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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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
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?
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.
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,
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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,
Biologics Safety Testing Market: US FDA-Approved Monoclonal Antibodies in 2025
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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.
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.
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Towards Healthcare is a leading global provider of technological solutions, clinical research services, and advanced analytics, with a strong emphasis on life science research. Dedicated to advancing innovation in the life sciences sector, we build strategic partnerships that generate actionable insights and transformative breakthroughs. As a global strategy consulting firm, we empower life science leaders to gain a competitive edge, drive research excellence, and accelerate sustainable growth.
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