U.S Cleanroom Technology Market

The U.S Cleanroom Technology Market is estimated to surpass $2.4 billion mark by 2027 growing at an estimated CAGR of more than 4.4% during the forecast period 2022 to 2027. U.S. Cleanroom Technology market is expanding at a rapid pace owing to two main factors; 1) increased use of various cleanroom equipment such as HVAC systems, laminar airflow units, air ionizers, air diffusers, fan filter units, high-efficiency particulate arrestance (HEPA) filters and 2) increasing usage of cleanroom consumables, especially in pharmaceutical companies, and biotech companies. Cleanrooms have allowed being a chief-strategy facilitator in combating contamination and particle-induced defects. Monitoring particulate contamination and controlling process variables through the integration of feedback and feed-forward of defect information has allowed establishing high-yield processes to be carried out in clean rooms. The active growth in end-user industry applications is estimated to enhance the market potential. For example, the growth of Ready to Eat foods has impacted clean areas and facility sanitation, particularly for meats, seafood, and animal products. Moreover, technological up-gradation such as the introduction of mobile cleanrooms in the pharmaceutical industry or supply chain processes also acts as a key driver for the already growing market. Additionally, such detection can highlight problems, which at granular levels can be analyzed by emerging software such as Smart-Control, which allows entering data for analysis while the trend rules and threshold are provided by the facility manager. In cases of breaches, a graphical form of analysis of personnel, locations or contamination can be instantly generated for inclusion in reports which in turn can be provided to required stakeholders.

Key Takeaways

• Product integrity and contamination controls have been a prevalent concern in various industries before the COVID-19 pandemic struck. However, with such developments in recent times-the knowledge and adoption of clean rooms have been multiplicated. Clean rooms and wash-down protocols have played a key role in ensuring that the end-products are removed from any form of contaminants from the production process, which in turn is imperative to meet standards provided by the government bodies and private wants.
• Furthermore, active collaborations between a wide range of industries have allowed for phenomenal growth in the market. For example, MMC (Modern Methods of Construction)- MTX is collaborating with B Braun Medicals, a leading healthcare solutions company to provide end-to-end clean room solutions for aseptic medical products and services. Additionally, MTX Clean-rooms facilities can be delivered 60% faster than the alternatives-thereby helping to fulfill the demand for growing industries, while simultaneously ensuring maximum Pre-Manufactured Value (PMV), and state-of-the-art facilities.
• Integration of AI and IoT provides credible support to the entire framework for Clean-Rooms. Routine review of Environmental Monitoring (EM) data provides confidence in the quality of manufacturing areas and the surrounding clean environments and ensures that any adverse trends which may be forming are detected quickly.

U.S Cleanroom Technology Market Segment Analysis - By Industry Vertical

By Application Type, the Pharmaceutical segment is dominating the U.S. Cleanroom Technology Market with a revenue of $710.59 million in 2022 and is estimated to grow at a CAGR of 3.93% during the forecast period. Clean room usage is mandated in various forms of pharmaceutical material handling or device handling. Additionally, Pharmaceutical clean-rooms are generally in the range of ISO 5,6,7 or 8. US FDA and cGMP requirements for pharmaceutical manufacturing and general process handling propel the usage of clean-rooms in the industry. Modular cleanroom construction has become a rising trend in pharmaceutical manufacturing. A prime benefit for the same, as expressed by industry stalwarts is that they are similar to high-speed doors and walls for clean applications - prevention of microbial growth. Moreover, fabric curtain walls, flexibility, quick installation, and cost-efficiency establishes the following forms of clean-room among the highest-ranked. However, Hospitals and Diagnostic Centers segment is set to be the fastest-growing segment with a CAGR of 4.78% during the forecast period 2022-2027 and is projected to generate a revenue of $354.21 million by 2027. Ongoing implementation of FDAs FSMA (Food Safety Modernization Act) will continue to increase the usage of clean rooms and clean areas. Additionally, FSMA Final Rule for Preventive Controls for Human Food requires food facilities to have a food safety plan in place that includes an analysis of hazards and risk-based preventive controls to minimize or prevent identified hazards. The following measures would allow the Clean Room Technology market to grow.

U.S Cleanroom Technology Market Segment Analysis - By Construction Type

By Construction Type, the Hard-Wall segment is dominating the U.S. Cleanroom Technology Market with a revenue of $721.59 million in 2022 and is estimated to grow at a CAGR of 4.10% during the forecast period. Hard-Wall Clean Rooms have standardized fan filter units, LED lights, Control Panel, and an all-steel frame. Hard-Wall Cleanrooms are coming up with adjustable differential pressure vents to manage the room pressure as guided by ISO requirements. Moreover, cleanrooms are designed with seismic safety in mind. Rigid steel frames and ceiling grids are designed with sufficient factors of safety to provide vertical and lateral strength recommended by professional engineers. Technologies such as Whisper-Flow from Terra Universal enable to cut down on various noises, by controlling noise at 75% quieter than 70dB. However, the Pass-Through segment is set to be the fastest-growing segment with a CAGR of 4.93% during the forecast period 2022-2027 and is projected to generate a revenue of $736.51 million by 2027. Pass-Through construction form of Clean-Rooms are offering advantages over the former ways of construction types. Firstly, they help in reducing foot traffic by minimizing the need for non-vital personnel to enter the controlled environment. Secondly, IoT integrations are providing smart-pass throughs that are enabling data transfer improving productivity. Lastly, pass-through cabinets can be integrated to meet industry-specific requirements-enabling a multi-factor growth approach for the segment in the forecast period.

