Australia, often overlooked due to its distance from the rest of the West and relatively small population, has emerged as a leading hub for clinical research, biotechnology, healthcare digitalization and niche manufacturing. With a population accounting for just 0.3% of the world's total, it ranks as 13th largest economy globally in 2021 with a GDP per capita of $60,443 compared to the U.S. $70,248. Despite its geographic isolation, Australia's pharmaceutical sales totaled $14.588 billion in 2021 and is projected to exceed $19.744 billion by 2027. Its advantageous position as a bridge between the East and West is increasingly appealing as multinational pharmaceutical companies shift investments towards the Asia-Pacific region. Australia spends approximately 10% of its GDP on health in 2021 which amounted to about $220 billion AUD. The Australian government is particularly concerned with its aging population and significant impact on future healthcare demand and products. In women’s health, breast cancer is of primary concern in particular due to the relatively higher prevalence rate and increased incidence rate in post-menopausal women. Opportunities thus exist for products that offer notable improvements in clinical outcomes, featuring distinct capabilities that accelerate patient recovery, reduce hospital and rehabilitation expenses, and mitigate the overall economic burden of illness.
This presentation will outline strategies and recommendations for the introduction of a novel drug and companion diagnostic test kit targeting HR+, HER2- breast cancer to the Australian market. It provides an overview of Australia’s cultural and business landscape, healthcare system, demographics, and current standard of care. The regulatory pathway recommendations are presented based on market research, with an emphasis on a pricing strategy that considers Australia’s reimbursement system for subsidized medications for a successful market introduction.