| Product Code: ETC13167712 | Publication Date: Apr 2025 | Updated Date: Jul 2025 | Product Type: Market Research Report | |
| Publisher: 6Wresearch | Author: Shubham Deep | No. of Pages: 190 | No. of Figures: 80 | No. of Tables: 40 |
According to 6Wresearch internal database and industry insights, the Global Pharmacovigilance Market was valued at USD 7.8 Billion in 2024 and is expected to reach USD 13.5 Billion by 2031, growing at a compound annual growth rate of 8.40% during the forecast period (2025-2031).
The Global Pharmacovigilance Market involves the surveillance and monitoring of pharmaceutical products to ensure their safety and effectiveness post-market approval. This market is driven by the increasing focus on patient safety, stringent regulatory requirements, and the rising number of adverse drug reactions. The market encompasses various services such as drug safety monitoring, regulatory compliance, signal detection, risk management, and pharmacovigilance software solutions. Key players in this market include pharmaceutical companies, contract research organizations (CROs), and business process outsourcing (BPO) firms. With the growing demand for pharmaceutical products and the need for effective drug safety monitoring, the Global Pharmacovigilance Market is expected to witness significant growth in the coming years.
The Global Pharmacovigilance Market is experiencing significant growth driven by increased regulatory requirements, rising drug consumption, and the emergence of new technologies like AI and machine learning for adverse event detection. The market is witnessing a shift towards proactive risk management strategies, real-world evidence generation, and the integration of big data analytics to improve drug safety monitoring. Opportunities lie in expanding pharmacovigilance services in emerging markets, enhancing signal detection capabilities through advanced technologies, and streamlining adverse event reporting processes through automation. Collaboration between pharmaceutical companies, regulators, and technology providers will be crucial for leveraging these trends and opportunities to ensure patient safety and drug efficacy in the evolving healthcare landscape.
The Global Pharmacovigilance Market faces several challenges, including regulatory complexities across different regions, varying reporting requirements, and the need for standardization of processes and terminology. Additionally, the increasing volume of adverse event reports due to the growing number of drugs in the market poses a challenge in terms of efficient data management and analysis. Ensuring timely and accurate reporting of adverse events, maintaining patient confidentiality, and addressing issues related to data quality and completeness are also significant challenges faced by organizations operating in the pharmacovigilance market. Furthermore, the rapid advancements in technology and the need to adapt to new data sources such as social media and real-world evidence present additional hurdles in ensuring effective pharmacovigilance practices.
The Global Pharmacovigilance Market is primarily driven by the increasing focus on patient safety and regulatory compliance in the pharmaceutical industry. The rising incidence of adverse drug reactions and the need to monitor and report them effectively have heightened the demand for pharmacovigilance services. Additionally, the expanding pharmaceutical market, growing complexity of drug development and approval processes, and the implementation of stringent regulations by regulatory authorities globally are also key drivers. The emergence of biopharmaceuticals and biosimilars, along with the trend towards outsourcing pharmacovigilance activities to specialized service providers, further contribute to the market growth. Overall, the emphasis on ensuring the safety and efficacy of drugs throughout their lifecycle is propelling the growth of the pharmacovigilance market.
Government policies related to the Global Pharmacovigilance Market focus on ensuring the safety and efficacy of pharmaceutical products by monitoring and evaluating adverse drug reactions. Regulatory bodies such as the FDA in the United States and the EMA in Europe require pharmaceutical companies to establish pharmacovigilance systems to collect, analyze, and report any adverse events associated with their products. These policies aim to protect public health by identifying and mitigating potential risks posed by medications, promoting transparency in drug safety information, and facilitating the continuous monitoring of drug safety throughout the product lifecycle. Additionally, governments emphasize the importance of international collaboration and data sharing to enhance pharmacovigilance efforts on a global scale and strengthen regulatory oversight in the pharmaceutical industry.
