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Sterility Testing Market Size, COVID-19 Impact Analysis, Regional Outlook, Application Development Potential, Price Trends, Competitive Market Share & Forecast, 2022 – 2028

  • Report ID: GMI4077

Sterility Testing Market Size is set to register a healthy CAGR between 2022 and 2028 owing to the growing need for reliable testing and the development of product-specific methods in the process of drug development. The industry growth is majorly driven by the increasing demand for cell line testing, in-process, media, and final product testing for the biopharmaceutical, pharmaceutical, and medical device industries.

On the basis of type, the reagents and kits segment is expected to record considerable expansion through 2028. This rise is credited to the availability of a range of products that help in minimizing the risk of false negative and false positive results. These also include sterility testing pumps that are designed for seamless integration into all testing environments and help in maximizing safety and streamlining workflow. The growing demand for similar products is slated to boost segmental growth over the estimated period.

Based on application, the pharmaceutical and biological manufacturing segment is estimated to account for a substantial share in the sterility testing market by 2028. This rise is attributed to the increasing regulatory intervention owing to the growing importance of sterility testing procedures in the process of pharmaceutical manufacturing. Several regulators have formulated a number of scientifically robust and product-specific protocols for ensuring compliance to these harmonized methods and avoiding the introduction of unnecessary risk, fueling segmental expansion through the coming years.

Citing the regional landscape, the North America sterility testing market share is projected to record commendable growth through 2028 owing to the rising advocation of sterility testing methods by regulators in the region. For instance, in September 2021, the U.S. FDA issued a draft guidance for helping manufacturers in controlling the microbiological contamination of their NSDs (non-sterile drugs). The guidance stems from the regulator’s concerns over a high number of recalls and adverse events associated with contaminated products.

Major players in the sterility testing market comprise Nelson Laboratories, Charles River, WuXi AppTec, Merck KGaA, biomerieux SA, SGS SA, Thermo Fisher Scientific, and others. These companies are taking keen interest in the adoption of acquisitions, mergers, partnerships, collaborations, and product developments for consolidating their position in the market.

Some of the instances have been mentioned below:

  • In October 2020, Thermo Fisher Scientific announced plans for the development of two new sterile filling lines in Singapore for the extension of capacity to the APAC region for the manufacturing and development of vaccines and therapies.
  • In September 2021, Nelson Labs and Sterigenics Germany GmbH launched an expanded center of excellence for increased sterilization capacity and microbiological laboratory testing in their Wiesbaden facilities. The expansion is expected to address the significantly escalated demand for these services by the pharmaceutical and medical device industries.

Impact of COVID-19 pandemic on sterility testing market outlook

The SARS-CoV-2 pandemic has triggered the demand for sterility testing of vaccines by various governments for determining if they do not have any kind of infective substance. For instance, in March 2021, the Oyo State government announced plans for conducting sterility test on the 127,740 doses of AstraZeneca COVID vaccines that were procured from the NPHDA (National Primary Healthcare Development Agency). Such factors are set to open a host of opportunities for the development of novel sterility testing methods through the pandemic period.

The sterility testing market research report includes in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2017 to 2028 for the following segments:

Market, by Product

  • Kits and Reagents
  • Instruments
  • Services

Market, by Test

  • Membrane Filtration
  • Direct Inoculation
  • Container Closure Integrity Test
  • Antimicrobial Effectiveness Testing
  • Rapid Micro Test
    • ATP Bioluminescence
    • Fluorescent Labelling
    • Electrical Resistance

Market, by Application

  • Pharmaceutical and Biological Manufacturing
  • Medical Devices Manufacturing
  • Other Applications

Market, by End-use

  • Pharmaceutical
  • Biotechnology
  • Contract Manufacturing Organization

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
    • Singapore
  • Latin America
    • Brazil
    • Mexico
  • Middle East and Africa
    • Saudi Arabia
    • South Africa


What Information does this report contain?

Historical data coverage: 2017 to 2021; Growth Projections: 2022 to 2028.
Expert analysis: industry, governing, innovation and technological trends; factors impacting development; drawbacks, SWOT.
6-7 year performance forecasts: major segments covering applications, top products and geographies.
Competitive landscape reporting: market leaders and important players, competencies and capacities of these companies in terms of production as well as sustainability and prospects.

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Our Market Research Reports Include:

  • Market snapshot
  • Market Segmentation
  • Value Chain Analysis
  • Growth Dynamics
  • Potential Market Opportunities
  • Regulatory Overview
  • Technology Evolution
  • Innovation & Sustainability

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