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US Pharmacovigilance Market

ID: MRFR/Pharma/49917-HCR
200 Pages
Rahul Gotadki
October 2025

US Pharmacovigilance Market Research Report By Service Type (Adverse Event Reporting, Risk Assessment, Data Mining, Pharmacovigilance Consulting), By Deployment Mode (Cloud-Based, On-Premise), By Source (Spontaneous Reporting, Literature Reports, Scheduled Reporting), and By End-user (Pharmaceutical Companies, Biotechnology Companies, Contract Research Organizations) - Growth & Industry Forecast 2025 To 2035

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US Pharmacovigilance Market Infographic
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US Pharmacovigilance Market Summary

As per Market Research Future analysis, the US pharmacovigilance market Size was estimated at 1786.6 USD Million in 2024. The US pharmacovigilance market is projected to grow from 1940.61 USD Million in 2025 to 4436.48 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 8.6% during the forecast period 2025 - 2035

Key Market Trends & Highlights

The US pharmacovigilance market is poised for growth driven by regulatory compliance and technological advancements.

  • Regulatory compliance and safety monitoring remain pivotal in shaping the US pharmacovigilance market.
  • Technological advancements in data management are enhancing the efficiency of pharmacovigilance processes.
  • The integration of AI and machine learning is transforming data analysis and risk assessment in pharmacovigilance.
  • Increasing regulatory scrutiny and rising demand for patient safety are key drivers propelling market expansion.

Market Size & Forecast

2024 Market Size 1786.6 (USD Million)
2035 Market Size 4436.48 (USD Million)
CAGR (2025 - 2035) 8.62%

Major Players

Covance (US), Parexel International (US), IQVIA (US), Wuxi AppTec (CN), Syneos Health (US), Medpace (US), PPD (US), Charles River Laboratories (US)

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US Pharmacovigilance Market Trends

The pharmacovigilance market is currently experiencing notable growth, driven by increasing regulatory requirements and the rising emphasis on patient safety. Regulatory bodies, such as the FDA, are enhancing their focus on monitoring drug safety, which compels pharmaceutical companies to invest in robust pharmacovigilance systems. This trend is further supported by advancements in technology, enabling more efficient data collection and analysis. As a result, organizations are adopting innovative solutions to streamline their pharmacovigilance processes, ensuring compliance with stringent regulations while improving overall drug safety outcomes. Moreover, the integration of artificial intelligence and machine learning into pharmacovigilance practices appears to be transforming the landscape. These technologies facilitate the identification of adverse drug reactions and enhance signal detection capabilities. Consequently, companies are likely to leverage these tools to optimize their pharmacovigilance operations, thereby reducing costs and improving efficiency. The ongoing evolution of this market suggests a promising future, with continuous advancements in technology and regulatory frameworks shaping its trajectory.

Regulatory Compliance and Safety Monitoring

The increasing focus on regulatory compliance is a key driver in the pharmacovigilance market. Regulatory agencies are implementing stricter guidelines for monitoring drug safety, compelling pharmaceutical companies to enhance their pharmacovigilance practices. This trend emphasizes the need for comprehensive safety monitoring systems to ensure compliance and protect patient health.

Technological Advancements in Data Management

Technological innovations are significantly impacting the pharmacovigilance market. The adoption of advanced data management systems, including cloud-based solutions, is streamlining the collection and analysis of safety data. These advancements enable organizations to respond more effectively to safety signals and improve overall operational efficiency.

Integration of AI and Machine Learning

The integration of artificial intelligence and machine learning technologies is revolutionizing the pharmacovigilance market. These tools enhance the ability to detect adverse drug reactions and analyze vast amounts of data quickly. As a result, companies are increasingly utilizing AI-driven solutions to improve their pharmacovigilance processes and ensure timely reporting.

