Report Descriptions:

The Global Biological Safety Testing Products and Services Market was estimated at USD 5.38 billion in 2025 and is projected to reach USD 15.03 billion by 2035, growing at a robust CAGR of 10.88% during the forecast period from 2026 to 2035. The Biological Safety Testing Products and Services market report provides a comprehensive industry assessment, analyzing economic conditions, technological advancements, regulatory frameworks, and evolving consumer behavior to deliver a clear view of future growth potential.

With 2025 as the base year, the Biological Safety Testing Products and Services market is witnessing steady expansion driven by innovation, rising consumer demand, and rapid technological progress. Companies are increasingly refining their go-to-market (GTM) strategies to capture emerging opportunities and respond to shifting market dynamics.

Looking ahead to 2035, the market is expected to sustain its growth momentum, supported by continuous R&D investments, strategic partnerships, and mergers and acquisitions. Businesses that prioritize innovation, agile GTM strategies, and alignment with consumer needs are likely to achieve long-term success. The report delivers detailed insights into key drivers, restraints, opportunities, and challenges across segments, regions, and countries, supported by qualitative and quantitative analysis covering the period from 2017 to 2035.

Historical Analysis (2017 - 2024): Reviews past market trends, performance metrics, and growth patterns to identify factors shaping current and future market behavior.

Forecast and Projections (2026 - 2035): Provides forward-looking market estimates, highlighting growth opportunities, emerging trends, and regional developments.

Compound Annual Growth Rate (CAGR): Presents a clear CAGR calculation for 2026 - 2035, enabling stakeholders to evaluate market growth potential over the forecast period.

Biological Safety Testing Products and Services Market

Biological Safety Testing Products and Services Market

The biological safety testing products and services market encompasses a comprehensive ecosystem of products, platforms, technologies, and outsourced services used to ensure the safety, purity, potency, and regulatory compliance of biologics, vaccines, cell & gene therapies, and advanced therapeutics.

The market includes critical testing areas such as sterility testing, endotoxin testing, viral clearance, adventitious agent detection, bioburden analysis, cell line authentication, and residual host cell contamination testing. These services are delivered through reagents and kits, analytical instruments, and contract testing services provided by specialized CROs and CDMOs. As biologics now represent over 35% of the global pharmaceutical pipeline, biological safety testing has become a non-negotiable pillar of modern drug development and manufacturing.

What are the drivers of biological safety testing products and services market

The market is expanding rapidly due to regulatory tightening, biologics innovation, and technological transformation.

• Regulatory pressure is intensifying: Agencies such as the FDA, EMA, and PMDA require multi-layered safety testing for every biologic batch, driving mandatory demand across development and commercial manufacturing.

• Biologics and advanced therapies boom: Cell and gene therapies are growing at a 20%+ CAGR, each requiring extensive viral safety, sterility, and genetic stability testing.

• Over 60% of new drug approvals globally are biologics, significantly increasing the volume and complexity of safety testing per product lifecycle.

• Technology-driven efficiency gains: Adoption of next-generation sequencing (NGS), high-throughput automation, and AI-based analytics is reducing testing timelines by up to 3040%.

• Rising cost of batch failure: A single contaminated biologics batch can result in losses exceeding USD 550 million, making proactive safety testing a strategic investment rather than a cost center.

What are the challenges and restraining factors of biological safety testing products and services market

Despite strong growth, structural and operational challenges persist.

• High testing costs: Comprehensive biosafety testing can account for 1525% of total biologics development costs, creating barriers for small and early-stage biotech firms.

• Regulatory fragmentation: Differences between FDA, EMA, NMPA, and PMDA requirements increase compliance complexity and delay global product launches.

• Skilled workforce shortage: The global biosafety testing sector faces a talent gap, with demand for trained specialists exceeding supply by 2030% in key markets.

• Market saturation in developed regions: North America and Western Europe face intense competition, compressing margins and raising entry barriers for new players.

What are the regional trends of biological safety testing products and services market

North America: The largest and most advanced market, accounting for over 40% of global revenue. Growth is driven by strict FDA oversight, heavy biologics investment, and rapid adoption of automation and AI-enabled testing.

Europe: A highly regulated but innovation-focused market led by Germany and Switzerland. EMA-driven biosafety standards and strong biosimilar pipelines support sustained demand.

Asia Pacific: The fastest-growing region, expanding at 1012% CAGR. China and India are scaling biologics manufacturing and clinical trials, driving demand for local and outsourced safety testing.

Latin America: Moderate growth led by Brazil and Mexico, supported by improving healthcare infrastructure and export-oriented regulatory alignment.

Middle East & Africa: Early-stage but promising, driven by healthcare modernization, public-private partnerships, and growing awareness of biosafety compliance.

