Pharmacovigilance Market: Global Industry Analysis and Forecast (2024-2030), By Drug Development, Service Provider, End-use, and Region

Pharmacovigilance Market Overview:

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem. Medicines and vaccines have transformed the prevention and treatment of diseases. In addition to their benefits, medicinal products also have side effects, some of which are undesirable or unexpected. For instance, in Canada, it is mandatory to have a pharmacovigilance system to ensure continuous monitoring of medicinal products and medical devices for their safe use. 

 

This guideline provides an overview of the regulatory requirements for manufacturers and importers related to the reporting of adverse drug reactions (ADRs) and unusual failures in the efficacy of new drugs to Health Canada, as outlined in the Food and Drug Regulations. The guideline applies to pharmaceuticals, biologics, vaccines, medical gases, and radiopharmaceuticals but excludes products like disinfectants, veterinary products, natural health products, and blood components.

 

Cloud-based solutions are gradually being adopted to support pharmacovigilance by providing computing services over the Internet, including servers, storage, networking, software, analytics, and intelligence. A key advantage of cloud-based systems for pharmacovigilance is the ease with which they can be upgraded. As drug safety regulations evolve or new technological advancements emerge, these systems can be automatically updated to meet the latest requirements.

 

Beyond the pharmaceutical industry, the integration of cloud technology also benefits healthcare providers by enabling easier access to drug safety information, whether the data originates from clinical research or post-market experience. On Dec 20, 2023, Thermo Fisher Scientific Inc. introduced CorEvidence, a cloud-based data lake platform developed to streamline pharmacovigilance case processing and safety data management. This platform is intended to improve the CorEvitas clinical research registries provided by Thermo Fisher's PPD clinical research division.

 

The sciences companies across the world can harness the power of AI and analytics to accelerate the development of new, more effective drugs for patients. The companies Safety helps transform safety case processing and meet business and regulatory requirements effectively and efficiently. For instance, the US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency use Quantitative Signal Detection Algorithms in their pharmacovigilance systems. Several key initiatives are underway to explore the role of AI in the lifecycle of medicines and pharmacovigilance.

 

In 2023, the FDA and European Medicines Agency (EMA) launched a working group to examine AI's impact on drug development, with Health Canada and Japan's PMDA joining as observers in 2024. Additionally, the Council for International Organizations of Medical Sciences (CIOMS) XIV has formed a working group to develop a scientific consensus document on AI in pharmacovigilance, bringing together regulators, industry experts, and academia. The Pharmaceutical Inspecting Cooperation Scheme’s (PIC/S) Good Pharmacovigilance Practices (GVP) group is also considering establishing an expert circle dedicated to integrating AI and machine learning into pharmacovigilance processes.

 

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Pharmacovigilance Market Dynamics:

Unlocking the power of pharmacovigilance Drives Market Growth

The pharmacovigilance industry needs more efficient and effective drug safety practices. After the COVID-19 pandemic and the rapid development of vaccines have emphasized the critical importance of pharmacovigilance, as the global healthcare community seeks to ensure the safety and efficacy of new treatments under unprecedented circumstances. This urgency has led to the adoption of advanced technologies such as Artificial Intelligence (AI) and automation, which are transforming the pharmacovigilance landscape. One of the primary driving factors is the integration of AI into pharmacovigilance processes. AI systems have demonstrated their potential in enhancing drug safety monitoring by automating data analysis, identifying patterns in adverse drug reactions (ADRs), and predicting potential risks.

 

The majority of organisations utilizing AI in pharmacovigilance have created new roles and jobs for drug safety professionals. This indicates that AI is not only a tool for efficiency but also a catalyst for job creation and skill development in the industry. Even, the development of advanced pharmacovigilance platforms, such as the updated DrugCard, represents a leap forward in the field. These platforms provide users with sophisticated tools to navigate the complexities of drug safety monitoring, ensuring that patient safety remains a top priority setting new benchmarks for the Pharmacovigilance market development.

 

The growing emphasis is on developing more robust data management systems that handle the increasing volume and complexity of pharmacovigilance data. The use of advanced data management tools, such as cloud-based solutions, is becoming essential for efficiently collecting, analyzing, and interpreting data from multiple sources. On September 26, 2023, Bharat Serums and Vaccines Limited (BSV) launched the 'BSV AER' mobile application to enhance adverse event reporting.

 

This app, connected to BSV's pharmacovigilance system, allows Healthcare Professionals (HCPs), consumers, and company personnel to report potential adverse events electronically from anywhere in India. Designed for ease of use, BSV AER enables timely and accurate reporting, helping BSV’s medical team promptly assess and manage reported events. Ensuring data quality and accuracy is also paramount, as it directly impacts the ability to make informed decisions about drug safety and efficacy.

 

The evolving complexity of pharmaceuticals, particularly with the advent of biological medications and gene therapies, adds another layer of difficulty to pharmacovigilance efforts. In addition to technological innovations, companies are focusing on optimizing their investment in pharmacovigilance by balancing cost-efficiency with patient safety. The Indian Pharmacopoeia Commission (IPC) has issued a drug safety alert for mefenamic acid, warning of potential adverse reactions, including DRESS syndrome.

