Biologics Safety Testing Market Size, Share, Growth, Trends, and Global Industry Analysis: By Product Type (Reagents and Kits, Instruments, Services), By Test Type (Sterility Tests, Bioburden Tests, Endotoxin Tests, Residual Host Contamination detection Tests, Cell Line Authentication and Characterization Tests, Others), By Application (Cellular and Gene Therapy, Vaccine and Therapeutics Development, Tissue and Tissue-Related Products Testing, Blood and Blood-Related Products Testing, Stem Cell Research), By End-User (Pharmaceutical Companies, Biotechnology Companies), and Region Forecast 2020-2031

Biologics Safety Testing Market size was valued at US$ 4.3 billion in 2024 and is expected to reach US$ 9.1 billion by 2031, growing at a significant CAGR of 11.1% from 2025-2031. Biologics are the large and complex molecules derived from the genes of living organisms by advanced DNA technologies. Biologics are commonly used in the treatment of chronic diseases such as rheumatoid arthritis, cancer, and other chronic diseases. These biologics are complex molecules such as recombinant proteins and monoclonal antibodies among others. Biologics safety testing is carried out to ensure patient safety. Biological safety testing is carried out by using various tests such as sterility tests, endotoxins tests, residual host contamination detection tests, and bioburden tests among others.

The market exhibiting lucrative growth, which is attributed to an increase in the R&D for the development of newer biologics by pharmaceutical and biopharmaceutical companies for the treatment of chronic diseases such as diabetes, and cancer and the innovation of newer biologics safety tests. Moreover, a rise in funding from the government, and an increase in the prevalence of chronic diseases are anticipated to fuel the market over the forecast period. Furthermore, acquisitions and mergers, collaborations, and the launching of newer tests by market players also immensely boost the market

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 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.

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.
• In June 2016, Charles River Laboratories acquired Blue Stream Laboratories to strengthen its capabilities in biologics development and safety assessments.
• In March 2016, Abreos Biosciences collaborated with True Diagnostics to develop point-of-care tests for biologics.