Sterility Testing Market Size, Share & Trends Analysis Report By Test Type (Rapid Sterility Tests, Conventional Sterility Tests), By Product Type (Instruments, Kits & Reagents, Others), By Application (Medical device Manufacturing, Biopharmaceutical Manufacturing, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Market Overview

The global sterility testing market size was valued at USD 1.15 billion in 2022. It is projected to reach USD 2.39 billion by 2031, growing with a CAGR of 8.4% during the forecast period (2023–2031).

Sterile generally refers to the absence of any bacteria, viruses, or other living microbes. Sterility testing is used to determine whether biological parenteral intended for human use contain any extraneous viable contaminating microorganisms. Sterility testing is used for quality assurance in the biopharmaceutical industry and medical devices industries. Skilled professionals are required to carry out the sterility testing procedure, which assures authentic sterility test data. Sterility testing is a crucial step in producing pharmaceuticals, medical devices, and drugs to determine how well a sterilization process works. It is done at every production stage to lower the possibility of product contamination. Sterility testing exclusivity in various industries is the factor for the rise in demand which is anticipated to boost market growth across the globe. The pharmaceutical and medical sectors are the primary areas where sterility testing of the products remains a crucial and common work for microbiologists. Sterility testing processes are used for products in many industries, including food and beverage makers. Ongoing research & development, a surge in the prevalence of diseases, and a rise in demand for sterility testing are some of the factors driving the global sterility testing market. The high prevalence of chronic diseases such as cancers, cardiac diseases, and other severe diseases across the globe is a vital factor for increasing demand for sterility testing. 

Market Dynamics

Global sterility testing market drivers

Growth of the pharmaceutical industry

To be utilized by medical professionals on patients, all pharmaceutical items must be of the utmost quality and be extremely safe. Otherwise, it could harm the patients. The offered product is confirmed to be suitably sterile through sterility testing. Sterility testing is done in the pharmaceutical industry at every production stage to reduce the danger of product contamination. Therefore, the expansion of the pharmaceutical industry in the upcoming years will significantly increase sterility testing's total utilization. Process monitoring and quality control are conducted across the whole production chain of pharmaceutical and biopharmaceutical products due to the strict regulatory controls in place. Sterility testing is done during the procedure for raw materials, bulk lot releases, and final product releases.

Increase in research and development

The sterility testing industry is growing as a result of the increased governmental and private funding for research and development in biosciences. For instance, the Department of Biotechnology (DBT) of India received a budget of INR 35 billion, a 25% increase from the budget for 2020–21. This funding will be used primarily for biotechnology research and development will help the sterility testing market expand. Other factors supporting the market growth are developing diagnostics & healthcare infrastructures and growing pharmaceutical and biotechnology companies worldwide.

Global sterility testing market restraint

Stringent government regulations

Stringent regulatory guidelines and time-consuming approval processes are the vital factors that are likely to affect the sterility testing market adversely and restrain the market growth during the forecast period. Other factors which may slow the market growth are a lack of skilled professionals and a high degree of consolidation, which acts as a barrier for new entrants to the market.

Regional Analysis

In terms of region, the global sterility testing market is segmented into North America, Europe, Asia Pacific, the Middle East & Africa, and Latin America.

North America dominates the global sterility testing market. The presence of leading biopharmaceutical and biotechnology companies, along with ongoing research & development for cures for chronic diseases, are some of the other factors supporting the market growth in the region. The market's expansion is primarily driven by an increase in the production of medical products and equipment, the prevalence of infectious disorders, and R&D activities. As per the Centers for Disease Control and Prevention, about half of all adults in the United States have one or more chronic health issues. The market has been greatly impacted by research activities that have increased in intensity due to the rising number of disorders. The market growth in this region has also been fueled by technical advancements, pharmaceutical industry expansion, increased government assistance, and increased R&D spending.

