Global Biological Safety Testing Services Market Size, Trend & Opportunity Analysis Report, by Product (Reagents & Kits, Services), and Forecast, 2024–2035

Market Definition and Introduction

The global biological safety testing services market was valued at USD 5.06 billion in 2024 and is projected to surge to USD 15.95 billion by 2035, registering an impressive CAGR of 11.00% during the forecast period (2024–2035). In bordering biotechnology to pharmaceuticals with a step plan of regulatory requirements, biological safety testing services will always be indispensable for ascertaining safety, efficacy, and compliance of biological entities, vaccines, cell and gene therapies, or any advanced medicinal products. Currently, the life sciences market is constantly shifting towards far more complicated therapeutics and personalized medicines, thereby warranting an increased demand for complex testing services-from sterility and endotoxin analysis to mycoplasma testing-that will ultimately factor into the growth curve of this high-growth industry.

The dynamics within the biopharmaceutical sector have, through rampant innovation, propelled the testing services industry to meet both preclinical and commercial stage needs. The demand for rapid solutions in personalized medicine has grown side by side with the furious growth of testing platforms that generate accurate and regulatory-compliant results for cell-based therapeutics. In particular, the FDA and EMA have increased pressure on biologics manufacturers to provide evidence of safety for their products through all phases of development and production. Hence, continuing regulatory scrutiny has intensified the outsourcing of testing activities to specialized contract research organizations (CROs) that possess the necessary infrastructure and know-how for implementing these demanding procedures on a large scale.

On the other hand, upgraded analytical techniques-such as high-throughput screening systems, NGS, and real-time PCR-are transforming players in the market with enhanced operational capacity. It is integrating automation and AI-guided data analytics into its processes to accelerate turnaround times and improve accuracy. Thus, on one hand, the rapid growth of the aforementioned market can also be linked to a paradigm shift toward end-to-end testing partnerships in which providers become strategic allies to safely and fast-track innovative therapies into the market.

Recent Developments in the Industry

Charles River Laboratories Upgrades its Integrated Biosafety Testing Capabilities with Advanced Virology Platforms.

In January 2024, Charles River Laboratories announced enhancing its global biosafety testing network with the latest virology platforms that would improve viral clearance studies and bio-safety assurance in biologics manufacturing.

SGS SA Introduced Rapid Sterility Testing Services to Speed Up Time to Market for Biologics.

In May 2024, SGS SA launched a new suite of rapid sterility assays, which employ automated detection technologies to shorten testing timelines while ensuring compliance with global pharmacopoeia standards.

WuXi AppTec invests in high-capacity biosafety laboratories for cell and gene therapies of the future.

In October 2023, WuXi AppTec announced extended biosafety laboratories in China and the U.S. that will mainly handle complicated safety evaluations of therapies involving the use of cells or genes.

Market Dynamics

Expansion of Biopharmaceutical Pipelines Backs Huge Demand for Safety Testing Services

The fast tracking of biologics and advanced therapies, including monoclonal antibodies, recombinant proteins, and cell-based products-has exponentially increased the volume and diversity of testing demands. From research to commercialization, each stage of development has very stringent safety validation demands aimed mainly at ensuring patient safety and regulatory compliance, thereby making specialized testing services a needful part of any product lifecycle.

Rigorous Global Regulation Heightens the Relevance of Outsourced Biological Safety Testing

International agencies such as the FDA, EMA, and WHO have ramped up their oversight of biopharmaceutical manufacturing processes to ensure that companies keep exacting quality and safety records. These regulations, taken together with the cost and complexity of in-house testing infrastructure, are edging manufacturers toward outsourcing, where CROs provide certified, scalable, and highly specialized services.

Technological Improvements Strengthening Testing Accuracy and Operational Efficiency

The introduction of high-sensitivity assays, NGS, and AI-driven analytics has disrupted biosafety testing. Service providers now can obtain results at unprecedented speed without sacrificing accuracy, so that manufacturers can base their real-time decisions on the most current data, allowing shortening of the time to market for new drugs. This agility, powered by technology, has become an important differentiator for competitiveness in the marketplace.

