The Australia active pharmaceutical ingredients (API) market was valued at USD 3.14 Billion in 2025 and is expected to grow at a CAGR of 4.70%, reaching USD 4.97 Billion by 2035. The market growth is driven by rising local manufacturing, government investment, growing demand for generics, and supply chain resilience are driving market.
Base Year
Historical Period
Forecast Period
Neurizon’s 2025 licensing deal is expected to boost Australia’s API export potential and position it as an innovation hub.
IDT Australia’s new API contract in July 2025 is likely to strengthen domestic production and reduce import dependency long-term.
TGA clearance of locally manufactured APIs by EVE Health Group is set to accelerate commercialization and local API demand.
Compound Annual Growth Rate
4.7%
Value in USD Billion
2026-2035
*this image is indicative*
The market is witnessing consistent growth, fueled by expanding local manufacturing, strategic partnerships, and favorable regulatory support. In the historical period, Australia contributed 4% of the global API market revenue, highlighting its growing role in pharmaceutical supply chains. The rising demand for generics, government investment, and efforts to strengthen domestic production are expected to drive further market expansion over the forecast period. The market is expected to grow at a CAGR of 4.70% during the forecast period of 2026-2035 and attain a market value of USD 4.97 Billion by 2035.
Strategic Licensing Deals Driving API Market Growth in Australia
The strong R&D capabilities and rising demand for innovative therapeutic ingredients are key drivers of the market. For instance, in July 2025, Neurizon announced a global licensing agreement with Elanco for the commercialization of NUZ-001, a novel API for veterinary neurological disorders. Under this deal, Neurizon retains Australian rights, positioning the country as a manufacturing and innovation hub. This agreement is expected to boost domestic API development and export potential, contributing significantly to market growth over the forecast period through increased commercialization opportunities and pharmaceutical R&D investments.
Major market trends include an emphasis on boosting local production capabilities and surge in regulatory approvals by TGA.
Domestic API Production Strengthens Supply Chain Resilience in Australia
Increasing demand for locally manufactured APIs and expansion of production capabilities are key growth drivers in Australia’s pharmaceutical sector. For instance, in July 2025, IDT Australia secured a new AUD 3.2 million (USD 2.08 million) contract to supply intermediate APIs to one of the country’s largest active pharmaceutical ingredient plants. This agreement underscores Australia’s growing capacity for mass API production and aligns with national efforts to reduce reliance on imports. Over the forecast period, this development is expected to reinforce domestic API manufacturing, improve supply chain resilience, and drive market growth through increased scale and operational efficiency.
Regulatory Clearances to Accelerate Australia Active Pharmaceutical Ingredients (API) Market Demand
Strong health policy support and rising demand for fast-acting therapeutics are driving growth in the market. For instance, in July 2025, EVE Health Group secured Therapeutic Goods Administration (TGA) approval for its lead API products, Libbo (tadalafil soluble film) and Dyspro (cannabinoid gummy), targeting erectile dysfunction and dysmenorrhoea. The company has already placed its first commercial purchase order for Dyspro, with manufacturing underway at a GMP-certified Australian facility. This milestone enables domestic production and supply, fueling API market growth through increased local R&D, manufacturing capacity, and commercialization opportunities over the forecast period.
Small Molecule APIs Dominating Market Share by Molecule
Small molecule APIs are expected to maintain the largest market share in Australia, supported by their 88% revenue contribution during the historical period. Their dominance is driven by wide applications in chronic disease treatments, simpler synthesis processes, and strong demand in the generics market. Small molecules are cost-effective, highly stable, and easier to manufacture at scale, making them ideal for domestic production and export. With growing focus on generic drug development and streamlined manufacturing, this segment is likely to lead Australia’s API market over the forecast period.
The key features of the market report comprise funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
Operating in Australia for over 60 years, Novartis delivers prescription pharmaceuticals, generics and eye‑care products. It employs around 800 professionals locally, invests roughly AU $20 million annually in clinical trials, collaborates with academic centres like BioCurate, and reaches 2.8 million patients in Australia and New Zealand with treatments focused on cardiovascular, immunology, oncology and eye care.
Bayer has operated in Australia since 1925, with around 900 staff across multi‑site operations. Its pharmaceuticals division markets prescription drugs in women’s health, cardiology, oncology, hematology and ophthalmology, supported by agile restructuring to accelerate innovative therapies. Its consumer health and crop science divisions also complement its life‑sciences footprint locally.
Since 2018 Glenmark Australia (part of the global Glenmark group) has offered affordable branded, generics and OTC medicines, with focus on dermatology, respiratory and oncology. Its first branded product local launch—Supirocin antibacterial cream—went live in mid‑2024, followed by ten more. Respiratory and dermatology assets like Ryaltris have earned high double‑digit market share in Australia.
GSK Australia markets innovative medicines and vaccines, working with the PBS to deliver access. It has supplied COVID‑19 therapies such as sotrovimab (XEVUDY) under TGA approvals, supported HIV initiatives through ViiV Healthcare, and engages in community research. GSK repurposed its Melbourne facilities toward biopharma and continues emphasis on domestic clinical research and local manufacturing support.
*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*
Other key players in the market include Merck KGaA, AstraZeneca Plc, Sanofi SA, Sun Pharmaceutical Industries, Teva Pharmaceutical Industries Ltd., and IDT Australia.
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Molecule
Market Breakup by Type
Market Breakup by Type of Drug
Market Breakup by Therapeutic Application
Market Breakup by End User
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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| REPORT FEATURES | DETAILS |
| Base Year | 2025 |
| Historical Period | 2019-2025 |
| Forecast Period | 2026-2035 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Molecule |
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| Breakup by Type |
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| Breakup by Type of Drug |
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| Breakup by Therapeutic Application |
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| Breakup by End User |
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| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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