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," the global biological safety testing market reached a value of USD 5.0 Billion in 2024. Biological safety testing ensures the non-contamination of biopharmaceuticals, medicines, and laboratories. It includes endotoxin, sterility, cell line authentication and characterization, bioburden tests, and adventitious agent detection as standard tests. It is widely conducted to assure contamination-free biopharmaceutical products such as vaccines, drugs, therapeutics, blood-derived products, stem cells, tissue banks, and other biologics. Biological safety testing ensures that all biological materials, across the development process, are safe, free of contaminants, characterized, and meet regulatory compliances. It assists in reducing risk and exposure to toxic and harmful elements and decontamination of medical equipment, laboratories, and healthcare institutions.
Global Biological Safety Testing Market Trends:
The significant growth in the pharmaceutical industry across the globe is creating a positive outlook for the market. Biological safety testing helps ehance manufacturing effectiveness by assessing the safety of targeted and specific therapies, circumventing potential shortcomings, and evaluating their outcomes. Additionally, the increasing demand for biopharmaceutical products due to the rising prevalence of chronic diseases, such as cancer, diabetes, rheumatoid arthritis, psoriasis, and Crohn’s disease, is acting as another growth-inducing factor. Furthermore, the implementation of various government initiatives to ensure the safety and authenticity of biological products is favoring the market growth. Apart from this, the increasing demand for biological safety testing to ensure the safety and efficacy of novel gene therapies for the treatment of various disorders, such as albinism, Angelman syndrome, ankylosing spondylitis, Apert syndrome, and cystic fibrosis, is providing an impetus to the market growth. Moreover, the widespread utilization of biotechnology-derived products in the healthcare industry for diagnosis, prevention, and treatment of diseases is propelling the market growth. Other factors, including increasing demand for single-use medical products, rising need for testing services, and extensive research and development (R&D) activities, are anticipated to drive the market growth. On account of the aforementioned factors, the market value is expected to reach USD 13.3 Billion by 2033, exhibiting a CAGR of 10.38% during 2025-2033.
Market Summary:
- On the basis of the product and services, the market has been divided into kits and reagents, instruments, and services.
- Based on the test type, the market has been classified into endotoxin, sterility, cell line authentication and characterization, bioburden, residual host and contaminant detection, adventitious agent detection tests, and others.
- On the basis of the application, the market has been divided into vaccine development, blood products testing, cellular and gene therapy, tissue and tissue-related products testing, and stem cell research.
- On a regional basis, the market has been categorized into North America (the United States and Canada), Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others), Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others) Latin America (Brazil, Mexico and others), and Middle East and Africa.
- The competitive landscape of the industry has also been examined, with some of the key players being 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) and WuXi Biologics.
Report Coverage:
Report Features |
Details |
Base Year of the Analysis |
2024 |
Historical Period |
2019-2024 |
Forecast Period |
2025-2033 |
Units |
Billion USD |
Segment Coverage |
Product and Services, Test Type, Application, Region |
Region Covered |
Asia Pacific, Europe, North America, Latin America, Middle East and Africa |
Countries Covered |
United States, Canada, Germany, France, United Kingdom, Italy, Spain, Russia, China, Japan, India, South Korea, Australia, Indonesia, Brazil, Mexico |
Companies Covered |
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) and WuXi Biologics |
Customization Scope |
10% Free Customization |
Post-Sale Analyst Support |
10-12 Weeks |
Delivery Format |
PDF and Excel through Email (We can also provide the editable version of the report in PPT/Word format on special request) |
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