Europe’s sterility testing market is expected to experience significant growth over the forecast period. A high number of diagnostics labs and research & development facilities in the region and a rise in the demand for sterility testing are some of the vital factors driving the Europe market. The European market is also driven by high healthcare costs, government funding for R&D, and a large patient population. The market is expanding due to the expanding biotechnology and pharmaceutical sectors. Additionally, the presence of developed economies in the area, such as the United Kingdom and France, promotes market expansion during the anticipated timeframe.

Asia Pacific is the fastest-growing market for sterility testing owing to the high number of pathology labs, diagnostics labs, and research & development facilities. The increasing prevalence of chronic diseases in the region is the other factor for the rise in demand for sterility testing in the Asia Pacific region. Due to a rise in the number of new pharmaceuticals being approved and considerable spending on quality control, Japan holds a significant portion of the market. China and India have expanding markets due to their large populations, increased demand for higher-quality products, fast-changing economies, rising healthcare costs, and expanding numbers of pharmaceutical and biotechnology firms.

The Middle East & Africa is anticipated to account for a significant share of the global sterility testing market owing to the developing healthcare and diagnostic infrastructure. Increasing tourism and rising medical tourism in the region is the other factor positively influencing the market growth. Latin America accounts for the least share of the global market owing to the poor healthcare and diagnostics infrastructure and lack of awareness among people regarding sterility testing. Another factor that may hamper the market growth is the lack of skilled professionals in the region, along with less healthcare expenditure.

Segmental Analysis

The global sterility testing market is segmented on the basis of test type, product type, and application.

Based on test type, the market is segmented into rapid sterility tests and conventional sterility tests.

The conventional sterility tests segment is expected to account for the largest share of the global sterility testing market. The growth of conventional sterility tests is attributed to the low setup cost and return on investment within a short period of time. Conventional sterility tests are further segregated into membrane filtration and immersion test.

Compared to the conventional sterility testing method, the incubation durations are decreased with rapid sterility testing. It only takes six days of incubation to produce a rapid sterility test result. When taking into account supply chain concerns, product release dates, and the promptness of contamination investigations, a test time reduction of between 8 and 12 days delivers a considerable benefit. Utilizing advanced technology intended to detect microbial growth far more quickly than it can be detected by the human eye allows for a shorter incubation period. Rapid sterility tests are further segmented into solid phase cytometry, bioluminescence, flow cytometry, immunological methods, nucleic acid amplification, and others.

Based on product type, the market is segregated into instruments, kits & reagents, and others.

Amongst product types, the kits & reagents segment is expected to account for the major share of the global sterility testing market owing to the requirement of repetitive purchase, easy product affordability, and ongoing research & development activity.

On the basis of application, the market is segregated into medical device manufacturing, biopharmaceutical manufacturing, and others.

Biopharmaceutical manufacturing is anticipated to dominate the market owing to the ongoing research and development for several chronic and severe diseases. Pharmaceutical production must include sterility testing since failure to do so can have catastrophic results. Before being approved for release onto the market, finished product samples must go through a 14-day incubation phase. Many developing nations have sped up drug introductions and shortened regulatory approval timelines in response to the rising demand for healthcare. These regulatory changes are projected to quicken the market expansion of sterility testing in biopharmaceutical manufacturing.

Routine medical device sterility testing must be carried out during the manufacturing process. Bioburden tests, quarterly dosage audits, cleaning and disinfection tests, and environmental monitoring are a few examples of these tests. The goal of sterilization is to render non-sterile devices sanitized by inactivating microbial contaminants. Medical device sterility testing is necessary for both routine release testing and the sterilization validation process.

Recent Developments

• September 2021- The opening of a newly expanded center for microbiological laboratory testing and improved sterilization capacity in their Wiesbaden, Germany facilities was announced by Nelson Labs and Sterigenics Germany GmbH, world leaders in comprehensive laboratory testing and sterilization services. The medical device and pharmaceutical sectors' sharply rising need for these services will be addressed by this development.
• March 2021- Charles River Laboratories International, Inc. revealed that it had acquired Retrogenix Limited, an early-stage CRO that offered specialized bioanalytical services using its proprietary cell microarray technology.