Sterility testing Market Size Worth USD 75.37 Billion in 2032 | Emergen Research

Rising number of drug launches and increasing production capacities for pharmaceutical and biopharmaceutical industries for sterility testing are key factors driving Sterility testing market revenue growth

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.

Request Free Sample Copy (To Understand the Complete Structure of this Report [Summary + TOC]) @ https://www.emergenresearch.com/request-sample/2629

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.

Emergen Research is Offering Limited Time Discount (Grab a Copy at Discounted Price Now) @ https://www.emergenresearch.com/request-discount/2629

Scope of Research

Direct Order Can Be Placed Through This Link [Exclusive Copy] @ https://www.emergenresearch.com/select-license/2629

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
    1. Adenosine Triphosphate (ATP) Bioluminescence
    2. Fluorescent Labeling
    3. 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
    1. U.S.
    2. Canada
  • Europe
    1. Germany
    2. France
    3. UK
    4. Italy
    5. Spain
    6. Benelux
    7. Russia
    8. Rest of Europe
  • Asia Pacific
    1. China
    2. Japan
    3. South Korea
    4. India
    5. ASEAN Countries
    6. Oceania
    7. Rest of APAC
  • Latin America
    1. Brazil
    2. Mexico
    3. Rest of LATAM
  • Middle East & Africa
    1. GCC Countries
    2. Israel
    3. Turkey
    4. South Africa
    5. Rest of Middle East & Africa

Browse Full Report Description + Research Methodology + Table of Content + Infographics@ https://www.emergenresearch.com/industry-report/sterility-testing-market

Curated Reports You Shouldn’t Miss: Dive In Now!

Liquid Biopsy Market, By Product Type (Assays Kits, Instruments, Services), By Circulating Biomarkers, By Sample Type, By Technology, By Disease, By Application, By End-Use, and By Region Forecast to 2030

Microfluidics Market, By Material Type (Polymer, Silicon, Glass, Others), By Application (Point-of-Care Testing, Drug Delivery Systems, Others), By Components (Microfluidic Chips, Micropumps, Microneedles, Others), and By Region Forecast to 2030

Femtech Market By Type (Devices, Software, Services), By End-Use (Direct-to-Consumer, Hospitals, Fertility Clinics, Surgical Centers, Diagnostic Centers), By Application (Reproductive Health, Pregnancy & Nursing Care, Pelvic & Uterine Healthcare), By Region, Forecasts to 2027

Deep Brain Stimulation (DBS) Market By Product Type (Dual Channel, Single Channel, Rechargeable DBS Systems, Non-Rechargeable DBS Systems), By Application, By End-use, and By Region Forecast to 2032

Craniomaxillofacial Devices Market Analysis, By Product (Cranial Flap Fixation Device, CMF Distraction Device, Drugs), By Material (Metal Based Implants, Bioabsorbable Material), By Application, By End-Use, Forecasts to 2027

About Emergen Research

Emergen Research is a market research and consulting company that provides syndicated research reports, customized research reports, and consulting services. Our solutions purely focus on your purpose to locate, target, and analyze consumer behavior shifts across demographics, across industries, and help clients make smarter business decisions. We offer market intelligence studies ensuring relevant and fact-based research across multiple industries, including Healthcare, Touch Points, Chemicals, Types, and Energy.

Contact Us:

Eric Lee

Corporate Sales Specialist

Emergen Research | Web: https://www.emergenresearch.com/

Direct Line: +1 (604) 757-9756

E-mail: sales@emergenresearch.com

Explore Our Blogs and Insights Section: https://www.emergenresearch.com/insights