Sterilization Monitoring Market: A Report on Growth, Innovation, and Contribution to Sustainable Development Goals

Executive Summary

The global sterilization monitoring market is on a significant growth trajectory, projected to expand from USD 962.8 million in 2024 to USD 1,843.2 million by 2033, at a Compound Annual Growth Rate (CAGR) of 7.57%. This expansion is fundamentally linked to the global pursuit of Sustainable Development Goal 3 (SDG 3): Good Health and Well-being. The market’s primary function—ensuring the sterility of medical equipment—is critical for preventing Healthcare-Associated Infections (HAIs), safeguarding patient safety during surgical procedures, and strengthening public health systems worldwide. Key market characteristics include the dominance of North America, the leadership of biological indicators in technology, and the widespread use of steam sterilization methods. Innovations in this sector are not only enhancing healthcare efficacy but are also aligning with SDG 9 (Industry, Innovation, and Infrastructure) and SDG 12 (Responsible Consumption and Production) by promoting advanced, safer, and more environmentally conscious technologies.

Market Dynamics and Alignment with Sustainable Development Goals

Primary Growth Drivers

The market’s expansion is propelled by several factors that directly support the achievement of global sustainability targets.

• Rising Incidence of Healthcare-Associated Infections (HAIs): The increasing prevalence of HAIs is a major catalyst. According to the European Centre for Disease Prevention and Control, approximately 4.3 million patients in the EU/EEA are affected by HAIs annually. Effective sterilization monitoring is a cornerstone of infection prevention and control (IPC) strategies, directly contributing to SDG Target 3.3, which aims to end the epidemics of communicable diseases.
• Increasing Volume of Surgical Procedures: A global rise in inpatient and outpatient surgeries necessitates robust sterilization protocols to ensure patient safety. This trend underscores the importance of resilient healthcare infrastructure, a key component of SDG 9, and reinforces the need for reliable monitoring to support universal access to safe surgical care as part of SDG 3.
• Stringent Regulatory Frameworks: Regulatory bodies like the U.S. FDA and EPA enforce strict standards for medical device sterilization. These regulations not only protect public health (SDG 3) but also drive innovation (SDG 9) and encourage sustainable practices, such as the EPA’s new rules to reduce Ethylene Oxide (EtO) emissions, aligning with SDG 12.

Technology Insights: Advancing Health and Innovation (SDG 3 & SDG 9)

Biological Indicators (BIs)

The biological indicators segment commanded the largest market share (58.12%) in 2024 and is projected to grow at the fastest rate. BIs are considered the gold standard for sterilization assurance as they directly challenge the process with highly resistant microorganisms. Their reliability is paramount for achieving the highest standards of patient safety, making them indispensable for compliance and central to upholding SDG 3. The development of rapid-result BIs, which reduce turnaround times, represents a significant technological advancement under SDG 9, allowing healthcare facilities to operate more efficiently without compromising safety.

Chemical Indicators (CIs)

Chemical indicators are expected to see significant growth. They provide immediate, real-time visual confirmation that sterilization parameters have been met. This rapid feedback mechanism allows for quick identification of process failures, enhancing the safety and reliability of healthcare services (SDG 3). The integration of CIs with digital tracking systems automates documentation and improves traceability, reflecting the kind of innovation in infrastructure targeted by SDG 9.

Product and Method Analysis

Product Insights

Strips held the largest revenue share in 2024 and are expected to exhibit the fastest growth. Their dominance is attributed to their cost-effectiveness, simplicity, and ability to provide rapid visual results, making them accessible for a wide range of healthcare facilities. This accessibility supports the goal of universal health coverage (SDG Target 3.8) by ensuring that even facilities with limited resources can implement effective sterilization monitoring.

Method Insights

1. Steam Sterilization: This method held the largest market share in 2024. Its efficacy, reliability, and cost-effectiveness make it a foundational technology in healthcare. Robust monitoring for steam sterilization is crucial for maintaining the safety of the vast number of procedures that rely on it, directly supporting SDG 3.
2. Hydrogen Peroxide Sterilization: This segment is projected to grow at the fastest rate. As a low-temperature sterilization method, it is essential for heat-sensitive instruments. Furthermore, its byproducts (water and oxygen) are environmentally benign, aligning its adoption with the principles of SDG 12 (Responsible Consumption and Production) by offering a safer, more sustainable alternative to methods like EtO.

