The lowering of the overall cost of healthcare through the reprocessing of single-use devices is the primary factor driving this market. The process has been rationalized and legislated in Japan. In India, 80% of healthcare is provided by the private sector. There are certain policies being used by the private sector, which helps diminish the financial burden substantially and reduces the overall economic burden through reduced medical bills generated for the patient. In the past decade, increased use of reprocessed single-use devices has been observed in the emerging markets, which are likely to drive the growth of the single-use medical device reprocessing market. Other major factors responsible are the rising significance of medical waste minimization and positive effects on environmental sustainability.

The FDA defines reusable medical devices as those “devices that health care providers can reprocess and reuse on multiple patients.” The poor regulations regarding the SUD reprocessing in emerging markets is the major obstacle for the growth of SUD reprocessing market in the developing countries. According to Seth GS Medical College in Mumbai, India, the absence of protection from the legal liabilities and litigations for reusing disposable items due to lack of guidelines and norms, prevents the reuse of the devices marked as SUDs. Further, the practice of SUDs reprocessing is unregulated due to the scarcity of guidance from the regulatory authorities in India.

Key Market Trends

Class II Device Segment Captures the Largest Market Share in the market

The market has been segmented, based on device type, into Class I & Class II devices. Class II devices are expected to record the highest CAGR, owing to the increasing number of cardiac interventions and the consequent economic load demand for assessing SUDs’ reuse. Japan does not have any regulations for the reprocessing of single-use medical devices. Therefore, regulatory authorities, such as the Ministry of Health, Labor and Welfare (MHLW) (Japan), in collaboration with the FDA are focusing on generating new medical device reprocessing guidelines for Japan.

Competitive Landscape

The major players in the Asia-Pacific single-use medical device reprocessing market include Medline Industries, Inc., NEScientific, Inc., ReNu Medical Inc., Soma Technology, Inc., Sterilmed Inc. (Johnson & Johnson), and Stryker Corporation.

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