市場調查報告書
商品編碼
1634182
全球無塵室耗材市場 - 2025 - 2033Global Cleanroom Consumables Market - 2025 - 2033 |
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2024年,全球無塵室耗材市場達到108億美元,預計2033年將達186.6億美元,2025-2033年預測期間複合年成長率為6.5%。
潔淨室耗材是受控環境(稱為無塵室)中使用的必需用品,旨在減少污染並保持無菌氣氛。這些消耗品對於許多技術先進的行業至關重要,包括製藥、生物技術、電子和醫療設備製造。它們包括手套、長袍、口罩、濕紙巾、棉花棒、鞋套和其他防護服。這些配件旨在防止無塵室環境中灰塵、細菌和其他污染物等污染物的引入和傳播。對於需要嚴格環境控制以維持產品品質和安全的組織來說,無塵室至關重要。它們不僅用於生產,還用於污染可能影響結果的研究設施。
對無塵室耗材的需求不斷成長是預測期內推動市場的促進因素。技術發展和新材料的引入提高了潔淨室耗材的有效性和效率,以滿足日益成長的需求。例如,2024 年 11 月,Sybron 為飯店、教育和醫療保健產業推出了新的可生物分解丁腈一次性手套系列,同時將其普通乳膠和丁腈手套下架。這種新型手套的價格與丁腈手套相同,可以作為普通廢物處理,對環境的影響較小:它們在 491 天內可生物分解 81%。這些手套不含粉末,並具有紋理表面以增強抓握力。
驅動程式和限制
對無塵室耗材的需求不斷增加
對無塵室耗材的需求不斷成長預計將成為全球無塵室耗材市場成長的重要因素。由於製藥、生物技術、電子和醫療器材產業的擴張、對無塵室和環境的需求不斷增加以及技術進步,全球無塵室耗材市場有望大幅擴張。生物技術公司正在迅速擴張,特別是在基因工程和生物製藥等領域。該行業依賴無塵室設置來確保產品品質和安全,導致手套、防護服和清潔用品等無塵室消耗品的使用增加。隨著生技公司不斷探索和開發新型療法,對合規性和有效的無塵室解決方案的需求仍然很高。越來越多的生物技術公司進入市場推動了這一趨勢。
例如,艾伯維(AbbVie)、AGC Biologics、安進(Amgen)、諾華(Novartis) 和賽默飛世爾科技(Thermo Fisher Scientific) 等主要參與者透過在全球範圍內對新製造設施進行大量投資,展現了對該行業的信心。在新加坡、日本、北卡羅來納州、俄亥俄州、冰島和其他地區的擴張標誌著策略性推動提高新療法的全球產能,包括生物製劑、細胞和基因療法以及基於 mRNA 的藥物。艾伯維 (AbbVie) 宣布斥資 2.23 億美元擴建其新加坡生物製劑生產工廠,增加 24,000 公升生物製劑原料藥產能。此外,阿斯特捷利康也宣布投資3億美元在馬裡蘭州羅克維爾開設新的細胞治療設施,旨在美國推出其細胞治療平台用於癌症試驗。安進在俄亥俄州新奧爾巴尼開設了一家新的人工智慧生物製造工廠。
此外,技術發展和新材料的引入提高了無塵室耗材的有效性和效率。模組化無塵室解決方案可實現更快的設定和擴展,同時遵守嚴格的清潔標準。這些系統需要各種消耗品才能正常運作,這推動了市場的成長。
例如,2024 年 9 月,無塵室設計與建造專家 Schilling Engineering 與立陶宛的 Qvalitek 建立了合作夥伴關係。 Qvalitek 提供驗證和鑑定服務,確保製程和設備符合嚴格的監管要求並建立品質標準。作為合作的一部分,總部位於德國的 Schilling 將專注於模組化軟牆潔淨室和硬牆潔淨室艙的分銷和驗證。
此外,2024 年 8 月,Total Clean Air (TCA) 推出了新的可客製化模組化無塵室產品。 Modulab 提供無與倫比的強度、效率,並大幅減少碳足跡。 Modulab 服務於多種行業,包括製藥、醫療器材、電子、工程和航太。該產品自軟發布以來兩個月內已實現 50 萬英鎊(63.9 萬美元)的營收。
嚴格的監管要求
嚴格的監管要求等因素預計將阻礙全球無塵室耗材市場。製藥、生物技術、電子和醫療設備領域的組織正在不斷擴張,它們面臨著旨在提供產品品質和安全性的日益複雜的法規。美國食品藥物管理局 (FDA)、職業安全與健康管理局 (OSHA) 和世界衛生組織 (WHO) 等監管機構對無塵室耗材製定了嚴格的要求。這些要求迫使製造商必須經歷複雜的認證程序,這可能既耗時又昂貴,特別是對於中小型企業 (SME) 而言。
這種複雜性可能會使新公司難以進入市場,從而減少行業的競爭和創新。除了監管障礙之外,一次性無塵室耗材處置的環境問題也帶來了巨大的挑戰。手套、濕紙巾和防護衣等一次性產品的廣泛使用產生了大量廢物,加劇了環境問題。全球對環境議題的認知不斷增強,促使企業探索替代品或生產可回收材料。
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The global cleanroom consumables market reached US$ 10.8 billion in 2024 and is expected to reach US$ 18.66 billion by 2033, growing at a CAGR of 6.5% during the forecast period 2025-2033.
Cleanroom consumables are essential supplies used in controlled environments known as cleanrooms, which are intended to reduce contamination and maintain a sterile atmosphere. These consumables are essential in many technologically advanced sectors, including pharmaceuticals, biotechnology, electronics, and medical device manufacturing. They include gloves, gowns, face masks, wipes, swabs, shoe covers, and other protective apparel. These accessories are meant to prevent the introduction and propagation of contaminants such as dust, bacteria, and other pollutants within the cleanroom environment. Cleanrooms are essential to organizations that demand restricted environmental controls to maintain product quality and safety. They are used not only in production but also in research facilities where contamination could influence results.
