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Muni Kumar Meravath is a seasoned Healthcare Market Research Analyst with over 6 years of experience in the healthc.....
Drug Safety Software Market By Mode of Delivery By End User and Geography
Drug Safety Software Market By Mode of Delivery By End User and Geography
Drug Safety Software Market size was valued at US$ 312.3 million in 2023 and is expected to grow at a 6.6% CAGR from 2024 to 2030. Drug Safety Software, also known as Pharmacovigilance Software, is a specialized tool designed to monitor, detect, assess, and prevent adverse effects of pharmaceutical products. It helps healthcare organizations and pharmaceutical companies manage the safety of drugs throughout their lifecycle, from clinical trials to post-market surveillance. The volume of Individual Case Safety Reports (ICSRs) has been growing at an annual rate of 30-35% globally, putting immense pressure on pharmacovigilance teams and driving the demand for efficient drug safety software solutions. The rising occurrence of adverse drug reactions and medication errors emphasizes the significance of pharmacovigilance and drug safety protocols. Pharmacovigilance software facilitates the effective identification, documentation, and examination of adverse events, aiding pharmaceutical firms and healthcare entities in managing risks and improving patient safety.
However, ensuring regulatory compliance stands as the most crucial hurdle in drug safety software implementation. Regulatory bodies such as the FDA and EMA impose strict guidelines on pharmacovigilance activities. Any non-compliance can lead to severe consequences such as fines, product recalls, and reputational damage. North America region held the major market share in 2023 and is expected to dominate the global market in the forecasted years.
In August 2023, Parexel and Partex announced Innovative Alliance Leveraging Artificial Intelligence and Big Data to Accelerate Drug Discovery and Development.
In December 2021, Oracle Corporation acquired Cerner Corporation. The underlying reasons for the acquisition were:
Study Period
2024-2030Base Year
2023CAGR
6.6%Largest Market
North AmericaFastest Growing Market
North America
The rising incidence of Adverse Drug Reactions (ADRs) drives the drug safety software market. These systems are crucial for managing drug safety and pharmacovigilance, providing real-time data on adverse events and potential risks. With ADRs being a significant cause of morbidity and mortality worldwide, accounting for approximately 5% of all hospital admissions, the demand for drug safety monitoring is increasing. The growing complexity of drug development further contributes to this trend.
Additionally, the increasing adoption of pharmacovigilance software by outsourcing companies is boosting market growth. Contract Research Organizations (CROs) and Business Process Outsourcing (BPO) firms are increasingly utilizing these systems to manage large volumes of safety data efficiently. Technological advancements in AI and machine learning, along with regulatory requirements for systematic post-market surveillance, have also increased the adoption of drug safety software in pharmaceutical companies and healthcare facilities.
The North America Drug Safety Software Market accounted for the largest share of the market holding 39.7% of the total market share and is expected to retain its dominance in forecasted years. A growing number of clinical trials & Government initiatives such as providing open access to its database for application developers and scientists solidifies North America's preeminent position in this market. Asia Pacific is likely to grow at a CAGR of 6.1%, it’s because of the large patient pool & Growing emphasis on medication safety, leading to growth in demand for clinical trials has been directed toward a growing emphasis on pharmacovigilance and drug safety software.
Latin America
Europe
Asia Pacific
Middle East
North America
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Report Benchmarks |
Details |
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Report Study Period |
2024-2030 |
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Market Size in 2023 |
US$ 312.3 million |
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Market CAGR |
6.6% |
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By Functionality |
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By End User |
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By Region |
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The global drug safety software market size was valued at US$ 312.3 million in 2023 and is projected to grow at a significant CAGR of 6.6% from 2024-2030.
The globalization of clinical trials coupled with the rising incidence of adverse events is creating significant opportunities for companies to enhance their revenue over the forecast years.
IQVIA, Accenture, Cognizant, Sparta Systems, Inc., Laboratory Corporation of America Holdings, IBM, ICON Plc., Capgemini, Oracle, Parexel International Corporation, Ennov Solutions Inc., Extedo GmbH, United BioSource Corporation, Ab Cube, ArisGlobal are a few companies operating in drug safety software market.
The integration of artificial intelligence (AI) and machine learning (ML) into drug safety software and the rising adoption of cloud-based drug safety software stand out as significant trends within the drug safety software market.
