市场调查报告书
商品编码
1504252
全球医疗器材清洁市场评估:按流程、按 EPA 分类、按设备、依类型、按方法、依应用、依最终用户、依地区、机会、预测(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 |
全球医疗器材清洁市场规模预计将从2023年的 51.4 亿美元增至2031年的 93.4 亿美元,预计2024-2031年年复合成长率为 7.75%。 COVID-19大流行后消毒标准的製定,对创新产品的需求不断增加,超音波探头消毒剂的日益普及以及环氧乙烷的主导地位等各种因素塑造市场。
监管标准是全球医疗器材清洁市场的守护者,确保所有产品和程序都遵守严格的安全和品质要求。最终,它成为医疗环境中清洁解决方案开发的指南针,保护病患和医护人员的健康和安全。市场对新型清洁解决方案和技术的需求显着增加。这些解决方案优先考虑患者安全,同时提高消毒效果和效率。这种需求的增加是迫切需要更先进的感染预防和病人安全解决方案的直接结果,并凸显了提高医疗保健消毒标准的共同承诺。
人们对专门为超音波探头设计的消毒剂的日益青睐表明市场需求不断增加。这一趋势凸显了为各种医疗设备客製化清洁解决方案的需求。环氧乙烷是一种有效且适应性强的消毒剂,在全球医疗器材清洁市场中占据了重要占有率。环氧乙烷对医疗器材进行高效消毒的能力巩固了其作为医疗器材清洁程序最佳选择的声誉。环氧乙烷由于其广泛的材料相容性而广泛应用于医疗产业的各种应用。
监理标准的製定塑造市场
市场很大程度上受到医疗器材产业保护病人安全和品质的监管标准的影响。这些指南确保遵循严格的清洁和消毒程序,以保护患者安全并避免感染。随着监管机构在全球范围内完善这些建议,医疗保健提供者将需要采用创新的清洁解决方案和技术。随着製造商和医疗机构回应这些严格的监管要求,对专业清洁服务和耗材的需求不断增加,最终推动产业的成长和发展。
例如,2023年7月,美国食品药物管理局(FDA)宣布,随着美国环保署(EPA)推进限制使用环氧乙烷(EtO)的法规,该机构的Center for Devices and Radiological Health(CDRH)宣布已批准一项关于使用低温汽化过氧化氢对医疗器械进行消毒的新国际共识标准。
对创新产品的需求不断成长推动市场成长
由于医疗设备的复杂性不断增加以及对感染预防的日益重视,全球医疗设备清洁市场对创新产品的需求显着增加。复杂的医疗设备可能达不到现代清洁技术的要求,需要更先进的方法。此外,COVID-19 大流行的影响凸显了严格卫生预防措施的必要性以及对强大清洁解决方案的需求增加。 UV-C 雷射灭菌和酵素清洁剂等创新改变清洁技术,这些创新提供了降低感染风险和提高患者安全的卓越功能。
例如,美国食品药物管理局已批准首个用于 3D 列印医疗设备的灭菌系统将于2023年 8月投放市场。凭藉其专用循环,V-PRO max 2 低温灭菌系统可对使用 3D 列印技术列印的解剖模型和患者定製手术导板等手术器械进行灭菌。
本报告研究和分析了全球医疗器材清洁市场,提供市场规模和预测、市场动态以及主要参与者的现状和前景。
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.