Setting

North America Pharmacovigilance and Drug Safety Software Market 2021-2031 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

Published: 31 Jul 2022 | Report Code: 10248650 | Pages: 111

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 2021-2031 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 2018-2021 and provides forecast from 2022 till 2031 with 2021 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 2021-2031 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 2021-2031 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 2021-2031 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 2021-2031 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 2021-2031 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 2021-2031 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 2021-2031. 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.)

Table of Contents:
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
Selected Key Players: 
Ab Cube
Accenture PLC
ArisGlobal 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.)