Summary

The Europe pharmacovigilance and drug safety software market size was valued at US$ 52.37 million in 2023 and is expected to reach US$ 84.66 million by 2031; it is estimated to record a CAGR of 6.2% from 2023 to 2031.

Cloud-based pharmacovigilance and drug safety software is likely to remain a key market trend.

Unlike traditional systems, cloud-based platforms offer real-time access to data from anywhere across Europe, enabling pharmaceutical companies to respond swiftly to emerging safety concerns. Cloud-based platforms enable real-time monitoring of adverse events that allow pharmaceutical companies to detect and respond to safety signals more quickly. With real-time data access, companies can generate safety reports on demand, significantly reducing the time required for decision-making. This immediacy is crucial in preventing adverse events from escalating into serious public health issues. Also, one of the most significant advantages of cloud-based drug safety solutions is their scalability. As a company grows or as the volume of data increases, the cloud platform can scale accordingly without requiring additional infrastructure investments. This flexibility is particularly important in pharmacovigilance, where the volume of data can fluctuate significantly depending on the stage of the drug's lifecycle. Cloud-based systems are enabling the creation of global pharmacovigilance networks, where data can be shared across borders in real-time. These networks will enable more comprehensive drug safety monitoring, with insights and safety signals being shared worldwide, leading to faster identification and mitigation of risks.

Cloud-based platforms enable real-time monitoring of adverse events, permitting pharmaceutical companies to detect and respond to safety signals more quickly. With real-time data access, companies can generate safety reports on demand, significantly reducing the time required for decision-making. This immediacy is crucial in preventing adverse events from escalating into serious public health issues. Various companies offer cloud-based pharmacovigilance and drug safety software, such as Clinevo Technologies, Sarjen Systems Pvt. Ltd, and others Therefore, cloud-based pharmacovigilance and drug safety software is expected to bring significant trends in the Europe pharmacovigilance and drug safety software market in the coming years.

The UK is witnessing advancements in the healthcare industry. The increased focus on digitizing healthcare and leveraging AI-powered analytics has fueled the adoption of pharmacovigilance and drug safety software in the country. Companies in the UK, including IQVIA, offer platforms that integrate AI and cloud solutions to improve real-time drug safety monitoring. These tools help organizations reduce the risks related to adverse reactions by using predictive analytics to preemptively identify potential issues, a critical feature in managing complex drug portfolios.

The Yellow Card Scheme is run by the Medicines and Healthcare Products Regulatory Agency (MHRA), where dentists, doctors, and hospital pharmacists are encouraged to report all serious suspected reactions to established medicines and suspected reactions to new medicines. In the UK, most doctors report directly to the National Regulatory Authority rather than pharmaceutical companies. In the UK, Good Pharmacovigilance Practice (GPvP) is the minimum standard required for monitoring the safety of medicines on sale to the public. Therefore, the abovementioned factors are expected to contribute to the pharmacovigilance and drug safety software market in the UK during the forecast period.

Based on form, the Europe pharmacovigilance and drug safety software market is segmented into standard and customized. The standard segment held the largest Europe pharmacovigilance and drug safety software market share. Standard pharmacovigilance and drug safety software refers to pre-configured, off-the-shelf solutions that provide a comprehensive set of tools designed to meet the general needs of drug safety monitoring. This software offers essential features such as adverse event reporting, case management, signal detection, risk management, and regulatory compliance. Standard software are typically aligned with global pharmacovigilance regulations, such as those from the EMA, FDA, and ICH, making them suitable for a wide range of organizations. These software are mostly user-friendly and come with built-in templates, workflows, and automation capabilities to simplify safe data processing.

They are cost-effective and can be deployed relatively quickly. However, as the software is not tailored to specific needs, it might lack flexibility in handling unique processes or local regulatory requirements. A few examples of standard solutions include Oracle Argus Safety and Veeva Vault Safety, which cater to the broad requirements of most pharmaceutical and biotech companies.

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 Europe pharmacovigilance and drug safety software market players that are profiled in this market study.

