Biological and Chemical Indicators Market Analysis and Forecast to 2033: By Biological Indicators Type (Self-Contained Biological Indicators (SCBI){Rapid Fluorescence System, Others}, Spore Strips, Spore Suspension, Others), Chemical Indicators Type (Type

Biological and Chemical Indicators Market Analysis and Forecast to 2033: By Biological Indicators Type (Self-Contained Biological Indicators (SCBI){Rapid Fluorescence System, Others}, Spore Strips, Spore Suspension, Others), Chemical Indicators Type (Type 1, Type 2, Type 3, Type 4, Type 5, Type 6), Sterilization Method (Steam, Hydrogen Peroxide, Others), Application (Biopharma Industry, Hospitals & Clinics, Ambulatory Surgical Centers, Diagnostic Labs, Research Labs), and Region

The Biological and Chemical Indicators market size was USD 0.9 billion in 2023 and is anticipated to reach USD 2.1 billion in 2033, growing at a rate of 8.4% from 2024 to 2033.

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.

Market Scope and Report Structure

Market Trends and Drivers

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.

COVID-19 Impact

Pre-COVID-19 Pandemic Scenario

Before the COVID-19 pandemic, the Biological and Chemical Indicator Market was experiencing steady growth, driven by increasing awareness about infection control practices, stringent regulations in healthcare settings, and the rising demand for sterilization and disinfection procedures. The market witnessed consistent adoption across pharmaceutical, medical device manufacturing, food and beverage, and other industries where sterilization is critical for ensuring product safety and efficacy. Biological indicators, such as spore strips containing bacterial spores, were widely used in hospitals and medical facilities to monitor the effectiveness of sterilization processes in autoclaves and other medical equipment.

Technological advancements in biological and chemical indicators were also contributing to market expansion, with innovations aimed at enhancing efficiency, accuracy, and ease of use. Overall, the pre-COVID-19 landscape portrayed a promising trajectory for the Biological and Chemical Indicator Market, with sustained demand and favorable industry dynamics.

COVID-19 Pandemic Scenario

The COVID-19 pandemic has exerted a substantial impact on the biological and chemical indicator market, primarily driven by the heightened demand for effective sterilization processes in healthcare settings. With clinics, ambulatory surgical centers (ASC), and hospitals facing increased pressure to implement stringent disinfection and cleaning protocols, there is a surge in the market demand for short-term indicators to authenticate sterilization processes. Biological indicators played a crucial role in verifying the efficacy of sterilization processes for reusable medical devices and personal protective equipment (PPE) in high-demand areas such as COVID-19 testing laboratories and vaccine manufacturing facilities.

The urgency to mitigate the risk of COVID-19 transmission has placed frontline healthcare workers in a pivotal role, emphasizing the need for reliable sterilization measures during surgical procedures. This has translated into a growing requirement for biological and chemical indicators, as these play a crucial role in ensuring the effectiveness of sterilization processes, ultimately contributing to the safety of both healthcare professionals and hospitalized patients.

Post-COVID-19 Pandemic Scenario

Post-COVID-19, the Biological and Chemical Indicator Market is expected to witness recovery and growth as economies stabilize, healthcare systems adapt to new norms, and industries prioritize infection control measures. The pandemic highlighted the critical importance of sterilization and disinfection practices in preventing the spread of infectious diseases, driving renewed focus and investment in related technologies and solutions. Moreover, advancements in biological and chemical indicators, coupled with increased awareness about infection control, are anticipated to fuel market expansion. Biological indicators continued to be instrumental in validating sterilization processes during drug manufacturing, packaging, and distribution in the pharmaceutical industry.

Regulatory initiatives aimed at increasing sterilization standards and guidelines may further boost market growth post-COVID-19. While challenges such as supply chain disruptions and economic uncertainties may persist in the short term, the long-term outlook for the market remains optimistic, with opportunities for innovation in response to growing healthcare and industry needs.

