The global single-use medical device reprocessing market size was valued at USD 645.43 million in 2022. It is estimated to reach a predicted value of USD 2465.65 million by 2031, registering a CAGR of 15.1% during the forecast period (2023-2031). Single-use medical device reprocessing includes, among other steps, disinfection, cleaning, remanufacturing, testing, packaging and labeling, and sterilization of a used medical device to be reused. The key factors fueling the growth of the single-use medical device reprocessing market are cost savings from reprocessing single-use devices and regulatory pressure to reduce medical waste volumes. For instance, Innovative Health partnered with Acutus Medical in October 2019 to provide advanced electrophysiology (EP) technology to improve patient outcomes cost-effectively. Such initiatives may contribute to the expansion of the market.
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Cost Savings Through Reprocessing Single-use Devices
Reprocessing single-use medical devices have been witnessed as an increased cost-saving measure and have been a common practice in medical rooms and healthcare institutions for many years. According to an article published in June 2020, titled “Is cost-saving and sustainability putting patients at risk through reprocessed single-use medical devices?” the cost to reprocess a single-use device is approximately half that of purchasing a new device cost savings for healthcare facilities that reprocess SUDs are significant. Thus, there is a massive opportunity for cost-saving through reprocessing single-use medical devices, which is a significant driving factor for the growth of the studied market across the world.
In addition, in 2019, as per the 2019 AMDR Survey, USD 544,877,193 was saved by hospitals and surgical centers that used reprocessed single-use medical devices, which indicates a growth of more than 15% in 2018. The survey also reported that USD 21,724,304 was saved through reduced waste disposal by hospitals that used reprocessed single-use devices in 2019. Thus, these statistics indicate that the cost savings achieved through reprocessing single-use medical devices may drive the demand and adoption of single-use medical devices in the coming period. Moreover, several market players are reprocessing medical devices, which may lead to cost savings. Hence, cost savings through reprocessing single-use medical devices is a significant factor driving the market growth.
Regulatory Pressure to Reduce Volume of Medical Waste
Reprocessing single-use medical devices is a cost-effective and environment-friendly solution and is a crucial strategy for achieving financial and environmental stability. Several studies indicate that reprocessed single-use medical devices reduce medical waste. For instance, per a January 2021 published article titled “Combining Life Cycle Assessment and Circularity Assessment to Analyze Environmental Impacts of the Medical Remanufacturing of Electrophysiology Catheters,” the study analyzes the environmental consequences of electrophysiology catheters considering two modeling perspectives, the implementation of life-cycle assessment (LCA), including a cut-off approach and combining LCA and a circularity indicator measuring multiple life cycles. The study states that investigating the LCA results of using a remanufactured as an alternative to a newly-manufactured catheter revealed that the global warming impact is reduced by 50.4% and the abiotic resource use by 28.8%. Thus, the regulatory pressure is increasing on reducing medical waste, due to which the demand for reprocessing single-use medical devices is also increasing, thereby driving market growth.
Potential of Material Alteration and Cross Infection with Reprocessed Device
The reprocessed single-use medical devices have the potential for material alteration and cross-infection, which is one of the factors limiting the usage and adoption of these devices. For instance, as per a January 2021 update by the United States Food and Drug Administration (USFDA), the USFDA revealed investigating numerous medical device reports (MDRs) describing patient infections and other possible contamination issues associated with reprocessing urological endoscopes, including cystoscopes, ureteroscopes, and cystourethroscopy, devices used to view and access the urinary tract. The same source also reports that from January 2017 through February 2021, the USFDA received over 450 medical device reports (MDRs) describing post-procedure patient infections or other possible contamination issues associated with reprocessing these devices.
Several studies also indicate that cross-infection is commonly associated with these devices. For instance, in a July 2020 article titled “Rate and impact of duodenoscope contamination: A systematic review and meta-analysis,” the analysis demonstrates a 15.25% contamination rate of reprocessed patient-ready duodenoscopes. Additionally, the analysis indicates that double high-level disinfection (dHLD) and ethylene oxide (EtO) reprocessing methods are superior to single HLD but still not efficient in cleaning the duodenoscopes properly. Thus, the potential of material alteration and cross-infection with reprocessed devices is a significant factor that may restrain the growth of the overall market.
Growing Focus on the Circular Economy
The growing focus on the circular economy globally is increasing the demand for single-use medical devices. For instance, as per a December 2020 published article titled, “Transforming The Medical Device Industry: Road Map To A Circular Economy,” maximizing resource productivity and minimizing waste, a circular economy offers a means of operating within planetary boundaries, with the added benefits of building resilient supply chains and creating social value. Thus, reuse and reprocessing are good options. Many disposable items are labeled by the original equipment manufacturer (OEM) as single-use. Thus, these devices can also be reprocessed. For instance, as per a May 2020 update by the World Health Organization (WHO), in response to the ongoing COVID-19 crisis, the UNIDO is supporting medical waste management efforts in countries worldwide. The organization has significant experience working with countries to improve waste management processes. For example, in India, the UNIDO is collaborating with the Ministry of Environment, Forests, and Climate Change on a project focusing on medical waste management in five states: Gujarat, Karnataka, Maharashtra, Odisha, and Punjab.