| 1.Executive Summary |
| 2.Global Drug Safety Software Market Introduction |
| 2.1.Global Drug Safety Software Market - Taxonomy |
| 2.2.Global Drug Safety Software Market - Definitions |
| 2.2.1. By Mode of Delivery |
| 2.2.2. By End-user |
| 2.2.3. By Region |
| 3.Global Drug Safety Software Market Dynamics |
| 3.1. Drivers |
| 3.2. Restraints |
| 3.3. Opportunities/Unmet Needs of the Market |
| 3.4. Trends |
| 3.5. Product Landscape |
| 3.6. New Product Launches |
| 3.7. Impact of COVID 19 on Market |
| 4.Global Drug Safety Software Market Analysis, 2019 - 2023 and Forecast 2024 - 2030 |
| 4.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million) |
| 4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) |
| 4.3. Market Opportunity Analysis |
| 5.Global Drug Safety Software Market By Mode of Delivery, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million) |
| 5.1. Cloud-Based |
| 5.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million) |
| 5.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.1.3. Market Opportunity Analysis |
| 5.2. On-Premises |
| 5.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million) |
| 5.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.2.3. Market Opportunity Analysis |
| 6.Global Drug Safety Software Market By End-user, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million) |
| 6.1. Pharmaceutical and Biotechnology Companies |
| 6.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million) |
| 6.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 6.1.3. Market Opportunity Analysis |
| 6.2. Contract Research Organizations |
| 6.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million) |
| 6.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 6.2.3. Market Opportunity Analysis |
| 6.3. Pharmacovigilance Service Providers |
| 6.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million) |
| 6.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 6.3.3. Market Opportunity Analysis |
| 7.Global Drug Safety Software Market By Region, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million) |
| 7.1. North America |
| 7.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million) |
| 7.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 7.1.3. Market Opportunity Analysis |
| 7.2. Europe |
| 7.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million) |
| 7.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 7.2.3. Market Opportunity Analysis |
| 7.3. Asia Pacific (APAC) |
| 7.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million) |
| 7.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 7.3.3. Market Opportunity Analysis |
| 7.4. Middle East and Africa (MEA) |
| 7.4.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million) |
| 7.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 7.4.3. Market Opportunity Analysis |
| 7.5. Latin America |
| 7.5.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million) |
| 7.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 7.5.3. Market Opportunity Analysis |
| 8.North America Drug Safety Software Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million) |
| 8.1. Mode of Delivery Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
| 8.1.1.Cloud-Based |
| 8.1.2.On-Premises |
| 8.2. End-user Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
| 8.2.1.Pharmaceutical and Biotechnology Companies |
| 8.2.2.Contract Research Organizations |
| 8.2.3.Pharmacovigilance Service Providers |
| 8.3. Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
| 8.3.1.United States of America (USA) |
| 8.3.2.Canada |
| 9.Europe Drug Safety Software Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million) |
| 9.1. Mode of Delivery Analysis and Forecast by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
| 9.1.1.Cloud-Based |
| 9.1.2.On-Premises |
| 9.2. End-user Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
| 9.2.1.Pharmaceutical and Biotechnology Companies |
| 9.2.2.Contract Research Organizations |
| 9.2.3.Pharmacovigilance Service Providers |
| 9.3. Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
| 9.3.1.Germany |
| 9.3.2.France |
| 9.3.3.Italy |
| 9.3.4.United Kingdom (UK) |
| 9.3.5.Spain |
| 10.Asia Pacific (APAC) Drug Safety Software Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million) |
| 10.1. Mode of Delivery Analysis and Forecast by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
| 10.1.1.Cloud-Based |
| 10.1.2.On-Premises |
| 10.2. End-user Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
| 10.2.1.Pharmaceutical and Biotechnology Companies |
| 10.2.2.Contract Research Organizations |
| 10.2.3.Pharmacovigilance Service Providers |
| 10.3. Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
| 10.3.1.China |
| 10.3.2.India |
| 10.3.3.Australia and New Zealand (ANZ) |
| 10.3.4.Japan |
| 10.3.5.Rest of APAC |
| 11.Middle East and Africa (MEA) Drug Safety Software Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million) |
| 11.1. Mode of Delivery Analysis and Forecast by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
| 11.1.1.Cloud-Based |
| 11.1.2.On-Premises |
| 11.2. End-user Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
| 11.2.1.Pharmaceutical and Biotechnology Companies |
| 11.2.2.Contract Research Organizations |
| 11.2.3.Pharmacovigilance Service Providers |
| 11.3. Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
| 11.3.1.GCC Countries |
| 11.3.2.South Africa |
| 11.3.3.Rest of MEA |
| 12.Latin America Drug Safety Software Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million) |
| 12.1. Mode of Delivery Analysis and Forecast by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
| 12.1.1.Cloud-Based |
| 12.1.2.On-Premises |
| 12.2. End-user Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
| 12.2.1.Pharmaceutical and Biotechnology Companies |
| 12.2.2.Contract Research Organizations |
| 12.2.3.Pharmacovigilance Service Providers |
| 12.3. Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) |
| 12.3.1.Brazil |
| 12.3.2.Mexico |
| 12.3.3.Rest of LA |
| 13. Competition Landscape |
| 13.1. Market Player Profiles (Introduction, Brand/Product Sales, Financial Analysis, Product Offerings, Key Developments, Collaborations, M & A, Strategies, and SWOT Analysis) |
| 13.2.1.Aris Global LLC |
| 13.2.2.IQVIA |
| 13.2.3.Wipro |
| 13.2.4.Accenture |
| 13.2.5.Oracle |
| 13.2.6.Parexel International (MA) Corporation |
| 13.2.7.Sparta Systems [Honeywell International Inc.] |
| 13.2.8.ICON PLC |
| 13.2.9.Cognizant |
| 13.2.10.AB Cube S.A.S |
| 14. Research Methodology |
| 15. Appendix and Abbreviations |
Key Market Players
Author
Muni Kumar Meravath is a seasoned Healthcare Market Research Analyst with over 6 years of experience in the healthcare domain, encompassing pharmaceuticals, medical devices, and diagnostics. A graduate in Pharmacy, he possesses a strong foundation in the intricacies of the healthcare sector. He further enhanced his expertise by pursuing an MBA in Pharmaceuticals, equipping him with valuable business acumen. His analytical skills and market insights have contributed to strategic decision-making and enhanced market positioning for various healthcare organizations. Committed to driving innovation and excellence, Muni continues to seek opportunities to improve healthcare delivery through data-driven insights.