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% during 2023–2031. Cloud-based pharmacovigilance and drug safety software is likely to bring new key trends into the market in the coming years.
Europe Pharmacovigilance and Drug Safety Software Market Analysis
Pharmacovigilance and drug safety software ensures quick detection and assessment of adverse reactions associated with medications. By enhanced safety monitoring and automating data collection and analysis, the software expedites the identification of potential safety concerns, allowing for quick intervention to mitigate risks. This proactive approach enhances regulatory compliance, patient safety, and overall public health outcomes. Also, with the presence of advanced analytics and real-time monitoring capabilities, pharmacovigilance and drug safety software provide a strong framework for optimizing drug safety surveillance. The integration of AI and predictive analytics with pharmacovigilance and drug safety software enhances the capability to identify potential safety risks before they escalate into serious issues. These advanced technologies help analyze large volumes of structured and unstructured data to detect upcoming safety signals and trends, which triggers proactive risk mitigation strategies. Therefore, owing to various advantages, the demand for pharmacovigilance and drug safety software is increasing in Europe.
Europe Pharmacovigilance and Drug Safety Software Market Overview
Pharmacovigilance is the science of maintaining public health by ensuring the safety and efficacy of pharmaceutical products. Pharmacovigilance and drug safety software is a vital tool that addresses manual data entry errors, the overwhelming volume of safety data, and 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 as well as improve patient safety through early signal detection. As regulations evolve and European collaboration intensifies, the adoption of pharmacovigilance and drug safety software is advantageous, making it 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. 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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Europe Pharmacovigilance and Drug Safety Software Market: Strategic Insights
Market Size Value in US$ 40.5 Million in 2019 Market Size Value by US$ 71.1 Million by 2027 Growth rate CAGR of 7.1% from 2020-2027 Forecast Period 2020-2027 Base Year 2020
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Europe Pharmacovigilance and Drug Safety Software Market: Strategic Insights
| Market Size Value in | US$ 40.5 Million in 2019 |
| Market Size Value by | US$ 71.1 Million by 2027 |
| Growth rate | CAGR of 7.1% from 2020-2027 |
| Forecast Period | 2020-2027 |
| Base Year | 2020 |
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Europe Pharmacovigilance and Drug Safety Software Market Drivers and Opportunities
Rise in Incidences of Adverse Drug Reactions
In Europe, adverse drug reactions (ADRs) can be a significant cause of death and illness. 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 in Europe. Pharmacovigilance software enables healthcare providers and pharmaceutical companies to systematically collect, analyze, and report data related to ADRs and overcome the challenges associated with it.
ADRs are a major cause of rising mortality death rates in Europe. 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 population 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).
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. This necessitates the adoption of pharmacovigilance and drug safety software to collect, analyze, and manage the growing volume of safety data. 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 Europe pharmacovigilance and drug safety software market growth.
Integration of Software with AI, ML, and NLP
Artificial intelligence (AI), machine learning (ML), Natural Language Processing (NLP), and other technologies are transforming resource-intensive pharmacovigilance workloads, ensuring a more informed, more efficient approach. Pharmacovigilance and drug safety software platforms are mostly equipped with advanced analytics and AI capabilities that enhance the detection of safety signals. These tools can analyze vast amounts of data, identifying correlations and patterns that traditional methods might overlook. AI-driven predictive analytics can also forecast potential safety issues, allowing companies to take proactive measures. ML models are leveraged to predict potential adverse events associated with drug consumption. For instance, pharmacovigilance campaigns use ML to sift through vast datasets, detecting patterns that might indicate a risk of adverse drug reactions. ML algorithms are particularly adept at handling unstructured data, such as social media and patient records, to forecast safety concerns.
AI systems are progressively being used to advance real-time drug safety monitoring. This proactive surveillance includes clinical trial data, scanning medical literature, and patient registries for adverse events (AEs); it can also enhance the accuracy and speed of ADR detections. Further, utilizing NLP, AI systems can extract relevant information, such as drug names and symptoms, from vast textual datasets, enabling accurate and rapid adverse event reporting. This accelerates the identification of unknown or new drug safety issues, thereby significantly enhancing the advancements in pharmacovigilance efforts. Various companies offer AI-based pharmacovigilance and drug safety software, including ArisGlobal. Thus, the integration of pharmacovigilance and drug safety software with AI, ML, and NLP is expected to create lucrative opportunities for the market growth during the forecast period.