The Global Pharmacovigilance Market is poised for significant growth in the coming years, driven by increasing regulatory requirements, rising focus on patient safety, and the expansion of the pharmaceutical industry. The market is expected to witness a compound annual growth rate (CAGR) of around 10% from 2021 to 2026. Factors such as the growing number of adverse drug reactions, the emergence of biopharmaceuticals, and the adoption of advanced technologies like artificial intelligence and big data analytics for drug safety monitoring are further propelling market growth. Additionally, the trend towards outsourcing pharmacovigilance services to specialized vendors to reduce operational costs and improve efficiency is expected to contribute to the market expansion. Overall, the Global Pharmacovigilance Market presents lucrative opportunities for players across the pharmaceutical and healthcare sectors.
In the global pharmacovigilance market, Asia is expected to witness significant growth due to the increasing focus on healthcare infrastructure development in countries like India and China. North America is a key player in the market, driven by stringent regulatory requirements and the presence of major pharmaceutical companies. Europe is also a prominent region, with established pharmacovigilance systems and a strong emphasis on drug safety regulations. The Middle East and Africa are experiencing growth as well, supported by the expanding pharmaceutical industry and rising awareness about adverse drug reactions. Latin America is emerging as a lucrative market, with increasing investments in healthcare and a growing demand for pharmacovigilance services to ensure drug safety and regulatory compliance.
Global Pharmacovigilance Market |
1 Executive Summary |
2 Introduction |
2.1 Key Highlights of the Report |
2.2 Report Description |
2.3 Market Scope & Segmentation |
2.4 Research Methodology |
2.5 Assumptions |
3 Global Pharmacovigilance Market Overview |
3.1 Global Regional Macro Economic Indicators |
3.2 Global Pharmacovigilance Market Revenues & Volume, 2021 & 2031F |
3.3 Global Pharmacovigilance Market - Industry Life Cycle |
3.4 Global Pharmacovigilance Market - Porter's Five Forces |
3.5 Global Pharmacovigilance Market Revenues & Volume Share, By Regions, 2021 & 2031F |
3.6 Global Pharmacovigilance Market Revenues & Volume Share, By Clinical Trial Phase, 2021 & 2031F |
3.7 Global Pharmacovigilance Market Revenues & Volume Share, By Service Provider, 2021 & 2031F |
3.8 Global Pharmacovigilance Market Revenues & Volume Share, By Type of Reporting, 2021 & 2031F |
3.9 Global Pharmacovigilance Market Revenues & Volume Share, By End User, 2021 & 2031F |
4 Global Pharmacovigilance Market Dynamics |
4.1 Impact Analysis |
4.2 Market Drivers |
4.3 Market Restraints |
5 Global Pharmacovigilance Market Trends |
6 Global Pharmacovigilance Market, 2021 - 2031 |
6.1 Global Pharmacovigilance Market, Revenues & Volume, By Clinical Trial Phase, 2021 - 2031 |
6.1.1 Overview & Analysis |
6.1.2 Global Pharmacovigilance Market, Revenues & Volume, By Preclinical, 2021 - 2031 |
6.1.3 Global Pharmacovigilance Market, Revenues & Volume, By Phase I, 2021 - 2031 |
6.1.4 Global Pharmacovigilance Market, Revenues & Volume, By Phase II, 2021 - 2031 |
6.1.5 Global Pharmacovigilance Market, Revenues & Volume, By Phase III, 2021 - 2031 |
6.1.6 Global Pharmacovigilance Market, Revenues & Volume, By Phase IV, 2021 - 2031 |
6.2 Global Pharmacovigilance Market, Revenues & Volume, By Service Provider, 2021 - 2031 |
6.2.1 Overview & Analysis |
6.2.2 Global Pharmacovigilance Market, Revenues & Volume, By In-house, 2021 - 2031 |