The overall Europe pharmacovigilance and drug safety software market size has been derived using both primary and secondary sources. Exhaustive secondary research has been conducted using internal and external sources to obtain qualitative and quantitative information related to the Europe pharmacovigilance and drug safety software market size. The process also helps obtain an overview and forecast of the market with respect to all the market segments. Also, multiple primary interviews have been conducted with industry participants to validate the data and gain analytical insights. This process includes industry experts such as VPs, business development managers, market intelligence managers, and national sales managers, along with external consultants such as valuation experts, research analysts, and key opinion leaders, specializing in the Europe pharmacovigilance and drug safety software market.

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Table of Contents

TABLE OF CONTENTS

1. Introduction 22
1.1 The Insight Partners Research Report Guidance. 22
1.2 Market Segmentation. 23
2. Executive Summary 25
2.1 Key Insights. 25
2.2 Market Attractiveness. 26
3. Research Methodology 27
3.1 Secondary Research. 29
3.2 Primary Research. 29
3.2.1 Hypothesis formulation: 30
3.2.2 Macro-economic factor analysis: 30
3.2.3 Developing base number: 30
3.2.4 Data Triangulation: 30
3.2.5 Country level data: 31
4. Europe Pharmacovigilance and Drug Safety Software Market Landscape 32
4.1 Overview. 32
4.2 PEST Analysis. 34
4.3 Ecosystem Analysis. 35
4.3.1 Software/Service Providers: 36
4.3.2 System Integrators: 36
4.3.3 Regulatory Bodies: 36
4.3.4 End-Users: 36
4.3.5 List of Vendors in the Value Chain. 37
5. Europe Pharmacovigilance and Drug Safety Software Market – Key Market Dynamics 38
5.1 Europe Pharmacovigilance and Drug Safety Software Market – Key Market Dynamics. 38
5.2 Market Drivers. 39
5.2.1 Rise in Incidences of Adverse Drug Reactions. 39
5.2.2 Globalization of Pharmacovigilance. 39
5.2.3 Surge in Drug Development Rates: 40
5.3 Market Restraints. 41
5.3.1 High Installation and Maintenance Costs. 41
5.4 Market Opportunities. 41
5.4.1 Integration of Software with AI, ML, and NLP. 41
5.5 Future Trends. 42
5.5.1 Cloud-Based Pharmacovigilance and Drug Safety Software: 42
5.6 Impact of Drivers and Restraints: 43
6. Europe Pharmacovigilance and Drug Safety Software Market Analysis 44
6.1 Europe Pharmacovigilance and Drug Safety Software Market Revenue (US$ Thousand), 2021–2031. 44
6.2 Europe Pharmacovigilance and Drug Safety Software Market Forecast and Analysis. 45
7. Europe Pharmacovigilance and Drug Safety Software Market Analysis – by Offering 46
7.1 Software. 48
7.1.1 Overview. 48
7.1.2 Software: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 49
7.2 Services. 50
7.2.1 Overview. 50
7.2.2 Services: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 50
8. Europe Pharmacovigilance and Drug Safety Software Market Analysis – by Deployment 51
8.1 Cloud. 53
8.1.1 Overview. 53
8.1.2 Cloud: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 53
8.2 On Premises. 54
8.2.1 Overview. 54
8.2.2 On Premises: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 54
9. Europe Pharmacovigilance and Drug Safety Software Market Analysis – by Enterprise Size 55
9.1 Large Enterprises. 56
9.1.1 Overview. 56
9.1.2 Large Enterprises: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 57
9.2 SMEs. 58
9.2.1 Overview. 58
9.2.2 SMEs: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 59
10. Europe Pharmacovigilance and Drug Safety Software Market Analysis – by Form 60
10.1 Standard. 62
10.1.1 Overview. 62
10.1.2 Standard: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 63
10.2 Customized. 64
10.2.1 Overview. 64
10.2.2 Customized: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 65
11. Europe Pharmacovigilance and Drug Safety Software Market Analysis – by Functionality 66
11.1 Signal and Risk Management 68
11.1.1 Overview. 68
11.1.2 Signal and Risk Management: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 69
11.2 Issue Tracking and Adverse Event Tracking. 70
11.2.1 Overview. 70
11.2.2 Issue Tracking and Adverse Event Tracking: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 70
11.3 Case Management 71
11.3.1 Overview. 71
11.3.2 Case Management: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 71
11.4 Clinical Safety Management and Clinical Trial Safety. 72
