Biological & Chemical Indicators Market by Sterilization Type (Thermal Sterilization, Chemical Sterilization, Radiation Sterilization), Indicator Class (Biological Indicators, Chemical Indicators, Enzyme Indicators), Packaging Form, End User & Region - Forecast to 2020-2030

Introduction

Global revenue pool of biological & chemical indicators market will expand nearly 2X over forecast period, 2030-2030.As sterile drug products are on rise, manufacturing ecosystems are feeling the pressure to ensure implementation of suitable control measures in order to address several sources of potential contamination. These include equipment, operators, and other materials present in manufacturing ecosystems.

Stringent good manufacturing practices (GMP) norms pertaining to laboratory testing and quality control of finished products is influencing pharmaceutical and biotech companies to incorporate sterilization practices.

As such, it will become increasingly crucial for manufacturers of biological & chemical indicators to remain agile in a bid to keep pace with evolving biomanufacturing requirements.  

Enzymatic Indicators – An Industry-changing Advancement

Enzymatic indicators (EI) are emerging as surrogate to conventional biological indicators (BI) to improve reliability of biodecontamination validation processes by vaporized hydrogen peroxide (VH2O2).

EIs offer several advantages over conventional indicators such as rapid delivery of results that have positive impact including, minimal financial losses to pharmaceutical companies, reduced wasted man hours, and lessened risks associated with BIs.

EIs are upgradation to conventional 7-day waiting time for BIs decontamination validation. That said, due to regulatory stringency and associated high costs, it will take time for EIs to penetrate into market and see at-scale end-user adoption.

Addressing Challenges of Inconvenience and Longer Processing Duration

In a bid to balance costs associated with sterilization validations, majority of manufacturers of sterilization product leverage conventional biological and chemical indicators. However, these sterilization indicators require longer duration of time - about 2-7 days to deliver results.

Additional aseptic transfer and incubation makes validation procedure complicated and time-intensive. Moreover, chemical indicators can provide false positive outcomes and are usually not recommended by healthcare regulatory agencies. These disadvantages of conventional sterilization indicators are creating fundamental challenges for players in biological & chemical indicators market.

For instance, Mesa Laboratories Inc.’s biological indicator - EZTest – requires 1-2 days to provide sterilization validation results. This considerably affect release time of manufactured parenteral finished products to markets.

Region-wise Analysis

North America Biological & Chemical Indicators Market

The biological and chemical indicator market in North America is majorly driven by increasing risk of infections during surgeries and maternity care as well as hospital acquired infections (HAI). The Centers for Disease Control (CDC) estimates that HAIs cause about 1.7 million infections and 99,000 associated deaths every year in hospitals in the US alone.

Going forward, the US Environmental Protection Agency (EPA) is providing updates on efforts in progress with the Georgia Environmental Protection Division (EPD) to rapidly and safely ramp up production at sterilization units in Covington and Madison as response to notable rise in demand for sterile medical equipment during COVID-19 pandemic.

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Europe Biological & Chemical Indicators Market

In Europe, biological & chemical indicators are particularly gaining traction in myriads of healthcare facilities, given rising epidemiological numbers due to COVID-19 pandemic. As such, various manufacturers in the region are making bold commitments to develop and deliver advanced sterility indicators for sterilization of medical equipment to hospitals.

Further, frequent product launches in medical devices, drugs, and biologics, as well as favorable reimbursement policies are driving biological & chemical indicators market in Europe. While the UK and France majorly capture substantial share of regional market revenue, Germany and Spain will share nearly identical divide in coming years.

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East Asia Biological & Chemical Indicators Market

Adoption of sterilization technology is increasing at highest rate in East Asia, primarily attributable to surging healthcare expenditure, top-line growth of pharmaceutical industry, and flourishing medical tourism sector.

In addition, East Asia has been among the worst hit regions by the COVID-19 pandemic. South Korea and China have recorded significant rise in prevalence rate of COVID-19 spread.

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Compared to markets in North America and Europe, East Asia biological & chemical indicators market is growing at rapid CAGR. China continues to spearhead the regional market, followed by Japan, in terms of revenue share, while market in South Korea is growing at notable CAGR.

FMI’s report has analyzed biological & chemical indicators market in 20+ countries across North America, Europe, South Asia, Latin America, East Asia, Oceania and Middle East & Africa.

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Category-wise Insights

Thermal Stabilization to Remain Prevalent

Thermal stabilization has been prevalent method for controlling microbial growth on medical equipment. The approach is highly effective in warding off unwanted microbes and is cost-efficient. About 70% of overall biological & chemical indicators market revenue would be realized by thermal stabilization.

Under the category, steam heat stabilization accounts for greater value share, while dry heat stabilization will pick pace in near future. However, adoption of thermal stabilization will stagger in coming years as the technique can degrade unstable media.

As such, market players are turning their sights to chemical and radiation stabilization techniques to sustain their revenue pool.

Biological Indicators Hold Dominance

About 8 out of 10 end users bank on biological indicators as they are effective in eliminating huge number of highly resistant bacterial spores, offering at-scale assurance to end users in sterilization processes.

