North America Pharmacovigilance and Drug Safety Software Market 2022-2031 by Functionality (Adverse Event Reporting, Drug Safety Audits, Issue Tracking, Fully Integrated), Clinical Phase (Pre-clinical, Phase I-IV), Method, Delivery Mode (On-premise, On-demand), Indication, End User (Pharma and Biotech Companies, CROs, BPOs, Others), and Country: Trend Forecast and Growth Opportunity
- Report ID: 43103
- Date: Aug, 2022
- Pages: 111
- Category: Healthcare & Pharmaceuticals
North America pharmacovigilance and drug safety software market is projected to grow by 6.7% annually in the forecast period and reach $158.6 million by 2031, driven by the increasing prevalence of chronic diseases due to the aging population, the growing drug discovery pipelines, increase in incidence of adverse drug reactions (ADR), more stringent regulatory guidelines for drug safety, and the increasing adoption of AI and cloud technologies in PV software and solutions.
Highlighted with 23 tables and 56 figures, this 111-page report “North America Pharmacovigilance and Drug Safety Software Market 2022-2031 by Functionality (Adverse Event Reporting, Drug Safety Audits, Issue Tracking, Fully Integrated), Clinical Phase (Pre-clinical, Phase I-IV), Method, Delivery Mode (On-premise, On-demand), Indication, End User (Pharma and Biotech Companies, CROs, BPOs, Others), and Country: Trend Forecast and Growth Opportunity” is based on a comprehensive research of the entire North America pharmacovigilance and drug safety software market and all its sub-segments through extensively detailed classifications.
Profound analysis and assessment are generated from premium primary and secondary information sources with inputs derived from industry professionals across the value chain. The report is based on studies on 2018-2022 and provides forecast from 2022 till 2031 with 2022 as the base year. (Please note: The report will be updated before delivery so that the latest historical year is the base year and the forecast covers at least 5 years over the base year.)
In-depth qualitative analyses include identification and investigation of the following aspects:
• Market Structure
• Growth Drivers
• Restraints and Challenges
• Emerging Product Trends & Market Opportunities
• Porter’s Fiver Forces
The trend and outlook of North America market is forecast in optimistic, balanced, and conservative view by taking into account of COVID-19 and Russia-Ukraine conflict. The balanced (most likely) projection is used to quantify North America pharmacovigilance and drug safety software market in every aspect of the classification from perspectives of Functionality, Clinical Phase, Method, Delivery Mode, Indication, End User, and Country.
Based on Functionality, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2022-2031 included in each section.
• Adverse Event Reporting Software
• Drug Safety Audits Software
• Issue Tracking Software
• Fully Integrated Software
Based on Clinical Phase, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2022-2031 included in each section.
• Pre-clinical
• Phase I
• Phase II
• Phase III
• Phase IV
By Method, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2022-2031 included in each section.
• Spontaneous Reporting
• Intensified ADR Reporting
• Targeted Spontaneous Reporting
• Cohort Event Monitoring
• EHR Mining
By Delivery Mode, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2022-2031 included in each section.
• On-premise Delivery
• On-demand Delivery
By Indication, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2022-2031 included in each section.
• Oncology
• Respiratory Disorders
• Cardiology
• Neurology
• Immunology
• Pain Management
• Other Indications
By End Users, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2022-2031 included in each section.
• Pharmaceutical and Biotechnology Companies
• Contract Research Organizations (CROs)
• Business Process Outsourcing Firms (BPOs)
• Other End Users
Geographically, the following national/local markets are fully investigated:
• U.S.
• Canada
• Mexico
For each key country, detailed analysis and data for annual revenue ($ mn) are available for 2022-2031. The breakdown of national markets by Functionality, Delivery Mode and End User over the forecast years are also included.
The report also covers current competitive scenario and the predicted trend; and profiles key vendors including market leaders and important emerging players.
Selected Key Players:
Ab Cube
Accenture PLC
ArisNorth America LLC
Cognizant Technology Solutions Corporation
Ennov Solutions Inc.
Extedo GmbH
Honeywell International Inc. (Sparta Systems Inc.)
IQVIA Inc.
Max Application
Oracle Corporation
Sarjen Systems Pvt. Ltd.
United BioSource LLC
Veeva Systems Inc.
Wipro Limited
(Please note: The report will be updated before delivery so that the latest historical year is the base year and the forecast covers at least 5 years over the base year.)
