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Sterilization Consumables Market Size, Share & Industry Analysis, By Product (Chemical Indicators [By Product {Steam & Hydrogen Peroxide Chemical Indicators}, & By Parameter {Single or Multi-Variable Indicators}], Biological Indicators [By Product {Steam or Hydrogen Peroxide Biological Indicators}, By Type {Traditional & Rapid Biological Indicators}, Bowie-dick Test Packs, Indicator Tapes{Steam Indicator Tape, Hydrogen Peroxide Tape}, & ATP Monitoring Consumables {Swabs, Reagents), By End-user (Hospitals & Clinics, Pharmaceutical & Medical Device Manufacturers), & Regional Forecast, 2025-2032

Last Updated: December 01, 2025 | Format: PDF | Report ID: FBI113646

 

KEY MARKET INSIGHTS

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The global sterilization consumables market size was valued at USD 1.64 billion in 2024. The market is projected to grow from USD 1.71 billion in 2025 to USD 2.33 billion by 2032, exhibiting a CAGR of 4.5% during the forecast period.

Sterilization consumables are the products used in the sterilization process to kill microorganisms and prevent the spread of infections. These consumables are essential to maintain a sterile environment in healthcare settings and ensure patient and medical personnel's safety.

The market is driven by rising strategic collaborations between market players and distributors to enhance product offerings in the global market. Furthermore, the rising hospital admissions and high burden of hospital-acquired infections are some of the important factors that generate the demand for sterilization products.

  • In September 2024, Hygiena LLC partnered with DKSH Holding Ltd. As per this agreement, DKSH will offer comprehensive market analysis, marketing, sales, distribution, and after-sales services, ensuring Hygiena's cutting-edge products reach key industries in Cambodia, Laos, and Myanmar.

Moreover, the market is fragmented due to the presence of key players, such as Solventum, STERIS, ASP (Fortive), Getinge, and Terragene, among others. The growing market players' focus on participating in medical conferences to create product awareness among healthcare professionals is one of the important factors enhancing these companies' share in the global market.

  • For instance, in January 2025, Terragene was present at Arab Health 2025, an event held in Dubai, UAE. During the event, the company showcased its sterilization consumables to create awareness among healthcare professionals who visited the company's booth.

MARKET DYNAMICS

MARKET DRIVERS

Growing Prevalence of Hospital-Acquired Infections Propels Market Growth

The prevalence of hospital-acquired infections (HAI), including sepsis, urinary tract infections, and surgical site infections, among others, is increasing substantially across the world.

  • For instance, as per the study published by the National Center for Biotechnology Information (NCBI) in February 2025, urinary tract infection (UTI) increased by 60.4% from 252.3 million in 1990 to 404.6 million in 2019 across the globe.
  • Also, as per the data provided by the Government of Canada in June 2024, the number of hospital-acquired Clostridioides difficile infection cases was 3,643 in 2021 and increased to 3,846 in 2022.

Furthermore, the increasing number of hospital admissions citing various factors, including the rising geriatric population globally, is leading to an increasing number of patients suffering from HAIs on any given day/point in developed and developing countries alike.

Growing Number of Surgical Procedures Boosts Demand for Sterilization Products

The rise in surgical procedures generates a greater demand for sterilization products. This higher demand is mainly attributed to the fact that, as the number of surgical procedures increases, more equipment and related products must be sterilized. This increases the need for sterilization products to maintain patient safety and prevent infections before, during, and after surgical procedures.

  • For example, as per the data provided by the Australian Institute of Health and Welfare in May 2025, around 3.1 million hospitalizations involved surgery in Australia in 2023-2024.
  • Similarly, per the data published by the Canadian Institute for Health Information in October 2024, around 2.2 million surgical procedures were conducted in Canada in 2022-2023, whereas it increased to 2.3 million in 2023-2024.

The growing number of surgical procedures has been increasing the product demand in healthcare facilities, thereby fueling the sterilization consumables market growth.

MARKET RESTRAINTS

Rising Number of Product Recalls to Restrict Market Growth

In recent years, key players have made significant technological advancements in consumables and new product launches. However, the voluntary recalls of certain sterilization indicators and other consumables due to damage and hampered quality have been limiting their adoption among healthcare professionals. This recall leads to a shift of consumer preference toward other products available in the market, thereby restricting market growth in the coming years.

