The global biologics safety testing market size is calculated at USD 4.58 billion in 2025 and is expected to reach around USD 14.45 billion by 2034, growing at a CAGR of 13.64% for the forecasted period.
Ottawa, Oct. 16, 2025 (GLOBE NEWSWIRE) — The global biologics safety testing market size was valued at USD 4.03 billion in 2024 and is predicted to hit around USD 14.45 billion by 2034, rising at a 13.64% CAGR, a study published by Towards Healthcare a sister firm of Precedence Research.
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Key Takeaways
- Biologics safety testing industry poised to reach USD 4.03 billion in 2024.
- Forecasted to grow to USD 14.45 billion by 2034.
- Expected to maintain a CAGR of 13.64% from 2025 to 2034.
- North America was dominant in the market in 2024.
- Asia-Pacific is expected to grow at the fastest CAGR in the studied years.
- By product type, the kits & reagents segment led the global biologics safety testing market in 2024.
- By product type, the instruments segment is expected to be the fastest-growing during 2025-2034.
- By test type, the endotoxin tests segment held a major revenue share of the market in 2024.
- By test type, the sterility tests segment is expected to witness rapid expansion in the coming years.
- By application, the monoclonal antibodies segment dominated the global biologics safety testing market in 2024.
- By application, the cell & gene therapy products segment is expected to grow at a rapid CAGR in the studied years.
- By end-user, the pharmaceutical & biopharmaceutical companies segment accounted for the biggest share of the market in 2024.
- By end-user, the contract research & manufacturing organizations (CROs/CDMOs) segment is expected to be the fastest-growing during 2025-2034.
- By technology, the traditional methods segment was dominant in the market in 2024.
- By technology, the rapid microbiological methods segment is expected to witness the fastest growth in the predicted timeframe.
What is the Biologics Safety Testing?
These types of testing support the verification of biologic products, like vaccines and gene therapies, and give information regarding safety, purity, and effectiveness by testing for contaminants, such as viruses, bacteria, and endotoxins. The biologics safety testing market is mainly fueled by the development of innovative therapies, including cell and gene therapies, stringent regulatory guidelines, and the growing outsourcing of safety testing to specialized firms. Nowadays, recent innovations comprise novel animal-free testing solutions for endotoxins, the growth of biosafety testing laboratories, and advancements in next-generation sequencing (NGS) and PCR (Polymerase Chain Reaction) to optimize speed, accuracy, and efficacy.
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Key Metrics and Overview
| Metric | Details | |
| Market Size in 2025 | USD 4.58 Billion | |
| Projected Market Size in 2034 | USD 14.45 Billion | |
| CAGR (2025 – 2034) | 13.64 | % |
| Leading Region | North America Share by 42% | |
| Market Segmentation | By Product Type, By Test Type, By Application, By End User, By Technology, By Region | |
| Top Key Players | 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) | |
What are the Major Drivers in the Biologics Safety Testing Market?
An expansion of the pharmaceutical and biotechnology sectors, especially in vaccines, monoclonal antibodies, and advanced cell and gene therapies, is a prominent driver for the rising demand for safety testing. Moreover, the globe is actively boosting R&D investment in life sciences is also fostering the development of newer and complex biologics that necessitate rigorous safety testing. Whereas, ongoing advances in testing approaches, such as automation, high-throughput screening, and AI, are enhancing effectiveness and accuracy.
What are the Key Drifts in the Biologics Safety Testing Market?
- In September 2025, Carolina Molecular, a molecular testing services laboratory, and Astoriom, an expert in stability storage and biorepository services, partnered to offer feasible, integrated solutions for molecular testing and complete biospecimen storage.
- In September 2025, Kriya Therapeutics secured an oversubscribed Series D funding round, with $320m, focused on fueling its gene therapy pipeline targeting chronic diseases.
What is the Crucial Challenge in the Market?
The biologics safety testing market encompasses complex and emerging regulatory frameworks, the inherent difficulty and diversity of biologics themselves, and the accelerated expenditure of advanced testing methods.
Regional Analysis
Why did North America Dominate the Market in 2024?
In 2024, North America captured a dominant share by 42% of the market. This market is primarily fueled by a rise in biopharmaceutical research and development (R&D), robust regulatory frameworks, and rapid technological breakthroughs. The biologics safety testing market is promoting the application of next-generation sequencing (NGS) for more accurate contaminant detection and the combination of bioinformatics and data analytics for better trend analysis.