Thus, several initiatives are being launched that would increase the demand for single-use medical device reprocessing in the future, thereby augmenting the usage of reprocessed single-use medical devices.
The global single-use medical device reprocessing market is segmented by device type and region.
By device type, the global single-use medical device reprocessing market is segmented into class I devices (laparoscopic graspers, scalpels, tourniquet cuffs, other class I devices), class II devices (pulse oximeter sensors, sequential compression sleeves, catheters, and guidewires, other class II devices). The class II devices segment accounted for the largest market share and is estimated to exhibit a CAGR of 15.9% during the forecast period. Within class II devices, the sequential compression sleeves accounted for the largest market share and are estimated to exhibit a CAGR of 16.5% during the forecast period. Sequential compression sleeves are designed to increase venous blood flow in patients with deep vein thrombosis and pulmonary embolism. Compression sleeves are considered reusable, as they can withstand cleaning and sterilization. The quality of the device and physical characteristics are not likely to be affected by reprocessing, with the device remaining safe and effective for its intended use. Hospitals are estimated to save nearly USD 300,000 by reprocessing compression sleeves.
Furthermore, as per Practice Green Health Organization data published in 2019, the cost of new deep vein thrombosis compression sleeves is approximately USD 125, whereas the reprocessed sleeve costs USD 11. Such a substantial gap is expected to promote reprocessed compression sleeves across medical facilities, thereby boosting segment growth over the analysis period. These factors are collectively expected to drive the segment's growth over the forecast period.
By region, the global single-use medical device reprocessing market is segmented into North America, Europe, Asia-Pacific, Middle East & Africa, and South America.
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North America accounted for the largest market share and is anticipated to exhibit a CAGR of 15.8% during the forecast period. Regulatory pressure to reduce medical waste volume, increased acceptance of reprocessed single-use devices, and significant cost savings from using reprocessed single-used devices (SUD) are the factors that drive the studied market in the United States. The rising chronic disease prevalence in the United States has significantly increased surgical procedures in recent years. Hospitals and other healthcare facilities are increasingly investing in reprocessed medical devices instead of brand-new ones for surgical interventions due to cost savings. Over the forecast period, this is expected to create appealing growth prospects for the market. Furthermore, with technological advances, companies have developed more sophisticated and complex devices using appropriate materials to stand up to the steam sterilization method. For instance, in August 2021, Boston Scientific received an FDA nod for a single-use bronchoscope, an effective reprocessing of reusable bronchoscope after a procedure that makes the devices safe for use on other patients. Thus, considering the factors mentioned above, the studied market in the United States is expected to grow during the forecast period.
Europe is the second largest region. It is estimated to reach a predicted value of USD 645 million by 2031, registering a CAGR of 15.4%. The studied market in Germany is projected to hold a significant share of the SUD reprocessing market in Europe. The primary driver of this market is the reduction of overall healthcare costs through reprocessing single-use devices. Reprocessing has been regulated in Germany for over a decade, with many hospitals reporting significant cost savings. Public authorities and the EU-accredited notified bodies are closely monitoring it. On 19 August 2020, the European Union Commission implemented Regulation (Eu) 2020/1207, which defines standard specifications for reprocessing single-use devices within healthcare facilities and external reprocessors. In Germany, regulatory bodies have legalized and regulated reprocessing, which is expected to increase demand for reprocessed SUD and thus boost the market's growth. As per the article published in Elsevier Journal 2018 titled "Towards design strategies for circular medical products," the amount of waste generated per hospital patient per day is 3.6 kg, which is expected to rise over time. Thus, the increasing amount of waste and regulatory pressure to reduce their volume is expected to boost the market studied.
Asia-Pacific is the third largest region. The Chinese single-use medical device reprocessing market is expected to project moderate growth during the forecast period, owing to no legal mandate available for reprocessing single-use medical devices in the country. Reprocessing single-use medical devices are not so strictly regulated and monitored in the developing world. China reports high rates of disposable device reuse, but the country has no specially designated third-party reprocessors. In April 2018, a paper published named "Safety of laparoscopic graspers with different configurations during liver tissue clamping" stated that in China, the use of laparoscopic graspers would increase, ultimately increasing the cost of waste disposal for hospitals. Thus, reprocessing of laparoscopic accessories, such as graspers, is gaining popularity. Additionally, the reduced risk of contamination and convenience further bolstered the adoption of such reprocessed devices during surgical operations. Hence, owing to the factors such as no legal mandate being available for the reprocessing of single-use medical devices in the country, the market studied is expected to grow slowly during the forecast period.
Key players in the global single-use medical device reprocessing market are
Class I Devices
Class II Devices