Table of Contents
Overview
New York, NY – June 27, 2025 – Global Biological Safety Testing Products and Services Market size is expected to be worth around US$ 14.2 Billion by 2034 from US$ 5.1 Billion in 2024, growing at a CAGR of 10.8% during the forecast period 2025 to 2034. In 2024, North America led the market, achieving over 38.3% share with a revenue of US$ 2.0 Billion.
The demand for biological safety testing products and services is witnessing steady growth, driven by the increasing need for regulatory compliance and product quality assurance in the biopharmaceutical and biotechnology sectors. These testing solutions are essential in ensuring the safety, purity, and efficacy of biologics, vaccines, cell and gene therapies, and raw materials used in production.
Biological safety testing includes a wide range of assessments such as sterility testing, endotoxin detection, mycoplasma testing, bioburden analysis, and adventitious agent detection. These tests are critical for meeting Good Manufacturing Practices (GMP) and global regulatory requirements set by authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO).
Leading service providers and product manufacturers are enhancing their portfolios with rapid, sensitive, and automated testing platforms to support faster development timelines and reduce contamination risks. These advancements are particularly vital in supporting clinical trials, commercial manufacturing, and biosimilar development. As biologics production scales up globally, the demand for reliable biological safety testing solutions is expected to grow substantially. Investments in advanced biosafety laboratories and outsourcing of testing services further drive the market expansion.
Key Takeaways
- In 2023, the biological safety testing products and services market was valued at US$ 5.1 billion and is projected to reach approximately US$ 14.2 billion by 2033, expanding at a CAGR of 10.8% during the forecast period.
- By product type, the market is segmented into reagents & kits, services, and instruments. Among these, reagents & kits dominated in 2023, accounting for 45.3% of the total market share.
- Based on application, the market covers vaccines & therapeutics, tissue & tissue-based products, stem cell applications, gene therapy, and blood & blood-based products. The vaccines & therapeutics segment led the market with a significant 50.6% share in 2023.
- By test type, the market includes endotoxin tests, bioburden tests, cell line authentication & characterization tests, sterility tests, and others. Endotoxin testing emerged as the leading segment, holding a 40.9% revenue share.
- North America remained the dominant region in 2023, contributing 38.3% to the global market, driven by advanced biopharmaceutical infrastructure and stringent regulatory standards.
Segmentation Analysis
- Product Type Analysis: In 2023, the reagents and kits segment dominated the market with a 45.3% share. This growth was driven by the demand for accurate and rapid diagnostic solutions in pharmaceutical and biotech applications. Increased adoption of personalized therapies and precision medicine further supports this segment. Technological improvements enhancing sensitivity and specificity, along with stricter safety and quality standards in drug development, are expected to fuel continued demand for reagents and kits in biological safety testing procedures.
- Application Analysis: The vaccines and therapeutics segment held a leading share of 50.6% in 2023, largely due to heightened global vaccine development efforts and the rising burden of infectious diseases. The COVID-19 pandemic accelerated investments in vaccine safety testing. Growth in biologics like monoclonal antibodies, which require thorough safety validation, is also contributing to demand. As innovation in therapies advances, pharmaceutical firms are expected to increasingly rely on safety testing services, reinforcing the segment’s position in the market.
- Test Type Analysis: Endotoxin tests accounted for a substantial 40.9% revenue share in 2023, propelled by their critical role in ensuring the safety of injectable drugs and medical devices. The need to detect endotoxin contamination in high-risk products such as implants and biologics is growing. Regulatory emphasis on sterile manufacturing standards continues to drive this demand. Additionally, innovations in detection techniques that improve accuracy and speed are expected to sustain the strong growth trajectory of this segment.
Market Segments
Product Type
- Reagents & Kits
- Services
- Instruments
Application
- Vaccines & Therapeutics
- Vaccines
- Recombinant Protein
- Monoclonal Antibodies
- Tissue & Tissue-based Products
- Stem Cell
- Gene Therapy
- Blood & Blood-based Products
Test Type
- Endotoxin Tests
- Bioburden Tests
- Cell Line Authentication & Characterization Tests
- Sterility Tests
- Others
Regional Analysis
North America led the biological safety testing products and services market in 2023, securing a 38.3% revenue share. This dominance is attributed to stringent regulatory frameworks and a high volume of biopharmaceutical development in the region. The U.S. FDA continues to implement strict guidelines to ensure sterility and safety, compelling companies to invest in advanced testing solutions.
