Global Biological Safety Testing Products and Services Market Size Study, By Product (Reagents & Kits, Instruments, Services), By Application (Vaccines & Therapeutics, Gene Therapy, Blood & Blood-based Products, Tissue & Tissue-based Products, Stem Cells)

The global biological safety testing products and services market was valued at approximately USD 4.57 billion in 2023 and is anticipated to expand at a CAGR of 10.7% over the forecast period 2024-2032. Increasing demand for biologics, vaccines, and gene therapy products has propelled the need for stringent safety evaluations, fostering the adoption of biological safety testing solutions. As regulatory authorities impose rigorous safety standards for pharmaceutical and biopharmaceutical products, the demand for innovative testing methodologies is increasing.

Biological safety testing ensures that pharmaceutical and biologics manufacturing processes remain free from contamination. Rising government funding and private investments in drug development, coupled with the expansion of biotechnology and pharmaceutical industries, have further boosted the adoption of advanced biological safety testing methods. Companies are prioritizing regulatory compliance to mitigate risks associated with microbial contamination, residual host-cell proteins, and endotoxin levels. For instance, in 2023, Charles River Laboratories expanded its safety testing capabilities with enhanced in vitro testing solutions, catering to the evolving needs of biopharmaceutical developers.

Furthermore, the growing focus on personalized medicine and gene therapies has necessitated advanced biological safety testing protocols. The rise in cell-based therapies and monoclonal antibodies (mAbs) has heightened concerns regarding product integrity, sterility, and safety. Regulatory bodies such as the FDA, EMA, and WHO have implemented stringent guidelines requiring robust biological safety testing at various stages of development and manufacturing. Technological advancements, including CRISPR-based testing methods and next-generation sequencing (NGS), have further enhanced testing accuracy and efficiency.

Despite these positive trends, high costs associated with biological safety testing instruments and services remain a challenge for small and mid-sized biopharmaceutical firms. However, ongoing technological advancements, the emergence of AI-driven biosafety solutions, and the increasing integration of automated testing platforms are expected to reduce operational costs over time. Additionally, market players are focusing on expanding their service portfolios through acquisitions and strategic partnerships. In January 2023, Thermo Fisher Scientific acquired a major stake in a biosafety testing service provider to enhance its global presence and strengthen its regulatory compliance capabilities.

Major Market Players Included in this Report Are:
• Charles River Laboratories
• Thermo Fisher Scientific Inc.
• Merck KGaA (MilliporeSigma)
• Lonza
• Eurofins Scientific
• SGS Société Générale de Surveillance SA
• Samsung Biologics
• Sartorius AG
• BIOMÉRIEUX
• BSL Bioservice
• FUJIFILM Diosynth Biotechnologies
• Nelson Labs
• Wuxi AppTec
• Cytovance Biologics
• StemExpress

The Detailed Segments and Sub-segments of the Market are Explained Below:

By Product:
• Reagents & Kits
• Instruments
• Services

By Application:
• Vaccines & Therapeutics
Vaccines
Monoclonal Antibodies
Recombinant Proteins
• Blood & Blood-based Products
• Gene Therapy
• Tissue & Tissue-based Products
• Stem Cells

By Test Type:
• Endotoxin Tests
• Sterility Tests
• Cell Line Authentication & Characterization Tests
• Bioburden Tests
• Adventitious Agent Detection Tests
• Residual Host Contamination Detection Tests
• Others

By Region:

North America
• U.S.
• Canada

Europe
• UK
• Germany
• France
• Italy
• Spain
• Denmark
• Sweden
• Norway

Asia Pacific
• Japan
• China
• India
• South Korea
• Australia
• Thailand

Latin America
• Brazil
• Mexico
• Argentina

Middle East & Africa
• South Africa
• Saudi Arabia
• UAE
• Kuwait

Years considered for the study are as follows:
• Historical Year – 2022
• Base Year – 2023
• Forecast Period – 2024 to 2032

Key Takeaways:
• Market Estimates & Forecast for 10 years (2022-2032)
• Annualized revenues & regional-level analysis for each market segment
• Geographical landscape analysis with country-level market insights
• Competitive landscape with information on major market players
• Key business strategies & investment recommendations
• Competitive structure & demand-supply analysis
• Comprehensive regulatory framework overview impacting market growth

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