Pharmacovigilance and Drug Safety Software Market Report 2027

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

Publication Month : Jan 2021

  • Report Code : TIPHC00002557
  • Category : Healthcare IT
  • Status : Published
  • No. of Pages : 186
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[Research Report] The pharmacovigilance and drug safety software market is expected to reach US$ 292.97 Mn in 2027 from US$ 160.67 Mn in 2019. The market is estimated to grow with a CAGR of 7.6% from 2020-2027.

The scope of the pharmacovigilance and drug safety software market includes software type, product type, end user, and region. The market for pharmacovigilance and drug safety software, based on region, is segmented into North America, Europe, Asia Pacific, Middle East & Africa, and South and Central America.The report offers insights and in-depth analysis of the Pharmacovigilance and Drug Safety Software market emphasizing on various parameters such as market trends, technological advancements, market dynamics, and competitive landscape analysis of leading market players across the world. It also includes COVID–19 impact analysis across all the regions.


Lucrative Regions for Pharmacovigilance and Drug Safety Software Market

Lucrative Regions for Pharmacovigilance and Drug Safety Software Market
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Market Insights

Globalization Of Pharmacovigilance

Pharmacovigilance is the processes for monitoring and evaluating adverse drug reactions and it is a key component of effective drug regulation systems, clinical practice and public health programs. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled. In the current global network of pharmacovigilance centers coordinated by the Uppsala Monitoring Centre. Pharmacovigilance is an critical and integral part of clinical research and these days it is growing in many countries. Today many pharmacovigilance centers are working for drug safety monitoring in this global pitch, however, at the turn of the millennium pharmacovigilance faces major challenges in aspect of better safety and monitoring of drugs.

The centralized reporting and storage of adverse drug reaction reports will help to monitor and prevent future adverse drug reaction from the drug. European Medicines Agency (EMA) and US Food and Drug Administration (FDA) strengthening in pharmacovigilance area by interacting on different topics related to post-marketing safety, scientific exchange. Discussions on priority such as biosimilars, medicines to treat cancer, orphan medicines, medicines for children, and blood-based products, among other topics.

Thus, increasing the globalization in pharmacovigilance sector helps in drug safety software. It improves the quality and efficacy of pharmacovigilance and drug safety software and is expected to favor the growth of the market during the forecast period.

Software Type-Based Insights

Based on software type the market is segmented into adverse event reporting software, drug safety audits software, issue tracking software, and fully integrated software. In 2019, the adverse event reporting software segment held the largest share of the market, by software. However, the fully integrated software segment is anticipated to grow at the highest rate during the forecast period owing to its accuracy to avoid data redundancy by eliminating errors and tracking individual case safety reports.

Global Pharmacovigilance and Drug Safety Software Market, by Software Type – 2019 & 2027

Global Pharmacovigilance and Drug Safety Software Market, by Software Type – 2019 & 2027
  • Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
  • Request discounts available for Start-Ups & Universities

Delivery Mode -Based Insights

Based on delivery mode the market is segmented into on premise and cloud based. In 2019, the on-premise segment held the largest share of the market, by delivery mode. However, Cloud based segment is expected to grow at the fastest rate during the coming years owing to the benefits associated such as remote access to data, real-time data tracking.

End User-Based Insights

Based on end user the market is segmented into pharmaceutical and biotech companies, contract research organizations (CROs) and business process outsourcing (BPO) Firms. In 2019, the contract research organizations segment held the largest share of the market, by end user. Moreover, Contract Research Organizations segment is expected to grow at the fastest rate during the coming years owing to increasing drug discovery activities in the pharmaceutical companies.

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Pharmacovigilance and Drug Safety Software Market: Strategic Insights

Market Size Value inUS$ 160.67 Million in 2019
Market Size Value byUS$ 292.97 Million by 2027
Growth rateCAGR of 7.6% from 2020-2027
Forecast Period2020-2027
Base Year2020
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Inorganic strategies such as partnerships, and mergers and acquisitions are commonly adopted by companies to cater to changing customer demand and maintain their brand name across the world. Market players operating in the pharmacovigilance and drug safety software market also adopt organic strategies such as product launch and expansion to outstretch their footprint and product portfolio worldwide as well as to meet the growing demand.

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



  • North America

    • US
    • Canada
    • Mexico
  • Europe

    • France
    • Germany
    • Italy
    • UK
    • Spain
    • Rest of Europe
  • Asia Pacific (APAC)

    • China
    • India
    • South Korea
    • Japan
    • Australia
    • Rest of APAC
  • Middle East & Africa (MEA)

    • South Africa
    • Saudi Arabia
    • UAE
    • Rest of MEA
  • South and Central America (SCAM)

    • Brazil
    • Argentina
    • Rest of SCAM

Company Profiles

  • Veeva Systems                                              
  • IQVIA Inc.                                                         
  • Ennov                                                               
  • AB Cube                                                          
  • United Biosource LLC                                   
  • ArisGlobal LLC                                                
  • Sparta Systems                                              
  • Oracle Corporation                                        
  • Sarjen Systems Pvt. Ltd                                
  • EXTEDO                                                            
  • Maxapplication                                              
  • 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 ; and End User , and Geography

Regional Scope
Regional Scope

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

Country Scope
Country Scope

Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States

Frequently Asked Questions

What are Pharmacovigilance and Drug Safety Software ?

Pharmacovigilance (PV) plays an important role in drug monitoring and identification of drug interactions with human. The fully integrated software segment are expected to contribute in the growth of pharmacovigilance and drug safety market.

What are the driving factors for the Pharmacovigilance and Drug Safety Software market across the globe?

Rising incidences of adverse drug reaction (ADR) and globalization of pharmacovigilance have been boosting the market over the years. However, the expensive technology are likely to have a negative impact on the growth of the market in the coming years.

What is the cost of Pharmacovigilance and Drug Safety Software?

The costs of the pharmacovigilance and drug safety software are much higher, and they may cost US$ 1,0000–5,0000, or more, per software. The cost may also differ from product to product and software types.

The List of Companies - Pharmacovigilance and Drug Safety Software Market

  1. Veeva Systems          
  2. IQVIA Inc.      
  3. Ennov            
  4. AB Cube        
  5. United Biosource LLC             
  6. ArisGlobal LLC           
  7. Sparta Systems         
  8. Oracle Corporation     
  9. Sarjen Systems Pvt. Ltd         
  10. EXTEDO        
  11. Maxapplication           
  12. Online Business Applications, Inc.

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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