Drug Safety Solutions and Pharmacovigilance Software Market Overview and Analysis:
The Pharmacovigilance and Drug Safety Software Market size is expected to grow from USD 189.56 million in 2022 registering a CAGR of 5.73% during the forecast period (2023-2030).
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Pharmacovigilance (PV) software comprises drug safety management software solution that enables to create, classify, review, submit, and maintain pharmacovigilance data and adverse event reports.
The pharmacovigilance and drug safety software market is expected to register high growth due to the increasing incidence of adverse drug reactions (ADRs), which is the major driving factor for the growth of the pharmacovigilance and drug safety software market.
Drug Safety Solutions and Pharmacovigilance Software Market Latest Trends:
Pharmacovigilance and drug safety software are continually evolving to meet the growing demands of the pharmaceutical industry, regulatory bodies, and the need for patient safety. The introduction of artificial intelligence (AI) and machine learning are revolutionizing pharmacovigilance. These technologies are used to analyze vast datasets, including electronic health records and social media, to identify potential adverse events, assess causality, and predict safety issues. AI-powered algorithms can also improve the efficiency and accuracy of case processing. Moreover, the use of RWD, including data from electronic health records, claims databases, and patient registries, is expanding in pharmacovigilance. This data provides a real-world perspective on drug safety and can help identify previously unknown risks and benefits.
Segmentation:
The Pharmacovigilance and Drug Safety Software Market is Segmented
By Functionality
- Adverse Event Reporting Software
- Drug Safety Audits Software
- Issue Tracking Software
- Fully Integrated Software
Mode of Delivery :
- On-premise Delivery
- On-demand/Cloud-based (SaaS) Delivery)
End User :
- Pharmaceutical and Biotechnology Companies
- Contract Research Organizations
- Business Process Outsourcing Firms
- Other Pharmacovigilance Service Providers
Geography
- North America
- Europe
- Asia-Pacific
- Middle East
- Africa
- South America
The report offers the value (in USD million) for the above segments.
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Drivers:
Increasing Incidence of Adverse Drug Reactions (ADRs)
The increasing incidence of ADRs is a multifaceted issue influenced by various factors, including polypharmacy, aging populations, medication errors, complex medications, and genetic variability. Addressing this challenge necessitates a comprehensive approach that includes healthcare professional education, improved reporting systems, patient engagement, and a focus on developing safer medications and therapeutic strategies.
Reducing ADRs is essential not only for patient safety but also for the sustainability of healthcare systems and the advancement of medical care. For instance, as per the article published by Frontiers in 2022, adverse drug reactions (ADRs) represent a public health problem worldwide that deserves attention due to the impact it has on mortality, morbidity, and healthcare costs. Thus, more hospital admissions due to adverse drug reactions are likely to boost the need for adverse event reporting software in the coming years. Thus, the market is expected to witness significant growth over the forecast period.
Increasing Adoption of Pharmacovigilance Software by Outsourcing Companies
The increasing adoption of pharmacovigilance software by outsourcing companies is a response to the growing complexity of regulatory requirements, data volumes, and the need for efficiency. This trend is transforming the way pharmacovigilance is conducted, offering benefits such as enhanced data quality, compliance, and efficiency. As the pharmaceutical industry continues to expand, the role of outsourcing companies and their reliance on advanced software solutions will only become more crucial in ensuring drug safety and regulatory adherence. Thus, the growth of the market is expected to witness significant growth over the forecast period.
Restraints:
Lack of Awareness about Pharmacovigilance
Pharmacovigilance serves as a critical pillar in the post-marketing surveillance of drugs and medical products. Its primary goal is to identify and prevent adverse effects, ensuring that only safe and effective medications are available to the public. Pharmacovigilance often involves complex terminologies and processes that may not be easily understood by the general public. Healthcare professionals themselves may find it challenging to keep up with the rapidly evolving field. Thus, the growth of the market is expected to slow down over the forecast period.
