The global Biological And Chemical Indicators Market is set to value at USD 490.3 million in 2023. With an estimated growth rate of 5.9% CAGR during the forecast period, the market is likely to surpass USD 866.9 million by 2033.
The increasing emphasis on patient safety and infection control in the healthcare sector drives the demand for biological and chemical indicators. Some factors driving the market growth include:
| Data Points | Market Insights |
|---|---|
| Market Value 2023 | USD 490.3 million |
| Market Value 2033 | USD 866.9 million |
| CAGR 2023 to 2033 | 5.9% |
| Share of Top 5 Countries | 61.4% |
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The biological and chemical indicators industry is witnessing several innovations in terms of product development and technological advancements. The development of self-contained biological indicators and the integration of electronic monitoring systems are some of the innovations in this market.
The use of biological indicators in the food and beverage processing industries is also expected to provide significant growth opportunities for players in this market. In addition, the increasing adoption of chemical sterilization methods is expected to drive the demand for chemical indicators, creating opportunities for market players to develop new and innovative products.
The sales of biological and chemical indicators are expected to be driven by the increasing awareness of the importance of sterilization procedures in healthcare facilities. The demand for biological indicators is expected to witness significant growth due to their accuracy and reliability in monitoring the effectiveness of thermal sterilization processes.
The adoption of chemical sterilization methods is also driving the demand for chemical indicators. This market is witnessing several innovations in terms of product development and technological advancements, creating opportunities for players to develop new and innovative products.
With the increasing emphasis on patient safety and infection control in the healthcare sector, the biological and chemical indicators industry is expected to witness significant growth during the forecast period.
As projected by Future Market Insights, the biological indicators by indicator class are estimated to see a market value of USD 393.2 million, which shows more than half of the total biological and chemical indicators industry in 2022.
The increasing adoption rate of universal sterilization indicators, increasing advanced product development, rising commercialization of parenteral therapeutics, diagnosing disease, and development of In-house sterilization monitoring solutions are the primary factors boosting the development of the biological and chemical indicators industry.
The biological and chemical indicators market holds nearly 10.4% of the market value share of the USD 4.1 billion sterilization market in 2021. In addition, collaborative efforts and initiatives to do efficient workflow and the emerging trend of exploring next-generation techniques are expected to lead to rapid growth in the biological and chemical indicators industry.
| Particulars | Details |
|---|---|
| H1, 2021 | 7.28% |
| H1, 2022 Projected | 7.28% |
| H1, 2022 Outlook | 7.28% |
| BPS Change - H1, 2022 (O) - H1, 2022 (P) | (-) 10 ↓ |
| BPS Change - H1, 2022 (O) - H1, 2021 | (-) 13 ↓ |
According to FMI, the biological and chemical indicators market is likely to dip in the BPS change by nearly 13 basis point share (BPS) in H1-2022 (O) compared to H1-2021. Furthermore, variation in BPS change is also observed by comparing the H1-2022 outlook and H1-2022 projected period by nearly 10 BPS.
The shortcomings of rapid biological indicators include that under unfavorable conditions such as temperature variation, the period available to detect fluorescence is not adequate, thus presenting with lower output than expected. This factor is associated with several disadvantages to the market.
The underdeveloped regions have limitations regarding the resources and capabilities for sterilization procedures and monitoring, which contributes to the BPS value reduction.
The growth rates and development possibilities of the global biological and chemical indicators industry have been analyzed by FMI. The market is subject to be influenced by quality assessment, regulations, and the impact of macro and industrial variables.
Principal Consultant
The growing risk of infections during surgeries and hospital-acquired infections creates a huge demand for safety and hygiene in the sterile production process.
Numerous hygiene awareness programs in various regions to promote the use of sterile instruments and equipment is likely to create opportunities in the biological and chemical indicators industry shortly.
For Instance, the Georgia Environmental Protection Division (EPD) and USA Environmental Protection Agency (EPA) gave joint protocol to provide support by increasing the production at sterilization facilities in Covington and Madison during COVID there was high demand and short supply for sterile medical equipment.
