Biologics Safety Testing Market worth $9.66 billion by 2031
The report "Biologics Safety Testing Market by Product (Kits, Reagents, Instruments), Services, Test Type (Mycoplasma, Sterility, Endotoxin, Bioburden), Product & Services by Application (Vaccines, mAbs, CGT), End User, Competition, Region - Global Forecast to 2031" is projected to reach USD 9.66 billion by 2031 from USD 5.57 billion in 2026, at a CAGR of 11.6% during the forecast period.
Browse 260 market data Tables and 60 Figures spread through 270 Pages and in-depth TOC on "Biologics Safety Testing Market by Product (Kits, Reagents, Instruments), Services, Test Type (Mycoplasma, Sterility, Endotoxin, Bioburden), Product & Services by Application (Vaccines, mAbs, CGT), End User, Competition, Region - Global Forecast to 2031 "
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The global biologics safety testing market is experiencing growth, driven by the rising biologics and biosimilars pipeline, the expansion of CDMOs, and a structural shift toward outsourced testing.
The Service segment accounted for the largest share of the global biologics safety testing market, by offerings, in 2025.
Based on offerings, the biologics safety testing market is segmented into products and services. The services segment dominated the biologics safety testing market share in 2025, driven by increasing outsourcing to CROs and CDMOs, rising complexity of biologics, and the need for specialized expertise. The growing demand for end-to-end testing across development and manufacturing, along with stringent regulatory requirements, further supports the segment's leadership. Additionally, the expansion of cell and gene therapies and increasing biologics production continue to boost service adoption, reinforcing its dominant position in the global biologics safety testing market.
Vaccine safety testing is estimated to be the fastest-growing service application segment in the biologics safety testing market.
The global biologics safety testing service market is segmented by monoclonal antibodies & therapeutic proteins safety testing, vaccines safety testing, cellular & gene therapy safety testing, blood & blood products safety testing, and other applications. During the forecast period, the vaccines safety testing segment is projected to be the fastest-growing in the biologics safety testing services market, driven by increasing global immunization programs, rising vaccine production, and the continuous development of new and improved vaccines. Stringent regulatory requirements for batch release and quality assurance further accelerate demand for comprehensive safety testing solutions.
North America accounted for the largest regional share in the global biologics safety testing market in 2025.
North America accounted for the largest share of regional revenues in the biologics safety testing market and remains the primary growth engine. The region’s dominance is driven by a high concentration of leading biopharmaceutical companies, advanced research infrastructure, and strong regulatory oversight from agencies such as the FDA. Increasing biologics production, rapid adoption of cell and gene therapies, and a robust clinical trials landscape further support demand for safety testing. Additionally, significant public and private funding, along with widespread outsourcing to CROs and CDMOs, positions the US as a key hub for innovation and market growth.
Key players in the biologics safety testing market include Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), Lonza (Switzerland), FUJIFILM Corporation (Japan), Sartorius AG (Germany), F. Hoffmann-La Roche Ltd. (Switzerland), Charles River Laboratories (US), bioMérieux (France), Maravai LifeSciences (US), WuXi AppTec (China), SGS Société Générale de Surveillance SA (Switzerland), Sotera Health (US), Samsung Biologics (South Korea), GenScript (US), Agilent Technologies, Inc. (US), Syngene International Limited (India), Eurofins Scientific (Luxembourg), Laboratory Corporation of America Holdings (US), Bio-Rad Laboratories, Inc. (US), and QIAGEN (Netherlands).
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