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The pharmacovigilance and drug safety software market size is expected to reach US$ 359.30 million by 2031 from US$ 214.39 million in 2023. The market is estimated to record a CAGR of 6.7% during 2023–2031. Cloud-based pharmacovigilance and drug safety software is likely to bring new key trends into the market in the coming years.
Pharmacovigilance and Drug Safety Software Market Analysis
The rising integration of technologies such as artificial intelligence and machine learning with pharmacovigilance and drug safety software to automate drug safety tasks is driving the market. Several key players are integrating these advanced technologies to automate the workflow in the pharmaceutical industry. For instance, in January 2024, PubHive Ltd., a provider of AI-powered scientific safety and literature information workflows, launched centralized Summary of Product Characteristics (SmPC) management software with AI-powered pharmacovigilance workflows for life science companies. The company offers its software to Clinical Research Organizations (CROs) and their pharmacovigilance and drug safety departments. This AI-based solution simplifies and streamlines processes and helps meet compliances, as well as empowers pharmacovigilance teams to work faster and more effectively.
Pharmacovigilance and Drug Safety Software Market Overview
Pharmacovigilance and drug safety software is a vital tool that addresses manual data entry errors and manages the huge volume of safety data, among various other challenges. From clinical trials to post-marketing surveillance, this software is indispensable throughout the drug development lifecycle. Pharmacovigilance and drug safety software helps reduce adverse event processing time and improve patient safety through early signal detection. As regulations evolve and collaboration between European companies intensifies, the adoption of pharmacovigilance and drug safety software will become imperative for pharmaceutical companies and regulatory bodies. In 2022, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) updated its guidelines on pharmacovigilance to adhere to international standards, highlighting the importance of robust pharmacovigilance and drug safety software. Also, in March 2024, The US Food and Drug Administration (FDA) provided guidance specifying the submission of investigational new drug (IND) safety reports for severe and suspected adverse events related to pharma drugs. These reports are submitted in electronic common technical document (eCTD) formats using PDF files. Further, the software ensures compliance with regulatory standards by facilitating the creation of comprehensive safety reports and submissions to regulatory authorities, which helps companies avoid penalties and maintain their reputation.
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Pharmacovigilance and Drug Safety Software Market: Strategic Insights
Market Size Value in US$ 160.67 Million in 2019 Market Size Value by US$ 292.97 Million by 2027 Growth rate CAGR of 7.6% from 2020-2027 Forecast Period 2020-2027 Base Year 2020
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Pharmacovigilance and Drug Safety Software Market: Strategic Insights
| Market Size Value in | US$ 160.67 Million in 2019 |
| Market Size Value by | US$ 292.97 Million by 2027 |
| Growth rate | CAGR of 7.6% from 2020-2027 |
| Forecast Period | 2020-2027 |
| Base Year | 2020 |
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Pharmacovigilance and Drug Safety Software Market Drivers and Opportunities
Rise in Incidences of Adverse Drug Reactions to Favor Market
The cases of adverse drug reactions (ADRs) are increasing worldwide owing to the increasing prevalence of chronic diseases. As all drugs have the potential for adverse drug reactions, a risk-benefit analysis is necessary whenever a drug is prescribed. ADRs remain a challenge in modern healthcare, particularly given the growing complexity of therapeutics, an aging population, and rising multimorbidity across the globe. Pharmacovigilance software enables healthcare providers and pharmaceutical companies to collect, analyze systematically, and report data related to ADRs and overcome the challenges associated with it. The increasing prevalence of ADRs across the globe is propelling the demand for pharmacovigilance and drug safety software. According to the database of ADRs available in the US Food and Drug Administration's Adverse Event Reporting System (FAERS), in 2022, more than 1.25 million severe adverse cases were reported, along with over 175,000 deaths.
ADRs are a major cause of the growing mortality death rate across the globe. According to the report of The European Union Drugs Agency (EUDA), in terms of overdoses, the mortality rate in the European Union in 2021 accounted for ~18.3 deaths per million people aged from 15 to 64. Also, at least 6,166 deaths caused by overdoses involving illicit drugs occurred in the European Union in 2021 (5,796 in 2020). This total reached ~6,677 deaths when Norway and Türkiye were included (6,434 in 2020).