End-Use and Regional Perspectives

End-Use Insights

Hospitals and clinics were the largest end-use segment in 2024, driven by the high volume of surgical procedures. The fastest growth is anticipated in Ambulatory Surgery Centers (ASCs), reflecting a global shift towards outpatient procedures. This decentralization of healthcare services expands access to care (SDG 3) but requires that stringent sterilization standards are maintained across all settings, reinforcing the need for reliable and accessible monitoring products.

Regional Insights

• North America: Dominated the market with a 35.49% share in 2024. The region’s advanced healthcare infrastructure, stringent regulations, and high adoption of innovative technologies set a global benchmark for patient safety, embodying the principles of SDG 3 and SDG 9.
• Europe: Market growth is driven by strong regulatory oversight and a focus on infection control. Initiatives to enhance medical safety and the adoption of real-time monitoring systems contribute to building resilient and effective healthcare systems.
• Asia Pacific: This region is experiencing rapid growth due to expanding healthcare infrastructure, rising surgical volumes, and increasing awareness of infection control protocols. This development is critical for improving health outcomes and strengthening health systems in line with SDG 3.
• Latin America & Middle East & Africa: Growth in these regions is linked to modernizing healthcare infrastructure and a greater focus on preventing HAIs. Investments in sterilization technologies are a key step toward achieving better health outcomes and building capacity for risk reduction under SDG Target 3.d.

Competitive Landscape and Recent Developments

The market is moderately fragmented, featuring key players such as 3M, STERIS, ASP, and Getinge. Strategic activities, including product innovation and M&A, are driving the market forward. Recent developments highlight the industry’s commitment to the SDGs:

• June 2025: Solventum’s launch of the Attest Super Rapid VH2O2 Clear Challenge Pack is an innovation (SDG 9) that enhances sterilization assurance and efficiency, contributing to better patient safety (SDG 3).
• March 2024: The EPA’s final amendments on EtO emissions directly address environmental and health risks, representing a significant step toward responsible production patterns (SDG 12) and protecting community health (SDG 3).
• October 2023: ASP’s expansion of its Steam Monitoring portfolio with integrated digital solutions improves workflow and compliance, showcasing how digital innovation (SDG 9) can strengthen health systems (SDG 3).

Analysis of Sustainable Development Goals in the Sterilization Monitoring Market

1. Which SDGs are addressed or connected to the issues highlighted in the article?

The article on the sterilization monitoring market discusses issues and advancements that are directly and indirectly connected to several Sustainable Development Goals. The primary focus on healthcare safety, technological innovation, and environmental regulations links the market to the following SDGs:

• SDG 3: Good Health and Well-being

  This is the most prominent SDG in the article. The entire premise of the sterilization monitoring market is to ensure patient safety and prevent disease. The article’s emphasis on reducing Healthcare-Associated Infections (HAIs), ensuring the sterility of surgical instruments, and improving the quality of healthcare services directly aligns with the goal of ensuring healthy lives and promoting well-being for all at all ages.

• SDG 9: Industry, Innovation, and Infrastructure

  The article extensively covers the role of innovation and technology in the sterilization monitoring market. It details the development of advanced solutions like rapid biological indicators, digital monitoring systems, and new chemical indicators. This focus on technological advancement, upgrading healthcare infrastructure with modern equipment, and fostering innovation within the medical technology industry connects directly to SDG 9.

• SDG 12: Responsible Consumption and Production

  The article touches upon the environmental impact of sterilization processes and the regulatory efforts to mitigate these effects. The discussion of new EPA regulations for Ethylene Oxide (EtO) emissions and the development of “environmentally friendly sterilization methods” and products that avoid hazardous materials like lead aligns with the goal of ensuring sustainable consumption and production patterns, particularly the sound management of chemicals and wastes.

2. What specific targets under those SDGs can be identified based on the article’s content?

Based on the article’s content, several specific targets under the identified SDGs can be pinpointed:

1. SDG 3: Good Health and Well-being

   • Target 3.8: Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.

