Biologics Safety Testing Market Size, Share, By Offering [Services (Sterility Testing Services, Mycoplasma Testing Services, Endotoxin Testing Services, Bioburden Testing Services, Virus Safety Testing Services, and Others), Consumables (Reagents and Kits
Description
Biologics Safety Testing Market Size, Share, By Offering [Services (Sterility Testing Services, Mycoplasma Testing Services, Endotoxin Testing Services, Bioburden Testing Services, Virus Safety Testing Services, and Others), Consumables (Reagents and Kits), and Instruments], Application (Vaccines & Therapeutics, Cellular & Gene Therapy, Blood & Blood-based Therapy, and Others), End Users (Pharmaceutical & Biopharmaceutical Companies, Research Institutions, and Others) and Region - Trends, Analysis, and Forecast till 2035
The Biologics Safety Testing Market Report offers an in-depth exploration of emerging market trends, driving factors, challenges, and key segments that shape the industry. It includes a thorough examination of regulatory frameworks, company profiles, and the latest industry developments. The report delves into product development, positioning strategies, and the impact of new technologies on the market landscape. By identifying challenges and opportunities, the report provides a detailed roadmap for market growth.
The biologics safety testing market is the process of evaluating the safety of biologic products before used to human being. The aim of biologics safety testing is to verify that these products are free from harmful contaminants, pathogens, and other potential risks that could affect human health. It involves clinical trials, sterility and stability testing, ongoing monitoring and others. The development of more advanced technologies such as PCR (Polymerase Chain Reaction), next-generation sequencing (NGS), and cell-based assays is improving the accuracy, efficiency, and speed of biologics safety testing, resulting to drive biologics safety testing market growth.
Report Highlights:
Biologics safety testing market size is accounted for USD 4.9 Billion in 2025.
The biologics safety testing market size is expected to increase at a rate of USD 13.2 Billion by 2035, and growing at a CAGR of 11.5%.
On the basis of offerings, services segment hold the major biologics safety testing market share.
Under application, vaccines and therapeutics is the leading segment in biologics safety testing market size.
Pharmaceutical and biopharmaceutical companies is the most dominating segment in biologics safety testing market share, by end-user way.
North America hold the largest biologics safety testing market.
Asia Pacific is growing at fastest CAGR in biologics safety testing market.
Key Highlights
In October 2024, SGS announced expansion of new capacity and capabilities at the Center of Excellence in Lincolnshire, Illinois, for the analytical services for biologics and complex drug testing. This center aimed to provide services such as, early cell bank safety assessment, product characterization, method development, raw material testing and final product release. These enhancements aimed to facilitate analytical testing in both the discovery and commercial stages in biopharmaceutical network, and provide delivery of comprehensive, streamlined, and flexible service model to client.
Report Analysis:
General Safety Tests/ Abnormal Toxicity Tests:
The General Safety Tests, or Abnormal Toxicity Tests, are crucial for ensuring the safety of biological products before this are administered to humans or animals. These tests help detect potential toxic contaminants in the final product that could cause harm. Common biological products subjected to these tests include antitoxins, vaccines, blood derivatives, and immunologic diagnostic aids. The tests are typically short-term and evaluate overt signs of toxicity, such as survival rates and body weight loss, after a single application of the material to a test system.
The purpose is to identify any non-specific toxic effects that could arise from extraneous substances present in the product. These tests help regulatory bodies and manufacturers ensure the safety of new biological products before it can reach the market, minimizing the risk to human or animal health.
Segmentation:
By Offering:
Mycoplasma Testing Services
Endotoxin Testing Services
Bioburden Testing Services
Virus Safety Testing Services
Others
Canada
U.K.
France
Russia
Italy
Spain
Netherlands
Rest of Europe
India
Japan
Australia
Indonesia
Malaysia
South Korea
Rest of Asia Pacific
Mexico
Argentina
Rest of Latin America
Israel
South Africa
Rest of Middle East & Africa
The report also includes a competitive analysis with a detailed SWOT review, examining the strengths, weaknesses, opportunities, and threats of each leading company, as well as their market share and product offerings.
Biologics Safety Testing Market Companies:
Abcam Limited
PathogenDx
SGS Société Générale de Surveillance SA.
Thermo Fisher Scientific, Inc.
Boehringer Ingelheim International GmbH
Sartorius AG
Wuxi AppTec
Lonza
Merck KGaA
Charles River Laboratories
Invetech
Eurofins Scientific
Samsung Biologics
BIOMÉRIEUX
Microtrac Retsch GmbH
What Our Report Delivers:
Key Questions Answered in the Report.
What was the Biologics Safety Testing Market size in 2025?
What is projected growth rate of the Biologics Safety Testing Market during 2025-2035?
What are the key factors driving the Biologics Safety Testing Market growth?