In 2023, multiple guidance documents were released to improve microbial contamination control. Moreover, the National Institutes of Health (NIH) allocated approximately US$34.92 billion in extramural research grants across 58,951 awards during Fiscal Year 2023. This strong R&D investment supports the continued growth of biological safety testing in North America.
Asia Pacific is expected to witness the fastest CAGR over the forecast period, driven by expanding biopharmaceutical capabilities and rising healthcare expenditures. Countries such as China and India are strengthening their manufacturing sectors under initiatives like India’s “Make in India,” boosting demand for robust safety testing. Additionally, the growing incidence of infectious diseases and regulatory convergence with global standards are encouraging the adoption of advanced testing tools. These factors collectively contribute to the region’s accelerated market expansion.
Emerging Trends
- Integration of Next-Generation Sequencing for Rapid Pathogen Detection: Advanced Molecular Detection (AMD) programs are increasingly combining traditional epidemiology with next-generation sequencing (NGS) and bioinformatics. This approach enables faster characterization of viruses (e.g., influenza) and bacteria during outbreak investigations, and supports detailed analysis of almost every major infectious disease area in U.S. public health laboratories.
- Expansion of the Laboratory Response Network (LRN)-B: The U.S. CDC’s LRN-B has grown to approximately 120 member laboratories covering state, local, military, veterinary, and international sites that are equipped to perform specialized testing for high-risk environmental and clinical samples. This expansion underscores a shift toward a more distributed and resilient biosafety testing infrastructure.
- Regulatory Emphasis on Safety Testing for Cellular and Gene Therapies: The FDA’s Center for Biologics Evaluation and Research has published six draft guidances on cellular and gene therapy products since late 2023, including “Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products” (April 2024). These guidances formalize sterility and adventitious agent testing requirements for an expanding pipeline of advanced therapies.
- Adoption of Portable Sequencing Technologies: Portable “nanopore” sequencers devices smaller than a deck of cards are gaining traction for in-field biosafety testing. These instruments remain stable in varied environmental conditions, allowing for flexible pathogen surveillance outside conventional laboratory settings.
- Shift Toward Protocol-Driven, Risk-Based Biorisk Management: The sixth edition of the CDC’s *Biosafety in Microbiological and Biomedical Laboratories (BMBL) emphasizes protocol-driven risk assessments and includes new guidance on large-scale biosafety and laboratory sustainability. This reflects a broader trend toward formalized, risk-based approaches across biomedical laboratories.
Use Cases
- Outbreak Investigation and Surveillance: Public health agencies apply AMD-enabled NGS in influenza and viral hepatitis programs, supporting detailed genomic characterization. Since 2014, this integration has been used across dozens of state and local health departments to rapidly detect and halt disease spread.
- Rapid Emergency Response via LRN-B: During public health emergencies, the LRN-B network of ~120 laboratories provides standardized reagents, protocols, and training to ensure rapid testing of clinical and environmental samples, bolstering national preparedness for biothreats.
- Quality Control in Advanced Therapy Manufacturing: FDA draft guidances (e.g., Safety Testing of Allogeneic Cells, April 2024) outline sterility and adventitious agent testing for cell and gene therapies. Six guidances issued since late 2023 support consistent safety testing across hundreds of investigational products.
- Global Laboratory Capacity Building: Through the Strengthening Laboratory Management Toward Accreditation program, the CDC has helped over 400 laboratories worldwide achieve international accreditation, enhancing global biosafety testing standards and harmonization.
Conclusion
The global biological safety testing products and services market is poised for significant growth, driven by rising regulatory compliance demands, expanding biopharmaceutical production, and increasing adoption of advanced therapies. With a projected market value of US$ 14.2 billion by 2034 and a CAGR of 10.8%, the sector is supported by strong R&D investments, especially in North America.
Emerging technologies such as next-generation sequencing and portable testing platforms, alongside evolving global regulatory frameworks, are enhancing testing accuracy and accessibility. The market’s expansion is further bolstered by increased outsourcing, global capacity building, and growing demand for reliable safety in biologics and cell-based therapies.
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