Cleanroom Technologies Market Surges Toward US$10.58 Billion by 2031, Driven by Semiconductor Expansion and Biopharma Sterile Manufacturing

AUSTIN, Texas and TOKYO, Dec. 4, 2025 /PRNewswire/ -- According to DataM Intelligence, the Global Cleanroom Technologies Market Size reached an estimated US$6.53 billion in 2024 and is projected to climb steadily to US$10.58 billion by 2031, registering a CAGR of 7.14% during the forecast period. The rise of advanced sterile production systems, tighter global GMP regulations, and accelerated investments in wafer-level chip manufacturing have positioned clean room technologies as a mission-critical infrastructure segment for the decade ahead.

Rising Semiconductor and Biopharma Output Anchors 2024 Market Momentum

Clean room facilities have become indispensable as global industries move toward precision manufacturing, nanotechnology, biologics, and injectable therapies. In 2024, demand accelerated sharply as the U.S., Japan, South Korea, Taiwan, and the EU expanded chip fabrication programs, while pharmaceutical companies scaled up sterile injectables, mRNA production, and gene therapy fill-finish operations.

According to DataM Intelligence, consumables and equipment segments both expanded solidly, with growth driven by:

• Increased investment in ISO-certified Class 1 to Class 10000 cleanrooms
• Surging demand for high-efficiency filtration, HVAC precision control, and laminar airflow systems
• Rapid adoption of disinfectants, wipes, gloves, and cleanroom apparel across life sciences and semiconductor clusters
• Regulatory pressure from FDA, PMDA (Japan), and EMA for contamination-free manufacturing environments

In 2024 alone, global semiconductor spending on cleanroom infrastructure increased by more than 15% compared to 2023, supported by new fab announcements from U.S., Japan, and EU semiconductor partnerships.

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U.S. Market Expands to US$1.95 Billion in 2024, Driven by CHIPS Act and Device Manufacturing Rules

The United States remains the epicenter of clean-room adoption, supported by semiconductor policy reforms, new biopharma capacity, and high-performance medical device manufacturing.

• North America accounted for 36.49% of the global market in 2023
• Using this proportional trend, the U.S. market alone is estimated at US$1.95 billion in 2024

The last three months witnessed multiple high-value developments, including:

U.S. Market Updates

• US$6.1 billion in new semiconductor cleanroom construction commitments across Arizona, Texas, and New York fabs.
• 18% quarterly increase in demand for ISO 5–ISO 7 medical device cleanrooms due to new sterility compliance updates from the FDA.
• Over US$420 million invested in HVAC and HEPA-ULPA retrofitting projects across biotech clusters in Boston, San Diego, and North Carolina.
• Passage of new CHIPS-funding tranches enabling US$1.4 billion in cleanroom-specific grants for precision wafer manufacturing.

These expansions have significantly tightened demand for Class 100–Class 10000 cleanrooms, resulting in strengthened adoption of standard/drywall and modular variants across semiconductor and life sciences facilities.

Japan Market Reaches US$620 Million in 2024 as Pharma 5.0 and Chip Collaborations Accelerate

Japan remains one of the world's most mature cleanroom markets, driven by stringent pharmaceutical regulations and the rapid restructuring of the domestic semiconductor supply chain. Based on Asia-Pacific's 32.55% share in 2023 and Japan's historical contribution, Japan's market reached an estimated US$620 million in 2024, supported by pharma digitalization and microelectronics expansion.

Japan Market Updates

• US$1.2 billion allocated by the Japanese government for cleanroom-enabled chip R&D under the Japan-U.S. semiconductor collaboration.
• 14% quarter-over-quarter increase in sterile biologics and vaccine fill-finish cleanrooms installed under PMDA upgrades.
• US$160 million in private-sector investment in modular cleanrooms for regenerative medicine and cell therapy production.
• 10% increase in demand for ISO 4 and ISO 5 facilities in sensor, photonics, and micro-LED manufacturing.

Japan's "Pharma 5.0" transformation-centered on digital validation, automated contamination control, and robotics-has further strengthened its leadership in sterile production environments.

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Browse in-depth TOC on 'Cleanroom Technologies Market'

70 – Tables

66 – Figures

316 – Pages

Market Segmentation Analysis:

1. By Type – Equipment and Consumables

In 2024, the type-wise structure reinforces a rising preference for high-margin consumables.

• Equipment market (2024): US$2.83 billion
  
  Driven by HVAC systems, laminar airflow units, HEPA/ULPA filters, desiccator cabinets, and air showers.
• Consumables market (2024): US$3.74 billion
  
  Wipes, gloves, apparel, disinfectants, and vacuum systems saw record adoption in pharmaceuticals and semiconductors.

Consumables continued to expand faster due to recurring demand and stricter regulatory audits, accounting for 57% of the 2024 global market.

