Pharmacovigilance Market Size & Share Analysis - Trends, Drivers, Competitive Landscape, and Forecasts (2025 - 2030)

Pharmacovigilance Market Size

Pharmacovigilance Market Trends & Growth Drivers

Increasing Prevalence of Chronic Conditions Driving Market Growth

• A major driver for the industry is the rising prevalence of chronic diseases.
• As per the National Cancer Institute (NCI), more than 16 million cancer survivors will exist in the U.S. by 2040.
• Additionally, the number of new cancer cases diagnosed per year is expected to rise by around 30 million each year.
• As the disease causes long-lasting and, often, excruciating pain, the demand for painkillers is rising. Thus, the rising number of cancer survivors and increasing drug demand are driving the market.
• Various other chronic conditions, such as cardiovascular diseases, diabetes, and autoimmune diseases, necessitate the use of drug combinations, which can cause ADRs. To deal with this problem, pharmacovigilance is used.
• Patients suffering from cardiovascular conditions can be prescribed a combination of antihypertensives, statins, and anticoagulants, each of which carries a unique set of side-effects.
• Likewise, people with diabetes may combine oral hypoglycemics and insulin, requiring close observation to prevent potentially dangerous interactions.
• Aside from that, the increasing manufacturing of new pharmaceuticals and the presence of a strict government regulatory framework are propelling the industry forward.
• The U.S. Food and Drug Administration and the European Medicines Agency, for example, develop regulatory standards for various stages of clinical studies. 
• Furthermore, the increasing government initiatives and charitable organizations' focus on drug safety awareness are adding to the market's growth.

Integration of AI and ML Is Key Trend in Market

• The use of advanced technology, particularly AI and ML, to improve medication safety reporting and monitoring is a key trend in the pharmacovigilance market.
• More efficiently than using conventional techniques, these tools can scan large, complicated datasets from a variety of sources, such as patient reports, electronic health records, and data from clinical trials, to identify patterns and ADRs.
• These technologies can offer significant insight into potential safety issues in the future by evaluating past data and identifying risk indicators, enabling more-proactive risk management.
• Moreover, the increasing use of NLP has made it possible for pharmacovigilance systems to gather and examine data from unstructured sources such as patient forums and social media.
• This extensive data collection, which incorporates a range of patient experiences and input, improves the comprehensiveness of safety monitoring.

Lack of Skilled Labor Is Major Challenge for Market

• As pharmacovigilance relies on advanced technologies like machine learning (ML) and artificial intelligence (AI), there is a need for specialized skills to manage and operate these systems.
• Organizations are unable to take full advantage of these technologies' potential to improve drug safety monitoring and analysis due to a lack of qualified staff with the necessary skills.
• Inadequate data analysis due to inexperienced analysts can cause safety signals to be overlooked and any threats to take longer to be detected.
• Moreover, skilled professionals are necessary to ensure the quality of the reports presented to regulatory bodies, manage follow-ups, and accurately document adverse events.

Pharmacovigilance Market Analysis

Product Life Cycle Analysis

• The phase IV category will hold the largest market share, of 40%, in 2024. This is a result of the large number of clinical trials performed to examine the efficacy and safety of a new drug.
• Furthermore, because it is a critical stage of clinical studies, where unexpected ADRs can be ascertained, the data gathered during this stage is of critical value.
• The phase III category is expected to grow significantly in the coming years because effective pharmacovigilance during phase III trials gives information regarding potential drug interactions as well as the safety and effectiveness of the drugs.
• Further, the spending on R&D and the rate of introduction of new drugs have both increased in the past two decades.
• For instance, PhRMA member companies have invested nearly USD 1 trillion dollars in R&D since 2000, establishing the biopharmaceutical sector as the most R&D-intensive industry in the U.S. economy.

The product life cycles analyzed in this report are:

• Pre-Clinical
• Phase I
• Phase II
• Phase III (Fastest-Growing Category)
• Phase IV (Largest Category)

Service Provider Analysis

• The third parties category will hold the larger market share, of 60%, in 2024 and it is expected to grow at a CAGR of 14.3% in the forecast period.
• This is because outsourcing pharmacovigilance services can be affordable and eliminate the requirement for a substantial upfront investment in staff and technology.
• Moreover, technologies such as ML and AI are used by third-party providers for signal detection and data processing.
• The precision and effectiveness of pharmacovigilance operations are improved by these technologies.
• Additionally, majority of the outsourcing companies are aware of international regulations and capable of ensuring compliance in a variety of legal contexts.

The service providers analyzed in this report are:

• In-House
• Third Parties (Larger and Faster-Growing Category)

Service Analysis

• The spontaneous reporting category will hold the largest market share in 2024 owing to its wide use in detecting significant, new, and rare ADRs, which is ascribed to its efficiency and cost-effectiveness.
• Furthermore, the reports generated using this method are frequently used by regulatory bodies and the pharmaceutical industry.
• It forms the backbone of most pharmacovigilance systems and continues to be a primary method for ADR reporting.
• EHR mining will grow fastest in the forecast period because of its capacity to swiftly and effectively analyze enormous volumes of data.
• It improves the capacity to identify and handle ADRs and offers real-time insights.
• Moreover, the integration of advanced analytics and ML with EHR systems has further driven growth in this area.

