Biological Safety Testing Products And Services Market Size, Share & Trends Analysis Report By Product, By Application (Vaccines & Therapeutics, Gene Therapy), By Test Type (Endotoxin Tests, Bioburden Tests), By Region, And Segment Forecasts, 2025 - 2033

Biological Safety Testing Products And Services Market Summary

The growing demand for biologics has led to an unprecedented increase in the number of biopharmaceutical companies. The escalating competition to produce highly effective therapeutic drugs on a large scale has encouraged manufacturers to focus on improving various aspects of industrial processes, including cost-effectiveness and productivity. For instance, in July 2023, Biocon Biologics, an India-based organization, announced the launch of the rheumatoid arthritis drug Humira, a biosimilar version of AbbVie in the U.S., at a lower price that would be readily available throughout the region. Several organizations are thus implementing improved manufacturing practices involving rigorous biological testing at multiple levels of the production cycle with greater accessibility, thereby driving the market growth.

The expansion of the biopharmaceutical and biotechnology sectors is a key driver of the biological safety testing products and services market. The global growth of biologics, biosimilars, cell and gene therapies, and regenerative medicines is accelerating demand for accurate, validated biosafety testing. As regulatory expectations rise and therapeutic pipelines deepen, companies are investing heavily in testing infrastructure, innovation, and partnerships to address the biosafety needs of evolving biologic modalities. A surge of capital projects, mergers, and platform developments globally further supports this growth.

The increasing number of government initiatives to stimulate biological safety testing products and services is expected to drive overall growth throughout the forecast period. For instance, in June 2022, Pfizer and BioNTech announced their collaboration with the U.S. Government to provide additional vaccine supplies to control the spread of the COVID-19 virus. Consequently, government and private organizations are expected to improve underlying biological safety practices in response to the rising incidence of microbial contamination and bioburden during the production of pharmaceuticals and biologics.

Moreover, the presence of regulatory authorities enforcing significant safety standards is expected to enhance the adoption of testing tools. For example, in June 2023, the FDA introduced a new guideline that encourages biosimilar developers to use a more cost-effective approach to testing. The FDA guideline, called "BioRationality," aims to promote a more scientifically rational and efficient way to develop and approve biosimilars. The new guideline suggests alternative testing methodologies to streamline the development process and reduce costs. Stringent guidelines and recommendations from these authorities increase the use of these tools by quality assurance technicians, thus fueling market growth.

Biological safety testing services play a crucial role in verifying the absence of bacterial contaminants and ensuring the safety of vaccines and biopharmaceuticals. These services include a variety of assessments, such as bioburden testing, toxicology testing, and analytical testing. Parameters like accuracy, linearity, range, and specificity are examined to evaluate the quality of products offered by companies in this field.

Market Concentration & Characteristics

The biological safety testing product and services market is marked by significant innovation, incorporating advanced technologies like CRISPR and next-generation sequencing for heightened accuracy.

Several market players, such as Merck KGaA; Thermo Fisher Scientific, Inc.; and Charles River Laboratories, are involved in merger and acquisition activities. Through M&A activity, these companies can expand their geographic reach and enter new territories.

Necessitating compliance with rigorous safety and quality standards, drives the adoption of advanced testing methodologies, which significantly impact the market.

In the biological safety testing product and services industry, potential substitutes include alternative testing methods such as silico modeling and rapid microbial detection technologies, challenging traditional methods.

The market is expanding globally with a focus on regions like Asia Pacific, driven by increasing pharmaceutical and biotechnology activities, regulatory harmonization, and the growing importance of safety testing in emerging markets.

Product Insights

The reagents and kits represented the largest market share at 39.69% in 2024. The rise of cell and gene therapies has increased the demand for precise, compliant, and scalable safety testing solutions. Standardized kits help ensure regulatory compliance while minimizing manual errors. This is especially important for CMOs and biotech startups that need plug-and-play testing tools without extensive in-house expertise. Innovation continues to propel this segment forward. Lonza’s PYROGENT Ultra Gel Clot kits and Thermo Fisher’s MycoSEQ Mycoplasma Detection Kit provide robust, regulatory-compliant assays. Similarly, recombinant Factor C (rFC) technologies offer sustainable alternatives to traditional LAL-based endotoxin testing.