US Pharmacovigilance Market Drivers

Increasing Regulatory Scrutiny

The pharmacovigilance market is experiencing heightened regulatory scrutiny, particularly in the US. Regulatory bodies such as the FDA are intensifying their focus on drug safety and adverse event reporting. This trend is likely driven by the increasing complexity of drug therapies and the need for robust safety monitoring systems. As a result, pharmaceutical companies are compelled to invest in comprehensive pharmacovigilance systems to ensure compliance with stringent regulations. The market for pharmacovigilance services is projected to grow significantly, with estimates suggesting a CAGR of around 10% over the next few years. This growth reflects the industry's response to regulatory demands and the necessity for effective risk management strategies.

Expansion of Biopharmaceuticals

The rapid expansion of biopharmaceuticals is a key driver of the pharmacovigilance market. As the biopharmaceutical sector continues to grow, the complexity of monitoring the safety of biologics increases. This complexity necessitates enhanced pharmacovigilance practices to ensure the safety and efficacy of these products. Regulatory agencies are placing greater emphasis on the need for rigorous safety monitoring of biopharmaceuticals, which is prompting companies to invest in specialized pharmacovigilance systems. The market is expected to grow in response to this trend, with estimates suggesting a CAGR of around 14% for pharmacovigilance services tailored to biopharmaceuticals over the next several years.

Rising Demand for Patient Safety

Patient safety remains a paramount concern within the pharmacovigilance market. As healthcare providers and patients become more aware of the potential risks associated with medications, there is an increasing demand for effective monitoring systems. This demand is further fueled by the growing prevalence of chronic diseases, which often require long-term medication use. Consequently, pharmaceutical companies are investing in advanced pharmacovigilance solutions to enhance patient safety and ensure timely reporting of adverse events. The market is expected to witness substantial growth, with projections indicating an increase in spending on pharmacovigilance services by approximately 15% in the coming years. This trend underscores the industry's commitment to prioritizing patient welfare.

Growing Focus on Real-World Evidence

The emphasis on real-world evidence (RWE) is reshaping the pharmacovigilance market. Regulatory agencies are increasingly considering RWE in their decision-making processes, which necessitates robust pharmacovigilance systems to collect and analyze data from diverse sources. This trend is particularly relevant in the context of post-marketing surveillance, where understanding the long-term effects of drugs in real-world settings is crucial. Pharmaceutical companies are thus investing in RWE capabilities to enhance their pharmacovigilance efforts. The market is likely to see a surge in demand for services that facilitate the integration of RWE into pharmacovigilance practices, with growth projections indicating an increase of approximately 18% in RWE-related pharmacovigilance services.

Technological Integration in Drug Development

The integration of advanced technologies in drug development is significantly influencing the pharmacovigilance market. As pharmaceutical companies adopt innovative data management solutions, the efficiency of adverse event reporting and analysis improves. Technologies such as cloud computing and big data analytics are becoming essential tools for monitoring drug safety. This shift is likely to enhance the speed and accuracy of pharmacovigilance processes, thereby reducing the time required for regulatory submissions. The market is projected to expand as companies increasingly recognize the value of these technologies, with estimates suggesting a growth rate of around 12% in the adoption of tech-driven pharmacovigilance solutions over the next few years.

Market Segment Insights

By Service Type: Adverse Event Reporting (Largest) vs. Pharmacovigilance Consulting (Fastest-Growing)

In the US pharmacovigilance market, the service type segment reveals a dynamic distribution of market share among its core components. Adverse Event Reporting stands as the largest sector, reflecting its critical role in monitoring drug safety and informing regulatory compliance. Other segments such as Risk Assessment and Data Mining follow closely, demonstrating significant contributions to the overall market landscape, illustrating the diverse functions within pharmacovigilance. The growth trends in this segment are strongly influenced by increasing regulatory demands and advancements in technology. Prominent factors driving expansion include the rise in drug development activities, coupled with a heightened emphasis on patient safety and epidemiological studies. Notably, Pharmacovigilance Consulting is emerging rapidly, driven by the necessity for specialized expertise to navigate complex regulatory environments, thereby enhancing overall market velocity.

