Market Overview

The global Biological Safety Testing Market was valued at USD 4.95 Billion in 2024 and is projected to reach USD 13.29 Billion by 2033, with a CAGR of 10.38% during the forecast period from 2025 to 2033. Market growth is driven by increasing demand for biopharmaceuticals, vaccines, biosimilars, and advancements in cell and gene therapies. The COVID-19 pandemic and a heightened emphasis on regulatory compliance have also significantly bolstered the market.

Study Assumption Years

• Base Year: 2024
• Historical Years: 2019-2024
• Forecast Period: 2025-2033

Biological Safety Testing Market Key Takeaways

• The global biological safety testing market was valued at USD 4.95 Billion in 2024.
• The market exhibits a CAGR of 10.38% between 2025 and 2033.
• North America dominated with over 38.8% market share in 2024.
• The market expansion is fueled by pharmaceutical and biotechnology sector growth, COVID-19 pandemic impact, and increasing regulatory compliance.
• Rising demand for biopharmaceuticals, vaccines, and biosimilars due to chronic and infectious diseases heightens market need.
• Innovations in automated and high-throughput testing technologies are enhancing testing efficiency globally.

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Market Growth Factors

The biological safety testing market is largely fueled by the rapid growth of the pharmaceutical and biotechnology industries. In 2023, global spending on pharmaceutical research and development soared to around USD 300 billion. This increase supports the creation of therapies, biologics, and vaccines aimed at tackling complex diseases, which in turn requires thorough safety evaluations. Biological safety testing plays a crucial role in ensuring patient safety by detecting contaminants like bacteria, viruses, and endotoxins, all while adhering to strict regulations. The rise of innovative treatments, such as gene and cell therapies, also calls for specialized safety assessments, further driving demand in the market.

The COVID-19 pandemic has significantly boosted market growth by highlighting the need for vaccine and treatment development. According to the World Health Organization, over 13 billion COVID-19 vaccine doses were administered worldwide by 2021, underscoring the essential role of rigorous safety testing in preparing for pandemics. Governments around the globe have ramped up regulatory oversight, leading to increased demand for services like vaccine safety assessments, virus detection, and quality control measures for diagnostics, all aimed at ensuring readiness for future health crises.

Another key factor propelling growth is the need for strict regulatory compliance. Global regulatory bodies require comprehensive safety evaluations for biopharmaceutical approvals. Notably, advanced therapy medicinal products, including gene and cell therapies, are seeing a rise in approvals, as demonstrated by the European Medicines Agency's favorable draft opinion on Durveqtix in May 2024. Pharmaceutical and biotech companies must keep up with evolving standards to gain market access, which in turn boosts the demand for specialized biological safety testing to navigate complex regulatory landscapes.

Market Segmentation

By Product and Services:

• Kits and Reagents: Leading segment with 41.3% market share in 2024. Driven by demand for decentralized and point-of-care testing kits that allow rapid and efficient safety assessments in resource-limited settings, alongside expansions in life sciences R&D and quality testing in food and beverages.
• Instruments
• Services

By Test Type:

• Endotoxin Tests: Dominant market segment holding 24.9% share in 2024. Critical for ensuring the safety of medical devices and pharmaceuticals by detecting toxic substances from Gram-negative bacteria. Increasing biopharmaceuticals and personalized medicine demand underpin growth.
• Sterility Tests
• Cell Line Authentication and Characterization Tests
• Bioburden Tests
• Residual Host Contaminant Detection Tests
• Adventitious Agent Detection Tests
• Others

By Application:

• Vaccine Development: Largest application segment with 28.7% market share in 2024 due to global need for safe vaccines, regulatory requirements for comprehensive safety assessments, and novel vaccine technologies like mRNA.
• Blood Products Testing
• Cellular and Gene Therapy
• Tissue and Tissue-related Products Testing
• Stem Cell Research

Regional Insights

North America dominated the biological safety testing market in 2024 with over 38.8% share. It benefits from a robust pharmaceutical and biotechnology industry emphasizing innovation and rigorous safety evaluations. Proactive regulatory frameworks by the FDA and other bodies enforce comprehensive assessments. The COVID-19 pandemic further increased vaccine research and testing demand. The region's advanced healthcare infrastructure and heightened product safety awareness continue to support regional market growth.

Recent Developments & News

• November 2024: Maravai LifeSciences announced plans to acquire DNA and RNA from Officinae Bio, enhancing TriLink BioTechnologies' mRNA production and research capabilities utilizing AI-based nucleic acid technologies.
• September 2024: Eurofins expanded biological safety testing capabilities by acquiring Modern Testing Services, augmenting consumer products industry testing across 35 locations in 20 countries.
• July 2024: SGS North America extended biologics testing services at its Lincolnshire Center of Excellence to support novel biologics and biosimilars characterization and regulatory compliance.
• June 2024: Charles River Laboratories received a USD 1.3 million grant with MatTek Corporation to develop an in vitro inhalation toxicology test minimizing animal testing.
• February 2024: Creative Biogene developed a microbial platform for validation in microbial tests that enhances detection reliability tailored to client needs.

Key Players

• Avance Biosciences
• Charles River Laboratories
• Creative Biogene
• Eurofins Scientific
• Lonza Group AG
• Maravai LifeSciences
• Pace Analytical Services Inc.
• Pacific BioLabs
• Sartorius AG
• SGS SA
• ViruSure GmbH (Asahi Kasei Corporation)
• WuXi Biologics

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