1 Introduction 8
1.1 Industry Definition and Research Scope 8
1.1.1 Industry Definition 8
1.1.2 Research Scope 9
1.2 Research Methodology 12
1.2.1 Overview of Market Research Methodology 12
1.2.2 Market Assumption 13
1.2.3 Secondary Data 13
1.2.4 Primary Data 13
1.2.5 Data Filtration and Model Design 14
1.2.6 Market Size/Share Estimation 15
1.2.7 Research Limitations 16
1.3 Executive Summary 17
2 Market Overview and Dynamics 20
2.1 Market Size and Forecast 20
2.1.1 Impact of COVID-19 on World Economy 21
2.1.2 Impact of COVID-19 on the Market 25
2.2 Major Growth Drivers 27
2.3 Market Restraints and Challenges 32
2.4 Emerging Opportunities and Market Trends 35
2.5 Porter’s Fiver Forces Analysis 39
3 Segmentation of North America Market by Functionality 43
3.1 Market Overview by Functionality 43
3.2 Adverse Event Reporting Software 45
3.3 Drug Safety Audits Software 46
3.4 Issue Tracking Software 47
3.5 Fully Integrated Software 48
4 Segmentation of North America Market by Clinical Phase 49
4.1 Market Overview by Clinical Phase 49
4.2 Pre-clinical 51
4.3 Phase I 52
4.4 Phase II 53
4.5 Phase III 54
4.6 Phase IV 55
5 Segmentation of North America Market by Method 56
5.1 Market Overview by Method 56
5.2 Spontaneous Reporting 58
5.3 Intensified ADR Reporting 59
5.4 Targeted Spontaneous Reporting 60
5.5 Cohort Event Monitoring 61
5.6 EHR Mining 62
6 Segmentation of North America Market by Delivery Mode 63
6.1 Market Overview by Delivery Mode 63
6.2 On-premise Delivery 65
6.3 On-demand Delivery 66
7 Segmentation of North America Market by Indication 67
7.1 Market Overview by Indication 67
7.2 Oncology 69
7.3 Respiratory Disorders 70
7.4 Cardiology 71
7.5 Neurology 72
7.6 Immunology 73
7.7 Pain Management 74
7.8 Other Indications 75
8 Segmentation of North America Market by End User 76
8.1 Market Overview by End User 76
8.2 Pharmaceutical and Biotechnology Companies 78
8.3 Contract Research Organizations (CROs) 79
8.4 Business Process Outsourcing Firms (BPOs) 80
8.5 Other End Users 81
9 North America Market 2021-2031 by Country 82
9.1 Overview of North America Market 82
9.2 U.S. 85
9.3 Canada 88
9.4 Mexico 90
10 Competitive Landscape 92
10.1 Overview of Key Vendors 92
10.2 New Product Launch, Partnership, Investment, and M&A 95
10.3 Company Profiles 96
Ab Cube 96
Accenture PLC 98
ArisNorth America LLC 99
Cognizant Technology Solutions Corporation 100
Ennov Solutions Inc. 101
Extedo GmbH 102
Honeywell International Inc. (Sparta Systems Inc.) 103
IQVIA Inc. 104
Max Application 105
Oracle Corporation 106
Sarjen Systems Pvt. Ltd. 107
United BioSource LLC 108
Veeva Systems Inc. 109
Wipro Limited 110
RELATED REPORTS 111
List of Tables
Table 1. Snapshot of North America Pharmacovigilance and Drug Safety Software Market in Balanced Perspective, 2021-2031 18
Table 2. World Economic Outlook, 2021-2031 22
Table 3. World Economic Outlook, 2021-2023 23
Table 4. Main Product Trends and Market Opportunities in North America Pharmacovigilance and Drug Safety Software Market 35
Table 5. North America Pharmacovigilance and Drug Safety Software Market by Functionality, 2021-2031, $ mn 43
Table 6. North America Pharmacovigilance and Drug Safety Software Market by Clinical Phase, 2021-2031, $ mn 49
Table 7. North America Pharmacovigilance and Drug Safety Software Market by Method, 2021-2031, $ mn 56
Table 8. North America Pharmacovigilance and Drug Safety Software Market by Delivery Mode, 2021-2031, $ mn 63
Table 9. North America Pharmacovigilance and Drug Safety Software Market by Indication, 2021-2031, $ mn 67
Table 10. North America Pharmacovigilance and Drug Safety Software Market by End User, 2021-2031, $ mn 76
Table 11. North America Pharmacovigilance and Drug Safety Software Market by Country, 2021-2031, $ mn 83
Table 12. U.S. Pharmacovigilance and Drug Safety Software Market by Functionality, 2021-2031, $ mn 87
Table 13. U.S. Pharmacovigilance and Drug Safety Software Market by Delivery Mode, 2021-2031, $ mn 87
Table 14. U.S. Pharmacovigilance and Drug Safety Software Market by End User, 2021-2031, $ mn 87
Table 15. Canada Pharmacovigilance and Drug Safety Software Market by Functionality, 2021-2031, $ mn 89
Table 16. Canada Pharmacovigilance and Drug Safety Software Market by Delivery Mode, 2021-2031, $ mn 89
Table 17. Canada Pharmacovigilance and Drug Safety Software Market by End User, 2021-2031, $ mn 89
