Biosafety Testing Service Market Forecast to Grow at 9.1% CAGR by 2033 Driven by Biologics Expansion, Regulatory Demands, and Advanced Safety Technologies

According to a new study by DataHorizzon Research, the Biosafety Testing Service (BTS) Market is projected to grow at a CAGR of 9.1% from 2025 to 2033, driven by the rapid expansion of biologics and cell-based therapies, increasing regulatory scrutiny, and rising adoption of biosafety validation across pharmaceutical, biotechnology, and medical device industries. As global healthcare systems prioritize product integrity and patient safety, biosafety testing services have become essential to ensuring that biologics, vaccines, medical implants, and gene therapies comply with rigorous global safety standards. The growing pipeline of innovative therapeutics continues to strengthen demand for comprehensive biosafety assessments.

Market Size & Insights

The biosafety testing service market is valued at approximately USD 3.8 billion in 2024 and is anticipated to reach around USD 8.2 billion by 2033, reflecting a CAGR of 9.1% from 2025 to 2033.

The biosafety testing service (BTS) market is experiencing substantial growth as industries increasingly rely on outsourced testing laboratories to ensure product purity, detect contaminants, and meet global regulatory requirements. With the biopharmaceutical sector expanding rapidly-driven by monoclonal antibodies, cell and gene therapies, biosimilars, and next-generation vaccines-biosafety testing services play a vital role in verifying sterility, identifying viral contaminants, assessing endotoxin levels, and validating raw materials used in production.

Biopharma companies face mounting regulatory pressure from agencies such as the FDA, EMA, and WHO to maintain high safety standards throughout the product lifecycle. Outsourced BTS providers offer advanced technologies, specialized expertise, and high-throughput testing capabilities that support compliance and shorten development cycles. Additionally, the rise in clinical trials, expansion of biologics manufacturing sites, and globalization of supply chains are accelerating market growth.

The increasing complexity of biologics manufacturing requires more sophisticated biosafety services such as mycoplasma detection, microbial identification, cell line authentication, and adventitious agent testing. As pharmaceutical companies prioritize risk mitigation, quality assurance, and faster time-to-market, biosafety testing becomes indispensable within research, development, and commercial production ecosystems.

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Important Points

• Biosafety testing ensures biologics, vaccines, and medical products meet global safety and purity standards.
• Outsourcing of biosafety services is rising due to high operational complexity and specialized testing needs.
• Increasing production of biosimilars and cell therapies boosts demand for advanced biosafety validation.
• Regulatory agencies are enforcing stringent guidelines for contamination detection and quality assurance.
• Rapid innovation in biologics manufacturing is increasing the volume and frequency of safety testing.
• Globalization of supply chains requires more robust biosafety monitoring to ensure consistent quality.

Key Factors Driving Future Growth

• Expansion of biologics, biosimilars, and personalized medicine.
• Rising number of cell & gene therapy clinical trials requiring intensive biosafety validation.
• Increasing investments in biomanufacturing facilities worldwide.
• Stricter regulatory frameworks around safety compliance and product sterility.
• Growth of contract research organizations (CROs) offering integrated biosafety testing solutions.
• Advancements in microbial detection, next-generation sequencing, and rapid sterility testing technologies.

Top 10 Market Companies
• Charles River Laboratories
• Eurofins Scientific
• SGS
• WuXi AppTec
• Thermo Fisher Scientific
• Labcorp
• Merck KGaA (BioReliance)
• Nelson Labs
• Pace Analytical
• Intertek Group

Market Segments

By Service Type
o Endotoxin Testing
o Sterility Testing
o Cell Line Authentication

By Application
o Vaccine Development
o Cell & Gene Therapy
o Blood Products

By Region
o North America
o Europe
o Asia Pacific
o Latin America
o Middle East & Africa

Recent Developments

• Introduction of rapid sterility and mycoplasma detection platforms powered by NGS technologies.
• Expansion of global testing capacities by leading CROs to support increasing biologics pipelines.
• Development of automation-driven biosafety workflows to reduce testing time and improve accuracy.
• Growing collaborations between biopharma companies and specialized BTS providers for end-to-end validation services.
• Regulatory updates accelerating demand for viral clearance studies and cell bank characterization.
• Increased adoption of digital LIMS systems for integrated biosafety data management and traceability.

Regional Insights

North America leads the biosafety testing service market due to strong biopharmaceutical innovation, high regulatory compliance standards, and the presence of leading contract testing organizations. Europe follows closely, supported by advanced biotechnology clusters and stringent EMA biosafety guidelines. Asia-Pacific is the fastest-growing region as China, India, South Korea, and Singapore rapidly expand their biologics manufacturing capacities and invest in safety infrastructure. Latin America and the Middle East are gradually increasing testing adoption as healthcare manufacturing modernizes. Across all regions, the rise of biologics production and global supply chain expansion is reinforcing the need for robust biosafety testing frameworks.

Market Outlook

The future outlook for the biosafety testing service (BTS) market is highly optimistic as biologics continue to dominate pharmaceutical pipelines and regulatory agencies demand more comprehensive safety validation. Over the next decade, the growing prevalence of gene therapies, viral vector technologies, personalized medicines, and regenerative treatments will significantly increase the need for specialized biosafety testing. Contract testing laboratories are expected to expand capabilities in high-throughput analytics, rapid microbial detection, and sequencing-based pathogen identification.

Automation and digitalization will reshape the BTS landscape by enabling faster turnaround times, higher accuracy, and improved data integrity. Artificial intelligence and machine learning will enhance contamination detection, process optimization, and predictive risk modeling for biomanufacturers. Additionally, the construction of new biomanufacturing plants worldwide will elevate the demand for end-to-end biosafety services, from raw materials screening to final product certification.

As supply chains become more globally interconnected, biosafety testing providers will play a crucial role in maintaining cross-border quality standards and mitigating contamination risks. Overall, continuous scientific innovation, regulatory evolution, and the expansion of the biotechnology sector will ensure long-term, sustained growth for the biosafety testing service market.

Contact:
Ajay N
Ph: +1-970-633-3460

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DataHorizzon is a market research and advisory company that assists organizations across the globe in formulating growth strategies for changing business dynamics. Its offerings include consulting services across enterprises and business insights to make actionable decisions. DHR's comprehensive research methodology for predicting long-term and sustainable trends in the market facilitates complex decisions for organizations.

This release was published on openPR.