U.S. Sterilization Indicator Tape Market Size, Share, Analysis, By Type (Steam Indicator Tapes and Hydrogen Peroxide Tapes), By Application (Healthcare Facilities, Pharmaceutical & Medical Device Companies, and Others), and Forecast, 2023-2030

The U.S. sterilization indicator tape market size was worth USD 45.6 million in 2023 and is projected to grow at a CAGR of 3.7% during the forecast period. 

The U.S. has seen a significant rise in pharmaceutical and biotechnological companies in the past decade. The research and development activities in such companies have increased the need for sterilization procedures and are likely to encourage the adoption of sterilization validation products such as indicator tapes. For instance, 3M spent around USD 1.86 billion in 2022 on research & development, which increased from USD 1.43 billion in 2010.

The growing incidence of Healthcare-Associated Infections (HAIs) in various healthcare facilities has driven the demand for sterilization techniques, thus influencing the U.S. sterilization indicator tape market growth. The impact of COVID-19 on the market was positive in 2020 as many infected patients visited healthcare institutions, which led to the usage of several medical instruments, thus increasing the demand for sterilization products.

LATEST TRENDS

Strong Emphasis on Sterilization Process in Healthcare Facilities 

Healthcare facilities, such as hospitals and specialty clinics, have adopted sterilization as one of their essential procedures. The surgical instruments used by healthcare professionals are thoroughly sterilized before being used for medical procedures. In addition, government agencies have implemented guidelines and protocols for sterilization in the country. Healthcare facilities have been prominent in adopting these guidelines to reduce HAIs, other medical complications, and overall costs. 

Lack of sterilization procedures is responsible for increasing hospital-acquired conditions, which is one of the significant drivers for the U.S. market. Hospital-acquired infections require additional resources, cause patient discomfort, and hamper patient safety. For instance, according to data published by the Centers for Disease Control and Prevention (CDC) in 2021, 1 in 31 hospital patients and 1 in 43 nursing home residents suffer from HAI daily.

Before any surgical procedure, reusable medical devices are sterilized to avoid any risk of infection from a contaminated device. Thus, sterilization of medical devices is deemed a continuous process and is anticipated to drive demand for sterilization equipment and consumables, including sterilization indicator tapes. Thus, the increasing number of hospital-acquired conditions is encouraging the usage of indicators and is anticipated to expand the U.S. sterilization indicator tape market share during the forecast period.

DRIVING FACTORS

Stringent Regulations for Sterilization of Medical Devices to Augment Market Growth

Stringent regulations established for sterilizing medical devices have increased the demand for sterilization equipment such as sterilization indicator tape. For instance, in April 2022, the U.S. FDA raised awareness to reduce the risk of infection from reprocessed and reusable medical devices by reviewing all premarket and postmarket information from different manufacturers regarding and communicating regulatory requirements.

Such stringent initiatives regarding sterilization by government bodies are projected to drive the market over the forecast period.

RESTRAINING FACTORS

Limited Shelf Life and Storage Concerns May Hamper Market Growth 

A sterilization indicator tape must be protected against direct UV light and stored at 15^oC – 25^oC with a relative humidity of 40 - 60%. Moreover, sterilization indicator tape has a shelf life of less than two years after manufacture. Thus, storage concerns and limited shelf life might hamper the growth of the market to a certain extent.

The gross domestic R&D spending in the U.S. accounted for 709.71 USD billion in 2021. This reflects an increase of around 5.6% on the amount spent in the previous year – USD 671.90 billion.

SEGMENTATION

By Type Analysis

Based on type, the market is segmented into steam indicator tapes and hydrogen peroxide tapes.

The steam indicator tapes segment held a larger share in 2022 owing to the increasing demand for advanced steam sterilization indicators from pharmaceutical and medical device companies along with increasing expenditure on research & development in the country.

• For instance, in July 2022, Consolidated Sterilizers Systems announced its official venture into the healthcare sterilizers market with its three new FDA-cleared steam sterilizers. These sterilizers will be used in healthcare facilities such as hospitals, clinics, and ASCs. The growing R&D initiatives in the healthcare sector are likely to increase the demand for sterilization. Steam sterilization being the most preferred method of sterilization in healthcare R&D, which is projected to surge the demand for sterilization indicator tapes in the U.S.

By Application Analysis

Based on application, the market is segmented into healthcare facilities, pharmaceutical & medical device companies, and others.

The pharmaceutical & medical devices segment witnessed significant growth in 2022 due to the launch of new pharmaceutical manufacturing companies. The new facilities will require sterilized products and equipment to perform the manufacturing process to avoid cross-contamination. Thus, the demand for sterilization products, such as sterilizers, and their consumables, such as indicator tapes, is expected to increase.

• In January 2022, Eli Lily and Company announced an investment of USD 1.0 billion to create a new manufacturing plant in Concord, North Carolina. The facility will be used to manufacture parenteral products and devices.

KEY INDUSTRY PLAYERS

In terms of the competitive landscape, this market consists of several established and emerging players. 3M dominated the U.S. market in 2022 owing to its solid geographical presence and robust product portfolio. Moreover, the company is actively involved in strategic collaborations and partnerships to expand its product portfolio.

Other key players with a considerable presence in the U.S. market include STERIS plc, Propper Manufacturing Co., Inc. (U.S.), ASP, Healthmark Industries Company, Inc. (U.S.), Defend by Young Mydent LLC., and others.

• In January 2020, Healthmark Industries Company, Inc. added Terragene Auto Reader Incubator and Biological Indicators to their sterilization product portfolio. Such strategic initiatives are expected to strengthen companies' market presence further.

LIST OF KEY COMPANIES PROFILED:

• STERIS plc (U.S.)


• 3M (U.S.)


• Propper Manufacturing Co., Inc. (U.S.)


• ASP (U.S.)


• Healthmark Industries Company, Inc. (U.S.)


• Defend by Young Mydent LLC. (U.S.)


• Merck KGaA (Germany)


• Globe Scientific Inc. (U.S.)


• Crosstex International, Inc. (U.S.)


• Ted Pella, Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS: 

• April 2022 – Healthmark Industries Company, Inc. announced the launch of Steriking pouches for long medical devices. The launch of this product is an add-on to its Steriking Sterilization product line.


• September 2021 – STERIS plc announced the launch of the next generation of integrated vaporized hydrogen peroxide biocontamination system, VHP 100i and 1000i. The systems are launched to be integrated into the facility’s building automation and HVAC systems and can help run a decontamination cycle at programmed intervals.


• June 2021 – STERIS plc acquired Cantel Medical, a global provider of infection prevention products. This acquisition helped STERIS expand its presence in the sterilization market.

REPORT COVERAGE

The market research report provides a detailed analysis of the market. It focuses on key industry developments such as mergers, partnerships, & acquisitions, competitive landscape, and the impact of COVID-19 on the market. Besides this, the research report also offers insights into the market trends and highlights key industry dynamics. In addition to the aforementioned factors, it encompasses several factors that have contributed to the growth of the market in recent years.

Report Scope & Segmentation