According to our latest study on "Pharmacovigilance and Drug Safety Software Market Size and Forecasts (2021 - 2031), Global and Regional Share, Trends, and Growth Opportunity Analysis - by Offering, Deployment, Enterprise Size, Form, Functionality, and End User," the pharmacovigilance and drug safety software market size was valued at US$ US$ 214.39 million in 2023 and is expected to reach US$ 359.31 million by 2031; it is estimated to record a CAGR of 6.7% from 2023 to 2031.

The pharmacovigilance and drug safety software market is segmented into five major regions-North America, Europe, Asia Pacific (APAC), the Middle East & Africa (MEA), and South & Central America. North America dominated the market in 2023, followed by Europe and APAC, respectively. The Europe pharmacovigilance and drug safety software market is segmented into Germany, France, the UK, Italy, Spain, and Russia. In terms of revenue, Germany dominated the pharmacovigilance and drug safety software market share. The strong presence of the healthcare industry boosts the requirement for pharmacovigilance and drug safety software in Germany. As per the report of The International Trade Administration, Germany became the third-largest medical technology market in the world after the US and Japan. It is the largest European market, twice the size of the French market and three times as large as those of the UK, Italy, and Spain. The medical device market in Germany is among the most profitable healthcare markets worldwide, accounting for ~US$ 42 billion annually, or 25% of the European market total. Furthermore, there are various healthcare organizations and associations in the country such as The German Medical Association, German Health Alliance, German Hospital Federation (DKGEV), etc. As the regulatory landscape evolves, healthcare organizations and pharmaceutical companies are investing in advanced pharmacovigilance and drug safety software solutions to manage their pharmacovigilance activities effectively. Therefore, the presence of health organizations and associations is expected to offer growth opportunities in the Germany pharmacovigilance and drug safety software market during the forecast period.

The market for pharmacovigilance and drug safety software in France is expected to grow during the forecast period as the government in the country applies various regulations on pharmacovigilance. For instance, regulation (EU) No 1235/2010 and Directive 2010/84/EU constitute the legal framework for obtaining authorization to place products on the market in France and the Rest of the EU. It is aimed at allowing pharmaceutical manufacturers to launch their products in France. Also, these provisions on pharmacovigilance introduce, among other measures, mandatory reporting of adverse drug reactions by health professionals or enterprises exploiting a drug. Also, in 2011, the French Parliament adopted Law No. 2011-2012 on reinforcing drug safety, aimed at restoring public trust in the drug regulatory system following the scandal that erupted in France.

Key Findings of Pharmacovigilance and drug safety software market Study:

The pharmacovigilance and drug safety software market is segmented into offering, deployment, enterprise size, form, functionality, and end user. Based on organization size, the global pharmacovigilance and drug safety software market is bifurcated into large organizations and small and medium organizations. In terms of offerings, the market is divided into solutions/software and services. Based on form, the global pharmacovigilance and drug safety software market is bifurcated into standard and customized. By functionality, the global pharmacovigilance and drug safety software market is 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. Based on end users, the global pharmacovigilance and drug safety software market is segmented into pharmaceutical and biotechnology companies, contract research organizations, business process outsourcing firms, and other pharmacovigilance service providers.

On the basis of end user, the Europe pharmacovigilance and drug safety software market is segmented into pharmaceutical and biotechnology companies, contract research organizations, business process outsourcing (BPO) firms, and others. The pharmaceutical and biotechnology companies segment held the largest pharmacovigilance and drug safety software market share. This is owing to the rising adoption of pharmacovigilance and drug safety software by the companies. The pharmaceutical and biotechnology companies develop and construct dynamic scheduling software, advanced laboratory automation systems, and lab automation instruments. These companies help accelerate and streamline discovery for biotech, pharmaceutical, and academic research clients. The pharmaceutical industry experiences ever-changing regulations on testing and clinical trials, which prompts pharmaceutical companies to accelerate the drug development process. They must also maintain high levels of safety and control in their processes. Pharmaceutical companies are outsourcing a few pharmacovigilance operational activities to focus on their core competency in drug development as well as research. Furthermore, a primary benefit of outsourcing is the reduction of overall operational costs.

In the changing market dynamics, pharmaceutical companies are increasingly looking to outsource critical functions, including manufacturing and research. Contract research organizations (CROs) provide clinical trials and other research support services for the pharmaceutical, biotechnology, and medical device industries. CROs offer comprehensive services such as project management, database design and build, data entry and validation, clinical trial data management, medicine and disease coding, quality and metric reporting, statistical analysis plans and reports, validation programming, safety and efficacy summaries, and final study reports.

Strict drug regulation is another critical factor that forces pharmaceutical companies to outsource. Any errors in the drug development or approval process can lead to significant consequences for both drug companies and end consumers. In the pharmaceutical industry, there is a massive amount of data, along with complex requirements that must be fulfilled for the efficient drug approval process. All these factors lead to more companies opting to partner with CROs that have significant experience in handling documentation that meets regulatory requirements. The extensive services provided by CROs need robust IT support to manage these activities effectively.

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; and Veeva Systems are among the key players profiled in the pharmacovigilance and drug safety software market report. Several other major players were studied and analyzed during the pharmacovigilance and drug safety software market analysis to get a holistic view of the market and its ecosystem. The pharmacovigilance and drug safety software market also provides detailed market insights, which help the key players strategize their growth. The report includes growth prospects owing to the current pharmacovigilance and drug safety software market trends and their foreseeable impact during the forecast period.


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