USD 182.3 Million
Pharmacovigilance and Drug Safety Software Market Size, Share, Growth Analysis, By Functionality (Adverse Event Reporting Software, Drug Safety Audits Software), By Deployment Mode (On Premise, Cloud), By End User (Pharma and Biotech Companies, BPO), By Region - Industry Forecast 2025-2032
Report ID:
SQMIG35G2302 |
Region:
Global |
Published Date: November, 2024
Pages:
207
|Tables:
88
|Figures:
71
Pharmacovigilance and Drug Safety Software Market Insights
Pharmacovigilance and Drug Safety Software Market size was valued at USD 194.33 Million in 2023 and is poised to grow from USD 214.73 Million in 2024 to USD 358.06 Million by 2032, growing at a CAGR of 10.5% during the forecast period (2025-2032).
The global pharmacovigilance and drug safety software refers to specialized computer programs designed to improve tracking, analysis, checks and reports related to Adverse Drug Reactions (ADRs) and other drug safety issues. In Romania on its part, software programs for pharmacovigilance are crucial in ensuring safe and efficient use of medicines by monitoring their effectiveness and side effects. These software tools can facilitate collection, management and analysis of big data on drug safety by pharmaceutical companies, regulatory agencies and healthcare professionals. Moreover, they can identify potential risks and trends which enable timely interventions and risk minimization strategies.
Primary users of the PV software include large pharmacovigilance solution providers, BPOs, and contract research organizations (CROs). The market's future is being shaped by many forces, possibilities, and constraints. The global pharmacovigilance and drug safety software market has been driven by several significant factors, one of which is the rising prevalence of adverse drug reactions. Additionally, the market's future has been brightened by the growing rate at which outsourcing organizations are adopting this kind of software. However, the FDA, EMEA, and other government agencies have stepped up their pressure on biotechnology and pharmaceutical companies to produce safe medications. Additionally contributing to the industry's growing market share is the previously mentioned factor.
Market snapshot - 2024-2031
Global Market Size
Largest Segment
On Premise
Fastest Growth
Pharma and Biotech Companies
Growth Rate
10.5%
Global Pharmacovigilance And Drug Safety Software Market ($ Bn)
Country Share by North America (%)
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Pharmacovigilance and Drug Safety Software Market Segmental Analysis
Global Pharmacovigilance and Drug Safety Software Market is segmented by Function, Deployment Mode, End User and region. Based on Function, the market is segmented into Adverse Event Reporting Software, Drug Safety Audits Software, Issue Tracking Software and Fully Integrated Software Based on Deployment Mode, the market is segmented into On Premise and Cloud. Based on end user, the market is segmented into Pharma and Biotech Companies, Contract Research Organizations, Business Process Outsourcing and Other. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & and Africa.
Analysis by Functionality
As per categorization by functionality, the market is classified as adverse event reporting software, drug safety audits software, issue tracking software and fully integrated software. Among these, adverse event reporting software earned the largest share and continues to dominate the market. AI is revolutionizing the way adverse event reporting software works through automated reporting, real-time data analysis, and enhanced regulatory compliance. It is being exalted in the pharmacovigilance industry due to the global obligation to monitor adverse drug reactions to ensure patients are safe and adhere to the strictest regulations in pharmaceutical companies across the world.
The global pharmacovigilance and drug safety software market is going to see the fastest growth in the sub-segment of fully integrated software as it can bring together various drug safety functions such as adverse event reporting, audits, and issue tracking. This streamlining of workflows cuts down on cost and improves efficiency of pharmaceutical companies making them an increasingly attractive option. There has been rapid adoption driven by the demand for integrated, hence scalable solutions as regulatory requirements have become more complex while safety data volumes have increased drastically.
Analysis by Product
Pharma and biotech companies are innovating pharmacovigilance by leveraging AI-driven analytics, real-time safety monitoring, and cloud-based platforms to manage drug safety across global markets. Due to their main duties for regulatory conformity, pharmaceutical safety data reporting and assuring patient safety in drug growth, they have taken over the business.
Contract Research Organizations (CROs) are the fastest-growing sub-segment in the global pharmacovigilance and drug safety software market due to the increasing trend of outsourcing drug safety activities. The contract research organizations (CROs) increasingly become key players in the management of clinical trials, regulatory compliance and adverse event reporting as pharmaceutical companies look for cost effective solutions with flexibility. Regulatory compliance and efficiency enhancement make the CROs a major growth driver due to their technology infrastructure supporting global drug safety operations incorporated with AI powered analytics.
Global Pharmacovigilance And Drug Safety Software Market By Functionality (%)
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Pharmacovigilance and Drug Safety Software Market Regional Insights
The reason that North America continues to maintain its industry leadership position in the global pharmacovigilance and drug safety software market is due to its vigorous pharmaceutical sector, strict regulations, and sophisticated healthcare delivery systems. Leading producers of medicines and biological products are in the region where there are highly progressive bodies such as The Food and Drug Administration (FDA), which promote high pharmacovigilance solution requirement levels. Additionally, North America’s focus on technological innovation, including AI, cloud-based platforms, and real-time drug safety monitoring, enhances the efficiency of drug safety practices. The high volume of clinical trials, coupled with a growing emphasis on patient safety and regulatory compliance, further solidifies the region’s leadership in the market.
