Global Pharmacovigilance Market by Service Type (Adverse Drug Reaction (ADR) Monitoring, Risk Management, Data Management and Analysis, Regulatory Reporting, Others), by Source of Data (Clinical Trials, Post-Marketing Surveillance, Literature Review, Spontaneous Reporting, Others), by End-User (Pharmaceutical Companies, Contract Research Organizations (CROs), Regulatory Authorities, Healthcare Providers, Others); Insights & Forecast (2024 – 2030)

As per Intent Market Research, the Pharmacovigilance Market was valued at USD 7.8 Billion in 2024-e and will surpass USD 14.4 Billion by 2030; growing at a CAGR of 10.7% during 2025 - 2030.

 The pharmacovigilance market plays a crucial role in ensuring the safety and efficacy of pharmaceutical products after they enter the market. This field involves monitoring the safety profile of drugs through the identification, assessment, and prevention of adverse drug reactions (ADRs). With the increasing complexity of drug development and regulatory scrutiny, pharmacovigilance has become an integral component of post-marketing surveillance. As the pharmaceutical industry focuses on improving patient safety and regulatory compliance, the demand for comprehensive pharmacovigilance services continues to grow globally.

Adverse Drug Reaction (ADR) Monitoring Leads the Market Due to Increasing Drug Safety Concerns

Adverse Drug Reaction (ADR) monitoring is the largest service type in the pharmacovigilance market, driven by the increasing focus on patient safety and the need to identify potential risks associated with drugs after they are approved for sale. ADR monitoring involves collecting, analyzing, and evaluating reports of adverse effects caused by drugs, allowing healthcare providers and regulators to take necessary actions, such as warning labels, dosage adjustments, or even drug recalls.

With the rising number of pharmaceutical products entering the market and the growing complexity of drug formulations, the demand for ADR monitoring services has intensified. Pharmaceutical companies, healthcare providers, and regulatory authorities are focusing on improving safety profiles through efficient ADR detection and reporting systems. This has made ADR monitoring a critical component of the pharmacovigilance process, further propelling the market growth.

Pharmacovigilance Market Size

Post-Marketing Surveillance is the Fastest Growing Data Source Due to Regulatory Mandates

Post-marketing surveillance is the fastest-growing data source in the pharmacovigilance market. After a drug is released to the market, continuous monitoring is essential to detect rare or long-term adverse effects that may not have been identified during clinical trials. Post-marketing surveillance provides crucial data on the real-world safety and efficacy of drugs, helping to ensure that any potential risks are promptly identified and mitigated.

Regulatory authorities across the globe, such as the FDA and EMA, have mandated post-marketing surveillance programs to monitor the safety of drugs once they are made available to the public. This regulatory push, combined with increasing consumer awareness, is driving the growth of post-marketing surveillance services. Pharmaceutical companies are investing in more robust surveillance systems to ensure compliance and maintain public trust in their products.

Pharmaceutical Companies Are the Largest End-User Due to Extensive Safety Monitoring Requirements

Pharmaceutical companies are the largest end-users in the pharmacovigilance market due to the extensive safety monitoring requirements mandated by regulatory authorities. These companies rely on pharmacovigilance services to collect data, manage adverse event reports, and ensure compliance with safety regulations. With increasing global regulatory scrutiny and the need to maintain a strong safety profile for drugs, pharmaceutical companies are investing heavily in pharmacovigilance to protect patient safety and avoid costly recalls or penalties.

The pharmaceutical industry's role in managing post-marketing drug safety is critical, and as the number of new drugs continues to rise, so too does the need for comprehensive pharmacovigilance systems to support ongoing safety monitoring and regulatory reporting.

North America Dominates the Market Due to Strong Regulatory Framework and Healthcare Infrastructure

North America is the largest market for pharmacovigilance services, driven by a strong regulatory framework, advanced healthcare infrastructure, and a high number of pharmaceutical companies operating in the region. The United States and Canada have well-established regulatory authorities, such as the FDA and Health Canada, which enforce strict pharmacovigilance guidelines to ensure drug safety and efficacy.

In addition to regulatory pressures, North American pharmaceutical companies are at the forefront of adopting advanced pharmacovigilance solutions, such as automated ADR monitoring systems and AI-powered data analysis tools. This has positioned North America as the dominant region in the global pharmacovigilance market, with significant investments in safety monitoring technologies and services.

Pharmacovigilance Market Size by Region 2030

Competitive Landscape and Key Players

The pharmacovigilance market is highly competitive, with key players such as Parexel International, Accenture, Covance, Syneos Health, and IQVIA leading the industry. These companies provide a range of pharmacovigilance services, including ADR monitoring, risk management, data analysis, and regulatory reporting, to help pharmaceutical companies comply with regulatory requirements and ensure drug safety.