The instruments segment is projected to experience the fastest CAGR during the forecast period, driven by rising demand for precise, automated, and high-throughput technologies. As biologics, vaccines, and cell and gene therapies continue to dominate the global pharmaceutical pipeline, the necessity for advanced instrumentation to support complex biosafety testing workflows has become increasingly critical. This segment encompasses a wide range of equipment, including PCR machines, endotoxin and mycoplasma detection systems, biosafety cabinets, automated microbial identification platforms, and next-generation sequencing (NGS) instruments. One of the primary growth drivers is the industry's heightened focus on automation and compliance, particularly with data integrity standards like 21 CFR Part 11, which makes digitally integrated instruments vital for regulatory adherence. Rapid Microbiological Methods (RMMs) are transforming sterility testing practices. In March 2025, Nelson Labs, a Sotera Health company, expanded its RMM-based sterility testing to three labs across the U.S. and Europe. This advanced approach supports a wide spectrum of medical devices and pharmaceutical products, broadening.

Application Insights

The vaccine and therapeutics segment held the largest share of 24.24% in 2024 and is expected to experience the fastest CAGR during the forecast period. The segment’s dominance is attributed to the presence of well-defined guidelines that ensure the safety of developed vaccines while maintaining their therapeutic value and minimizing toxicity. In January 2023, BioNTech SE announced its collaboration Memorandum of Understanding with the UK Government, which aims to assist patients by expediting clinical trials for mRNA personalized immunotherapies. The collaboration is anticipated to focus on three areas: cancer immunotherapies, infectious diseases, and vaccines, thereby strengthening their presence in the UK. Therefore, the growth of this segment is expected to be driven by the issuance of various guidelines and recommendations from regulatory authorities, like the U.S. FDA, concerning the characterization and qualification of materials used in the production of vaccines for infectious disease indications.

The gene therapy segment is expected to witness substantial growth during the forecast period due to the increased risk of contamination with residual DNA. The presence of residual DNA presents a potential risk to the final product because of its high infectivity potential. Moreover, mAbs are crucial in the identification and characterizing critical quality attributes (CQAs) of biopharmaceuticals. These CQAs are specific characteristics that define the product’s safety, purity, and potency. Monoclonal antibodies are utilized in assays to evaluate parameters such as product-related impurities, degradation products, and host cell proteins, ensuring that the biopharmaceuticals meet the necessary quality standards. Therefore, the demand for monoclonal antibodies (mAbs) in the biological safety testing product and services industry is witnessing significant growth.

Test Type Insights

Endotoxin tests held a dominant position in the biological safety testing products and services market, capturing a revenue share of 21.49% in 2024. A notable regulatory advancement is the approval of Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents by the USP Microbiology Expert Committee. This chapter allows the use of non-animal-derived reagents for endotoxin testing, facilitating the industry’s shift towards more ethical and sustainable testing practices. Early adoption is scheduled for November 2024, with the chapter becoming official in May 2025, marking a pivotal step in modernizing compendial methods while decreasing reliance on traditional animal-based reagents like Limulus Amebocyte Lysate (LAL).

Technological innovation is a significant driver. In January 2024, Charles River Laboratories expanded its endotoxin testing solutions with the launch of the Endosafe Trillium rCR cartridge. This new offering integrates the company’s established Endosafe cartridge platform with its recombinant cascade reagent (rCR), providing a fully animal-free, efficient, and sustainable testing option. By enhancing speed and efficiency in quality control processes, this innovation aligns with both regulatory expectations and the company’s broader 4Rs sustainability commitments—Replacement, Reduction, Refinement, and Responsibility.

The bioburden tests segment is projected to experience the highest CAGR during the forecast period. This growth can be attributed to the widespread adoption of these tests for determining the bioburden limit in various biologics and medical devices. In April 2023, STEMart, a U.S.-based provider, announced the launch of bioburden and sterility testing for medical devices under the regulation of the ISO 11731 technique. Furthermore, the integrating advanced colorimetric methods and computation has enabled the rapid generation of results and accurate quantification of bioburden. Additionally, bioburden testing aids in identifying and quantifying the microbial load present in these products. Establishing acceptable limits for microbial contamination helps mitigate the risk of infection and adverse reactions in patients. The rapid advancements in this segment are also expected to fuel its growth.