Country-Wise Outlook:

United States:

The U.S. dominates the global biological safety testing market, supported by the worlds largest biopharmaceutical industry and stringent FDA requirements. With 20,000+ active clinical trials and annual biotech R&D spending exceeding USD 100 billion, demand for sterility, viral safety, and genetic testing remains unparalleled. Major investmentssuch as Mercks USD 305 million integrated biosafety and cell banking facilityhighlight the shift toward in-house, high-speed testing models.

Germany:

Germany is Europes biosafety testing powerhouse, benefiting from a strong pharmaceutical base, EMA-aligned regulations, and deep academiaindustry collaboration. The country employs 130,000+ biotech professionals and invests billions annually in life science R&D, accelerating adoption of automated and AI-driven biosafety platforms.

Japan:

Japans biological safety testing market is driven by its aging population, advanced healthcare system, and strong biologics pipeline. With biotech R&D spending exceeding USD 15 billion annually, Japan emphasizes high-throughput, molecular, and precision testing under PMDA oversight, positioning it as a key Asia-Pacific hub.

Competitive Analysis:

The biological safety testing market is highly competitive and expertise-driven. Market leaders differentiate through regulatory credibility, testing breadth, turnaround time, and integration depth.

Companies offering end-to-end testing solutionsfrom raw material qualification to final product releasegain a strategic advantage by reducing complexity for biopharma clients. Advanced capabilities in viral clearance, NGS-based adventitious agent detection, and AI-assisted data interpretation are key competitive levers.

Strategic partnerships with CDMOs, expansion into emerging biologics hubs, and continuous investment in automation define leadership positioning. Regulatory expertise is equally critical, as compliance failures can disqualify vendors from high-value biologics programs.

Key players include Charles River Laboratories, Thermo Fisher Scientific Inc., Merck KGaA (MilliporeSigma), Sartorius AG, Eurofins Scientific, SGS SA, bioMrieux, Lonza Group, Samsung Biologics, WuXi AppTec, Promega Corporation, Cytovance Biologics, Toxikon Corporation, Avance Biosciences, BSL Bioservice, and other players.

Recent Development:

April 2025: Eurofins expanded its U.S. biosafety footprint with a new ethylene oxide (EtO) sterilization solution, strengthening medical device and biologics safety services.

May 2025: Chengdu Origen Biotechnology and Vanotech advanced VAN-2401 into a multi-center Phase 1 clinical trial in the U.S., underscoring rising biosafety testing demand for next-generation gene therapies.

Study Period for the Biological Safety Testing Products and Services Market:

Report Highlights:

Our team of experienced researchers has meticulously gathered and analyzed data to deliver a thorough examination of market dynamics, competitive landscape, and emerging technologies. With a focus on delivering actionable intelligence, this report aims to empower decision-makers with the information needed to make informed choices and stay ahead of the competition. Whether you are a seasoned industry player or a new entrant, our market research report serves as a strategic tool to navigate the complexities of the market, aiding in successful business planning and growth strategies.

Key Chapters of our Biological Safety Testing Products and Services Market Report includes:

Market Dynamics, Variables, and Industry Analysis:

This chapter of our Biological Safety Testing Products and Services market report provides an in-depth examination of the factors shaping the industry landscape. This section typically encompasses several key elements to offer a comprehensive understanding of the industry landscape such as market drivers & restraints analysis, market opportunities & trend analysis, market size & growth analysis, competitive analysis, SWOT analysis, business environment tools such as Porter's five forces & PESTEL analysis, Ansoff Matrix analysis, penetration & growth prospect analysis, regulatory framework & reimbursement scenario analysis, impact of macro & micro economic factors analysis such as Covid-19 impact, GDP growth, market inflation, U.S.- China trade war, Russia-Ukraine war impact, and supply chain analysis.

Segment Analysis & Forecast to 2035:

The segment analysis chapter of Biological Safety Testing Products and Services market report is a critical section that delves into a detailed examination of the market's various segments. Segmentation involves dividing the market into distinct categories based on certain criteria to better understand and address the diverse needs of consumers. This chapter typically follows the introduction and provides a more granular view of the market, offering valuable insights for businesses and stakeholders. The components of the chapter lude segment definitions to understand the inclusions and exclusions of the study, assumptions, market size estimates and growth trend analysis of each segment, qualitative analysis of the segment, technological advancements, market penetration rate, market adoption rate, market share examination by each segment, segment growth drivers and restraint barriers, consumer behaviour and challenge analysis.

Regional Market Analysis & Forecast to 2035:

The chapter in Biological Safety Testing Products and Services market research report is a pivotal section that examines and predicts the market dynamics and trends specific to different geographical regions. This chapter is crucial for businesses and stakeholders seeking a comprehensive understanding of how the market behaves across various locations, enabling them to tailor strategies and make informed decisions based on regional variations. The regional analysis chapter of our Biological Safety Testing Products and Services market report is classified into regions & country-level. The chapter consists of North America (U.S., Canada), Europe (UK, Germany, France, Italy, Spain, Russia, Sweden, Denmark, Norway, Rest of Europe), Asia Pacific (Japan, China, India, Australia, South Korea, Thailand, Rest of Asia Pacific), Latin America (Brazil, Mexico, Argentina, Colombia, Rest of Latin America), Middle East & Africa (South Africa, Saudi Arabia, UAE, Kuwait, Rest of Middle East & Africa).