Unusual Testing Requirements in Responding to the Boom of Cell and Gene Therapies

Cell and gene therapies pose unique biosafety challenges such as vector characterization, genomic integration studies, and viral clearance studies. The specialized expertise that is required for these tests is stimulating demand for those providers with deep technical capabilities and modern containment facilities.

Supply Chain Complexities and Skilled Talent Shortages Continue as Major Impediments

Notwithstanding the strong growth trajectory of the market, it faces headwinds caused by global supply chain disruptions in reagents and consumables, as well as the lack of skilled technical personnel who can handle complex and profusion testing protocols. Both these factors might hamper service delivery in addressing high operational costs for testing providers.

Attractive Opportunities in the Market

Advanced Therapy Medicinal Products – Growing ATMP pipeline increases demand for specialized safety testing
Rapid Assay Development – High demand for accelerated testing timelines in biopharma R&D
Global Outsourcing Expansion – Emerging markets offer cost-effective biosafety testing solutions
Regulatory Compliance Services – End-to-end support for meeting evolving global standards
Automation & AI Integration – Digital transformation to optimize accuracy and throughput
Pandemic Preparedness – Biosafety infrastructure expansion for vaccine and therapeutic readiness
Multi-Site Laboratory Networks – Global footprints enabling region-specific regulatory alignment
Customized Safety Protocols – Tailor-made testing solutions for novel biologics and delivery systems

Report Segmentation

By Product: Reagents & Kits, Services

By End Use: Biopharmaceutical Companies, Contract Research Organizations, Academic & Research Institutes

By Region: North America (U.S., Canada, Mexico), Europe (UK, Germany, France, Spain, Italy, Spain, Rest of Europe), Asia-Pacific (China, India, Japan, Australia, South Korea, Rest of Asia-Pacific), LAMEA (Brazil, Argentina, UAE, Saudi Arabia (KSA), Africa Rest of Latin America)

Key Market Players

Charles River Laboratories, SGS SA, Eurofins Scientific, Merck KGaA, Thermo Fisher Scientific Inc., Lonza Group, Sartorius AG, WuXi AppTec, BioOutsource Ltd (a Sartorius company), and Toxikon Corporation.

Report Aspects

Base Year: 2024
Historic Years: 2022, 2023, 2024
Forecast Period: 2024-2035
Report Pages: 293

Dominating Segments

Market Leadership in the Services Segment Sustained by Outsourcing Trends in Biopharma

Services are witnessing the most substantial market share in biological safety testing because pharmaceutical and biotech companies are now inclined to outsource their complex testing to specialized providers, equipped with regulatory certifications, state-of-the-art infrastructures, and expansive global networks. Outsourcing reduces the need for internal capital expenditure while ensuring compliance and efficiency in operations.

Reagents and Kits Segment Begins to Gain Traction due to Increased Uptake of Rapid Testing Technologies.

Sterility testing, endotoxin detection, and mycoplasma analysis assays are among the many assays whose requirements for reagents and kits are increasing due to a plethora of point-of-use and high-throughput testing platforms that have been developed. Such tools develop in contribution to enabling faster, more reliable result acquisition, thus strengthening the adoption of these reagents and kits in outsourcing and internal applications.

Academic & Research Institutes Segment to Emerge as Innovation Hubs for the Development of Safety Protocols

Safety testing is emerging as an important end-use area for universities and research institutions for translational research and early therapeutic development. Their collaborations with CROs and biopharma firms are influencing innovations in testing methodology and regulatory science.