Adverse Event Reporting (Dominant) vs. Pharmacovigilance Consulting (Emerging)

Adverse Event Reporting is characterized by its robust and established role in the US pharmacovigilance market, serving as the backbone for ensuring patient safety and regulatory adherence. This service collects and analyzes data related to adverse drug reactions, bolstering its dominance. On the other hand, Pharmacovigilance Consulting is emerging swiftly, appealing to pharmaceutical companies for its strategic guidance in navigating regulatory landscapes. This segment's growth reflects a shift towards tailored consulting services, focusing on risk management and compliance strategies tailored to each client's unique challenges, positioning it as a vital counterpart to the more traditional reporting services.

By Deployment Mode: Cloud-Based (Largest) vs. On-Premise (Fastest-Growing)

In the US pharmacovigilance market, the deployment mode segment is characterized by a distinct division between cloud-based and on-premise solutions. Cloud-based systems hold a significant share of the market, primarily due to their flexibility, cost-effectiveness, and ease of access. On-premise solutions, while traditionally favored for their control and security, are starting to capture attention as organizations seek to enhance compliance and data privacy, albeit at a slower rate. Growth trends in the deployment mode segment indicate a rapid shift towards cloud-based systems, driven by advancements in technology and the increasing demand for real-time data processing. The COVID-19 pandemic has accelerated this transition as more organizations recognize the benefits of remote access and collaboration. Meanwhile, on-premise systems are evolving to meet the needs of businesses looking for customized solutions, thereby presenting themselves as an emerging alternative to traditional methods.

Deployment Mode: Cloud-Based (Dominant) vs. On-Premise (Emerging)

Cloud-based deployment in the US pharmacovigilance market is recognized as the dominant approach due to its scalability, cost efficiency, and ease of integration with other digital platforms. Organizations are increasingly favoring these solutions for their ability to offer real-time analytics, which are crucial for effective drug safety monitoring. On-premise solutions, while declining in popularity, are seen as emerging for organizations that prioritize data control, compliance, and local processing. These systems are being enhanced with innovative features to cater to specific industry needs, thus slowly gaining traction as businesses pursue tailored pharmacovigilance solutions.

By Source: Spontaneous Reporting (Largest) vs. Scheduled Reporting (Fastest-Growing)

In the US pharmacovigilance market, Spontaneous Reporting dominates with the largest share, accounting for a significant proportion of reported adverse drug reactions. Literature Reports also represent a crucial segment, but its market share is eclipsed by Spontaneous Reporting due to the latter's established practices among healthcare professionals and regulatory bodies. The growth trends in this segment indicate that Scheduled Reporting is gaining traction as the fastest-growing source due to increasing demand for systematic monitoring and regulatory compliance. Drivers for this growth include advancements in technology, which enhance data collection, and a greater emphasis on patient safety across various healthcare industries, leading to more structured reporting mechanisms.

Spontaneous Reporting (Dominant) vs. Scheduled Reporting (Emerging)

Spontaneous Reporting is the dominant source in the US pharmacovigilance market, characterized by its reactive nature where healthcare professionals report adverse events as they occur. Its well-established processes and widespread acceptance among practitioners contribute to its market leadership. Scheduled Reporting, on the other hand, is emerging as a critical player driven by the increasing need for regular and systematic evaluations of drug safety. Scheduled Reporting aims to decrease adverse events through proactive monitoring and is being adopted by various healthcare organizations looking to enhance patient safety and compliance with regulatory standards.

By End User: Pharmaceutical Companies (Largest) vs. Biotechnology Companies (Fastest-Growing)

The market share distribution among the end user segments in the US pharmacovigilance market reveals that pharmaceutical companies hold the largest share, dominating the landscape due to their extensive resources and established processes. In contrast, biotechnology companies, while smaller in share, are experiencing rapid growth as innovations in drug development necessitate robust safety monitoring solutions. Contract Research Organizations (CROs) also play a crucial role, offering specialized services that support both pharmaceutical and biotechnology sectors. Growth trends in this segment are driven by increasing regulatory scrutiny and the rising need for effective risk management strategies. Pharmaceutical companies invest heavily in pharmacovigilance to enhance their compliance efforts, while biotechnology firms are adopting advanced technologies to streamline safety processes. The emergence of personalized medicine and biologics further propels the demand for pharmacovigilance services, positioning biotechnology companies as the fastest-growing segment in this market.

