Biological Safety Testing Market Size, Share, and Growth Forecast, 2025 - 2032

Biological Safety Testing Market Size and Trend Analysis

The global biological safety testing market size is likely to be valued at US$4.85 Bn in 2025 and reach US$10.26 Bn by 2032, growing at a CAGR of 11.3% during the forecast period from 2025 to 2032, mainly driven by the increasing demand for biopharmaceuticals, stringent regulatory requirements, and advancements in biotechnology.

Key Industry Highlights:

• Leading Region: North America is likely to register a 42.5% share in 2025, driven by a strong biopharma industry, advanced healthcare infrastructure, and stringent regulatory frameworks in the U.S. and Canada.
• Fastest-growing Region: Asia Pacific is the fastest-growing region, fueled by expanding biopharma manufacturing, government support, and increasing R&D investments in China and India.
• Dominant Product & Service: Services account for 58.7% of the market share, driven by the high demand for sterility and endotoxin testing in biopharma production.
• Leading Application: Biopharma & Biotech Companies contribute over 45.3% of market revenue, propelled by the rising production of biologics and biosimilars.
• Investment Plans: China’s 14th Five-Year Plan for National Drug Safety and High-Quality Development targets capacity building in drug inspection and testing institutions, establishing regulatory science labs, inspection networks, and talent development for drug safety oversight, boosting demand for safety testing services.

Key Insights	Details
Biological Safety Testing Market Size (2025E)	US$ 4.58Bn
Market Value Forecast (2032F)	US$ 10.26Bn
Projected Growth (CAGR 2025 to 2032)	11.3%
Historical Market Growth (CAGR 2019 to 2024)	10.6%

Market Dynamics

Driver - Rising Demand for Biopharmaceuticals and Stringent Regulatory Requirements

The biological safety testing market is surging, fuelled by the rising global demand for biopharmaceuticals, including monoclonal antibodies, vaccines, and gene therapies, as well as the tightening of regulatory standards by agencies such as the U.S. FDA, EMA, and China’s NMPA. Biologics require rigorous safety screening for sterility, endotoxins, adventitious agents, and cell line authentication to ensure compliance with Good Manufacturing Practices (GMP).

For instance, Charles River Laboratories has expanded its testing infrastructure across the U.S. and Europe, including the launch of a BSL-3 facility and an animal-free endotoxin test, to address rising testing demands and sustainability goals. Similarly, Eurofins Scientific has opened new biologic testing facilities in the U.K. to support advanced therapeutic development.

Rise in biosimilar and monoclonal antibody approvals is further amplifying testing needs. For example, the FDA approved several biosimilars in 2024, and the Antibody Society reports 10 new antibody therapeutics gained first approvals in the U.S. or EU in 2023.

Restraint - High Costs and Complexity of Testing Procedures

The biological safety testing market encounters significant hurdles stemming from the high costs and operational complexity of testing procedures. Techniques such as cell line authentication and adventitious agent detection are essential for ensuring biologic product safety but require advanced laboratory infrastructure, highly trained personnel, and extended turnaround times. The cost burden is further intensified by the need to comply with stringent international regulatory frameworks, including USP <71> for sterility and USP <85> for endotoxin testing, which mandate precise protocols and documentation.

Additionally, while rapid testing technologies (e.g., PCR-based endotoxin detection) promise greater efficiency, their implementation involves high capital investment in instrumentation and validation—posing a barrier for small and mid-sized biopharma firms. These challenges are particularly acute in cost-sensitive regions, such as parts of South Asia and Latin America, where limited infrastructure and budget constraints hinder broader adoption of high-end testing capabilities, thereby restraining overall market growth despite rising demand.

Opportunity - Growth in Cell and Gene Therapy Development

The rapid advancement of cell and gene therapies presents significant opportunities. These therapies require extensive safety testing to ensure product purity and patient safety, driving demand for specialized tests such as adventitious agent detection and cell line characterization. The Alliance for Regenerative Medicine reported that over 1,200 cell and gene therapy clinical trials were underway globally in 2024, with a projected market value of $75 billion by 2030.

Companies such as Lonza and Thermo Fisher Scientific are innovating with automated testing platforms to support these therapies, particularly in North America and Europe. Government initiatives, such as the National Institute of Dental and Craniofacial Research (NIDCR), invested over $73 million in basic, translational, and clinical regenerative medicine research, further bolsters demand for safety testing. The development of personalized medicine and increasing regulatory approvals for advanced therapies create a favorable environment for market expansion, offering manufacturers opportunities to develop tailored testing solutions through 2032.

Category-wise Insights

By Product & Service

• Services dominate, nearly accounting for 58.7% share in 2025, driven by the high demand for sterility testing and endotoxin testing services in biopharma production. These services are critical for ensuring compliance with regulatory standards, particularly for biologics and vaccines. Companies such as Charles River Laboratories and SGS SA offer comprehensive testing portfolios, catering to the needs of biopharma giants in North America and Europe, where regulatory scrutiny is intense.
• The products segment, including reagents, kits, and consumables, is the fastest-growing, fueled by the rising adoption of rapid testing technologies and single-use systems. The increasing focus on in-house testing by biopharma companies drives demand for reagents and kits, with players such as Merck KGaA and Thermo Fisher Scientific expanding their offerings to support high-throughput testing in the Asia Pacific and North America.