The services analyzed in this report are:

• Spontaneous Reporting (Largest Category)
• Intensified ADR Reporting
• Targeted Spontaneous Reporting
• Cohort Event Monitoring
• EHR Mining (Fastest-Growing Category)

Process Flow Analysis

• Based on process flow, signal detection will dominate the market in 2024 due to its role in enhancing drug safety through advanced data analysis.
• It employs advanced statistical techniques, ML, and AI to analyze ADR data to detect possible safety concerns.
• The need for signal detection is also growing as a result of the rising usage of global safety databases and patient-reported outcomes in providing a comprehensive view of drug safety.
• The growth in this category is also supported by the regulatory initiatives that encourage more-rigorous monitoring and reporting practices.

The process flow analyzed in this report are:

• Case Data Management
• Signal Detection (Largest and Fastest-Growing Category)
• Risk Management System

Therapeutic Area Analysis

• The oncology category will hold the largest share, in 2024.
• Monitoring the safety of cancer drugs is extremely important due to their side-effects.
• In oncology, these services aid in the prevention, detection, and management of drug-induced adverse effects, as well as the avoidance of unnecessary medical prescription orders.
• Patients should be aware of the side-effects of both traditional systemic anti-cancer medications and novel targeted therapy.
• Hence, the growing consumer awareness of cancer drugs and their symptoms is propelling the need for clinical trials.
• The FDA's Oncology Center of Excellence has been attempting to raise the standard of safety data collection and optimize safety monitoring procedures.
• This initiative reflects the growing recognition of the need for strong pharmacovigilance systems in oncology.
• Neurology is the fastest-growing category due to the rising incidence of neurological conditions, as well as the creation of new therapeutics, such as advanced medications for Alzheimer's disease.
• For instance, an estimated 6.9 million Americans age 65 and older are living with Alzheimer's in 2024. 

The therapeutic areas analyzed in this report are:

• Oncology (Largest Category)
• Neurology (Fastest-Growing Category)
• Cardiology
• Pulmonology
• Others

End User Analysis

• Pharmaceutical companies are the largest category in 2024 because drug safety monitoring is essential at every stage of the product lifecycle, from post-marketing surveillance to clinical trials.
• Pharmacovigilance is necessary for a wide range of ingredients of pharmaceuticals to guarantee patient safety and regulatory compliance.
• The necessity for strong pharmacovigilance is further highlighted by the recent developments in the pharmaceutical industry, such as the approval of novel high-risk medications and biologics.
• Biotechnology companies will grow fastest in the forecast period due to the quick development and commercialization of biotech products, such as customized medicines and diagnostic assays.
• The U.S. FDA provides detailed reports on the approval and monitoring of advanced therapies such as CAR-T cells.
• For instance, Kymriah (tisagenlecleucel) and other CAR-T therapies are closely monitored due to their complex safety profiles.
• This requirement for detailed safety monitoring highlights the growing role of pharmacovigilance in biotechnology.

The end users analyzed in this report are:

• Pharmaceutical Companies (Largest Category)
• Biotechnology Companies (Fastest-Growing Category)
• Medical Device Manufacturers
• Others

Regional Analysis

• Geographically, North America will generate the highest revenue of 45% in 2024 owing to the presence of developed healthcare infrastructure, high healthcare expenditure, and a growing number of advanced drug research studies.
• Moreover, the FDA has been strengthening its pharmacovigilance initiatives in the U.S. with the launch of the Risk Evaluation and Mitigation Strategies (REMS) initiative.
• This program ensures that the risks of certain drugs are properly managed, reflecting the region's commitment to comprehensive drug safety monitoring.
• The APAC region is expected to witness the fastest growth, of over 14.4%, during the forecast period, mainly on account of the improving healthcare infrastructure, increasing drug research, and rising prevalence of chronic pain in the region.
• The China National Medical Products Administration (NMPA) announced a 20% increase in clinical trials and drug approvals in 2023, demonstrating the country's substantial growth in spending in drug development.
• As more medications reach the market, this expansion will further fuel the need for pharmacovigilance services.

The regions and countries analyzed in this report are:

• North America (Largest Regional Market)
  • U.S. (Larger Country Market)
  • Canada (Faster-Growing Country Market)
• Europe
  • Germany
  • France
  • U.K. (Largest and Fastest-Growing Country Market)
  • Italy
  • Spain
  • Rest of Europe
• Asia-Pacific (APAC) (Fastest-Growing Country Market)
  • China (Largest and Fastest-Growing Country Market)
  • India
  • Japan
  • Australia
  • South Korea
  • Rest of APAC
• Latin America (LATAM)
  • Brazil (Largest and Fastest-Growing Country Market)
  • Mexico
  • Rest of LATAM
• Middle East and Africa (MEA)
  • Saudi Arabia
  • South Africa (Largest and Fastest-Growing Country Market)
  • Rest of MEA

Pharmacovigilance Market Share

The pharmacovigilance market is fragmented in nature because the market contains a mix of large multinational pharmaceutical companies, specialized pharmacovigilance service providers, and smaller regional firms. Each operator frequently has its specialty or area of expertise, adding to the overall fragmentation. Moreover, different nations have different pharmacovigilance regulations and standards. Due to the need of businesses to negotiate and comply with a variety of rules, these disparities lead to market fragmentation.

Pharmacovigilance Market News

• In May 2023, LEO Pharma and ICON entered into a strategic partnership to propel clinical trial execution within medical dermatology.
• In March 2023, Bristol Myers Squib Company set up a drug development center in Hyderabad.
• In February 2023, PAREXEL International Corporation introduced the Expert Series – New Medicines, Novel Insights. The series will offer insights from global experts analyzing drug development trends and providing evidence-based guidance to the biopharmaceutical industry.