2. By Construction Type – Standard/Drywall Leads in 2024

• Standard/Drywall cleanrooms remained the dominant model, capturing approx. 45% of the 2024 market, supported by major installations in drug manufacturing and chip fabs.
• Hardwall cleanrooms saw faster growth, reaching around 35% of the market, driven by semiconductor precision requirements and aerospace electronics.
• Softwall cleanrooms maintained niche adoption at approximately 20%, particularly in small-scale labs and portable R&D setups.

3. By Cleanliness Standards – ISO 7 & ISO 8 Continue to Lead

Global clean room technologies market in ISO 3 Cleanrooms was US$236.14 million in 2023 and is expected to reach US$535.67 million by 2031, growing with a CAGR of 10.9% between 2024 and 2031.

According to US Federal Standard 209E, ISO 7 cleanrooms are also known as Class 1 cleanrooms. Within this classification system, ISO 3 Cleanrooms are exceptionally clean and provide controlled settings that are appropriate for a variety of industries, including biotechnology, pharmaceuticals, electronics manufacturing, and healthcare. The concentration of particles bigger than 0.5 micrometers in an ISO 3 Cleanroom is limited to 10,200 particles per cubic meter of air, according ISO guidelines. It takes sophisticated clean room architecture, effective filtering systems, and strict contamination control procedures to achieve and maintain such low particle counts.

The ISO 7–ISO 8 category captured the largest share in 2024 due to its extensive use in electronics, industrial manufacturing, and general pharmaceutical production.

2024 Approximate Market Distribution:

• ISO 7 Cleanrooms: 23%
• ISO 8 Cleanrooms: 29%
• ISO 5 Cleanrooms: 10% (biologics, sterile injectables, and compounding labs)
• ISO 1–ISO 3: Small but fastest-growing due to chip manufacturing nodes below 5nm.

4. By Certification – Class 100000 and Class 10000 Lead

Class 1 cleanrooms, or ISO Class 1 cleanrooms, are the cleanest available in the cleanroom technology market worldwide. The strictest regulations are followed in these cleanrooms, guaranteeing a highly regulated setting with minimal particle counts. The need for Class 1 cleanrooms has grown due to the demands of sectors including semiconductor manufacturing, aircraft, and pharmaceuticals that depend heavily on contamination control and precise production.

2024 certification distribution closely mirrors ISO classes:

• Class 100000: 37%
• Class 10000: 23%
• Class 1000 and Class 100: 9–18% combined
• Class 1 and Class 10: Small but rising as semiconductor precision scales up.

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Top 5 Companies by Annual Revenue

Several prominent companies are competing vigorously to maintain and expand their market share. Companies are expanding their geographical presence to tap into emerging markets.

The five major companies in the global clean room technologies market hold 53.80% of the total market in 2023, whereas the three major players account for nearly 37.43% of the total market. In 2023, Dupont De Nemours, Inc. held the majority of the market share at 15.11% of the global clean room technologies market, followed by Kimberly-Clark Corporation with 12.22%, Exyte GmbH with 9.15% and Azbil Corporation with 7.22% of the total market, respectively.

These companies are at the leading edge of the development, invention, and application of Clean Room Technologies, significantly influencing and propelling the industry.

FY 2024 financial disclosures:

1. DuPont de Nemours, Inc. – US$12.39 billion
2. Kimberly-Clark Corporation – US$20.05 billion
3. Illinois Tool Works (ITW) – US$15.9 billion
4. Azbil Corporation – US$1.97 billion

These companies continue to dominate the cleanroom ecosystem through high-precision filtration, airflow, contamination control, modular construction, and consumables.

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Industry Outlook for 2025–2031: Clean Manufacturing Becomes a Strategic Global Priority

According to DataM Intelligence, cleanroom technologies will evolve from a compliance-driven expenditure to a strategic enabler of innovation. Key drivers include:

• Next-generation chip fabrication (2nm and below)
• Biologics, immunotherapy, and cell-based manufacturing
• Robotics-enabled aseptic processing
• Clean-automation systems and AI-based contamination monitoring
• Modular and rapid-deploy cleanroom solutions for emerging pharma hubs

Related Report:

1. Cleanroom Consumables Market Size to Grow from US$10.8 B in 2024 to US$18.66 B by 2033 - Cleanroom Essentials Gain Traction Across Pharma, Battery & Semiconductor Industries.
2. AI in Operating Room Market Size to Grow from US$573.5 M in 2024 to Over US$2.06 B by 2033 - Powering the Future of Smart Surgery.
3. Operating Room Equipment Market Size to Grow to US$42.7 B by 2031 - Fueled by Rising Surgeries & Tech-Driven OR Upgrades.
4. Operating Room Integration Market Size to Grow from US$2.1 B in 2023 to Over US$4.2 B by 2031 - Double-Digit CAGR Powers Shift to Smart, Hybrid ORs.

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SOURCE DataM Intelligence 4 Market Research LLP