Drug Safety Solutions and Pharmacovigilance Market by Type of Service (Pre-market Drug Safety Assessment, Post-market Drug Safety Assessment, Risk Management), and by End-Use Industry (Pharmaceutical Companies, Biopharmaceutical Companies); Global Insights & Forecast (2024 – 2030)

As per Intent Market Research, the Drug Safety Solutions and Pharmacovigilance Market was valued at USD 6.8 billion in 2023 and will surpass USD 13.4 billion by 2030; growing at a CAGR of 10.3% during 2024 - 2030.

ddThe drug safety solutions and pharmacovigilance market is pivotal to ensuring the safety and efficacy of pharmaceutical products throughout their lifecycle. As the global pharmaceutical industry continues to expand, the demand for robust pharmacovigilance services has grown significantly. These services focus on monitoring the safety of drugs post-market and assessing potential risks before drugs are launched. With increasing regulatory requirements and a heightened awareness of the importance of drug safety, pharmacovigilance has become an integral part of the drug development and marketing process. The market encompasses various services, including pre-market and post-market drug safety assessments, risk management, and others, which collectively help mitigate the risks associated with adverse drug reactions and improve patient safety.

Post-Market Drug Safety Assessment Is Largest Owing to Regulatory Requirements

The post-market drug safety assessment segment holds the largest share in the drug safety solutions and pharmacovigilance market, driven by regulatory requirements and the increasing need to monitor the safety of drugs after they have been approved for public use. Once a drug enters the market, continuous monitoring for adverse effects becomes essential to ensure public health safety. Regulatory agencies such as the FDA and EMA require pharmaceutical companies to report any adverse drug reactions, necessitating the use of pharmacovigilance solutions. As pharmaceutical companies are obligated to follow these guidelines and ensure the ongoing safety of their products, post-market safety assessment has become a critical part of the drug lifecycle. This segment's dominance is fueled by an increasing focus on compliance and patient safety, with companies investing heavily in systems and technologies that facilitate real-time monitoring of drug safety data.

Risk Management Is Fastest Growing Owing to Rising Concerns About Drug Safety

The risk management segment is the fastest growing within the drug safety solutions and pharmacovigilance market, driven by the increasing concern over drug-related risks and the growing need for systematic identification, evaluation, and mitigation of these risks. With the advent of complex drug regimens, biologics, and personalized medicine, pharmaceutical companies face an increasingly intricate landscape of potential adverse effects. As a result, the demand for risk management strategies to assess and minimize drug-related risks has surged. These services help companies to proactively manage safety issues, mitigate risks, and ensure compliance with global regulatory standards. With the rise in patient-centric healthcare and personalized therapies, risk management solutions are expected to see sustained growth as pharmaceutical companies seek to improve patient outcomes and avoid regulatory and legal risks.

Pharmaceutical Companies Are Largest End-Use Industry Due to Regulatory Mandates

Pharmaceutical companies constitute the largest end-use industry for drug safety solutions and pharmacovigilance services, owing to the extensive regulatory mandates they face for ensuring the safety of their products. As the primary stakeholders in the drug development process, pharmaceutical companies are responsible for conducting pre-market and post-market drug safety assessments, as well as implementing risk management strategies. They are required to continuously collect and analyze data on drug safety, monitor adverse drug reactions, and submit safety reports to regulatory authorities. The scale of operations and the complexity of regulatory compliance make pharmaceutical companies the largest users of pharmacovigilance services. Additionally, with the growing number of new drug approvals, these companies require comprehensive solutions to manage the safety profiles of their products and maintain compliance with global regulations.

North America Leads the Market Owing to Strict Regulatory Framework

North America leads the drug safety solutions and pharmacovigilance market, primarily due to the stringent regulatory framework and the high demand for compliance with safety standards. The region is home to major pharmaceutical companies that are subject to rigorous drug safety monitoring requirements from regulatory bodies such as the FDA. In addition to regulatory pressures, the increasing number of drug launches and the growing complexity of the pharmaceutical landscape have contributed to the rising demand for pharmacovigilance services. The strong healthcare infrastructure, the presence of advanced technologies, and a well-established pharmacovigilance ecosystem make North America the largest regional market for drug safety solutions. Moreover, increasing collaborations between pharmaceutical companies and third-party service providers are driving the growth of the market in this region.

Leading Companies and Competitive Landscape

The drug safety solutions and pharmacovigilance market is characterized by the presence of key players offering a wide range of services aimed at ensuring the safety and efficacy of pharmaceutical products. Leading companies in this market include Covance, Parexel International, PPD, Charles River Laboratories, and PRA Health Sciences, among others. These companies are focused on providing comprehensive pharmacovigilance solutions that span the entire drug development process, from pre-market assessments to post-market monitoring and risk management. With the increasing importance of compliance and safety, these players are investing in advanced technologies such as AI and machine learning to improve the efficiency of pharmacovigilance processes. The competitive landscape is further shaped by partnerships, collaborations, and acquisitions, as companies strive to enhance their service offerings and expand their market presence. As regulatory requirements evolve, these leading companies are positioned to play a critical role in advancing the standards and practices in drug safety.

Recent Developments:

• IQVIA launched a new AI-powered pharmacovigilance platform designed to automate adverse event reporting and improve signal detection in drug safety monitoring.
• Parexel International expanded its pharmacovigilance services by incorporating advanced data analytics tools to enhance drug safety assessments.
• Covance entered into a partnership with a leading pharmaceutical company to offer integrated pharmacovigilance services for post-market surveillance.
• Accenture acquired a pharmacovigilance solutions provider to expand its services in drug safety monitoring for pharmaceutical companies.
• Cognizant Technology Solutions introduced a new machine learning-based pharmacovigilance tool to streamline adverse drug event reporting and improve regulatory compliance.

List of Leading Companies:

• Accenture
• Parexel International
• IQVIA
• Covance
• PPD
• Charles River Laboratories
• Wipro Limited
• Pharmaceutical Product Development (PPD)
• Medpace
• Labcorp Drug Development
• Cognizant Technology Solutions
• Syneos Health
• PRA Health Sciences
• Veristat
• KPMG

Report Scope: