Biological Safety Testing Market – By Product and Services (Consumables, Instruments, Services, Reagents & Kits), Application (Gene Therapy, Stem Cells), Test Type (Endotoxin Test, Sterility Test, Bioburden Tests) – Global Forecast (2024 – 2032)

Biological Safety Testing Market – By Product and Services (Consumables, Instruments, Services, Reagents & Kits), Application (Gene Therapy, Stem Cells), Test Type (Endotoxin Test, Sterility Test, Bioburden Tests) – Global Forecast (2024 – 2032)

Biological safety testing market size is set to register 13.6% CAGR during 2024-2032, driven by the rising regulatory scrutiny and stringent safety standards imposed by health authorities worldwide. Regulatory agencies, such as the FDA, EMA, and WHO are mandating the rigorous safety testing of pharmaceutical products, vaccines, and drug products to ensure that it is free from contamination and safe for human use. This emphasis on regulation has led to the strong demand for biosafety testing services and product quality, as manufacturers are seeking to meet these stringent standards.

The expansion of the biopharmaceutical sector due to the growing incidence of chronic diseases and the high demand for generic drugs has created the need for advanced safety testing methods to ensure the efficacy of new therapies. As per the National Institute of Health, around 1 in 3 people suffer from multiple chronic conditions. With the development of new antimicrobial agents, such as monoclonal antibodies, gene therapy and cell-based therapies, there is growing need to develop specialized safety analytical techniques to detect a wide range of contaminants including bacteria, viruses, mycoplasma, and endotoxins.

The biological safety testing industry is segmented into product and services, application, test type and region.

Based on application, the market size from the gene therapy segment is poised to generate substantial revenue by 2032. This is due to the complexity and critical nature of gene therapy, which requires rigorous safety studies to ensure efficacy and safety. As gene therapy involves the use of genes to treat and prevent diseases, strict regulations and careful testing protocols are used to identify any potential contaminants seeds, including viruses, residual host cell DNA, and other contaminants.

Biological safety testing industry from the mycoplasma test type segment is set to grow over the forecast period, backed by the increasing importance of detecting contamination in biopharmaceutical and biotechnology products. Mycoplasmas, which are small, fast-moving organisms without cell walls, can severely affect cell cultures while compromising product quality and safety. Advanced detection methods, such as polymer chain reaction (PCR) and enzyme-linked immunosorbent assays (ELISA) to provide rapid and sensitive detection will also boost the segment growth.

Asia Pacific biological safety testing industry will grow significantly through 2032, attributed to the rapid expansion of the biopharmaceutical sector and the increasing investments in biotechnology R&D activities. In countries, such as China, India and South Korea, strong government support is provided through better funding and regulation to boost the local biotechnology and pharmaceutical sectors. The increasing prevalence of chronic diseases and the subsequent demand for new treatments and vaccines will drive the demand for rigorous biosafety testing to ensure the safety of products, adding to the regional market growth.