North America Pharmacovigilance and Drug Safety Software Market Dynamics and Trends by 2027

North America Pharmacovigilance and Drug Safety Software Market Forecast to 2027 - COVID-19 Impact and Regional Analysis By Software Type (Adverse Event Reporting Software, Drug Safety Audits Software, Issue Tracking Software, and Fully Integrated Software); Delivery Mode (On-premise, and Cloud-based); End User (Pharmaceutical and Biotech Companies, Contract Research Organizations (CROs), and Business Process Outsourcing (BPO) Firms)

  • Report Date : Jun 2021
  • Report Code : TIPRE00022774
  • Category : Technology, Media and Telecommunications
  • Status : Published
  • Available Report Formats : pdf-format excel-format
  • No. of Pages : 121

The pharmacovigilance and drug safety software market in North America is expected to grow from US$ 73.4 million in 2019 to US$ 136.0 million by 2027; it is estimated to grow at a CAGR of 7.8% from 2020 to 2027.



Adverse drug reactions (ADRs) is an important public health problem, signifying a significant cause of illness and death. Because all drugs have the potential for adverse drug reactions, a risk-benefit analysis is necessary whenever a drug is prescribed. According to the Agency for Healthcare Research and Quality 2018, In the US, 3 to 7% of all hospitalizations are due to adverse drug reactions. ADRs occur from 10 to 20% of admissions; about 10 to 20% of these ADRs are severe. These statistics do not include the number of ADRs that occur in ambulatory and nursing home patients. Although the exact number of ADRs is not specified, ADRs represent a significant public health problem that is, for the most part, preventable. ADR reported by a patient or healthcare professional adds to safety monitoring and thus to the safe and effective use of medicines. The increasing amount of data generated through adverse drug reaction report need to be handled and stored carefully. All these data come in different forms, language, location, etc. To arrange these uniformly the automation systems/software are helpful. Thus, the rising incidences of adverse drug reactions (ADRs) are likely to drive the market’s growth.

Since the outbreak of COVID-19, North America has been beholding a growing number of COVID-19. Several measures are being taken to restrain the disease and prevent the transmission; nevertheless, the excessive number of COVID cases has resulted in the cancellation of doctor's appointment, decreased in demand for the elective Pharmacovigilance and Drug Safety Software due to long period of lockdown. In the US, due to a growing number of contaminated patients, healthcare practitioners and leading organizations are distracting the flow of health services from research and development to primary care, which slows down the process of innovation. In addition, many health organizations namely US Food and Drug Administration (FDA) is evaluating the effects of the pandemic, and how clinical trials and pharmacovigilance programmes can be handled in the coming years. This rapidly changing situation has meant that sponsors need to be more cautious and diligent in assessing the consequences of the pandemic and shifts in authority expectations in order to minimize the impact on safety reporting and to ensure patient safety. The value of demanding updated guidelines and implementing regulatory changes quickly is greater than ever as it can mitigate disruption to clinical trials. To successfully deal with a highly complex situation, a proven and comprehensive safety reporting solution may be required.

With the new features and technologies, vendors can attract new customers and expand their footprints in emerging markets. This factor is likely to drive the pharmacovigilance and drug safety software market. The North America pharmacovigilance and drug safety software market is expected to grow at a good CAGR during the forecast period.


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North America Pharmacovigilance and Drug Safety Software Market Segmentation    

By Software Type

  • Fully Integrated Software
  • Adverse Event Reporting Software
  • Drug Safety Audits Software
  • Issue Tracking Software

By Delivery Mode

  • Cloud-based
  • On-premise

By End User

  • Contract Research Organizations
  • Pharmaceutical and Biotech Companies
  • Business Process Outsourcing

By Country

  • North America

    • US
    • Canada
    • Mexico

Companies Mentioned

  • Veeva Systems            
  • IQVIA Inc.         
  • Ennov     
  • AB Cube           
  • United Biosource LLC    
  • ArisGlobal LLC    
  • Sparta Systems           
  • Oracle Corporation       
  • Sarjen Systems Pvt. Ltd          
  • EXTEDO
  • Online Business Applications, Inc.
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Software Type, Delivery Mode, End User

