Biological Safety Testing Market to Reach US$ 9.81 Billion by 2031 at 12.4% CAGR; North America Leads with 41% Share - Key Players: Thermo Fisher, Lonza, Eurofins, Charles River

The Global Biological Safety Testing Market was valued at US$ 4.32 billion in 2024 and is expected to reach US$ 9.81 billion by 2031, growing at a CAGR of 12.4% during the forecast period 2025-2031. Growth is driven by the rising production of biologics, vaccines, cell and gene therapies, and biosimilars, all of which require stringent safety evaluations to meet global regulatory standards. Increasing investments in biopharmaceutical R&D and the expansion of manufacturing facilities further support the adoption of advanced safety testing solutions.

Biological safety testing encompasses sterility testing, bioburden analysis, viral safety assessments, endotoxin testing, residual host cell protein (HCP) analysis, and other essential quality checks that ensure the purity, safety, and efficacy of biological products. Continuous advancements in analytical methods, automation, and high-throughput technologies are enhancing accuracy and reducing turnaround times. As regulatory expectations strengthen and biologics pipelines expand worldwide, the demand for reliable biological safety testing is expected to accelerate across major healthcare and biopharma markets.

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The Biological Safety Testing Market refers to the industry that provides assays and services to ensure the safety, purity, and quality of biopharmaceutical products by detecting contaminants such as viruses, bacteria, and endotoxins.

Key Developments
✅ October 2025: Leading biopharmaceutical companies expanded end-to-end biological safety testing programs to support cell and gene therapy pipelines, increasing demand for mycoplasma, sterility, and viral safety assays.

✅ September 2025: U.S. contract research organizations (CROs) implemented high-throughput automated biosafety testing platforms to accelerate biologics release timelines and reduce human error.

✅ August 2025: European regulatory authorities issued updated safety guidelines for adventitious agent testing in ATMPs, prompting wider adoption of rapid PCR-based and next-gen sequencing (NGS) biosafety workflows.

✅ July 2025: Asia-Pacific biologics manufacturers invested in integrated biosafety labs with AI-driven contamination detection systems to enhance quality control for vaccines and recombinant therapeutics.

✅ May 2025: Global testing service providers launched next-generation viral vector safety testing solutions optimized for AAV, lentivirus, and mRNA-based therapeutics.

✅ March 2025: International biotech startups introduced rapid mycoplasma and endotoxin detection kits enabling real-time in-process monitoring in biologics manufacturing.

Mergers & Acquisitions
✅ November 2025: A major global biosafety testing company acquired a U.S.-based viral safety analytics firm to expand its capabilities in gene therapy quality assurance.

✅ August 2025: A European life sciences tools provider partnered with an Asian diagnostics company to co-develop high-speed biosafety testing systems for emerging biologics platforms.

✅ June 2025: A leading North American CRO acquired a microbial detection technology startup to integrate advanced rapid testing solutions into its biologics safety portfolio.

Key Players
Avance Biosciences | Cytovance Biologics | Eurofins Scientific | Lonza | Merck KGaA | Promega Corporation | Thermo Fisher Scientific | Toxikon | WuXi AppTec | Charles River Laboratories

Key Highlights
Avance Biosciences - Holds a 6.2% share, driven by its specialized genomic, molecular biology, and cell-based assay services supporting biopharmaceutical research and regulatory submissions.

Cytovance Biologics - Holds a 5.4% share, supported by its strong expertise in microbial and mammalian biologics manufacturing, process development, and CDMO capabilities.

Eurofins Scientific - Holds a 12.7% share, fueled by its broad portfolio of analytical testing, bioanalysis, and regulatory-compliant laboratory solutions for global biotech companies.

Lonza - Holds a 14.3% share, driven by its leadership in biologics manufacturing, advanced therapy production, and end-to-end drug development services.

Merck KGaA - Holds an 11.9% share, supported by its high-quality reagents, assay technologies, and comprehensive solutions for bioprocessing and biosafety testing.

Promega Corporation - Holds a 7.1% share, driven by its industry-leading molecular biology tools, assay technologies, and innovations in drug discovery support.

