I. Technology upgrade and innovation direction
1. Popularization of intelligent clean system
Internet of Things (IoT) technology is widely used. Sensors are used to monitor clean room temperature, humidity, pressure difference, particle concentration and other parameters in real time. AI algorithms predict equipment failures and automatically adjust operating parameters.
Case: A semiconductor factory uses digital twin technology to link physical clean rooms with virtual models, reducing energy consumption by 18%.
2. Demand for energy-saving technology surges
Enterprise ESG goals promote efficient energy-saving solutions, such as variable frequency fans and heat recovery air conditioning units (HRV), combined with photovoltaic power generation to reduce overall energy consumption.
Dynamics: EU new regulations require that the carbon emission intensity of newly built clean rooms decrease by 30% after 2025, forcing technology iteration.
3. New materials and modular construction
New materials such as antibacterial coated color steel plates and nano self-cleaning FFU filters improve the durability of clean rooms. Prefabricated clean rooms (such as container laboratories) shorten the construction period by 50% to meet the needs of rapid expansion.
II. Changes in policies and industry standards
1. Global GMP/ISO standards are becoming stricter
China's new version of GMP (revised in 2023) clarifies the dynamic monitoring requirements for Class A/B clean areas. The EU GMP Appendix 1 adds a "continuous monitoring" clause to promote companies to upgrade online particle monitoring systems.
Industry impact: Demand for renovation of old workshops is growing, and the domestic pharmaceutical industry purification engineering market will increase by 21% year-on-year in 2023.
2. Upgrade of biosafety and epidemic prevention-related regulations
The construction of high-level biological laboratories (BSL-3/4) is accelerating, and CDCs and vaccine companies are strengthening negative pressure isolation and airtightness design.
Policy drive: WHO's "Biological Risk Management Framework" promotes the standardization of double-door interlocking and waste gas inactivation systems in biopharmaceutical workshops.
III. Market demand and competitive landscape
1. Emerging industry demand explosion
Power batteries & semiconductors: The dew point of lithium battery workshops is controlled below -40°C, and the purification of wafer fab AMC (airborne molecular contaminants) has become a new track.
Cell therapy and gene drugs: Orders for C+A grade (local grade 100) isolator systems increased by 35% year-on-year.
2. Regional capacity transfer dividends
Expansion of pharmaceutical OEM capacity in Southeast Asia/India (such as the API Park in India) drives local demand for localized purification engineering services.
Opportunities for Chinese companies: Exporting an integrated solution of "equipment + design + certification" to seize the $3 billion incremental market in Southeast Asia.
3. Acceleration of domestic substitution
The localization rate of core equipment such as high-end filters and fans will increase from 45% in 2020 to 68% in 2023, breaking the monopoly of overseas brands.
IV. Risks and challenges
1. The proportion of cost-sensitive customers has increased
Small and medium-sized food/medical device companies tend to choose the "basic purification + phased upgrade" model, forcing engineering companies to optimize their cost structure.
2. Cross-border competitors enter the game
Traditional electromechanical installation companies enter purification engineering by acquiring design institutes, and low-price strategies impact the mid- and low-end markets.
3. Talent and technology barriers
Interdisciplinary compound talents (understanding process + HVAC + automation) are scarce, and enterprises need to establish an internal training system or jointly train with universities.
V. Strategic recommendations
Focus on high value-added fields: Deeply cultivate biopharmaceutical and semiconductor head customers, and provide "process optimization + purification" customized services.
Layout green certification: Obtain LEED and WELL building standard certification capabilities to match the supply chain requirements of multinational companies.
Strengthen data services: Develop a clean room energy efficiency management SaaS platform and transform from an engineering company to an operation and maintenance service provider.