Australia Pharmacovigilance Market

Australia Pharmacovigilance Market Overview:

The Australia pharmacovigilance market size reached USD 170.0 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 326.2 Million by 2033, exhibiting a growth rate (CAGR) of 7.51%​​​​​​​ during 2025-2033. Stringent therapeutic goods administration (TGA) regulations, surging demand for real-time adverse event reporting, increasing clinical trial, growth in biologics, biosimilars, and personalized medicine, rising patient awareness, digital health adoption, surging artificial intelligence (AI) integration, and strategic contract research organization (CRO) partnerships are some of the factors bolstering the market.

Australia Pharmacovigilance Market Trends:

Regulatory Oversight by the Therapeutic Goods Administration (TGA)

The therapeutic goods administration (TGA) plays a central role in shaping the pharmacovigilance landscape in Australia. In 2025, the TGA published its Therapeutic Goods Advertising and Compliance Education Plan for 2024-2025. The plan outlines priorities for compliance education, focusing on unlawful advertising of medicinal cannabis, psilocybin, and unapproved products in the wellness and beauty industries. Its stringent regulatory framework mandates pharmaceutical companies to establish comprehensive risk management systems and comply with post-marketing surveillance obligations. The TGA requires sponsors to monitor and report adverse events, implement risk minimization strategies, and submit Periodic Safety Update Reports (PSURs) for high-risk medicines. These regulatory expectations have led to increased investments in safety databases, quality management systems, and internal compliance mechanisms among market participants. Furthermore, regulatory inspections and audits by the TGA are becoming more rigorous, reinforcing the need for continuous pharmacovigilance readiness, which is further boosting the Australia pharmacovigilance market share.

Demand for Real-Time Drug Safety Reporting

The growing use of real-time pharmacovigilance systems and the increasing focus on timely accurate reporting of adverse drug reactions are primary factors driving the market growth. To curtail potential hazards to human health, regulatory agencies, healthcare providers, and pharmaceutical companies are placing a growing emphasis on rapid signal detection and responses. This has further surged the use of real-time monitoring as it informs when a potential product safety issue arises, which can then be identified sooner, protecting patient health. In line with this, key businesses are investing in cloud-based safety platforms, automated signal detection tools, and advanced analytics. These systems enable real-time case intake and triage, facilitating expedited reporting to the Therapeutic Goods Administration (TGA) and other stakeholders. Apart from this, mobile reporting apps and digital patient engagement resources are driving the quantity and quality of safety data submitted by both consumers and clinical professionals, which is providing a thrust to the Australia pharmacovigilance market growth.

Growth in Biologics, Biosimilars, and Personalized Medicine

The growing pipeline of biologics, biosimilars, and personalized therapies in Australia is contributing to greater complexities in post-market safety surveillance, driving the market growth. For instance, in 2024, Cartherics, Melbourne-based biotechnology company, is progressing its personalized cell therapy, CTH-004, for the treatment of ovarian cancer. The autologous therapy, sourced from a patient’s own cells, is slated to undergo clinical trials in Australia and China in 2024 and 2025. These products frequently utilize novel mechanisms of action, delivery systems, and target populations of patients, requiring heightened surveillance in the post-approval setting. As the number of these therapies continue to enter the Australian market, stakeholders are expanding their pharmacovigilance functions through specialized personnel, improved data analytics, and cross-functional collaboration with clinical, regulatory and medical affairs teams. Apart from this, the need for therapy-specific safety protocols and technology-enabled monitoring systems is creating a positive Australia pharmacovigilance market growth.

Australia Pharmacovigilance Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the region level for 2025-2033. Our report has categorized the market based on service provider, product life cycle, type, process flow, therapeutic area, and end use.

Service Provider Insights:

• In-house
• Contract Outsourcing 

The report has provided a detailed breakup and analysis of the market based on the service provider. This includes in-house and contract outsourcing.

