[Latest Market Insights] Global Pharmaceutical Sterility Testing Market Forecasted to reach US$ 2.3 billion by 2028, registering a CAGR of over 10% - Says RationalStat

According to a deep-dive market assessment by RationalStat, the global pharmaceutical sterility testing market has been analyzed on the basis of market segments, including industry, and geography/regions (incl. North America, Latin America, Western Europe, Eastern Europe, Middle East & Africa, and Asia Pacific). The report also offers global and regional market sizing for the historical period of 2019-2022 and the forecast period of 2019-2028.


Wilmington, Delaware, Aug. 16, 2023 (GLOBE NEWSWIRE) -- A mix of regulatory regulations, industry expansion, technical improvements, and a heightened focus on patient safety drives the global pharmaceutical sterility testing market. The demand for rigorous sterility testing techniques and services is projected to remain high as the pharmaceutical industry evolves.

The Global Pharmaceutical Sterility Testing Market is estimated at US$ 1.3 billion in 2022 and is expected to grow at a significant CAGR of over 10% during the forecast period of 2019-2028, analysis by RationalStat

Market Scope and Report Overview

Market intelligence for the global pharmaceutical sterility testing market covers market sizes on the basis of market value (US$/EUR Million) and volume (units) by various products/services/equipment, demand assessment across the key regions, customer sentiments, price points, cost structures, margin analysis across the value chain, financial assessments, historical and forecast data, key developments across the industry, import-export data, trade overview, components market by leading companies, etc.

In addition, the long-term sector and products/services 10-year outlook and its implications on the pharmaceutical sterility testing market. It also includes the industry's current state – Production Levels, Capacity Utilization, Tech quotient, etc. Key information will be manufacturing capacity by country, installed base, import volumes, market size, key players, market size, dynamics, market data, insights, etc.

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Global Pharmaceutical Sterility Testing Market: Segmental and Market Share Analysis

On the basis of product, with a revenue share of 65% in 2022, the kits and reagents segment dominates the global pharmaceutical sterility testing market. Because such things are widely available. Furthermore, the segment's growth is being driven by the convenience of use and repeat purchasing of these devices.

On the basis of manufacturing type, the outsourcing segment dominated the global pharmaceutical sterility testing market in 2022. Outsourcing saves pharmaceutical and medical device businesses time and money because they don't have to hire and educate new people or invest in new equipment.

On the basis of test type, bacterial endotoxin testing is essential for all medications given intravenously. These tests are also used to evaluate medical items like implants. The increased need for parenteral medications and implants is fueling the global pharmaceutical sterility testing market expansion.

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Competition Analysis and Market Structure

These players adopt various strategies in order to reinforce their market share and gain a competitive edge over other competitors in the market. Mergers & acquisitions, partnerships and collaborations, and product launches are some of the strategies followed by industry players.  Some of the key developments in the global pharmaceutical sterility testing market include,

  • In June 2022, Berkshire Sterile Manufacturing (BSM), a fill-finish CMO located in Lee, MA announced that its sterility testing isolator is ready to perform onsite sterility testing for its GMP batches. The new service is expected to shorten the release for most if not all the company’s clients.
  • In September 2021, Nelson Labs and Sterigenics Germany GmbH announced the opening of a newly expanded center of excellence for microbiological laboratory testing as well as increased sterilization capacity in their Wiesbaden, Germany, facilities.
  • In October 2019, Alcami Corporation, a provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, announced the launch of its new rapid sterility offering, a service that leverages cutting-edge microbiological testing technology to deliver significantly faster-testing results to clients. Alcami invested in the Milliflex Rapid System for the rapid sterility test, which uses adenosine triphosphate (ATP) bioluminescence for the detection of microorganisms after five days.

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Market Segmentation: Global Pharmaceutical Sterility Testing Market Analysis 

RationalStat has segmented the global pharmaceutical sterility testing market on the basis of product, application, test type, manufacturing type, end-use, and region.