Chemical indicators, on the other hand, deliver immediate validation that items have been treated the moment they are isolated from sterilizers, making them key constituent of various sterility assurance programs.

While biological indicators continue to define stakeholders’ bottom lines, chemical and enzyme indicators are reflecting opportunistic growth potential.

Self-contained BIs Currently Leading

Self-contained biological indicators (BI) for monitoring sterilization procedures offer uniform, fast, and reliable results, ensuring effective steam sterilization processing. In addition, Self-contained BIs reduce the possibility of contamination and reduces the potential for inaccurate outcomes associated with post-exposure transfer.

That said, self-contained BIs will lose their revenue share to other packaging forms such as strip and disc chemical indicators (CI), spore suspension BIs, and strip and disc BIs. While certain self-contained BIs are subject to longer turnaround times, the value provided by these BIs remain unmatched.

Biopharmaceutical Industry to Remain Primary End User

Conventionally, biopharmaceutical industry has been primary end user of biological & chemical indicators, and the status quo will remain likely over following decade. The trend is receiving impetus from rising manufacturing of parenteral therapeutics including, new (biologics/synthetics) and generic therapeutics.

Recent estimates reveal that, by 2029, sales of parenteral drugs will register around US$ 802 Mn. Furthermore, strict regulatory compliance requirements of sterilization validation is fueling the demand for biological & chemical indicators in biopharmaceuticals commercialization.

FMI further states that market players are also uncovering new revenue lines in research labs and diagnostic labs, which are exhibiting rapid adoption CAGR, respectively.  

Competitive Landscape

Leading players in are biological & chemical indicators market are focusing on developing accurate and rapid biological and chemical indicators for biopharmaceutical companies and healthcare professionals with enhanced product quality, performance and ease of use.

As the market is characterized by presence of over 20 market players with tech-driven developments, new product roll-outs, innovative sterilization techniques, and end-user convenience have become key differentiating strategies. For instance,

Protak Scientific Ltd. has developed and commercialized novel category of sterilization indicators - enzyme indicators. The product utilizes thermostable Adenylate kinase (tAK) enzyme separated from thermophilic bacteria present in hot springs (Sulpholobus acidocaldarius). tAK is highly suitable as alternate marker to monitor decontamination procedures. It delivers results within 2 minutes using rapid and sensitive luminescence assay. Further, enzyme indicators are approved in the US and Europe.

Getinge AB has rolled out Assured Superfast 20 Biological Indicator to ensure validation of sterile processes within 20 minutes and further assure patient convenience and safety in healthcare facilities. This product delivers precise and uniform results that allow healthcare professionals to positively proceed within the given timeframe, thus, beneficial during COVID-19 pandemic.

3M Company has unveiled its Attest Mini Auto-reader 490M, which is a 24-minute in-house sterilization monitoring solution developed specifically for dental teams. Its competitive price and compact size makes in-office monitoring feasible for dental offices.

In addition to these, some other key players in biological & chemical indicators market include

• Steris Plc
• Thermo Fisher Scientific Inc.
• Mesa Labs, Inc.
• McKesson Medical-Surgical Inc.,
• Crosstex International Inc.
• Propper Manufacturing Co. Inc.,
• GKE-GmbH,
• Siltex Australia Pvt. Ltd.
• Terragene S.A.
• Liofilchem S.r.l.
• Andersen Products Inc.
• ParaSure Limited
• Excelsior Scientific

The list is only indicative – full list biological & chemical indicators market key players is available upon request.

Biological & Chemical Indicators Market Report: Scope

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Biological & Chemical Indicators Market Segmentation

Sterilization Type

• Thermal Sterilization
  • Steam Heat
  • Dry Heat
• Chemical Sterilization
  • Ethylene Oxide
  • Hydrogen Peroxide
  • Formaldehyde
• Radiation Sterilization

Indicator Class

• Biological Indicators
  • Bacillus atrophaeus (BA) Spores
  • Geobacillus stearothermophilus (GS) Spores
  • Others
• Chemical Indicators
  • Class 1 (Process)
  • Class 4 (Multi-Variable)
  • Class 2 (Specific-Use)
  • Class 3 (Single-Variable)
  • Class 5 (Integrating)
  • Class 6 (Cycle Verification)
• Enzyme Indicators

Packaging Form

• Self-Contained BI
• Spore Suspension BI
• Strip and Disc BI
• Strip and Disc CI
• Others

End User

• Biopharma Industry
• Hospitals
• Clinics
• Ambulatory Surgical Centers
• Diagnostic Labs
• Research Labs

Regional Outlook

• North America (US, and Canada)
• Latin America (Brazil, and Mexico)
• Europe (Germany, UK, Russia, France, and Italy)
• South Asia (India, Indonesia, Thailand, Australia and New Zealand)
• East Asia (China, Japan, and South Korea)
• Oceania (Australia and New Zealand)
• Middle East & Africa (MEA) (Turkey, GCC Countries, and South Africa)