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Expansion Forecast of the Biological and Chemical Indicators Market: From USD 0.9 Billion in 2023 to USD 2.1 Billion by 2033, with a CAGR of 8.4% from 2024 to 2033

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Expansion Forecast of the Biological and Chemical Indicators Market: From USD 0.9 Billion in 2023 to USD 2.1 Billion by 2033, with a CAGR of 8.4% from 2024 to 2033

March 11
15:55 2024
Expansion Forecast of the Biological and Chemical Indicators Market: From USD 0.9 Billion in 2023 to USD 2.1 Billion by 2033, with a CAGR of 8.4% from 2024 to 2033
Biological and Chemical Indicators Market
Biological and Chemical Indicators Market Analysis and Forecast to 2033 | Global Insight Services

Market Definition: 

Biological and chemical indicators are crucial tools in various fields, serving to monitor and validate sterilization processes, particularly in healthcare settings.

Biological indicators involve the use of living organisms, such as spores or enzymes, to assess the efficacy of sterilization methods. These organisms are chosen for their resistance to specific sterilization conditions. Following exposure to the sterilization process, the survival or inactivation of these biological indicators indicates the success or failure of the procedure.

Chemical indicators, on the other hand, rely on chemical reactions to confirm exposure to sterilization conditions. They typically involve the use of indicator strips, labels, or inks that change color or exhibit a visible response when exposed to specific sterilizing agents, indicating that the desired conditions have been met. Chemical indicators provide a quick visual confirmation of the sterilization process without relying on the survival or inactivation of living organisms.

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Market Outlook:

Rising need for sterilization of medical devices and equipment in healthcare settings and the increasing adoption of automation in sterilization procedures

In healthcare settings, the demand for sterilization of medical devices and equipment has surged significantly. This is primarily due to the growing importance of preventing infections and ensuring patient safety. Healthcare facilities are increasingly aware of the important role of sterilization in maintaining hygienic environments and reducing the risk of cross-contamination. Additionally, manufacturers are increasing their focus on advanced product launches, which will enhance demand as well as market growth. For instance, in July 2020, 3M launched the new 3M Attest Mini Auto-reader 490M enables dentists to quickly test and monitor sterilizers in-house, providing results in 24 minutes.

Moreover, the adoption of automation in sterilization procedures has become a key trend in recent years. Automation not only enhances efficiency but also ensures consistency and accuracy in the sterilization process. It minimizes the likelihood of human error and helps healthcare providers meet stringent regulatory requirements. For instance, cold plasma sterilization is a cutting-edge technology poised to revolutionize sterilization processes in healthcare settings. By utilizing ionized gas, it effectively eradicates microorganisms, offering rapid sterilization cycles ideal for sensitive medical instruments and emergencies. This innovative approach represents the future of sterilization in the medical industry, promising enhanced efficiency and safety in healthcare facilities. Cold plasma sterilization, alongside other advanced sterilization technologies, contributes significantly to the growth of the biological and chemical indicator market by driving demand for reliable monitoring solutions. As new sterilization methods emerge, there is an increased need for indicators to verify their effectiveness in eliminating microorganisms.


Increasing prevalence of Hospital Acquired Infections (HAIs)

The increasing prevalence of Hospital Acquired Infections (HAIs) will drive significant growth in the biological and chemical indicator market. For instance, according to the European Center for Disease Prevention and Control, the frequency of HAI in Africa ranges between 2.5% and 14.8%, which is more than double the prevalence in Europe on average. Also, according to the NCBI study, the rate of HAIs is increasing by 0.06 percent annually. A February 2023 study from the National Center for Biotechnology Information (NCBI) disclosed that the collective incidence of Healthcare-Associated Infections (HAIs) in Southeast Asia stood at 21.6% (95% CI: 15.5 – 29.1%), demonstrating considerable heterogeneity with an I2 statistic of 100%. Indonesia exhibited the highest prevalence, reaching 30.4%, while Singapore reported the lowest prevalence rate at 8.4%.

As healthcare facilities make efforts to improve patient safety and reduce the risk of HAIs, there’s a growing focus on implementing sterilization and disinfection protocols. Biological and chemical indicators play vital roles in this condition, enabling healthcare providers to validate the effectiveness of sterilization processes and ensure compliance with regulatory standards.


Market Restraints and Challenges

Limited Adoption of Sterilization Monitoring in Developing Nations Could Impede Market Growth

The low penetration of sterilization monitoring in developing countries poses a significant hindrance to the expansion of the market for sterilization indicator products. In contrast to developed nations, where these products are widely utilized to monitor the sterilization process in various facilities, the procedure remains inconsistent in low- and middle-income countries (LMICs). The absence of strict policies for sterilization monitoring and routine evaluations of sterilizers in developing nations contributes to a lack of adherence to regulatory guidelines and sterilization norms.

