Vancouver, Jan. 03, 2024 (GLOBE NEWSWIRE) -- The global sterility testing market witnessed a substantial size of USD 22.40 Billion in 2022, marking a remarkable surge. Projections indicate a rapid revenue Compound Annual Growth Rate (CAGR) of 12.9% during the forecast period, driven by an upswing in drug launches, expanding production capacities in pharmaceutical and biopharmaceutical industries, and intensified Research & Development (R&D) efforts for sterility testing.
Sterility testing, a critical process ensuring the absence of viable microorganisms in pharmaceutical and medical device products, serves as a cornerstone for quality control procedures. This process, aligned with regulatory guidelines, employs various techniques to detect microorganism presence. The market's growth is further propelled by the global surge in diseases, escalating demand for vaccines and drugs, and ongoing advancements in life sciences research.
In September 2022, the Indian government's announcement of a new cervical cancer vaccine underscores the pivotal role of sterility testing in ensuring product safety. Accessibility to Point of Care (POC) devices and expanding healthcare research further contribute to market growth.
However, challenges such as the high cost of sterility testing equipment and a shortage of skilled specialists due to stringent government regulations may impede market revenue growth. Industry consolidation, regulatory frameworks, and prolonged licensing procedures pose significant barriers for new entrants. Additionally, limitations in sterility testing, including potential false-positive or false-negative results, testing frequency constraints, sample size limitations, and detection sensitivity, necessitate a comprehensive understanding for standardized compliance.
Leading companies in the pharmaceutical and biopharmaceutical sectors are actively implementing Environmental Monitoring (EM) strategies to prevent sterility test failures. For instance, Charles River Laboratories introduced the Celsis automated detection system and the EndoScan-V software program for endotoxin testing.
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Product & Service Insights: Kits & Reagents Lead Market Share
The kits & reagents segment dominated the global sterility testing market in 2022, holding the largest revenue share. This can be attributed to the rising adoption of automated testing systems, necessitating the use of kits & reagents. Automated methods deliver faster and more accurate results crucial for quality control in pharmaceuticals and medical devices industries. The demand for specific kits and reagents is propelled by the usage of automated systems.
Test Type Insights: Membrane Filtration Segment Shows Steady Growth
The membrane filtration segment is anticipated to witness a steady and fast revenue growth rate in the global sterility testing market during the forecast period. Technological advancements in membrane filtration designs and operations enhance filtration efficiency, enabling low-temperature and low-energy filtering processes. The segment's growth is further driven by the increasing need for liquid dose formulation sterility testing.
Application Insights: Pharmaceutical and Biological Segment Dominates
The pharmaceutical and biological segment is projected to hold a significantly large revenue share in the global sterility testing market during the forecast period. This dominance is attributed to the growing demand for vaccines and drugs, the rapid expansion of the pharmaceutical industry, and increased regulatory actions requiring sterility testing for equipment.
Regional Insights: North America Leads, Asia Pacific Shows Fastest Growth
North America claimed the largest revenue share in the global sterility testing market in 2022, driven by substantial R&D expenditure, government regulations, and advancements in biotechnology and pharmaceuticals. Meanwhile, the Asia Pacific market is expected to register the fastest revenue growth rate, propelled by rapid urbanization, increased health consciousness, and rising disposable income.
As the industry continues to evolve, companies like Berkshire Sterile Manufacturing (BSM) in the U.S. and AUSTAR in China are introducing innovative technologies to enhance sterility testing capabilities, ensuring the safety and quality of pharmaceutical products.
In conclusion, the global sterility testing market is poised for robust growth, fueled by key factors such as increasing drug launches, R&D efforts, and the critical role of sterility testing in maintaining product safety. The market dynamics suggest promising opportunities for industry participants across various segments and regions.