With the increasing complexity of pharmacovigilance data and the growing use of technology, many of the leading players are investing in advanced solutions, such as cloud-based platforms, AI, and machine learning, to streamline data collection and analysis processes. Companies are also expanding their service offerings to cover the entire drug lifecycle, from pre-marketing safety assessments to post-marketing surveillance, to meet the evolving needs of the pharmaceutical industry.

Recent Developments:

  • IQVIA Inc. announced the launch of a new pharmacovigilance platform to improve ADR reporting and risk assessment.
  • F. Hoffmann-La Roche Ltd. expanded its global pharmacovigilance network to enhance drug safety and regulatory compliance.
  • Parexel International Corporation entered into a partnership to enhance its pharmacovigilance services with advanced AI-powered analytics.
  • Merck & Co., Inc. introduced a real-time pharmacovigilance dashboard for better monitoring of drug safety across regions.
  • Johnson & Johnson Services, Inc. acquired a pharmacovigilance software company to strengthen its drug safety infrastructure.

List of Leading Companies:

  • F. Hoffmann-La Roche Ltd.
  • Novartis International AG
  • Pfizer Inc.
  • GlaxoSmithKline plc
  • Johnson & Johnson Services, Inc.
  • Bristol-Myers Squibb Company
  • Sanofi S.A.
  • AbbVie Inc.
  • Merck & Co., Inc.
  • IQVIA Inc.
  • Parexel International Corporation
  • Celerion Inc.
  • ICON plc
  • Wipro Limited
  • Covance Inc.

Report Scope:

Report Features

Description

Market Size (2024-e)

USD 7.8 Billion

Forecasted Value (2030)

USD 14.4 Billion

CAGR (2025 – 2030)

10.7%

Base Year for Estimation

2024-e

Historic Year

2023

Forecast Period

2025 – 2030

Report Coverage

Market Forecast, Market Dynamics, Competitive Landscape, Recent Developments

Segments Covered

Global Pharmacovigilance Market by Service Type (Adverse Drug Reaction (ADR) Monitoring, Risk Management, Data Management and Analysis, Regulatory Reporting, Others), by Source of Data (Clinical Trials, Post-Marketing Surveillance, Literature Review, Spontaneous Reporting, Others), by End-User (Pharmaceutical Companies, Contract Research Organizations (CROs), Regulatory Authorities, Healthcare Providers, Others); Insights & Forecast (2024 – 2030)

Regional Analysis

North America (US, Canada, Mexico), Europe (Germany, France, UK, Italy, Spain, and Rest of Europe), Asia-Pacific (China, Japan, South Korea, Australia, India, and Rest of Asia-Pacific), Latin America (Brazil, Argentina, and Rest of Latin America), Middle East & Africa (Saudi Arabia, UAE, Rest of Middle East & Africa)

Major Companies

F. Hoffmann-La Roche Ltd., Novartis International AG, Pfizer Inc., GlaxoSmithKline plc, Johnson & Johnson Services, Inc., Bristol-Myers Squibb Company, AbbVie Inc., Merck & Co., Inc., IQVIA Inc., Parexel International Corporation, Celerion Inc., ICON plc, Covance Inc.

Customization Scope

Customization for segments, region/country-level will be provided. Moreover, additional customization can be done based on the requirements

