Pharmacovigilance and Drug Safety Software Market Skyrockets to $359.30 Million by 2031 Dominated by Tech Giants - ArisEurope, ICON plc and Syneos Health | The Insight Partners

The global pharmacovigilance and drug safety software market is set for explosive growth, with projections indicating a surge to $359.30 million by 2031. This remarkable expansion, driven by rise in incidences of adverse drug reactions and globalization of pharmacovigilance.


US & Canada, Nov. 18, 2024 (GLOBE NEWSWIRE) -- According to a new comprehensive report from The Insight Partners, the global pharmacovigilance and drug safety software market is observing significant growth owing to surge in drug development spending and cloud-based pharmacovigilance and drug safety software. For Detailed Market Insights, Visit: https://www.theinsightpartners.com/reports/pharmacovigilance-pv-and-drug-safety-software-market


The report runs an in-depth analysis of market trends, key players, and future opportunities. In general, the pharmacovigilance and drug safety software market comprise a vast array of offerings, organization size, deployment, form, functionality, end user and geography which are expected to register strength during the coming years.


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Market Overview and Growth Trajectory:

Pharmacovigilance and Drug Safety Software Market Growth: According to an exhaustive report by The Insight Partners, the Pharmacovigilance and Drug Safety Software Market is experiencing significant growth, driven by implementation of unified solution. The market, valued at $214.39 million in 2023, is expected to grow at a Compound Annual Growth Rate (CAGR) of 6.7% during 2023–2031.

Technological Innovations: Unlike traditional systems, cloud-based platforms offer real-time access to data from anywhere across Europe, enabling pharmaceutical companies to respond swiftly to emerging safety concerns. Cloud-based platforms enable real-time monitoring of adverse events that allow pharmaceutical companies to detect and respond to safety signals more quickly. With real-time data access, companies can generate safety reports on demand, significantly reducing the time required for decision-making. This immediacy is crucial in preventing adverse events from escalating into serious public health issues. Also, one of the most significant advantages of cloud-based drug safety solutions is their scalability. As a company grows or as the volume of data increases, the cloud platform can scale accordingly without requiring additional infrastructure investments. This flexibility is essential in pharmacovigilance, where the volume of data can fluctuate significantly depending on the stage of the drug's lifecycle. Cloud-based systems are enabling the creation of global pharmacovigilance networks, where data can be shared across borders in real-time. These networks will enable more comprehensive drug safety monitoring, with insights and safety signals being shared worldwide, leading to faster identification and mitigation of risks.


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Rise In Incidences of Adverse Drug Reactions: The cases of adverse drug reactions (ADRs) are increasing worldwide owing to the increasing prevalence of chronic diseases. As all drugs have the potential for adverse drug reactions, a risk-benefit analysis is necessary whenever a drug is prescribed. ADRs remain a challenge in modern healthcare, particularly given the growing complexity of therapeutics, an aging population, and rising multimorbidity across the globe. Pharmacovigilance software enables healthcare providers and pharmaceutical companies to collect, analyze systematically, and report data related to ADRs and overcome the challenges associated with it. The increasing prevalence of ADRs across the globe is propelling the demand for pharmacovigilance and drug safety software market growth. According to the database of ADRs available in the US Food and Drug Administration's Adverse Event Reporting System (FAERS), in 2022, more than 1.25 million severe adverse cases were reported, along with over 175,000 deaths.

Globalization of Pharmacovigilance: Pharmacovigilance is the process of monitoring and evaluating adverse drug reactions, and it is a major component of effective drug regulation systems, clinical practice, and public health programs. The globalization of pharmacovigilance fosters collaboration among stakeholders, including regulatory authorities, healthcare providers, and pharmaceutical companies. For instance, the European Medicines Agency (EMA) has placed a growing importance on collaborating with international pharmaceutical regulators to focus on areas such as the safety of medicines, inspections, and exchange of information on issues of mutual concern. Such a collaborative environment enhances data sharing and improves the overall understanding of drug safety profiles. As companies seek to leverage these global networks, the need for integrated pharmacovigilance solutions that can operate across the globe is becoming increasingly essential.


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Geographical Insights: North America dominated the pharmacovigilance and drug safety software market in 2023. Europe is the second-largest contributor to the global pharmacovigilance and drug safety software market, followed by Asia Pacific. Further, Asia Pacific is expected to record the highest CAGR in the pharmacovigilance and drug safety software market during the forecast period.


