Impact Analysis of Covid-19
The complete version of the Report will include the impact of the COVID-19, and anticipated change on the future outlook of the industry, by taking into the account the political, economic, social, and technological parameters.
Reprocessed medical devices are products that undergo reprocessing procedures and are used again. Reprocessing is a validated process used for a medical device that has been either used or is contaminated. Reprocessing of a single used device or reusable device undergo steps like cleaning, disinfection and sterilization.
Australia reprocessed medical devices market is estimated to account for US$ 119.7Mn in terms of value by the end of 2027.
Australia Reprocessed Medical Devices Market: Drivers
Use of reprocessed medical devices leads to significant savings in the healthcare sector, which is expected to boost demand for such devices, thereby propelling growth of Australia reprocessed medical devices market over the forecast period. For instance, according to Association of Medical Device Reprocessors, reprocessing medical devices originally labeled for single use saved hospitals and surgery centers nearly US$ 500 million in 2018.
Moreover, introduction of quality management systems for medical devices is also expected to aid in growth of Australia reprocessed medical devices market. For instance, in April 2020, Cleanpart GmbH introduced a quality management system for medical devices according to DIN EN ISO 13485:2016
Cardiology Devices held dominant position in Australia reprocessed medical devices market in 2019, accounting for 51.7% share in terms of value, followed by Gastroenterology Devices, and Laparoscopy Devices, respectively.
Figure 1: Australia Reprocessed Medical Devices Market Share (%) Value, By Device, 2019
Australia Reprocessed Medical Devices Market: Restraints
Risk of cross contamination and hospital acquired infections is expected to hinder growth of Australia reprocessed medical devices market. Absence of stringent regulations for reprocessed medical devices may result in increased cases of contamination and infections due to the use of these devices.
Moreover, negative perception about reprocessed medical devices is also expected to limit the market growth. It is often perceived that reprocessed medical devices are inferior to new devices in terms of safety, efficacy and product quality. Despite evidences and studies demonstrating how reprocessed medical devices are safe and effective, negative perceptions about the usage persist.
Australia Reprocessed Medical Devices Market Report Coverage
||Market Size in 2019:
||US$ 34.6 Mn
|Historical Data for:
||2016 to 2019
||2020 to 2027
|Forecast Period 2020 to 2027 CAGR:
||2027 Value Projection:
||US$ 119.7 Mn
- By Device: Gastroenterology Devices, Cardiology Devices, Laparoscopy Devices, Orthopedic/ Arthroscopic Devices, ENT Devices, Others.
- By Classification: Critical, Semi - Critical, Non - Critical.
- By End User: Hospitals, Diagnostic Centers, Ambulatory Surgical Centers.
Stryker Sustainability Solutions, Inc., Medline ReNewal, Hygia Health Services, Inc., Cleanpart GmbH, ReNu Medical, Inc., SureTek Medical, and NEScientific
- Increasing prevalence of chronic diseases
|Restraints & Challenges:
- Risk of hospital acquired infection and cross contamination
Australia Reprocessed Medical Devices Market: Opportunities
Reduced product pricing of reprocessed medical devices is expected to offer lucrative growth opportunities for players in Australia reprocessed medical devices market. Reprocessed medical devices are sold at approximately half the price of a new device (e.g. cost of a new diagnostic EP catheter ranges from US$ 400 to US$ 600, whereas cost of a reprocessed diagnostic EP catheter would cost around US$ 200 to US$ 300).
Moreover, strengthening distribution network is also expected to aid in growth of Australia reprocessed medical devices market.
Australia reprocessed medical devices market market was valued at US$ 34.6 Mn in 2019 and is forecast to reach a value of US$ 119.7 Mn by 2027 at a CAGR of 17.5% between 2020 and 2027.
Figure 2: Australia Reprocessed Medical Devices Market Value (US$ Mn), 2016 – 2027
Market Trends/Key Takeaways
Major medical device manufacturers are focused on investment in reprocessed medical devices. For instance, in April 2019, NEScientific Inc. and ReNu Medical, Inc. joined The Association of Medical Device Reprocessors. Similarly, in November 2018, Cardinal Health also joined the association.
In Australia, hospitals and third-party reprocessors of single-use medical devices are required to conform to the same regulatory standards as the original manufacturer. Moreover, hospitals and third-party reprocessors of single-use medical devices are required to demonstrate that reprocessed devices are equally safe and perform as well as the original manufactured device.
- In South Australia, the medical devices labelled as “Single use only” must not be reprocessed. However, a product labelled as “Single patient use” can be reprocessed or recycled.
- The regulatory authorities for re-manufacturing of medical device labelled as “single use” are covered by the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 and the Therapeutic Goods Regulations 2002
- If a device is reprocessed or manufactured it must include instructions for use for the reprocessed product based on Essential Principle 13.4 of the Regulations details the Australian requirements for Instructions for Use
Australia Reprocessed Medical Devices Market: Competitive Landscape
Major players operating in Australia reprocessed medical devices market include, Stryker Sustainability Solutions, Inc., Medline ReNewal, Hygia Health Services, Inc., Cleanpart GmbH, ReNu Medical, Inc., SureTek Medical, and NEScientific.
Australia Reprocessed Medical Devices Market: Key Developments
Major players in Australia reprocessed medical devices market are focused on adopting M&A strategies to expand their product portfolio. For instance, in 2018, Stryker Corporation acquired the U.S.-based Hygia Health Services Inc., a company focused into reprocessing patient care single-use devices.