Industry Overview

Pharmacovigilance (PV) and drug safety software enables to submit, produce, maintain, categorize, and analysis PV data and contrary event report. It is used by contract research organizations, business process outsourcing firms, pharmaceutical, and biotechnology companies and others. The Global Pharmacovigilance and Drug Safety Software Market is growing at a significant rate, due to mounting occurrence of adverse drug reactions. Different functionality contributed to the pharmacovigilance and drug safety software market size. The market has witnessed a high demand for adverse event reporting software over the last few years due to mounting occurrence of an adverse drug.

Market Segmentation

Insight by Delivery Mode

On the basis of delivery mode, the drug safety software market is subdivided on-demand/cloud-based (Saas) delivery mode and on-premise delivery mode. Of all delivery modes, on-premise delivery mode segment accounted the largest share in the market due to mounting implementation of software by large pharmaceutical companies and its benefits of decreased prices owing to power utilization and system maintenance. In addition, on-demand/cloud-based (Saas) delivery mode segment is expected to grow at the fastest rate in the market due to mounting implementation of these platforms by contract research organizations and pharmaceutical companies, and benefits associated with a cloud-based system.

Insight by Functionality

On the basis of functionality the pharmacovigilance software market is subdivided into issue tracking software, adverse event reporting software, fully integrated software, and drug safety audits software. Mounting occurrence of adverse drug and advantages such as management and data entry with minimum errors are some of the factors responsible for the growth of the adverse event reporting software. Of all the functionality, the adverse event reporting software accounted foremost share in the pharmacovigilance and drug safety software market.

In addition, the fully integrated software segment is expected to grow at the fastest rate in the market due to mounting necessity to avoid errors in database management.

Insight by End User

The different end users of the pharmacovigilance and drug safety software market are business process outsourcing (BPO) firms, pharma and biotech companies, contract research organizations (CROS) and others. Among all end users, PV in contract research organizations is expected to grow at the fastest rate in the market due to boosting trend of outsourcing.

Global Pharmacovigilance And Drug Safety Software Market Report Coverage

Report Metric	Details
Historical Period	2020 - 2024
Base Year Considered	2025
Forecast Period	2026 - 2035
Market Size in 2025	U.S.D.  xx.x Billion
Revenue Forecast in 2035	U.S.D.  xx.x Billion
Growth Rate	x.x%
Segments Covered in the Report	By Delivery Mode, By Functionality and By End User
Report Scope	Market Trends, Drivers, and Restraints; Revenue Estimation and Forecast; Segmentation Analysis; Impact of COVID-19; Companies’ Strategic Developments; Market Share Analysis of Key Players; Company Profiling
Regions Covered in the Report	North America, Europe, Asia-Pacific, Middle East, South America and Rest of the World

Industry Dynamics

Growth Drivers

The mounting occurrence of adverse drug reactions (ADRs), budding complexity related to drug safety regulations, and escalating implementation of PV software by outsourcing companies are the primary growth drivers for pharmacovigilance and drug safety software market. Government regulatory bodies such as the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have strengthened security regulations for previous and post commercialization of drugs, which has mounted burden on the pharmaceutical and biotechnology companies to invent safe drugs and assess their consequences after sales.

In addition, technological development of software system such as cloud-based PV software, expanding geriatric population, mounting occurrence of chronic and lifestyle associated diseases, mounting alertness about public safety and mounting health information functionality market are also up surging the demand in the pharmacovigilance and drug safety software market.

Challenges

The high cost and lack of skilled professionals are the major challenges for the growth of pharmacovigilance and drug safety software market.

Industry Ecosystem

Globally, the manufacturing companies trying to enter the pharmacovigilance and drug safety software market are required to maintain stringent regulatory standards. Moreover, the high level of capital requirement also poses a major barrier for the entry of new players. This offers an edge to the established players in the industry competition.

Geographic Overview

Geographically, North America is the largest pharmacovigilance and drug safety software market as in the region the government assisted schemes preferring the implementation of PV software systems is increasing. Budding complexity related to drug safety regulations, mounting number of adverse drug reaction, mounting occurrence of chronic and lifestyle associated diseases, mounting alertness about public safety and technological development of software service are also up surging the growth of the North American pharmacovigilance and drug safety software market.

Asia-Pacific is observed to witness the fastest growth in the market, due to budding private and public assets in pharmaceutical R&D. In addition, mounting alertness about public safety, upsurge in research outsourcing by pharmaceutical giants, mounting need and occurrence of clinical trials, mounting number of adverse drug reaction, and substantial cost-saving benefits are also creating a positive impact on the pharmacovigilance and drug safety software market growth in the region.

Competitive Insight

Key players in the pharmacovigilance and drug safety software market are catering to the demand of these devices by investing in technologically advanced products in their product portfolio across the globe. In June 2018, ArisGlobal, and APCER Life Sciences launched LifeSphere Safety MultiVigilance an integrated cloud technology and pharmacovigilance services platform. In addition in October 2017, Oracle collaborated with dMed to meet mounting regulatory compliance and safety management requirements in China. Ennov, AB-Cube, Oracle Corporation, Arisglobal, Sarjen Systems Pvt. Ltd, Online Business Applications, Inc., United Biosource Corporation, Extedo GMBH, Sparta Systems, Inc., and Umbra Global pharmacovigilance, and drug safety software.

The Pharmacovigilance And Drug Safety Software Market report offers a comprehensive market segmentation analysis along with an estimation for the forecast period 2025–2030.

Segments Covered in the Report

• By Delivery Mode
  • On-demand/cloud-based (Saas) delivery mode
  • On-premise delivery mode
• By Functionality
  • Issue tracking software
  • Adverse event reporting software
  • Fully integrated software
  • Drug safety audits software
• By End User
  • Business process outsourcing (BPO) firms
  • Pharma and biotech companies
  • Contract research organizations (CROS)
  • Others

Region Covered in the Report

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia-Pacific (APAC)
  • China
  • Japan
  • India
  • South Korea
  • Rest of Asia-Pacific
• Rest of the World (RoW)
  • Brazil
  • Saudi Arabia
  • South Africa
  • U.A.E.
  • Other Countries

Source: VynZ Research

Source: VynZ Research