     The article supports this target by highlighting the market’s role in providing “access to quality essential health-care services.” The growth in sterilization monitoring is driven by the need to prevent infections from “inadequately sterilized equipment” and to ensure safety during the “growing surgical procedures in hospitals.” This ensures that healthcare services, particularly surgeries, are safe and effective.

   • Target 3.d: Strengthen the capacity of all countries, in particular developing countries, for early warning, risk reduction and management of national and global health risks.

     The prevention of Healthcare-Associated Infections (HAIs) is a core theme of the article and a clear example of “risk reduction and management of… health risks.” The article cites that HAIs are a global issue, affecting millions in the EU and driving market growth worldwide, thus emphasizing the need to strengthen capacity to manage this risk.

2. SDG 9: Industry, Innovation, and Infrastructure

   • Target 9.4: By 2030, upgrade infrastructure and retrofit industries to make them sustainable…

     This target is reflected in the discussion of regulatory changes forcing industries to adapt. The article mentions the FDA’s policy and new EPA regulations for Ethylene Oxide (EtO) sterilization, which requires “sterilization facilities… transitioning to meet new Environmental Protection Agency (EPA) regulations.” This is a direct example of retrofitting industries for sustainability and safety.

   • Target 9.5: Enhance scientific research, upgrade the technological capabilities of industrial sectors… encouraging innovation…

     The article is replete with examples of this target in action. It describes how “innovation in sterilization monitoring primarily revolves around the development of faster, more reliable, and integrated solutions,” such as rapid biological indicators, digital integration with hospital systems, and multi-modal indicators. The mention of numerous companies (3M, ASP, STERIS) launching new products exemplifies the focus on R&D and upgrading technological capabilities.

3. SDG 12: Responsible Consumption and Production

   • Target 12.4: By 2020, achieve the environmentally sound management of chemicals and all wastes throughout their life cycle… and significantly reduce their release to air, water and soil…

     This target is directly addressed by the section on regulatory influence. The article states that in March 2024, the EPA announced final amendments to “reduce EtO emissions” from commercial sterilizers. The goal is to “decrease the lifetime cancer risk from EtO emissions,” which is a clear action towards the environmentally sound management of hazardous chemicals.

3. Are there any indicators mentioned or implied in the article that can be used to measure progress towards the identified targets?

The article provides several quantitative and qualitative indicators that can be used to measure progress towards the identified targets:

• Indicators for SDG 3 (Good Health and Well-being)

  • Incidence of Healthcare-Associated Infections (HAIs): The article explicitly provides a metric: “approximately 4.3 million hospitalized patients across the EU and European Economic Area (EEA) are affected by HAIs annually.” Tracking this number over time would measure progress in health risk reduction (Target 3.d).
  • Number of surgical procedures: The article includes detailed Eurostat tables listing the rates of various surgeries (e.g., cataract surgery, caesarean sections, hip replacements) per country. An increase in these procedures, coupled with low infection rates, indicates improved access to safe and quality healthcare (Target 3.8).

• Indicators for SDG 9 (Industry, Innovation, and Infrastructure)

  • Market size and growth of advanced technologies: The article quantifies the market size (“USD 962.8 million in 2024”) and its projected growth (“CAGR of 7.57%”). This financial data serves as a proxy indicator for investment in and adoption of innovative infrastructure (Target 9.5).
  • Rate of technological innovation and adoption: The article provides qualitative evidence of innovation, such as the launch of new products like “ASP’s SEALSURE Chemical Indicator Tape” and “STERRAD VELOCITY Biological Indicator.” The shift towards “hydrogen peroxide sterilization” as a faster-growing segment also indicates the adoption of newer, upgraded technologies (Target 9.5).

• Indicators for SDG 12 (Responsible Consumption and Production)

  • Reduction in hazardous chemical emissions: A direct indicator is mentioned in the context of EPA regulations for EtO, which “are expected to cut the number of individuals with a risk of one in one million or higher by approximately 92 percent.” This is a measurable goal for reducing the release of hazardous substances (Target 12.4).
  • Availability and adoption of environmentally friendly products: The article mentions specific products like “Hu-Friedy’s IMS Monitor Tape is environmentally friendly and excludes the risk of lead contamination.” The market share or adoption rate of such products would be a clear indicator of progress (Target 12.4).

4. Table of SDGs, Targets, and Indicators

Source: grandviewresearch.com