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

US, Canada

1. Introduction

1.1 Scope of the Study

1.2 The Insight Partners Research Report Guidance

1.3 Market Segmentation

1.3.1 Pharmacovigilance and Drug Safety Software Market – By Software Type

1.3.2 Pharmacovigilance and Drug Safety Software Market – By Delivery Mode

1.3.3 Pharmacovigilance and Drug Safety Software Market – By End User

1.3.4 North America Pharmacovigilance and Drug Safety Software Market – By Country

2. North America Pharmacovigilance and Drug Safety Software Market – Key Takeaways

3. Research Methodology

3.1 Coverage

3.2 Secondary Research

3.3 Primary Research

4. North America Pharmacovigilance and Drug Safety Software Market – Market Landscape

4.1 Overview

4.2 PEST Analysis

4.2.1 Pharmacovigilance and Drug Safety Software Market- North America PEST Analysis

4.3 Expert Opinion

5. North America Pharmacovigilance and Drug Safety Software Market - Key Market Dynamics

5.1 Market Drivers

5.1.1 Rising Incidences of Adverse Drug Reactions (ADRs)

5.1.2 Globalization of Pharmacovigilance

5.2 Market Restraints

5.2.1 Expensive Technology

5.3 Future Trends

5.3.1 Artificial Intelligence in Pharmacovigilance

5.4 Impact Analysis

6. Pharmacovigilance and Drug Safety Software Market – North America Analysis

6.1 North America Pharmacovigilance and Drug Safety Software Market Revenue Forecasts and Analysis

7. North America Pharmacovigilance and Drug Safety Software Market Analysis and Forecasts To 2027 – By Software Type

7.1 Overview

7.2 Pharmacovigilance (PV) and Drug Safety Software Market, by Software Type, 2019 & 2027 (%)

7.3 Adverse Event Reporting Software Market

7.3.1 Overview

7.3.2 Adverse Event Reporting Software Market Revenue and Forecasts to 2027 (US$ Mn)

7.4 Drug Safety Audits Software

7.4.1 Overview

7.4.2 Drug Safety Audits Software Market Revenue and Forecasts to 2027 (US$ Mn)

7.5 Issue Tracking Software

7.5.1 Overview

7.5.2 Issue Tracking Software Market Revenue and Forecasts to 2027 (US$ Mn)

7.6 Fully Integrated Software

7.6.1 Overview

7.6.2 Fully Integrated Software Market Revenue and Forecasts to 2027 (US$ Mn)

8. North America Pharmacovigilance and Drug Safety Software Market Analysis and Forecasts To 2027 – By Delivery Mode

8.1 Overview

8.2 Pharmacovigilance (PV) and Drug Safety Software Market, By Delivery Mode 2019 & 2027 (%)

8.3 On-premise

8.3.1 Overview

8.3.2 On-premise Market Revenue and Forecasts to 2027 (US$ Mn)

8.4 Cloud- Based

8.4.1 Overview

8.4.2 Cloud Based Market Revenue and Forecasts to 2027 (US$ Mn)

9. North America Pharmacovigilance and Drug Safety Software Market Analysis and Forecasts to 2027– By End User

9.1 Overview

9.2 Pharmacovigilance (PV) and Drug Safety Software Market, By End User, 2019 & 2027 (%)

9.3 Pharmaceutical and Biotech Companies Market

9.3.1 Overview

9.3.2 Pharmaceutical and Biotech Companies Market Revenue and Forecasts to 2027 (US$ Mn)

9.4 Contract Research Organizations (CROs) Market

9.4.1 Overview

9.4.2 Contract Research Organizations (CROs) Market Revenue and Forecasts to 2027 (US$ Mn)

9.5 Business Process Outsourcing (BPO) Firms Market

9.5.1 Overview

9.5.2 Business Process Outsourcing (BPO) Firms Market Revenue and Forecasts to 2027 (US$ Mn)

10. Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027 – Geographical Analysis