Competitive Analysis & Company Profiles:

This section of a Biological Safety Testing Products and Services market report is a crucial segment that provides a comprehensive overview of the competitive landscape within the market. This section is vital for businesses, investors, and stakeholders seeking insights into key players, their market positioning, strengths, weaknesses, strategies, and potential impacts on the overall market dynamics. The chapter includes research methodology used to analyse the market competition, list of key players operating in the market, detailed company profile section which includes company overview, business verticals, financial performance, product/services benchmarking, geographical presence, and strategic initiatives.

Key Players Operating in the Biological Safety Testing Products and Services Market are as follows:

• Charles River Laboratories
• Thermo Fisher Scientific Inc.
• Merck KGaA (MilliporeSigma)
• Sartorius AG (Sartorius Stedim)
• Eurofins Scientific
• SGS Socit Gnrale de Surveillance SA
• BIOMRIEUX
• Lonza Group
• Samsung Biologics
• BSL Bioservice
• Avance Biosciences
• Cytovance Biologics
• Promega Corporation
• Wuxi AppTec
• Toxikon Corporation

Biological Safety Testing Products and Services Market

Report Scope:

Quintile Reports has segmented the Biological Safety Testing Products and Services market into the following segments:

Report Scope	Details
Report Version	2026
Growth Rate	CAGR of 10.88 from 2026 to 2035
Base year	2025
Actual estimates/Historical data	2017 - 2024
Forecast period	2026 - 2035
Quantitative units	Revenue in USD million/billion & CAGR from 2026 to 2035
Country scope	North America (U.S., Canada), Europe (UK, Germany, France, Italy, Spain, Russia, Sweden, Denmark, Norway, Rest of Europe), Asia Pacific (Japan, China, India, Australia, South Korea, Thailand, Rest of Asia Pacific), Latin America (Brazil, Mexico, Argentina, Colombia, Rest of Latin America), Middle East & Africa (South Africa, Saudi Arabia, UAE, Kuwait, Rest of Middle East & Africa).
The Segment covered by Product	Reagents & Kits Instruments Services
The Segment covered by Application	Vaccines & Therapeutics (Vaccines Monoclonal Antibodies Recombinant Proteins) Blood & Blood-based Products Gene Therapy Tissue & Tissue-based Products Stem Cell
Companies covered	Charles River Laboratories Thermo Fisher Scientific Inc. Merck KGaA (MilliporeSigma) Sartorius AG (Sartorius Stedim) Eurofins Scientific SGS Socit Gnrale de Surveillance SA BIOMRIEUX Lonza Group Samsung Biologics BSL Bioservice Avance Biosciences Cytovance Biologics Promega Corporation Wuxi AppTec Toxikon Corporation
Report coverage	Revenue forecast, company share, competitive landscape, growth factors, and trends
Free customization scope (equivalent to 5 analyst working days)	If you need specific information, which is not currently within the scope of the report, we will provide it to you as a part of the customization

Key Reasons to Acquire the Biological Safety Testing Products and Services Market Research Report:

• This report offers a comprehensive analysis of the Biological Safety Testing Products and Services market from 2017 to 2035, including market segments, current trends, estimations, and dynamics
• It also provides information on key drivers, restraints, and opportunities
• Porter's five forces analysis is used to assess the potency of buyers and suppliers, helping stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network
• The report includes an in-depth analysis of the Biological Safety Testing Products and Services market segmentation to identify prevailing market opportunities
• Major countries in each region are mapped according to their revenue contribution to the global market
• Market player positioning is also analyzed to facilitate benchmarking and provide a clear understanding of the present position of the market players
• The report includes an analysis of the regional and global Biological Safety Testing Products and Services market trends, key players, market segments, application areas, and market growth strategies

Available Customizations:

With the given market data, Quintile Reports offers customizations according to the company's specific needs. The following customization options are available for the report:

• You may ask for a global, regional, or country-specific report.
• You may ask if there are any particular types, applications, or products on which you would like to focus.
• You may ask for specific competitors/players to be profiled.

Biological Safety Testing Products and Services Market Report

Statistics for the 2025 Biological Safety Testing Products and Services market share, size, and revenue growth rate were created by Quintile Report™. Biological Safety Testing Products and Services analysis includes a market forecast outlook for 2035 and a historical overview. Get a free PDF sample of this market analysis, please get in touch with our principal analyst at sales@quintilereports.com