Surgical care is essential to manage diverse health conditions, such as injuries, malignancy, infections, and cardiovascular diseases. An increase in the number of surgical procedures is likely to directly impact the sale of biological and chemical indicators.
According to a WHO study, in 2020, around 310 million surgical procedures were used to address the burden of different diseases for the global population.
Inconvenience, long waiting times for results, sub-standard sterilization practices, and increasing adoption of disposable biological and chemical indicators are the key factors restraining the market growth over the forecast period.
The classical sterilization indicators, such as biological indicators, take a longer period, about 7 days, to show results. In addition, chemical indicators can give false positive results and are generally not recommended by healthcare regulatory agencies. This disadvantage of classic sterilization indicators is expected to hamper the adoption rate of the products.
Underdeveloped regions have limited resources and capabilities for sterilization procedures and monitoring. In the non-regulated market, several professionals rely on non-validated sterilization procedures or violate standard sterilization protocols.
Such practices are expected to reduce the use of sterilization indicators during sterilization procedures, a major factor restraining the market.
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| United States Market Size (USD million) by End of Forecast Period (2033) | USD 169.4 million |
|---|---|
| CAGR % 2023 to End of Forecast (2033) | 4.9% |
The United States biological and chemical indicators industry is expected to reach a valuation of USD 169.4 million by the end of the forecast period in 2033, with a CAGR of 4.9% between 2023 and 2033.
The dominant share of the United States can mainly be due to the launch of technologically advanced products, regulatory stringency and compliance, and increasing discretionary funding for cancer research. With advancements in manufacturing and digitalization, healthcare professionals expect customized sterilization indicator solutions in sterilization monitoring operations.
Several innovative biological and chemical indicator suppliers in the United States market are offering customized services of sterilization indicators specific to the need of the end users. This driver is expected to provide a competitive edge for the players in the market.
For example, Sterilization Indicators contract manufacturer (OME) and Propper Manufacturing Co., Inc., United States, offer multiple packaging forms and indicators for customization needs to healthcare end users. These include cost-effective, environmentally friendly, tailored to specific customer needs, and maintaining ISO and FDA compliance.
Regulatory authorities of regulated markets such as the United States and ISO regions have issued separate guidelines on the regulatory requirements of the sterilization validation procedures for compliance with the sterilization procedures. This regulatory stringency is expected to increase the demand for biological and chemical indicators across the global and United States market.
| Europe Region Analysis | Value and CAGR |
|---|---|
| Germany Market Size (USD million) by End of Forecast Period (2033) | USD 20.7 million |
| CAGR % 2023 to End of Forecast (2033) | 3.7% |
| United Kingdom Market Size (USD million) by End of Forecast Period (2033) | USD 19.5 million |
| CAGR % 2023 to End of Forecast (2033) | 6.0% |
In Germany, the biological and chemical indicators market is predicted to reach a valuation of USD 20.7 million by 2033, with a CAGR of 3.7% from 2023 to 2033.
German companies have a strong focus and continuous investments in research and technological advancement for developing and commercializing rapid sterilization monitoring products. These are expected to raise the adoption of biological indicators due to their high speed and high efficacy features.
The United Kingdom biological and chemical indicators market is estimated to be valued at USD 19.5 million by 2033, with a CAGR of 6.0% during the forecast period.
For instance, Protak Scientific Ltd., a Europe-based innovative startup, invented and commercialized a new class of sterilization indicators known as Enzyme Indicators. The product uses a thermostable Adenylate kinase (tAK) enzyme isolated from thermophilic bacteria found in hot springs (Sulpholobus acidocaldarius).
| China Market Size (USD million) by End of Forecast Period (2033) | USD 32.7 million |
|---|---|
| CAGR % 2023 to End of Forecast (2033) | 5.3% |
China's biological and chemical indicators market is projected to attain a value of USD 32.7 million by the end of the forecast period in 2033, with a CAGR of 5.3% from 2023 to 2033. Increasing community and hospital-acquired infections create opportunities for biological and chemical indicators in the Chinese market.