U.S Cleanroom Technology Market Drivers

Extensive Application Within the Pharmaceutical and Healthcare Sector

The pharmaceutical or healthcare industry in this world is one among the few most vibrant one’s. The industry is constantly exposed to technical as well as regulatory shifts. Currently, the industry is facing a huge repositioning in terms of quality management and international authorities have set strict measures for maintenance of international manufacturing standards regarding contamination and biocontamination. Since, the pharmaceutical and healthcare sector are rapidly surging in terms of sales, the requirements of building more and more cleanrooms within pharmaceuticals and healthcare facilities is also on the rise. The figure of the left shows the increase in federal funding for upgrading health facilities in the U.S. including building cleanrooms. Cleanrooms are considered extremely important to uphold high standards of manufacturing of clinical products since these provide ideal conditions for production. Cleanrooms are also efficient in controlling the spread of microorganisms and are also penetrating other aspects of healthcare industry such as hospital hygiene. All these factors are collectively fueling the growth of cleanrooms in U.S. The Federal funding of National Institute of Health increased to $41 Billion in 2022 from $33 Billion in 2011.

Increasing Inflow of investments in High-Tech Manufacturing Industry

The major portion of demand of cleanrooms in the United States arise directly from the construction activities of plants and new production lines of the major manufacturing industries. All the manufacturing industries especially the industries involved in manufacturing of chemical equipment and semiconductor devices require a high standard of production requisites. Cleanroom is one of the priorities of optimal manufacturing conditions. Hence, with the growth of almost every manufacturing industry in the U.S including chemical products, computers and electronic parts, food and beverages among others, the demand of cleanrooms in the country is increasing. For example, the high-end manufacturing of the integrated circuit. Companies manufacturing IC in the U.S experience high demand from all over the world. Produced under a controlled environment is one of the major strategies used during product marketing hence the demand for high end cleanrooms from such industries is surging. According to DARPA, the enacted budget for the organization in FY 2022 was estimated to be approximately $3.868 billion. However, this is projected to rise in 2022 as the President's FY2023 budget request for DARPA is $4.119 billion.

U.S Cleanroom Technology Market Challenges

High Building and Operational Cost of Cleanrooms

Many industries including pharmaceuticals, food & beverages, healthcare, life sciences and other manufacturing industries used clean rooms. Decontamination of cleanrooms is a frequent process that has to be followed. This adds up to the operational cost of cleanrooms. Not only this, but the building up of cleanrooms is also a costly process. The main reason behind this is the requirement of specialized materials and systems which drive the manufacturing cost. Some of the materials used are- expoxy, urethane for flooring, fiber-reinforced plastic panels for wall coating, Chlorinated polyvinyl chloride for wall ceilings, gypsum wall boards for making of cleanroom wall among many others. The below table depicts the cost of maintenance of cleanrooms in almost every industrial facility which is the main factor restraining the growth of cleanrooms in the U.S market. U.S. Cleanroom technology average selling price varies between $200 to $1200 per square feet, in addition to this the price may vary based on the end user industry. The overall prices of cleanroom technologies in the US is anticipated to increase during the forecast period 2022-2027 owing to the global rise in the cost of raw materials such as Aluminum, Steel and Melamine. According to Eurometal, price of stainless steel is anticipated to rise in 2022 owing to factors such as higher demand, lower supply and higher raw material costs. In addition, reduction in the supply of nickel from Russia owing to the Russia-Ukraine conflict has further worsened the production of stainless steel. According to S&P Global, the Russian company PJSC MMC Norilsk Nickel produced 195,000 tons of mined nickel in 2022, or 7.2% of global supply. Nickel is vital for production of steel as they are produced with 80%-90% scrap and around 10% Class 1 nickel.

Market Landscape

Product launches, acquisitions, and R&D activities are key strategies adopted by players in the BLE Market. The top 10 U.S Cleanroom Technology companies include:

• Kimberly-Clark Corporation
• Illinois Tool Works
• Daikin Industries
• Exyte Technology
• Du Pont
• Azbil Telstar
• Terra Universal
• Labconco Corp.
• Clean Air Technology
• Dynarex Corp.

Recent Developments

• In November 2022, Azbil Corporation through its subsidiary, Azbil Telstar, announced the launch of the TVAC3, a compact and cube shaped Thermal Vacuum Chamber which can be used to test cubesat satellites and small satellites components. The cleanroom compatible solution has been launched in several countries including the USA, and boasts of a reduced footprint, which provides easy access for its maintenance.
• In January 2022, Kimberly Clark Professional announced the release of their Kimtech Opal Nitrile Gloves across several markets including the USA. The gloves are powder free and have been manufactured without vulcanisation accelerators. They cater to research and production facilities, life sciences and non-sterile drug manufacturers as well as other cleanroom environments.
• In June 2020, Illinois Tool Works, through its subsidiary Texwipe has announced the launch of their REVOLVE line of cleanroom consumables which have been manufactured using upcycled polyester extracted from plastic bottles. The product portfolio includes dry and pre-wetted as well as sterile and non sterile range of cleanroom wipers.

This product will be delivered within 2 business days.