Key Takeaways

Services Lead – Outsourced testing remains the backbone of biosafety validation in biologics manufacturing
Rapid Growth in Reagents – Adoption of fast, reliable kits supports high-throughput testing demands
ATMP Surge – Specialized safety protocols required for cell and gene therapy pipelines
Regulatory Pressure – Intensified compliance demands accelerate outsourcing trends
APAC Momentum – Industrial growth and biotech expansion boost regional market share
Technological Integration – AI and automation improve accuracy and turnaround times
Pandemic Preparedness – Testing capacity expansion aligns with global health security strategies
Supply Chain Watch – Reagent availability and skilled labor remain operational risks
Academic Collaboration – Research-driven testing innovations advance industry standards
Strategic Expansion – Global lab networks strengthen geographic and regulatory reach

Regional Insights

North America will continue its leadership role due to good biopharma infrastructure and regulatory stringency.

North America will continue its leadership role due to good biopharma infrastructure and regulatory stringency. A thick network of biopharmaceutical companies, CROs, and regulatory authorities in the U.S. and Canada forms a mature ecosystem for biological safety testing services. Stringent FDA requirements and a high level of R&D funding further consolidate the leadership of this region.

Europe Fostering Green and Sustainable Testing Practices in Biopharma Operations.

European markets, with the leadership of Germany, the UK, and France, are emphasizing sustainable laboratory practices, data integrity compliance, and harmonized regulatory standards under the EMA framework. These favorable regulatory environments entail a higher service adoption rate.

The Asia-Pacific-one-of-the-quickest-to-grow market-driven by the expansion of biotech.

China, India, and South Korea are rapidly developing their biotechnological manufacturing capacity and investing in biosafety infrastructure. Supportive governmental policies, paired with growing domestic demand for biologics, will see APAC outpace growth in the rest of the regions.

Core Strategic Questions Answered in This Report

Q. What is the expected growth trajectory of the biological safety testing services market from 2024 to 2035?

The global biological safety testing services market is projected to grow from USD 5.06 billion in 2024 to USD 15.95 billion by 2035, registering a CAGR of 11.00%. This expansion is fueled by the rising complexity of biologics, stringent regulatory frameworks, and the increasing outsourcing of testing services to specialized providers.

Q. Which key factors are fuelling the growth of the biological safety testing services market?

Several key factors are propelling market growth:

Rising demand for safety validation in biologics and advanced therapies
Stringent global regulations driving outsourcing trends
Technological advancements in rapid and high-throughput testing platforms
Expansion of global biopharma manufacturing capabilities
Growing emphasis on pandemic preparedness and biosafety infrastructure

Q. What are the primary challenges hindering the growth of the biological safety testing services market?

Major challenges include:

Shortages of skilled technical personnel
Supply chain volatility affecting reagent availability
High capital investment in biosafety infrastructure
Complexity in maintaining multi-regional regulatory compliance
Operational delays due to high service demand and limited capacity

Q. Which regions currently lead the biological safety testing services market in terms of market share?

North America leads the global biological safety testing services market, supported by a robust biopharma sector, stringent regulatory frameworks, and extensive CRO networks. Europe follows closely, excelling in harmonized regulations and sustainable laboratory practices.

Q. What emerging opportunities are anticipated in the biological safety testing services market?

The market offers substantial opportunities, including:
Specialized testing for cell and gene therapies
AI-driven automation to improve accuracy and efficiency
Expansion of global CRO networks for multi-regional compliance
Rapid assay development for pandemic preparedness
Strategic collaborations to advance testing protocols and regulatory science

Key Benefits for Stakeholders

The report offers a quantitative assessment of market segments, emerging trends, projections, and market dynamics for the period 2024 to 2035.
The report presents comprehensive market research, including insights into key growth drivers, challenges, and potential opportunities.
Porter's Five Forces analysis evaluates the influence of buyers and suppliers, helping stakeholders make strategic, profit-driven decisions and strengthen their supplier-buyer relationships.
A detailed examination of market segmentation helps identify existing and emerging opportunities.
Key countries within each region are analysed based on their revenue contributions to the overall market.
The positioning of market players enables effective benchmarking and provides clarity on their current standing within the industry.
The report covers regional and global market trends, major players, key segments, application areas, and strategies for market expansion. Show more