Pharmacovigilance and Drug Safety Software Market Report 2031
The pharmacovigilance and drug safety software market was valued at US$ 1.97 billion in 2021 and is expected to reach US$ 3.29 billion by 2031. The market is expected to register a CAGR of 5.9% in 2023–2031. Artificial intelligence in pharmacovigilance will likely remain a key pharmacovigilance and drug safety software market trend.
Pharmacovigilance and Drug Safety Software Market Analysis
Pharmacovigilance (PV) plays an essential role in the healthcare system through assessment, monitoring, and finding drug interactions and their effects in humans. Pharmacovigilance helps companies monitor adverse drug reaction events during the trial and post-marketing periods. Key factors driving the market are rising adverse drug reaction incidences and the globalization of pharmacovigilance, which have been boosting the market over the years. However, expensive technology is likely to have a negative impact on market growth in the coming years.
Pharmacovigilance and Drug Safety Software Market Overview
The rise in a high volume of pharmacovigilance data and ADR events during recent years across the globe is a prime contributing factor to the rising demand for sophisticated pharmacovigilance and drug safety software. The industry players operating in the market of pharmacovigilance (PV) and drug safety market include AB Cube, United BioSource LLC, ARISGLOBAL LLC, Sparta Systems, Inc., Oracle Corporation, Sarjen Systems Pvt. Ltd., EXTEDO, ENNOV, Max Application, and Anju Software, Inc. The players operating in the pharmacovigilance (PV) and drug safety software market have been focusing on various organic and inorganic growth strategies during the previous years.
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Pharmacovigilance and Drug Safety Software Market: Strategic Insights
Market Size Value in US$ 160.67 Million in 2019 Market Size Value by US$ 292.97 Million by 2027 Growth rate CAGR of 7.6% from 2020-2027 Forecast Period 2020-2027 Base Year 2020
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Pharmacovigilance and Drug Safety Software Market: Strategic Insights
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Market Size Value in | US$ 160.67 Million in 2019 |
Market Size Value by | US$ 292.97 Million by 2027 |
Growth rate | CAGR of 7.6% from 2020-2027 |
Forecast Period | 2020-2027 |
Base Year | 2020 |
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Pharmacovigilance and Drug Safety Software Market Drivers and Opportunities
Globalization Of Pharmacovigilance
Pharmacovigilance, which refers to the procedures for tracking and assessing adverse drug responses, is an essential part of clinical practice, public health initiatives, and efficient drug control systems. The volume of data processed increased due to the reported number of Adverse Drug Reactions (ADRs) within the existing Uppsala Monitoring Center-coordinated global network of pharmacovigilance facilities. Pharmacovigilance is becoming increasingly common in many nations, and it is an essential and crucial component of clinical research. However, at the turn of the millennium, pharmacovigilance faces significant challenges in the aspect of better safety and monitoring of drugs.
Growth Opportunities in Developing Countries– An Opportunity in Pharmacovigilance and Drug Safety Software Market
The emerging Asian Pacific markets are creating significant opportunities for key market players to expand their businesses. It will likely be a prime factor contributing to market growth in the coming years. Most players concentrate on developing markets such as India and China, owing to the presence of many clinical research organization and business process outsourcing firms in countries.
Various players from the pharmaceutical industry have been investing a significant amount of their revenue in research and development activities to develop better medicines to be used in the healthcare industry. Asia Pacific is foreseen to register the fastest growth during the forecast period. The presence of key pharmaceutical companies in the region contributes to APAC's market growth. These activities in the region are increasing the demand for pharmacovigilance and drug safety software’s.
Pharmacovigilance and Drug Safety Software Market Report Segmentation Analysis
Key segments that contributed to the derivation of the pharmacovigilance and drug safety software market analysis are disorder and service provider.
- Based on software type, the pharmacovigilance and drug safety software market is segmented into adverse event reporting software, drug safety audits software, issue tracking software, fully integrated software. The adverse event reporting software segment held a larger market share in 2023.
- By delivery mode, the pharmacovigilance and drug safety software market is segmented into on-premise, cloud-based. The on-premise segment held the largest share of the market in 2023.
- By End Users, the pharmacovigilance and drug safety software market is classified into pharmaceutical and biotech companies, contract research organizations (CROs), business process outsourcing (BPO) firms, pharmacovigilance service providers. The contract research organizations (CROs) segment held the largest share of the market in 2023.
Pharmacovigilance and Drug Safety Software Market Share Analysis by Geography
The geographic scope of the pharmacovigilance and drug safety software market report is mainly divided into five regions: North America, Asia Pacific, Europe, Middle East & Africa, and South America/South & Central America.
The United States offers significant growth opportunities in the Pharmacovigilance (PV) and drug safety software market, which is expected to drive the market’s growth considerably. The Institute of Medicine reported in 2000 that from 44,000 to 98,000 deaths occur annually from medical errors, and an estimated 7,000 deaths occur due to Adverse Drug Reactions (ADRs).
According to the U.S Food and Drugs Admiration, a study conducted in the hospital on hospitalized patient populations has placed much higher estimates on the overall incidence of serious Adverse Drug Reactions (ADRs). These studies estimate that 6.7% of hospitalized patients have a serious adverse drug reaction with a fatality rate of 0.32%. According to this study data, it estimates that there are more than 2,216,000 serious ADRs in hospitalized patients, causing over 106,000 deaths annually, which indicates that ADRs are the 4th leading cause of death ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents, and automobile deaths.
Pharmacovigilance and Drug Safety Software Market Report Scope
Pharmacovigilance and Drug Safety Software Market News and Recent Developments
The 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. The following is a list of developments in the market for speech and language disorders and strategies:
- To move their pharmacovigilance from Contract Research Organization (CRO) services to in-house practices using this cutting-edge pharmacovigilance software, PegBio chose ArisGlobal's flagship product, LifeSphere MultiVigilance. (PegBio: Pearl, Press Release, 2022).
Dotmatics, the leader in scientific software for research and development that links data, science, and decision-making, has released a new platform for scientific research and development called Small Molecule Drug Discovery Solution. It features enhanced data management features and pre-configured workflows. The solution makes innovation easier for businesses by using best practices developed over the company's more than 15 years of supporting small molecule drug research. (Source: Dotmatics, Press Release, 2022)
Pharmacovigilance and Drug Safety Software Market Report Coverage and Deliverables
The “Pharmacovigilance and Drug Safety Software Market Size and Forecast (2021–2031)” report provides a detailed analysis of the market covering below areas:
- Market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
- Market dynamics such as drivers, restraints, and key opportunities
- Key future trends
- Detailed PEST/Porter’s Five Forces and SWOT analysis
- Global and regional market analysis covering key market trends, major players, regulations, and recent market developments
- Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments
- Detailed company profiles
![Report Coverage](https://www.theinsightpartners.com/assets/rdimages/report_coverage.png)
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
![Segment Covered](https://www.theinsightpartners.com/assets/rdimages/segment_covered.png)
Segment Covered
Software Type ; Delivery Mode ; and End User , and Geography
![Regional Scope](https://www.theinsightpartners.com/assets/rdimages/regional_scope.png)
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
![Country Scope](https://www.theinsightpartners.com/assets/rdimages/country_scope.png)
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
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.