Pharmacovigilance and Drug Safety Software Market Size - By Functionality (Adverse Event Reporting Software, Issue Tracking Software), Mode of Delivery (On-premise, On-demand), End-use, Global Forecast, 2022 – 2032

Pharmacovigilance and Drug Safety Software Market Size - By Functionality (Adverse Event Reporting Software, Issue Tracking Software), Mode of Delivery (On-premise, On-demand), End-use, Global Forecast, 2022 – 2032

Pharmacovigilance & Drug Safety Software Market Size

Pharmacovigilance and Drug Safety Software Market size was valued at USD 171.7 million in 2022 and is estimated to grow at a CAGR of 6.6% to reach USD 319.9 million by 2032 attributed to the rising number of adverse drug reactions (ADRs) that has increased the need for reliable and efficient pharmacovigilance and drug safety software use.
 

Stringent guidelines by government and regulatory bodies have increased the adoption of pharmacovigilance and drug safety software for drug safety monitoring, signal detection, and risk management. Also, increasing number of drug development and clinical trials has further soared the demand for pharmacovigilance and drug safety software by pharmaceutical companies to effectively monitor the safety profiles of drugs in development and during clinical trials. Further, the adoption of artificial intelligence and machine learning in pharmacovigilance software has proven instrumental in streamlining the process of identifying potential safety issues and improving patient outcomes.
 

Pharmacovigilance and drug safety software are tools used by pharmaceutical companies, regulatory agencies, and healthcare organizations to monitor, track, and manage the safety and effectiveness of drugs and other medical products. These software systems play a crucial role in the process of pharmacovigilance, which involves the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
 

COVID-19 Impact

The rapid drug development propelled by the COVID-19 pandemic led to newer drugs, treatments, and vaccines being introduced at a rapid pace in the market. With the increase in the rate of drug development, the role of pharmacovigilance and drug safety software has emerged in managing large quantities of data to assess the risks and benefits of a particular drug. Additionally, the pandemic also highlighted the importance of real-time monitoring, adverse event reporting, and signal detection to identify any potential safety issues associated with new drugs.
 

Pharmacovigilance & Drug Safety Software Industry Trends

One of the key drivers of the pharmacovigilance and drug safety software market is the rising number of adverse drug reactions (ADR’s) globally. For instance, according to the Agency for Healthcare Research and Quality, in 2018, 3-7% of all hospitalizations in the U.S. were caused due to adverse drug reactions (ADRs). ADRs can have serious implications for patient health and safety, leading to potential legal and financial consequences for pharmaceutical companies. Hence, regulatory authorities are responding to this concern by implementing stricter regulations for drug safety.
 

Pharmacovigilance and Drug Safety Software Market Restraint

The high cost of ownership, installation, and maintenance of pharmacovigilance and drug safety software are the major challenges that may hamper the industry development by 2032. Many small and medium scale pharmaceutical manufacturers often operate with limited financial resources and may find it difficult to invest in expensive software solutions or to afford regular maintenance fees. Further, the initial costs of acquiring pharmacovigilance software licenses, implementation, and customization can be significant, making it a financial burden for small manufacturers while adopting such software systems.
 

Pharmacovigilance & Drug Safety Software Market Analysis

By functionality, the pharmacovigilance and drug safety software market is classified into adverse event reporting software, drug safety audits software, issue tracking software, fully integrated software, and other functionalities. The fully integrated software segment held 32.9% industry share in 2022. attributed to the increasing demand for automated, user-friendly, and technologically advanced platforms that enhance operational efficiency and ensure adherence to stringent safety regulations. Also, fully integrated software ensures data integrity and consistency, enabling efficient data retrieval, analysis, and reporting. Such aforementioned factors have increased the adoption of fully integrated software.
 

Based on mode of delivery, the pharmacovigilance and drug safety software market is segmented into on-premise and on-demand/cloud-based (SaaS). The on-demand/cloud-based (SaaS) segment held a significant share of the market of 56.7% in 2022. High adoption of on-demand/cloud-based (SaaS) software can be attributed to several advantages such as enhanced accessibility, seamless scalability, and reduced infrastructure costs. The on-demand model also facilitates real-time collaboration among stakeholders, enabling faster decision-making and comprehensive data analysis. Also, the SaaS model's flexibility and ease of implementation have allowed companies to access advanced pharmacovigilance tools that were once exclusive to larger enterprises.
 

By end-use, the pharmacovigilance and drug safety software market is divided into pharmaceutical & biotechnology companies, contract research organizations (CROS), business process outsourcing (BPO) firms, and other end-users. The pharmaceutical and biotechnology companies segment accounted for USD 59.5 million in 2022. These companies widely adopt pharmacovigilance and drug safety software solutions to streamline clinical trial programs and to focus on post-market surveillance. By implementing such software, pharmaceutical and biotechnology companies can streamline their pharmacovigilance processes, improve data collection & analysis, and ensure compliance with regulatory requirements.
 

Moreover, the software helps these companies in reporting adverse events to regulatory authorities, facilitating transparent communication and accountability. Such vast benefits of using this software have increased their adoption by pharmaceutical & biotechnology companies.
 

North America pharmacovigilance and drug safety software market is accounting for 37.4% of the total market’s revenue in 2022. The increasing demand for efficient and reliable drug safety solutions, coupled with stringent regulatory requirements, has propelled the business gains in the region. Also, the rising prevalence of chronic diseases, the growing number of clinical trials, and the escalating volume of drug approvals have further fueled the demand for pharmacovigilance and drug safety software. High number of CRO’s offering pharmacovigilance outsourcing services in the region is expected to increase the demand for such software.
 

Pharmacovigilance & Drug Safety Software Market Share

Major market players operating in the pharmacovigilance and drug safety software market include

• Arisglobal
• AB Cube S.A.S.
• Extedo GMBH
• Ennov Solutions Inc.
• United BioSource Corporation
•  Oracle Corporation,
• Online Business
• Applications Inc.
• Sarjen Systems Pvt. Ltd
• United Biosource Corporation
• Genepact
• Umbra Global among others.
   

Pharmacovigilance & Drug Safety Software Industry News

• In October 2022, PegBio selected LifeSphere MultiVigilance product from ArisGlobal, to transition their pharmacovigilance from contract research organization (CRO) services to in-house practices with this leading pharmacovigilance software. This helped the company to strengthen their inhouse pharmacovigilance and drug safety solutions and led to saving of funds.
   
• In December 2020, the Medicines and Healthcare products Regulatory Authority (MHRA) signed a deal with Genpact for obtaining the Pharmacovigilance Artificial Intelligence (PVAI) tool for USD 2.07 million. This helped the company to increase the popularity of its product and further increase its sales.
   

The pharmacovigilance and drug safety software market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2018 to 2032, for the following segments

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By Functionality

• Adverse Event Reporting Software
• Drug Safety Audits Software
• Issue Tracking Software
• Fully Integrated Software
• Other Functionalities

By Mode of Delivery

• On-premise
• On-demand/Cloud-based (SaaS)

By End-use

• Pharmaceutical & Biotechnology Companies
• Contract Research Organizations (CROs)
• Business Process Outsourcing (BPO) Firms
• Other End-users
   

The above information is provided for the following regions and countries

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • Rest of MEA