USD 5.2 billion
Biological Safety Testing Market Size, Share, and Growth Analysis
Biological Safety Testing Market By Product (Reagents & Kits, Services), By Test Type (Endotoxin Tests, Sterility Tests), By Application (Vaccines & Therapeutics, Blood & Blood-based Products), By Region - Industry Forecast 2025-2032
Report ID:
SQMIG35J2092 |
Region:
Global |
Published Date: January, 2025
Pages:
157
|Tables:
65
|Figures:
75
Format -
Biological Safety Testing Market Insights
Global Biological Safety Testing Market size was valued at USD 5.2 billion in 2023 and is poised to grow from USD 5.81 billion in 2024 to USD 14.08 billion by 2032, growing at a CAGR of 11.7% during the forecast period (2025-2032).
The global biological safety testing market is experiencing significant growth due to various factors such as increasing research and development activities in the pharmaceutical and biotechnology sectors, rising prevalence of infectious diseases, and growing awareness about the importance of quality control in the healthcare industry.
Biological safety testing involves the evaluation of biological products, such as vaccines, blood products, and cell-based therapies, to ensure their safety and efficacy before they are released for commercial use. The market is driven by the stringent regulatory requirements for the approval of biological products, which necessitate comprehensive safety testing to minimize the risk of adverse events.
Additionally, the increasing demand for advanced testing methods, such as nucleic acid amplification and sequencing techniques, is contributing to the market growth. These methods offer enhanced sensitivity and specificity in detecting potential contaminants in biological products, thereby improving patient safety.
Moreover, the growing adoption of in vitro testing methods, such as cell-based assays and immunoassays, is further propelling market expansion. These methods provide quicker results, reduce the need for animal testing, and offer cost-efficiency, driving their preference among researchers and manufacturers.
US Biological Safety Testing Market is poised to grow at a sustainable CAGR for the next forecast year.
Market snapshot - 2025-2032
Global Market Size
Largest Segment
Instruments
Fastest Growth
Instruments
Growth Rate
11.7% CAGR
Global Biological Safety Testing Market ($ Bn)
Country Share for North America Region (%)
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Biological Safety Testing Market Segments Analysis
Global Biological Safety Testing Market is segmented by Product, Test Type, Application and region. Based on Product, the market is segmented into Reagents & Kits, Services and Instruments. Based on Test Type, the market is segmented into Endotoxin Tests, Sterility Tests, Cell Line Authentication & Characterization Tests, Bioburden Tests, Adventitious Agent Detection Tests, Residual Host Contamination Detection Tests and Others. Based on Application, the market is segmented into Vaccines & Therapeutics, Blood & Blood-based Products, Gene Therapy, Tissue & Tissue-based Products, Stem Cell and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.
Biological Safety Testing Market Analysis by Product
The instruments segment holds a dominant market share. Instruments and equipment used in biological safety testing, such as biosafety cabinets, centrifuges, incubators, and microscopes. With the increasing demand for advanced testing technologies and the need for efficient laboratory workflows. Moreover, the continuous advancements in instrument capabilities, such as automation and integration of advanced features, contribute to its rapid growth.
The reagents and kits segment is a growing segment in market share. Reagents and kits are essential components in biological safety testing, providing specific reagents, buffers, controls, and detection systems required for conducting various assays and tests. The growing adoption of in vitro testing methods and the increasing demand for specific and high-quality reagents drive the growth of this segment. Additionally, the development of innovative and user-friendly kits with improved sensitivity and specificity further fuels market expansion.
Biological Safety Testing Market Analysis by Application
Pharmaceutical and biologics testing is a dominant segment within the biological safety testing market. This segment holds a significant market share due to the extensive regulatory requirements and rigorous testing procedures mandated for pharmaceutical products. The pharmaceutical and biologics testing segment is driven by the increasing demand for novel therapeutics, the rising prevalence of chronic diseases, and the continuous advancements in drug discovery and development.
Blood and blood-based therapy is the fastest growing segment in the biological safety testing market. This segment is driven by the growing demand for blood transfusions, the need to prevent transfusion-transmitted infections, and the implementation of strict regulatory guidelines for blood safety. The increasing incidence of blood-borne diseases and the focus on maintaining a safe blood supply contribute to the growth of this segment.
Global Biological Safety Testing Market By Product
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Biological Safety Testing Market Regional Insights
North America dominates the biological safety testing market, accounting for over of the total revenue. The region's dominance can be attributed to several factors, including a well-established healthcare infrastructure, favorable government initiatives, and a large number of pharmaceutical and biotechnology companies. The United States, in particular, plays a pivotal role in driving market growth, owing to substantial investments in research and development activities. The stringent regulatory framework, enforced by agencies such as the Food and Drug Administration (FDA), further emphasizes the need for comprehensive safety testing, boosting market demand.