The fastest-growing region in the global pharmacovigilance and drug safety software market is Europe, given its strict regulatory framework guided by EMA and increased emphasis on the safety of medicines. Growing pharmaceutical and biotech industries in this region, accompanied by rising clinical trial activities are some of the factors that have led to a rise in demand for advanced pharmacovigilance solutions. The growing marketing rush is also driven by the increasing usage of digital technologies such as AI and machine learning in adverse events reporting and safety monitoring. One major factor supporting this market's growth in Europe is the effort to enhance patient safety, compliance with emerging regulations and innovation in drug safety practices.
Global Pharmacovigilance And Drug Safety Software Market By Geography
- Largest
- Fastest
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Pharmacovigilance and Drug Safety Software Market Dynamics
Drivers
Regulatory Compliance
- Increasing demand for pharmacovigilance and drug safety software is driven by strict global regulations from agencies like FDA, EMA, etc. Adverse event reporting and drug safety monitoring have become mandatory for pharmaceutical firms to be compliant; thereby creating an undying need for reliable and scalable software solutions that eases managing the regulatory requirements.
Rising Drug Development Activities
- As the number of clinical trials and drug development initiatives continue to grow, especially for new therapies and vaccines, safety data volume has surged. This creates a pressing need for advanced pharmacovigilance and drug safety software so adverse events can be managed and analyzed effectively to guarantee the patient’s safety throughout the drug’s development process.
Restraints
Complex Integration with Existing Systems
- Integrating novel pharmacovigilance and safe drug software with current systems and workflows is usually complex and disruptive. Data migration must be done amicably for it to work well with older, more established systems that may not be as useful as before. In this case, companies might take longer than expected to get new advanced solutions as they are just too expensive for them.
Regulatory Variability Across Regions
- Uneven regulatory requirements and standards across various regions pose significant challenges to the design and implementation of pharmacovigilance and drug safety software. To comply with different regulatory requirements, firms must customize their systems, which increases development costs and extends the implementation time, particularly for international businesses.
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Pharmacovigilance and Drug Safety Software Market Competitive Landscape
At the international arena several notable organizations are witnessed in terms of competition within global pharmacovigilance and drug safety software market. They are typified by Oracle whose pharmacovigilance solutions are strong; Veeva Systems known for its all-inclusive drug safety administration systems; ArisGlobal which provides sophisticated pharmaceuticals safety applications as well as clinical trial programs. Through improving technology field, integrating facilities and compliance functionalities these firms stimulate invention causing an increase in rivalry thus determining how the sector operates.
Top Player’s Company Profiles
- Oracle Corporation
- Veeva Systems Inc.
- AB-Cube
- ArisGlobal
- SAP SE
- Parexel International Corporation
- Accenture plc
- PharmaLex GmbH
- Cognizant Technology Solutions
- Ennov
- Lachman Consultants
- PAREXEL International Corporation
- Qualogy
- Roche
- IBM Corporation
- IQVIA
- United BioSource (UBC)
- Laboratory Corporation of America Holdings
- ICON Plc.
- Capgemini
Recent Developments
- In August 2024, In the latest update of Oracle Argus Safety 8.0, Oracle Corporation has improved its pharmacovigilance and drug safety software by incorporating advanced AI and machine learning capabilities. This enhancement ensures that reporting on adverse events is made easier, data analysis accuracy is improved, and there is swifter compliance with changing regulations.
- In June 2024, Veeva’s Tower reports about Veeva Vault Safety, an advanced platform that offers real-time analytics and automated risk assessment. It provides complete insights as well as streamlined workflows for managing adverse events and safety data for proper drug monitoring and adherence to rules.
- In April 2024, ArisGlobal released its LifeSphere Safety 7.2, introducing state-of-the-art natural language processing tools. Thus, this will make it easier to extract data from unstructured data sources and hence improve the efficiency of adverse event reporting and regulatory compliance. In addition, this update includes options for advanced integration with other clinical and safety systems.
Pharmacovigilance and Drug Safety Software Key Market Trends
- Integration of AI and Machine Learning: AI and machine learning technologies are being increasingly incorporated into the global pharmacovigilance and drug safety software market. These developments contribute to better data analysis, automation of adverse event reporting, and enhanced predictive analytics, which results in improved efficiency and accuracy in drug safety management and compliance.
- Shift Towards Cloud-Based Solutions: The adoption of cloud-based pharmacovigilance and drug safety software is on the rise due to their scalability, cost-effectiveness and accessibility. With cloud platforms, it is possible to share data in real-time, integrate seamlessly and collaborate effectively across different countries; thus ensuring that drugs are safer and conform to regulations.
Pharmacovigilance and Drug Safety Software Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, in conclusion, the global pharmacovigilance and drug safety software market is evolving rapidly due to advancements in technology and increasing regulatory demands. Machine learning and artificial intelligence amalgamations for example are changing data analysis processes and adverse event reporting, while movement to cloud solutions gives way to flexibility and effectiveness.
Despite challenges like high implementation costs and complex system integrations, the market is expanding with notable contributions from key players like Oracle, Veeva Systems, and ArisGlobal. With significant growth in regions like Europe and North America, the industry is set for continued advancements and market expansion.
| Report Metric | Details |
|---|---|
| Market size value in 2022 | USD 182.3 Million |
| Market size value in 2031 | USD 324.04 Million |
| Growth Rate | 10.5% |
| Base year | 2023 |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Million |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Pharmacovigilance and Drug Safety Software Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Pharmacovigilance and Drug Safety Software Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Pharmacovigilance and Drug Safety Software Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Pharmacovigilance and Drug Safety Software Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Pharmacovigilance and Drug Safety Software Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Pharmacovigilance and Drug Safety Software Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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