1. Introduction

   1.1. Market Definition

   1.2. Scope of the Study

   1.3. Research Assumptions

   1.4. Study Limitations

2. Research Methodology

   2.1. Research Approach

      2.1.1. Top-Down Method

      2.1.2. Bottom-Up Method

      2.1.3. Factor Impact Analysis

  2.2. Insights & Data Collection Process

      2.2.1. Secondary Research

      2.2.2. Primary Research

   2.3. Data Mining Process

      2.3.1. Data Analysis

      2.3.2. Data Validation and Revalidation

      2.3.3. Data Triangulation

3. Executive Summary

   3.1. Major Markets & Segments

   3.2. Highest Growing Regions and Respective Countries

   3.3. Impact of Growth Drivers & Inhibitors

   3.4. Regulatory Overview by Country

4. Pharmacovigilance Market, by Service Type (Market Size & Forecast: USD Million, 2023 – 2030)

   4.1. Adverse Drug Reaction (ADR) Monitoring

   4.2. Risk Management

   4.3. Data Management and Analysis

   4.4. Regulatory Reporting

   4.5. Others

5. Pharmacovigilance Market, by Source of Data (Market Size & Forecast: USD Million, 2023 – 2030)

   5.1. Clinical Trials

   5.2. Post-Marketing Surveillance

   5.3. Literature Review

   5.4. Spontaneous Reporting

   5.5. Others

6. Pharmacovigilance Market, by End-User (Market Size & Forecast: USD Million, 2023 – 2030)

   6.1. Pharmaceutical Companies

   6.2. Contract Research Organizations (CROs)

   6.3. Regulatory Authorities

   6.4. Healthcare Providers

   6.5. Others

7. Regional Analysis (Market Size & Forecast: USD Million, 2023 – 2030)

   7.1. Regional Overview

   7.2. North America

      7.2.1. Regional Trends & Growth Drivers

      7.2.2. Barriers & Challenges

      7.2.3. Opportunities

      7.2.4. Factor Impact Analysis

      7.2.5. Technology Trends

      7.2.6. North America Pharmacovigilance Market, by Service Type

      7.2.7. North America Pharmacovigilance Market, by Source of Data

      7.2.8. North America Pharmacovigilance Market, by End-User

      7.2.9. By Country

         7.2.9.1. US

               7.2.9.1.1. US Pharmacovigilance Market, by Service Type

               7.2.9.1.2. US Pharmacovigilance Market, by Source of Data

               7.2.9.1.3. US Pharmacovigilance Market, by End-User

         7.2.9.2. Canada

         7.2.9.3. Mexico

    *Similar segmentation will be provided for each region and country

   7.3. Europe

   7.4. Asia-Pacific

   7.5. Latin America

   7.6. Middle East & Africa

8. Competitive Landscape

   8.1. Overview of the Key Players

   8.2. Competitive Ecosystem

      8.2.1. Level of Fragmentation

      8.2.2. Market Consolidation

      8.2.3. Product Innovation

   8.3. Company Share Analysis

   8.4. Company Benchmarking Matrix

      8.4.1. Strategic Overview

      8.4.2. Product Innovations

   8.5. Start-up Ecosystem

   8.6. Strategic Competitive Insights/ Customer Imperatives

   8.7. ESG Matrix/ Sustainability Matrix

   8.8. Manufacturing Network

      8.8.1. Locations

      8.8.2. Supply Chain and Logistics

      8.8.3. Product Flexibility/Customization

      8.8.4. Digital Transformation and Connectivity

      8.8.5. Environmental and Regulatory Compliance

   8.9. Technology Readiness Level Matrix

   8.10. Technology Maturity Curve

   8.11. Buying Criteria

9. Company Profiles

   9.1. F. Hoffmann-La Roche Ltd.

      9.1.1. Company Overview

      9.1.2. Company Financials

      9.1.3. Product/Service Portfolio

      9.1.4. Recent Developments

      9.1.5. IMR Analysis

    *Similar information will be provided for other companies 

   9.2. Novartis International AG

   9.3. Pfizer Inc.

   9.4. GlaxoSmithKline plc

   9.5. Johnson & Johnson Services, Inc.

   9.6. Bristol-Myers Squibb Company

   9.7. Sanofi S.A.

   9.8. AbbVie Inc.

   9.9. Merck & Co., Inc.

   9.10. IQVIA Inc.

   9.11. Parexel International Corporation

   9.12. Celerion Inc.

   9.13. ICON plc

   9.14. Wipro Limited

   9.15. Covance Inc.

10. Appendix

A comprehensive market research approach was employed to gather and analyze data on the Pharmacovigilance Market. In the process, the analysis was also done to analyze the parent market and relevant adjacencies to measure the impact of them on the Pharmacovigilance Market. The research methodology encompassed both secondary and primary research techniques, ensuring the accuracy and credibility of the findings.

Research Approach -

Secondary Research

Secondary research involved a thorough review of pertinent industry reports, journals, articles, and publications. Additionally, annual reports, press releases, and investor presentations of industry players were scrutinized to gain insights into their market positioning and strategies.

Primary Research

Primary research involved conducting in-depth interviews with industry experts, stakeholders, and market participants across the E-Waste Management ecosystem. The primary research objectives included:

  • Validating findings and assumptions derived from secondary research
  • Gathering qualitative and quantitative data on market trends, drivers, and challenges
  • Understanding the demand-side dynamics, encompassing end-users, component manufacturers, facility providers, and service providers
  • Assessing the supply-side landscape, including technological advancements and recent developments

Market Size Assessment

A combination of top-down and bottom-up approaches was utilized to analyze the overall size of the Pharmacovigilance Market. These methods were also employed to assess the size of various subsegments within the market. The market size assessment methodology encompassed the following steps:

  1. Identification of key industry players and relevant revenues through extensive secondary research
  2. Determination of the industry's supply chain and market size, in terms of value, through primary and secondary research processes
  3. Calculation of percentage shares, splits, and breakdowns using secondary sources and verification through primary sources

Bottom Up and Top Down -

Data Triangulation

To ensure the accuracy and reliability of the market size, data triangulation was implemented. This involved cross-referencing data from various sources, including demand and supply side factors, market trends, and expert opinions. Additionally, top-down and bottom-up approaches were employed to validate the market size assessment.

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