Thermo Fisher Scientific - Holds a 15.8% share, supported by its extensive instrumentation portfolio, analytical solutions, and growing dominance in biopharmaceutical testing and manufacturing services.

Toxikon - Holds a 4.6% share, recognized for its preclinical safety testing, toxicology services, and strong regulatory expertise.

WuXi AppTec - Holds a 10.5% share, driven by its full-service CRO/CMO platform, integrated drug discovery solutions, and global expansion in biologics and cell/gene therapy support.

Charles River Laboratories - Holds an 11.5% share, supported by its strong preclinical services, advanced safety assessment capabilities, and extensive global research infrastructure.

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Market Drivers

- Increasing demand for biologics, vaccines, and cell & gene therapies requiring stringent safety and quality testing.

- Rising prevalence of chronic diseases driving the development of advanced biopharmaceuticals.

- Growing regulatory requirements from FDA, EMA, and WHO for contamination control and product safety.

- Rapid expansion of biopharmaceutical manufacturing and outsourcing to CROs and CDMOs.

- Advancements in analytical technologies, including high-sensitivity assays and rapid microbial detection systems.

- Increasing use of biological materials in drug development, tissue engineering, and regenerative medicine.

- Rising focus on ensuring product purity, sterility, and absence of mycoplasma, viruses, and endotoxins in biologics.

Industry Developments

- Launch of rapid, automated testing platforms for sterility, mycoplasma, and adventitious agent detection.

- Strategic partnerships between biotech firms and testing service providers to enhance biosafety testing capacity.

- Development of next-generation assay technologies including PCR-based and high-throughput screening methods.

- Expansion of global biological safety testing facilities to support growing biologics production.

- Increasing investment in digital quality systems and AI-enabled data analysis for biosafety workflows.

- Rising adoption of in vitro alternative testing models to meet ethical and regulatory requirements.

Regional Insights

North America - 41% share: "Driven by strong biopharmaceutical R&D, large-scale biologics production, and stringent regulatory frameworks."

Europe - 30% share: "Supported by advanced biotechnology ecosystems, strict biosafety regulations, and growing vaccine manufacturing."

Asia Pacific - 22% share: "Fueled by expanding biopharma manufacturing, government support for biotech innovation, and rising outsourcing activities."

Latin America - 4% share: "Boosted by growing pharmaceutical production and increasing adoption of standardized biosafety practices."

Middle East & Africa - 3% share: "Driven by expanding healthcare infrastructure and rising investment in biologics and vaccine development."

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Key Segments

➥ By Product
Reagents and Kits: Essential consumables used for microbial detection, contamination analysis, and quality assurance across biopharma manufacturing and research environments.

Instruments: Includes automated analyzers, microbial detection systems, PCR instruments, and other advanced platforms supporting high-precision contamination testing.

Other Products: Encompasses culture media, lab accessories, software tools, and supporting materials used for routine and advanced microbial quality control workflows.

➥ By Application
Vaccines and Therapeutics: Used to ensure sterility, purity, and safety in the development and production of vaccines, biologics, and therapeutic formulations.

Cellular and Gene Therapy: Critical for contamination testing, aseptic validation, and quality monitoring in cell-based therapies, viral vectors, and gene modification processes.

Blood and Blood-Based Therapy: Ensures microbial safety in blood products, plasma-derived therapies, and transfusion-related processes.

Other Applications: Covers contamination testing in biosimilars, monoclonal antibodies, tissue engineering products, and broader biopharmaceutical manufacturing.

➥ By Test
Bioburden Tests: Evaluate the total number of viable microorganisms present in raw materials, intermediates, and final products.

Sterility Tests: Confirm the absence of viable microorganisms in sterile pharmaceutical products, ensuring compliance with regulatory standards.

Endotoxin Tests: Detect pyrogenic contaminants using LAL assays, recombinant factor C technology, or alternative endotoxin detection methods.

Other Tests: Includes mycoplasma testing, environmental monitoring assays, microbial limit tests, and rapid microbiological methods (RMM).

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