Biological Safety Testing Market: By Product (Reagents and Kits, Instruments, and Other Products), By Application (Vaccines and Therapeutics, Cellular and Gene Therapy, Blood and Blood-based Therapy, and Other Applications), By Test (Sterility Tests, Bioburden Tests, Endotoxin Tests, Other Tests) and Geography

Biological Safety Testing Market size was valued at USD 3,192.2 million in 2022 and is poised to grow at a significant CAGR of 13.7% from 2023-2029. The term "biological safety testing" refers to bio-analytical tests carried out for the pharmaceutical manufacturing/packaging industry by pharmaceutical and biotechnology companies or contract research organizations. These tests may involve a number of scientific fields, including pharmacology, toxicology, microbiology, and others. The safety of the material from raw materials through intermediate and final products is the main focus of these test methods. The development of biologics and biosimilars, increased worries over cell culture contamination, and increasing investments in biopharmaceutical R&D are some of the reasons that are fueling the expansion of the global market for biologics safety testing. Additionally, participants in the biologics safety testing market can expect considerable development prospects from emerging countries and the growing outsourcing of biopharmaceutical activities to CROs. The expansion of this market, however, is anticipated to be somewhat constrained by a lack of qualified specialists throughout the forecast period. Chronic diseases like cancer, diabetes, and neurological and cardiovascular conditions are now much more common than they were in the past. It is anticipated that research into and demand for various drugs, cell therapies, diagnostics, and active biological products would increase as a result of the increasing incidence and prevalence of these disorders. The employment of biologics safety testing products and services is encouraged by the regulatory testing rules, which require that every biological sample used in research and development be examined for the presence and elimination of various contaminants (such as mycoplasma, endotoxins, and viruses).  Market expansion is projected to be fueled by higher R&D spending by pharmaceutical and biotechnology companies as well as a stronger focus on life science projects for developing novel therapeutic and diagnostic products.

Biological Safety Testing Market Key Developments:

• In April 2021, Lonza has enhanced its "PyroTec PRO Automated Robotic Solution" solution for endotoxin testing. It is compatible with the PYROGENT-5000 Turbidimetric LAL (Limulus Amebocyte Lysate) Assay, the Kinetic-QCL Chromogenic LAL Assay, and the PyroGene rFC Assay from the firm.