Global Drug Safety Solutions and Pharmacovigilance Market, By Type (Software and Services), Product (Standard Form and Customized Form), Functionality (Adverse Event Reporting Software, Drug Safety Audits Software, and Issue Tracking Software), Delivery (On-Premise Delivery Mode and On-Demand/Cloud-Based (SAAS) Delivery Mode), End Users (Biotechnology and Pharmaceuticals, Contract Research Organizations (CROS), Hospitals, KPOs/BPOs, and Healthcare Providers), Distribution Channel (Direct Sales and Retail Sales) – Industry Trends and Forecast to 2031.
Drug Safety Solutions and Pharmacovigilance Market Analysis and Size
Several factors, including the increasing prevalence of adverse drug reactions and the rising demand for effective drug safety monitoring systems drive the drug safety solutions and pharmacovigilance market. The market is also fueled by major pharmaceutical companies' growing investment in drug development and the rising adoption of pharmacovigilance services by regulatory authorities to ensure public safety. Moreover, emerging advanced technologies such as artificial intelligence and big data analytics further boost market growth.
The global drug safety solutions and pharmacovigilance market size was valued at USD 8.39 billion in 2023 and is projected to reach USD 14.96 billion by 2031, with a CAGR of 7.5% during the forecast period of 2024 to 2031. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.
Report Scope and Market Segmentation
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Report Metric
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Details
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Forecast Period
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2024 to 2031
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Base Year
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2023
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Historic Years
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2022 (Customizable to 2016 - 2021)
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Quantitative Units
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Revenue in USD Billion, Volumes in Units, Pricing in USD
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Segments Covered
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Type (Software and Services), Product (Standard Form and Customized Form), Functionality (Adverse Event Reporting Software, Drug Safety Audits Software, and Issue Tracking Software), Delivery (On-Premise Delivery Mode and On-Demand/Cloud-Based (SAAS) Delivery Mode), End Users (Biotechnology and Pharmaceuticals, Contract Research Organizations (CROS), Hospitals, KPOs/BPOs, and Healthcare Providers), Distribution Channel (Direct Sales and Retail Sales)
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Countries Covered
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U.S., Canada, Mexico, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific, Saudi Arabia, U.A.E., South Africa, Egypt, Israel, Rest of Middle East and Africa, Brazil, Argentina, and Rest of South America
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Market Players Covered
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PPD Inc (U.S.), Drug Safety Solutions Limited (U.S.), C3i (U.S.), Worldwide Clinical Trials (U.S.), Bioclinica (U.S.), United Biosource LLC (U.S.), Ennov (Hong Kong), AB Cube S.A.S. (France), Labcorp Drug Development (U.S.), Accenture (Ireland), ICON plc (U.S.), Ergomed plc (U.K.), IQVIA (U.S.), Genpact (U.S.), Cognizant (U.S.), Parexel International Corporation (U.S.), ArisGlobal (U.S.)
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Market Opportunities
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Market Definition
Drug safety solutions and pharmacovigilance refer to practices and systems implemented by pharmaceutical companies and regulatory agencies to monitor and ensure the safety of drugs. Pharmacovigilance involves detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. It aims to improve patient safety and public health by identifying and evaluating the risks associated with pharmaceutical products throughout their lifecycle, from pre-market clinical trials to post-market surveillance.
Drug Safety Solutions and Pharmacovigilance Market Dynamics
Drivers
- Increasing Prevalence of Adverse Drug Reactions
As the use of pharmaceuticals continues to increase, so does the likelihood of ADRs, necessitating robust pharmacovigilance systems to monitor and manage these risks effectively. With more complex and personalized treatments becoming common, the importance of pharmacovigilance in ensuring patient safety and drug efficacy is increasing. The rising incidence of adverse drug reactions (ADRs) globally is a significant driver for the drug safety solutions and pharmacovigilance market.
- Growing Demand for Personalized Medicine
Personalized medicine requires monitoring patient responses to tailor treatments, highlighting the importance of robust pharmacovigilance systems. As personalized medicine becomes more mainstream, pharmacovigilance will play a crucial role in identifying and managing individualized risks associated with these treatments. This shift towards personalized medicine, driven by advancements in genomics and biomarker research, drives the need for more comprehensive pharmacovigilance strategies and market growth.
Opportunities
- Expansion of Pharmacovigilance Outsourcing
The expansion of pharmacovigilance outsourcing refers to the increasing trend among pharmaceutical companies to delegate pharmacovigilance activities to external service providers. As pharmaceutical companies face growing regulatory requirements and the need for specialized expertise in pharmacovigilance, they opt to outsource these functions to third-party service providers. This allows companies to access specialized knowledge and resources while reducing operational costs. Outsourcing pharmacovigilance tasks is expected to grow rapidly, offering new opportunities for market growth.