The Asia Pacific region is expected to witness the fastest growth in the biological safety testing market. Factors driving this growth include increasing investments in healthcare infrastructure, rising healthcare expenditure, and a growing focus on research and development activities. Countries such as China, Japan, and India are at the forefront of market growth in this region. These countries have witnessed a surge in pharmaceutical and biotechnology industries, along with significant government initiatives to promote healthcare advancements. Additionally, the presence of a large patient population and rising awareness regarding the safety of biological products contribute to market expansion.
Global Biological Safety Testing Market By Geography
- Largest
- Fastest
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Biological Safety Testing Market Dynamics
Biological Safety Testing Market Drivers
Growing Adoption of In Vitro Testing Methods
- In vitro testing methods, such as cell-based assays and immunoassays, are gaining popularity due to their advantages over traditional animal-based testing. These methods provide quicker results, reduce the need for animal testing, and offer cost-efficiency, thereby driving their adoption and fueling market growth.
- The increasing prevalence of infectious diseases, such as COVID-19, has heightened the importance of biological safety testing. The need to detect and prevent the spread of pathogens and contaminants has become paramount, driving the demand for testing methods that can effectively identify and eliminate potential risks.
Biological Safety Testing Market Restraints
Shortage of Skilled Professionals
- The shortage of skilled professionals proficient in biological safety testing techniques can impede market growth. The complex nature of testing methodologies requires trained personnel with expertise in handling biological samples, interpreting results, and ensuring compliance with regulatory standards. The limited availability of skilled professionals can hinder the expansion of the market.
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Biological Safety Testing Market Competitive Landscape
These participants are engaging in strategic collaborations with various information technology companies to strengthen their market presence by offering customers improved information management solutions.
Top Players in Biological Safety Testing Market
- bioMerieux S.A. (France)
- Charles River Laboratories International, Inc. (United States)
- Eurofins Scientific SE (Luxembourg)
- Lonza Group Ltd. (Switzerland)
- Merck KGaA (Germany)
- Samsung Biologics (South Korea)
- Sartorius AG (Germany)
- SGS Société Générale de Surveillance SA (Switzerland)
- Thermo Fisher Scientific Inc. (United States)
- Avance Biosciences (United States)
- Promega Corporation (United States)
- Toxikon Corporation (United States)
- WuXi AppTec (China)
- Pace Analytical Services LLC (United States)
- Nelson Laboratories, LLC (United States)
- BioReliance Corporation (United States)
- Microbac Laboratories, Inc. (United States)
- Intertek Group plc (United Kingdom)
- Covance Inc. (United States)
Biological Safety Testing Market Recent Developments
- In March 2023, Lonza announced the launch of a new biological safety testing platform. This platform uses artificial intelligence to automate and streamline the biological safety testing process.
- In February 2023, WuXi AppTec launched a new biological safety testing facility in Suzhou, China. This facility is equipped with the latest technology and will provide a wide range of biological safety testing services to clients in the Asia-Pacific region.
- In January 2023, Charles River Laboratories announced the acquisition of Eurofins Scientific's biological safety testing business. This acquisition will expand Charles River's capabilities in biological safety testing and help the company meet the growing demand for these services.
Biological Safety Testing Key Market Trends
- Growing Focus on Patient Safety: Patient safety has emerged as a critical concern in the healthcare industry, leading to a heightened emphasis on rigorous biological safety testing. The occurrence of adverse events due to contaminated or substandard biological products can have severe consequences for patients. As a result, healthcare providers, regulatory authorities, and manufacturers are prioritizing quality control measures to ensure the safety and well-being of patients. This focus on patient safety drives the demand for comprehensive biological safety testing and promotes market growth.
Biological Safety Testing Market SkyQuest Analysis
SkyQuest's ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyzes the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
According to our analyses, the global biological safety testing market is poised for significant growth driven by various factors. Increasing research and development activities in the pharmaceutical and biotechnology sectors, coupled with the rising prevalence of infectious diseases, are propelling the demand for comprehensive safety testing of biological products. Stringent regulatory requirements for product approval and the need for quality control in the healthcare industry are also driving market expansion. Advanced testing methods such as nucleic acid amplification and sequencing techniques, as well as the adoption of in vitro testing methods, are gaining traction due to their enhanced sensitivity, specificity, and cost-efficiency. With the increasing demand for biologics, advancements in testing technologies, and growing investments in healthcare infrastructure, the global biological safety testing market is expected to thrive in the coming years.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 5.2 billion |
| Market size value in 2032 | USD 14.08 billion |
| Growth Rate | 11.7% |
| Base year | 2024 |
| Forecast period | 2025-2032 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
|
| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Biological Safety Testing Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Biological Safety Testing Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Biological Safety Testing Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Biological Safety Testing Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Biological Safety Testing Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Biological Safety Testing Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
Biological Safety Testing Market Report Snapshots
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