The global biological safety testing services market was valued at USD 3.55 billion in 2024 and is projected to Hit USD 10.82 billion by 2034, registering a CAGR of 11.79% from 2025 to 2034. The biological safety testing services market has been growing due to the advancement in biotechnology and increasing demands for complex biological therapies. The rise of modern technology and renewable energy has been impelled by changing consumer needs.
Biological Safety Testing Services Market Key Takeaways:
· The bioburden testing services segment captured the highest market share in 2024.
· The cell line authentication and characterization tests segment are projected to experience the fastest CAGR during the forecast period
· The vaccine & therapeutics segment dominated the biological safety testing services industry in 2024.
· The cell and gene therapy segments are expected to experience the fastest CAGR during the forecast period.
· The biopharmaceutical companies segment dominated the biological safety testing services market share 27.0% in 2024.
· North America accounted for the largest market share of 34.0% in 2024
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Biological safety testing services is essential for ensuring the safety of vaccines and biopharmaceuticals by detecting bacterial contaminants. Biological safety testing services market is critical in protecting human health by confirming the safety and efficacy of biological products such as vaccines, therapeutic proteins, gene therapies, and cell-based treatments. It involves different services and technologies designed to evaluate the safety of these products, playing a vital role in the development and regulation of biopharmaceuticals. The growing complexity of biopharmaceuticals, coupled with stricter regulatory requirements, is fueling the development and expansion of this market.
The biological safety testing services market grows greatly with opportunities from outsourcing, next-gen therapies, and technological advancements like AI, machine learning, and high-throughput screening. The adoption of alternative testing methods, personalized medicine, and the advance of biopharmaceuticals in emerging markets give a further boost to the demand for specialized safety assessments and services.
Furthermore, according to WHO by the year 2030, chronic diseases are set to incur a USD 47 trillion cost worldwide. This is an opportunity for the biological safety testing services market to assist the development of safer, effective treatments in the management of these diseases.
AI is significantly modernizing the biological safety testing services market by making processes more effective, accurate, and knowledgeable. Machine learning and advanced analytics also offer predictive capabilities, allowing for more effective risk management and the advancement of precision medicine. Automated workflows, real-time data interrogation, and AI-driven insights speed up the testing process, reducing time-to-market for biopharmaceuticals. AI also helps champion innovation with tools such as the Merck's Aptegra™ CHO genetic stability assay and AIDDISON™ Platform- bioinformatics and generative design to expedite biosafety testing. These various advances permit accelerated, yet more precise, testing and, therefore, spur advancement within the sector and fuel growth while preparing companies for success.
Market Trends
· Technological Advances: The integration of AI, machine learning, robotics, and high-throughput screening is enhancing the efficiency and accuracy of biological safety testing services, reduced time to get more reliable results as well as the availability of more advanced therapeutic results.
· Reduce Animal Testing: Legislative and technological advancements enable reduction of animal testing as more in vitro and computational alternative methods become available that can show ethical, reliable safety data for the biopharmaceuticals.
· Targeted Therapies Adoption: The targeted therapies have led the biological safety testing market to expand with specialized testing services to check the safety of gene therapies, biologics, and the other next-gen targeted therapy designed for specific conditions.
Biological Safety Testing Services Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 3.97 billion |
|
Revenue forecast in 2034 |
USD 10.82 billion |
|
Growth rate |
CAGR of 11.79% from 2025 to 2034 |
|
Actual data |
2018 - 2024 |
|
Forecast period |
2025 - 2034 |
|
Quantitative units |
Revenue in USD million/billion and CAGR from 2025 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Service, Application, End-use, Region |
|
Regional scope |
North America; Europe; Asia Pacific; Latin America; MEA |
|
Country scope |
U.S.; Canada; Mexico; Germany; UK; France; Italy; Spain; Denmark; Sweden; Norway; China; Japan; India; South Korea; Australia; Thailand; Brazil; Argentina; South Africa; Saudi Arabia, UAE; Kuwait |
|
Key companies profiled |
Charles River Laboratories International, Inc.; Lonza Group Ltd.; Merck KGaA; SGS SA; Eurofins Scientific; WuXi AppTec; Thermo Fisher Scientific Inc.; Sartorius AG; Toxikon Corporation; bioMérieux SA |
|
Customization scope |
Free report customization (equivalent up to 8 analyst’s working days) with purchase. Addition or alteration to country, regional & segment scope. |
Segment Insights
By Services Insights
The segment of bioburden testing services dominates the biological safety testing services market due to its important role in ensuring the sterility and safety of biopharmaceutical products. It detects microbial contamination in raw materials, intermediates, and final products, which is a regulatory requirement for biologics, vaccines, and gene therapies.
The segment of cell line authentication and characterization is expected to grow the fastest CAGR during forecasted period because of the increasing usage of cell-based therapies, regenerative medicine, and biologics. Schiager and Fralay also cite research on monoclonal antibodies and personalized medicine, which are factors driving the growth of the segment.
