Sterility Testing Market Size, Share, Industry, Forecast and Outlook (2024-2031)

Sterility Testing Market is Segmented By Product Type (Kits and Reagents), By Test Type (Membrane Filtration, Direct Inoculation, Other ), By Application (Pharmaceutical and Biological Manufacturing, Medical devises Manufacturing, Other), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031

Sterility Testing Market Overview

Sterility Testing Market is expected to grow at a CAGR of 12.22% during the forecast period (2024-2031).

Sterility testing is a GMP (Good Manufacturing Process) microbiology testing requirement to ensure that sterile products are free of viable microorganisms before release and patient administration.

Sterility Testing Market Summary

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Sterility Testing Market Dynamics and Trends

The major factors contributing to the growth of the global sterility testing market are the increasing R&D, and the increasing number of drug approvals is expected to drive the market growth.

The increasing number of drug approvals is expected to drive the market growth in the forecast period

The development or validation of product-specific methods and reliable sterility testing are critical steps in drug development. Sterility testing is required to ensure no viable contaminating microorganisms in a product. This testing is done in an isolator or cleanroom environment using direct inoculation or membrane filtration methods. Pharmaceutical articles must be sterile tested during the sterilization validation process and routine release testing. USP requirements use sterility testing as an official test to determine the suitability of a lot.

For instance, according to the Congressional Budget Office's April 2021 report on "Research and Development in Pharmaceutical Industry," there was a 60% increase in the number of new drugs approved for sale in the United States between 2010 and 2019, with 59 new drugs approved in the country in 2018. Hence, with increasing drug approvals and launches, the global sterility testing market is expected to grow in the forecast period.

The problems associated with sterility testing is expected to hamper the market growth

In addition to the significant limitation of testing sterilized products, there is also the uncertainty associated with sterility testing execution. Contamination of the test by non–product-related microorganisms is one of the issues with sterility testing. The USP describes a typical contamination rate for sterility testing of 0.1 percent or 1 per 1,000 samples. This level is likely to rise as test article size, complexity, and manipulation increase. Thus, even if one attempted to test the fully sterilized product with the massive sample size required to verify a typical SAL of 106, the test method would almost certainly fall short of the required precision. In addition to the significant limitation of testing sterilized products, there is also the uncertainty associated with sterility testing execution.

COVID-19 Impact Analysis on Sterility Testing Market

The COVID-19 pandemic forced most pharmaceutical and biotechnological companies to focus on research and development to identify leads that can diagnose and treat the SARS-CoV-2 infection, as well as forcing them to look beyond just conventional medicine and therapy, resulting in massive investment in research and development activities by private and government entities all over the world, significantly increasing the growth of sterility testing market.

Based on application, the pharmaceutical and biological manufacturing segment is expected to drive the market growth

Sterility testing is performed at all pharmaceutical and biological product manufacturing levels to reduce the risk of product contamination. The rapid growth of the pharmaceutical and biological industries will significantly increase the overall use of sterility testing, resulting in high demand for sterility testing products and solutions. Sterility testing is performed in the manufacturing process of any pharmaceutical or biological product for raw materials, finished product, and even before the final product is released to ensure the absence of microorganisms as per the mandated regulations of the regulatory authority or institutions, and as the demand for pharmaceutical and medical products for various health conditions increases, so does the frequency of sterility testing in the industries. Furthermore, rising investment in research and development and increasing regulatory approvals for drugs and other biologics are propelling new drugs and products, which is expected to fuel the market in the coming years.

For instance, on 22nd November 2019,  Reading Scientific Services Ltd. launched a fast, responsive, and flexible sterility testing service for pharmaceutical companies.

Global Sterility Testing Market Geographical Share

North America region is expected to hold the largest market share in the global sterility testing market

The increased research and innovation in the biotechnology and pharmaceutical industries in the regions increased investment in research and development activities in the life sciences and medical technology, and favorable government initiatives are expected to drive the market growth. For instance, according to Statistics Canada's May 2021 report "The Canadian Research and Development Pharmaceutical Sector," in 2018, the pharmaceutical sector added nearly USD 15 billion in value-added to the Canadian economy while spending approximately USD 1.5 billion to USD 2 billion on research and development.

Furthermore, high-end research activities in academics and research institutes will drive the growth of the country's sterility testing market over the forecast period.

Sterility Testing Market Companies and Competitive Landscape

The global sterility testing market is highly competitive with mergers, collaborations, and product launches. Some of the major key players in the market are BioMérieux, Charles River Laboratories, Inc., Merck KGaA, Sartorius AG, SGS S.A., Sotera Health LLC, Thermo Fisher Scientific, Alcami Corporation, Redberry, Lucideon

Redberry

Overview: Redberry company creates new platforms to avoid the culture phase of microorganisms in industrial microbiology and thus provide immediate results at previously unheard-of costs, performance, and ease-of-use. It was founded in 2017.

Product Portfolio:Red One, a fully automated rapid microbial detection. Red One detects viable active microorganisms (bacteria, yeasts, and moulds) and eukaryotic cells. It can count samples with concentrations ranging from 10 to 5 10e5 microorganisms per cap (linear range).

Key Developments: On December 14th, 2020, Redberry launched Red One, a fully automated rapid microbial detection platform for in-process control and the release of industrial products.