Pharmaceutical Companies (Dominant) vs. Biotechnology Companies (Emerging)

Pharmaceutical companies dominate the US pharmacovigilance market due to their vast experience in drug safety monitoring and extensive regulatory compliance frameworks. Their established market presence allows them to leverage data management technologies effectively, ensuring efficient reporting and risk assessment. In contrast, biotechnology companies are emerging as vital players, driven by their innovative approaches to drug discovery and development. These companies are increasingly recognizing the importance of pharmacovigilance in their operational processes, leading to an upsurge in investments. While they currently hold a smaller market share, their rapid adaptation to safety monitoring practices and emphasis on novel therapies ensure that they are positioned for significant growth in the coming years.

Get more detailed insights about US Pharmacovigilance Market

Key Players and Competitive Insights

The pharmacovigilance market exhibits a dynamic competitive landscape, characterized by a blend of innovation, strategic partnerships, and a focus on regulatory compliance. Key players such as Covance (US), Parexel International (US), and IQVIA (US) are at the forefront, leveraging their extensive expertise to enhance drug safety monitoring and reporting. Covance (US) emphasizes its commitment to technological advancements, particularly in data analytics and real-time monitoring, which positions it favorably in a market increasingly driven by data integrity and speed. Parexel International (US) focuses on expanding its global footprint through strategic collaborations, thereby enhancing its service offerings and operational efficiency. Meanwhile, IQVIA (US) integrates artificial intelligence (AI) into its pharmacovigilance processes, suggesting a shift towards more automated and efficient systems that could redefine industry standards.The business tactics employed by these companies reflect a concerted effort to optimize operations and enhance service delivery. The market structure appears moderately fragmented, with several players vying for market share while also collaborating on various initiatives. This competitive environment is shaped by the collective influence of these key players, who are increasingly localizing their operations to better serve regional markets and streamline supply chains. Such strategies not only improve responsiveness but also align with regulatory requirements, which are becoming more stringent.

In October Covance (US) announced a partnership with a leading AI firm to develop a new platform aimed at enhancing pharmacovigilance data analysis. This strategic move is likely to bolster Covance's capabilities in predictive analytics, enabling clients to anticipate potential safety issues more effectively. The integration of AI into their processes could significantly reduce the time required for data processing, thereby improving overall efficiency and client satisfaction.

In September Parexel International (US) expanded its operations in Europe through a strategic acquisition of a local pharmacovigilance firm. This acquisition not only enhances Parexel's service portfolio but also strengthens its regulatory compliance capabilities in the European market. Such a move indicates a proactive approach to addressing the complexities of global pharmacovigilance, positioning Parexel as a more formidable competitor in the international arena.

In August IQVIA (US) launched a new suite of digital tools designed to streamline adverse event reporting for pharmaceutical companies. This initiative reflects a growing trend towards digitalization in the industry, as companies seek to leverage technology to improve efficiency and accuracy in reporting. The introduction of these tools may provide IQVIA with a competitive edge, as clients increasingly prioritize technological solutions that enhance operational effectiveness.

As of November the competitive trends in the pharmacovigilance market are heavily influenced by digital transformation, sustainability initiatives, and the integration of AI technologies. Strategic alliances are becoming more prevalent, as companies recognize the value of collaboration in navigating complex regulatory landscapes and enhancing service offerings. Looking ahead, it appears that competitive differentiation will increasingly hinge on innovation and technological advancements rather than solely on price. The emphasis on supply chain reliability and the ability to adapt to regulatory changes will likely define the future landscape of the pharmacovigilance market.

Key Companies in the US Pharmacovigilance Market include

Industry Developments

The US Pharmacovigilance Market has witnessed significant developments, especially with increased regulatory scrutiny and a focus on patient safety. Companies like Oracle and IQVIA have reported expansions in their pharmacovigilance services to enhance drug safety monitoring.

In September 2023, Medpace announced the acquisition of a niche pharmacovigilance consultancy, bolstering its capabilities in risk management services. Parexel and Syneos Health have also collaborated to improve data analytics in pharmacovigilance, aiming for more efficient regulatory compliance.

