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

The global biologics safety testing market is estimated 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 of 2026 to 2031. The global biologics safety testing market is projected to witness strong growth over the forecast period, supported by the rising biologics and biosimilars pipeline and the growth of advanced modalities such as cell & gene therapies and mRNA products. Market estimates from published industry sources indicate robust growth through 2031, driven by strong expansion in biologics development and manufacturing, as well as rising demand for stringent safety testing to ensure product quality. However, the high cost of advanced testing equipment, limited specialized expertise, and regulatory divergence across regions are expected to remain key factors restraining broader market expansion.

“The assays, kits, and reagents segment accounted for the largest share by product in the biologics safety testing market in 2025.”

Based on product, the biologics safety testing market is broadly segmented into assays, kits & reagents, and instruments. In 2025, assays, kits, and reagents accounted for the largest share of the biologics safety testing market, driven by their widespread use in routine applications such as endotoxin, mycoplasma, sterility, and viral detection testing. Their ease of use, reliability, and compatibility with automated and high-throughput systems make them essential across laboratories. Additionally, their cost-effectiveness and ability to deliver rapid, reproducible results support consistent demand from biopharmaceutical companies, CROs, and research institutions globally.

“The monoclonal antibodies and therapeutic proteins segment accounted for the largest share of the biologics safety testing product applications market in 2025.”

Based on application, the global biologics safety testing product market is segmented into vaccines, monoclonal antibodies & therapeutic proteins, cellular & gene therapy products, blood & blood products, and other applications. The monoclonal antibodies & therapeutic proteins segment accounted for the largest share of the biologics safety testing product market in 2025, driven by their extensive use in treating chronic and complex diseases. The growing pipeline, increasing approvals, and large-scale commercial production of these biologics require rigorous safety testing. Additionally, stringent regulatory requirements and the need to ensure product purity, potency, and consistency further contribute to the segment’s market position globally.

“The Asia Pacific is growing at the highest CAGR in the biologics safety testing market from 2026 to 2031.”

The biologics safety testing market is segmented into North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa. During the forecast period, the Asia Pacific region is estimated to grow at the highest CAGR, supported by expanding biopharmaceutical manufacturing, increasing adoption of biologics and biosimilars, and rising clinical trial activity. Growth is further driven by improving regulatory frameworks, and the presence of key regional and global players such as Samsung Biologics and WuXi AppTec is actively strengthening biologics development and safety testing capabilities.

The primary interviews conducted for this report can be categorized as follows:

• By Respondent: Supply Side - 70% and Demand Side - 30%
• By Company Type: Tier 1 - 40%, Tier 2 - 30%, and Tier 3 - 30%
• By Designation: CXOs and Directors - 30%, Managers - 45%, and Others - 25%
• By Region: North America - 40%, Europe - 25%, Asia Pacific - 20%, Latin America - 10%, and the Middle East - 5%

List of Companies Profiled in the Report

• Thermo Fisher Scientific Inc.
• Merck KGaA
• Lonza
• FUJIFILM Corporation
• Sartorius AG
• F. Hoffmann- La Roche Ltd.
• Charles River Laboratories
• bioMérieux
• WuXi AppTec
• SGS Société Générale de Surveillance SA
• Sotera Health
• Samsung Biologics
• GenScript
• Agilent Technologies, Inc.
• Syngene International Limited
• Eurofins Scientific
• Laboratory Corporation of America Holdings
• Bio-Rad Laboratories, Inc.
• QIAGEN

Research Coverage

This research report categorizes the biologics safety testing market by offering, by test type, by application (product & service applications), by end user (product & service end users), and by region. The scope of the report covers detailed information regarding the major factors, such as drivers, challenges, opportunities, and restraints, influencing the growth of the biologics safety testing market. A detailed analysis of the key industry players has been done to provide insights into their business overview, product portfolio, key strategies such as product and service approvals and launches, collaborations, partnerships, expansions, agreements, and recent developments associated with the biologics safety testing market. This report covers competitive analysis of top players and upcoming startups in the biologics safety testing market ecosystem.

Key Benefits of Buying the Report

The report will help market leaders/new entrants by providing the closest approximations of revenue for the overall biologics safety testing market and its subsegments. It will also help stakeholders better understand the competitive landscape and gain more insights to position their business more effectively and develop suitable go-to-market strategies. This report will enable stakeholders to understand the market’s pulse and provide information on key market drivers, restraints, opportunities, and challenges.

The report provides insights into the following pointers:

• Analysis of key drivers (rising biologics and biosimilars pipeline, stringent and evolving regulatory requirements, growth of advanced modalities like cell & gene therapies and mRNA products, expansion of CDMOs and the structural shift toward outsourced testing), restraints (high cost of advanced testing equipment and limited specialized expertise, regulatory divergence across regions), opportunities (growing focus on next-generation therapeutics, the shift toward animal-free testing approaches) and challenges (assay standardization gap) influencing the growth of biologics safety testing market
• Product Development/Innovation: Detailed insights on newly launched products of the biologics safety testing market
• Market Development: Comprehensive information about lucrative markets – the report analyses the biologics safety testing market across varied regions
• Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the biologics safety testing market
• Competitive Assessment: In-depth assessment of market shares, growth strategies, and product offerings of leading players such as Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), Lonza (Switzerland), FUJIFILM Corporation (Japan), Sartorius AG (Germany), F. Hoffmann-La Roche Ltd. (Switzerland), and Charles River Laboratories (US), among others

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