Biological Safety Testing Products and Services Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Reagents & Kits, Services, Instruments), By Application (Vaccines & Therapeutics, Gene Therapy, Monoclonal Antibodies, Recombinant Protein, Blood & Blood-based Products, 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 and Competition, 2020-2030F

Market Overview

The Global Biological Safety Testing Products and Services Market, valued at USD 4.77 Billion in 2024, is projected to experience a CAGR of 9.32% to reach USD 8.14 Billion by 2030. The Global Biological Safety Testing Products and Services Market encompasses assays, reagents, instruments, and contract testing services crucial for ensuring the purity, potency, and safety of biological products such as vaccines, gene therapies, and biopharmaceuticals throughout their development and manufacturing lifecycle. The market's growth is primarily driven by the increasing complexity of advanced therapeutic modalities, stringent global regulatory mandates for biopharmaceutical approval, and the expanding pipeline of new biologics and biosimilars. According to the Pharmaceutical Research and Manufacturers Association (PhRMA), biopharmaceutical firms in the U.S. spent approximately $96 billion on research and development in 2023, directly fueling the need for extensive safety assessments.

This substantial investment in biopharmaceutical innovation necessitates robust biological safety testing to meet rigorous quality standards before market entry. However, a significant challenge impeding market expansion is the substantial capital expenditure required for establishing and maintaining advanced testing infrastructure, alongside the scarcity of skilled professionals proficient in specialized biological safety methodologies.

Key Market Drivers

The expanding pipeline of cell and gene therapies and stringent global regulatory requirements for biologics represent two pivotal drivers for the Global Biological Safety Testing Products and Services Market. The increasing proliferation of novel advanced therapeutic modalities, particularly cell and gene therapies, inherently demands extensive and specialized safety assessments throughout their development and manufacturing. These therapies involve complex biological constructs that necessitate rigorous testing to ensure product purity, potency, and freedom from adventitious agents. According to the Alliance for Regenerative Medicine's annual Cell & Gene State of the Industry Briefing, in January 2024, seven cell and gene therapies received FDA approval in the U. S. in 2023, with predictions for up to 17 approvals in the U.S. and EU in 2024. This surge in approvals and anticipated pipeline growth directly correlates with a heightened demand for comprehensive biological safety testing solutions.

Concurrently, the stringent global regulatory requirements governing biologics are non-negotiable for market entry and product commercialization, thus creating a mandatory demand for robust safety testing. Regulatory bodies worldwide impose rigorous standards to safeguard patient health, requiring extensive characterization and quality control testing for all biological products. According to an article on Biologics and Biosimilars Landscape, in February 2025, the FDA broke its record for annual original Biologics License Application approvals by authorizing 18 new biosimilars in 2024. This regulatory environment compels biopharmaceutical companies to invest significantly in advanced biological safety testing products and services to ensure compliance and expedite product approval. The combined influence of a burgeoning therapeutic pipeline and an uncompromising regulatory landscape therefore underpins the sustained growth of the biological safety testing market. Overall, this market is expanding within a broader biopharmaceutical context where, according to MDPI, in 2024, the worldwide biologic market was projected to reach USD 444.40 billion, reflecting the increasing importance of biological therapeutics.

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Key Market Challenges

The substantial capital expenditure required for establishing and maintaining advanced testing infrastructure presents a significant impediment to the growth of the Global Biological Safety Testing Products and Services Market. This financial barrier limits the ability of new service providers to enter the market and hinders existing firms from expanding their capabilities or upgrading to the latest technologies. Developing and equipping laboratories with advanced assays, reagents, and instruments for complex biological product analysis demands considerable upfront investment, directly constraining the overall capacity available to meet increasing industry demand for safety assessments.

Furthermore, the scarcity of skilled professionals proficient in specialized biological safety methodologies directly hampers market expansion. The specialized nature of these testing processes necessitates a highly trained workforce, and a shortage of such talent can lead to operational bottlenecks and delays in testing crucial biological products. According to Pharmaceutical Engineering, in 2025, 80% of pharmaceutical manufacturers reported a mismatch between existing employee skills and evolving job requirements. This skills gap affects the efficiency and accuracy of safety testing, prolonging development timelines for new vaccines, gene therapies, and biopharmaceuticals, and ultimately limiting the market's ability to support the accelerating biopharmaceutical pipeline.

Key Market Trends

The Global Biological Safety Testing Products and Services Market is significantly shaped by advancements in rapid and high-throughput testing technologies. These innovations address the critical industry need for accelerated development timelines and increased efficiency in assessing biological product safety. The integration of advanced platforms, such as next-generation sequencing and automated systems, allows for faster detection of contaminants and more comprehensive characterization of complex biologics. According to the World Health Organization, global pharmaceutical production increased by 12% in 2023, necessitating corresponding growth in safety testing services. This surge in production highlights the demand for technologies that can keep pace without compromising accuracy. For instance, Thermo Fisher Scientific partnered with the National Cancer Institute in July 2024 to accelerate research into myeloid cancers utilizing next-generation sequencing technology for rapid genomic testing, demonstrating how advanced technologies contribute to quicker clinical insights for critical therapies.