Veeva Systems and ArisGlobal have been enhancing their software solutions to provide better automation in the adverse event reporting process, responding to the evolving needs of the industry. The US Food and Drug Administration has prompted an increase in life cycle management practices for drug safety data, which has generated opportunities for companies like Covance and Celerion.

The market continues to show growth potential, driven by technological advancements and heightened demand for effective monitoring of drug safety profiles. The last two years have also seen regulatory changes, pushing firms to invest more in pharmacovigilance infrastructure, ensuring compliance with evolving guidelines.

Future Outlook

US Pharmacovigilance Market Future Outlook

The Pharmacovigilance Market is projected to grow at 8.62% CAGR from 2025 to 2035, driven by regulatory demands, technological advancements, and increasing patient safety awareness.

New opportunities lie in:

  • Integration of AI-driven analytics for real-time adverse event reporting.
  • Development of mobile applications for patient-reported outcomes.
  • Expansion of cloud-based pharmacovigilance solutions for scalability.

By 2035, the market is expected to achieve robust growth, enhancing safety and compliance in the pharmaceutical sector.

Market Segmentation

US Pharmacovigilance Market Source Outlook

  • Spontaneous Reporting
  • Literature Reports
  • Scheduled Reporting

US Pharmacovigilance Market End User Outlook

  • Pharmaceutical Companies
  • Biotechnology Companies
  • Contract Research Organizations

US Pharmacovigilance Market Service Type Outlook

  • Adverse Event Reporting
  • Risk Assessment
  • Data Mining
  • Pharmacovigilance Consulting

US Pharmacovigilance Market Deployment Mode Outlook

  • Cloud-Based
  • On-Premise

Report Scope

MARKET SIZE 2024 1786.6(USD Million)
MARKET SIZE 2025 1940.61(USD Million)
MARKET SIZE 2035 4436.48(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR) 8.62% (2025 - 2035)
REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR 2024
Market Forecast Period 2025 - 2035
Historical Data 2019 - 2024
Market Forecast Units USD Million
Key Companies Profiled Covance (US), Parexel International (US), IQVIA (US), Wuxi AppTec (CN), Syneos Health (US), Medpace (US), PPD (US), Charles River Laboratories (US)
Segments Covered Service Type, Deployment Mode, Source, End User
Key Market Opportunities Integration of artificial intelligence in data analysis enhances efficiency in the pharmacovigilance market.
Key Market Dynamics Growing regulatory scrutiny and technological advancements drive innovation in the pharmacovigilance market.
Countries Covered US
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FAQs

What was the market size of the US Pharmacovigilance Market in 2024?

The US Pharmacovigilance Market was valued at 1.66 billion USD in 2024.

What is the projected market value of the US Pharmacovigilance Market by 2035?

By 2035, the US Pharmacovigilance Market is projected to reach a value of 3.15 billion USD.

What is the expected compound annual growth rate (CAGR) for the US Pharmacovigilance Market from 2025 to 2035?

The market is expected to have a CAGR of 6.002% during the forecast period from 2025 to 2035.

Which service type within the US Pharmacovigilance Market is anticipated to have the highest value in 2035?

Adverse Event Reporting is anticipated to have the highest value, expected to reach 1.0 billion USD in 2035.

What was the market size for Risk Assessment in the US Pharmacovigilance Market in 2024?

Risk Assessment was valued at 0.3 billion USD in the year 2024.

Who are the key players in the US Pharmacovigilance Market?

Key players in the market include Oracle, Medpace, Parexel, Syneos Health, and IQVIA, among others.

What is the expected value of Data Mining services in the US Pharmacovigilance Market for 2035?

Data Mining is expected to be valued at 0.8 billion USD in 2035.

How much was Pharmacovigilance Consulting expected to be worth in 2024?

Pharmacovigilance Consulting was worth 0.46 billion USD in 2024.

What are the expected growth opportunities in the US Pharmacovigilance Market?

The market presents opportunities driven by advancements in technology and increasing regulatory requirements.

What is the projected market growth rate for the US Pharmacovigilance Market from 2025 to 2035?

The market is expected to grow at a rate of 6.002% during the forecast period from 2025 to 2035.

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