The global cleanroom technology market size was estimated at USD 3,097.8 million in 2016 and is expected to witness a lucrative CAGR of 5.1% over the forecast period. Stringent regulatory standards for cleanrooms, technological advancements, and increased demand for cleanrooms to develop quality products are some of the major factors estimated to drive the market.
Cleanrooms are classified on the basis of number and size of particulate matter permitted per volume of air in the manufacturing unit. Federal Standard 209, British Standard 5295, ISO Standard, and Pharmaceutical Cleanroom Classifications are the regulatory standards used for classifying cleanrooms. International Organization for Standardization (ISO) produced a standardized system for cleanroom classification in order to bring uniformity, as most of the manufacturing companies followed their respective country-specific standards. Companies must comply with these standards for product approvals and develop quality and standardized products. As a result, demand for equipment and consumables employed in cleanrooms is rising globally.
U.S. cleanroom technology market by product type, 2014 - 2025 (USD million)
Increase in demand for installing cleanroom technologies for manufacturing quality products in various industries is also expected to drive the market over the forecast period. Various sources of contaminations such as personnel, raw materials, product flow, and machinery are likely to contaminate the product being manufactured. Cleanroom technology protects the final products as well as manufacturing processes against contaminants. It is an integral part of healthcare industry, serving the purpose of developing standardized products as per regulatory norms.
Technological advancements are one of the important factors expected to drive the market. Cleanroom technologies have transitioned from being conventional constructive to modular flexible cleanrooms. Benefits such as quick installation, reconfiguration as per requirement, and cost-effectiveness are some of the key factors that boost demand for modular cleanrooms in various industries. In September 2017, Telstar developed a standardized version of biological safety cabinet-BioVanguard-which belongs to class 2 biological safety cabinets that have low power consumption, maintenance cost, and noise levels. BioVanguard requires low maintenance and has long-lasting HEPA filters due to presence of integrated prefilter system. It can also be customized for application in pharmaceutical, medical devices, and biotechnology industries.
The global healthcare industry is flourishing due to increase in demand for pharmaceutical products, nutraceuticals & cosmeceuticals, medical devices, and biotechnology products. Cleanrooms are crucial in these sectors as products manufactured by these industries have a direct impact on human lives. Cleanroom technologies have a number of applications in pharmaceutical industries. According to data published by WHO, total revenue generated from pharmaceutical industries has reached over USD 300 billion, which can be attributed to branded or innovative patented drugs. However, generics are equally important as they are easily available to a large fraction of population worldwide. Thus, the use of this technology is expected to increase in the healthcare sector.
Product Type Insights
In 2016, consumables emerged as the largest segment that accounted for approximately 54.0% of the total revenue share. Personnel working in cleanrooms are major source of contamination. The consumables consist of disposable and reusable materials such as gloves, face masks, beard covers, wipers, swabs, sticky mats, adhesive tapes, suits, shoe covers, and aprons. These consumables play a critical role in maintaining cleanliness standards. Use of consumables ensures prevention of contamination from shoes, hands, beard, and hair of personnel.
Gloves accounted for the highest revenue share among cleanroom consumables in 2016. The primary purpose of wearing gloves is to reduce contamination. Demand for gloves is expected to surge due their increased use in diverse industries, such as pharmaceutical, medical device, biotechnology industries, and diagnostic centers. Thus, increase in operations in these sectors, growing concerns about safety of manufacturing products, and regulations imposed by various regulatory bodies for cleanliness are some of the key reasons that can be attributed to its largest revenue share.
However, equipment is expected to emerge as the fastest growing segment with a growth rate of approximately 5.7%. Equipment inside cleanrooms are designed to limit air contamination, and thus, help maintain cleanliness levels that comply with regulatory standards. In addition, cleanroom equipment minimizes ingress of particulate contaminants. The appropriate design of airflow regulated by such devices prevents surface accumulation of particulate matter, thus maintaining cleanliness. Installation of these equipment is expected to increase over the forecast period due to emergence of stringent regulations in the healthcare sector.
