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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