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.

Biological and Chemical Indicators Market By Biological Indicators Type

The self-contained biological indicators (SCBI) segment value was USD 395.3 million in 2023. Based on the type of biological indicator, the market is categorized into self-contained biological indicators (SCBI), spore strips, spore suspensions, and others. Further, the self-contained biological indicators (SCBI) segment is classified into rapid fluorescence systems and others. SCBIs offer a robust growth factor due to their contained environment, which includes a nutrient-rich medium and a suitable temperature range for microbial proliferation. Within this enclosed system, spores encounter optimal conditions for germination and subsequent growth, allowing for an accurate assessment of sterilization processes. The controlled environment ensures consistent and reliable results, making SCBIs a preferred choice for validation and monitoring in various sterilization procedures.

Spore strips facilitate microbial growth by providing a substrate coated with spores, typically Bacillus or Geobacillus species. The growth factor lies in their simplicity and versatility, as spore strips can be easily deployed in diverse settings for monitoring sterilization efficacy. Their small size and ease of use enable convenient placement in sterilization chambers or equipment, where spores can proliferate under favorable conditions, reflecting the effectiveness of sterilization protocols through visible growth.

Biological and Chemical Indicators Market, by Chemical Indicators Type

The type 1 chemical indicator (process) segment was worth USD 83.3 Million in 2023. There are multiple types of chemical indicators, ranging from Type 1 to Type 6. The larger the number, the more sterilization parameters are monitored. Based on the type of chemical indicators, the market is segmented into type 1 chemical indicator, type 2 chemical indicator, type 4 chemical indicator type 5 chemical indicator, and type 6 chemical indicator. ISO 11140-1:2014 organizes chemical indicators intended for autoclaves and sterilizers into different types:

Type 1: Process Indicators

Type 2: Indicators for Specific Uses

Type 3 Chemical Indicator (Single Variable)

Type 4: Multi-Variable Indicators

Type 5: Integrating Indicators (Integrators)

Type 6: Emulating Indicators (Cycle Verification Indicators)

The demand for chemical indicators in the healthcare industry continues to rise as stringent sterilization standards and infection prevention protocols drive the need for reliable monitoring solutions. As healthcare facilities prioritize patient safety and regulatory compliance, there's a growing requirement for advanced chemical indicators that offer comprehensive monitoring capabilities across various sterilization modalities. The market seeks indicators that not only confirm exposure to the sterilization process but also provide assurance of critical parameters such as time, temperature, and sterilant concentration.

Furthermore, the preference for Type 5 and Type 6 indicators reflects a trend towards integrating and cycle-specific monitoring solutions, enhancing confidence in sterilization efficacy. With a focus on performance, brand reputation, validated applications, and ease of use, healthcare facilities are keen to source chemical indicators from trusted suppliers like STERIS, ensuring seamless integration into their sterilization workflows while meeting regulatory standards outlined in ISO 14161.

Biological and Chemical Indicators Market, by Sterilization Method

The Steam sterilization segment size was USD 510.0 Million in 2023. Steam sterilization, also known as autoclaving, has been a cornerstone in the field of sterilization for decades. Its growth factor lies in its reliability, effectiveness, and wide applicability across various industries, including healthcare, laboratories, and food processing. The method employs high-pressure steam to kill microorganisms, spores, and pathogens, making it one of the most efficient sterilization techniques available. With advancements in technology, the integration of steam sterilization processes into automated systems has streamlined workflows, reduced human error, and enhanced overall efficiency. Moreover, the eco-friendliness of steam sterilization, as it utilizes water as its primary agent without leaving harmful residues, aligns well with the growing emphasis on sustainable practices in modern industries.