In 2016, pharmaceutical industries emerged as the largest segment that accounted for approximately 48.7% of the total revenue share. Advancements in pharmaceutical cleanroom technology, both in terms of technicality and regulations, is one of the key factors that can be attributed to the revenue share held by pharmaceutical industry. Increase in demand for substitution of conventional cleanroom technology by Restricted Access Barrier Systems (RABS) and isolators is also among few determinants that indicate current penetration of this technology in pharmaceutical industries. In addition, stringent regulations, especially in the U.S., regarding drug approvals when they are imported from emerging economies, such as India, China, and Brazil, are also encouraging the pharma companies to ensure controlled environment and presence of lower levels of pollutants.
Cleanroom technology market share by end use, 2016 (%)
Biotechnology held the second largest revenue share, followed by medical devices manufacturing industries. However, biotechnology sector is expected to be the fastest growing segment over the forecast period due to increase in demand for controlled environment in working areas. Rise in demand for certified products and technological advancements in this sector to ensure controlled environment are some of the key factors anticipated to boost the demand for cleanroom technologies.
Legislation regarding manufacturing standards of medical devices, such as surgical equipment and implants, is one of the crucial factors anticipated to boost the demand. Medical devices that are used directly used internally are regulated by stringent regulations, which is also expected to increase the number of installations of cleanrooms in medical device industry. In addition, demand for hygiene and infection control is high in hospitals & diagnostic facilities. As per an industry paper published in California, approximately 4% of hospitals used cleanroom technologies during 2011.
In 2016, the North America dominated with a revenue share of approximately 36.5%, accounting for the largest share of cleanroom technology market due to factors such as local presence of key pharmaceutical companies, high healthcare expenditure, and increased number of hospital-associated infections. The aforementioned factors and favorable reimbursement policies can also be attributed to high penetration of cleanroom technology in the North American healthcare sector.
The U.S. is one of the major economies in the North American markets. The U.S. healthcare sector has the largest contribution in national GDP (17%), which is one of the crucial factors that can be attributed to increased usage of cleanroom technologies in healthcare sectors. Increase in the number of pharmaceutical, nutraceutical, and medical devices industries due to worldwide rise in disease burden can also be attributed to the surge in demand for controlled environment in pharma, hospitals, and medical devices manufacturing sectors.
However, Asia Pacific is expected to emerge as the fastest growing segment with a growth rate of approximately 6.7%. Increase in production of generics due to rise in number of patent expirations of blockbuster drugs, geriatric patient population, and disease burden is among few factors expected to boost the usage of cleanroom technology in laboratories, hospitals, and medical devices manufacturing sectors. Growing development in medical devices manufacturing and pharmaceutical sectors in the emerging economies of this region, such as China and India, is one of the key factors anticipated to boost its demand over the forecast period.
The market is highly fragmented in nature with participants such as Clean Air Products; M+W Group; KCWW; DuPont; Abtech; Integrated Clean Room Technologies Pvt Ltd; Clean Room Depot, Inc.; Terra Universal, Inc.; and Labconco. Manufacturers are striving to increase their market share through strategies such as development of new products and advancements of the existing ones.
Base year for estimation
Actual estimates/Historical data
2014 - 2016
2017 - 2025
Revenue in USD Million and CAGR from 2017 to 2025
North America, Europe, Asia Pacific, Latin America, Middle East & Africa
U.S., Canada, Germany, UK, China, Japan, Brazil, Mexico, South Africa
Revenue forecast, company share, competitive landscape, growth factors, and trends
15% free customization scope (equivalent to 5-analyst working days)
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Segments covered in the report
This report forecasts revenue growth at global, regional, & country levels and provides an analysis on the industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research, Inc. has segmented the cleanroom technology market on the basis of product type, end use, and region:
Product Type Outlook (Revenue, USD Million, 2014 - 2025)
Heating Ventilation and Air Conditioning System (HVAC)
Cleanroom air filters
Air shower and diffuser
Laminar air flow unit
End-use Outlook (Revenue, USD Million, 2014 - 2025)
Medical device industry
Hospitals and diagnostic centers
Regional Outlook (Revenue, USD Million, 2014 - 2025)
Middle East & Africa
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