Guarding Biotech Progress | Biological Safety Testing Services Market Rises with Biologics and Cell Therapies

Biopharmaceutical innovation and manufacturing capabilities are booming, and it’s going to continue growing through 2030, driving the global biological safety testing services market. Biologics, cell therapies, gene therapies, and other advanced medicinal products are becoming more complex, and developers need tailored and highly specialized safety testing throughout drug development.

The biological safety testing services market size is expected to witness strong growth over the next 5 years. Key factors driving growth are stringent regulations, high service outsourcing, and need to confirm safety, sterility, and efficacy of biologically derived drugs, vaccines, or therapeutic products. Biological safety testing is important for drug approval in alignment with US FDA, EMA, and ICH regulations in clinical and commercial stages.

“The increasing development of next-generation therapeutics is also introducing new opportunities in biologics safety testing services to help ensure consistent product quality. Biosimilars, advanced antibody therapeutics, regenerative medicine, and personalized treatment will be larger markets in pharmaceuticals & biotech industries,” stated an analyst at The Research Insights in a new study on this market

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Top Drivers for Market Growth:

• Surge in biologics, cell therapy, and CAR-T products for cancer and other diseases
• Outsourcing trend for highly specialized tests to fast, cost-effective, and regulatory-compliant CROs
• Regulatory mandates on global compliance standards like USP, EP, and cGMP guidelines
• Increased R&D spending in gene therapy, mRNA vaccines, and monoclonal antibody therapeutics

Market Share by Region:

• North America accounts for the largest market share, with US, Canada, and Mexico as the key countries
• Asia-Pacific is expected to grow at the highest CAGR due to manufacturing growth in China, India, and South Korea
• Europe also expected to have healthy growth from its favorable regulation, R&D investment, and industry initiatives

Top Market Players:

Major players in the biological safety testing services market include:

Charles River Laboratories, Eurofins Scientific, Merck KGaA, SGS SA, Lonza Group, and WuXi AppTec

These companies are expanding portfolios, and investing in faster, automated testing methods, data systems, and global laboratory networks.

Emerging Market Trends:

• Accelerating adoption of rapid microbial methods (RMMs) and real-time PCR-based testing
• Increasing integration of digital quality systems and automated AI-powered lab equipment
• Growing use of biosafety testing in cell & gene therapy manufacturing processes

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