Sterility Testing Market Worth $1.9 Billion by 2028 | Research Report With New Growth-Boosting Business Opportunities

Some of the leading players operating in the sterility testing market are Charles River Laboratories (US), Merck KGaA (Germany), bioMérieux SA (France), SGS SA (Switzerland), WuXi AppTec (China), Nelson Laboratories, LLC (US)
The sterility testing industry is expected to grow significantly in the near future. This growth is driven by increasing demand from biopharmaceutical and medical device manufacturers, as well as stricter regulatory requirements for sterility testing.

Sterility Testing Market in terms of revenue was estimated to be worth $1.1 billion in 2023 and is poised to reach $1.9 billion by 2028, growing at a CAGR of 10.5% from 2023 to 2028 according to a new report by MarketsandMarkets™. Rising expansion of pharmaceutical & biopharmaceutical production capacities, increasing development of novel biopharmaceutical products, and rising investments in life science research are the key factors driving the growth of this market. However, the growing adoption of single-use technology is a major factor restraining the market growth.

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The kits & reagents segment accounted for the largest share of the product & service segment in 2022

On the basis of product & service, the sterility testing market is segmented into kits & reagents, instruments, and services. In 2022, the kits & reagents segment accounted for the largest market share in sterility testing. Kits & reagents are widely used in the pharmaceutical and biotechnology industries as it is easy to use. Moreover, the long shelf life of these products is contributing to their rising adoption in academic institutions and contract research organizations.

 By test-type segment, membrane filtration accounted for the largest market share in 2022

Based on the test type, the sterility testing market is divided into membrane filtration, direct inoculation, and other tests. The membrane filtration segment accounted for the biggest share of the sterility testing market in 2022. Factors such as the growing demand for sterility testing of liquid dose formulations and the utility of such tests in samples containing preservatives and bacteriostatic & fungistatic compounds will boost segmental growth.

In 2022, the Asia region accounted as the fastest-growing region in the market

In 2022, the Asia region accounted for the fastest-growing region of the sterility testing market. Factors responsible for the growth of this region include the rising trend of outsourcing pharmaceutical activities to CROs and CDMOs coupled with growing demand from emerging markets such as China and India.Moreover, growing public and private investments in pharmaceutical and biopharmaceutical R&D activities in the region will also propel the growth of Asian sterility testing market over the forecast period.

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Sterility Testing Market Dynamics:


Rising expansion of pharmaceutical & biopharmaceutical production capacities
Increasing development of novel biopharmaceutical products
Rising investments in life science research


Growing adoption of single-use technology
Stringent regulatory guidelines for product approval


Emerging markets
Increasing outsourcing of services to sterility testing providers


Shortage of skilled professionals

Key Market Players:

Some of the leading players operating in the sterility testing market are Charles River Laboratories (US), Merck KGaA (Germany), bioMérieux SA (France), SGS SA (Switzerland), WuXi AppTec (China), Nelson Laboratories, LLC (US), Pacific BioLabs (US), Sartorius AG (Germany), Thermofisher Scientific Inc. (US), and Samsung Biologics (South Korea).

The study includes an in-depth competitive analysis of these key players in the sterility testing market with their company profiles, recent developments, and key market strategies.

Recent Developments

In November 2022, Merck KGaA (Switzerland) invested USD 306.5 million in expanding its biosafety testing capacity at Rockville, Maryland, US. This site will provide biosafety testing and analytical development services in the US.
In September 2022, Merck KGaA (Switzerland) opened its viral clearance (VC) laboratory as the first phase of the China Biologics Testing Center. This site is set to operate in China and will locally conduct viral clearance studies across pre-clinical development to commercialization.
In June 2022, Charles River Laboratories, Inc. (US) opened a new facility of High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, UK. The 16,000 sq. ft facility will provide plasmid DNA manufacturing services.
In May 2022, bioMérieux SA (France) acquired Specific Diagnostics (US). With this acquisition, bioMérieux will improve its presence in antimicrobial resistance while expanding its market-leading position globally in clinical microbiology.

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Sterility Testing Market Advantages:

Sterility testing offers improved accuracy and precision in the assessment of the sterility of pharmaceutical products.
It allows manufacturers to quickly detect any contaminants and thus ensure the safety of their products.
It is cost effective as it can be used to assess a large number of samples at once.
Sterility testing is highly reliable and offers a reliable measure of sterility for a given sample.
It is a relatively quick process and does not require complex equipment.
Sterility testing is a relatively simple procedure and can be done in-house by the manufacturer.
It helps to reduce the risk of product contamination and ensure the quality of the product.
Sterility testing can be used to detect the presence of micro-organisms that could potentially cause serious illnesses or even death.

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