The increasing demand for cleanroom consumables is the driving factor that drives the market over the forecast period. Technological developments and the introduction of new materials improve the effectiveness and efficiency of cleanroom consumables to meet the increasing need. For instance, in November 2024, Sybron launched a new line of biodegradable nitrile single-use gloves for the hospitality, education, and healthcare industries, while delisting its normal latex and nitrile gloves. The new gloves, which are available at the same price points as nitrile gloves, may be disposed of in ordinary waste with a lower environmental impact: they biodegrade by 81% within 491 days. These gloves are free of powder and have a textured surface for enhanced grip.
Market Dynamics: Drivers & Restraints
Increasing demand for cleanroom consumables
The increasing demand for cleanroom consumables is expected to be a significant factor in the growth of the global cleanroom consumables market. The global cleanroom consumables market is poised for significant expansion, owing to the expansion of pharmaceuticals, biotechnology, electronics, and medical devices industries, the increasing need for clean rooms and environment, and technological advancements. The biotechnology companies are rapidly expanding, especially in fields such as genetic engineering and biopharmaceuticals. The industry's reliance on cleanroom settings to assure product quality and safety has resulted in increased use of cleanroom consumables such as gloves, gowns, and cleaning supplies. As biotechnology companies continue to explore and develop novel therapeutics, the demand for compliance and effective cleanroom solutions will remain high. This trend is being fueled by an increasing number of biotechnology companies entering the market.
For instance, Major players like AbbVie, AGC Biologics, Amgen, Novartis, and Thermo Fisher Scientific are demonstrating confidence in the industry with substantial investments in new manufacturing facilities worldwide. Expansions in Singapore, Japan, North Carolina, Ohio, Iceland, and other regions signal a strategic push to increase global production capacity for new therapies, including biologics, cell and gene therapies, and mRNA-based medicines. AbbVie announced a $223 million expansion of its Singapore biologics manufacturing facility, adding 24,000 liters of biologics drug-substance capacity. In addition, AstraZeneca announced a $300 million investment to open a new cell therapy facility in Rockville, Maryland, aiming to launch its cell therapy platforms in the U.S. for cancer trials. Amgen opened a new AI-enabled biomanufacturing facility in New Albany, Ohio.
