市場調查報告書
商品編碼
1504252
全球醫療器材清潔市場評估:按流程、按 EPA 分類、按設備、依類型、按方法、依應用、依最終用戶、依地區、機會、預測(2017-2031)Medical Device Cleaning Market Assessment, By Process, By EPA Classification, By Device, By Type, By Technique, By Application, By End-user, By Region, Opportunities and Forecast, 2017-2031F |
全球醫療器材清潔市場規模預計將從2023年的 51.4 億美元增至2031年的 93.4 億美元,預計2024-2031年年複合成長率為 7.75%。 COVID-19大流行後消毒標準的製定,對創新產品的需求不斷增加,超音波探頭消毒劑的日益普及以及環氧乙烷的主導地位等各種因素塑造市場。
監管標準是全球醫療器材清潔市場的守護者,確保所有產品和程序都遵守嚴格的安全和品質要求。最終,它成為醫療環境中清潔解決方案開發的指南針,保護病患和醫護人員的健康和安全。市場對新型清潔解決方案和技術的需求顯著增加。這些解決方案優先考慮患者安全,同時提高消毒效果和效率。這種需求的增加是迫切需要更先進的感染預防和病人安全解決方案的直接結果,並凸顯了提高醫療保健消毒標準的共同承諾。
人們對專門為超音波探頭設計的消毒劑的日益青睞表明市場需求不斷增加。這一趨勢凸顯了為各種醫療設備客製化清潔解決方案的需求。環氧乙烷是一種有效且適應性強的消毒劑,在全球醫療器材清潔市場中佔據了重要佔有率。環氧乙烷對醫療器材進行高效消毒的能力鞏固了其作為醫療器材清潔程序最佳選擇的聲譽。環氧乙烷由於其廣泛的材料相容性而廣泛應用於醫療產業的各種應用。
監理標準的製定塑造市場
市場很大程度上受到醫療器材產業保護病人安全和品質的監管標準的影響。這些指南確保遵循嚴格的清潔和消毒程序,以保護患者安全並避免感染。隨著監管機構在全球範圍內完善這些建議,醫療保健提供者將需要採用創新的清潔解決方案和技術。隨著製造商和醫療機構回應這些嚴格的監管要求,對專業清潔服務和耗材的需求不斷增加,最終推動產業的成長和發展。
例如,2023年7月,美國食品藥物管理局(FDA)宣布,隨著美國環保署(EPA)推進限制使用環氧乙烷(EtO)的法規,該機構的Center for Devices and Radiological Health(CDRH)宣布已批准一項關於使用低溫汽化過氧化氫對醫療器械進行消毒的新國際共識標準。
對創新產品的需求不斷成長推動市場成長
由於醫療設備的複雜性不斷增加以及對感染預防的日益重視,全球醫療設備清潔市場對創新產品的需求顯著增加。複雜的醫療設備可能達不到現代清潔技術的要求,需要更先進的方法。此外,COVID-19 大流行的影響凸顯了嚴格衛生預防措施的必要性以及對強大清潔解決方案的需求增加。 UV-C 雷射滅菌和酵素清潔劑等創新改變清潔技術,這些創新提供了降低感染風險和提高患者安全的卓越功能。
例如,美國食品藥物管理局已批准首個用於 3D 列印醫療設備的滅菌系統將於2023年 8月投放市場。憑藉其專用循環,V-PRO max 2 低溫滅菌系統可對使用 3D 列印技術列印的解剖模型和患者定製手術導板等手術器械進行滅菌。
本報告研究和分析了全球醫療器材清潔市場,提供市場規模和預測、市場動態以及主要參與者的現狀和前景。
Global medical device cleaning market is projected to witness a CAGR of 7.75% during the forecast period 2024-2031F, growing from USD 5.14 billion in 2023 to USD 9.34 billion in 2031F. Various factors are shaping the market, including establishing standards related to disinfection post-COVID-19 pandemic, rising demand for innovative products, increasing popularity of disinfectants for ultrasound probes, and the dominance of ethylene oxide.
Regulatory standards act as guardians of the global medical device cleaning market, ensuring that all goods and procedures follow stringent safety and quality requirements. In the end, they safeguard the health and safety of patients and medical staff by serving as a compass for developing cleaning solutions in healthcare environments. There is a significant increase in demand for novel cleaning solutions and techniques in the global medical device cleaning market. These solutions prioritize patient safety while enhancing disinfection's effectiveness and efficiency. This rising demand directly results from the pressing need for more advanced solutions to prevent infections and protect patient safety, highlighting a shared commitment to raise the bar for healthcare disinfection.
The increasing preference towards disinfectants specifically designed for ultrasound probes indicates a growing demand in the global medical device cleaning market. This trend highlights the need for tailored cleaning solutions for different medical equipment. An effective and adaptable sterilizing agent, ethylene oxide has established a significant share in the global medical device cleaning market. Its reputation as the best option for medical device cleaning procedures has been solidified because it can sterilize medical devices with high efficacy. Ethylene oxide is a popular choice for a variety of applications in the healthcare industry due to its broad range of material compatibility.
The establishment of Regulatory Standards is Shaping the Market
The global medical device cleaning market is significantly shaped by regulatory standards, which protect patient safety and quality in the medical device industry. These guidelines guarantee that strict cleaning and disinfection procedures are followed in order to protect patient safety and avoid infections. Healthcare providers must adopt innovative cleaning solutions and technologies as regulatory organizations globally refine these recommendations. As manufacturers and healthcare institutions work to meet these strict regulatory requirements, there is an increasing demand for specialized cleaning services and supplies, ultimately promoting growth and advancement within the industry.
