Global Sterility Testing Market Size, Share, Growth Analysis, By Test(Membrane filtration sterility testing and direct inoculation sterility testing), By End user(Pharmaceutical & biotechnology and medical devices), By Product(Instruments, Services) - Industry Forecast 2024-2031

Sterility Testing Market Drivers

New emerging technologies

• The demand for sterility tests will increase with the improvement in the pharmaceutical and medical sectors. Global biotechnology industry growth is one factor that will support the expansion of the sterility testing market in the coming years. Concerns about the safety of biological pharmaceutical products are also increasing. In the coming years, these factors will drive the market for sterility testing. Sterility testing has benefited from the advancement of new technologies that have increased the efficiency of the process, thereby fueling market expansion. For filterable pharmaceutical items, the method of choice for sterility testing is membrane filtration.

• According to USP <71>, in this sterility testing procedure, the products are filtered through a 0.45 or 0.2 micron membrane filter. After washing with suitable USP fluid to remove inhibitors, the filtrate is placed in a fluid thioglycollate medium (FTM) and soybean casein digest medium (SCDM). Each day during the 14-day incubation period, both media were examined for the presence of microbial growth in accordance with USP <71>. To promote the growth of both anaerobic and aerobic microbes, the sterilization test recommends the use of a fluid thioglycollate medium (FTM) and Soybean casein digest media (SCDM). These types of practices drive market growth.

Expansion of the pharmaceutical industry

• The global pharmaceutical market was valued at USD 934.8 billion in 2017 and will grow by 5.8% to reach USD 1170 billion in 2021. Sterility testing is performed at every stage of production in the pharmaceutical and biopharmaceutical sector to minimize the possibility of product contamination. Therefore, the expansion of this end-use industry will significantly increase the overall consumption of sterility testing in the coming years. Strict regulatory controls ensure process monitoring and quality control throughout the production chain of pharmaceutical and biopharmaceutical products. Sterilization testing is done during this process for raw material, bulk lot release testing, and final product release testing. By application, the pharmaceutical and biotechnology industries have experienced significant expansion in recent years; As a result, the pharmaceutical and biological product market has grown significantly and is a major driver of the market.

Sterility Testing Market Restraints

Stringent government regulations

• Increased sterility testing unit costs as a result of stringent regulatory norms and an acute shortage of skilled sterility testing experts are severely hampering the market expansion. High levels of integration, stringent regulatory frameworks, and lengthy licensing processes are all significant barriers to new market players.