Furthermore, technological developments and the introduction of new materials improve the effectiveness and efficiency of cleanroom consumables. Modular cleanroom solutions enable faster setups and expansions while adhering to strict cleanliness standards. These systems require a wide range of consumables to function properly, which drives market growth.
For instance, in September 2024, Cleanroom Design and Build expert Schilling Engineering entered into a partnership with Lithuania-based Qvalitek. Qvalitek offers validation and qualification services that ensure processes and equipment meet demanding regulatory requirements and establish quality standards. Schilling, based in Germany, will focus on the distribution and validation of modular soft wall cleanrooms and hard wall cleanroom cabins as a part of the collaboration.
Moreover, in August 2024, Total Clean Air (TCA) introduced its new customizable modular cleanroom offering. Modulab offers unparalleled strength, efficiency, and a heavily reduced carbon footprint. Modulab caters to a wide range of industries including pharmaceutical, medical device, electronic, engineering, and aerospace. This product has turned £500k ($639k) in the two months since its soft launch.
Stringent regulatory requirements
Factors such as stringent regulatory requirements are expected to hamper the global cleanroom consumables market. Pharmaceuticals, biotechnology, electronics, and medical devices are expanding organizations that face increasingly complex regulations aimed at providing product quality and safety. Regulatory authorities like as the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), and the World Health Organization (WHO) set stringent requirements for cleanroom consumables. These requirements compel manufacturers to go through a complex certification procedure that can be time-consuming and expensive, particularly for small and medium-sized businesses (SMEs).
This intricacy can make market entry difficult for new firms, reducing competition and innovation in the industry. In addition to regulatory barriers, environmental concerns about the disposal of single-use cleanroom consumables cause substantial challenges. The widespread use of disposable products such as gloves, wipes, and gowns generates significant waste, increasing environmental concerns. The growing global awareness of environmental issues is driving companies to explore alternatives or produce recyclable materials.
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The global cleanroom consumables market is segmented based on safety consumables, cleaning consumables, cleanroom stationery, end-user, and region.
Protective apparel segment is expected to dominate the global cleanroom consumables market share
The Protective apparel segment is anticipated to dominate the global cleanroom consumables market owing to its critical role in maintaining sterile environments across various industries.
Cleanroom apparel, which includes coveralls and gowns, is critical for preventing contamination from individuals in controlled areas. As the pharmaceutical, biotechnology, and medical device sectors grow, so does the demand for high-quality protective clothing. For instance, in August 2024, BASF collaborated with the Pest Control Products Board (PCPB), the International Centre for PPE (ICPPE) at the University of Maryland Eastern Shore, and Syngenta to develop a novel protective garment designed to improve operator safety. The new personal protective clothing is certified under KS ISO 27065 C1, which defines performance requirements for minimum protective clothing worn by operators and for re-entry workers. The fabric and garments have been tested by a certified ISO laboratory and are similar in performance to garments worn in most operator exposure studies.
Advancements in material technology are also facilitating the protective gear industry by increasing the effectiveness of cleanroom garments. Modern cleanroom set is made from tightly woven, breathable textiles that create a solid barrier against particles and microorganisms while remaining comfortable for the wearer. This innovation is critical in industries where employees must work for extended periods of time while maintaining sterility and comfort. Furthermore, as organizations increasingly use disposable cleanroom garments to improve cleanliness procedures, this trend drives growth in the protective apparel segment.
