At 5.6% CAGR, Asia Pacific Pharmacovigilance and Drug Safety Software Market is Speculated to be Worth US$ 68.66 Million by 2031, says Business Market Insights

According to Business Market Insights’ research, the Asia Pacific pharmacovigilance and drug safety software market was valued at US$ 44.40 million in 2023 and is expected to reach US$ 68.66 million by 2031, registering a CAGR of 5.6% from 2023 to 2031. Globalization of pharmacovigilance and integration of software with AI, ML, and NLP are among the critical factors attributed to drive the Asia Pacific pharmacovigilance and drug safety software market growth.

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. Governments of various countries across the globe are conducting pharmacovigilance programs by collaborating with regulatory bodies in their respective countries. Regulators understand the importance of pharmacovigilance in ensuring drug safety. Further, in September 2024, the Indian Pharmacopoeia Commission and Central Drugs Standard Control Organization published version 2.0 of their pharmacovigilance guidelines by enacting changes such as the extension of the deadline for reporting non-serious adverse ADRs events and revising the record-keeping requirements. Further, Malaysia's National Pharmaceutical Regulatory Agency published the second revised edition of its guidelines on bioequivalence and pharmacovigilance inspections. The agency provided more information on the drug inspection process and the scope of assessments related to drug evaluations. The Philippine Food and Drug Administration (FDA) has also published detailed actions in response to feedback on the registration of new drug products and to provide information on active pharmaceutical ingredients (APIs) for human usage.

Increasing awareness and adoption of the best pharmacovigilance practices in different countries across the globe have created a massive demand for pharmacovigilance and drug safety software. The new RNF system features advanced functions for the management and analysis of reports of suspected adverse reactions to ensure an accurate assessment of the safety of medicines. The implementation of comprehensive pharmacovigilance systems that can efficiently manage and report adverse drug reactions (ADRs) on a global scale contributes to the globalization of pharmacovigilance. Thus, the rapid globalization of pharmacovigilance drives the global pharmacovigilance and drug safety software market.

On the contrary, the high installation and maintenance costs hampers the growth of Asia Pacific pharmacovigilance and drug safety software market.

Based on offering, the Asia Pacific pharmacovigilance and drug safety software market is bifurcated into software and services. The software segment held 65.6% market share in 2023, amassing US$ 29,121.68 thousand. It is projected to garner US$ 47,287.86 thousand by 2031 to register 6.2% CAGR during 2023–2031.

In terms of deployment, the Asia Pacific pharmacovigilance and drug safety software market is segmented into cloud and on premises. The cloud segment held 73.4% share of Asia Pacific pharmacovigilance and drug safety software market in 2023, amassing US$ 32,575.17 thousand. It is anticipated to garner US$ 54,220.89 thousand by 2031 to expand at 6.6% CAGR during 2023–2031.

By enterprise size, the Asia Pacific pharmacovigilance and drug safety software market is divided into large enterprises and SMEs. The large enterprises segment held 67.4% share of Asia Pacific pharmacovigilance and drug safety software market in 2023, amassing US$ 29,940.12 thousand. It is projected to garner US$ 47,765.64 thousand by 2031 to expand at 6.0% CAGR from 2023 to 2031.

Based on form, the Asia Pacific pharmacovigilance and drug safety software market is categorized into standard and customized. The standard segment held 68.9% share of Asia Pacific pharmacovigilance and drug safety software market in 2023, amassing US$ 30,600.64 thousand. It is predicted to garner US$ 46,113.95 thousand by 2031 to expand at 5.3% CAGR between 2023 and 2031.

By functionality, the Asia Pacific pharmacovigilance and drug safety software market is segmented into signal and risk management, issue tracking and adverse event tracking, case management, clinical safety management and clinical trial safety, quality and compliance, medical writing, audit support and training compliance, healthcare analytics, and others. The signal and risk management segment held 26.4% share of Asia Pacific pharmacovigilance and drug safety software market in 2023, amassing US$ 11,714.70 thousand. It is estimated to garner US$ 21,360.31 thousand by 2031 to expand at 7.8% CAGR during 2023–2031.

In terms of end user, the Asia Pacific pharmacovigilance and drug safety software market is categorized into pharmaceutical and biotechnology companies, contract research organizations, business process outsourcing (BPO) firms, and others. The pharmaceutical and biotechnology companies segment held 45.4% share of Asia Pacific pharmacovigilance and drug safety software market in 2023, amassing US$ 20,172.64 thousand. It is projected to garner US$ 35,528.63 thousand by 2031 to expand at 7.3% CAGR from 2023 to 2031.

Based on country, the Asia Pacific pharmacovigilance and drug safety software market is categorized into China, Japan, India, Australia, South Korea, and the Rest of Asia Pacific. Our regional analysis states that China captured 34.5% share of Asia Pacific pharmacovigilance and drug safety software market in 2023. It was assessed at US$ 15,337.21 thousand in 2023 and is likely to hit US$ 25,471.58 thousand by 2031, registering a CAGR of 6.5% during 2023–2031.

Key players operating in the pharmacovigilance and drug safety software market are Veeva Systems Inc, IQVIA Holdings Inc, AB Cube S.A.S., ArisGlobal LLC, Oracle Corp, Max Application, ICON Plc, Cognizant Technology Solutions Corp, Accenture Plc, Syneos Health Inc, Genpact Ltd., Laboratory Corp of America Holdings, Parexel International Corp, Qinecsa Solutions, and Clinevo Technologies, among others.

• In 2023, 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.
• In 2021, Cognizant announced it has been named one of the leading companies in the pharmacovigilance market, offering an end-to-end spectrum of patient safety services in a new report by analyst firm Everest Group. Pharmacovigilance is the practice area aimed at ensuring drug safety through in-depth data collection and evaluation.

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