The global biologics safety testing market is experiencing robust growth, fueled by the rapid expansion of biologics manufacturing, gene therapy advancements, and rising regulatory scrutiny across pharmaceutical and biopharmaceutical sectors. As biologics—including monoclonal antibodies, cell and gene therapies, and vaccines—continue to dominate drug pipelines, the need for rigorous safety testing solutions is more urgent than ever.
Biologics are highly complex therapies derived from living organisms, making them more susceptible to contamination during production. Ensuring the safety of these therapies is paramount, and it requires comprehensive testing for sterility, endotoxins, mycoplasma, viruses, and bioburden. This has created substantial demand for both services and consumables in the safety testing ecosystem.
According to Prophecy Market Insights, the market is segmented by Offering, Application, and End-user, with services currently accounting for the largest revenue share due to outsourcing trends among pharmaceutical companies.
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Breakdown of Offerings: Services, Consumables, and Instruments
The biologics safety testing market by Offering includes Services, Consumables, and Instruments. Among the services, categories such as Sterility Testing, Endotoxin Testing, Mycoplasma Testing, Bioburden Testing, and Virus Safety Testing are in high demand due to mandatory regulatory compliance set by the FDA, EMA, and WHO.
Consumables—including reagents and test kits—are also growing rapidly as labs and CROs increasingly rely on ready-to-use products to streamline workflows. Meanwhile, instruments like PCR analyzers, automated culture systems, and next-gen sequencing tools are transforming biologics safety testing into a high-throughput, digital-first process.
Contract testing laboratories and in-house R&D teams alike are expanding their use of these tools to detect minute levels of contaminants, minimize risks, and ensure product safety across multiple production stages.
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Applications Expand with Rise of Gene and Blood-Based Therapies
By Application, the biologics safety testing market serves Vaccines & Therapeutics, Cellular & Gene Therapy, Blood & Blood-based Therapy, and Others. Cellular and gene therapy testing is one of the fastest-growing segments as biotech firms and research institutions push for regulatory approval of advanced therapies.
The need for viral clearance, genetic integrity, and microbial testing in autologous and allogeneic therapies has brought biologics safety testing into the spotlight. Similarly, blood-based biologics and plasma-derived products are subject to strict endotoxin and sterility validation procedures.
With the global emphasis on pandemic preparedness and chronic disease treatment, biologics testing has become foundational to public health and drug development strategies.
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Key Market Players and Industry Dynamics
The biologics safety testing market is highly competitive and innovation-driven. Major players are continuously investing in automation, rapid microbial detection, and AI-integrated testing platforms to reduce turnaround time and increase accuracy.
Notable players include:
- Abcam Limited
- PathogenDx
- SGS Société Générale de Surveillance SA
- Thermo Fisher Scientific Inc.
- Boehringer Ingelheim International GmbH
- Sartorius AG
- Wuxi AppTec
- Lonza
- Merck KGaA
- Charles River Laboratories
- Invetech
- Eurofins Scientific
- Samsung Biologics
- BIOMÉRIEUX
- Microtrac Retsch GmbH
These companies are developing robust testing platforms tailored to GMP compliance, accelerating clinical timelines and increasing scalability for biologics manufacturing.
Global Outlook and Expert Perspective
North America leads the market due to a concentration of biologics manufacturers, CROs, and advanced regulatory systems. Europe follows with strict safety frameworks and increased biologics R&D. Meanwhile, Asia-Pacific is experiencing the fastest growth, driven by biologics facility expansion, government incentives, and growing biologic approvals in countries like China, India, and South Korea.
“Biologics safety testing is no longer a back-end function—it is an essential pillar of therapeutic innovation, quality control, and regulatory acceptance,”
notes Riya B. More, Research Associate at Prophecy Market Insights.
This detailed analysis provides strategic foresight into the evolving landscape of biologics testing, offering actionable intelligence for stakeholders across the pharmaceutical value chain.