Table 18. Mexico Pharmacovigilance and Drug Safety Software Market by Functionality, 2021-2031, $ mn 91
Table 19. Mexico Pharmacovigilance and Drug Safety Software Market by Delivery Mode, 2021-2031, $ mn 91
Table 20. Mexico Pharmacovigilance and Drug Safety Software Market by End User, 2021-2031, $ mn 91
Table 21. Ab Cube: Company Snapshot 96
Table 22. Ab Cube: Business Segmentation 97
Table 23. Ab Cube: Product Portfolio 97
List of Figures
Figure 1. Research Method Flow Chart 12
Figure 2. Bottom-up Approach and Top-down Approach for Market Estimation 15
Figure 3. North America Market Forecast in Optimistic, Conservative and Balanced Perspectives, 2021-2031 17
Figure 4. North America Pharmacovigilance and Drug Safety Software Market, 2021-2031, $ mn 20
Figure 5. Impact of COVID-19 on Business 25
Figure 6. Primary Drivers and Impact Factors of North America Pharmacovigilance and Drug Safety Software Market 27
Figure 7. Percentage of Trial Participants by Country, 2015-2019 30
Figure 8. World Drug Discovery Market, 2019-2030, $ mn 31
Figure 9. Primary Restraints and Impact Factors of North America Pharmacovigilance and Drug Safety Software Market 32
Figure 10. Investment Opportunity Analysis 36
Figure 11. Porter’s Fiver Forces Analysis of North America Pharmacovigilance and Drug Safety Software Market 39
Figure 12. Breakdown of North America Pharmacovigilance and Drug Safety Software Market by Functionality, 2021-2031, % of Revenue 44
Figure 13. North America Addressable Market Cap in 2022-2031 by Functionality, Value ($ mn) and Share (%) 44
Figure 14. North America Pharmacovigilance and Drug Safety Software Market by Functionality: Adverse Event Reporting Software, 2021-2031, $ mn 45
Figure 15. North America Pharmacovigilance and Drug Safety Software Market by Functionality: Drug Safety Audits Software, 2021-2031, $ mn 46
Figure 16. North America Pharmacovigilance and Drug Safety Software Market by Functionality: Issue Tracking Software, 2021-2031, $ mn 47
Figure 17. North America Pharmacovigilance and Drug Safety Software Market by Functionality: Fully Integrated Software, 2021-2031, $ mn 48
Figure 18. Breakdown of North America Pharmacovigilance and Drug Safety Software Market by Clinical Phase, 2021-2031, % of Sales Revenue 50
Figure 19. North America Addressable Market Cap in 2022-2031 by Clinical Phase, Value ($ mn) and Share (%) 50
Figure 20. North America Pharmacovigilance and Drug Safety Software Market by Clinical Phase: Pre-clinical, 2021-2031, $ mn 51
Figure 21. North America Pharmacovigilance and Drug Safety Software Market by Clinical Phase: Phase I, 2021-2031, $ mn 52
Figure 22. North America Pharmacovigilance and Drug Safety Software Market by Clinical Phase: Phase II, 2021-2031, $ mn 53
Figure 23. North America Pharmacovigilance and Drug Safety Software Market by Clinical Phase: Phase III, 2021-2031, $ mn 54
Figure 24. North America Pharmacovigilance and Drug Safety Software Market by Clinical Phase: Phase IV, 2021-2031, $ mn 55
Figure 25. Breakdown of North America Pharmacovigilance and Drug Safety Software Market by Method, 2021-2031, % of Sales Revenue 57
Figure 26. North America Addressable Market Cap in 2022-2031 by Method, Value ($ mn) and Share (%) 57
Figure 27. North America Pharmacovigilance and Drug Safety Software Market by Method: Spontaneous Reporting, 2021-2031, $ mn 58
Figure 28. North America Pharmacovigilance and Drug Safety Software Market by Method: Intensified ADR Reporting, 2021-2031, $ mn 59
Figure 29. North America Pharmacovigilance and Drug Safety Software Market by Method: Targeted Spontaneous Reporting, 2021-2031, $ mn 60
Figure 30. North America Pharmacovigilance and Drug Safety Software Market by Method: Cohort Event Monitoring, 2021-2031, $ mn 61
Figure 31. North America Pharmacovigilance and Drug Safety Software Market by Method: EHR Mining, 2021-2031, $ mn 62
Figure 32. Breakdown of North America Pharmacovigilance and Drug Safety Software Market by Delivery Mode, 2021-2031, % of Revenue 64
Figure 33. North America Addressable Market Cap in 2022-2031 by Delivery Mode, Value ($ mn) and Share (%) 64
Figure 34. North America Pharmacovigilance and Drug Safety Software Market by Delivery Mode: On-premise Delivery, 2021-2031, $ mn 65