By Test Type

• Endotoxin tests hold the largest market share, approximately 24.6% in 2025, due to their critical role in ensuring the safety of injectable drugs and medical devices. These tests are mandated by regulatory bodies such as the FDA and EMA, driving demand across biopharma and medical device sectors. Companies such as BIOMÉRIEUX and Lonza lead with advanced endotoxin testing solutions, particularly in North America.
• Adventitious agent detection tests are the fastest-growing segment, propelled by the rise in cell and gene therapy development. These tests ensure the absence of viral contaminants in biologics, with growing demand in Europe and Asia Pacific. Innovations by Eurofins Scientific and Sartorius AG in high-sensitivity detection systems support this segment’s rapid expansion.

By End-use

• Biopharma and biotech companies account for over 45.3% of market revenue in 2025, driven by the increasing production of biologics, vaccines, and biosimilars. These companies rely heavily on safety testing to meet stringent regulatory requirements, with major players such as Samsung Biologics and Lonza offering tailored testing solutions in North America and the Asia Pacific.
• CDMOs are the fastest-growing end-use segment, fueled by the outsourcing of biopharma manufacturing and testing. The rise in biologics production and the need for specialized testing services drive demand, particularly in the Asia Pacific, where CDMOs such as Samsung Biologics are expanding operations to support global biopharma clients.

Regional Insights

North America Biological Safety Testing Market Trends

North America region is set to dominate commanding a substantial 42.5% share in 2025, driven by its robust biopharmaceutical industry and advanced healthcare infrastructure across the U.S. and Canada. The U.S., home to a large number of biologics and vaccine manufacturers, places a strong emphasis on rigorous safety testing to meet stringent regulatory standards set by the FDA. This ensures that products comply with high-quality and safety requirements, fueling steady demand for sterility, endotoxin, and adventitious agent testing.

Canada’s expanding biotechnology sector also contributes significantly to market growth, with increased need for biological safety tests to support innovative drug development and manufacturing, as highlighted by the Canadian Biotechnology Action Network. Leading companies such as Charles River Laboratories and Thermo Fisher Scientific dominate the biological safety testing market by offering comprehensive testing services and extensive laboratory networks.

Asia Pacific Biological Safety Testing Market Trends

Asia Pacific is the fastest-growing region. This leadership is fueled by rapid expansion in biopharmaceutical manufacturing and strong government initiatives in key countries such as China and India. China, a global powerhouse in biologics production, is advancing its capabilities through the 14th Five-Year Plan for National Drug Safety and High-Quality Development, which focuses on enhancing drug inspection and testing infrastructure through 2030. Meanwhile, India’s thriving biotechnology sector benefits from strategic programs such as the National Biotechnology Development Strategy, driving increased demand for comprehensive safety testing services.

The region’s robust contract manufacturing landscape, featuring industry leaders such as Samsung Biologics, further bolsters growth by providing scalable and efficient production capabilities. Additionally, heightened R&D investments and stricter regulatory compliance in emerging sectors such as marine biotech underscore the region’s commitment to quality and innovation. Together, these factors ensure Asia Pacific’s continued dominance through 2032.

Europe Biological Safety Testing Market Trends

Europe is the second fastest-growing region in the biological safety testing market, supported by its stringent regulatory frameworks, growing biopharmaceutical sector, and advancements in cell and gene therapy, particularly in Germany and France. The region’s strong pharmaceutical foundation, valued at over €300 billion, underpins the increasing need for comprehensive safety testing in biologics production. Germany plays a leading role in cell and gene therapy development, creating a rising demand for adventitious agent detection, sterility, and endotoxin testing. Companies such as Merck KGaA and Sartorius AG are at the forefront, investing in advanced safety technologies to meet evolving EU compliance standards.

Additionally, the EU’s Horizon Europe program, with a budget of nearly €95.5 billion (2021–2027), promotes cutting-edge R&D in biotechnology and life sciences, indirectly fueling demand for high-quality safety testing services. With strong government backing, innovation-driven manufacturers, and harmonized regulations, Europe is well-positioned to sustain robust biological safety testing market growth through 2032.

Competitive Landscape

The global biological safety testing market is highly competitive, characterized by a fragmented landscape with numerous global and regional players. Leading companies such as Charles River Laboratories, Merck KGaA, and Eurofins Scientific dominate through extensive testing portfolios and global networks. Regional players such as Samsung Biologics focus on localized offerings in the Asia Pacific. Companies are investing in advanced testing technologies, such as rapid microbial detection and automated systems, to enhance market share, driven by demand in the biopharma and cell therapy sectors.

Key Industry Developments

• March 2025: Thermo Fisher Scientific launched the Thermo Scientific 1500 Series Class II, Type A2 Biological Safety Cabinet (BSC) The new cabinet offers protection for personnel, products, and the environment, and incorporates advanced features such as SmartFlow Plus airflow technology, Digital Airflow Verification (DAVe Plus), a 7-inch touchscreen, and an ergonomically designed SmartClean front window while meeting NSF/ANSI 49 safety standards
• October 2024: Samsung Biologics announced that its fifth biomanufacturing plant, located as part of the Bio Campus II in Songdo, South Korea, was expected to be operational by April 2025. The announcement also highlighted that the plant adds 180,000 L of biomanufacturing capacity, bringing the total site capacity to 784,000 L across Plants 1 through 5.

Companies Covered in Biological Safety Testing Market

• Charles River Laboratories
• BSL Bioservice
• Merck KGaA (MilliporeSigma)
• Samsung Biologics
• Sartorius AG
• Eurofins Scientific
• SGS Société Générale de Surveillance SA
• Thermo Fisher Scientific Inc.
• BIOMÉRIEUX, Lonza
• Others