  • For example, in December 2022, STERIS voluntarily recalled its VERIFY Dual Species Self-Contained Biological Indicators, 100 per box item number S3061, as the spores of G. stearothermophilus and B. atrophaeus were inconsistent and gave false-negative results. Thus, the manufacturer recalled the lot due to the hampered product quality.

MARKET OPPORTUNITIES

Significant Growth in Pharmaceutical and Medical Devices Manufacturing in Developing Countries Provides Lucrative Opportunities for Market Growth

Developing countries of Europe, Asia Pacific, and Latin America are witnessing significant growth in the pharmaceutical and medical devices industries, driven by increasing demand for medical devices and healthcare services in these countries. This growth is supported by increasing government initiatives toward strengthening their healthcare sector. In addition, the increasing focus of pharmaceutical and medical device companies on expanding their manufacturing capacity is expected to create opportunities for the market.

  • For example, in November 2024, Abbott opened a new manufacturing facility in Kilkenny, Ireland. This site is equipped with global manufacturing capabilities. With the opening of this facility, the company aimed to enhance the manufacturing of various diagnosis and treatment-related products.
  • Also, in February 2024, Terumo Corporation announced the opening of its new medical device manufacturing facility at its Caguas, Puerto Rico, site. With the opening of the new facility, the company aimed to produce devices and technologies to improve patient care within healthcare settings.

Furthermore, implementing stringent sterilization regulations and growing awareness among healthcare providers, including hospitals, clinics, and clinical laboratories, is anticipated to enhance the adoption of sterilization processes. These factors are expected to create significant growth opportunities for the consumables market throughout the forecast period.

MARKET CHALLENGES

High Cost of Sterilization Consumables is Limiting Their Adoption in Low and Middle-income Countries

The high cost of sterilization consumables presents a significant challenge, predominantly in resource-constrained healthcare facilities of low and middle-income countries, by limiting the adoption of advanced sterilization technologies.

  • For instance, the retail cost of luminometers, which are used to monitor ATP levels, can start from nearly USD 800 and go as high as USD 4,000.
  • Also, BI-O.K., the self-contained steam biological indicator vials used in the steam sterilization process, can cost USD 93.10, 20/box to USD 404.35, 100/box.

Therefore, the high cost of sterilization products decreases their adoption in low-income countries and creates a major challenge for market players to expand their business in these economies.

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STERILIZATION CONSUMABLES MARKET TRENDS

Rising Key Players’ Focus on New Product Launches Drives Market Growth

The increasing number of cases of hospital-acquired infections, along with a growing number of surgical procedures globally, has been fueling the demand for effective sterilization. As a result, market players have been focusing on developing and launching novel sterilization products to enhance the sterilization process.

  • For example, in June 2025, Solventum launched the Attest Super Rapid Vaporized Hydrogen Peroxide (VH2O2) Clear Challenge Pack in the global market. This ready-to-use test integrates with a biological indicator (BI) to confirm microbial neutralization and a chemical indicator (CI) to verify proper sterilizer function in a single-use test pack with a transparent container.
  • Similarly, in December 2020, STERIS announced the global launch of Spordex self-contained biological indicator (SCBI) ampoules to confirm the sterilization of liquids in steam autoclave cycles.

SEGMENTATION ANALYSIS

By Product

Rising Number of Biological Indicator Sterilization Services by Market Players Boosted Segment Growth

Based on product, the market is segmented into chemical indicators, biological indicators, Bowie-dick test packs, indicator tapes, and ATP monitoring consumables.

Based on the product, the chemical indicators are divided into steam chemical indicators, hydrogen peroxide chemical indicators, and others. Similarly, based on the parameter, the chemical indicators are divided into single-variable indicators and multi-variable indicators.

On the other hand, the biological indicators are divided into steam biological indicators, hydrogen peroxide biological indicators, and others based on the product. Also, based on form, they are divided into self-contained vials, indicator strips, and others. Similarly, based on type, the biological indicators are divided into traditional biological indicators and rapid biological indicators.

Moreover, the indicator tapes are further categorized into steam indicator tapes, hydrogen peroxide tapes, and others. Furthermore, the ATP monitoring consumables are segmented into swabs, reagents, and others.

