Bio Decontamination Market Report Scope & Overview:

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The Bio Decontamination Market was valued at USD 236.09 million in 2023 and is expected to reach USD 501.37 million by 2032, growing at a CAGR of 8.76% from 2024-2032.

The Bio Decontamination Market is growing due to the increasing concerns of contamination in healthcare, pharmaceuticals, and biotechnology. The increasing incidence of hospital-acquired infections (HAIs) and the importance of sterile environments in pharmaceutical production have fueled the demand for effective decontamination solutions. Faced with increasing regulatory standards globally for sterilization and other contamination control, many sectors are seeking new decontamination technologies to ensure compliance.

The growing need for rigorous cleaning and disinfection protocols to lower infection rates in healthcare, particularly around hospitals and surgical settings, is what drives this. Moreover, other industries within the pharmaceutical industry are also subject to strict regulations about aseptic processing, which is expected to fuel market growth. According to WHO, for every 100 patients, 7 will acquire at least one healthcare-associated infection (HAI) in high-income countries, while 15 patients in low- and middle-income countries will be affected. On average, one in every ten patients with an HAI will die as a result of the infection.

Bio-decontamination technologies have shown innovation in recent times. TOMI Environmental Solutions, for instance, partnered with Cellares to combine its SteraMist Ionized Hydrogen Peroxide (iHP) technology and its SteraMist delivery system with Cellares' Cell Shuttle to improve the cell therapy manufacturing process. This collaboration highlights the increasing utilization of advanced decontamination systems in sensitive environments such as cell therapy manufacturing. February 2024, CURIS Systems and AST announced a partnership between CURIS’s vapor decontamination technology and AST’s aseptic fill-finish processing expertise in a significant step toward bio-decontamination solutions in the pharmaceutical manufacturing industry.

These novel techniques have revolutionized the market with an emphasis on increased efficiency, sustainability,  regulatory compliance, and environmental sustainability. Industries seek scalable, user-friendly solutions, which is also contributing to the growing momentum toward automated and portable bio-decontamination systems. With rising global contamination threats, bio-decontamination continues to play a significant role in protecting public health and the functionality of healthcare & pharmaceutical systems.

MARKET DYNAMICS

DRIVERS

• Strict regulatory standards and compliance propel the Bio Decontamination market growth.

The pharmaceutical and biotechnology sectors are under growing pressure to adhere to strict contamination control regulations dictated by authorities like the U.S. FDA and EMA. This is where the advanced bio-decontamination systems step in to help industries comply with these stringent standards. The adoption of cutting-edge sterilization techniques is no longer optional, as regulatory bodies are constantly revising their recommendations. For example, CURIS System entered into a strategic partnership with AST in 2024 to combine its proprietary vapor decontamination technology with aseptic fill-finish processing, taking a proactive stance on meeting regulatory requirements for sterile environments. With regulations changing, pharmaceutical manufacturing firms are spending on such technologies, which meet and exceed current safety standards, thus fueling market growth in bio-decontamination.

• The demand for bio-decontamination solutions is increasing due to the rising need for sterile environments in the pharmaceutical and biotechnology industries.

With the rise of bio-decontamination solutions, the growth in demand for these solutions is at an all-time high owing to the growing demand for sterile environments in the pharmaceutical and biotechnology industries. Contamination control is essential for the manufacture of biologics, cell therapies, and other sensitive products. Stringent regulatory specifications for aseptic techniques and sterilization are driving pharmaceutical companies to embrace newer decontamination solutions. There is an example of decontamination solutions entering a highly controlled environment such as cell therapy manufacturing with the introduction of SteraMist iHP technology alongside Cellares’ Cell Shuttle through TOMI Environmental Solutions. With the growth of the biotechnology and pharmaceutical sectors, there is an increasing demand for effective, reliable, and efficient bio-decontamination systems to ensure the integrity of the manufacturing process which in turn drives the market growth.

RESTRAINT

• One of the key restraints in the Bio Decontamination Market is the high initial investment and maintenance costs associated with advanced decontamination systems.

High capital and maintenance costs of advanced decontamination systems are factors that are anticipated to restrain the growth of the Bio Decontamination Market. Innovative technologies like hydrogen peroxide vapor and UV light systems are usefully effective but require various levels of capital spent for installation, equipment, and infrastructure overhaul, particularly in highly regulated environments like pharmaceutical manufacturing and hospitals. Furthermore, these systems necessitate regular maintenance, calibration, and monitoring for their optimal performance, contributing to operational costs. The high capital expenses also act as a barrier for small and medium enterprises or healthcare facilities with budget constraints; thus, slowing down the market growth to a certain extent in some countries and sectors.

MARKET SEGMENTATION

By Component

The equipment segment dominated the market with a 53.71% market share in 2023. The reason for this dominance lies in the advancement of the latest, versatile equipment that delivers efficient solutions to numerous applications. Although much of the focus is on increased infection control, sterile production, and biosafety, there is still a significant need for high-tech equipment to fill the gap in meeting demand for effective decontamination solutions. Consequently, the equipment segment is likely to remain the keystone segment of the market.