By Application Insights
Vaccines & therapeutics accounted for the majority share of the biological safety testing market in 2024, which tipped the scale in favor of its expected continued dominance throughout the forecast. Also, the increase in the development of vaccines and therapeutics is backed by biopharmaceutical companies for a rising burden of chronic diseases. Comprehensive safety testing is vital to ascertain patients on vaccines' effectiveness, absence of contaminants, and safety for human use.
The cell and gene therapy segment, in addition, is projected to grow significantly driven by the key developments in the treatment of such conditions as cancer, genetic disorders, and autoimmune diseases, all of which require supportive rigorous safety assessments before their application to patients.
By End Use Insights
The biopharmaceutical companies segment dominated the biological safety testing services market share 27.0% in 2024. This is due to the need for rigorous safety testing as part of vaccine, therapeutic, and biologic development and manufacture. This great demand for such services arises from the need for ensuring the safety and efficacy of products.
Academic and research institutions segments, expected to grow fastest during the forecast period attributable to increased investments in biomedical research, particularly cell and gene therapies and vaccine development. The advancements, in turn, require a comprehensive safety assessment, which opens ground for biological safety testing services in research settings.
Regional Insights
North America: Dominating the Biological Safety Testing Services Market
North America accounted for the largest market share of 34.0% in 2024. The market was, of course, facilitated by the advanced healthcare infrastructure in North America, besides being under a stringent regulatory environment. The FDA and Health Canada regulate the testing procedures performed on pharmaceutical biotechnology products according to stringent safety standards for the sake of the safety of pharmaceuticals and biologics basing on the demand for safety evaluations from the sector within the creative biopharmaceutical industry.
United States: The Dominating Country in Biological Safety Testing
The U.S. will lead the market primarily due to strict regulations set forth by the FDA and constant innovation in the area of biologics. The prospect in the U.S., in terms of biological safety testing services, is further projected by government funding for life sciences research, implementation of biosimilars, and increasing clinical trials since they, in their own little way, relate to the tooling for the protection of human health. Additionally, increasing prevalence of chronic diseases in US is one the key driving factor for this market
· As per the May 2024 CDC data, cancer remains the second leading cause of death in the U.S., with 1.7 million cases and more than 600,000 deaths each year. Cancer treatment costs will certainly exceed USD 240 billion by 2030. Add to this, over 38 million people with diabetes, and 98 million adults with prediabetes who stand at risk of bigger problems such as heart disease, kidney failure, and even blindness.
Asia Pacific: The Fastest Growing Region in Biological Safety Testing Services
Asia Pacific will be the fastest-growing market for biological safety testing services on account of the rising biopharmaceutical production, increase in clinical trials, and government assistance in attracting more biotechnology research. Cost-effective testing services are also allowing more outsourcing to Contract Research Organizations (CROs) in the region. Especially regarding biopharmaceutical manufacturing, China and India are poised to become central players with their cost advantages and strong government support, which is expected to drive continued growth in the region at large.
· On March 20, 2024, Merck KGaA announced a USD 319 million investment to establish a new Bioprocessing Production Center in Daejeon, South Korea. This facility marks the largest investment by Merck’s Life Science sector in the Asia-Pacific region, highlighting its commitment to strengthening capabilities in the rapidly growing market.
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Some of the prominent players in the biological safety testing services market include:
· Charles River Laboratories International, Inc.
· Lonza Group Ltd.
· Merck KGaA
· SGS SA
· Eurofins Scientific
· WuXi AppTec
· Thermo Fisher Scientific Inc.
· Sartorius AG
· Toxikon Corporation
Biological Safety Testing Services Market Recent Development
· On February 7, 2025, Intelligent Bio Solutions Inc. (INBS) entered a partnership with the Avon Freight Group for rollout of its Intelligence Fingerprinting Drug Testing Solution at three UK sites for random drug testing, supporting risk management and employee well-being. The collaborative arrangements add to INBS' client base, which will now cover more than 400 accounts in 19 countries, thus ensuring momentum in global growth ahead of a planned U.S. launch.
· On October 9, 2024, Merck opened a new €290 million biosafety testing facility in Rockville, Maryland, USA, to address the increasing global demand for biosafety testing services.
· In October 2024, SGS SA announced expansion of its biopharmaceutical testing services to provide to the growing global demands for large-molecule drug development. This initiative furthers the support for biologics falling under methods such as safety of cell bank, characterization of product, method development, and final product release.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the biological safety testing services market
By Services
· Bioburden Testing Services
· Endotoxin Testing Services
· Sterility Testing Services
· Viral Clearance and Validation Services
· Cell Line Authentication and Characterization Tests
· Residual Host Contamination Testing Services
· Adventitious Agent Detection Testing Services
· Others
By Application
· Vaccine & Therapeutics
o Monoclonal Antibodies
o Vaccines
o Recombinant Protein
· Cell and Gene Therapy
· Blood & Blood Products
· Tissue & Tissue-based Products
· Others
By End-use
· Biopharmaceutical Companies
· Pharmaceutical Companies
· Academic and Research Institutions
· Others
By Regional
· North America
· Europe
· Asia Pacific
· Latin America
· Middle East and Africa (MEA)
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