According to Nova One Advisor, the global pharmacovigilance market size was exhibited at USD 7.55 billion in 2023 and is projected to hit around USD 13.78 billion by 2033, growing at a CAGR of 6.2% during the forecast period 2024 to 2033.
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The market is driven by the increasing prevalence of adverse drug reactions (ADRs) and drug abuse that require a combination of drugs. In addition, strict government regulatory frameworks for drug safety and an upward shift in the production of novel drugs are significantly driving the market growth.
The pharmacovigilance market deals with the process of prevention, understanding, assessment, and detection of adverse effects related to medical products and drugs. It includes monitoring the effects of medical drugs after they have been approved for marketing, especially looking into adverse effects and documenting information about hazards. The market consists of contract service providers, drug manufacturers, and regulatory authorities such as the FDA that monitor the safety of medical devices and marketed drugs. The increasing prevalence of chronic diseases, such as respiratory & cardiovascular diseases, diabetes, and cancers, has led to an increase in drug consumption globally.
According to the National Center for Biotechnology Information (NCBI), about 5% of total hospitalizations in Europe annually are due to ADR. Outsourced services include medical reporting, clinical trial data collection, medical writing, and other pharmacovigilance-associated services. Manufacturers are searching for ways to reduce operational expenses and costs by transitioning from fully integrated pharmaceutical companies to collaborative partnerships with service providers, which further anticipated to drives the market growth during the forecast period.
Pharmacovigilance Market Key Takeaways:
• Phase IV (post-marketing) segment dominated the overall pharmacovigilance market in the product life cycle segment with over 75.9% revenue share in 2023.
• The contract outsourcing segment held the largest market share of 60.4% in 2023.
• The spontaneous reporting segment dominated the market in 2023 with a share of 30.2%.
• The oncology segment dominated the pharmacovigilance market, with a share of 26.9% in 2023.
• The signal detection segment held the largest revenue share in 2023.
• The case data management segment is anticipated to grow at a lucrative CAGR in the coming years.
• The pharmaceuticals segment dominated the market with a revenue share of over 45.0% in 2023.
• The biotechnology companies segment is expected to grow at the fastest CAGR during the forecast period.
• North America dominated the pharmacovigilance market in 2023 and held the largest market share of over 32.5%.
Pharmacovigilance Market Growth Factors
• The rising drug consumption and increasing prevalence of adverse drug reactions are expected to boost the market growth.
• An increase in the trend of outsourcing pharmacovigilance services and the prevalence of drug toxicity contribute to market expansion.
• The increasing drug development activities in areas such as companion diagnostics, orphan drugs biosimilars, personalized medicines are further anticipated to drive the market growth.
• Increasing research and development activities and product launches in the field of vaccines and drugs are expected to boost market growth.
U.S. Pharmacovigilance Market Size, Share and Trends 2024 to 2033
The U.S. pharmacovigilance market size was exhibited at USD 188.60 million in 2024 and is projected to hit around USD 290.10 million by 2033, growing at a CAGR of 4.4% during the forecast period 2024 to 2033.
North America dominated the pharmacovigilance market share of over 33.0% in 2023. The market growth is attributed to the presence of a large number of pharmaceutical companies in this region.
The rise in associated ADRs and drug abuse is a leading cause of mortality and morbidity in the region. In addition, increasing concerns and awareness related to the safety of drugs are anticipated to enhance the growth of the pharmacovigilance market in the region.
U.S. Pharmacovigilance Market Trends
The U.S. held the highest market share in 2023, leading to a strict regulatory environment and high drug consumption. The U.S. FDA strictly regulates the initiatives for medical devices and drugs. Implementation of regulations and acts as Mitigation Strategy and Risk Evaluation Act to come out potential risks related to drug safety-associated events. Such factors are anticipated to drive the growth of the pharmacovigilance market in the U.S.
Asia Pacific to Witness Rapid Growth
Asia Pacific is expected to grow at significant growth during the forecast period. The region offers a significant cost-saving benefit, with savings ranging from 50% to 80% compared to established countries, thus leading to a rise in the number of clinical trials conducted in the region. Hence, the increasing demand for clinical trials has led to an increasing focus on drug safety and PV in the region. China, India, Japan, and South Korea are the major countries in the Asia Pacific.
China Pharmacovigilance Market Trends
China is the leading country when it comes to healthcare. The rising government initiatives, rising healthcare expenditure, and increasing prevalence of ADRs are likely to boost the market in China. The expansion of the biotechnology sector and the rising adoption of pharmacovigilance practices further drive the market growth in China. In addition, the growing disposable income and economic development make China the fastest-growing market in Asia Pacific.