  • Global Pharmaceutical Sterility Testing Market Value (US$ Million), Volume (‘000 units), and Market Share (2019-2028) Analysis by Product
    • Kits and Reagents
    • Instruments
    • Services
  • Global Pharmaceutical Sterility Testing Market Value (US$ Million), Volume (‘000 units),and Market Share (2019-2028) Analysis by Application
    • Sterile Drugs
    • Medical Devices
    • Biologics and Therapeutics
  • Global Pharmaceutical Sterility Testing Market Value (US$ Million), Volume (‘000 units), and Market Share (2019-2028) Analysis by Test Type
    • Sterility Testing
      • Membrane Filtration
      • Direct Inoculation
    • Bioburden Testing
    • Bacterial Endotoxin Testing
    • Container Closure Integrity Testing
    • Rapid Micro Test
      • ATP Bioluminescence
      • Fluorescent Labeling
      • Electrical Resistance
    • Others (Antimicrobial Effectiveness Testing, etc.)
  • Global Pharmaceutical Sterility Testing Market Value (US$ Million), Volume (‘000 units), and Market Share (2019-2028) Analysis by Manufacturing Type
    • In-House
    • Outsourced
  • Global Pharmaceutical Sterility Testing Market Value (US$ Million), Volume (‘000 units), and Market Share (2019-2028) Analysis by End User
    • Compounding Pharmacies
    • Medical Devices Companies
    • Pharmaceutical Companies
  • Global Pharmaceutical Sterility Testing Market Value (US$ Million), Volume (‘000 units), and Market Share (2019-2028) Analysis by Region
    • North America Pharmaceutical Sterility Testing Market
      • US
      • Canada
    • Latin America Pharmaceutical Sterility Testing Market
      • Brazil
      • Mexico
      • Rest of Latin America
    • Western Europe Pharmaceutical Sterility Testing Market
      • Germany
      • UK
      • France
      • Spain
      • Italy
      • Benelux
      • Nordic
      • Rest of Western Europe
    • Eastern Europe Pharmaceutical Sterility Testing Market
      • Russia
      • Poland
      • Hungary
      • Other CIS Countries
      • Rest of Eastern Europe
    • Asia Pacific Pharmaceutical Sterility Testing Market
      • China
      • Japan
      • India
      • South Korea
      • Australia
      • ASEAN
        • Indonesia
        • Thailand
        • Philippines
        • Vietnam
        • Malaysia
        • Rest of ASEAN
      • Rest of Asia Pacific
    • Middle East & Africa Pharmaceutical Sterility Testing Market
      • GCC
        • Saudi Arabia (KSA)
        • United Arab Emirates (UAE)
        • Rest of the GCC
      • South Africa
      • Nigeria
      • Turkey
      • Rest of the Middle East & Africa
  • Leading Companies and Market Players
    • Charles River Laboratories International, Inc.
    • Sartorius AG
    • Merck KGaA
    • Thermo Fisher Scientific Inc.
    • bioMérieux SA
    • WuXi AppTec Co., Ltd.
    • SGS SA
    • Nelson Laboratories, LLC
    • Pace Analytical Services, LLC
    • Toxikon Corporation

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Key Questions Answered in the Pharmaceutical Sterility Testing Market Report:

  • What will be the market value of the Global Pharmaceutical Sterility Testing Market by 2028?
  • What is the market size of the Global Pharmaceutical Sterility Testing Market?
  • What are the market drivers of the Global Pharmaceutical Sterility Testing Market?
  • What are the key trends in the Global Pharmaceutical Sterility Testing Market?
  • Which is the leading region in the Global Pharmaceutical Sterility Testing Market?
  • What are the major companies operating in the Global Pharmaceutical Sterility Testing Market?
  • What are the market shares by key segments in the Global Pharmaceutical Sterility Testing Market?

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