The biopharmaceutical industry is actively engaged in the development of novel biologics and sensitive products. Among the newly commercialized biologics, the majority of therapeutics are formulated in the parenteral dosage form.
This increase in parenteral dosage manufacturing volume across the biopharmaceutical industry is expected to fuel the growth of China's biological and chemical indicators industry.
In 2022, India's demand for biological and chemical indicators was expected to grow at a market share of 72.0%. Outsourcing of biopharma research is done extensively in emerging countries like India.
The clinical trial partnership of various key players with emerging companies to speed up the clinical trial process is rising. The partnership is expected to help both companies to achieve the best results in less time. Such partnership agreements amongst players are likely to help gain traction in the Indian market.
| Top Sterilization Type | Thermal Sterilization |
|---|---|
| CAGR % 2023 to End of Forecast (2033) | 6.9% |
By sterilization type, thermal sterilization is anticipated to hold the largest share of 69.4% in 2022. The segment is anticipated to record a CAGR of 6.9% during the forecast period.
This is due to a significant preference for steam heat sterilization over other sterilization types owing to a high possibility of toxicity, handling risk, and environmental pollution associated with other sterilization types. Thermal sterilization uses the thermal liability of a microorganism to prevent its growth. Hence growing popularity and demand for this segment make it the leading one.
By indicator class, biological indicators are likely to lead the market and are projected to account for 85.8% of the total market revenue share in 2022.
The biological indicators segment is widely dominated due to regulatory recommendations to use biological indicators instead of chemical ones to achieve a high standard of sterility assurance. In addition, increasing commercialization of user-friendly biological indicators with rapid sterilization validation compliance is a key factor in the rising biological indicators adoption rate.
By form, self-contained BI is anticipated to hold the largest share of 42.0% in 2022. The high flexibility and efficiency of self-contained BI to deliver rapid results and an overall increase in operational efficiency leads this segment to hold the highest share.
| Top End User | Biopharma Industry |
|---|---|
| CAGR % 2023 to End of Forecast (2033) | 4.8% |
By End User, the biopharma industry is anticipated to hold nearly half of the global market share in revenue in 2022. The biopharma industry is anticipated to maintain the lead with a CAGR of 4.8% during the forecast period.
Among all end users, the biopharma industry is a leading segment that hospitals follow. The rising parenteral formulation, including new (biologics/synthetics) and generic formulations and stringent regulatory compliance requirements of sterilization validation, is rising the demand for sterilization indicators in the biopharmaceutical industry.
Companies operating in the biological and chemical indicators industry are naturally fragmented, with few players. These players are involved in several strategic alliances. The agreement and system automation accelerates the manufacturer’s strategy to capitalize on the market share and capture a significant market share.
Innovation is a major driver of growth in the biological and chemical indicators industry, with players continuously investing in research and development to improve their offerings. For instance, STERIS plc recently introduced a new range of chemical indicators that provide accurate and reliable monitoring of sterilization processes.
Similarly, 3M Company has developed a unique biological indicator system that can detect the presence of spores in just one hour.
One of the major challenges facing players in the biological and chemical indicators industry is the need for stringent regulatory compliance. Companies need to adhere to various regulatory guidelines to ensure the safety and efficacy of their products.
To address this challenge, players invest heavily in quality control and assurance measures to maintain compliance with regulatory standards.
Another challenge facing players in the industry is the increasing competition and pricing pressures. With new players entering the market, existing players need to differentiate themselves by offering unique value propositions and competitive pricing strategies.
Companies invest in marketing and branding initiatives to address this challenge to increase brand awareness and market share.
