Australia Biosimilars Market Research Report, 2030

The regulatory body for therapeutic goods in Australia is the Therapeutic Goods Administration (TGA). TGA is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products, including biosimilars. TGA has approved 65 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor, insulin, erythropoietin, follicle stimulating hormone (FSH), monoclonal antibody and tumour necrosis factor (TNF)-inhibitor, for use in Australia. In comparison to other nations, the early market uptake of biosimilar medicines in Australia was comparatively slow. While the biosimilar uptake drivers have no doubt encouraged greater use of biosimilars in Australia in recent years, the growth in the number of brands with biosimilar competition is largely the result of the increasing development of biosimilar products over the last decade as patents protecting the reference biologics approach their expiry. More than $1 billion in savings could be unleashed by the arrival of biosimilar medicines over the next five years, to the benefit of the one in five Australians struggling with lifelong chronic disease. According to the research report, “Australia Biosimilars Market Research Report, 2030” published by Actual Market Research, the Australia Biosimilars market is projected to grow with 19.85% CAGR by 2025-30. Australia’s market is growing steadily, driven by supportive government policies, PBS listings, and rising demand for affordable biologic treatments. Increasing clinical trial activity and broader acceptance among healthcare providers are also encouraging biosimilar development, competition, and early adoption across key therapeutic areas. The government’s focus on affordable biologics has enabled broader access to advanced therapies while encouraging competition among biosimilar developers. A key driver has been the Pharmaceutical Benefits Advisory Committee (PBAC), which evaluates medicines for subsidization under the Pharmaceutical Benefits Scheme (PBS). These evaluations are essential to ensure patients receive cost-effective treatments without compromising on quality. In May 2024, PBAC recommended Amgen’s Wezlana, the first ustekinumab biosimilar, for PBS listing. This recommendation followed the product’s approval by the Therapeutic Goods Administration (TGA) in January 2024. Wezlana was approved for Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis indications previously served only by higher-cost originator products. This move signaled a turning point, encouraging the integration of biosimilars into frontline treatment plans. The market has since seen greater acceptance among healthcare providers and improved availability across healthcare systems. As a result, patients now have more affordable alternatives, and biosimilar developers gain confidence to enter the Australian market. With continued PBAC endorsements and streamlined pathways for PBS listings, market participants are expected to increase, boosting availability and reducing therapy costs in chronic disease care.

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The steady growth of insulin biosimilars in Australia's pharmaceutical landscape is driven by the increasing prevalence of diabetes, the expiration of patents on original insulin products, and supportive government policies aimed at enhancing healthcare affordability and accessibility. The rising incidence of diabetes in Australia has amplified the demand for insulin therapies. As patents for original insulin products expire, biosimilar manufacturers have the opportunity to enter the market, fostering competition and potentially leading to price reductions. The Australian government's initiatives, including the Pharmaceutical Benefits Scheme (PBS), have played a pivotal role in promoting the adoption of biosimilars by subsidizing costs and encouraging their prescription. These factors collectively contribute to the robust growth trajectory of insulin biosimilars in Australia, ensuring that patients have access to effective and affordable diabetes management options. The steady growth of biosimilars targeting infectious diseases in Australia is influenced by several key factors, including an aging population, rising healthcare costs, and the expiration of patents for original biologic therapies. As the demand for cost-effective treatment options increases, biosimilars offer a viable alternative to high-priced biologics, ensuring broader patient access. The Australian government's initiatives, such as the Pharmaceutical Benefits Scheme (PBS), have been instrumental in promoting the adoption of biosimilars by providing subsidies and encouraging their use over reference biologics. These policies aim to alleviate the financial burden on the healthcare system while maintaining treatment efficacy. Additionally, Australia's robust healthcare infrastructure and regulatory framework support the development and integration of biosimilars into clinical practice, further contributing to their growth in the infectious disease sector. The in-house manufacturing segment is leading with a steady growth rate in Australia’s biosimilars industry due to several strategic and operational advantages that domestic producers hold in the local market. Australian biosimilar manufacturers benefit from proximity to the end market, allowing for better control over quality, compliance with stringent Therapeutic Goods Administration (TGA) regulations, and more agile responses to changing healthcare demands. In-house production facilitates close collaboration between research, development, and manufacturing teams, which enhances efficiency, innovation, and ensures faster time-to-market for biosimilar products. Moreover, Australia's healthcare policies, including the Pharmaceutical Benefits Scheme (PBS), often favor domestically produced biosimilars by offering favorable reimbursement terms and encouraging local supply chains to reduce dependency on imports. This reduces logistical complexities and risks related to international supply disruptions, which have become more prominent recently. The steady government support through grants, incentives, and investments in biotechnology infrastructure further strengthens local manufacturers, encouraging continued growth in in-house biosimilar production. Additionally, Australian companies are increasingly investing in advanced manufacturing technologies such as continuous bioprocessing and automation, which improve scalability and cost-effectiveness. Considered in this report • Historic Year: 2019 • Base year: 2024 • Estimated year: 2025 • Forecast year: 2030

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Nikita Jabrela

Business Development Manager

Aspects covered in this report • Biosimilars Market with its value and forecast along with its segments • Various drivers and challenges • On-going trends and developments • Top profiled companies • Strategic recommendation By Product • Monoclonal Antibodies • Insulin • Erythropoietin • Others (Includes recombinant glycosylated and non-glycosylated proteins) By Application • Oncology • Chronic & Autoimmune Disorders • Blood Disorders • Growth Hormonal Deficiency • Infectious Disease • Others (Filgrastim/Pegfilgrastim, Teriparatide, Somatropin, Etanercept)

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By Manufacturer • In-house • Contract Research and Manufacturing Services The approach of the report: This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases. After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources. Intended audience This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.