For example, the Food and Drug Administration (FDA) announced in July 2023 that its Center for Devices and Radiological Health (CDRH) recognized a new international consensus standard on the use of low-temperature vaporized hydrogen peroxide to sterilize medical devices, amid a regulatory effort by the US Environmental Protection Agency (EPA) to limit the use of ethylene oxide (EtO).
Rising Demand for Innovative Products are Driving Market Growth
The need for innovative products in the global medical device cleaning market is rising significantly due to the advancements in medical devices becoming more complicated and the growing emphasis on infection prevention. Modern cleaning techniques may not be sufficient for complex medical equipment, necessitating more sophisticated approaches. Furthermore, the COVID-19 pandemic's effects have highlighted the need for strict hygiene precautions, which have increased the demand for powerful cleaning solutions. Cleaning techniques are being revolutionized by innovations like UV-C laser sterilization and enzyme-based detergents, which offer enhanced capabilities that reduce infection risks and improve patient safety.
For example, the Food and Drug Administration approved the first sterilization system for 3D-printed medical equipment to be marketed in August 2023. With its specialized cycle, the V-PRO maX 2 Low-Temperature Sterilization System can sterilize surgical equipment like anatomical models printed using 3D printing technology and surgical guides customized for each patient that is meant to be used just once during an operation.
Increasing Popularity of Disinfectants for Ultrasound Probes Boosting Market Size
The use of specialty disinfectants made especially for ultrasound probes is growing significantly in the global medical device cleaning market. Since these devices come into close contact with patients' bodies, there is a growing awareness of the significance of maintaining good standards of hygiene, which is driving this development. Since ultrasound probes are used so often and in so many different medical settings, wrong disinfection techniques or inadequate disinfection increases the potential for cross-contamination and infection transmission. Consequently, there is an increased need for efficient, quick-acting disinfectants that can guarantee patient security without endangering delicate equipment. As a result, producers are creating specialty disinfectants that work well with the components of ultrasonic probes and have strong antibacterial properties to limit the spread of infection.
In June 2023, US Food and Drug Administration (FDA) announced clearance for Tristel ULT, a disinfecting foam manufactured by Parker Laboratories Inc., a global leader in ultrasound supplies and accessories. The foam is made up of chlorine dioxide and is used for disinfecting probes that are used for skin-surface transducers and inside the body cavities.
Ethylene Oxide is Dominating the Market
The demand for ethylene oxide is increasing in the global market for medical device cleaning because of its ability to sterilize medical devices that are prone to moisture and heat. This chemical compound is known for its capacity to permeate deeply into complex electronics, guaranteeing complete sterilization while protecting fragile components. Ethylene oxide is an essential tool in healthcare facilities because of its broad range of antibacterial capabilities, which successfully eradicate bacteria, viruses, fungi, and spores. However, there are issues with the safety of the environment and human health while using Ethylene Oxide, which has prompted regulatory scrutiny and the search for better alternatives.
For example, PAMA Manufacturing and Sterilization announced in January 2023 the launch of a new ethylene oxide (EO) sterilization solution that is intended to preserve the sterility outcomes of the conventional system while being safe, affordable, and environmentally friendly. The system is ISO 11135 certified and also prevents the release of EO directly into the environment.
North America Dominating the Global Medical Device Cleaning Market
North America accounts for a significant portion of the global medical device cleaning market due to its advanced healthcare system, stringent laws, and emphasis on infection control procedures. Due to the availability of many hospitals and clinics, huge healthcare spending, and strict laws and regulations related to disinfection, the United States is the major region responsible for key business activities related to medical device cleaning. The need for advanced and efficient medical equipment cleaning solutions is being influenced by these variables. Additionally, North America's position in the global medical device cleaning market is strengthened by the existence of major manufacturers who continuously invest in the research and development of new technologies, ensuring its supremacy and promoting improvements in medical device cleanliness and safety standards.
For example, in July 2023, STEMart Inc., a US-based provider of comprehensive services for all stages of medical device development, launched a new ethylene oxide sterilant residual testing service. By identifying acceptable residual levels, the new services will assist manufacturers and healthcare providers in guaranteeing the security of EO-sterilized medical devices.
Future Market Scenario (2024-2031F)
The global medical device cleaning market is moving toward sustainable and environmentally friendly cleaning products. Healthcare facilities and equipment makers are actively searching for environmentally friendly cleaning solutions as they grow more conscious of the negative consequences of disposing of chemicals in the environment.
Specialized cleaning solutions made especially for disposable devices are becoming more and more common as healthcare institutions use more disposable devices to reduce the danger of cross-contamination and streamline cleaning procedures, propelling the growth of the global medical device cleaning market.
Automation and robotics are being preferred to clean medical devices boosting the growth of the global medical device cleaning market. When it comes to cleaning and sterilizing medical equipment, automated cleaning solutions offer effectiveness, consistency, and reduce human errors.
Key Players Landscape and Outlook
Prominent companies operating in the global medical device cleaning market are progressively forming partnerships as a means of leveraging each other's advantages. These businesses may more effectively and efficiently promote innovation by combining their technological know-how, R&D capacities, and market presence through partnerships. The development of superior cleaning and sterilization solutions is made possible by this cooperative approach, which facilitates the sharing of best practices in production and quality assurance. These kinds of partnerships frequently lead to improved products, more avenues for distribution, and higher standards of customer service. In the end, these collaborations promote growth and sustainability in the global medical device cleaning market by increasing competition, and innovation, and meeting the changing needs of healthcare providers.
In November 2023, AdaptivEndo and Plasmapp announced their collaboration to assess the potential applications of low-temperature hydrogen peroxide gas plasma for flexible endoscopy. AdaptivEndo was actively looking for partnerships to evaluate different opportunities in gas plasma for flexible endoscopy.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.