10.1 North America: Pharmacovigilance and Drug Safety Software Market

10.1.1 Overview

10.1.2 North America Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By Country (%)

10.1.3 US Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027 (US$ Mn)

10.1.3.1 US Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027 (US$ Mn)

10.1.3.2 US Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By Software Type (US$ Mn)

10.1.3.3 US Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By Delivery Mode (US$ Mn)

10.1.3.4 US Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By End User (US$ Mn)

10.1.4 Canada Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027 (US$ Mn)

10.1.4.1 Canada Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027 (US$ Mn)

10.1.4.2 Canada Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By Software Type (US$ Mn)

10.1.4.3 Canada Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By Delivery Mode (US$ Mn)

10.1.4.4 Canada Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By End User (US$ Mn)

10.1.5 Mexico Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027 (US$ Mn)

10.1.5.1 Mexico Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027 (US$ Mn)

10.1.5.2 Mexico Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By Software Type (US$ Mn)

10.1.5.3 Mexico Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By Delivery Mode (US$ Mn)

10.1.5.4 Mexico Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By End User (US$ Mn)

11. Impact Of COVID-19 Pandemic on North America Pharmacovigilance and Drug Safety Software Market

11.1 North America: Impact Assessment of COVID-19 Pandemic

12. Industry Landscape

12.1 Overview

12.2 Growth Strategies in the Pharmacovigilance and Drug Safety Software Market

12.3 Organic Developments

12.3.1 Overview

12.3.2 Organic Developments Done by Companies

12.4 Inorganic Developments

12.4.1 Overview

12.4.2 Inorganic Growth Strategies by Companies

13. COMPANY PROFILES

13.1 Veeva Systems

13.1.1 Key Facts

13.1.2 Business Description

13.1.3 Products and Services

13.1.4 Financial Overview

13.1.5 SWOT Analysis

13.1.6 Key Developments

13.2 IQVIA Inc.

13.2.1 Key Facts

13.2.2 Business Description

13.2.3 Products and Services

13.2.4 Financial Overview

13.2.5 SWOT Analysis

13.2.6 Key Developments

13.3 Ennov

13.3.1 Key Facts

13.3.2 Business Description

13.3.3 Products and Services

13.3.4 Financial Overview

13.3.5 SWOT Analysis

13.3.6 Key Developments

13.4 AB Cube

13.4.1 Key Facts

13.4.2 Business Description

13.4.3 Products and Services

13.4.4 Financial Overview

13.4.5 SWOT Analysis

13.4.6 Key Developments

13.5 United Biosource LLC

13.5.1 Key Facts

13.5.2 Business Description

13.5.3 Products and Services

13.5.4 Financial Overview

13.5.5 SWOT Analysis

13.5.6 Key Developments

13.6 ArisGlobal LLC

13.6.1 Key Facts

13.6.2 Business Description

13.6.3 Products and Services

13.6.4 Financial Overview

13.6.5 SWOT Analysis

13.6.6 Key Developments

13.7 Sparta Systems

13.7.1 Key Facts

13.7.2 Business Description

13.7.3 Products and Services

13.7.4 Financial Overview

13.7.5 SWOT Analysis

13.7.6 Key Developments

13.8 Oracle Corporation

13.8.1 Key Facts

13.8.2 Business Description

13.8.3 Products and Services

13.8.4 Financial Overview

13.8.5 SWOT Analysis

13.8.6 Key Developments

13.9 Sarjen Systems Pvt. Ltd

13.9.1 Key Facts

13.9.2 Business Description

13.9.3 Products and Services

13.9.4 Financial Overview

13.9.5 SWOT Analysis

13.9.6 Key Developments

13.10 EXTEDO

13.10.1 Key Facts

13.10.2 Business Description

13.10.3 Products and Services

13.10.4 Financial Overview

13.10.5 SWOT Analysis

13.10.6 Key Developments

13.11 Online Business Applications, Inc.

13.11.1 Key Facts

13.11.2 Business Description

13.11.3 Products and Services

13.11.4 Financial Overview

13.11.5 SWOT Analysis

13.11.6 Key Developments

14. Appendix

14.1 About the Insight Partners

14.2 Glossary of Terms

LIST OF TABLES

Table 1. US Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By Software Type(US$ Mn)

