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市场调查报告书
商品编码
1324341
到 2030 年灭菌指示带的全球市场预测:按类型、最终用户和地区分析Sterilization Indicator Tape Market Forecasts to 2030 - Global Analysis By Type (Hydrogen Peroxide Tapes and Steam Indicator Tapes), End User (Pharmaceutical & Medical Devices Companies, Healthcare Facilities and Other End Users), and By Geography |
根据 Stratistics MRC 的数据,2023 年全球灭菌指示胶带销售额为 1.365 亿美元,预计在预测期内将以 6.9% 的年复合成长率增长,到 2030 年达到 2.177 亿美元。
该胶带具有化学指示剂,当暴露于灭菌过程中经常使用的温度时,该化学指示剂会改变颜色。医疗机构和实验室的工作人员使用高压灭菌胶带确保试管和其他相关物品无菌。
明尼苏达大学发表的报导显示,2020年第四季度中心静脉管相关血流感染(CLABSI)的标准感染率(SIR)较2019年同期增加了47.0%。
灭菌是製药和生物技术领域最重要的程序之一。这些公司需要无菌环境和无菌工具来进行研发。使用各种灭菌技术,包括化学和生物标记,来证明在整个设计和製造流程中已实现无菌。例如,根据美国研究与製药工业协会(PhRMA)的数据,其会员企业2021年的研发预算总计为1023亿美元。由于过去十年製药和生物技术行业的快速发展,灭菌过程变得越来越普遍。
在发达国家,工业和医疗机构通常使用灭菌指示物来监控灭菌程序。低收入和中等收入国家的灭菌程序仍然多种多样,这限制了灭菌盒的使用并限制了市场的增长。由于严格的法规法律以及对企业和医疗机构的频繁审核,富裕国家通常遵循消毒程序。然而,由于缺乏严格的灭菌监测和定期灭菌器评估机制,开发中国家法规指南和灭菌规范的实施受到限制。
进入任何医疗机构或组织的患者都有感染医院感染的风险,也称为医院获得性感染 (HAI)。入院 30 天内或出院 48 小时内接受住院治疗的患者可能会患上此类疾病。这些感染疾病的最常见原因是卫生不当和器械消毒方法不良。因此,世界各地的医疗机构正在实施严格的灭菌指南,要求使用无菌设备,以阻止 HAI 的传播。
这些盒式磁带的价格过高,而且人们普遍不了解使用无菌标籤胶带的好处。此外,由于中小企业数量众多,市场高度分散。结果,客户发现很难选择最合适的产品。
COVID-19 的爆发对无菌加工的需求产生了积极影响。在外科和牙科手术中使用清洁、无感染的医疗器械对于防止污染变得越来越重要,并且灭菌程序的数量猛增。这次疫情导致到医院就诊的患者人数增加。采用这种指示带也是因为患者数量的增加影响了对可重复使用医疗设备的需求。此次疫情凸显了医院、牙科诊所和其他医疗机构遵守灭菌规程并保持对可重复使用医疗设备的控制的重要性。
由于对用过氧化氢处理的热敏产品的需求不断增加,预计过氧化氢胶带细分市场将出现良好的增长。在预测期内,过氧化氢指示带的需求预计将受到低温灭菌中过氧化氢使用量增加的影响。指示带确保无菌包装的安全,同时允许即时识别加工产品。当进行蒸汽灭菌时,化学指示剂从米色变为深棕色或黑色。
医院、诊所和实验室等确保有效灭菌程序的医疗机构数量不断增加,正在推动市场扩张。此外,医院感染疾病,这推动了无菌胶带的使用以防止污染。
北美在医疗器械灭菌方面有严格的法规,对这些物品的接受度较高,医疗基础设施完善,医院数量不断增加,所有这些都要素该地区的市场扩张,预计将占最大的市场份额预测期内的市场份额。此外,由于该地区研发活动的活性化,对无菌指示带等无菌验证产品的需求不断增长。
由于严格的药品生产法规政策、防止医院感染的严格灭菌标准以及医疗设备和其他设备的无菌和安全性,预计欧洲在预测期内将经历最高的年复合成长率。确保医疗器械促进协会制定的欧洲标准 EN17180 草案中描述了使用汽化过氧化氢水溶液作为灭菌剂的 VH2O2 灭菌器的规格和测试。这些灭菌器适用于医疗设备的灭菌,特别是热敏性和湿敏性设备。
According to Stratistics MRC, the Global Sterilization Indicator Tape Market is accounted for $136.5 million in 2023 and is expected to reach $217.7 million by 2030 growing at a CAGR of 6.9% during the forecast period. Autoclave tape is an adhesive tape used to show the processor that an item has achieved a certain temperature and show if it has undergone the sterilization procedure. The tape features a chemical indicator that, when exposed to temperatures frequently employed in sterilization procedures, will change colour. Workers in medical facilities and research labs use autoclave tape to verify that test tubes and other relevant objects have undergone sterilization.
According to an article published by the University of Minnesota, the Standard Infection Ratio (SIR) for Central Line-associated Bloodstream Infection (CLABSI) increased by 47.0% in the fourth quarter of 2020 compared to the same period in 2019.
