Sterility Testing Market Size, Industry Analysis Report, Regional Outlook, Application Development Potential, Price Trends, Competitive Market Share & Forecast, 2021 – 2027

Report ID: GMI4077

Summary Methodology

Sterility Testing Market size is projected to experience significant growth from 2019 to 2025.

The freedom from the presence of viable microorganisms is called as sterility. It is very hard to achieve absolute sterility. Therefore, when the probability is less than one out of one million that there is a contamination of replicating micro-organism then a container is defined as sterile. A wide range of biological medicinal products including blood products, vaccines, biotechnology products, cell products and tissue products undergo sterility testing as per WHO sterility guidelines. Companies such as pharmaceutical companies, biotechnology firms and medical device manufacturers perform sterility testing to examine process control, the quality of raw materials and validity of products.

The growing number of drug launches and increasing demand for medical devices will augment the sterility testing market over the forecast period. Moreover, improving focus on quality control as per instructions of regulatory bodies will drive the global sterility testing market.

Along with the advancements in pharmaceutical and medical field, the demand for sterility tests will also rise. Biotechnology industry is flourishing all over the globe, this factor will also boost the growth of sterility testing market over the forecast period. Safety concerns regarding biological medicinal products is also on a rise. Such factors will boost the sterility testing market in the forthcoming years.


New technological developments in the field of sterility testing have made the process more efficient that will drive market growth. However, lack of skilled professionals for conducting sterility tests and stringent government regulations could hamper industry growth all over the globe.

The kits and reagent segment are expected to contribute for the largest share by product in the global sterility testing market throughout the forecast period due to affordability and ease of use related to the product. The key factor contributing to the growth of kits and reagent segment is the repetitive purchase of these products by end users all around the world.

The U.S. held the largest share in the global sterility testing market in 2018 due to the availability of highly developed healthcare infrastructure, huge investment in pharmaceutical R&D, advanced technology as well as the presence of major market players in the region. Furthermore, the high healthcare expenditure will fuel market growth.

Japan is expected to show significant growth in the sterility testing market over the forecast period due to advancements in technology, rising quality standards in biotechnology and pharmacy and growing developments in the healthcare infrastructure. The above-mentioned factors will boost the demand for sterility testing.

Some of the key industry players include Charles River, Merck KGaA, SGS SA, WuXi AppTec, Thermo Fisher Scientific, Nelson Laboratories and biomérieux SA. Major strategic initiatives adopted by industry players include partnerships, mergers and innovative product launches to expand their business product portfolio.

Sterility Testing Market by Product, 2014-2025 (USD Million)

  • Kits and Reagents
  • Instruments
  • Services

Sterility Testing Market by Test, 2014-2025 (USD Million)

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

Sterility Testing Market by Application, 2014-2025 (USD Million)

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

Sterility Testing Market by End-use, 2014-2025 (USD Million)

  • 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

Company Profiles:

  • Charles River
  • Merck KGaA
  • SGS SA
  • WuXi AppTec
  • Thermo Fisher Scientific
  • Biomérieux SA
  • Nelson Laboratories

What Information does this report contain?

Historical data coverage: 2016 to 2020; Growth Projections: 2021 to 2027.
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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