Figure 35. North America Pharmacovigilance and Drug Safety Software Market by Delivery Mode: On-demand Delivery, 2021-2031, $ mn 66
Figure 36. Breakdown of North America Pharmacovigilance and Drug Safety Software Market by Indication, 2021-2031, % of Revenue 68
Figure 37. North America Addressable Market Cap in 2022-2031 by Indication, Value ($ mn) and Share (%) 68
Figure 38. North America Pharmacovigilance and Drug Safety Software Market by Indication: Oncology, 2021-2031, $ mn 69
Figure 39. North America Pharmacovigilance and Drug Safety Software Market by Indication: Respiratory Disorders, 2021-2031, $ mn 70
Figure 40. North America Pharmacovigilance and Drug Safety Software Market by Indication: Cardiology, 2021-2031, $ mn 71
Figure 41. North America Pharmacovigilance and Drug Safety Software Market by Indication: Neurology, 2021-2031, $ mn 72
Figure 42. North America Pharmacovigilance and Drug Safety Software Market by Indication: Immunology, 2021-2031, $ mn 73
Figure 43. North America Pharmacovigilance and Drug Safety Software Market by Indication: Pain Management, 2021-2031, $ mn 74
Figure 44. North America Pharmacovigilance and Drug Safety Software Market by Indication: Other Indications, 2021-2031, $ mn 75
Figure 45. Breakdown of North America Pharmacovigilance and Drug Safety Software Market by End User, 2021-2031, % of Revenue 76
Figure 46. North America Addressable Market Cap in 2022-2031 by End User, Value ($ mn) and Share (%) 77
Figure 47. North America Pharmacovigilance and Drug Safety Software Market by End User: Pharmaceutical and Biotechnology Companies, 2021-2031, $ mn 78
Figure 48. North America Pharmacovigilance and Drug Safety Software Market by End User: Contract Research Organizations (CROs), 2021-2031, $ mn 79
Figure 49. North America Pharmacovigilance and Drug Safety Software Market by End User: Business Process Outsourcing Firms (BPOs), 2021-2031, $ mn 80
Figure 50. North America Pharmacovigilance and Drug Safety Software Market by End User: Other End Users, 2021-2031, $ mn 81
Figure 51. Breakdown of North America Pharmacovigilance and Drug Safety Software Market by Country, 2021 and 2031, % of Revenue 83
Figure 52. Contribution to North America 2022-2031 Cumulative Market by Country, Value ($ mn) and Share (%) 84
Figure 53. U.S. Pharmacovigilance and Drug Safety Software Market, 2021-2031, $ mn 86
Figure 54. Canada Pharmacovigilance and Drug Safety Software Market, 2021-2031, $ mn 88
Figure 55. Pharmacovigilance and Drug Safety Software Market in Mexico, 2021-2031, $ mn 90
Figure 56. Growth Stage of North America Pharmacovigilance and Drug Safety Software Industry over the Forecast Period 92
Research methodology is mainly referring to the practical how of any offered piece of research. More specifically, it’s all about how a researcher systematically designs a study in order to assure extremely valid as well as reliable results that ultimately address the targets and objectives of the research.
In any formal research including academic journal, article, dissertation and so on, there will be a special section on a research methodology that mainly describes what, by whom, how to gather as well as how to evaluate the data are provided.
This research methodology has been segmented into following types:
Primary Research:
It is said to be original information that the researchers collect for the crucial purposes of answering the research questions of readers with the help of surveys, observations and experiments.
Secondary Research:
The secondary research is the data that has already been collected by various other researchers in the form of government analysis or scientific studies.
Qualitative Research:
It is descriptive and subjective method irrespective of facts. Both observation and description are essential in this type of research methodology. Its main vision is to analyze knowledge, attitudes, behaviours as well as opinions of people related to the topic of any research. This method has been operated through grounded research, case study and actionable research.
Quantitative Research:
It contains several laboratory experiments, basic surveys, mathematical calculations, simulations and so on. The possible measurement, quantity or amount is considered to be a major factor in the quantitative research methodology.
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