Hydrogen peroxide sterilization represents a newer, innovative approach to sterilization that has gained traction in recent years. Its growth factor stems from its ability to provide an alternative to traditional methods like steam sterilization, especially for heat-sensitive materials and equipment. Hydrogen peroxide vapor is highly effective in deactivating a wide range of microorganisms, including bacteria, viruses, and fungi. The method offers advantages such as shorter cycle times, lower temperatures, and a reduced potential for material degradation compared to heat-based methods. Additionally, the compatibility of hydrogen peroxide sterilization with a variety of materials, including plastics and electronics, makes it particularly suitable for industries where maintaining material integrity is crucial. As industries continue to seek efficient and versatile sterilization solutions, hydrogen peroxide sterilization is poised for further growth and adoption across diverse sectors.

Biological and Chemical Indicators Market By Application

The biopharma industry segment size was USD 477.4 Million in 2023. The biopharma industry is booming due to increased demand for innovative drugs and therapies, fueled by advancements in biotechnology and personalized medicine. Hospitals and clinics are expanding to meet growing healthcare needs, driven by population growth, aging demographics, and advancements in medical technology.

Ambulatory surgical centers are growing rapidly, thanks to minimally invasive techniques, outpatient preferences, and value-based care models. Diagnostic labs are thriving due to rising disease burdens, increased awareness, and technological advancements. Research labs are experiencing steady growth due to investments in biomedical research, collaborations, and advancements in scientific technologies.

Geographical Analysis of Biological and Chemical Indicators Market

The global biological and chemical indicator market is poised for robust growth, driven by several key factors. Increasing research and development activities, coupled with stringent government regulations, are catalyzing market expansion worldwide. Particularly in regions such as North America and Europe, where the healthcare sector is highly regulated, the demand for advanced sterilization processes is on the rise. Moreover, the North American region dominated the market.

Moreover, the escalating prevalence of chronic diseases like asthma, diabetes, and cancer is fueling the need for medicines and medical devices, further propelling the market growth in these regions. In emerging economies such as India, the sterility indicator market is experiencing significant traction. Rising R&D activities in the pharmaceutical and biotechnology sectors are driving the demand for various sterilization processes, with steam sterilization emerging as a prominent method in the pharmaceutical industry.

For instance, India witnessed a significant surge in biotechnology R&D spending, escalating from $320 million in 2021 to $1 billion in 2022. Furthermore, various activities to mitigate the burden of hospital-acquired infections (HAIs) are gaining momentum, particularly in regions like China, India, and the Middle East. For instance, according to data from NCBI, lower respiratory tract infections (47.2%), urinary tract infections (12.3%), upper respiratory tract infections (11.0%), and surgical site infections (6.2%) were identified as the most prevalent causes of hospital-acquired infections (HAI) among the 52 surveyed Chinese hospitals. The adoption of hospital sterile processing units is becoming more prevalent, leading to a surge in sterilization procedures and subsequently boosting the demand for sterility indicators. Additionally, the introduction of advanced indicators at competitive prices is enhancing their adoption in cost-constrained markets across Asia Pacific the Middle East, and Africa, thus contributing to the overall market growth in these regions.

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.

Recent Developments

In October 2023, Mesa Laboratories, Inc., a global leader in the design and manufacture of life science equipment and key quality control solutions, announced the successful purchase of GKE-GmbH's sterilization indicators business and SAL GmbH, a recognized independent testing lab. Mesa has also signed a formal deal to buy GKE's Chinese sales business, Beijing GKE Science & Technology Co. Ltd. ("GKE China"). The overall purchase price for the three firms is €85 million (€5 million for GKE China), subject to standard purchase price modifications and holdbacks. These three entities are together known as "GKE."  The all-cash transactions were or will be financed using profits from our credit facility and cash on hand.

In July 2023, Steelco launches a new NCG sensor, the NCG sensor monitors the precise value of non-condensable gases (NCGs) in the chamber in real-time throughout each sterilization procedure, allowing operators to perform the most reliable and efficient steam sterilization treatments conceivably.