Pharmacovigilance and Drug Safety Software Market Segmentation, Applications, Geographical Insights:

  • Based on organization size, the Europe pharmacovigilance and drug safety software market are bifurcated into large organizations and small and medium organizations. The large organizations segment dominated the market in 2023.

  • In terms of offerings, the market is divided into solutions/software and services. The software segment dominated the market in 2023.

  • Based on deployment, the Europe pharmacovigilance and drug safety software market are bifurcated into cloud and on-premises. The cloud segment dominated the market in 2023

  • Based on form, the Europe pharmacovigilance and drug safety software market are bifurcated into standard and customized. The standard segment dominated the market in 2023.

  • By functionality, the Europe pharmacovigilance and drug safety software market are segmented into case management, signal and risk management, quality and compliance, audit support and training compliance, issue tracking and adverse event tracking, clinical safety management and clinical trial safety, medical writing, healthcare analytics, and others. The signal and risk management segment dominated the market in 2023.

  • Based on end user, the Europe pharmacovigilance and drug safety software market are segmented into pharmaceutical and biotechnology companies, contract research organizations, business process outsourcing firms, and other pharmacovigilance service providers. The pharmaceutical and biotechnology companies segment dominated the market in 2023.

  • The pharmacovigilance and drug safety software market are segmented into five major regions: North America, Europe, APAC, Middle East and Africa, and South and Central America.

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Key Players and Competitive Landscape:

The Pharmacovigilance and Drug Safety Software Market is characterized by the presence of several major players, including:

  • ArisEurope
  • ICON plc
  • Syneos Health
  • Accenture
  • IQVIA
  • Genpact
  • Cognizant
  • Paraxel International Corporation
  • Laboratory Corporation of America Holdings
  • Max Application
  • Clinevo Technologies
  • Qinecsa Solutions
  • AB Cube
  • Veeva Systems

These companies are adopting strategies such as new product launches, joint ventures, and geographical expansion to maintain their competitive edge in the market.


Pharmacovigilance and Drug Safety Software Market Recent Developments and Innovations:

  • "ArisGlobal, a market leader in global drug development technology solutions, announced that Medac, a German-based pharmaceutical manufacturer specializing in the fields of oncology and hematology, urology, and autoimmune diseases, chose LifeSphere Safety to modernize its drug safety processes. Precise, patient- and population-specific analysis is crucial for minimizing treatment risks for patients and thus supports the best possible treatment outcome.”

  • “IQVIA, a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, announced a strategic collaboration with Argenx to advance treatment to patients with rare autoimmune diseases through innovative and integrated technology-enabled pharmacovigilance (PV) safety services and solutions.”

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Conclusion:

The rising integration of technologies such as artificial intelligence and machine learning with pharmacovigilance and drug safety software to automate drug safety tasks is driving the global market. Several key players are integrating these advanced technologies to automate the workflow in the pharmaceutical industry. For instance, in January 2024, PubHive Ltd., a provider of AI-powered scientific safety and literature information workflows, launched centralized Summary of Product Characteristics (SmPC) management software with AI-powered pharmacovigilance workflows for life science companies. The company offers its software to Clinical Research Organizations (CROs) and their pharmacovigilance and drug safety departments. This AI-based solution simplifies and streamlines processes and helps meet compliances, as well as empowers pharmacovigilance teams to work faster and more effectively.

A rise in government investments in adopting these AI-based advanced solutions to promote automation in the pharmaceutical sector is driving the market. For instance, in July 2024, the US Food and Drug Administration (FDA) announced the launch of a public workshop that focused on promoting Drug & Biological Product Development using artificial intelligence. The US FDA collaborated with drug sponsors and AI experts to provide guidelines for the use of AI in the development of drug safety and biological products. FDA awarded a grant of US$ 2 million for 13 months to MITRE Corporation to integrate Risk Evaluation and Mitigation Strategies (REMS) data in August 2023. The integration of AI and predictive analytics with pharmacovigilance and drug safety software enhances the capability to identify potential safety risks before they escalate into severe issues. These advanced technologies help analyze large volumes of structured and unstructured data to detect upcoming safety signals and trends, which triggers proactive risk mitigation strategies.


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With projected growth to $359.30 Million by 2031, the Pharmacovigilance and Drug Safety Software Market represents a significant opportunity for software and services providers, system integrators, investors, industry stakeholders, regulatory bodies, and end users. By staying abreast of market trends, embracing innovation, and focusing on quality and performance, companies can position themselves for success in this dynamic and evolving market landscape.


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