Theophylline and respiratory depression exposure grows with the use of macrolide antibiotics and increased consumption of vitamin K, leading to ADRs. As more ADRs are reported and recognized, pharmaceutical companies, healthcare providers, and regulatory bodies face greater pressure to improve drug safety monitoring and reporting processes. Pharmacovigilance and drug safety software helps avoid the risks associated with excessive drug consumption. This software helps streamline the process of detecting, assessing, and preventing adverse effects, enabling faster response times and more accurate risk assessments. Thus, the rising incidences of adverse drug reactions fuel the global pharmacovigilance and drug safety software market growth.
Globalization of Pharmacovigilance
Pharmacovigilance is the process of monitoring and evaluating adverse drug reactions, and it is a major component of effective drug regulation systems, clinical practice, and public health programs. The globalization of pharmacovigilance fosters collaboration among stakeholders, including regulatory authorities, healthcare providers, and pharmaceutical companies. For instance, the European Medicines Agency (EMA) has placed a growing importance on collaborating with international pharmaceutical regulators to focus on areas such as the safety of medicines, inspections, and exchange of information on issues of mutual concern. Such a collaborative environment enhances data sharing and improves the overall understanding of drug safety profiles. As companies seek to leverage these global networks, the need for integrated pharmacovigilance solutions that can operate across the globe is becoming increasingly essential.
Governments of various countries across the globe are conducting pharmacovigilance programs by collaborating with regulatory bodies in their respective countries. Regulators understand the importance of pharmacovigilance in ensuring drug safety. For instance, in North America, the US FDA regulates guidelines, laws, and regulations to conduct several practices such as the Good Clinical Practice Program (GCP) and Good Pharmacovigilance Practice Program (GVP) applicable to biomedical products. Further, in September 2024, the Indian Pharmacopoeia Commission and Central Drugs Standard Control Organization published version 2.0 of their pharmacovigilance guidelines by enacting changes such as the extension of the deadline for reporting non-serious adverse ADRs events and revising the record-keeping requirements. Further, Malaysia's National Pharmaceutical Regulatory Agency published the second revised edition of its guidelines on bioequivalence and pharmacovigilance inspections. The agency provided more information on the drug inspection process and the scope of assessments related to drug evaluations. The Philippine Food and Drug Administration (FDA) has also published detailed actions in response to feedback on the registration of new drug products and to provide information on active pharmaceutical ingredients (APIs) for human usage.
Pharmacovigilance and Drug Safety Software Market Report Segmentation Analysis
Key segments that contributed to the derivation of the pharmacovigilance and drug safety software market analysis are offerings, organization size, deployment, form, functionality, and end user.
- Based on organization size, the Europe pharmacovigilance and drug safety software market is bifurcated into large enterprises and SMEs. The large enterprises segment dominated the market in 2023.
- In terms of offerings, the market is divided into software and services. The software segment held a larger share of the market in 2023.
- Based on deployment, the Europe pharmacovigilance and drug safety software market is bifurcated into cloud and on-premises. The cloud segment dominated the market in 2023
- Based on form, the Europe pharmacovigilance and drug safety software market is divided into standard and customized. The standard segment dominated the market in 2023.
- By functionality, the Europe pharmacovigilance and drug safety software market is segmented into case management, signal and risk management, quality and compliance, audit support and training compliance, issue tracking and adverse event tracking, clinical safety management and clinical trial safety, medical writing, healthcare analytics, and others. The signal and risk management segment held the largest share of the market in 2023.
- Based on end user, the Europe pharmacovigilance and drug safety software market is segmented into pharmaceutical and biotechnology companies, contract research organizations, business process outsourcing firms, and other pharmacovigilance service providers. The pharmaceutical and biotechnology companies segment dominated the market in 2023.