The biological indicators segment dominated the market in 2024 and is expected to grow at the second-largest CAGR from 2025 to 2032. The dominance of this segment is attributed to the increasing focus of companies on the launch of biological indicators sterility testing services, which are increasing the utilization of sterilization products, thereby driving segmental growth.

  • For example, in October 2022, STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, introduced biological indicator sterility testing services for the medical device industry.

The chemical indicators segment accounted for the second-largest market share in 2024 and is projected to grow considerably throughout the forecast period.  The rising market players focus on participating in medical conferences to create consumer awareness about chemical indicators, enhancing segmental growth.

  • For instance, in April 2025, LISTER BIOMEDICAL CO., LTD. was at the China International Medical Equipment Fair (CMEF) held in Shanghai, China, from 8th to 11th April 2025. During the event, the company showcased its chemical indicators used in the sterilization process to create brand awareness among consumers.

Moreover, the bowie-dick test packs segment is expected to grow at a considerable CAGR from 2025 to 2032. The growing awareness about the importance of quality control and patient safety in sterilization is one of the major factors driving demand for bowie-dick test packs. These test packs are essential for verifying the effectiveness of air removal in autoclaves and steam sterilizers.

On the other hand, the ATP monitoring consumables segment is anticipated to grow at the highest CAGR from 2025 to 2032, owing to the rising usage of ATP monitoring devices in healthcare facilities to assess the cleanliness of surfaces and prevent the spread of infections.

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By Sterilization Method

Increasing Launch of Sterilization Consumables Used in the Steam Sterilization Process Fostered Segmental Growth

Based on the sterilization method, the market is divided into steam sterilization, hydrogen peroxide sterilization, ethylene oxide sterilization, and others.

The steam sterilization segment held a dominant sterilization consumables market share in 2024 and is estimated to grow at the second-largest CAGR from 2025 to 2032. The increasing launch of sterilization consumables used in steam sterilization processes is one of the major factors driving segmental growth.

  • For instance, in October 2023, ASP (Fortive) announced the expansion of its steam sterilization product portfolio with the launch of SEALSURE steam indicator tape in the global market.

Moreover, the hydrogen peroxide sterilization segment accounted for the second-largest market share in 2024 and is estimated to grow at the highest CAGR from 2025 to 2032. The increasing regulatory authorities' focus on creating awareness about the greater effectiveness of the hydrogen peroxide sterilization method in increasing its adoption in healthcare facilities is one of the prominent factors driving segmental growth.

  • For example, in January 2024, the U.S. Food and Drug Administration announced that it considered vaporized hydrogen peroxide (VHP) an established sterilization method for medical devices, recognizing VHP's long history of safety and effectiveness.

Furthermore, the ethylene oxide sterilization segment is expected to grow at a negative CAGR during the forecast period. The negative growth of this segment is mainly attributed to the growing government initiatives toward limited use of ethylene oxide sterilization in healthcare facilities, as long-term exposure to ethylene oxide causes carcinogenic effects.

  • For instance, in March 2024, the U.S. Environmental Protection Agency (EPA) published a much-anticipated rule that further restricts the use of the medical device sterilization agent ethylene oxide (EtO).

Meanwhile, the others segment is anticipated to grow considerably throughout the forecast period. The opening of new sterilization facilities and the expansion of existing sterilization services facilities, including ionizing sterilization, are some of the important factors driving segmental growth.

  • For example, in June 2024, STERIS completed the expansion of its existing facility, the Illinois gamma processing facility, to include x-ray processing.

By End-user

Hospital & Clinics Segment Dominated Market Due to High Burden of Hospital-acquired Infections

On the basis of end user, the market is segmented into hospitals & clinics, pharmaceutical & medical device manufacturers, and others.

The hospitals & clinics segment dominated the global market in 2024 and is expected to grow at the highest CAGR from 2025 to 2032. The growing burden of hospital-acquired infections across the globe has been increasing the demand for sterilization products in these healthcare facilities, fueling the segment's growth.

  • According to the data provided by the Centers for Disease Control and Prevention (CDC) in January 2024, around 30,100 Central Line-Associated Bloodstream Infections (CLABSI) occur in intensive care units and wards in the U.S. every year.

The pharmaceutical & medical device manufacturers segment accounted for a moderate market share in 2024 and is expected to grow moderately during the forecast period. The opening of manufacturing facilities for pharmaceuticals and biologics production by major market players also increases the demand for sterilization monitoring products, thus driving the market growth.

