Allied Market Research

2024

Sterility Testing Market

Sterility Testing Market Size, Share, Competitive Landscape and Trend Analysis Report, by Type, by Application and, by End User : Global Opportunity Analysis and Industry Forecast, 2023-2032

LS : Diagnostics and Biotech

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Author's: | Roshan Deshmukh
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Sterility Testing Market Outlook - 2027

Sterility can be defined as the freedom from the presence of viable microorganisms. In pharmaceutical practice, a container is defined as sterile when the probability is less than one out of one million that it is contaminated with replicating microorganisms. Because it is not possible to open and test each container of a biological medicinal product, a number of samples, representative of the lot being tested and taken at different times during the filling operation, must be used to monitor sterility. This implies that when only a few non-sterile containers exist in a very large set of homogeneous containers the probability of detecting a non-sterile container is relatively low. For this reason sterility testing uses methods with broad sensitivity, normally incubation of samples in growth media promoting growth across a wide range of microorganisms where replication can be detected visually. Sterility also relies on procedural measures that effectively prevent contamination of biological materials, such as clean room technology and other Good Manufacturing Practices. Tests for viral contaminants, which are normally specified in individual product requirements, are more complex and costly. The WHO sterility testing guidelines are applicable across a wide range of biological medicinal products including vaccines, blood products, biotechnology products, and cell and tissue products.

Covid-19 Scenario analysis:

While pharma and biotech firms race to develop a cure for Coronavirus SARS-CoV-2 (COVID-19), the need for rapid testing to ensure a vaccine is safe, effective, and accepted by regulatory authorities is critical. Every vaccine and injection that is administered to patients is required to be deemed sterile through final product sterility testing. The current method that many vaccine manufacturers use requires a 14-day sterility test, meaning each lot of vaccine must wait two weeks until it can be released to the public. Combined with additional production wait times incurred by in-process control tests using traditional methods, providing life-saving therapies to patients is being unnecessarily delayed. In preparation for mass production and global demand, manufacturers and governments need to seek faster solutions ahead of regulatory approval of a COVID-19 vaccine. Thus, the market is constantly in search for efficient sterility test during pandemic times too.

Top impacting factors: Market Scenario Analysis, Trends, Drivers and Impact analysis:

Drivers:

New emerging technologies:

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. Membrane filtration sterility testing method is the method of choice for the filterable pharmaceutical products. According to the USP <71> in this sterility testing method products are filtered through 0.45 or 0.2-micron membrane filter. The filters are then rinsed with appropriate USP fluid to remove the inhibitors and then transferred into fluid thioglycollate medium (FTM) and soybean casein digest medium (SCDM). Both media are incubated for 14 days and checked every day for the presence of microbial growth. USP<71> Sterility testing suggest the use of fluid thioglycollate medium (FTM) and soybean casein digest medium (SCDM) because of their ability to promote the growth of anaerobic and aerobic microorganisms respectively. Techniques like these are drivers for market.

Growth of pharmaceutical industries:

The global pharm market was worth $934.8 billion in 2017 and will reach $1170 billion in 2021, growing at 5.8%. This is an accelerated pace compared to 5.2% for the years before 2017, but is slower than the other two large healthcare segments, medical equipment and healthcare services. Healthcare as a whole is growing at over 7% year on year. In pharmaceutical and biopharmaceutical industries, sterility testing is carried out at all levels of manufacturing to minimize the risk of product contamination. Subsequently, the growth of this end-use industry in the coming years will considerably boost the overall use of sterility testing. With stringent regulatory controls in place, process monitoring and quality control are carried out for the entire production chain of pharmaceutical and biopharmaceutical products. In this process, sterility testing is carried out for raw materials, bulk lot release testing, and final product release testing. In the recent years, an impressive growth was witnessed in the pharm and biotech sectors, by application; thus, the pharmaceutical and biological manufacturing market had acquired a good market share globally and is driving force for market.

Restrains:

The lack of skilled professionals for conducting sterility tests.

Also, stringent government regulations.

The above factors are the reason for the restrains of the Sterility testing market.

Key benefits of the report:

  • This study presents the analytical depiction of the global Sterility Testing industry along with the current trends and future estimations to determine the imminent investment pockets.
  • The report presents information related to key drivers, restraints, and opportunities along with detailed analysis of the global Sterility Testing market share.
  • The current market is quantitatively analyzed to highlight the global Sterility Testing market growth scenario.
  • Porter’s five forces analysis illustrates the potency of buyers & suppliers in the market.
  • The report provides a detailed global Sterility Testing market analysis based on competitive intensity and how the competition will take shape in coming years.

Questions answered in the Sterility Testing Market research report:

  • What are the leading market players active in the Sterility Testing market?
  • What the current trends will influence the market in the next few years?
  • What are the driving factors, restraints, and opportunities in the market?
  • What are the projections for the future that would help in taking further strategic steps?

Sterility Testing Market Report Highlights

Aspects Details
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By Type
  • Product Flush Sterility Testing Membrane
  • Filtration Sterility Testing
  • Direct Transfer Sterility Testing
  • Others
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By Application
  • Pharmaceutical and Biological Manufacturing
  • Medical Devices Manufacturing
  • Other Applications
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By End User
  • Pharmaceutical industries
  • Biotechnology
  • Research Diagnostic
  • Contract Manufacturing Organization
  • Diagnostic
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By Region
  • North America  (U.S., Canada, Mexico)
  • Europe  (Germany, France, Italy, UK, Spain, Rest of Europe)
  • Asia-Pacific  (Japan, China, India, Australia, South Korea, Rest of Asia-Pacific)
  • LAMEA  (Brazil, South Africa, Saudi Arabia, Rest of LAMEA)
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Key Market Players

Nelson Laboratories, Sartorius AG, Merck KGaA, SGS S.A, Danaher Corporation, Thermo Fisher Scientific Inc, Pacific Biolabs, Biomérieux SA, Charles River Laboratories International, Toxikon Corporation

Key Market Players
Other Players

Wuxi Apptec, Rapid Micro Biosystems, Sigma-Aldrich Co. LLC.,

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Sterility Testing Market

Global Opportunity Analysis and Industry Forecast, 2023-2032