COVID-19 Impact on Drug Safety Solutions and Pharmacovigilance Software Market
The ever-evolving threat posed by the COVID-19 pandemic had a profound impact on communities, industries, businesses, and individuals worldwide. During this challenging period, it became absolutely crucial to closely monitor medical conditions and report safety concerns, especially given the extensive use of various treatments to combat the coronavirus. The medications employed to manage COVID-19 raised concerns about potential adverse reactions. As a result, healthcare professionals and organizations submitted numerous reports of adverse drug reactions to a database known as VigiBase, managed by the Uppsala Monitoring Centre (UMC). This surge in reported adverse reactions to COVID-19 treatments significantly heightened the demand for systems that could efficiently report and track these events during the pandemic.
In addition to this, in March 2021, as a direct response to the COVID-19 crisis, the U.S. Food and Drug Administration (FDA) introduced the FAERS Public Dashboard. This online tool was specifically developed to offer weekly updates regarding adverse event reports submitted to the FDA Adverse Event Reporting System (FAERS) for drugs and therapeutic biological products authorized for emergency use to combat COVID-19. These proactive government initiatives and the introduction of advanced safety reporting systems have paved the way for growth in the market under consideration. Consequently, the COVID-19 pandemic initially influenced this market positively, and while the most intense phase of the pandemic has receded, it is expected to experience sustained growth throughout the projected study period.
Segmental Analysis:
Adverse Event Reporting Software Segment is Expected to Witness Significant growth Over the Forecast Period
Adverse Event Reporting Software (AERS) is a critical tool used in healthcare, pharmaceuticals, and various other industries to monitor, manage, and report adverse events related to products and processes. These software solutions play a pivotal role in ensuring safety, compliance, and continuous improvement. Furthermore, the launch of new software is expected to drive the growth of the studied segment. For instance, in October 2021, the FDA launched the FAERS Public Dashboard for COVID-19 emergency use authorization (EUA) products. The COVID-19 EUA FAERS Public Dashboard provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biological products used under EUA in COVID-19. After launching the FAERS Public Dashboard, click on the COVID-19 EUA link on the home page to open the COVID-19 EUA FAERS Public Dashboard. Thus, the launch of such products is expected to contribute to the segment’s growth.
On-demand/ Cloud-based (SaaS) Delivery Segment is Expected to Witness Significant growth Over the Forecast Period
On-demand or cloud-based SaaS delivery is not only changing how software is consumed but is also contributing to increased efficiency, innovation, and competitiveness across industries. As technology continues to advance, it is likely that SaaS will remain a driving force in the digital transformation of businesses worldwide. SaaS applications are accessible from any internet-connected device, which fosters remote work, collaboration, and mobility. SaaS solutions are often multi-tenant, meaning that multiple customers share the same software instance. This approach promotes resource efficiency and cost savings. Thus, the segment is expected to witness significant growth over the forecast period.
Contract Research Organizations is Expected to Witness Significant Growth Over the Forecast Period
Contract Research Organizations (CROs) play a pivotal role in the pharmaceutical and biotechnology industries by providing outsourced research and development services. These organizations offer a wide range of services, including clinical trial management, data collection and analysis, regulatory affairs, and pharmacovigilance. Their contributions to pharmacovigilance and drug safety have become increasingly essential in the complex and highly regulated world of drug development. In this article, we will explore the relationship between CROs and pharmacovigilance, and the impact of CROs on the pharmacovigilance and drug safety software market. Outsourcing pharmacovigilance to CROs can be more cost-effective for pharmaceutical companies. CROs can spread the cost of infrastructure, personnel, and software across multiple clients, reducing the financial burden on individual companies. Thus, the segment is expected to witness significant growth over the forecast period.