For instance, in August 2024, Heathcoat Fabrics has launched a new fabric line that incorporates a novel graphene-printing method. Graphene is a carbon-based substance that is exceedingly lightweight, very thin, and extremely strong. It has several unique qualities, including electrical and heat conductivity, durability to high temperatures, natural antibacterial capabilities, and exceptional endurance. When used in thermal regulation, the lightweight, fine gauge knitted materials can provide advanced heat dispersion and an increased cooling rate of up to 60%. This enables clothing created from the material to distribute body heat and prevent overheating. The graphene prints also have high surface resistivity and anti-static properties, making them excellent for use in personal protective equipment (PPE).
North America is expected to hold a significant position in the global cleanroom consumables market share
North America is expected to hold a significant portion of the global cleanroom consumables market. North America will likely account for a significant share of the global cleanroom consumables market, owing to its expansion of pharmaceuticals, biotechnology, electronics, and medical devices industries, stringent regulatory requirements, the increasing need for clean rooms and environment, and technological advancements. One of the primary drivers of this demand is North America's strict regulatory environment.
Regulatory authorities such as the Food and Drug Administration (FDA) and the Occupational Safety and Health Administration (OSHA) set high criteria for cleanliness and safety in controlled workplaces. These laws require the use of high-quality cleanroom consumables to ensure compliance during manufacturing operations, especially in industries where contamination can result in substantial health concerns or product failures.
As companies attempt to fulfill these standards, they increase their investment in protective clothing, cleaning supplies, and other consumables required to maintain sterile surroundings. For instance, in August 2023, Tyndale Enterprises, Inc., a leading manufacturer of arc-rated, flame-resistant (AR / FR) clothing, announced its successful launch into the Canadian market to address the demand for protective clothing programs that give greater choice and service.
One of the most significant technological advances influencing this industry is the development of modular cleanroom systems. These technologies provide flexibility and scalability, enabling businesses to swiftly adapt their cleanroom environments to changing production requirements. Modular cleanrooms are easily erected and disassembled, reducing downtime and costs associated with traditional building methods. This adaptability is especially useful in businesses with volatile demand, such as pharmaceuticals and biotechnology, where rapid responses to market changes are critical. As more organizations discover the benefits of modular systems, the need for associated consumables such as protective clothing and cleaning supplies will upsurge.
For instance, in October 2024, Nortek Air Solutions CleanSpace, a US-based cleanroom air management systems expert, has relaunched SERVICOR, their modular cleanroom solution. SERVICOR's is relaunched to meet to increasing market demand for modular, scalable cleanrooms capable of meeting needed filtration levels. SERVICOR has been enhanced to satisfy the changing needs of numerous industries, such as medical device production and packaging, biotechnology, electronics, and advanced manufacturing.
Asia Pacific is growing at the fastest pace in the global cleanroom consumables market
The Asia Pacific region is emerging as the fastest-growing market for cleanroom consumables, owing to a combination of economic development, urbanization, and increasing demand from key industries such as pharmaceuticals, biotechnology, and electronics. The increasing pharmaceutical and biotechnology industries are major growth drivers in the Asia Pacific cleanroom consumables market. Countries such as China and India are making large investments in these areas, due to a growing demand for healthcare products and improved medical treatments.
To meet the increasing demand for cleanroom consumables, manufacturers in this region have launched products involving recent technologies. For instance, LINDSTROM INDIA has launched its first Cleanroom Unit in India. Lindstrom's cleanroom service offers hygienic production facilities by providing clothing, which prevents contamination during the manufacturing process, ensuring the entire safety of the products being produced. The cleanroom facility, which covers 50,000 square feet, has the potential to service 400,000 uniforms every month. The unit's workforce has received specific training from Finnish experts, and it functions in a classified cleanroom environment to ensure that its customers receive particle-free and contamination-free clothes.
The major global players in the global cleanroom consumables market include ANSELL LTD., Berkshire Corporation, Contec, Inc., DuPont, Texwipe, Kimberly-Clark Worldwide, Inc., Sierra Instruments, Inc., Veltek Associates, Inc., Hydroflex Group GmbH, and Chemtronics among others.
Emerging Players
ABN Cleanroom Technology, Allied Cleanrooms, and Modular Cleanrooms Inc. among others
The global cleanroom consumables market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
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