According to the latest report by IMARC Group, titled “Biological Safety Testing Market Report by Product and Services (Kits and Reagents, Instruments, Services), Test Type (Endotoxin Tests, Sterility Tests, Cell Line Authentication and Characterization Tests, Bioburden Tests, Residual Host Contaminant Detection Tests, Adventitious Agent Detection Tests, and Others), Application (Vaccine Development, Blood Products Testing, Cellular and Gene Therapy, Tissue and Tissue-related Products Testing, Stem Cell Research), and Region 2025-2033”, offers a comprehensive analysis of the industry, which comprises insights on the global biological safety testing market forecast. The report also includes competitor and regional analysis, and contemporary advancements in the global market.
The global biological safety testing market size reached USD 5.0 billion in 2024. Looking forward, IMARC Group expects the market to reach USD 13.3 billion by 2033, exhibiting a growth rate (CAGR) of 10.38% during 2025-2033.
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Biological Safety Testing Market Dynamics:
Surge in Biopharmaceutical Development:
The biopharmaceutical industry is leading to an increased demand for biological safety testing. As a consequence, the global biological safety testing market is also growing significantly. Significant market growth is primarily driven through additional safety assessments for various therapeutic areas. Biologics are complex in nature and, therefore, require vigorous testing to determine their potential efficacy for patients. The novel therapies such as gene/cell therapies and monoclonal antibodies are paving the way for new advancements in biotechnology and genetic engineering.
Stringent Regulatory Scrutiny:
With complex biopharmaceuticals comes an increase in regulation. Because of the increasing sophistication of biopharmaceuticals, strict measures are being put in place internationally. Novel therapies require stringent safety and efficacy assessments, which the FDA and EMA have implemented to regulate. These advanced policies entail thorough biological safety testing such as sterility, endotoxin, and viral safety testing. The increased testing services that are needed flank a robust demand in the market.
Technological Advancements:
With complex biopharmaceuticals comes an increase in regulation. Because of the increasing sophistication of biopharmaceuticals, strict measures are being put in place internationally. Novel therapies require stringent safety and efficacy assessments, which the FDA and EMA have implemented to regulate. These advanced policies entail thorough biological safety testing such as sterility, endotoxin, and viral safety testing. The increased testing services that are needed flank a robust demand in the market.
By the IMARC Group, Some of the Top Competitive Landscape Operating in the Biological Safety Testing Market are Given Below:
- Avance Biosciences
- Charles River Laboratories
- Creative Biogene
- Eurofins Scientific
- Lonza Group AG
- Maravai LifeSciences
- Pace Analytical Services Inc.
- Pacific BioLabs
- Sartorius AG
- SGS SA
- ViruSure GmbH (Asahi Kasei Corporation)
- WuXi Biologics
Explore the Full Report with Charts, Table of Contents, and List of Figures: https://www.imarcgroup.com/biological-safety-testing-market
Global Biological Safety Testing Market Trends:
The global biological safety testing market has some shifts that are expected to define its future direction. Investment in gene and cell therapies has expanded focus on advanced personalized medicine, which in turn will compel new specialized testing techniques. In addition, as more organizations seek to apply evidence-based decision making, there is adoption of modern and predictive analytics to refine testing methods and anticipate problems.
Key Market Segmentation:
Breakup by Product and Services:
- Kits and Reagents
- Instruments
- Services
According to the report, kits and reagents represented the largest segment.
Breakup by Test Type:
- Endotoxin Tests
- Sterility Tests
- Cell Line Authentication and Characterization Tests
- Bioburden Tests
- Residual Host Contaminant Detection Tests
- Adventitious Agent Detection Tests
- Others
According to the report, endotoxin tests accounted for the largest market share.
Breakup by Application:
- Vaccine Development
- Blood Products Testing
- Cellular and Gene Therapy
- Tissue and Tissue-related Products Testing
- Stem Cell Research
According to the report, vaccine development represented the largest segment.
Regional Insights:
- North America (United States, Canada)
- Asia Pacific (China, Japan, India, Australia, Indonesia, Korea, Others)
- Europe (Germany, France, United Kingdom, Italy, Spain, Others)
- Latin America (Brazil, Mexico, Others)
- Middle East and Africa (United Arab Emirates, Saudi Arabia, Qatar, Iraq, Other)
According to the report, North America accounted for the largest market share.
Key highlights of the Report:
- Market Performance
- Market Outlook
- COVID-19 Impact on the Market
- Porter’s Five Forces Analysis
- Historical, Current and Future Market Trends
- Market Drivers and Success Factors
- SWOT Analysis
- Structure of the Market
- Value Chain Analysis
- Comprehensive Mapping of the Competitive Landscape
Note: If you need specific information that is not currently within the scope of the report, we can provide it to you as a part of the customization.
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