Regional Insights

North America held the largest share of the biological safety testing products & services market, with a revenue share of 36.59% in 2024. The significant market share can be attributed to substantial investments in biotechnology, a growing adoption in cancer research, and the advancements in novel biologics, vaccines, and drugs. Additionally, increasing R&D investments by companies are key factors driving growth. Furthermore, the market is boosted by major players undertaking extensive expansion strategies. At the same time, the rising prevalence of chronic diseases in this region is expected to enhance the adoption of advanced technologies by researchers and healthcare professionals, thereby expanding the market growth. Moreover, North America has well-established regulatory bodies, such as the FDA, which set stringent guidelines and requirements for biological safety testing. Compliance with these regulations makes it crucial for manufacturers to ensure the safety and quality of their products. This stringent regulatory environment encourages the adoption of comprehensive biological safety testing, further driving market dominance.

U.S. Biological Safety Testing Products And Services Market Trends

The U.S. biological safety testing products & services industry held the largest share in North America in 2024 and is maintaining this dominance due to the presence of a robust and highly advanced biopharmaceutical industry in the country, as well as a considerable focus on research and development. Furthermore, the continuous presence of numerous pharmaceutical and biotechnology companies, along with academic and research institutions, generates a sustained demand for rigorous safety testing, further reinforcing the country's leadership in the field.

Europe Biological Safety Testing Products And Services Market Trends

The Europe biological safety testing products and services industry is growing steadily, supported by the increasing demand for biologics, the expansion of pharmaceutical and biotechnology companies, and stringent regulatory guidelines throughout the region. Countries like Germany, France, Italy, and the UK have well-established healthcare and biopharmaceutical infrastructures, boosting the need for biosafety services. Key market players include Merck KGaA, Thermo Fisher Scientific, Charles River Laboratories, Eurofins Scientific, SGS SA, Sartorius AG, and Lonza Group. These companies provide services such as sterility testing, endotoxin testing, bioburden analysis, and cell line authentication.

The UK biological safety testing products and services market is moderately concentrated, characterized by the presence of leading global and regional players with extensive expertise and diversified service portfolios. Key companies include Merck KGaA (MilliporeSigma), Charles River Laboratories, Eurofins Scientific, and SGS Group. These firms offer comprehensive biosafety testing services such as microbial contamination detection, viral clearance, endotoxin testing, and molecular biology analysis, all essential for regulatory compliance and biologics development.

The biological safety testing products and services market in Germany is experiencing significant growth fueled by the expanding biotechnology and pharmaceutical sectors, increased R&D investments, and stringent regulatory demands that ensure product safety. Key players include Merck KGaA, Sartorius AG, Charles River Laboratories, Eurofins Scientific, and Thermo Fisher Scientific. These companies provide viral clearance, sterility testing, endotoxin detection, genetic stability assays, and comprehensive biosafety services. Technological advances, such as Merck’s 2024 Aptegra CHO Genetic Stability Assay, which reduces testing time by 66% and cuts costs by 43%, are improving testing efficiency and regulatory compliance.

Asia Pacific Biological Safety Testing Products And Services Market Trends

The Asia Pacific biological safety testing products & services industry is anticipated to grow at a significant CAGR over the forecast period. Factors such as the growth in healthcare spending and rising awareness of the advantages associated with these products are anticipated to contribute to market growth. Additionally, the presence of organizations such as the Asia Pacific Biosafety Association, which plays a pivotal role in providing training on biosafety principles and practices to professionals throughout the region, is further expanding growth opportunities in the region.

The biological safety testing products and services market in Japan is experiencing significant growth, driven by the expanding biopharmaceutical and regenerative medicine sectors, alongside stringent regulatory requirements that ensure product safety and efficacy. Key product segments include reagents and testing kits, which are widely used in bioburden, endotoxin, and microbial contamination testing. Among the services, bioburden testing remains a major focus, complemented by endotoxin testing, cell line authentication, and mycoplasma detection, all of which are crucial for maintaining the safety of biologics and cell therapies.