Europe Pharmacovigilance and Drug Safety Software Market Report Segmentation Analysis
Key segments that contributed to the derivation of the Europe 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.
Europe Pharmacovigilance and Drug Safety Software Market Share Analysis by Geography
The Europe pharmacovigilance and drug safety software market is segmented into France, Germany, Italy, Spain, the UK, and the Rest of Europe. The rising demand for pharmacovigilance and drug safety software in Europe is attributed to various factors, including regulatory requirements, increasing drug approvals, growing emphasis on patient safety, and advancements in technology. The EU's pharmacovigilance system is one of the most advanced in the world. The European Medicines Agency (EMA) and other regulatory bodies are imposing stringent pharmacovigilance requirements that necessitate the adoption of advanced software solutions. For instance, the introduction of the EU Pharmacovigilance Directive (2010/84/EU) and the subsequent Regulation (EU) No 1235/2010 have imposed stricter rules for the monitoring of adverse drug reactions (ADRs). Companies must report safety data in real time, significantly increasing the demand for efficient software systems capable of handling large volumes of data.
Europe Pharmacovigilance and Drug Safety Software Market Report Scope
Europe Pharmacovigilance and Drug Safety Software Market News and Recent Developments
The Europe 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 Europe 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 suffering from rare autoimmune diseases through innovative and integrated technology-enabled pharmacovigilance (PV) safety services and solutions. (Source: IQVIA, Press Release, January 2023)
Europe Pharmacovigilance and Drug Safety Software Market Report Coverage and Deliverables
The "Europe Pharmacovigilance and Drug Safety Software Market Size and Forecast (2021–2031)" provides a detailed analysis of the market covering the areas mentioned below:
- Europe pharmacovigilance and drug safety software market size and forecast at country levels for all the key market segments covered under the scope
- Europe pharmacovigilance and drug safety software market trends as well as market dynamics such as drivers, restraints, and key opportunities
- Detailed PEST and SWOT analysis
- Europe pharmacovigilance and drug safety software market analysis covering key market trends, 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 Europe 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, End User
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
UK, Germany, France, Italy, Russia
Frequently Asked Questions
The Europe pharmacovigilance and drug safety software market was estimated to be US$ 52.37 million in 2023 and is expected to grow at a CAGR of 6.2% during the forecast period 2023 - 2031.
Cloud-based pharmacovigilance and drug safety software, which is anticipated to play a significant role in the Europe pharmacovigilance and drug safety software market in the coming years.
Rise in incidences of adverse drug reactions, globalization of pharmacovigilance, surge in drug development rates are the major factors that propel the Europe pharmacovigilance and drug safety software market.
The key players holding majority shares in the Europe pharmacovigilance and drug safety software market are 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.
The incremental growth expected to be recorded for the Europe pharmacovigilance and drug safety software market during the forecast period is US$ 32.29 million.
The Europe pharmacovigilance and drug safety software market is expected to reach US$ 84.66 million by 2031.