 

On Dec 12, 2023, Mefenamic acid, found in painkillers like Meftal, is used to treat conditions such as rheumatoid arthritis, osteoarthritis, and dysmenorrhoea. The IPC advises healthcare professionals, patients, and consumers to monitor for adverse reactions and report them to the Pharmacovigilance Programme of India (PvPI). Prolonged use of mefenamic acid increases the risk of stomach ulcers, bleeding, and cardiovascular issues, especially in individuals with pre-existing heart conditions.

 

Pharmacovigilance is viewed as a necessary cost of doing business, it is increasingly recognized as an asset that can inform drug discovery, enhance competitive differentiation, and guide protocol design. The companies are adopting best-in-class solutions, including Robotic Process Automation (RPA) and AI, to streamline pharmacovigilance operations. The global adoption of Lean Six Sigma methodologies and stage-gate review processes further enhances efficiency and ensures that pharmacovigilance activities are conducted with precision and compliance.

 

For instance, the launch of the new National Pharmacovigilance Network (RNF) on 20 June 2022 is a significant step toward enhancing drug safety monitoring in Italy. The primary goal of the RNF is to provide advanced functions for managing and analyzing suspected adverse drug reactions (ADRs). This upgrade aims to improve the accuracy of safety profile assessments for medicines, thereby boosting patient safety and optimizing treatment outcomes.

 

The Growing Volume of Adverse event cases and Increasing Disease Complexity Hampered the Pharmacovigilance Market Growth

The pharmacovigilance (PV) market faces several significant challenges as it evolves alongside advancements in technology and increasing global regulations. The major issue is data constraints, particularly when using AI programs that require vast amounts of sensitive health information. Protecting patient privacy by redacting identifying details such as names and birthdates complicates the process, making it difficult to train AI models effectively. Additionally, the language ambiguity inherent in medical jargon poses challenges for AI, which must be meticulously programmed to accurately interpret and translate complex PV data.

 

Inconsistent reporting of adverse events (AEs) further complicates the PV landscape. AEs may occur hours after drug administration, leading to underreporting by patients who fail to recognize and report these incidents to healthcare professionals. This is particularly concerning for drug manufacturers, as repeated reports of specific AEs could indicate potential safety issues. The growing volume of AE cases, driven by increasing disease complexity, adds another layer of difficulty in developing effective drugs with appropriate safety profiles in the Pharmacovigilance market.

 

System integration presents a significant hurdle for the industry. Many organizations struggle to incorporate new technologies like cloud computing into their existing systems, which lack standardization in medical domains, signal definitions, and coding. This lack of a standardized framework hampers the quality of signal analysis and complicates system integration. The rise of telehealth devices and social media introduces real-time data into AE identification systems, necessitating new PV protocols to evaluate this influx of information.

 

As more organizations utilize telehealth in research, the need for advanced analytics capabilities becomes increasingly critical. The global regulatory landscapes are becoming more complex, with increased scrutiny driving the need for enhanced PV capabilities. Evolving regulations, particularly in countries with emerging regulatory environments, further challenge the Pharmacovigilance market, requiring continuous adaptation and innovation.

 

Transforming Pharmacovigilance with Comprehensive Safety Assessments and Real-Time Monitoring

In USA, Pharmacovigilance has been significantly transformed by the integration of advanced technologies, leading to more efficient drug safety monitoring and enhanced patient care within the pharmacovigilance market. Among these, Artificial Intelligence (AI) and Machine Learning stand out by automating the analysis of vast datasets, such as electronic health records, social media, and scientific literature. These technologies rapidly identify potential adverse drug reactions (ADRs), drug interactions, and safety signals. Moreover, AI-driven algorithms can predict patient susceptibility to specific adverse effects, enabling personalized drug therapy and proactive intervention strategies in the pharmacovigilance market.

 

Natural Language Processing (NLP) further complements AI by enabling computers to interpret and understand human language. This is particularly valuable in mining unstructured data, such as medical narratives, case reports, and drug labels, within the pharmacovigilance market. NLP converts textual information into structured data, thereby automating adverse event reporting and signal detection. This automation reduces human errors and accelerates pharmacovigilance processes, ensuring quicker responses to emerging drug safety concerns.

 

The rise of big data analytics is another pivotal development in the pharmacovigilance market. With the exponential growth of healthcare data, powerful analytics tools are essential for identifying patterns and trends across diverse sources. This integration allows for comprehensive safety assessments and the detection of rare ADRs that might not be evident in smaller datasets. Big data analytics also support real-time monitoring of drug safety, enabling evidence-based decision-making for regulatory agencies and healthcare providers in the pharmacovigilance market.

