaceutical trade. These tariffs, ranging from 10% to 46%, specifically target pharmaceutical products, APIs (active pharmaceutical ingredients), medical packaging, and machinery from key manufacturers in China and India. This has led to increased production costs, supply chain delays, and regulatory challenges for U.S.-based pharmaceutical companies.

The tariffs have particularly impacted generic drug manufacturers, who rely heavily on APIs from China and India. Biopharmaceuticals and vaccines are also feeling the pressure, with tariffs on critical materials like bioproduction media and cold-chain packaging raising costs by up to 25%. Similarly, contract manufacturing organizations (CMOs) are grappling with the need to identify new suppliers and adjust production plans to mitigate rising costs.

Foreign governments, including the European Union, have retaliated with tariffs on U.S. pharmaceutical exports, further complicating global trade. Clinical trials are also impacted, as tariffs on drugs and diagnostic kits delay trial timelines.

Market research is increasingly crucial for navigating these challenges. By providing real-time data on API pricing, supplier reliability, and tariff impact, pharmaceutical firms can make informed decisions on sourcing, compliance, and investment strategies. This data-driven approach helps mitigate risks, optimize supply chains, and identify alternative manufacturing hubs to offset tariff-related disruptions.

Overall, market research is essential for pharmaceutical companies to adapt to the new tariff landscape, enabling them to maintain competitive advantage and navigate global trade dynamics effectively.

Competitive Landscape: Pharmacovigilance Market

Major market participants who are essential in determining consumer preferences and market dynamics have a major impact on the pharmacovigilance market. These major players provide consumers with easy access to a vast array of wardrobe options through their extensive retail networks and online platforms. Product adoption has increased as a result of their strong worldwide presence and a well-known brand, which has also increased consumer trust and loyalty. In addition, these industry titans never stop funding R&D, bringing cutting-edge styles, materials, and practical features to clothing wardrobes to meet changing customer demands and preferences. These big players' combined efforts have a big impact on the market's future direction and level of competition.

Top Companies Market Share in Pharmacovigilance Industry: (In no particular order of Rank)

• ArisGlobal (United States)
• Ennov Solutions Inc. (United States)
• EXTEDO GmbH (United States)
• Novartis (Switzerland)
• PARAXEL (United States)
• MAKROCARE (India)
• Online Business Applications (United States)
• United BioSource Corporation (United States)
• Cmed Group (United Kingdom)
• Medpace (United States)
• Sarjen Systems Pvt. Ltd (India)
• Sparta Systems (United States)
• Covance (United States)
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*List of Second Tier Companies, List of Third Tier/ Start-up Companies (Inquire with sales executive) Request Any Company Profile for Preview Purpose OR Data Validation!

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Which region dominates the pharmacovigilance market?

North America dominated the pharmacovigilance market in 2024. It held the largest market share of around xx% because the region is home to important pharmaceutical companies and medical device manufacturers, both of which significantly increase the region's overall income. One of the main causes of morbidity and death is the growth in drug addiction and the Adverse Drug Reactions (ADRs) that are linked to it. The aforementioned components support the Pharmacovigilance (PV) market in North America and are factors contributing to its high growth. Moreover, throughout the forecast period, rising patient awareness and concerns about medication safety are anticipated to have a beneficial effect on the market. Furthermore, this market is anticipated to be profitable due to the local presence of significant market players in the area who carry out strategic activities including mergers and acquisitions and the development of new products.
 

Which region expanding at the fastest CAGR in the pharmacovigilance market?

Over the forecast period, Asia Pacific is expected to rise at an enticing CAGR of xx%. The availability of generic medications is credited with the region's rise. Strict government regulations, a rise in public safety awareness, and an increase in ADRs are some of the factors anticipated to propel regional market expansion during the projected period. Moreover, Asia offers a significant cost-saving benefit, with savings of between 50% and 80% when compared to industrialized countries, which encourages more clinical trials to be carried out in this area. As a result, the region is paying more attention to PV and medication safety as a result of the increase in demand for clinical studies.

The current report Scope analyzes Pharmacovigilance Market on 5 major region Split (In case you wish to acquire a specific region edition (more granular data) or any country Edition data then please write us on info@cognitivemarketresearch.com

• North America (United States, Canada, Mexico)
• Europe (United Kingdom, France, Germany, Italy, Russia, Spain, Sweden, Denmark, Switzerland, Luxembourg, Rest of Europe)
• Asia Pacific (China, Japan, South Korea, India, Australia, Singapore, Taiwan, South East Asia, Rest of APAC)
• Latin America (Brazil, Argentina, Colombia, Peru, Chile, Rest of South America)
• Middle East (Saudi Arabia, Turkey, UAE, Egypt, Qatar, Rest of Middle East)
• Africa (Nigeria, South Africa, Rest of Africa)

The above graph is for illustrative purposes only.