Table 2. US Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By Delivery Mode (US$ Mn)

Table 3. US Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By End User (US$ Mn)

Table 4. Canada Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By Software Type(US$ Mn)

Table 5. Canada Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By Delivery Mode (US$ Mn)

Table 6. Canada Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By End User (US$ Mn)

Table 7. Mexico Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By Software Type(US$ Mn)

Table 8. Mexico Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By Delivery Mode (US$ Mn)

Table 9. Mexico Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By End User (US$ Mn)

Table 10. Organic Developments Done by Companies

Table 11. Recent Inorganic Growth Strategies by the Companies

Table 12. Glossary of Terms, Pharmacovigilance and Drug Safety Software Market

LIST OF FIGURES

Figure 1. Pharmacovigilance and Drug Safety Software Market Segmentation

Figure 2. North America Pharmacovigilance and Drug Safety Software Market Overview

Figure 3. Adverse Event Reporting Software Segment Held Largest Share of Software Type in Pharmacovigilance and Drug Safety Software Market

Figure 4. Contract Research Organizations Segment Held Largest Share of End User in Pharmacovigilance and Drug Safety Software Market

Figure 5. US is Expected to Show Remarkable Growth During the Forecast Period

Figure 6. Pharmacovigilance and Drug Safety Software Market - North America PEST Analysis

Figure 7. Pharmacovigilance and Drug Safety Software Market Impact Analysis of Driver and Restraints

Figure 8. North America Pharmacovigilance and Drug Safety Software Market – Revenue Forecasts and Analysis – 2019- 2027

Figure 9. Pharmacovigilance (PV) and Drug Safety Software Market, by Software Type, 2019 & 2027 (%)

Figure 10. Adverse Event Reporting Software Market Revenue and Forecasts to 2027 (US$ Mn)

Figure 11. Drug Safety Audits Software Market Revenue and Forecasts to 2027 (US$ Mn)

Figure 12. Issue Tracking Software Market Revenue and Forecasts to 2027 (US$ Mn)

Figure 13. Fully Integrated Software Market Revenue and Forecasts to 2027 (US$ Mn)

Figure 14. Pharmacovigilance (PV) and Drug Safety Software Market, by Delivery Mode 2019 & 2027 (%)

Figure 15. On-premise Market Revenue and Forecasts to 2027 (US$ Mn)

Figure 16. Cloud Based Market Revenue and Forecasts to 2027 (US$ Mn)

Figure 17. Pharmacovigilance (PV) and Drug Safety Software Market, by End User, 2019 & 2027 (%)

Figure 18. Pharmaceutical and Biotech Companies Market Revenue and Forecasts to 2027 (US$ Mn)

Figure 19. Contract Research Organizations (CROs) Market Revenue and Forecasts to 2027 (US$ Mn)

Figure 20. Business Process Outsourcing (BPO) Firms Revenue and Forecasts to 2027 (US$ Mn)

Figure 21. North America Pharmacovigilance and Drug Safety Software Market Revenue Overview, By Country, 2019 (US$ Mn)

Figure 22. North America Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027, By Country (%)

Figure 23. US Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027 (US$ Mn)

Figure 24. Canada Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts To 2027 (US$ Mn)

Figure 25. Mexico Pharmacovigilance and Drug Safety Software Market Revenue and Forecasts to 2027 (US$ Mn)

Figure 26. Impact of COVID-19 Pandemic in North American Country Markets

Figure 27. Growth Strategies in the Pharmacovigilance and Drug Safety Software Market

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The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. 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.

  1. 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:

Research Methodology

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.

  1. 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.

  1. 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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