11.4.1 Overview. 72
11.4.2 Clinical Safety Management and Clinical Trial Safety: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 72
11.5 Quality and Compliance. 73
11.5.1 Overview. 73
11.5.2 Quality and Compliance: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 73
11.6 Medical Writing. 74
11.6.1 Overview. 74
11.6.2 Medical Writing: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 74
11.7 Audit Support and Training Compliance. 75
11.7.1 Overview. 75
11.7.2 Audit Support and Training Compliance: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 75
11.8 Healthcare Analytics. 76
11.8.1 Overview. 76
11.8.2 Healthcare Analytics: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 76
11.9 Others. 77
11.9.1 Overview. 77
11.9.2 Others: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 77
12. Europe Pharmacovigilance and Drug Safety Software Market Analysis – by End User 78
12.1 Pharmaceutical and Biotechnology Companies. 80
12.1.1 Overview. 80
12.1.2 Pharmaceutical and Biotechnology Companies: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 80
12.2 Contract Research Organizations. 81
12.2.1 Overview. 81
12.2.2 Contract Research Organizations: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 82
12.3 Business Process Outsourcing (BPO) Firms. 83
12.3.1 Overview. 83
12.3.2 Business Process Outsourcing (BPO) Firms: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 83
12.4 Others. 84
12.4.1 Overview. 84
12.4.2 Others: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 84
13. Europe Pharmacovigilance and Drug Safety Software Market – Country Analysis 85
13.1 Europe. 85
13.1.1 Europe Pharmacovigilance and Drug Safety Software Market 85
13.1.2 Europe Pharmacovigilance and Drug Safety Software Market Revenue and Forecast and Analysis – by Country. 86
13.1.2.1 Europe Pharmacovigilance and Drug Safety Software Market Revenue and Forecast and Analysis – by Country. 87
13.1.2.2 Germany: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 88
13.1.2.2.1 Germany: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Offering. 89
13.1.2.2.2 Germany: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Deployment 89
13.1.2.2.3 Germany: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Enterprise Size. 90
13.1.2.2.4 Germany: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Form.. 90
13.1.2.2.5 Germany: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Functionality. 91
13.1.2.2.6 Germany: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by End User 92
13.1.2.3 France: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 93
13.1.2.3.1 France: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Offering. 94
13.1.2.3.2 France: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Deployment 94
13.1.2.3.3 France: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Enterprise Size. 95
13.1.2.3.4 France: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Form.. 95
13.1.2.3.5 France: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Functionality. 96
13.1.2.3.6 France: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by End User 97
13.1.2.4 United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 98
13.1.2.4.1 United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Offering. 99
13.1.2.4.2 United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Deployment 99
13.1.2.4.3 United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Enterprise Size. 100
13.1.2.4.4 United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Form.. 100
13.1.2.4.5 United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Functionality. 101
13.1.2.4.6 United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by End User 102
13.1.2.5 Italy: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 103
13.1.2.5.1 Italy: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Offering. 104
13.1.2.5.2 Italy: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Deployment 104
13.1.2.5.3 Italy: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Enterprise Size. 105
13.1.2.5.4 Italy: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Form.. 105
13.1.2.5.5 Italy: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Functionality. 106
13.1.2.5.6 Italy: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by End User 107
13.1.2.6 Spain: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 108
13.1.2.6.1 Spain: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Offering. 109