 

Electronic Health Records (EHRs) offer a wealth of patient data that is invaluable for the pharmacovigilance market. By analyzing EHRs, healthcare professionals can swiftly identify ADRs and assess the effectiveness of specific drug therapies. EHRs are also crucial for post-marketing surveillance studies, contributing to the continuous evaluation of drug safety and efficacy in the pharmacovigilance market. Wearable devices and remote monitoring technologies provide new opportunities for pharmacovigilance by collecting real-time patient data, such as vital signs and physiological measurements. These devices enable early detection of adverse events and provide insights into drug effectiveness. When integrated with AI-powered analytics, wearable data enhance proactive risk management and personalized healthcare interventions in the pharmacovigilance market.

 

Blockchain technology offers a secure and transparent platform for managing pharmacovigilance data across the healthcare ecosystem. Its decentralized nature ensures data integrity, enhances traceability, and fosters collaboration among stakeholders while safeguarding patient privacy in the pharmacovigilance market. Additionally, blockchain facilitates the rapid exchange of safety information, enabling timely decision-making during drug safety crises. The mobile health applications empower patients to actively participate in pharmacovigilance by reporting adverse events and side effects directly. These apps also provide real-time safety alerts, promote medication adherence, and foster a safety-conscious patient community. Together, these technologies are revolutionizing the pharmacovigilance market growth, ensuring safer and more effective drug therapies.

 

The Pharmacovigilance Timeline

 

Pharmacovigilance Market Segment Analysis:

Based on Drug Development, the market is divided into Pre-clinical, Phase 1, Phase 2, Phase 3, and Phase 4. Phase 3 witnessed the highest market share in 2023 and continued its dominance in the forecast period. Phase 3 trials typically involve a higher number of participants compared to earlier phases, resulting in more comprehensive data on potential adverse drug reactions (ADRs) and long-term effects. This extensive data collection is essential for ensuring that any safety concerns are identified and addressed before the drug's approval for widespread use. Additionally, regulatory agencies require robust pharmacovigilance data from Phase 3 trials to support the drug approval process. The insights gained during this phase help regulatory bodies make informed decisions about the drug's safety and efficacy, impacting its market entry and post-marketing surveillance strategies.

 

The increasing complexity of Phase 3 trials, coupled with advancements in technology such as Artificial Intelligence (AI) and Machine Learning, has further bolstered the market share of this phase. These technologies enhance data analysis and signal detection, improving the accuracy and efficiency of pharmacovigilance activities. The integration of big data analytics and electronic health records (EHRs) also supports more effective monitoring and evaluation of drug safety during Phase 3 trials.

 

Based on region: North America witnessed the highest market share in 2023 and continued its dominance in the forecast period. The region's dominance is largely attributed to its advanced healthcare infrastructure, stringent regulatory standards, and substantial investment in pharmaceutical research and development. The United States, in particular, plays a critical role, with the FDA enforcing rigorous pharmacovigilance practices to ensure comprehensive monitoring and reporting of adverse drug reactions (ADRs). Canada's adherence to similar high standards through Health Canada further supports North America's market leadership. The integration of cutting-edge technologies such as Artificial Intelligence (AI), Machine Learning, and big data analytics significantly enhances North America's pharmacovigilance capabilities.

 

These technologies improve the efficiency of data analysis, signal detection, and real-time safety monitoring, reinforcing the region's position at the forefront of pharmacovigilance innovation. The strong collaboration among pharmaceutical companies, regulatory bodies, and research institutions in North America fosters continuous advancements in drug safety practices. North America's robust regulatory framework and technological advancements ensure its ongoing dominance in the pharmacovigilance market. The region's emphasis on patient safety and high standards of practice continue to drive its market share and growth prospects.

Pharmacovigilance Market Scope
Market Size in 2023	USD 6.87 Billion
Market Size in 2030	USD 16.16 Billion
CAGR (2024-2030)	13%
Historic Data	2018-2022
Base Year	2023
Forecast Period	2024-2030
Segments	By Drug Development Pre-clinical Phase 1 Phase 2 Phase 3 Phase 4
	By Service Provider In-house Contract outsourcing
	By End-use Pharmaceutical & biotechnological companies Medical device companies Hospitals Others
Regional Scope	North America- United States, Canada, and Mexico Europe – UK, France, Germany, Italy, Spain, Sweden, Russia, and Rest of Europe Asia Pacific – China, India, Japan, South Korea, Australia, ASEAN, Rest of APAC Middle East and Africa - South Africa, GCC, Egypt, Nigeria, Rest of the Middle East and Africa South America – Brazil, Argentina, Rest of South America

 

Pharmacovigilance Market Key Players:

1. Oracle Corporation – (United States)
2. IBM Watson Health – (United States)
3. Veeva Systems Inc. – (United States)
4. Parexel International Corporation – (United States)
5. Charles River Laboratories – (United States)
6. Wipro Limited – (India)
7. Cognizant Technology Solutions – (United States)
8. Sage Bionetworks – (United States)
9. Pharmacovigilance Solutions (PVS) – (United Kingdom)
10. BioClinica – (United States)
11. Vigilare – (France)
12. Accenture – (Ireland)
13. Syneos Health – (United States)
14. Medpace – (United States)
15. Triton Compliance – (Germany)
16. QPS Holdings, LLC – (United States)
17. KCR – (Poland)
18. PRA Health Sciences – (United States)
19. Clintara – (United States)