Biological Safety Testing Market Report and Forecast 2025-2034

The global biological safety testing market size was valued at USD 4.53 Billion in 2024, driven by the increasing number of cases of infectious diseases across the globe. The market size is anticipated to grow at a CAGR of 13.20% during the forecast period of 2025-2034 to achieve a value of USD 15.65 Billion by 2034.

Biological Safety Testing: Introduction

Biological safety testing refers to a set of procedures and assessments conducted to ensure the safety of biopharmaceuticals, medical devices, and other products derived from biological sources. This testing aims to evaluate potential risks associated with these products, including contamination and adverse biological effects, ensuring compliance with regulatory standards. Techniques such as sterility testing, endotoxin testing, and cell-based assays are employed to assess the purity, potency, and safety of biological materials.

By rigorously examining these factors, biological safety testing guarantees the integrity and quality of biologically derived products, safeguarding public health and adhering to regulatory guidelines in the pharmaceutical and healthcare industries.

Global Biological Safety Testing Market Analysis

The increasing number of biopharmaceutical firms and laboratories in the market is one of the major factors bolstering the market growth. With more biopharmaceutical firms and laboratories, the market is also expected to experience an increase in the production of new biologics, which will further contribute to the rising biological safety testing market demand.

The recent strategic moves by Charles River Laboratories International, Inc. (CRL) and Merck are poised to significantly contribute to the growth of the global market for biological safety testing during the forecast period. Charles River's acquisition of SAMDI Tech, a provider of label-free high-throughput screening solutions for drug discovery research, expands its capabilities in biochemical analysis and binding interaction identification. This move aligns with the increasing demand for advanced technologies in drug development, driving the adoption of high-quality screening solutions.

The market growth is fostered by the rising interest of key players in investing in research and development activities. For example, Merck's substantial investment of 35 million euros in biosafety testing at its Glasgow and Stirling sites in Scotland underscores the industry's commitment to ensuring the safety and efficacy of pharmaceutical products. The expansion not only enhances Merck's capacity for biosafety testing but also creates job opportunities, reflecting a positive economic impact, and bolstering the global biological safety testing market growth.

These strategic initiatives collectively contribute to the strengthening of capabilities in drug development and manufacturing, emphasizing the importance of rigorous biosafety testing. As the pharmaceutical industry continues to advance, the global market is expected to experience growth, driven by increased demand for safety assurance in drug development processes and adherence to regulatory standards.

Global Biological Safety Testing Market Segmentations

Biological Safety Testing Market Report and Forecast 2025-2034” offers a detailed analysis of the market based on the following segments:

Market Breakup by Product Type

• Reagents and Kits
• Instruments
• Other Products

Market Breakup by Test

• Sterility Tests
• Bioburden Tests
• Endotoxin Tests
• Other Tests

Market Breakup by Application

• Vaccines and Therapeutics
• Cellular and Gene Therapy
• Blood and Blood-Based Therapy
• Other Applications

Market Breakup by Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa

Global Biological Safety Testing Market Overview

The market is driven by the increased research and development activities in the pharmaceuticals and biotechnology field. The increasing awareness of the benefits and importance of quality control in the healthcare sector is a major factor responsible for the market growth. The escalating demand for improved testing methods such as nucleic acid amplification and sequencing techniques and the increasing prevalence of infectious diseases are also driving the global biological safety market growth. The increasing awareness of sterility tests among pharmaceutical and biotechnological firms due to the stringent regulatory guidelines is collectively bolstering the market growth in the forecast period. The increasing production of pharmaceutical products due to the increasing prevalence of infectious medical conditions is a major factor responsible for market growth.

Geographically, North America is leading the market and is expected to drive the market in the forecast period. The regional market can be attributed to the increasing presence of biotechnology and pharmaceutical companies due to rising innovative technologies and the presence of favourable government initiatives.

Global Biological Safety Testing Market: Competitor Landscape

The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:

• Avance Biosciences
• Cytovance Biologics
• Eurofins Scientific
• Lonza
• Merck KGaA
• Promega Corporation
• Thermo Fisher Scientific
• Toxikon
• WuXi AppTec
• Biomerieux SA
• Nelson Laboratories, LLC
• Almac Group
• GenScript
• InvivoGen
• Maravai LifeSciences

Please note that this only represents a partial list of companies, and the complete list has been provided in the report.

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