  • For instance, in July 2022, GE Healthcare announced the opening of its first factory in Brazil and South America with a planned investment of USD 50.0 million over 10 years. Such strategic initiatives by the pharmaceutical companies have led to a rise in demand for sterilization monitoring products in their facilities, thereby driving the segment's growth.

On the other hand, the others segment is expected to grow at a stagnant CAGR throughout the forecast period. The increasing utilization of consumables during the sterilization process by academic and research institutes for research purposes is one of the prominent factors driving the segmental growth.

STERILIZATION CONSUMABLES MARKET REGIONAL OUTLOOK

Based on region, the market is studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America

North America Sterilization Consumables Market Size, 2024 (USD Billion)

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North America dominated the market in 2024, accounting for USD 0.61 billion globally. The increasing regulatory approvals and product launches of sterilization consumables are some of the important factors responsible for the market's dominance in the region.

  • For example, in May 2025, True Indicating, LLC, announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for its CSPN-15 Type 5 integrating indicator for steam. This clearance confirmed the availability of the product in the U.S. market.

In addition, the presence of many players providing sterilization consumables in this region is one of the additional factors supplementing market growth.

Europe

The market in Europe accounted for the second-largest share in 2024 and is expected to grow at the second-largest CAGR throughout the forecast period. The rising market players' focus on attending medical conferences to create product awareness among consumers is one of the important factors driving market growth in this region.

  • For example, in January 2025, Tuttnauer was present at the IDS 2025 medical conference in Cologne, Germany. During the event, the company was present at stand MO58 and featured its infection control products.
  • Similarly, in June 2024, Getinge was present at the ACHEMA 2024 medical conference held in Frankfurt, Germany. During the event, the company showcased its sterilization solutions to create consumer awareness and enhance its brand image in the global market.

Asia Pacific

Asia Pacific accounted for a moderate market share in 2024 and is expected to grow at the highest CAGR from 2025-2032. The increasing market players' focus on the launch of sterilization consumables to verify the effectiveness of the sterilization process is the main factor driving market growth in this region.

  • For instance, in August 2021, ASP (Fortive) announced the launch of the STERRAD VELOCITY biological indicator (bi)/process challenge device (PCD), with a 15-minute time to result in the Asia Pacific region.

Latin America and Middle East & Africa

The market in Latin America and Middle East & Africa is expected to grow steadily throughout the forecast period. This is attributable to their developing healthcare infrastructure for sterilization services across these two regions. As the number of sterilization services increases, the demand for the consumables used to verify the effectiveness and completion of the sterilization process also increases. This results in market expansion in these regions.

  • For instance, in March 2023, Servizi Italia Spa announced the inauguration of its first sterilization plant in São Paulo, Brazil. This facility provides moist heat sterilization services to hospitals located in São Paulo, Brazil.

Moreover, growing strategic alliances between major players for developing and launching sterilization consumable products supplement market growth in these regions.

COMPETITIVE LANDSCAPE

KEY INDUSTRY PLAYERS

Increasing Focus of Market Players on Attending Medical Conferences to Create Product Awareness among Consumers, Leading to Companies' Revenue Growth

The global sterilization consumables market is a fragmented market with the presence of several small and mid-sized companies. The market comprises key companies such as Solventum, STERIS, and ASP (Fortive). The significant proportion of these companies is largely attributed to their strong focus on attending medical conferences to create product awareness among consumers.

  • For example, in November 2024, Solventum was present at Piper Sandler's 36th annual healthcare conference held in New York, U.S. During the event, the company provided detailed information about its products to create awareness among consumers regarding its product offerings.

Furthermore, other players in the market include Getinge, Hygiena LLC, Terragene, etc. These companies have been focusing on new product launches and strategic acquisitions to expand their footprint in the global market.