The China biological safety testing products And services market is expanding, driven by increased biopharmaceutical manufacturing and strict regulatory requirements. This market includes viral clearance, sterility testing, endotoxin testing, and cell line characterization products and services. Leading companies provide advanced biosafety testing solutions to guarantee product safety and regulatory compliance for biologics, vaccines, and gene therapies. The rising demand for biologics and personalized medicine propels the adoption of cGMP-compliant testing services, bolstered by the expansion of bioprocess technical centers and collaborations between global and local firms. However, challenges persist in managing high costs and complicated regulations.

Latin America Biological Safety Testing Products And Services Market Trends

The Latin America biological safety testing products & services industry is expanding due to growing biopharmaceutical manufacturing and increasing healthcare infrastructure investments. Countries such as Brazil and Argentina are key contributors, driven by rising demand for biologics, vaccines, and advanced therapies. The market offers vital testing services such as sterility testing, endotoxin detection, viral clearance, and cell line characterization to ensure safety and regulatory compliance. Government efforts to improve biosafety regulations and collaborations between regional and international companies further support market growth. Ongoing advancements in testing technologies and rising focus on healthcare quality position Latin America as an emerging market for biological safety testing products and services.

Middle East and Africa Biological Safety Testing Products And Services Market Trends

The MEA biological safety testing products and services industry is increasingly competitive, driven by expanding pharmaceutical manufacturing, vaccine development, and public health initiatives. Major global players like Thermo Fisher Scientific, Merck, and Charles River lead with advanced safety assays and regulatory-compliant services. Regional competition is intensifying as local labs and healthcare firms invest in biosafety infrastructure and digital diagnostics. Governments across MEA are prioritizing infectious disease preparedness, fostering demand for high-standard testing. Strategic partnerships, mobile labs, and training programs are key to market entry, with innovation, cost-efficiency, and regulatory alignment serving as primary competitive advantages.

Key Biological Safety Testing Products And Services Company Insights

Market leaders engage in extensive R&D to manufacture cost-efficient and technologically advanced testing products. Several strategies, such as mergers and acquisitions, employed by these organizations to expand their market presence are expected to create significant growth opportunities over the forecast period. For instance, in January 2023, Charles River Laboratories, Inc. acquired SAMDI Tech, Inc., a provider of high-throughput screening (HTS) solutions for various drug discovery research. This acquisition intensifies its capacity to offer drug discovery and development services.

Recent Developments

• In May 2025, Thermo Fisher introduced the Thermo Scientific 1500 Series Class II, Type A2 Biological Safety Cabinet (BSC), engineered to deliver reliable protection, enhanced user comfort through ergonomic design, and ease of operation. This versatile solution is tailored to meet the demands of routine laboratory work across academic, pharmaceutical, and biotechnology environments.

• In April 2025, Eurofins expanded its U.S. portfolio by introducing a new ethylene oxide (EtO) sterilization solution, enhancing its capabilities in providing safe and effective sterilization for medical devices.

• In January 2025, Samsung Biologics is constructing its fifth biomanufacturing plant in Songdo, South Korea, which is expected to be operational by April 2025. This will increase its total biomanufacturing capacity to 784,000 liters.

Biological Safety Testing Products And Services Market Report Scope

Global Biological Safety Testing Products And Services Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global biological safety testing products & services market based on product, application, test type, and region:

• Product Outlook (Revenue, USD Million, 2021 - 2033)

  • Reagents & Kits

  • Instruments

  • Services

• Application Outlook (Revenue, USD Million, 2021 - 2033)

  • Vaccines & Therapeutics

    • Vaccines

    • Monoclonal Antibodies

    • Recombinant Protein

  • Blood & Blood-based Products

  • Gene Therapy

  • Tissue & Tissue-based Products

  • Stem Cell

• Test Type Outlook (Revenue, USD Million, 2021 - 2033)

  • Endotoxin Tests

  • Sterility Tests

  • Cell Line Authentication & Characterization Tests

  • Bioburden Tests

  • Adventitious Agent Detection Tests

  • Residual Host Contamination Detection Tests

  • Others

• Regional Outlook (Revenue, USD Million, 2021 - 2033)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait