Segmental Insights

By product type analysis

Which Product Type Led the Biologics Safety Testing Market in 2024?

By capturing a major share, the kits & reagents segment was dominant in the market in 2024. Specifically, ongoing developments of complex biologics, such as monoclonal antibodies (mAbs) and cell and gene therapies, are boosting the segmental growth. As well as the market is exploring integrated sequencing

On the other hand, the instruments segment is estimated to register rapid growth. PCR machines, endotoxin detection systems, biosafety cabinets, and automated microbial identification platforms are increasingly used in the market. The latest developments include automated systems for blood grouping and antibody testing, like the Galileo Echo and Echo Lumena, alongside new biological safety cabinets like the Thermo Scientific 1500 Series. Also, they are emphasizing AI-enabled solutions and prominent progress in the PCR method.

By test type analysis

Why did the Endotoxin Tests Segment Dominate the Market in 2024?

The endotoxin tests segment accounted for the dominating share of the biologic safety testing market in 2024. Recent advances are attributing rCR and rFC assays to facilitate more control, minimize interference, with extended sensitivity and specificity as compared to traditional Limulus Amebocyte Lysate (LAL) tests.

• In May 2025, the officially implemented the United States Pharmacopeia (USP) Chapter <86>, which involves the use of non-animal-derived recombinant reagents (rCR and rFC) for bacterial endotoxin testing.
  

Moreover, the sterility tests segment will expand rapidly during 2025-2034. Primarily, the globe is encouraging the adoption of faster, automated systems, like those applying nucleic acid amplification techniques (NAT) and ATP-bioluminescence. Inclusion of innovative other approaches, such as solid phase cytometry and Redberry technology, is also being validated to offer sterility test results in days rather than weeks.

By application analysis

Which Application Dominated the Biologics Safety Testing Market in 2024?

The monoclonal antibodies segment held the biggest revenue share of the market in 2024. Ongoing development of mAbs and their biosimilars, a rise in incidence of chronic diseases, stricter regulatory standards, and advances in testing technologies are fueling the adoption of these testing solutions. The market is shifting from traditional animal-based models to more effective, reliable, and ethical human-relevant methods.

Besides this, the cell & gene therapy products segment is predicted to register the fastest growth during 2025-2034. These kinds of products are highly prone to contamination from agents, such as mycoplasma and replication-competent viruses, making specialized testing vital for patient safety. The emergence of testing for residual host cell contamination, specifically HCDNA, employs sensitive techniques, such as Polymerase Chain Reaction (PCR), to ensure product safety.

By end-user analysis

What Made the Pharmaceutical & Biopharmaceutical Companies Segment Dominant in the Market in 2024?

In 2024, the pharmaceutical & biopharmaceutical companies segment held the largest revenue share of the biologic safety testing market. Thermo Fisher Scientific, Charles River Laboratories, Merck KGaA, Lonza, and Sartorius AG are widely involved in the development of new biologics, especially monoclonal antibodies and gene therapies demand for biosimilars

Moreover, the contract research & manufacturing organizations (CROs/CDMOs) segment will expand rapidly in the coming era. Mainly, numerous pharmaceutical

By technology analysis

How did the Traditional Methods Segment Lead the Market in 2024?

The traditional methods segment registered dominance in the biologics safety testing market in 2024. It mainly includes physical, chemical, and microbiological tests, like high-performance liquid chromatography (HPLC), sterility, endotoxin, and host cell protein testing. Day by day, the market is focusing on rapid, more sensitive, and comprehensive methods, such as next-generation sequencing (NGS), advanced cell-based assays, and mass spectrometry

However, the rapid microbiological methods segment is estimated to expand at a rapid CAGR. Current efforts in advancing spectroscopy (light scattering, spectral photometry), DNA-based techniques like PCR, and flow cytometry for the detection of microbial contamination lab-on-a-chip technologies

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Recent Developments in the Biologics Safety Testing Market

• In October 2025, Nelson Labs, a Sotera Health company, unveiled RapidCert, a new, faster biological indicator (RBI) sterility service using a combination of traditional BIs and rapid microbiological methods (RMMs).
• In October 2025, Celltrion, Inc. launched AVTOZMA (tocilizumab-anoh) intravenous (IV) formulation is now available to patients in the United States.
• In October 2025, Qkine, Ltd., a specialist bioactive protein manufacturer, launched its Cell Therapy Grade proteins, created to assist the stricter requirements of cell therapy research, process development, and GMP manufacturing.
  

Biologics Safety Testing Market Key Players List

• Charles River Laboratories International, Inc.
• Sartorius AG
• Thermo Fisher Scientific Inc.
• Merck KGaA (MilliporeSigma)
• Lonza Group AG
• Eurofins Scientific SE
• SGS S.A.
• WuXi AppTec
• BioReliance (Merck subsidiary)
• Pace Analytical Services, LLC
• Becton, Dickinson and Company (BD)
• Promega Corporation
• Bio-Rad Laboratories, Inc.
• Nelson Laboratories, LLC
• TheraIndx Lifesciences
• Stemcell Technologies Inc.
• Q2 Solutions (IQVIA Lab Subsidiary)
• GenScript Biotech Corporation
• Vironova AB (electron microscopy-based virus detection)
• Clean Biologics (Naobios, Clean Cells)

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Segments Covered in the Report

By Product Type

• Kits & Reagents
• Endotoxin detection kits
• Mycoplasma detection kits
• Residual DNA/protein detection reagents
• Instruments
• qPCR systems, ELISA readers, biosensors

By Test Type

• Endotoxin Tests (LAL / Recombinant Factor C)
• For pyrogen detection in injectable biologics
• Mycoplasma Tests
• PCR-based and culture-based
• Sterility Tests
• Residual Host Cell Protein & DNA Detection
• Bioburden Testing
• Adventitious Virus Detection
• Cell Line Characterization & Genetic Stability
• Toxicity Testing (in vitro and in vivo)

By Application

• Monoclonal Antibodies
• Vaccines
• Recombinant Proteins
• Cell & Gene Therapy Products
• Blood Products & Plasma-Derived Therapies
• Tissue-Engineered Products

By End User

• Pharmaceutical & Biopharmaceutical Companies
• Contract Research & Manufacturing Organizations (CROs/CDMOs) (Fastest Growing)
• Academic & Research Institutions
• Government & Regulatory Laboratories

By Technology

• Traditional Methods (Culture-based, LAL)
• Rapid Microbiological Methods (PCR, ELISA, biosensors)
• Cell-Based Assays
• Chromatographic & Electrophoretic Techniques
• Next-Generation Sequencing (NGS) for adventitious agents
  

By Region

• North America
  • U.S.
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Thailand
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Sweden
  • Denmark
  • Norway
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa (MEA)
  • South Africa
  • UAE
  • Saudi Arabia
  • Kuwait
    

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