There is high demand for in-vitro diagnostic (IVD) devices in Australia, as the country's ageing population requires more IVD-based tests. With close to 90 per cent of the IVD products being imported, the Government has implemented new regulatory changes to ensure that imported products are of superior quality.
New analysis from Frost & Sullivan (drugdiscovery.frost.com), In-vitro Diagnostics Market Outlook in Australia, finds that the market earned revenues of US$468 million in 2010 and estimates this to reach US$703.4 million in 2017.
"The new regulations are likely to increase the regulatory and product approval costs, which will have an immediate impact in this market," says Frost & Sullivan Industry Analyst Arun AK. "However, this is likely to boost customer confidence in the products and improve the quality of IVD testing in a longer run."
The IVD market in Australia is relatively small and likely to witness high growth in the molecular testing, point-of-care testing (POCT) and self-monitoring of blood glucose (SMBG) segments.
"Rising acceptance of molecular diagnostic tests encourages innovative regional companies to develop innovative tests," notes Arun. "However, the newly implemented regulatory framework, which forces all IVDs to undergo pre-market regulatory assessment in accordance with their level of risk, is likely to result in low turnover of products."
In market segments experiencing low growth, this regulation might lead to product withdrawals, resulting in limited product choices in the market. The financial burden placed on the manufacturers by regulatory changes is likely to restrain them from introducing novel tests in the market.
Though the regulatory changes will have a financial impact on the IVD companies, manufacturers can focus on introducing products in high-growth markets such as molecular testing to counter or minimise this effect. The existing high volume of tests requires laboratories to invest in automating their clinical testing process to manage such demand.
This will boost the adoption of integrated automation in the country. As price-based competition is increasing in the market, global companies can seek local collaborations to manufacture their products in Australia to gain a cost advantage and maintain their high profit margins.
If you are interested in more information on this study, please send an email to Donna Jeremiah, Corporate Communications, at djeremiah[.]frost.com, with your full name, company name, title, telephone number, company email address, company website, city, state and country.
In-vitro Diagnostics Market Outlook in Australia is part of the Clinical Diagnostics Growth Partnership Services program, which also includes research in the following markets: In-vitro Diagnostics (IVD) Market Outlook in South Korea, European Tissue Diagnostics Market and European Microarrays Market. All research services included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants.
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In-vitro Diagnostics Market Outlook in Australia / P4B8