North America is Expected to Witness Significant Growth Over the Forecast Period
The pharmacovigilance and drug safety software market in North America is poised for robust growth, primarily driven by increased research investments and government initiatives. Adverse drug reactions represent a significant contributor to hospitalizations and fatalities in the United States, thereby boosting the demand for pharmacovigilance and drug safety software. For instance, in 2021, the Vaccine Adverse Event Reporting System identified ten cases of anaphylaxis following the administration of approximately 4,041,396 initial doses of the Moderna COVID-19 vaccine (equating to 2.5 cases per million doses). This underscores the growing necessity for medical information and vigilance on the part of regulatory authorities, further fueling the expansion of this sector.
Government-led initiatives are also instrumental in propelling market growth in North America. For example, the Open FDA initiative, led by the U.S. government, offers open access to its database through search-based programs, benefiting application developers and scientists. Another notable project, Mini-Sentinel, initiated by the United States, advocates for an active surveillance system, facilitating the rapid dissemination of pertinent statistical information.
Furthermore, in response to the pandemic, the U.S. Food and Drug Administration introduced the FDA Adverse Event Reporting System (FAERS) in October 2021. This system includes a dashboard for COVID-19 emergency use authorization (EUA) products, providing real-time updates on adverse event reports for drugs authorized for emergency use in the context of COVID-19.
Hence, the pharmacovigilance and drug safety software market in North America is poised for growth due to the aforementioned factors.
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Drug Safety Solutions and Pharmacovigilance Software Market Competitive Landscape:
The pharmacovigilance and drug safety software market is fragmented in nature due to the presence of several companies operating globally as well as regionally. Key strategies implemented by the market players, including mergers, acquisitions, and strategic collaborations for R&D outsourcing or manufacturing activities, are driving market growth. The key market players include
- Ab Cube
- ArisGlobal
- Ennov Solutions Inc.
- Extedo GmbH
- Anju Software, Inc.
- Oracle Corporation
- Sarjen Systems Pvt Ltd
- Sparta Systems Inc.
- United BioSource Corporation
- Veeva Systems
Recent Development:
1. October 2022: PegBio selected LifeSphere MultiVigilance, a flagship product by ArisGlobal, to transition their pharmacovigilance from Contract Research Organization (CRO) services to in-house practices with this leading pharmacovigilance software.
2. July 2022: Dotmatics launched its Small Molecule Drug Discovery Solution, an integrated scientific R&D platform with pre-configured workflows and expanded data management capabilities.
Frequently Asked Questions (FAQ) :
Q1. How big is the Drug Safety Solutions and Pharmacovigilance Software Market?
The Pharmacovigilance and Drug Safety Software Market size is expected to grow from USD 189.56 million in 2022 registering a CAGR of 5.73% during the forecast period (2023-2030)
Q2. At what CAGR is the market projected to grow within the forecast period?
Pharmacovigilance and Drug Safety Software Market is registering a CAGR of 5.73% during the forecast period.
Q3. Who are the key players in Pharmacovigilance and Drug Safety Software Market?
Some key players operating in the pharmacovigilance and drug safety software market include: Ab Cube, ArisGlobal, Ennov Solutions Inc., Extedo GmbH and Anju Software, Inc.
Q4. What are the factors driving the Pharmacovigilance and Drug Safety Software Market?
Key factors that are driving the pharmacovigilance and drug safety software market growth include the Increasing Incidence of Adverse Drug Reactions (ADRs) and Increasing Adoption of Pharmacovigilance Software by Outsourcing Companies.
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Extensive primary research was conducted to gain a deeper insight of the market and industry performance. The analysis is based on both primary and secondary research as well as years of professional expertise in the respective industries.
In addition to analysing current and historical trends, our analysts predict where the market is headed over the next five years.
It varies by segment for these categories geographically presented in the list of market tables. Speaking about this particular report we have conducted primary surveys (interviews) with the key level executives (VP, CEO’s, Marketing Director, Business Development Manager and many more) of the major players active in the market.
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Market Size EstimationBoth, top-down and bottom-up approaches were used to estimate and validate the size of the Global market and to estimate the size of various other dependent submarkets in the overall Extra Neutral Alcohol. The key players in the market were identified through secondary research and their market contributions in the respective geographies were determined through primary and secondary research.
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