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Scope of Research
| Report Details | Outcome |
| Market Size in 2022 | USD 22.40 Billion |
| CAGR (2023–2032) | 12.9% |
| Revenue Forecast To 2032 | USD 75.37 Billion |
| Base Year For Estimation | 2022 |
| Historical Data | 202019–2021 |
| Forecast Period | 2023–2032 |
| Quantitative Units | Revenue in USD Billion and CAGR in % from 2023 to 2032 |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Segments Covered | Product & service, teat type, application, end-use, and region |
| Regional Scope | North America, Europe, Asia Pacific, Latin America, and Middle East & Africa |
| Country Scope | U.S., Canada, Mexico, Germany, France, UK, Italy, Spain, Benelux, Russia, Rest of Europe, China, India, Japan, South Korea, ASEAN Countries, Oceania, Rest of APAC, Brazil, Rest of LATAM, Saudi Arabia, UAE, South Africa, Turkey, and Rest of Middle East & Africa |
| Key Companies Profiled | Baxter, Berkshire Sterile Manufacturing, BioConvergence LLC, bioMerieux, Inc., Boston Analyics, Charles River Laboratories, Danaher Corporation, Gibraltar Laboratories, LexaMed, Merck KgaA, Neopharm Labs, Pacelabs, Sartorius AG, SGS SA, SOLVIAS AG, Thermo Fisher Scientific, Inc., Wuxi AppTec, STERIS, Becton, Dickinson and Company, and Rapid Micro Biosystems, Inc. |
| Customization Scope | 10 hours of free customization and expert consultation |
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Major Companies and Competitive Landscape
The global sterility testing market is fairly fragmented with many large and medium-sized players accounting for majority of market revenue. Major players are deploying various strategies, entering into mergers & acquisitions, strategic agreements & contracts, developing, testing, and introducing more effective sterility testing products in the market. Some major players included in the global sterility testing market report are:
- Baxter
- Berkshire Sterile Manufacturing
- BioConvergence LLC
- bioMerieux, Inc.
- Boston Analyics
- Charles River Laboratories
- Danaher Corporation
- Gibraltar Laboratories
- LexaMed
- Merck KGaA
- Neopharm Labs
- Pacelabs
- Sartorius AG
- SGS SA
- SOLVIAS AG
- Thermo Fisher Scientific, Inc.
- Wuxi AppTec
- STERIS
- Becton, Dickinson and Company
- Rapid Micro Biosystems, Inc.
Strategic Development
- In April 2023, Milliflex introduced the Rapid System 2.0, an automated sterility testing kit, which can optimize the test result in 5 days rather than the typical 14 days. Image analysis, ATP bioluminescence, and membrane filtration are some of the technologies that Milliflex utilizes. It takes 90 seconds to view these automatic results in 2D as well as 3D with an extensive evaluation.
- In April 2023, STEMart, a U.S. based service provider, launched sterility testing services based on the ISO 11731 technique for all medical devices. Medical device sterility is determined by sterility testing, whereas bioburden testing calculates the quantity of bacteria on a device's surface. The aim of sterility testing is to identify growth of fungi and bacteria to prevent false negative results in sterility tests. The process for evaluating the sterilization of medical devices can be found in ISO 11731.
Segments Covered in Report
For the purpose of this report, Emergen Research has segmented the global sterility testing market on the basis of product & service, teat type, application, end-use, and region:
- Product & Service Outlook (Revenue, USD Billion; 2019-2032)
- Kits & Reagents
- Services
- Instruments
- Test Type Outlook (Revenue, USD Billion; 2019-2032)
- Membrane Filtration
- Direct Inoculation
- Container Closure Integrity Test
- Antimicrobial Effectiveness Testing
- Rapid Micro Test
- Adenosine Triphosphate (ATP) Bioluminescence
- Fluorescent Labeling
- Electrical Resistance
- Application Outlook (Revenue, USD Billion; 2019-2032)
- Pharmaceutical and Biological
- Medical Devices
- Other Applications
- End-use Outlook (Revenue, USD Billion; 2019-2032)
- Pharmaceutical Companies
- Biotechnology Companies
- Others
- Regional Outlook (Revenue, USD Billion; 2019–2032)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Italy
- Spain
- Benelux
- Russia
- Rest of Europe
- Asia Pacific
- China
- Japan
- South Korea
- India
- ASEAN Countries
- Oceania
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Rest of LATAM
- Middle East & Africa
- GCC Countries
- Israel
- Turkey
- South Africa
- Rest of Middle East & Africa
- North America
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