2026 Global: Biologics Safety Testing Market-Competitive Review (2032) report
Description
The 2026 Global: Biologics Safety Testing Market-Competitive Review (2031) report features the global market size and projected growth/decline data for the period 2021 through 2032. The report primarily provides an examination of the business strategies for the ten largest global companies in the market and how their strategies differ.
Perry/Hope Partners' reports provide the most accurate industry forecasts based on our proprietary economic models. Our forecasts project the product market size nationally and by regions for 2021 to 2032 using regression analysis in our modeling. and Perry/Hope is the only market research publisher that utilizes both longitudinal (historical) and vertical (from market section to market division to market class) analysis, since we study every manufactured product in the countries we analyze. The report also provides written analysis on the market definition, market segments, and SWOT analysis (market strengths, weaknesses, opportunities, and threats).
The market study aims at estimating the market size and the growth potential of this market. Topics analyzed within the report include a detailed breakdown of the global markets for biologics safety testing market by geography and historical trend. The scope of the report extends to sizing of the biologics safety testing market market and global market trends with market data for 2024 as the base year, 2025 and 2026 as the estimate years with projection of CAGR from 2027 to 2032.
The report also features a list of the top ten largest global players in the market. A review of each company includes 1) an estimate of the market share, 2) a listing of the products and/or services in the market, and 3) the features of these products and/or services in the market. The report has a chapter on Comparative Business Strategies for the largest four players. An example of the Comparative Business Strategies analysis would be -- How does Netflix's business strategy to expand its market share in the global online streaming compare to Amazon Prime's business strategy through its video products and services?
The ten market players in this report and a brief synopsis of their participation in the market are:
The biologics safety testing market features dominant players like Thermo Fisher Scientific Inc., Charles River Laboratories International, Inc., Merck KGaA (MilliporeSigma), Lonza Group AG, and Sartorius AG, which lead through comprehensive services in endotoxin detection, sterility testing, and viral safety assays. These companies hold significant market share due to their global infrastructure, regulatory compliance expertise, and innovations such as Thermo Fisher's 2024 expansion of GMP lab services for mycoplasma testing and Merck KGaA's €29 million Biologics Testing Center in China opened in 2023. Eurofins Scientific SE and SGS SA follow closely, providing outsourcing solutions for bioburden and cell line characterization, bolstered by SGS's October 2024 biopharmaceutical expansion. WuXi AppTec excels in Asia-Pacific with contract research for monoclonal antibodies and gene therapies, while BioMérieux SA specializes in microbial contamination detection using advanced diagnostics. Their strategies include mergers, like Clean Cells' acquisitions, ensuring scalability amid rising biologics demand projected to grow the market to $11.50 billion by 2032.
Laboratory Corporation of America Holdings (LabCorp) and F. Hoffmann-La Roche Ltd rank among the top ten, with LabCorp's March 2023 collaboration with Forge Biologics enhancing gene therapy safety testing for AAV programs. These firms integrate safety profiling into pharma pipelines, addressing stringent FDA and EMA guidelines for vaccines, mAbs, and blood products. Bio-Rad Laboratories, Inc. contributes through U.S.-focused assays for purity verification, supporting 2024's 16 FDA-approved biologics and 63 biosimilars. Recent advancements, such as Charles River's Endosafe Trillium rCR cartridge for non-animal testing, underscore competitive edges in innovation. The top ten—Thermo Fisher, Charles River, Merck KGaA, Lonza, Sartorius, Eurofins, SGS, WuXi AppTec, BioMérieux, and LabCorp—collectively drive 70-80% of revenue via services dominating at 51.2% market share in 2025, fueled by cell and gene therapy outsourcing. North America leads with 36-40% share, propelled by R&D investments.
Market leaders invest heavily in facilities, exemplified by MilliporeSigma's $286 million U.S. biosafety expansion in 2022 and Sartorius AG's equipment for GMP compliance. Promega Corporation and Nelson Laboratories, LLC round out influences with reagents and validation services, though smaller than giants like Thermo Fisher operating in 180 countries. Competition intensifies via partnerships, such as Oxford Nanopore and PathoQuest's 2023 MOU for integration site analysis. Overall, these ten firms—prioritizing Thermo Fisher, Charles River, Merck, Lonza, Sartorius, Eurofins, SGS, WuXi, BioMérieux, and LabCorp—navigate regulatory demands, with services growing at 8.73-13.64% CAGR through 2032-2035, ensuring biologics safety for global pharma and biotech.
Perry/Hope Partners' reports provide the most accurate industry forecasts based on our proprietary economic models. Our forecasts project the product market size nationally and by regions for 2021 to 2032 using regression analysis in our modeling. and Perry/Hope is the only market research publisher that utilizes both longitudinal (historical) and vertical (from market section to market division to market class) analysis, since we study every manufactured product in the countries we analyze. The report also provides written analysis on the market definition, market segments, and SWOT analysis (market strengths, weaknesses, opportunities, and threats).
