Market Overview

According to fortune business insights, The global biologics safety testing market size was valued at USD 5.90 billion in 2024. The market is projected to grow from USD 6.40 billion in 2025 to USD 11.50 billion by 2032, exhibiting a CAGR of 8.73% during the forecast period. North America dominated the global biologics safety testing market with a market share of 37.97% in 2024.

The analysis shows that the market is experiencing significant growth due to the exponential increase in the production of biologics and biosimilars. This has led to a growing trend of outsourcing safety testing, prompting major players to expand their testing capabilities globally. For instance, Merck KGaA expanded its Biologics Testing Center in China to meet rising demand, highlighting the industry's focus on accessing a broad range of testing services from pre-clinical development to commercialization.

Major Players Profiled in the Market Report:

• Merck KGaA (Germany)SGS Société Générale de Surveillance SA (Switzerland)Thermo Fisher Scientific Inc. (U.S.)BD (U.S.)Sartorius AG (Germany)Charles River Laboratories (U.S.)Eurofins Scientific (Luxembourg)Lonza (Switzerland)Waters Corporation (U.S.)Reading Scientific Services Ltd (U.S.)Abzena (U.S.)

SegmentsServices Segment to Lead Market Due to Outsourcing TrendBased on products & services, the market is segmented into kits & reagents, instruments, and services. The services segment holds the largest market share, driven by the increasing adoption of cell and gene therapies and the rising trend of outsourcing complex safety testing to specialized providers with GMP-compliant facilities and regulatory expertise.

Viral Safety/Adventitious Agents Segment to Dominate Due to Regulatory MandatesBy test type, the market is classified into sterility, endotoxin, mycoplasma, bioburden, viral safety/adventitious agents, and others. The viral safety/adventitious agents segment holds the largest share, as viral safety testing is a critical and mandatory component at every stage of biologics manufacturing, requiring complex and method-intensive assessments to ensure product safety.

Monoclonal Antibodies (mAbs) & Recombinant Proteins Segment to Hold Largest ShareBased on application, the market is segmented into monoclonal antibodies (mAbs) & recombinant proteins, vaccines, cell & gene therapies, and others. The mAbs & recombinant proteins segment accounts for the largest market share, reflecting the high volume of these products in development and on the market, which requires extensive and rigorous safety testing.

Pharmaceutical & Biotechnology Companies Segment to Dominate the MarketBy end-user, the market is categorized into pharma & biotech companies, CROs/CDMOs, and academic & research institutes. The pharma & biotech companies segment holds the largest market share as these entities are the primary developers and manufacturers of biologics, conducting intensive quality checks and R&D activities that drive the demand for safety testing consumables and services.

Source: https://www.fortunebusinessinsights.com/biologics-safety-testing-market-114846

Report CoverageThe report offers:• Major growth drivers, restraining factors, opportunities, and potential challenges for the market.• Comprehensive insights into regional developments.• List of major industry players.• Key strategies adopted by the market players.• The latest industry developments include product launches, partnerships, mergers, and acquisitions.

Drivers & RestraintsExponential Growth of Biologics to Drive Market GrowthThe market is primarily driven by the rapid growth of biologics, particularly advanced modalities like cell and gene therapies. These next-generation products involve complex manufacturing processes with high contamination risks, necessitating rigorous, high-frequency safety testing at every stage of production and fueling demand for validated testing services and products.

However, the market's growth is impeded by infrastructure and talent constraints. Advanced biologics safety testing requires high-end laboratories (BSL-2/BSL-3), specialized equipment, and trained professionals. The high capital expenditure, operational costs, and strict regulatory compliance increase implementation costs and can slow adoption, particularly for smaller players.

Regional InsightsExpanding Biologics Pipeline to Fuel Growth in North AmericaNorth America holds the dominant market share, valued at USD 2.24 billion in 2024. The region's leadership is driven by the presence of a large number of pharmaceutical companies, an expanding pipeline of innovative biologics, and significant R&D investments, particularly in the U.S., which is the epicenter for new cell and gene therapies.

Europe is the second-largest market, with growth fueled by the rise of advanced therapies and the expansion of biosafety testing capabilities by key players. The Asia Pacific region is also experiencing notable growth, driven by increasing biologics production and investment in countries like China and India.

**Biologics Safety Testing Market Future Growth:**The future of the biologics safety testing market is being shaped by a decisive shift toward rapid and automated microbiology systems. To improve efficiency and reduce QC timelines, companies are increasingly adopting automated platforms that offer real-time microbial detection, rapid sterility tests, and AI-enabled analysis. This trend is especially critical for biologics with shorter shelf lives, such as cell and gene therapies. Strategic partnerships, like the one between Rapid Micro Biosystems and Samsung Biologics to automate quality control, highlight the industry's move toward more robust, efficient, and scalable safety testing operations.

Competitive LandscapeKey Players Strengthen Market Position Through Strategic CollaborationsThe market is concentrated, with key players such as Merck KGaA, SGS Société Générale de Surveillance SA, and Thermo Fisher Scientific Inc. holding significant shares. These companies are actively strengthening their market positions through strategic collaborations, mergers, acquisitions, and capacity expansions. By offering a comprehensive portfolio of products and services and investing in technological advancements, they are catering to the evolving needs of the biologics industry.

Key Industry Development• October 2025: Charles River Laboratories International, Inc. collaborated with Toxys to gain access to ReproTracker, an in-vitro assay for identifying developmental toxicity hazards.• September 2025: Bionique Testing Laboratories LLC, a subsidiary of Asahi Kasei, expanded its facility to meet the demand for rapid biosafety testing solutions.