13.1.2.6.2 Spain: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Deployment 109
13.1.2.6.3 Spain: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Enterprise Size. 110
13.1.2.6.4 Spain: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Form.. 110
13.1.2.6.5 Spain: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Functionality. 111
13.1.2.6.6 Spain: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by End User 112
13.1.2.7 Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 113
13.1.2.7.1 Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Offering. 114
13.1.2.7.2 Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Deployment 114
13.1.2.7.3 Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Enterprise Size. 115
13.1.2.7.4 Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Form.. 115
13.1.2.7.5 Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Functionality. 116
13.1.2.7.6 Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market Breakdown by End User 117
14. Competitive Landscape 118
14.1 Heat Map Analysis by Key Players. 118
14.2 Company Positioning & Concentration. 119
15. Industry Landscape 120
15.1 Overview. 120
15.2 Market Initiative. 120
15.3 Merger and Acquisition. 121
16. Company Profiles 122
16.1 ArisGlobal LLC. 122
16.1.1 Key Facts. 122
16.1.2 Business Description. 122
16.1.3 Products and Services. 123
16.1.4 Financial Overview. 123
16.1.5 SWOT Analysis. 124
16.1.6 Key Developments. 126
16.2 Max Application. 127
16.2.1 Key Facts. 127
16.2.2 Business Description. 127
16.2.3 Products and Services. 128
16.2.4 Financial Overview. 128
16.2.5 SWOT Analysis. 128
16.2.6 Key Developments. 129
16.3 Oracle Corp. 130
16.3.1 Key Facts. 130
16.3.2 Business Description. 130
16.3.3 Products and Services. 131
16.3.4 Financial Overview. 132
16.3.5 SWOT Analysis. 134
16.3.6 Key Developments. 136
16.4 Veeva Systems Inc. 137
16.4.1 Key Facts. 137
16.4.2 Business Description. 137
16.4.3 Products and Services. 138
16.4.4 Financial Overview. 139
16.4.5 SWOT Analysis. 141
16.4.6 Key Developments. 143
16.5 IQVIA Holdings Inc. 144
16.5.1 Key Facts. 144
16.5.2 Business Description. 144
16.5.3 Products and Services. 145
16.5.4 Financial Overview. 146
16.5.5 SWOT Analysis. 147
16.5.6 Key Developments. 149
16.6 ICON Plc. 150
16.6.1 Key Facts. 150
16.6.2 Business Description. 150
16.6.3 Products and Services. 151
16.6.4 Financial Overview. 152
16.6.5 SWOT Analysis. 153
16.6.6 Key Developments. 154
16.7 Cognizant Technology Solutions Corp. 155
16.7.1 Key Facts. 155
16.7.2 Business Description. 155
16.7.3 Products and Services. 156
16.7.4 Financial Overview. 157
16.7.5 SWOT Analysis. 158
16.7.6 Key Developments. 160
16.8 Accenture Plc. 161
16.8.1 Key Facts. 161
16.8.2 Business Description. 161
16.8.3 Products and Services. 162
16.8.4 Financial Overview. 163
16.8.5 SWOT Analysis. 165
16.8.6 Key Developments. 167
16.9 Syneos Health Inc. 168
16.9.1 Key Facts. 168
16.9.2 Business Description. 168
16.9.3 Products and Services. 169
16.9.4 Financial Overview. 170
16.9.5 SWOT Analysis. 172
16.9.6 Key Developments. 173
16.10 Genpact Ltd. 174
16.10.1 Key Facts. 174
16.10.2 Business Description. 174
16.10.3 Products and Services. 175
16.10.4 Financial Overview. 175
16.10.5 SWOT Analysis. 176
16.10.6 Key Developments. 177
16.11 AB Cube S.A.S. 178
16.11.1 Key Facts. 178
16.11.2 Business Description. 178
16.11.3 Products and Services. 179
16.11.4 Financial Overview. 179
16.11.5 SWOT Analysis. 179
16.11.6 Key Developments. 181
16.12 Laboratory Corp of America Holdings. 182
16.12.1 Key Facts. 182
16.12.2 Business Description. 182
16.12.3 Products and Services. 183
16.12.4 Financial Overview. 184
16.12.5 SWOT Analysis. 185
16.12.6 Key Developments. 187
16.13 Parexel International Corp. 188
16.13.1 Key Facts. 188
16.13.2 Business Description. 188
16.13.3 Products and Services. 189
16.13.4 Financial Overview. 190
16.13.5 SWOT Analysis. 190
16.13.6 Key Developments. 191
16.14 Qinecsa Solutions. 192
16.14.1 Key Facts. 192
16.14.2 Business Description. 192
16.14.3 Products and Services. 193
16.14.4 Financial Overview. 194
16.14.5 SWOT Analysis. 195
16.14.6 Key Developments. 197
16.15 Clinevo Technologies. 198
16.15.1 Key Facts. 198
16.15.2 Business Description. 198
16.15.3 Products and Services. 199
16.15.4 Financial Overview. 199
16.15.5 SWOT Analysis. 200
16.15.6 Key Developments. 201
17. Appendix 202
17.1 Word Index. 202
17.2 About the Insight Partners. 203