U.S. Pharmaceutical Sterility Testing market size was valued USD 733.7 Million in 2016, and is estimated to grow at a CAGR of 12.o% during 2020-2026. Growing investment in the healthcare industry and growing investment in the R&D for improving the quality of the product are driving the market.
The FDA published a standardized document for sterility testing of various products. The International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines have clear instructions to be followed. This provides clarity in sterility testing procedure and helps in getting rapid approvals and introduction of novel products. Adoption of new technologies has led to harmonization of quality and standards in the healthcare industry. This has further created a need for not only aseptic manufacturing techniques, but also for efficient, reliable, and effective terminal sterilization processes.
Government in developing economies such as India and China are increasingly focusing on providing cost-effective and quality medications. They are increasingly becoming U.S. FDA compliant.Hence, demand for sterility testing services and products is anticipated to increase over the forecast period.