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Segment Highlights
Pharmacovigilance Market Segment Insights
Service Provider Insights
The contract outsourcing segment held the largest market share of 60.4% in 2023. This is due to the rapid entry of multiple contract research organizations, which provide end-to-end clinical trial solutions. As contract outsourcing partners offer a flexible and balanced solution within cost-contained models, the segment is expected to grow fastest during the forecast period. Pharmacovigilance outsourcing encompasses intricate tasks, such as comprehensive risk management planning, Pharmacoeconomics, signal detection, and benefit-risk management.
Type Insights
The spontaneous reporting segment dominated the market in 2023 with a share of 30.2%, owing to its wide-scale usage in detecting new, serious, and rare ADRs efficiently & affordably. The increasing use of surveillance reports established through this process by pharmaceutical industries and regulatory authorities is responsible for the segment's dominance.
Therapeutic Area Insights
The oncology segment dominated the pharmacovigilance market, with a share of 26.9% in 2023. Pharmacovigilance in oncology deals with the assessment of safety data and specialized monitoring related to anticancer therapies and drugs. It includes the systematic analysis and collection of adverse events specific to oncology patients, identification of proactive risk management, and potential drug-related risks to ensure cancer treatment’s effective and safe use.
The rising number of research activities undertaken by the increasing government support to improve the living disorders of people living with cancer and several biopharmaceutical companies for cancer treatments driving the research activities expected the segment growth.
Process Flow Insights
The signal detection segment held the largest revenue share in 2023. Signal detection deals with signals and identifying various safety signals across plausible and registered healthcare data sources. Regulators require biopharmaceutical companies to balance spontaneous reporting signals and systems created from such systems.
The case data management segment is expected to grow at the fastest rate during the forecast period. Adverse event data can be produced from diverse modes including literature, post-marketing programs, clinical trials, and spontaneous reports. Furthermore, developing technologies such as machine learning and artificial intelligence are widely used for case data management.
End-user Insights
The pharmaceuticals segment dominated the market with a revenue share of over 45.0% in 2023. Pharmacovigilance helps pharmaceutical companies systematically evaluate, monitor, and collect safety data on their investigational products and marketed drugs. It supports the optimization and evaluation of drug safety profiles, promotes patient safety, and ensures compliance with regulatory requirements. In addition, pharmacovigilance enables pharmaceutical companies to reduce drug development costs.
Some of the prominent players in the pharmacovigilance market include:
• Accenture
• IQVIA Inc.
• Cognizant
• Clinquest Group B.V. (Linical Americas)
• IBM
• Laboratory Corporation of America Holdings
• ArisGlobal
• Capgemini
• ITClinical
• TAKE Solutions Limited
• Parexel International (MA) Corporation
• Wipro
• BioClinica Inc. (Clario)
• ClinChoice (formerly FMD K&L)
Pharmacovigilance Market Recent Developments
• In September 2024, Novo Nordisk Global Business Services (GBS) launched a sustainable initiative called Eco Med Safe. This launch aimed to promote the responsible and safe disposal of pharmaceutical products. This eco-pharmacovigilance initiative is designed to enhance public health and minimize environmental impact by safely disposing of expired or unused medicines.
• In September 2024, Truliant Consulting announced the launch of a white paper Automation and Artificial Intelligence in Pharmacovigilance. This white paper is the result of an open survey targeted to pharmaceutical companies to understand how they are implementing artificial intelligence (AI) in their Pharmacovigilance (PV) structures.
• In December 2023, a cloud-based data lake platform, CorEvidence, was launched by Thermo Fisher Scientific Inc. The aim behind this launch was to enhance CorEvitas clinical research registries offered by Thermo Fisher’s PPD clinical research business and designed to improve pharmacovigilance case processing and safety data management processes.
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Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the pharmacovigilance market
Product Life Cycle
• Pre-clinical
• Phase I
• Phase II
• Phase III
• Phase IV
Service Provider
• In-house
• Contract Outsourcing
Type
• Spontaneous Reporting
• Intensified ADR Reporting
• Targeted Spontaneous Reporting
• Cohort Event Monitoring
• EHR Mining
End Use
• Pharmaceuticals
• Biotechnology Companies
• Medical Device Manufacturers
• Others
Therapeutic Area
• Oncology
• Neurology
• Cardiology
• Respiratory Systems
• Others
Process Flow
• Case Data Management
o Case Logging
o Case Data Analysis
o Medical Reviewing & Reporting
• Signal Detection
o Adverse Event Logging
o Adverse Event Analysis
o Adverse Event Review & Reporting
• Risk Management System
o Risk Evaluation System
o Risk Mitigation System
Regional
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)
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