Market Overview

The global biological safety testing market size was valued at USD 4.95 Billion in 2024 and is projected to reach USD 13.29 Billion by 2033, growing at a CAGR of 10.38% during 2025-2033. Growth is driven by the rising demand for biopharmaceuticals, vaccines, biosimilars, and strict regulatory compliance globally. Innovations in testing technologies and the expansion of contract research organizations contribute to enhanced testing efficiency and market expansion.

Study Assumption Years

• Base Year: 2024

• Historical Year/Period: 2019-2024

• Forecast Year/Period: 2025-2033

Biological Safety Testing Market Key Takeaways

• The global biological safety testing market size was valued at USD 4.95 Billion in 2024.

• The market is expected to grow at a CAGR of 10.38% during 2025-2033.

• The forecast period is from 2025 to 2033.

• North America holds the largest market share of over 38.8% in 2024.

• The pharmaceutical and biotechnology sectors expanding due to increased R&D investments are major growth drivers.

• The impact of the COVID-19 pandemic has accelerated demand, especially for vaccine safety testing.

• Stringent regulatory compliance is intensifying testing requirements globally.

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Market Growth Factors

The biological safety testing market is propelled by the expanding pharmaceutical and biotechnology sectors. In 2023, global R&D spending in the pharmaceutical sector exceeded approximately USD 300 billion. This investment fuels the development of medications, biologics, and vaccines, necessitating detailed safety evaluations for contaminants such as bacteria, viruses, and endotoxins. Continuous innovation in therapies, including gene and cell therapies, further sustains high demand for biological safety testing.

The COVID-19 pandemic significantly accelerated the market by boosting vaccine and treatment developments, with over 13 billion COVID-19 vaccine doses administered globally by 2021. This heightened awareness of the critical role of safety testing led to increased scrutiny by governments and regulatory bodies, intensifying demand for vaccine safety assessments and diagnostic quality controls. It also emphasized preparedness for future health emergencies.

Rising emphasis on regulatory compliance is another crucial market driver. Regulatory bodies worldwide impose strict oversight of biopharmaceutical products, mandating comprehensive safety evaluations. The number of approved advanced therapy medicinal products (ATMPs), like gene and cell therapies, has increased recently. For example, the European Medicines Agency adopted a positive draft opinion for Durveqtix in May 2024. Such trends highlight the growing importance of biological safety testing to meet evolving regulatory standards, ensuring product safety and facilitating market access.

Market Segmentation

By Product and Services:

• Kits and Reagents: Leading with about 41.3% market share in 2024, fueled by the trend toward point-of-care diagnostics and decentralized testing. These kits support rapid and efficient safety assessments, especially in resource-limited settings and life sciences research.

• Instruments: Included as a key product segment offering testing hardware for biological safety assessments.

• Services: Comprehensive testing services including analytical and biosafety testing for pharmaceutical development.

By Test Type:

• Endotoxin Tests: Holding around 24.9% market share in 2024, crucial for ensuring safety and efficacy of medical devices and pharmaceuticals amid rising complexity in treatment options.

• Sterility Tests: Ensuring contamination-free products.

• Cell Line Authentication and Characterization Tests: Verifying the authenticity and quality of cell lines used in therapies.

• Bioburden Tests: Measuring microbial contamination.

• Residual Host Contaminant Detection Tests: Detecting residuals from production hosts.

• Adventitious Agent Detection Tests: Identifying unforeseen microbial contaminants.

By Application:

• Vaccine Development: Leading with approximately 28.7% share in 2024, driven by urgent global needs for safe vaccines, including new technologies like mRNA vaccines.

• Blood Products Testing: Ensuring safety of blood-derived products.

• Cellular and Gene Therapy: Testing for advanced therapeutic modalities.

• Tissue and Tissue-related Products Testing: Ensuring safety in tissue therapies.

• Stem Cell Research: Supporting safety assessments in regenerative medicine.

Regional Insights

North America dominated the biological safety testing market in 2024, with a market share exceeding 38.8%. The region's leadership is attributed to its robust pharmaceutical and biotechnology industries with high R&D activity, stringent FDA regulations, and advanced healthcare infrastructure. The readiness for public health threats like the COVID-19 pandemic has also accelerated vaccine development and testing demand in this region.

Recent Developments & News

• November 2024: Maravai LifeSciences announced plans to acquire DNA and RNA assets from Officinae Bio, enhancing mRNA manufacturing capabilities and advancing nucleic acid-based therapies and biologics safety testing.

• September 2024: Eurofins completed acquisition of Modern Testing Services, expanding its biological safety testing footprint in the consumer products sector with over 35 locations in 20 countries.

• July 2024: SGS North America expanded biologics testing services at its Lincolnshire Center of Excellence, adding advanced instrumentation and expertise to support novel biologics and biosimilars.

• June 2024: Charles River Laboratories, with MatTek Corporation, received a USD 1.3 million grant for developing an in vitro inhalation toxicology test to reduce animal testing.

• February 2024: Creative Biogene developed a microbial platform for validation in microbial tests, enhancing flexibility and efficiency in detecting undesirable organisms.

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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