Biological Safety Testing Products and Services Market Strengthens Labs
The global biological safety testing products & services market size was estimated at USD 4.89 billion in 2024 and is projected to reach USD 12.09 billion by 2033, expanding at a CAGR of 10.64% from 2025 to 2033. The increasing prevalence of target diseases, coupled with the rising production of next-generation biologics by biotechnology and pharmaceutical companies, continues to propel market growth. These factors are strengthening the demand for reliable, accurate, and scalable biosafety testing solutions across the industry.
Key Market Trends & Insights
- North America accounted for the largest market share, representing 36.59% of the global market in 2024.
- The U.S. market is expected to observe robust growth throughout the forecast period.
- By product, the reagents & kits segment dominated with a 39.69% market share in 2024.
- Based on application, the vaccines & therapeutics segment held the highest share in 2024.
- By test type, endotoxin tests represented the largest share in 2024.
Market Size & Forecast
- 2024 Market Size: USD 4.89 Billion
- 2033 Projected Market Size: USD 12.09 Billion
- CAGR (2025–2033): 10.64%
- 2024 Regional Leader: North America
The growing demand for biologics has led to a significant rise in the number of biopharmaceutical manufacturers, driving market expansion. Heightened competition to produce high-quality therapeutic drugs efficiently has encouraged companies to optimize production processes for greater cost-effectiveness and productivity. For example, in July 2023, Biocon Biologics launched a biosimilar version of Humira in the U.S. market at a reduced cost, improving accessibility for patients. This trend highlights the industry’s push toward enhanced manufacturing practices that involve rigorous biological safety testing at multiple stages of production.
The continuous advancement of the biopharmaceutical and biotechnology industries remains a primary growth driver. Increasing development of biologics, biosimilars, cell and gene therapies, and regenerative medicines has heightened the need for validated, standardized, and high-precision biosafety testing. As regulatory standards become more comprehensive globally, companies are ramping up investments in testing infrastructure, innovative technology platforms, and strategic partnerships to address evolving biosafety requirements.
Government initiatives also play a pivotal role in accelerating market growth. For instance, Pfizer and BioNTech’s 2022 collaboration with the U.S. Government to supply additional COVID-19 vaccines underscores the rising governmental support for enhanced biosafety practices. Such efforts are expected to strengthen overall safety protocols in response to growing concerns related to microbial contamination and bioburden in biologics and pharmaceutical production.
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Key Biological Safety Testing Products & Services Company Insights
Leading market players are heavily investing in R&D to develop advanced, cost-efficient testing technologies. Strategic initiatives, including acquisitions and partnerships, are further expanding their market footprint. For example, in January 2023, Charles River Laboratories, Inc. acquired SAMDI Tech, Inc., enhancing its high-throughput screening capabilities and reinforcing its position in drug discovery and development services.
Key Biological Safety Testing Products & Services Companies
- Charles River Laboratories
- BSL Bioservice
- Merck KGaA (MilliporeSigma)
- Samsung Biologics
- Sartorius AG
- Eurofins Scientific
- SGS Société Générale de Surveillance SA
- Thermo Fisher Scientific Inc.
- BIOMÉRIEUX
- Lonza
Conclusion
The biological safety testing products & services market is witnessing strong and sustained growth driven by expanding biologics development, rising regulatory demands, increasing government support, and continuous advancements in testing technologies. As pharmaceutical and biotechnology companies intensify their focus on safety, quality, and compliance, the need for robust biosafety testing will continue to rise. This positions the market for significant opportunities over the coming decade, with both established leaders and emerging players contributing to the sector’s rapid evolution.
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