Sterility Testing Market Analysis 2024 | Industry Analysis, Forecasts 2032, Growth Opportunities and Revenue
Rising number of drug launches and increasing production capacities for pharmaceutical and biopharmaceutical industries and Research & Development (R&D)
VANCOUVER, BRITISH COLUMBIA, CANADA, June 28, 2024 /EINPresswire.com/ -- The global sterility testing market size was USD 22.40 Billion in 2022 and is expected to register a rapid revenue CAGR of 12.9% during the forecast period. The global sterility testing market is experiencing robust growth, driven by an increasing number of drug launches and expanding production capacities in the pharmaceutical and biopharmaceutical sectors. Sterility testing, a crucial process ensuring product safety by detecting viable microorganisms, is integral to maintaining quality standards in pharmaceuticals and medical devices.
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Key Factors Driving Market Growth:
Rising Demand: Increasing prevalence of diseases and the urgent need for vaccines and drugs are major drivers of market revenue.
Technological Advancements: Advances in Point of Care (POC) testing devices and healthcare research contribute significantly to market expansion.
Industry Developments: Collaborations and expansions among industry players enhance market dynamics, ensuring efficient sterility testing processes.
Recent Developments: Recent collaborations and expansions, such as the establishment of enhanced microbiological laboratory facilities in Wiesbaden, Germany, reflect industry efforts to meet growing demand for stringent quality control measures.
Challenges: However, challenges such as the high cost of testing equipment and regulatory complexities pose constraints to market growth. Stringent regulations and the shortage of skilled professionals further challenge market expansion efforts.
Market Segmentation:
Product & Service: The market is segmented into services, instruments, and kits & reagents, with kits & reagents holding a significant market share due to their essential role in automated testing systems.
Test Type: Membrane filtration dominates the market, driven by technological advancements enhancing filtration efficiency and operational effectiveness.
Application: The pharmaceutical and biological segment leads in market share, driven by increasing pharmaceutical production and stringent regulatory requirements.
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Sterility Testing Top Companies and Competitive Landscape
The global sterility testing market is fairly fragmented with many large and medium-sized players accounting for the majority of market revenue. Major players are deploying various strategies, entering 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.
Sterility Testing Latest Industry News
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.
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Sterility Testing Market Segment Analysis
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
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