Pharmacovigilance and Drug Safety Software Market Share Analysis by Geography
The pharmacovigilance and drug safety software market is segmented into five major regions: North America, Europe, Asia Pacific (APAC), the Middle East & Africa (MEA), and South & Central America. North America dominated the market in 2023, followed by Europe and APAC.
North America is witnessing tremendous growth in the pharmacovigilance and drug safety software market, owing to the presence of various market players such as IQVIA Oracle Corporation, who are continuously working on the advancement of pharmacovigilance and drug safety software. In July 2024, Oracle Corporation launched an AI-based Oracle Argus platform as a Safety One Intake solution. This solution helps life science organizations to meet growing regulatory requirements as well as mitigate the rising volume of adverse event cases. This new pharmacovigilance platform aimed to increase productivity, improve data privacy, and enhance reporting. Thus, such product innovations by the market players in the region are fueling the growth of the pharmacovigilance and drug safety software market.
Pharmacovigilance and Drug Safety Software Market Report Scope
Pharmacovigilance and Drug Safety Software Market News and Recent Developments
The pharmacovigilance and drug safety software market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. A few of the key developments in the pharmacovigilance and drug safety software market are listed below:
- ArisGlobal, a market leader in global drug development technology solutions, announced that Medac, a German-based pharmaceutical manufacturer specializing in the fields of oncology and hematology, urology, and autoimmune diseases, chose LifeSphere Safety to modernize its drug safety processes. Precise, patient- and population-specific analysis is crucial for minimizing treatment risks for patients, which supports the best possible treatment outcome. (Source: ArisGlobal, Press Release, May 2023)
- IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, announced a strategic collaboration with Argenx to advance treatment to patients with rare autoimmune diseases through innovative and integrated technology-enabled pharmacovigilance (PV) safety services and solutions. (Source: IQVIA, Press Release, January 2023)
Pharmacovigilance and Drug Safety Software Market Report Coverage and Deliverables
The "Pharmacovigilance and Drug Safety Software Market Size and Forecast (2021–2031)" provides a detailed analysis of the market covering the areas mentioned below:
- Pharmacovigilance and drug safety software market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
- Pharmacovigilance and drug safety software market trends as well as market dynamics such as drivers, restraints, and key opportunities
- Detailed PEST and SWOT analysis
- Pharmacovigilance and drug safety software market analysis covering key market trends, global and regional framework, major players, regulations, and recent market developments
- Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments for the pharmacovigilance and drug safety software market
- Detailed company profiles
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Software Type ; Delivery Mode ; and End User , and Geography
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States
Frequently Asked Questions
Integration of cloud-based platforms that offers real-time access to data from anywhere across the globe, enabling pharmaceutical companies to respond swiftly to emerging safety concerns.
ArisEurope, ICON plc, Syneos Health, Accenture, IQVIA, Genpact, Cognizant, Paraxel International Corporation, Laboratory Corporation of America Holdings, Max Application, Clinevo Technologies, Qinecsa Solutions, AB Cube, and Veeva Systems are among the key players operating in the global pharmacovigilance and drug safety software market.
The pharmacovigilance and drug safety software market was valued at US$ 214.39 billion in 2023 and is anticipated to grow at a CAGR of 6.7% over the forecast period.
The rising cases of adverse drug reactions (ADRs) worldwide owing to the increasing prevalence of chronic diseases drives the market growth.
Asia Pacific is anticipated to grow at the fastest CAGR over the forecast period.
The software segment led the pharmacovigilance and drug safety software market with a significant share in 2023.
The pharmacovigilance and drug safety software market are expected to reach US$ 359.30 million by 2031 and is expected to register a CAGR of 6.7% during 2023–2031.
The List of Companies - Pharmacovigilance and Drug Safety Software Market
- ArisGlobal LLC
- Max Application
- Oracle Corp
- Veeva Systems Inc
- IQVIA Holdings Inc
- ICON Plc
- Cognizant Technology Solutions Corp
- Accenture Plc
- Syneos Health Inc
- Genpact Ltd.
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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