In February 2023, Cisa Group will participate in Caserta as a partner of the Italian Association of Sterilization Operators (AIOS). Cisa Group has confirmed its support for AIOS, one of the most prominent associations in the Italian healthcare sector. AIOS, which brings together operating room staff, has planned a series of courses for 2023, and Cisa Group affirms its participation in the delivery of these training days for healthcare workers involved in sterilization processes.

In November 2021, Steelco launched a new VS G2 series for centralized sterile reprocessing. The new VS G2 series of steam sterilizers incorporates and develops the most sophisticated Steelco technology to satisfy the demands of hospitals, CSSDs, and medical and outsourcing centers. The VS G2 series has a variety of models to maximize workflow and versatility. Unique cutting-edge technologies such as 4D Sensor and Advance Eco Options set a new level for performance, adaptability, safety, and utility consumption reduction. The VS G2 Series combines great productivity and efficiency with the lowest running costs per load, helping our clients achieve their environmental sustainability goals.

Biological and Chemical Indicators Market Report Coverage

The report offers a comprehensive quantitative as well as qualitative analysis of the current Biological and Chemical Indicators Market outlook and estimations from 2023 to 2033, which helps to recognize the prevalent opportunities.

The report also covers qualitative as well as quantitative analysis of the Biological and Chemical Indicators Market in terms of revenue ($Million).

Major players in the market are profiled in this report, and their key developmental strategies are studied in detail. This will provide an insight into the competitive landscape of the Biological and Chemical Indicators industry.

A thorough analysis of market trends and restraints is provided.

By region as well as country, market analysis is also presented in this report.

The Biological and Chemical Indicators Market Study comprises an analysis of 28 countries. The research also encompasses a segment analysis of every country in terms of value (USD Million) throughout the study period.

Analytical depiction of the Biological and Chemical Indicators Market along with current trends and future estimations to depict imminent investment pockets. The overall Biological and Chemical Indicators industry opportunity is examined by understanding profitable trends to gain a stronger foothold.

Porter’s five forces analysis, SWOT analysis, Pricing Analysis, Case Studies, COVID-19 impact analysis, Russia-Ukraine war impact, and PESTLE analysis of the Biological and Chemical Indicators Market are also analyzed.

The report also involves market strategy factors such as the ANSOFF Matrix, 4Ps Model, Demand-Supply Analysis, Competition Product Analysis, Recent Developments, Consumer Buying Interest, and Supply Chain Analysis among others.

Frequently Asked Questions

Q1. How big is the Biological and Chemical Indicators Market?

Ans: The Biological and Chemical Indicators market size was USD 912.0 million in 2023 and is anticipated to reach USD 2,111.3 million in 2033, growing at a rate of 8.4% from 2024 to 2033.

Q2. What is the Biological and Chemical Indicators Market growth rate?

Ans. The growth rate of the Biological and Chemical Indicators Market is 8.4%

Q3. Which region holds a major market share for the market?

Ans. North America holds a major market share in 2023.

Q4. Which segment accounted for the largest Biological and Chemical Indicators Market share?

Ans. By application, the biopharma industry segment accounted for the largest Biological and Chemical Indicators Market share in 2023.

Q5. Who are the key players in the Biological and Chemical Indicators Market?

Ans. The Biological and Chemical Indicators Market report includes players such as 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., among others.

Q6. What is the factor driving the biological and chemical indicators market growth?

Ans. The major factor driving the growth of the market is rising need for sterilization of medical devices and equipment in healthcare settings and the increasing adoption of automation in sterilization procedures

Q7. What are the key growth strategies of Biological and Chemical Indicators Market players?

Ans. The key growth strategies of biological and chemical indicator market players are product launch and product approval.

Q8. Which region will provide more business opportunities for the Biological and Chemical Indicators Market during the forecast period?

Ans. Asia-Pacific will provide more business opportunities for the Biological and Chemical Indicators Market during the forecast period.