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
List of Tables
Table 1. Europe Pharmacovigilance and Drug Safety Software Market Segmentation. 23
Table 2. List of Vendors. 37
Table 3. Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 45
Table 4. Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Offering. 47
Table 5. Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Deployment 52
Table 6. Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Enterprise Size. 56
Table 7. Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Form.. 61
Table 8. Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Functionality. 67
Table 9. Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by End User 79
Table 10. Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Country. 87
Table 11. Germany: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Offering. 89
Table 12. Germany: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Deployment 89
Table 13. Germany: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Enterprise Size. 90
Table 14. Germany: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Form.. 90
Table 15. Germany: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Functionality. 91
Table 16. Germany: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by End User 92
Table 17. France: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Offering. 94
Table 18. France: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Deployment 94
Table 19. France: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Enterprise Size. 95
Table 20. France: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Form.. 95
Table 21. France: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Functionality. 96
Table 22. France: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by End User 97
Table 23. United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Offering. 99
Table 24. United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Deployment 99
Table 25. United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Enterprise Size. 100
Table 26. United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Form.. 100
Table 27. United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Functionality. 101
Table 28. United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by End User 102
Table 29. Italy: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Offering. 104
Table 30. Italy: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Deployment 104
Table 31. Italy: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Enterprise Size. 105
Table 32. Italy: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Form.. 105
Table 33. Italy: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Functionality. 106
Table 34. Italy: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by End User 107
Table 35. Spain: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Offering. 109
Table 36. Spain: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Deployment 109
Table 37. Spain: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Enterprise Size. 110
Table 38. Spain: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Form.. 110
Table 39. Spain: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Functionality. 111
Table 40. Spain: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by End User 112
Table 41. Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Offering. 114
Table 42. Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Deployment 114
Table 43. Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Enterprise Size. 115
Table 44. Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Form.. 115
Table 45. Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by Functionality. 116
Table 46. Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) – by End User 117
Table 47. Company Positioning & Concentration. 119
Table 48. List of Abbreviation. 202
List of Figures
Figure 1. Europe Pharmacovigilance and Drug Safety Software Market Segmentation, by Country. 24
Figure 2. PEST Analysis. 34
Figure 3. Impact Analysis of Drivers and Restraints. 43
Figure 4. Europe Pharmacovigilance and Drug Safety Software Market Revenue (US$ Thousand), 2021–2031. 44
Figure 5. Europe Pharmacovigilance and Drug Safety Software Market Share (%) – by Offering, 2023 and 2031. 46
Figure 6. Software: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 49
Figure 7. Services: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 50
Figure 8. Europe Pharmacovigilance and Drug Safety Software Market Share (%) – by Deployment, 2023 and 2031. 51
Figure 9. Cloud: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 53
Figure 10. On Premises: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 54
Figure 11. Europe Pharmacovigilance and Drug Safety Software Market Share (%) – by Enterprise Size, 2023 and 2031. 55
Figure 12. Large Enterprises: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 57
Figure 13. SMEs: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 59
Figure 14. Europe Pharmacovigilance and Drug Safety Software Market Share (%) – by Form, 2023 and 2031. 60
Figure 15. Standard: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 63
Figure 16. Customized: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 65
Figure 17. Europe Pharmacovigilance and Drug Safety Software Market Share (%) – by Functionality, 2023 and 2031. 66
Figure 18. Signal and Risk Management: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 69
Figure 19. Issue Tracking and Adverse Event Tracking: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 70
Figure 20. Case Management: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 71
Figure 21. Clinical Safety Management and Clinical Trial Safety: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 72
Figure 22. Quality and Compliance: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 73
Figure 23. Medical Writing: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 74
Figure 24. Audit Support and Training Compliance: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 75
Figure 25. Healthcare Analytics: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 76
Figure 26. Others: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 77
Figure 27. Europe Pharmacovigilance and Drug Safety Software Market Share (%) – by End User, 2023 and 2031. 78
Figure 28. Pharmaceutical and Biotechnology Companies: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 80
Figure 29. Contract Research Organizations: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 82
Figure 30. Business Process Outsourcing (BPO) Firms: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 83
Figure 31. Others: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 84
Figure 32. Europe Pharmacovigilance and Drug Safety Software Market Breakdown by Key Countries, 2023 and 2031 (%) 86
Figure 33. Germany: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 88
Figure 34. France: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 93
Figure 35. United Kingdom: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 98
Figure 36. Italy: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 103
Figure 37. Spain: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 108
Figure 38. Rest of Europe: Europe Pharmacovigilance and Drug Safety Software Market – Revenue and Forecast to 2031 (US$ Thousand) 113
Figure 39. Heat Map Analysis by Key Players 118
The List of Companies - Europe 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.
- AB Cube S.A.S.
- Laboratory Corp of America Holdings
- Parexel International Corp
- Qinecsa Solutions
- Clinevo Technologies
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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