Additionally, healthcare facilities in LMICs, including hospitals, clinics, nursing homes, laboratories, and local healthcare manufacturers, often opt to forego the use of sterilization indicators as a cost-cutting measure. This cost-cutting mentality in healthcare settings can have severe consequences, leading to untreated post-operative complications such as Surgical Site Infection (SSI). Ignorance of standardization procedures further exacerbates the problem, negatively impacting the demand for sterilization indicator tapes. The consequences of inadequate sterilization practices were highlighted in a reported incident in Hyderabad, where a C-section death in a hospital was potentially linked to infection resulting from insufficient sterilization of dressing materials like gauze pads used post-surgery. These factors collectively contribute to a limited demand for sterilization indicator tapes in LMICs and restrain the growth of the biological and chemical indicator market.

Safety concerns related to ethylene oxide sterilization

The ethylene oxide (EO) sterilization process has long been recognized as an effective method for sterilizing medical devices, pharmaceuticals, and other healthcare products. However, safety concerns surrounding EO sterilization have emerged as a significant challenge for the growth of both the biological and chemical indicator markets. Ethylene oxide is a highly reactive and flammable gas classified as a carcinogen by the International Agency for Research on Cancer (IARC). Prolonged exposure to EO can pose serious health risks to workers involved in the sterilization process, including respiratory issues, skin irritation, and potential long-term health effects such as cancer. As a result, regulatory agencies have imposed stringent guidelines and regulations on EO sterilization facilities, requiring extensive safety measures and monitoring to mitigate risks to human health and the environment.

Furthermore, the use of EO as a sterilizing agent raises environmental concerns due to its potential for air and water pollution. Ethylene oxide emissions from sterilization facilities can contribute to air quality degradation and pose risks to nearby communities. Additionally, the disposal of EO residues and by-products presents challenges in waste management and environmental sustainability.


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Research Objectives:

•            Estimates and forecast the overall market size for the total market, across product, service type, type, end-user, and region

•            Detailed information and key takeaways on qualitative and quantitative trends, dynamics, business framework, competitive landscape, and company profiling

•            Identify factors influencing market growth and challenges, opportunities, drivers and restraints

•            Identify factors that could limit company participation in identified international markets to help properly calibrate market share expectations and growth rates

•            Trace and evaluate key development strategies like acquisitions, product launches, mergers, collaborations, business expansions, agreements, partnerships, and R&D activities

•            Thoroughly analyze smaller market segments strategically, focusing on their potential, individual patterns of growth, and impact on the overall market

•            To thoroughly outline the competitive landscape within the market, including an assessment of business and corporate strategies, aimed at monitoring and dissecting competitive advancements.

•            Identify the primary market participants, based on their business objectives, regional footprint, product offerings, and strategic initiatives


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Biological and Chemical Indicators Market Segmental Overview

The report analyses the biological and chemical indicator market based on biological indicator type, chemical indicator type, sterilization method, application, and region.


Major Players in the Biological and Chemical Indicators Market

Some of the key players in the Biological and Chemical Indicators Market are, Steris, 3M, Mesa Labs, Getinge AB, Ecolab, Propper Manufacturing Co, Excelsior Scientific, Terragene, North American Science Associates, Llc (Namsa), Tuttnauer (Fortissimo Capital), ASP Global Manufacturing Gmbh (Fortive Corporation), Matachana Group, Liofilchem, Andersen, Steelco (Miele), Nelson Laboratories (Sotera Health), CISA Group (Faper Group), Shinva Medical Instrument, and Hubei CFULL Medical Technology.


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Research Scope:


•            Scope – Highlights, Trends, Insights. Attractiveness, Forecast

•            Market Sizing – Product Type, End User, Offering Type, Technology, Region, Country, Others

•            Market Dynamics – Market Segmentation, Demand and Supply, Bargaining Power of Buyers and Sellers, Drivers, Restraints, Opportunities, Threat Analysis, Impact Analysis, Porters 5 Forces, Ansoff Analysis, Supply Chain

•            Business Framework – Case Studies, Regulatory Landscape, Pricing, Policies and Regulations, New Product Launches. M&As, Recent Developments

•            Competitive Landscape – Market Share Analysis, Market Leaders, Emerging Players, Vendor Benchmarking, Developmental Strategy Benchmarking, PESTLE Analysis, Value Chain Analysis

•            Company Profiles – Overview, Business Segments, Business Performance, Product Offering, Key Developmental Strategies, SWOT Analysis

•            Market Size in 2021 – $ 912.0 Mn

•            Market Size in 2031 – $ 2,111.3 Mn

•            CAGR % – 8.4%

•            Historic Period – 2015-2022

•            Forecast Period – 2024-2033

•            Base Year – 2023


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