For instance,
- In September 2025, US-based Genomenon, a leading genomic intelligence company, partnered with Taiwan headquartered Compass Bioinformatics, aligning Genomenon’s Mastermind FLEX Data into Compass Bioinformatics’ innovative InheriNext platform for genetic disease diagnostics.
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What Made the Asia Pacific Grow Significantly in the Market in 2024?
In the prospective period, the Asia Pacific is anticipated to witness rapid expansion in the biologics safety testing market. The possession of strong government support and a large manufacturing base, with raised demand for advanced therapies, like cell and gene therapies, is impacting the ASAP market. Alongside China, South Korea, Japan, and India are booming their laboratories by adopting sophisticated robotics and automation to manage high-volume sample processing, with minimal human error, and enhancing efficacy.
For instance,
- In June 2025, Korean pharmaceutical giant Chong Kun Dang made a 2.2 trillion won ($1.69 billion) investment to develop a cutting-edge biopharmaceutical R&D complex.
Biologics Safety Testing Market: US FDA-Approved Monoclonal Antibodies in 2025
| Linvoseltamab (Lynozyfic) | For adults with relapsed or refractory multiple myeloma. |
| Datopotamab deruxtecan (Datroway) | For unresectable or metastatic, HR-positive, HER2-negative breast cancer. |
| Telisotuzumab vedotin (Emrelis) | For locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). |
| Clesrovimab (Enflonsia) | For the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. |
| Nipocalimab (Imaavy) | For generalized myasthenia gravis. |
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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 and high-throughput screening, the wider emphasis on animal-free testing approaches, and the fuel for more sensitive and efficient reagents, like high-purity chemistries and extended-stability formulations.
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.
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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, and the increasing demand for biosimilars. Advances in non-animal testing methods, including the Endosafe Trillium rCR cartridge from Charles River Laboratories, are assisting the global market expansion.
Moreover, the contract research & manufacturing organizations (CROs/CDMOs) segment will expand rapidly in the coming era. Mainly, numerous pharmaceutical and biotechnology companies, particularly smaller ones, are fostering outsourcing these specialized services to CROs/CDMOs by omitting large capital investments and managing expenditures and complexity efficiently. Moreover, these organizations are providing end-to-end support from research and development through manufacturing and safety testing, in optimizing quality, consistency, and regulatory compliance.
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, in detecting a wide range of impurities and contaminants with higher accuracy.
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 quicker than traditional methods are impacting the segment’s progress. Technological developments are bolstering automated platforms for real-time monitoring, microfluidics, and lab-on-a-chip technologies for miniaturized testing, and enhanced endotoxin testing using recombinant lysates.
Browse More Insights of Towards Healthcare:
- The filtration in biologics market is set for strong growth from 2024 to 2034, fueled by rising global demand for monoclonal antibodies, vaccines, and cell and gene therapies.
- The global subcutaneous biologics market is valued at USD 1.89 billion in 2024, increasing to USD 2.1 billion in 2025, and is projected to reach approximately USD 5.37 billion by 2034, expanding at a CAGR of 11.09% during 2025–2034.
- The biologics contract research organization (CRO) market is estimated at USD 31.15 billion in 2024 and is expected to grow to USD 35.22 billion in 2025, with projections reaching around USD 106.28 billion by 2034.
- Meanwhile, the biologics contract development and manufacturing organization (CDMO) market stands at USD 22 billion in 2024, growing to USD 25.41 billion in 2025, and is anticipated to hit USD 92.79 billion by 2034, at a CAGR of 15.48% between 2025 and 2034.
- The biological PCR technology market was valued at USD 13.69 billion in 2023 and is projected to reach USD 28.93 billion by 2034, growing at a CAGR of 7.04% from 2024 to 2034.
- Similarly, the biological safety testing products and services market is expected to expand from USD 4.90 billion in 2023 to USD 15.07 billion by 2034, at a CAGR of 10.75%.
- In specialized segments, the spine biologics market is forecast to grow from USD 4.65 billion in 2025 to USD 7.34 billion by 2034, at a CAGR of 5.20%.
- The cancer biologics market is projected to rise from USD 119.41 billion in 2025 to USD 232.02 billion by 2034, growing at 7.66% CAGR, while the retinal biologics market is expected to increase from USD 27 billion in 2025 to USD 53.61 billion by 2034, at a CAGR of 7.92%.
- Overall, the global biologics market is on track to reach USD 938.04 billion by 2034, up from USD 485.19 billion in 2025, expanding at a CAGR of 7.6% over the forecast period.
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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