Another pivotal trend is the expansion of outsourced biological safety testing services to contract organizations. Biopharmaceutical companies are increasingly leveraging the specialized expertise, advanced infrastructure, and scalable capacity offered by contract research organizations and contract development and manufacturing organizations. This strategic shift enables companies to focus their internal resources on core drug discovery and development while ensuring compliance with stringent regulatory requirements through external partners. A May 2024 survey by the Biotechnology Innovation Organization found that 79% of the 124 companies that responded have at least one contract with or purchase one product from China-owned or -based CDMO/CMOs, underscoring the widespread reliance on external service providers. This outsourcing trend is further exemplified by leading service providers, as WuXi AppTec, a prominent contract research and manufacturing organization, reported in March 2025 that its sales in the U. S. , which accounted for 64% of its revenue in 2024, grew by 7.7% for the entire year, driven in part by manufacturing expansion efforts across multiple countries.

Segmental Insights

A key segmental insight for the Global Biological Safety Testing Products and Services Market highlights Reagents & Kits as the fastest-growing segment. This rapid expansion is primarily driven by the increasing complexity of biological products and the stringent regulatory scrutiny from bodies such as the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). As biopharmaceutical companies intensify their research and development activities, there is a growing demand for specialized, high-quality, and efficient reagents and kits to ensure the safety, purity, and potency of therapies throughout the entire manufacturing process. The need for consistent and reliable contamination detection and viral safety assessment further fuels this segment's growth.

Regional Insights

North America leads the Global Biological Safety Testing Products and Services Market due to its robust and advanced biopharmaceutical and biotechnology industries, which continually drive the development of novel biologics and advanced therapies. This region benefits from a well-established healthcare infrastructure, including sophisticated research institutions and specialized contract testing organizations. Crucially, stringent regulatory frameworks enforced by bodies such as the U. S. Food and Drug Administration (FDA) and Health Canada mandate comprehensive safety assessments for all biological products. These rigorous guidelines ensure product integrity and public health, thereby creating consistent demand for extensive biological safety testing services and propelling North America's market leadership.

Recent Developments

• In October 2024, MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, opened a new €290 million biosafety testing facility in Rockville, Maryland, USA. This 23,000-square-meter facility consolidates biosafety testing, analytical development, and cell bank manufacturing services from four separate buildings into a single location. The investment was made to expand the company's biosafety testing capabilities globally, addressing the growing demand for these services in drug development. The new site incorporates advanced testing capabilities, including rapid methods for virus testing of bulk harvest material, enhancing offerings within the Global Biological Safety Testing Products and Services Market.

• In May 2024, Sartorius, a life science group, launched its 4th generation Sterisart® Universal pump, representing an advancement in sterility testing equipment. This new pump was developed to ensure the reliable and contamination-free transfer of samples and media into Sterisart® canisters, meeting rigorous quality and safety standards for the pharmaceutical and biotechnology sectors. Featuring a compact design, 21 CFR Part 11 compliant documentation for electronic record keeping, and remote operation capabilities, it aims to improve user safety and operational efficiency in sterility testing workflows. This product directly contributes to the Global Biological Safety Testing Products and Services Market by providing enhanced tools for critical quality control.

• In April 2024, ViruSure GmbH, a contract research organization specializing in pathogen safety testing, announced a collaboration agreement with neotem Bioanalytics. This partnership aimed to enhance services for the biopharmaceutical industry by integrating neotem Bioanalytics' expertise in electron microscopy analysis with ViruSure's comprehensive virus and prion safety testing capabilities. The collaboration was established to resolve bottlenecks in high-quality and rapid transmission electron microscopy analysis, thereby improving timelines for pathogen safety testing. This directly supports the Global Biological Safety Testing Products and Services Market by streamlining essential testing processes for biological products such as vaccines and advanced therapy medicinal products.

• In April 2024, Merck, a prominent science and technology company, introduced the Aptegra™ CHO genetic stability assay. This novel, all-in-one validated assay utilizes whole genome sequencing and bioinformatics to significantly accelerate biosafety testing for clients. By replacing multiple traditional assays with a single, next-generation sequencing platform, the Aptegra™ solution was designed to reduce testing time by 66 percent and costs by 43 percent, while meeting regulatory requirements for genetic stability assurance. This product launch provides a new, more efficient tool for companies within the Global Biological Safety Testing Products and Services Market to expedite their move towards commercial production.

Key Market Players

• Charles River Laboratories International, Inc.
• BSL Bioservice Scientific Laboratories Munich GmbH
• Merck KGaA
• Samsung Biologics
• Sartorius AG
• Eurofins Scientific (Ireland) Limited
• SGS Société Générale de Surveillance SA
• Thermo Fisher Scientific Inc.
• BIOMÉRIEUX SA
• Lonza Group Ltd.

Report Scope:

In this report, the Global Biological Safety Testing Products and Services Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Biological Safety Testing Products and Services Market, By Product:

o   Reagents & Kits

o   Services

o   Instruments

• Biological Safety Testing Products and Services Market, By Application:

o   Vaccines & Therapeutics

o   Gene Therapy

o   Monoclonal Antibodies

o   Recombinant Protein

o   Blood & Blood-based Products

o   Tissue & Tissue-based Products

o   Stem Cells

• Biological Safety Testing Products and Services Market, By Test Type:

o   Endotoxin Tests

o   Sterility Tests

o   Cell Line Authentication & Characterization Tests

o   Bioburden Tests

o   Adventitious Agent Detection Tests

o   Residual Host Contamination Detection Tests

o   Others

• Biological Safety Testing Products and Services Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Biological Safety Testing Products and Services Market.

Available Customizations:

Global Biological Safety Testing Products and Services Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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