Sterilization is one of the most crucial procedures in the pharmaceutical and biotechnology sectors. These companies require a sterile setting and sterilized tools to conduct their research and development. To prove that sterility was attained throughout the design or manufacturing process, a range of sterilization techniques, including chemical and biological markers, are used. For instance, the Pharmaceutical Research and Manufacturers of America (PhRMA) states that in 2021, member businesses' research and development budgets totalled USD 102.3 billion. As a result of the pharmaceutical and biotechnology industries' rapid growth during the past ten years, there have been more sterilization processes performed.
In developed nations, industries and healthcare facilities routinely use sterilization indicator items to monitor the sterilizing procedure. Sterilization procedures are still variable in low- and middle-income nations, which restricts the use of sterilizing cassettes and restrains market growth. Sterilization procedures are commonly followed in wealthy countries because to strict regulatory laws and frequent audits of business and healthcare facilities. However, the lack of rigorous mechanisms for sterilization monitoring and routine sterilizer evaluation limits the implementation of regulatory guidelines and sterilization norms in developing nations.
Patients hospitalized to any healthcare facility or organization are at risk of contracting nosocomial infections, also known as hospital-acquired illnesses (HAIs). One of these illnesses can strike a patient receiving inpatient care up to 30 days after being admitted or 48 hours after being discharged. Inadequate sanitation practices or insufficient equipment sterilization methods are the most common causes of these infections. As a result, in an effort to stop the spread of HAIs, healthcare facilities all over the world have begun imposing stringent sterilization guidelines that demand the use of sterilization equipment.
The prohibitive cost of these cassettes and the general ignorance of the benefits of using sterilizing indication tapes. Moreover, with so many small and medium-sized businesses, the market is also tremendously fragmented. As a result, customers find it difficult to choose the best product.
The COVID-19 pandemic had a positive impact on the demand for sterilization processing. The number of sterilization procedures skyrocketed as the importance of using clean, infection-free medical equipment during surgical and dental procedures to prevent contamination grew. The outbreak led to a rise in the number of patients seen at hospitals. Due to the impact of the growing patient population on the demand for reusable medical equipment, these indicator tapes were also employed. The outbreak has made it clear how crucial it is for hospitals, dental offices, and other healthcare facilities to follow sterilization protocols and maintain control for reusable medical devices.
The hydrogen peroxide tapes segment is estimated to have a lucrative growth, due to the increasing need for heat-sensitive products to be treated with hydrogen peroxide. Over the forecast period, the demand for hydrogen peroxide indicator tapes is anticipated to be impacted by the rising use of hydrogen peroxide in low-temperature sterilization. Indicator tapes secure sterilizing packs while also instantly identifying processed products. When exposed to steam sterilization, the chemical indicator lines will visually shift from beige to a dark brown or black colour.
The healthcare segment is anticipated to witness the highest CAGR growth during the forecast period, due to rising in healthcare institutions including hospitals, clinics, and laboratories for confirming effective sterilization procedures, which is boosting market expansion. Additionally, the market expansion in healthcare facilities is being aided by the rise in incidences of hospital-acquired illnesses, which are pushing the use of sterilization tapes to prevent contamination.
North America is projected to hold the largest market share during the forecast period owing to solid regulatory rules for the sterilization of medical devices in the region, higher acceptance of these items, the presence of well-established healthcare infrastructure, an increase in the number of hospitals, and these factors all contribute to the market expansion in this region. Moreover, a rise in the need for sterilization validation goods, such as sterilization indicator tapes, is a result of rising research and development activity in the area.
Europe is projected to have the highest CAGR over the forecast period, owing to tight regulatory policies governing the production of pharmaceuticals, stringent sterilization standards to prevent hospital-acquired infections, and a focus on the sterilization procedure to guarantee the sterility and safety of medical equipment and other devices are all examples of such regulations. The specifications and testing for VH2O2 sterilizers, which use a vaporized aqueous solution of hydrogen peroxide as the sterilizing agent, are mentioned in EN 17180, a draft European Standard, according to the Association for the Advancement of Medical Instrumentation. These sterilizers should be used to sterilize medical equipment, in particular thermolabile and moisture-sensitive equipment.
Some of the key players profiled in the Sterilization Indicator TapeMarket include: 3M, STERIS plc, Healthmark Industries Company, Inc., ASP, Terragene, Getinge AB, GKE GmbH, Propper Manufacturing Co., Inc., PMS, Kartell S.p.A, Deltalab, Defend by Young Mydent LLC, SHINVA MEDICAL INSTRUMENT Co., LTD., Guangdong New EraNew Material Technology Co., Ltd., BRAND GMBH + CO KG, Excelsior Scientific and 4A Medical
In April 2022, The U.S. FDA approved 3M Attest Super Rapid Steam Biological Indicator 1592.It is a self-contained biological indicator designed to be used with the 3M Attest Auto-reader 490 having software version 4.0.0 or greater.
In July 2020, 3M launched Attest Mini Auto-reader 490M, a 24-minute in-house sterilization monitoring solution. The new product is part of the company's existing portfolio of sterilization equipment, broadening its offering across the globe.
In March 2020, The U.S. FDA approved STERIS VHP LTS-V low-temperature sterilizer for a customer application. The sterilizer is designed to support biotechnology, pharmaceutical and medical device manufacturing and related industries.