Australia Biosimilars Market Analysis

Australia Biosimilars Market Analysis

The Australia Biosimilars market size was valued at $230 Mn in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 23.7% from 2022 to 2030 and will reach $1263 Mn in 2030. In 2022, the market for Australian biosimilars was anticipated to be worth $230 million. From 2022 to 2030, it is predicted that market size will increase at a compound annual growth rate (CAGR) of 23.7%, reaching $1263 million. With a GDP of over $1.39 trillion, Australia had one of the largest economies. Around 9.3% of Australia's GDP was spent on health in 2019, according to the World Bank, in terms of health expenditures. A total of about $200 billion was spent on health as a result of this.

A biological medicine, commonly referred to as a "reference medicine," is a drug constructed of enormous, intricate molecules that are somehow obtained from a living organism. A variant of this reference drug that is extremely close but not identical is known as a "biosimilar medication" or "biosimilar." A biosimilar is different from a traditional small-molecule "generic" medication in this aspect since the former is often thought of as a pharmaceutical product that is comparable to the latter, at least in terms of active ingredients, to the original branded "originator" or "innovator" product. Since the science and technology required to produce them advance quickly, biological therapies are becoming more and more popular on the Australian and international pharmaceutical markets.

The cost of biological medicines to healthcare providers, such as the Australian Government through the Pharmaceutical Benefits Scheme (PBS), is comparatively high when compared to conventional "small molecule" drugs. This is because developing, producing, storing, and supplying biological medications costs more money. To encourage patients, pharmacists, and doctors to use more biosimilar drugs, the Australian government set aside $13.38 million in 2015 for a three-year awareness campaign. The government has granted an extra $3.35 million to the Generic Biosimilar Medicines Association (GBMA) to continue the awareness campaign through December 2020. The government is making a wager that buying biosimilars would increase competition and lead to considerable cost savings. As a result, nationwide demand for biosimilars will rise throughout the predicted period.

Market Dynamics

Market Growth Drivers

Biosimilars can help reduce overall healthcare expenses since they are less expensive than biologic drugs. In Australia, where the government lays a significant premium on limiting healthcare expenditures, this is essential. Also, the frequency of chronic illnesses is increasing, which is driving up demand for biologic drugs and biosimilars in Australia. These ailments include, for instance, autoimmune illnesses, cancer, and diabetes.

Due to the patents on many biologic treatments expiring, it is projected that the Australian biosimilar business would grow. As patents expire, manufacturers of biosimilar products might enter the market, providing patients with more affordable options. a favorable regulatory environment: The regulatory environment in Australia is favorable to biosimilars.

The Therapeutic Goods Administration (TGA) has established a standardized protocol for the approval of biosimilars, allowing manufacturers control over a streamlined and predictable approval process.

Market Restraints

Despite the fact that biosimilars are more readily accessible, it's possible that many Australian doctors and patients are unaware of these drugs or are concerned about their efficacy and safety. Also, there are several processes involved in the development of biosimilars that can be costly and time-consuming. This might result in fewer companies producing some medicines, which could cause a scarcity of such drugs. Also, because of the significant costs associated with research and development, certain organizations may find it challenging to produce a biosimilar.

Competitive Landscape

Key Players

• Amgen
• Biocon
• Celltrion Healthcare
• Dr. Reddy's Laboratories
• Fresenius Kabi
• Merck (known as MSD outside the US and Canada)
• Mylan
• Pfizer
• Sandoz (a subsidiary of Novartis)
• Samsung Bioepis
• Teva Pharmaceutical Industries

Recent Developments

February 2021: The TGA released revised guidelines for assessing biosimilars. The guidelines provide guidance on the information required for the assessment of biosimilars and make clear the Australian regulatory standards for biosimilars.

Adalimumab, etanercept, and trastuzumab biosimilars, among others, were marketed in Australia in 2021. These biosimilars provide patients with new therapeutic options and might reduce healthcare costs.

Increasing Usage of Biosimilars: Australia had a rise in the usage of biosimilars in 2021, and they now account for a bigger share of the market for biological medications. This trend is predicted to continue as more biosimilars become available and medical professionals become more acclimated to utilizing them. The TGA released revised guidelines for assessing biosimilars. The guidelines provide guidance on the information required for the assessment of biosimilars and make clear the Australian regulatory standards for biosimilars.

Australia had a rise in the usage of biosimilars in 2021, and they now account for a bigger share of the market for biological medications. This trend is predicted to continue as more biosimilars become available and medical professionals become more acclimated to utilizing them.

Healthcare Policies and Regulatory Landscape

The Australian Department of Health's Therapeutic Goods Administration (TGA), a division, is in responsible for regulating biosimilars there. The TGA regulates the effectiveness, safety, and quality of biological medicines, including biosimilars, through a comprehensive inspection process.

In Australia, the main difference between the regulatory standards for biosimilars and those for biological originator drugs is that biosimilars are exempt from having to go through the same extensive clinical testing as the original medicines. Biosimilars must instead demonstrate that they are equivalent to the reference product in terms of quality, safety, and efficacy through a rigorous comparison study.

The TGA requires significant analytical and preclinical evidence demonstrating that their product is highly equivalent to the reference product, as well as documentation from clinical studies comparing the biosimilar to the reference product in terms of safety, efficacy, and immunogenicity. After a biosimilar has received the TGA's seal of approval, medical professionals can prescribe it in the same manner as the reference product. After that, it appears on the ARTG (Australian Registry of Therapeutic Goods). Biosimilars are regarded as a critical tactic in Australia for increasing competition in the market for biological medicines, which might lead to lower pricing and improved patient access to care.