DELRAY BEACH, Fla., May 4, 2026 /PRNewswire/ — According to MarketsandMarkets™, the Biologics Safety Testing is projected to grow from about USD 5.57 billion in 2026 to USD 9.66 billion by 2031, at a CAGR of 11.6%.
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Biologics Safety Testing Market Size & Forecast:
- Market Size Available for Years: 2025–2031
- 2026 Market Size: USD 5.57 billion
- 2031 Projected Market Size: USD 9.66 billion
- CAGR (2026–2031): 11.6%
Biologics Safety Testing Market Trends & Insights:
- By offering, in 2025, the product segment had the largest share of 41.9%.
- Pharmaceutical & biotechnology companies dominated the biologics safety testing products market in 2025 with a share of 56.0%.
- North America accounted for the largest market share, by region, in 2025: 43%.
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The growth of advanced modalities such as cell & gene therapies and mRNA products is a major driver of the biologics safety testing market. Additionally, the expanding pipeline of biologics and biosimilars, along with stringent and evolving regulatory requirements, is driving the market growth.
By offerings, The Service segment accounted for the largest share of the global biologics safety testing market 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.
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By application, 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.
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Top Companies in Biologics Safety Testing Market:
The Top Companies in 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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