The market study aims at estimating the market size and the growth potential of this market. Topics analyzed within the report include a detailed breakdown of the global markets for biologics safety testing market by geography and historical trend. The scope of the report extends to sizing of the biologics safety testing market market and global market trends with market data for 2024 as the base year, 2025 and 2026 as the estimate years with projection of CAGR from 2027 to 2032.
The report also features a list of the top ten largest global players in the market. A review of each company includes 1) an estimate of the market share, 2) a listing of the products and/or services in the market, and 3) the features of these products and/or services in the market. The report has a chapter on Comparative Business Strategies for the largest four players. An example of the Comparative Business Strategies analysis would be -- How does Netflix's business strategy to expand its market share in the global online streaming compare to Amazon Prime's business strategy through its video products and services?
The ten market players in this report and a brief synopsis of their participation in the market are:
The biologics safety testing market features dominant players like Thermo Fisher Scientific Inc., Charles River Laboratories International, Inc., Merck KGaA (MilliporeSigma), Lonza Group AG, and Sartorius AG, which lead through comprehensive services in endotoxin detection, sterility testing, and viral safety assays. These companies hold significant market share due to their global infrastructure, regulatory compliance expertise, and innovations such as Thermo Fisher's 2024 expansion of GMP lab services for mycoplasma testing and Merck KGaA's €29 million Biologics Testing Center in China opened in 2023. Eurofins Scientific SE and SGS SA follow closely, providing outsourcing solutions for bioburden and cell line characterization, bolstered by SGS's October 2024 biopharmaceutical expansion. WuXi AppTec excels in Asia-Pacific with contract research for monoclonal antibodies and gene therapies, while BioMérieux SA specializes in microbial contamination detection using advanced diagnostics. Their strategies include mergers, like Clean Cells' acquisitions, ensuring scalability amid rising biologics demand projected to grow the market to $11.50 billion by 2032.
Laboratory Corporation of America Holdings (LabCorp) and F. Hoffmann-La Roche Ltd rank among the top ten, with LabCorp's March 2023 collaboration with Forge Biologics enhancing gene therapy safety testing for AAV programs. These firms integrate safety profiling into pharma pipelines, addressing stringent FDA and EMA guidelines for vaccines, mAbs, and blood products. Bio-Rad Laboratories, Inc. contributes through U.S.-focused assays for purity verification, supporting 2024's 16 FDA-approved biologics and 63 biosimilars. Recent advancements, such as Charles River's Endosafe Trillium rCR cartridge for non-animal testing, underscore competitive edges in innovation. The top ten—Thermo Fisher, Charles River, Merck KGaA, Lonza, Sartorius, Eurofins, SGS, WuXi AppTec, BioMérieux, and LabCorp—collectively drive 70-80% of revenue via services dominating at 51.2% market share in 2025, fueled by cell and gene therapy outsourcing. North America leads with 36-40% share, propelled by R&D investments.
Market leaders invest heavily in facilities, exemplified by MilliporeSigma's $286 million U.S. biosafety expansion in 2022 and Sartorius AG's equipment for GMP compliance. Promega Corporation and Nelson Laboratories, LLC round out influences with reagents and validation services, though smaller than giants like Thermo Fisher operating in 180 countries. Competition intensifies via partnerships, such as Oxford Nanopore and PathoQuest's 2023 MOU for integration site analysis. Overall, these ten firms—prioritizing Thermo Fisher, Charles River, Merck, Lonza, Sartorius, Eurofins, SGS, WuXi, BioMérieux, and LabCorp—navigate regulatory demands, with services growing at 8.73-13.64% CAGR through 2032-2035, ensuring biologics safety for global pharma and biotech.
Table of Contents
32 Pages
- 1.0 Scope of Report and Methodology
- 2.0 Market SWOT Analysis and Players
- 2.1 Market Definition
- 2.2 Market Segments
- 2.3 Market Strengths
- 2.4 Market Weaknesses
- 2.5 Market Threats
- 2.6 Market Opportunities
- 2.7 Major Players
- 3.0 Competitive Analysis
- 3.1 Market Player 1
- 3.2 Market Player 2
- 3.3 Market Player 3
- 3.4 Market Player 4
- 3.5 Market Player 5
- 3.6 Market Player 6
- 3.7 Market Player 7
- 3.8 Market Player 8
- 3.9 Market Player 9
- 3.10 Market Player 10
- 4.0 Comparative Business Strategies
- 4.1 Comparative Business Strategies of Player 1 and 2
- 4.2 Comparative Business Strategies of Player 1 and 3
- 4.3 Comparative Business Strategies of Player 1 and 4
- 4.4 Comparative Business Strategies of Player 2 and 3
- 4.5 Comparative Business Strategies of Player 2 and 4
- 4.6 Comparative Business Strategies of Player 3 and 4
- 5.0 Appendix
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