Pharmacovigilance Market Analysis

Pharmacovigilance by Type Segment Analysis

• Intensified adverse drug reaction reporting Cohort event monitoring
• Spontaneous reporting
• Electronic health record mining
• Targeted spontaneous reporting

Based on the type the market is segmented into intensified adverse drug reaction reporting, cohort event monitoring, spontaneous reporting, electronic health record mining, and targeted spontaneous reporting. The spontaneous reporting segment dominated the pharmacovigilance market in 2024 with a market share of xx% in the type segment, because of its widespread use in the effective and economical detection of novel, severe, and uncommon ADRs. Finding new, unusual, and harmful ADRs that were overlooked in pre-marketing clinical studies is also the primary goal. During a drug's entire life, beginning on the day it is introduced to the market, spontaneous reporting takes place. This strategy also has the advantage of providing data from real clinical practice as opposed to clinical studies, which exclude vulnerable individuals and have limited treatment durations.
•    For instance, in 2020, ICON plc introduced Vigilance AI, a new pharmacovigilance product. To streamline pharmacovigilance procedures and increase patient safety, vigilance AI is an artificial intelligence-powered platform that enables real-time identification and assessment of safety signals.
(Source:https://www.iconplc.com/solutions/clinical-and-scientific-operations/pharmacovigilance/ensuring-patient-safety)

The above Chart is for representative purposes and does not depict actual sale statistics. Access/Request the quantitative data to understand the trends and dominating segment of Pharmacovigilance Industry. Request a Free Sample PDF!

Pharmacovigilance by Application Segment Analysis

• In-house
• Contract Outsourcing

Based on service providers, the market is segmented into contract outsourcing, and in-house. The contract outsourcing segment held the largest market share of xx% in 2024. The contract outsourcing segment dominated the market due to the quick emergence of several Contract Research Organisations (CROs), particularly in the major Asia Pacific economies of China, Japan, and India, which provide end-to-end clinical trial solutions. The industry is expected to expand at the quickest rate (CAGR) of xx% because contract outsourcing partners provide a flexible and well-balanced solution within cost-contained models while guaranteeing overall quality. These days, pharmacovigilance outsourcing includes complex duties including pharmacoeconomics, benefit-risk management, signal detection, and extensive risk management planning. Benefits of the outsourcing strategy include cost-effectiveness, availability of specialized staff, and the chance to take benefit of CROs' vast pharmacovigilance knowledge. Pharmaceutical businesses may also carefully manage their resources and concentrate on their core capabilities thanks to outsourcing.

The above Graph is for representation purposes only. This chart does not depict actual Market share.

Pharmacovigilance Phase Segment Analysis

Based on phases, the global pharmacovigilance market is segmented into pre-clinical, phase I, phase II, phase Ill, and phase IV. The Phase IV segment accounted for a significant market share in 2024. This is mostly due to the ongoing technical assistance that a pharmaceutical producer offers once its product is approved for sale. The main objectives of a phase IV study are to determine if the medication works in real-world settings, to look at the long-term risks and benefits of using it, and to find any unusual adverse effects. A much bigger patient group and a longer monitoring period for any uncommon or long-term adverse effects of the medicine are possible in a phase 4 trial. If the drug's safety monitoring reveals issues, it may be removed from the market and no longer prescribed.
•    For instance, painkiller rofecoxib, which was taken off the market after phase 4 trials revealed had harmful cardiac adverse effects.
(Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC523096/)

• Pre-clinical
• Phase I
• Phase II
• Phase Ill
• Phase IV.

Pharmacovigilance End-User Segment Analysis

Based on end-use, the global pharmacovigilance market is segmented into hospitals, pharma and biotech companies, and others. The pharma and biotech companies segment accounted for a significant market share in 2024 due to the introduction and continuous launch of new drugs. Furthermore, organizations operating in the market are always striving to implement cutting-edge technologies like Artificial Intelligence (AI) and other innovations, which have a substantial impact on the growth of market revenue. The creation and use of drugs have skyrocketed in the last several years. Long-term, widespread usage of drugs can lead to side effects that were not detected in research trials. To broaden their product offering and establish a presence internationally, market players are also forging partnerships and alliances. 
•    For instance, on 8 April 2021, ResoluteAl, which is a research platform for science, headquartered in New York, U.S. released a set of tools to streamline post-market surveillance and pharmacovigilance analysis. ResoluteAl linked and improved access to six Food and Drug Administration (FDA) databases using data from OpenFDA.
(Source:https://pubmed.ncbi.nlm.nih.gov/31997227/)

• Hospitals
• Pharma and Biotech Companies
• Others.

Author's Detail

Manjiri Kanhere

Senior Research Associate at Cognitive Market Research

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Manjiri Kanhere is an experienced market researcher focused on the Pharma & Healthcare industry. With over 3+ years of experience, She has worked with major pharmaceutical companies and healthcare providers, helping them to understand market trends, identify new business opportunities, and develop effective sales & marketing strategies. Her expertise lies in the ability to analyze complex data sets and deliver insights that drive business decisions. At Cognitive Market Research, she handles the market research related to Pharma and healthcare industry.

Author's Conclusion