LIST OF KEY STERILIZATION CONSUMABLE COMPANIES PROFILED

  • STERIS (U.S.)
  • Getinge (Sweden)
  • ASP (Fortive) (U.S.)
  • Solventum (U.S.)
  • Hygiena LLC (U.S.)
  • Terragene (Argentina)
  • Ayka Medical Inc. (India)
  • BiomatiQ Scientific Pvt. Ltd. (India)
  • Tuttnauer (Netherlands)
  • LISTER BIOMEDICAL CO., LTD (China)

KEY INDUSTRY DEVELOPMENTS

  • November 2023 - STERIS announced that its applied sterilization technologies (AST) business participated in the U.S. Food and Drug Administration (FDA) Radiation Sterilization Master File Pilot Program.
  • September 2023 - Hygiena LLC, the global manufacturer and supplier of rapid microbial detection, monitoring, and identification, announced the inauguration of its new branch in Sydney, Australia.
  • May 2020 - Getinge introduced a new range of consumables for sterile reprocessing. Getinge Assured Superfast 20 Biological Indicator speeds up the ability of the Central Sterile Supply Department (CSSD) to release loads safely, ensuring that the sterile instruments can be in the right place at the right time.
  • January 2020 - ASP (Fortive) announced that it had received the U.S. FDA approval for STERRAD VELOCITY biological indicator (BI)/process challenge device (PCD) for use in STERRAD systems. This STERRAD VELOCITY BI assesses process performance for vaporized hydrogen peroxide (H2O2) sterilization.
  • April 2019 - Fortive acquired the Advanced Sterilization Products (ASP) Business from Ethicon, Inc., a Johnson & Johnson Services, Inc. subsidiary, for almost USD 2.7 billion in cash.

REPORT COVERAGE

The sterilization consumables market analysis report provides a detailed competitive landscape and market insights. It focuses on key aspects such as company profiles, products, sterilization methods, and end-users. In addition to the market size, it offers insights into the market trends and highlights key industry developments. In addition to the factors mentioned above, it encompasses several factors that have contributed to the growth of the advanced market over recent years.

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Report Scope & Segmentation

ATTRIBUTE

DETAILS

Study Period

2019-2032

Base Year

2024

Estimated Year

2025

Forecast Period

2025-2032

Historical Period

2019-2023

Growth rate

CAGR of 4.5% from 2025-2032

Unit

Value (USD billion)

Segmentation

By Product

  • Chemical Indicators
    • By Product
      • Steam Chemical Indicators
      • Hydrogen Peroxide Chemical Indicators
      • Others
    • By Parameter
      • Single-Variable Indicators
      • Multi-Variable Indicators
      • Biological Indicators
    • By Product
      • Steam Biological Indicators
      • Hydrogen Peroxide Biological Indicators
      • Others
    • By Form
      • Self-contained Vials
      • Indicator Strips
      • Others
    • By Type
      • Traditional Biological Indicators
      • Rapid Biological Indicators
  • Bowie-dick Test Packs
    • Indicator Tapes
    • Steam Indicator Tapes 
    • Hydrogen Peroxide Tapes
    • Others
  • ATP Monitoring Consumables
    • Swabs
    • Reagents
    • Others

By Sterilization Method

  • Steam Sterilization
  • Hydrogen Peroxide Sterilization
  • Ethylene Oxide Sterilization
  • Others

By End-user

  • Hospital & Clinics
  • Pharmaceutical & Medical Device Manufacturers
  • Others

By Region

  • North America (By Product, By Sterilization Method, By End-User, By Country)
    • U.S.
    • Canada
  • Europe (By  Product, By Sterilization Method, By End-User, By Country/Sub-Region)
    • U.K.
    • Germany
    • France
    • Italy
    • Spain
    • Scandinavia
    • Rest of Europe
  • Asia Pacific (By  Product, By Sterilization Method, By End-User, By Country/Sub-Region)
    • Japan
    • China
    • India
    • Australia
    • Southeast Asia
    • Rest of the Asia Pacific
  • Latin America (By  Product, By Sterilization Method, By End-User, By Country/Sub-Region)
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa (By  Product, By Sterilization Method, By End-User, By Country/Sub-Region)
    • GCC
    • South Africa
    • Rest of the Middle East & Africa


Frequently Asked Questions

Fortune Business Insights says that the global market stood at USD 1.64 billion in 2024 and is projected to record a valuation of USD 2.33 billion by 2032.

The market is expected to exhibit steady growth at a CAGR of 4.5% during the forecast period of 2025-2032.

Based on the product, the biological indicators segment held a leading position in the market in 2024.

The growing prevalence of hospital-acquired infections and a strong emphasis on sterilization in pharmaceutical and biotechnology industries are the key factors driving the market growth.

Solventum, STERIS, ASP (Fortive), and Getinge are the top players in the market.

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