6.2.3 Global Pharmacovigilance Market, Revenues & Volume, By Contract Outsourcing, 2021 - 2031 |
6.3 Global Pharmacovigilance Market, Revenues & Volume, By Type of Reporting, 2021 - 2031 |
6.3.1 Overview & Analysis |
6.3.2 Global Pharmacovigilance Market, Revenues & Volume, By Spontaneous Reporting, 2021 - 2031 |
6.3.3 Global Pharmacovigilance Market, Revenues & Volume, By Intensified ADR Reporting, 2021 - 2031 |
6.3.4 Global Pharmacovigilance Market, Revenues & Volume, By Targeted Spontaneous Reporting, 2021 - 2031 |
6.3.5 Global Pharmacovigilance Market, Revenues & Volume, By Cohort Event Monitoring, 2021 - 2031 |
6.3.6 Global Pharmacovigilance Market, Revenues & Volume, By EHR Mining, 2021 - 2031 |
6.4 Global Pharmacovigilance Market, Revenues & Volume, By End User, 2021 - 2031 |
6.4.1 Overview & Analysis |
6.4.2 Global Pharmacovigilance Market, Revenues & Volume, By Hospitals, 2021 - 2031 |
6.4.3 Global Pharmacovigilance Market, Revenues & Volume, By Pharmaceutical Companies, 2021 - 2031 |
6.4.4 Global Pharmacovigilance Market, Revenues & Volume, By Other End Users, 2021 - 2031 |
7 North America Pharmacovigilance Market, Overview & Analysis |
7.1 North America Pharmacovigilance Market Revenues & Volume, 2021 - 2031 |
7.2 North America Pharmacovigilance Market, Revenues & Volume, By Countries, 2021 - 2031 |
7.2.1 United States (US) Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
7.2.2 Canada Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
7.2.3 Rest of North America Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
7.3 North America Pharmacovigilance Market, Revenues & Volume, By Clinical Trial Phase, 2021 - 2031 |
7.4 North America Pharmacovigilance Market, Revenues & Volume, By Service Provider, 2021 - 2031 |
7.5 North America Pharmacovigilance Market, Revenues & Volume, By Type of Reporting, 2021 - 2031 |
7.6 North America Pharmacovigilance Market, Revenues & Volume, By End User, 2021 - 2031 |
8 Latin America (LATAM) Pharmacovigilance Market, Overview & Analysis |
8.1 Latin America (LATAM) Pharmacovigilance Market Revenues & Volume, 2021 - 2031 |
8.2 Latin America (LATAM) Pharmacovigilance Market, Revenues & Volume, By Countries, 2021 - 2031 |
8.2.1 Brazil Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
8.2.2 Mexico Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
8.2.3 Argentina Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
8.2.4 Rest of LATAM Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
8.3 Latin America (LATAM) Pharmacovigilance Market, Revenues & Volume, By Clinical Trial Phase, 2021 - 2031 |
8.4 Latin America (LATAM) Pharmacovigilance Market, Revenues & Volume, By Service Provider, 2021 - 2031 |
8.5 Latin America (LATAM) Pharmacovigilance Market, Revenues & Volume, By Type of Reporting, 2021 - 2031 |
8.6 Latin America (LATAM) Pharmacovigilance Market, Revenues & Volume, By End User, 2021 - 2031 |
9 Asia Pharmacovigilance Market, Overview & Analysis |
9.1 Asia Pharmacovigilance Market Revenues & Volume, 2021 - 2031 |
9.2 Asia Pharmacovigilance Market, Revenues & Volume, By Countries, 2021 - 2031 |
9.2.1 India Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
9.2.2 China Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
9.2.3 Japan Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
9.2.4 Rest of Asia Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
9.3 Asia Pharmacovigilance Market, Revenues & Volume, By Clinical Trial Phase, 2021 - 2031 |
9.4 Asia Pharmacovigilance Market, Revenues & Volume, By Service Provider, 2021 - 2031 |
9.5 Asia Pharmacovigilance Market, Revenues & Volume, By Type of Reporting, 2021 - 2031 |
