Australia Neurology Devices Market Analysis

Australia Neurology Device Market Executive Summary

The medical device market in Australia is growing, driven by increasing investment in healthcare infrastructure, an aging population, and growing demand for medical devices. Strong regulations: The Australian medical device market is regulated by the Therapeutic Goods Administration (TGA), which has strict standards for the approval and sale of medical devices. This provides a high level of safety for patients and helps ensure that only high-quality devices are available in the market. Focus on innovation: The Australian government has a strong focus on innovation and encourages investment in new medical technologies. This has led to a thriving ecosystem of startups and established companies developing innovative medical devices. Australia is largely import-dependent for medical devices, with a large portion of devices being sourced from overseas markets like Europe and Asia. This dependence on imports creates a challenge for local companies to compete in the domestic market. Australia has a high level of healthcare spending, with a well-developed healthcare system and strong insurance coverage for medical treatments. This provides a supportive environment for the growth of the medical device market. Neurology devices in Australia are regulated by the Therapeutic Goods Administration (TGA). Some common types of devices used in neurology include - EEG machines, TMS devices, neurostimulation devices, EMG machines, and sleep study devices. These devices require TGA approval before they can be sold or used in Australia. Australia Neurology Device Market size is at around $151.44 Mn in 2022 and is projected to reach $308.46 Mn in 2030, exhibiting a CAGR of 9.3% during the forecast period.

The Australian Register of Therapeutic Items (ARTG) is a central database that contains information on therapeutic goods that can be legally supplied in or exported from Australia. Sponsors of medical products featured in the ARTG assume legal responsibility for their supply in or from Australia. Before distributing medical devices, sponsors must ensure that they are included in the ARTG unless exempt or omitted. Please see the Australian Regulatory Guidelines for Medical Devices for further information on what a medical device sponsor must do (ARGMD). You must be a recognized Australian-based legal entity, among other things. To receive the documentation/information required to demonstrate that the type of medical device com

The risk-based approach to regulating therapeutic goods is intended to ensure that the amount of regulation corresponds to the risks posed by specific therapeutic products. Medical devices, including IVD medical devices, are evaluated in accordance with the Essential Principles and risk-based classification. Pre-market assessment: conformity assessment, market authorization, post-market monitoring: continuous compliance with all regulatory, safety, and performance requirements and standards complies with the regulatory requirements in Australia, supply regulatory documentation/information.

Market Dynamics

Market Growth Drivers

1. Increasing incidence of neurological disorders
2. Rising geriatric population
3. Growing awareness about neurology devices
4. Advances in technology and R&D investment
5. Government support for healthcare infrastructure

Market Restraints

Some neurological devices are costly, and patients may not be able to obtain them owing to financial constraints or limited reimbursement from public or commercial health insurance programs. Certain neurological devices may be difficult to obtain in some parts of Australia, particularly in rural or remote areas. The regulatory approval procedure for new or innovative neurological devices can be lengthy and complex, thereby limiting new product available in the Australian market.

Competitive Landscape

Key Players

• BHP Group
• Rio Tinto
• Commonwealth Bank of Australia
• Westpac Banking Corporation
• Australia and New Zealand Banking Group
• Telstra
• Woodside Petroleum
• National Australia Bank
• Santos Ltd.
• Wesfarmers Limited

Notable Recent Updates

August 2021 - The financing was supported by med-tech behemoth Cochlear, a firm based out of Australia. Seer's technology focuses on clinical monitoring at home, inventing devices that evaluate critical physiological signals including brain, heart, and respiratory function, as well as a person's behavior in their home environment, to deal with conditions like epilepsy diagnoses and management. More than 7,600 Australians have been monitored using Seer systems to identify epilepsy from other illnesses like as cardiac, sleep, or psychiatric issues. As a result, an estimated 140 years of hospital bedtime have been diverted from the health care system in 4.5 years, resulting in a $100 Mn savings.

Healthcare Policies and Regulatory Landscape

The Therapeutic Goods Administration (TGA) regulates the Australian medical device sector, which includes stringent regulations for the approval and sale of medical equipment. The Australian Regulatory Guidelines for Medical Devices (ARGMD) give information on medical device importation, exportation, and supply inside Australia. They also go through the legal standards that apply to medical equipment. The Australia and New Zealand Association of Neurology (ANZAN) works to ensure that high standards of clinical neurology are practiced in Australia and New Zealand by actively participating in training, continuing education, and encouraging teaching and research. Please keep in mind that this site is just for ANZAN members; we cannot provide advice or help to patients.

Reimbursement Scenario

The Australian medical technology industry includes both domestic and international enterprises that manufacture and supply medical devices, in-vitro diagnostics, and medical imaging equipment. The medical technology industry contributes significantly to the quality of healthcare in Australia. Medical technology reimbursement in Australia is difficult and takes numerous forms. Some processes are interconnected, such as Medicare, while others are stand-alone schemes.