- Integration of Real-World Data
Integrating real-world data (including electronic health records, claims data, and patient registries, can provide valuable insights into drug safety and effectiveness in real-world settings. By leveraging RWD, pharmacovigilance professionals can enhance signal detection, improve risk assessment, and optimize post-marketing surveillance, leading to more efficient and effective pharmacovigilance practices and creating new opportunities for the market.
Restraints/Challenges
- Regulatory Compliance and Reporting Burden
Regulatory requirements for pharmacovigilance are becoming more complex and stringent, requiring companies to invest significant resources in compliance efforts. This includes the timely and accurate reporting of adverse drug reactions (ADRs), maintaining comprehensive pharmacovigilance systems, and ensuring compliance with evolving regulations across different regions. Failure to comply with these requirements can lead to regulatory sanctions, fines, and reputational damage, posing a significant challenge to the market.
- Data Quality and Integration
Pharmacovigilance relies heavily on collecting, analyzing, and interpreting vast amounts of data from diverse sources, including clinical trials, post-market surveillance, and real-world evidence. Ensuring this data's quality, consistency, and reliability is critical for effective pharmacovigilance practices. However, data quality issues, such as incomplete or inaccurate reporting, data silos, and lack of standardization, can hinder the ability of companies to derive meaningful insights from their data and effectively identify and manage drug safety risks. The quality and integration of data is a major challenge for the market.
This drug safety solutions and pharmacovigilance market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the drug safety solutions and pharmacovigilance market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.
Drug Safety Solutions and Pharmacovigilance Market Scope
The drug safety solutions and pharmacovigilance market is segmented on the basis of type, product, functionality, end user, delivery, and distribution channel. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.
Type
- Software
- Services
Product
- Standard Form
- Customized Form
Functionality
- Adverse Event Reporting Software
- Drug Safety Audits Software
- Issue Tracking Software
Delivery
- On-Premise Delivery Mode
- On-Demand/Cloud-Based (SAAS) Delivery Mode
End Users
- Biotechnology and Pharmaceuticals
- Contract Research Organizations (CROS)
- Hospitals
- KPOs/BPOs
- Healthcare Providers
Distribution Channel
- Direct Sales
- Retail Sales
Drug Safety Solutions and Pharmacovigilance Market Regional Analysis/Insights
The drug safety solutions and pharmacovigilance market is analyzed and market size insights and trends are provided by country, type, product, functionality, end user, delivery, and distribution channel as referenced above.
The countries covered in the market are U.S., Canada, Mexico, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific, Saudi Arabia, U.A.E., South Africa, Egypt, Israel, Rest of Middle East and Africa, Brazil, Argentina, and Rest of South America.
North America is expected to dominate the market due to the escalating rates of drug abuse and adverse drug reactions. Major regional pharmaceutical companies are investing significantly in new drug research, further propelling market growth. These factors, coupled with the stringent regulatory framework in North America, are driving the demand for pharmacovigilance services in the region.
Asia-Pacific is expected to witness significant growth during the forecast period due to the expanding government initiatives and investments to improve healthcare infrastructure and services. Furthermore, there is a growing awareness among patients in the region regarding the importance of pharmacovigilance in ensuring drug safety.
The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.
Healthcare Infrastructure Growth Installed base and New Technology Penetration
The drug safety solutions and pharmacovigilance market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for drug safety solutions and pharmacovigilance market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the drug safety solutions and pharmacovigilance market. The data is available for historic period 2011-2021.
Competitive Landscape and Drug Safety Solutions and Pharmacovigilance Market Share Analysis
The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to the market.
Some of the major players operating in the drug safety solutions and pharmacovigilance market are:
- PPD Inc (U.S.)
- Drug Safety Solutions Limited (U.S.)
- C3i (U.S.)
- Worldwide Clinical Trials (U.S.)
- Bioclinica (U.S.)
- United Biosource LLC (U.S.)
- Ennov (Hong Kong)
- AB Cube S.A.S. (France)
- Labcorp Drug Development (U.S.)
- Accenture (Ireland)
- ICON plc (U.S.)
- Ergomed plc (U.K.)
- IQVIA (U.S.)
- Genpact (U.S.)
- Cognizant (U.S.)
- Parexel International Corporation (U.S.)
- ArisGlobal (U.S.)
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