From GlobeNewswire: 2025-05-23 09:50:00

The Biological Safety Testing Products and Services Market is on the rise, with a value of USD 4.62 billion in 2023 and projected to reach USD 11.58 billion by 2032. The United States market is expected to climb to USD 3.09 billion by 2032, driven by biopharma R&D and FDA oversight. Companies are adopting automated testing systems to meet demand.

The market growth is fueled by increasing demand for biologics, vaccines, and gene therapies globally, as well as stricter regulatory mandates. Companies are investing in R&D and innovation, with advancements in technology enhancing testing efficiency and accuracy. The rise of personalized medicine, especially in oncology, is also driving demand for specialized biological safety testing.

Major players in the market include Charles River Laboratories, Merck KGaA, Samsung Biologics, Sartorius AG, Eurofins Scientific, and Thermo Fisher Scientific. Reagents and kits dominated the market in 2023, while the instruments segment is expected to be the fastest-growing through 2032. The vaccines & therapeutics segment led in 2023, with endotoxin tests witnessing significant revenue.

North America held the largest share of the market in 2023, driven by a well-established biopharmaceutical sector and stringent safety regulations. The Asia Pacific region is projected to be the fastest-growing, fueled by the rapid expansion of the biotechnology sector in countries like China, India, and Japan, along with government initiatives to boost biopharmaceutical R&D. Chinese biopharma companies are embracing advanced safety testing technologies to meet global standards, driving regional growth. Recent developments include Lonza’s Nebula Multimode Reader, BioMérieux’s new pyrogen testing system, and Charles River Laboratories’ expanded services. Market segmentation includes products like reagents & kits, services, and instruments, along with applications such as vaccines, gene therapy, and stem cells.

To enhance biological safety testing, Merck KGaA launched new reagents for cell-based assays, Eurofins Scientific opened a biologic testing facility in the U.K., and Sartorius Stedim Biotech introduced rapid mycoplasma detection kits. The market offers segmentation by product, application, and test type, catering to the rising demand in North America and globally. Companies like Lonza, BioMérieux, and Charles River Laboratories are leading innovations in the field.



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