9.6 Asia Pharmacovigilance Market, Revenues & Volume, By End User, 2021 - 2031 |
10 Africa Pharmacovigilance Market, Overview & Analysis |
10.1 Africa Pharmacovigilance Market Revenues & Volume, 2021 - 2031 |
10.2 Africa Pharmacovigilance Market, Revenues & Volume, By Countries, 2021 - 2031 |
10.2.1 South Africa Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
10.2.2 Egypt Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
10.2.3 Nigeria Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
10.2.4 Rest of Africa Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
10.3 Africa Pharmacovigilance Market, Revenues & Volume, By Clinical Trial Phase, 2021 - 2031 |
10.4 Africa Pharmacovigilance Market, Revenues & Volume, By Service Provider, 2021 - 2031 |
10.5 Africa Pharmacovigilance Market, Revenues & Volume, By Type of Reporting, 2021 - 2031 |
10.6 Africa Pharmacovigilance Market, Revenues & Volume, By End User, 2021 - 2031 |
11 Europe Pharmacovigilance Market, Overview & Analysis |
11.1 Europe Pharmacovigilance Market Revenues & Volume, 2021 - 2031 |
11.2 Europe Pharmacovigilance Market, Revenues & Volume, By Countries, 2021 - 2031 |
11.2.1 United Kingdom Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
11.2.2 Germany Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
11.2.3 France Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
11.2.4 Rest of Europe Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
11.3 Europe Pharmacovigilance Market, Revenues & Volume, By Clinical Trial Phase, 2021 - 2031 |
11.4 Europe Pharmacovigilance Market, Revenues & Volume, By Service Provider, 2021 - 2031 |
11.5 Europe Pharmacovigilance Market, Revenues & Volume, By Type of Reporting, 2021 - 2031 |
11.6 Europe Pharmacovigilance Market, Revenues & Volume, By End User, 2021 - 2031 |
12 Middle East Pharmacovigilance Market, Overview & Analysis |
12.1 Middle East Pharmacovigilance Market Revenues & Volume, 2021 - 2031 |
12.2 Middle East Pharmacovigilance Market, Revenues & Volume, By Countries, 2021 - 2031 |
12.2.1 Saudi Arabia Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
12.2.2 UAE Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
12.2.3 Turkey Pharmacovigilance Market, Revenues & Volume, 2021 - 2031 |
12.3 Middle East Pharmacovigilance Market, Revenues & Volume, By Clinical Trial Phase, 2021 - 2031 |
12.4 Middle East Pharmacovigilance Market, Revenues & Volume, By Service Provider, 2021 - 2031 |
12.5 Middle East Pharmacovigilance Market, Revenues & Volume, By Type of Reporting, 2021 - 2031 |
12.6 Middle East Pharmacovigilance Market, Revenues & Volume, By End User, 2021 - 2031 |
13 Global Pharmacovigilance Market Key Performance Indicators |
14 Global Pharmacovigilance Market - Export/Import By Countries Assessment |
15 Global Pharmacovigilance Market - Opportunity Assessment |
15.1 Global Pharmacovigilance Market Opportunity Assessment, By Countries, 2021 & 2031F |
15.2 Global Pharmacovigilance Market Opportunity Assessment, By Clinical Trial Phase, 2021 & 2031F |
15.3 Global Pharmacovigilance Market Opportunity Assessment, By Service Provider, 2021 & 2031F |
15.4 Global Pharmacovigilance Market Opportunity Assessment, By Type of Reporting, 2021 & 2031F |
15.5 Global Pharmacovigilance Market Opportunity Assessment, By End User, 2021 & 2031F |
16 Global Pharmacovigilance Market - Competitive Landscape |
16.1 Global Pharmacovigilance Market Revenue Share, By Companies, 2024 |
16.2 Global Pharmacovigilance Market Competitive Benchmarking, By Operating and Technical Parameters |
17 Top 10 Company Profiles |
18 Recommendations |
19 Disclaimer |