Austin, May 23, 2025 (GLOBE NEWSWIRE) -- According to SNS Insider, the Biological Safety Testing Products and Services Market was valued at USD 4.62 billion in 2023 and is projected to reach USD 11.58 billion by 2032, growing at a CAGR of 10.77% over the forecast period 2024–2032. This growth is propelled by increasing global demand for biologics, vaccines, and gene therapies, as well as stricter regulatory mandates worldwide.
In the United States, the market stood at USD 1.36 billion in 2023 and is expected to climb to USD 3.09 billion by 2032, reflecting robust investment in biopharma R&D, increased FDA oversight, and a national drive toward innovation in therapeutic development.
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Market Overview
The Biological Safety Testing Products and Services Market has witnessed steady expansion due to the growing demand for vaccines, biopharmaceuticals, and gene therapies. As biotechnology companies face increasing pressure to comply with strict safety standards, the demand for biological safety testing products, such as reagents, kits, and instruments, has surged. Moreover, advancements in technology have enhanced testing efficiency and accuracy, further driving market demand.
On the supply side, companies are adopting automated testing systems to meet the demand for rapid, reliable safety assessments. The rise of personalized medicine, especially in oncology, is also propelling the demand for specialized biological safety testing. With more companies developing biologics and complex therapeutics, the need for comprehensive safety testing across various stages of drug development and production is expected to increase, significantly contributing to market growth.
Major Players Analysis Listed in this Report are:
- Charles River Laboratories – Endosafe nexgen-PTS, Accugenix Microbial Identification System
- BSL Bioservice – Mycoplasma Detection Assays, Adventitious Agent Testing Services
- Merck KGaA (MilliporeSigma) – Steritest NEO System, PyroMAT System
- Samsung Biologics – Viral Clearance Testing Service, Endotoxin & Bioburden Testing
- Sartorius AG – Microsart Filtration System, Sartoclear Dynamics Lab Filtration
- Eurofins Scientific – GMP Sterility Testing, Residual Host Cell Protein Analysis
- SGS Société Générale de Surveillance SA – Mycoplasma Testing Service, Bioburden & Endotoxin Testing
- Thermo Fisher Scientific Inc. – Applied Biosystems qPCR Kits, EndoPrep Endotoxin Testing
- BIOMÉRIEUX – BACT/ALERT 3D, Endozyme Endotoxin Detection Assays
- Lonza – PyroGene Recombinant Factor C Assay, MycoAlert Mycoplasma Detection Kits
Biological Safety Testing Products and Services Market Report Scope
| Report Attributes | Details |
| Market Size in 2023 | US$ 4.62 billion |
| Market Size by 2032 | US$ 11.58 billion |
| CAGR | CAGR of 10.77% From 2024 to 2032 |
| Base Year | 2023 |
| Forecast Period | 2024-2032 |
| Historical Data | 2020-2022 |
| Key Regional Coverage | North America (US, Canada, Mexico), Europe (Eastern Europe [Poland, Romania, Hungary, Turkey, Rest of Eastern Europe] Western Europe] Germany, France, UK, Italy, Spain, Netherlands, Switzerland, Austria, Rest of Western Europe]), Asia Pacific (China, India, Japan, South Korea, Vietnam, Singapore, Australia, Rest of Asia Pacific), Middle East & Africa (Middle East [UAE, Egypt, Saudi Arabia, Qatar, Rest of Middle East]), Africa [Nigeria, South Africa, Rest of Africa], Latin America (Brazil, Argentina, Colombia Rest of Latin America) |
| Key Growth Drivers | The expanding biopharmaceutical industry and the increasing regulatory requirements for product safety. |
Segment Analysis
By Product
Reagents and Kits: In 2023, reagents and kits dominated the market, accounting for over 40.5% of revenue. Reagents are essential for various biological safety tests, including endotoxin and bioburden tests, and are widely used in clinical and research laboratories. Continued innovation in reagent formulations and their growing application in high-throughput testing further boost their demand.
Instruments: The instruments segment is expected to be the fastest-growing through 2032, driven by the increasing number of biological safety testing labs and the rising complexity of biologic drugs. Instruments are crucial for performing advanced safety tests, such as cell-based assays and flow cytometry.
By Application
Vaccines & Therapeutics: The vaccines & therapeutics segment dominated in 2023, fueled by the need for strict regulatory compliance and safety testing standards. Collaborative efforts like BioNTech SE’s agreement with the UK government to accelerate mRNA vaccine trials highlight the growing need for safety testing in the vaccine development process.
By Test Type
Endotoxin Tests: The endotoxin test segment witnessed significant revenue in 2023. The increasing adoption of endotoxin testing in drug production ensures that biopharmaceuticals meet stringent safety standards. Recent product launches, such as Lonza's Nebula Multimode Reader in 2022, have improved the efficiency and accuracy of endotoxin detection, further driving segment growth.
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Regional Analysis
Dominating Region: North America
North America held the largest share of the Biological Safety Testing Products and Services Market in 2023, driven by its well-established biopharmaceutical sector and stringent safety regulations. The U.S. FDA’s guidelines for biologics and therapeutic products have bolstered the demand for biological safety testing services. Leading companies in this region, such as Lonza and Thermo Fisher Scientific, are continuously innovating and expanding their product portfolios to meet the region's growing demand for biologics safety testing.
Fastest-Growing Region: Asia Pacific
The Asia Pacific region is projected to be the fastest-growing in the biological safety testing market, driven by the rapid expansion of the biotechnology sector in countries like China, India, and Japan. Government initiatives to boost biopharmaceutical R&D, along with increasing foreign investments, are fueling this growth. In particular, Chinese biopharma companies are adopting advanced safety testing technologies to meet global safety standards, contributing significantly to the region's growth.
Recent Developments
- July 2023 – Lonza launched the Nebula Multimode Reader, enhancing the efficiency of endotoxin detection in safety testing labs.
- April 2023 – BioMérieux introduced a new pyrogen testing system designed to improve patient safety in biologics testing.
- February 2023 – Charles River Laboratories expanded its endotoxin and bioburden testing services to meet the rising demand for biologics testing in North America.
- November 2022 – Merck KGaA launched a new range of reagents for cell-based assays, enhancing the speed and accuracy of biological safety tests.
- August 2022 – Eurofins Scientific opened a new biologic testing facility in the U.K., aimed at supporting advanced therapeutic development.
- October 2021 – Sartorius Stedim Biotech introduced rapid mycoplasma detection kits to enhance biologics safety testing.
Biological Safety Testing Products and Services Market Segmentation
By Product
- Reagents & Kits
- Services
- Instruments
By Application
- Vaccines & Therapeutics
- Vaccines
- Monoclonal Antibodies
- Recombinant Protein
- Blood & Blood-based Products
- Gene Therapy
- Tissue & Tissue-based Products
- Stem Cell
By Test Type
- Endotoxin Tests
- Sterility Tests
- Cell Line Authentication & Characterization Tests
- Bioburden Tests
- Adventitious Agent Detection Tests
- Residual Host Contamination Detection Tests
- Others
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Table of Contents – Major Key Points
1. Introduction
2. Executive Summary
3. Research Methodology
4. Market Dynamics Impact Analysis
5. Statistical Insights and Trends Reporting
6. Competitive Landscape
7. Biological Safety Testing Products and Services Market by Product
8. Biological Safety Testing Products and Services Market by Application
9. Biological Safety Testing Products and Services Market by Test Type
10. Regional Analysis
11. Company Profiles
12. Use Cases and Best Practices
13. Conclusion
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