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市場調查報告書
商品編碼
1324341
到 2030 年滅菌指示帶的全球市場預測:按類型、最終用戶和地區分析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 |
根據 Stratistics MRC 的數據,2023 年全球滅菌指示膠帶銷售額為 1.365 億美元,預計在預測期內將以 6.9% 的年複合成長率成長,到 2030 年達到 2.177 億美元。
該膠帶具有化學指示劑,當暴露於滅菌過程中經常使用的溫度時,該化學指示劑會改變顏色。醫療機構和實驗室的工作人員使用高壓滅菌膠帶確保試管和其他相關物品無菌。
明尼蘇達大學發表的報導顯示,2020年第四季度中心靜脈管相關血流感染(CLABSI)的標準感染率(SIR)較2019年同期增加了47.0%。
滅菌是製藥和生物技術領域最重要的程序之一。這些公司需要無菌環境和無菌工具來進行研發。使用各種滅菌技術,包括化學和生物標記,來證明在整個設計和製造流程中已實現無菌。例如,根據美國研究與製藥工業協會(PhRMA)的數據,其會員企業2021年的研發預算總計為1023億美元。由於過去十年製藥和生物技術行業的快速發展,滅菌過程變得越來越普遍。
在已開發國家,工業和醫療機構通常使用滅菌指示物來監控滅菌程序。低收入和中等收入國家的滅菌程序仍然多種多樣,這限制了滅菌盒的使用並限制了市場的成長。由於嚴格的法規法律以及對企業和醫療機構的頻繁審核,富裕國家通常遵循消毒程序。然而,由於缺乏嚴格的滅菌監測和定期滅菌器評估機制,開發中國家法規指南和滅菌規範的實施受到限制。
進入任何醫療機構或組織的患者都有感染醫院感染的風險,也稱為院內感染 (HAI)。入院 30 天內或出院 48 小時內接受住院治療的患者可能會患上此類疾病。這些感染疾病的最常見原因是衛生不當和器械消毒方法不良。因此,世界各地的醫療機構正在實施嚴格的滅菌指南,要求使用無菌設備,以阻止 HAI 的傳播。
這些盒式磁帶的價格過高,而且人們普遍不了解使用無菌標籤膠帶的好處。此外,由於中小企業數量眾多,市場高度分散。結果,客戶發現很難選擇最合適的產品。
COVID-19 的爆發對無菌加工的需求產生了積極影響。在外科和牙科手術中使用清潔、無感染的醫療器械對於防止污染變得越來越重要,並且滅菌程序的數量猛增。這次疫情導致到醫院就診的患者人數增加。採用這種指示帶也是因為患者數量的增加影響了對可重複使用醫療設備的需求。此次疫情凸顯了醫院、牙科診所和其他醫療機構遵守滅菌規程並保持對可重複使用醫療設備的控制的重要性。
由於對用過氧化氫處理的熱敏產品的需求不斷增加,預計過氧化氫膠帶細分市場將出現良好的成長。在預測期內,過氧化氫指示帶的需求預計將受到低溫滅菌中過氧化氫使用量增加的影響。指示帶確保無菌包裝的安全,同時允許即時識別加工產品。當進行蒸汽滅菌時,化學指示劑從米色變為深棕色或黑色。
醫院、診所和實驗室等確保有效滅菌程序的醫療機構數量不斷增加,正在推動市場擴張。此外,醫院感染疾病,這推動了無菌膠帶的使用以防止污染。
北美在醫療器械滅菌方面有嚴格的法規,對這些物品的接受度較高,醫療基礎設施完善,醫院數量不斷增加,所有這些都要素該地區的市場擴張,預計將佔最大的市場佔有率預測期內的市場佔有率。此外,由於該地區研發活動的活性化,對無菌指示帶等無菌驗證產品的需求不斷成長。
由於嚴格的藥品生產法規政策、防止醫院感染的嚴格滅菌標準以及醫療設備和其他設備的無菌和安全性,預計歐洲在預測期內將經歷最高的年複合成長率。確保醫療器械促進協會制定的歐洲標準 EN17180 草案中描述了使用汽化過氧化氫水溶液作為滅菌劑的 VH2O2 滅菌器的規格和測試。這些滅菌器適用於醫療設備的滅菌,特別是熱敏性和濕敏性設備。
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.