Product Life Cycle Insights:

• Pre-clinical
• Phase I
• Phase II
• Phase III
• Phase IV

A detailed breakup and analysis of the market based on the product life cycle have also been provided in the report. This includes pre-clinical, phase I, phase II, phase III, and phase IV.

Type Insights:

• Spontaneous Reporting
• Intensified ADR Reporting
• Targeted Spontaneous Reporting
• Cohort Event Monitoring
• EHR Mining 

The report has provided a detailed breakup and analysis of the market based on the type. This includes spontaneous reporting, intensified ADR reporting, targeted spontaneous reporting, cohort event monitoring, and EHR mining.

Process Flow Insights:

• Case Data Management
  • Case Logging
  • Case Data Analysis
  • Medical Reviewing and Reporting
• Signal Detection
  • Adverse Event Logging
  • Adverse Event Analysis
  • Adverse Event Review and Reporting
• Risk Management System
  • Risk Evaluation System
  • Risk Mitigation System

A detailed breakup and analysis of the market based on the process flow have also been provided in the report. This includes case data management (case logging, case data analysis, and medical reviewing and reporting), signal detection (adverse event logging, adverse event analysis, and adverse event review and reporting), and risk management system (risk evaluation system and risk mitigation system).

Therapeutic Area Insights:

• Oncology
• Neurology
• Cardiology
• Respiratory Systems
• Others

The report has provided a detailed breakup and analysis of the market based on the therapeutic area. This includes oncology, neurology, cardiology, respiratory systems, and others.

End Use Insights:

• Pharmaceuticals Companies
• Biotechnology Companies
• Medical Device Companies
• Others

A detailed breakup and analysis of the market based on the end use have also been provided in the report. This includes pharmaceuticals companies, biotechnology companies, medical device companies, and others.

Regional Insights:

• Australia Capital Territory & New South Wales
• Victoria & Tasmania
• Queensland
• Northern Territory & Southern Australia
• Western Australia

The report has also provided a comprehensive analysis of all the major regional markets, which include Australia Capital Territory & New South Wales, Victoria & Tasmania, Queensland, Northern Territory & Southern Australia, Western Australia.

Competitive Landscape:

The market research report has also provided a comprehensive analysis of the competitive landscape. Competitive analysis such as market structure, key player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant has been covered in the report. Also, detailed profiles of all major companies have been provided.

Australia Pharmacovigilance Market News:

• In 2024, the TGA announced the implementation of the second phase of its Recall Reforms Program. These reforms aim to streamline the product recall process, reducing regulatory burdens on sponsors while maintaining a strong emphasis on public safety. Key changes include a simplified and more flexible reporting process, enhanced stakeholder communication during the 'Early Advice' phase, and improvements to TGA recall documentation and guidance.

Australia Pharmacovigilance Market Report Coverage:

Key Questions Answered in This Report:

• How has the Australia pharmacovigilance market performed so far and how will it perform in the coming years?
• What is the breakup of the Australia pharmacovigilance market on the basis of service provider?
• What is the breakup of the Australia pharmacovigilance market on the basis of product life cycle?
• What is the breakup of the Australia pharmacovigilance market on the basis of type?
• What is the breakup of the Australia pharmacovigilance market on the basis of process flow?
• What is the breakup of the Australia pharmacovigilance market on the basis of therapeutic area?
• What is the breakup of the Australia pharmacovigilance market on the basis of end use?
• What is the breakup of the Australia pharmacovigilance market on the basis of region?
• What are the various stages in the value chain of the Australia pharmacovigilance market? 
• What are the key driving factors and challenges in the Australia pharmacovigilance?
• What is the structure of the Australia pharmacovigilance market and who are the key players?
• What is the degree of competition in the Australia pharmacovigilance market? 

Key Benefits for Stakeholders:

• IMARC’s industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the Australia pharmacovigilance market from 2019-2033.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the Australia pharmacovigilance market.
• Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the Australia pharmacovigilance industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.