Latest Developments in the Biological and Chemical Indicators Industry:
| Attribute | Details |
|---|---|
| Forecast Period | 2017 to 2022 |
| Historical Data Available for | 2023 to 2033 |
| Market Analysis | USD million for Value |
| Key Countries Covered | USA, Canada, Brazil, Mexico, Argentina, Germany, United Kingdom, France, Italy, Spain, Russia, Nordic, China, Japan, South Korea, India, Indonesia, Malaysia, Thailand, Australia, New Zealand, GCC Countries, South Africa, Turkey |
| Key Segments Covered | Sterilization Type, Indicator Class, Packaging Form, End User, and Region |
| Key Companies Profiled | The 3M Company; Steris Plc.; Thermo Fisher Scientific, Inc.; Mesa Labs, Inc.; McKesson Medical-Surgical Inc.; Crosstex International, Inc.; Propper Manufacturing Co., Inc.; Terragene S.A.; Andersen Products, Inc.; Getinge AB; GKE-GmbH; Liofilchem S.r.l. /li>; Protak Scientific Ltd.; ParaSure Limited; Excelsior Scientific; Siltex Australia Pvt. Ltd. |
| Report Coverage | Market Forecast, Competition Intelligence, DROT Analysis, Market Dynamics and Challenges, Strategic Growth Initiatives |
| Customization & Pricing | Available upon Request |
The Biological and Chemical Indicators Market is set to attain a value of USD 490.3 million in 2023.
The Biological and Chemical Indicators Market is estimated to surpass USD 866.9 million by 2033.
The Biological and Chemical Indicators Market is projected to experience a CAGR of 5.9% through 2033.
Chinese population growth, rising healthcare costs, sepsis prevalence, and rising PCT assay knowledge all contribute to the country's market expansion.
The need for point-of-care services, the focus on patient safety, and technological advancements all contribute to the market's positive historical performance.
1. Executive Summary | Biological and Chemical Indicators Market
2. Market Overview
3. Market Background
4. Global Market Analysis 2018 to 2022 and Forecast, 2023 to 2033
5. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Sterilization Type
5.1. Thermal Sterilization
5.1.1. Steam Heat
5.1.2. Dry Heat
5.2. Chemical Sterilization
5.2.1. Ethylene Oxide
5.2.2. Hydrogen Peroxide
5.2.3. Formaldehyde
5.3. Radiation Sterilization
6. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Indicator Class
6.1. Biological Indicators
6.1.1. Geobacillus stearothermophilus (GS) Spores
6.1.2. Bacillus atrophaeus (BA) Spores
6.2. Chemical Indicators
6.2.1. Class 1 (Process)
6.2.2. Class 4 (Multi-Variable)
6.2.3. Class 2 (Specific-Use)
6.2.4. Class 3 (Single-Variable)
6.2.5. Class 5 (Integrating)
6.2.6. Class 6 (Cycle Verification)
6.3. Enzyme Indicators
7. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By End User
7.1. Biopharma Industry
7.2. Hospital & Clinics
7.3. Ambulatory Surgical Centres
7.4. Diagnostic Labs
7.5. Research Labs
8. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Region
8.1. North America
8.2. Latin America
8.3. Europe
8.4. South Asia
8.5. East Asia
8.6. Oceania
8.7. MEA
9. North America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
10. Latin America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
11. Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
12. South Asia Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
13. East Asia Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
14. Oceania Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
15. MEA Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country
16. Key Countries Market Analysis
17. Market Structure Analysis
18. Competition Analysis
18.1. The 3M Company
18.2. Steris Plc.
18.3. Thermo Fisher Scientific, Inc.
18.4. Mesa Labs, Inc.
18.5. McKesson Medical-Surgical Inc.
18.6. Crosstex International, Inc.
18.7. Propper Manufacturing Co., Inc.
18.8. Terragene S.A.
18.9. Andersen Products, Inc.
18.10. Getinge AB
18.11. GKE-GmbH
18.12. Liofilchem S.r.l.
18.13. Protak Scientific Ltd.
18.14. ParaSure Limited
18.15. Excelsior Scientific
18.16. Siltex Australia Pvt. Ltd.
19. Assumptions & Acronyms Used
20. Research Methodology
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Biological and Chemical Indicators Market