The consumables segment is estimated to be the fastest-growing segment during the forecast period. The growth can be attributed to the increasing use of advanced decontamination agents and significant demand for reliable consumables to ensure the efficiency of bio-decontamination procedures. Disinfectants, sterilants, and cleaning solutions are consumables necessary for correctly applying bio-decontamination regulations in diverse industries. In addition, the development of specialized consumables such as biological indicators and chemical integrators to validate and monitor decontamination processes is also contributing to the increased demand. As there is increasing demand for effective and reliable bio-decontamination solutions, consumables are expected to be the component to grow faster than others in the bio-decontamination market.

By Agent

The hydrogen peroxide segment dominated the Bio Decontamination Market because of its strong effectiveness, adaptability, and extensive variety of uses in sterilization methods. Hydrogen peroxide is commonly utilized in bio-decontamination systems due to its strong antimicrobial properties that can eliminate bacteria, viruses, fungi, and spores. It is especially useful for sanitizing delicate settings like pharmaceutical production sites, hospitals, and cleanrooms. The benefits of hydrogen peroxide include its capacity to decompose into water and oxygen, resulting in no harmful residues, which ensures safety for users and the environment. Moreover, it is quite economical, simple to use, and compatible with multiple decontamination techniques, such as vaporized hydrogen peroxide (VHP) systems, which further enhances its market dominance.

The hydrogen peroxide segment is exhibit to witness the fastest growth throughout the forecast period because of its strong effectiveness, adaptability, and extensive variety of uses in sterilization methods. Hydrogen peroxide is commonly utilized in bio-decontamination systems due to its strong antimicrobial properties that can eliminate bacteria, viruses, fungi, and spores. It is especially useful for sanitizing delicate settings like pharmaceutical production sites, hospitals, and cleanrooms. The benefits of hydrogen peroxide include its capacity to decompose into water and oxygen, resulting in no harmful residues, which ensures safety for users and the environment. Moreover, it is quite economical, simple to use, and compatible with multiple decontamination techniques, such as vaporized hydrogen peroxide (VHP) systems, which further enhances its market dominance.

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KEY REGIONAL ANALYSIS

In 2023, North America dominated the market and accounted for 46% of the market share of bio-decontamination in 2023. The increasing demand for bio-decontamination technologies has been driven by strong growth in the pharmaceutical and biotechnology sectors, particularly in the U.S. and Canada. A significant development transpired in April 2022 when leading bio-decontamination market player CURIS System gained the approval of Health Canada to initiate and sell its products in the Canadian market. Having earned this approval so soon after the Commercialization of the CURIS System signifies an important step in bringing CURIS System to a diverse range of customers in various sensitive and critical environments throughout Canada.

Europe is expected to witness significant growth in the bio-decontamination market owing to increasing concerns regarding environmental pollution. Motivated by the EU winners, the region is also turning its vision towards sustainability and green alternatives, including its Biocidal Products Regulation (BPR) which may govern the most demanding of levels to demonstrate for disinfectants and sterilants. This regulatory framework motivates innovative bio-decontamination technologies that are more environmentally friendly. One such example includes Ecolab’s Bioquell HPV-AQ, which is a 35% hydrogen peroxide disinfectant that was approved for EU authorization under the Biocidal Products Regulation (BPR) by the Biocidal Products Committee (BPC) at the European Chemicals Agency (ECHA) in July 2022. The approval has increased the use of hydrogen peroxide vapor systems, as well as ozone generators, mostly in Europe, where they are becoming popular because they are more suitable for materials and leave fewer chemical residues behind.

Some of the major key players in the Bio Decontamination Market

• TOMI Environmental Solutions, Inc. (SteraMist Surface Unit, SteraMist Environment System)

• Bioquell (Ecolab Inc.) (Bioquell BQ-50, Bioquell Pod)

• STERIS Corporation (VHP 100i Hydrogen Peroxide Sterilizer, Amsco Century Medium Steam Sterilizer)

• CURIS System (CURIS 3 Hydrogen Peroxide Fogger, CURIS Decontamination Pods)

• Ecolab Inc.

• ClorDiSys Solutions, Inc.

• EnviroSystems Inc.

• Zoono Group Limited

• JCE Biotechnology

• Fedegari Group

• PMT (Production and Material Technology)

• Howorth Air Technology 

• Noxilizer, Inc.

• Getinge AB

• AM Instruments

• Devea

• Sanosil AG

• Oxy’Pharm

• CleanSpace Technology

• Sotera Health

Suppliers (These suppliers play a critical role in providing the raw materials, components, and technologies used by bio-decontamination solution providers.)

• Honeywell International

• Thermo Fisher Scientific

• DPT Laboratories

• IWT (Industrial Water Treatment)

• Siemens AG

• BASF SE

• GE Healthcare

• Linde PLC

• Miele Professional

• Pall Corporation

RECENT DEVELOPMENT

• February 2024: CURIS System and AST announced a strategic partnership to transform bio-decontamination processes in the pharmaceutical manufacturing sector. This collaboration combines CURIS’s advanced vapor decontamination technology with AST’s expertise in aseptic fill-finish processing, specifically targeting the bio-decontamination of aseptic fill-finish isolators.

• August 2023: TOMI Environmental Solutions, Inc. collaborated with Cellares to integrate its SteraMist ionized Hydrogen Peroxide (iHP) technology into the Cell Shuttle, an innovative cell therapy manufacturing system designed to enhance decontamination efficiency and safety.