According to a new report published by Introspective Market Research, titled, Biologics Safety Testing Market by Test Type, Product Type, and End User, the Global Biologics Safety Testing Market Size Was Valued at USD 4.60 Billion in 2024 and is Projected to Reach USD 14.21 Billion by 2035, Growing at a CAGR of 10.8% from 2025–2035.
The biologics safety testing market plays a critical role in ensuring the safety, quality, and efficacy of biologic products such as vaccines, monoclonal antibodies, cell and gene therapies, and recombinant proteins. These tests are essential to detect contaminants including viruses, mycoplasma, endotoxins, and adventitious agents during biologics development and manufacturing. As biologics are derived from living organisms, safety testing is significantly more complex compared to conventional pharmaceuticals, making this market indispensable for regulatory compliance.
Biologics safety testing offers key advantages over traditional chemical testing by enabling highly sensitive, specific, and regulatory-approved detection methods. Advanced in vitro assays, molecular techniques, and cell-based testing improve accuracy while reducing testing timelines. These advantages support faster product approvals and lower development risks for manufacturers.
The market is witnessing robust growth driven by the rapid expansion of biologics pipelines, increasing adoption of biosimilars, and rising regulatory scrutiny by global health authorities. Pharmaceutical and biotechnology companies, along with contract research organizations (CROs), are major end users, leveraging safety testing services to meet stringent global quality standards throughout the forecast period.
Market Segmentation
The Biologics Safety Testing Market is segmented into Test Type, Product Type, and End User.
- By Test Type, the market is categorized into Sterility Testing, Endotoxin Testing, Mycoplasma Testing, and Adventitious Agent Testing.
- By Product Type, the market is categorized into Instruments, Kits & Reagents, and Services.
- By End User, the market is categorized into Pharmaceutical & Biotechnology Companies, Contract Research Organizations (CROs), and Academic & Research Institutes.
Growth Driver
The primary growth driver for the biologics safety testing market is the accelerating development and commercialization of biologics and advanced therapies. With a growing number of monoclonal antibodies, vaccines, and cell and gene therapies entering clinical and commercial stages, the need for comprehensive safety testing has intensified. Regulatory agencies worldwide mandate rigorous testing to ensure patient safety, driving consistent demand for validated testing solutions. Additionally, increasing investment in biologics R&D by pharmaceutical and biotechnology companies continues to fuel market expansion.
Market Opportunity
A key market opportunity lies in the adoption of rapid and alternative testing methods. Traditional safety testing methods are often time-consuming, which can delay product release. The shift toward rapid microbiological methods, in vitro assays, and automated platforms presents significant growth potential. These advanced technologies reduce testing time while maintaining compliance with regulatory standards. Emerging markets, coupled with increasing outsourcing of testing services to specialized CROs, further create lucrative opportunities for market participants.
Detailed Segmentation
Biologics Safety Testing Market, Segmentation
The Biologics Safety Testing Market is segmented on the basis of Test Type, Product Type, and End User.
Test Type
The Test Type segment is further classified into Sterility Testing, Endotoxin Testing, and Mycoplasma Testing. Among these, the Sterility Testing sub-segment accounted for the highest market share in 2024. Sterility testing is mandatory for all biologic products to ensure the absence of viable microorganisms. Its critical role in regulatory approval and batch release, along with widespread adoption across vaccines and injectable biologics, has driven its dominance in the market.
Product Type
The Product Type segment is further classified into Instruments, Kits & Reagents, and Services. Among these, the Services sub-segment accounted for the highest market share in 2024. Many biologics manufacturers outsource safety testing to specialized service providers to reduce infrastructure costs and ensure regulatory compliance. The availability of expertise, advanced technologies, and faster turnaround times has significantly boosted demand for testing services globally.
Some of The Leading/Active Market Players Are-
• Thermo Fisher Scientific (US)
• Merck KGaA (Germany)
• Charles River Laboratories (US)
• Lonza Group (Switzerland)
• SGS SA (Switzerland)
• Eurofins Scientific (Luxembourg)
• WuXi AppTec (China)
• Bio-Rad Laboratories (US)
• Sartorius AG (Germany)
• Toxikon Corporation (US)
• Intertek Group (UK)
• Fujifilm Diosynth Biotechnologies (Japan)
• North American Science Associates (US)
• Avance Biosciences (US)
and other active players.
Key Industry Developments
In March 2024, a leading life sciences company expanded its biologics safety testing service portfolio to support cell and gene therapy manufacturers.
The expansion included advanced viral clearance and rapid sterility testing solutions, aimed at reducing testing timelines and supporting faster regulatory submissions for next-generation biologics.
In September 2024, a global CRO announced the establishment of a new biologics testing facility in Asia-Pacific.
This facility focuses on mycoplasma and adventitious agent testing, strengthening regional testing capabilities and supporting the growing biologics manufacturing base in emerging markets.
Key Findings of the Study
• Sterility testing and services dominate the market
• North America leads due to strong biologics pipelines
• Rising biologics R&D is the key growth driver
• Rapid testing technologies are an emerging trend