What are leading players in the Biologics Safety Testing Market ?
What are the key regions analyzed in the Biologics Safety Testing Market ?
Which region is dominating in the Biologics Safety Testing Market
The Biologics Safety Testing Market Report offers an in-depth exploration of emerging market trends, driving factors, challenges, and key segments that shape the industry. It includes a thorough examination of regulatory frameworks, company profiles, and the latest industry developments. The report delves into product development, positioning strategies, and the impact of new technologies on the market landscape. By identifying challenges and opportunities, the report provides a detailed roadmap for market growth.
The biologics safety testing market is the process of evaluating the safety of biologic products before used to human being. The aim of biologics safety testing is to verify that these products are free from harmful contaminants, pathogens, and other potential risks that could affect human health. It involves clinical trials, sterility and stability testing, ongoing monitoring and others. The development of more advanced technologies such as PCR (Polymerase Chain Reaction), next-generation sequencing (NGS), and cell-based assays is improving the accuracy, efficiency, and speed of biologics safety testing, resulting to drive biologics safety testing market growth.
Report Highlights:
Biologics safety testing market size is accounted for USD 4.9 Billion in 2025.
The biologics safety testing market size is expected to increase at a rate of USD 13.2 Billion by 2035, and growing at a CAGR of 11.5%.
On the basis of offerings, services segment hold the major biologics safety testing market share.
Under application, vaccines and therapeutics is the leading segment in biologics safety testing market size.
Pharmaceutical and biopharmaceutical companies is the most dominating segment in biologics safety testing market share, by end-user way.
North America hold the largest biologics safety testing market.
Asia Pacific is growing at fastest CAGR in biologics safety testing market.
Key Highlights
In October 2024, SGS announced expansion of new capacity and capabilities at the Center of Excellence in Lincolnshire, Illinois, for the analytical services for biologics and complex drug testing. This center aimed to provide services such as, early cell bank safety assessment, product characterization, method development, raw material testing and final product release. These enhancements aimed to facilitate analytical testing in both the discovery and commercial stages in biopharmaceutical network, and provide delivery of comprehensive, streamlined, and flexible service model to client.
Report Analysis:
General Safety Tests/ Abnormal Toxicity Tests:
The General Safety Tests, or Abnormal Toxicity Tests, are crucial for ensuring the safety of biological products before this are administered to humans or animals. These tests help detect potential toxic contaminants in the final product that could cause harm. Common biological products subjected to these tests include antitoxins, vaccines, blood derivatives, and immunologic diagnostic aids. The tests are typically short-term and evaluate overt signs of toxicity, such as survival rates and body weight loss, after a single application of the material to a test system.
The purpose is to identify any non-specific toxic effects that could arise from extraneous substances present in the product. These tests help regulatory bodies and manufacturers ensure the safety of new biological products before it can reach the market, minimizing the risk to human or animal health.
Segmentation:
By Offering:
- Services
Mycoplasma Testing Services
Endotoxin Testing Services
Bioburden Testing Services
Virus Safety Testing Services
Others
- Consumables
- Instruments
- Vaccines & Therapeutics
- Cellular & Gene Therapy
- Blood & Blood-based Therapy
- Others
- Pharmaceutical & Biopharmaceutical Companies
- Research Institutions
- Others
- North America
Canada
- Europe
U.K.
France
Russia
Italy
Spain
Netherlands
Rest of Europe
- Asia Pacific
India
Japan
Australia
Indonesia
Malaysia
South Korea
Rest of Asia Pacific
- Latin America
Mexico
Argentina
Rest of Latin America
- Middle East & Africa
Israel
South Africa
Rest of Middle East & Africa
The report also includes a competitive analysis with a detailed SWOT review, examining the strengths, weaknesses, opportunities, and threats of each leading company, as well as their market share and product offerings.
Biologics Safety Testing Market Companies:
Abcam Limited
PathogenDx
SGS Société Générale de Surveillance SA.
Thermo Fisher Scientific, Inc.
Boehringer Ingelheim International GmbH
Sartorius AG
Wuxi AppTec
Lonza
Merck KGaA
Charles River Laboratories
Invetech
Eurofins Scientific
Samsung Biologics
BIOMÉRIEUX
Microtrac Retsch GmbH
What Our Report Delivers:
- Regional & Country-Level Market Insights: Detailed market share analysis across key regions and countries to help you understand competitive positioning.
- Guidance for New Market Players: Actionable strategic recommendations for businesses entering the market, ensuring a strong foothold from the start.
- Comprehensive Market Forecasts: Reliable data projections for 2024, 2025, 2026, 2028, and 2032 to support long-term planning and investment decisions.
- In-Depth Market Dynamics: Analysis of drivers, restraints, opportunities, and emerging threats, along with challenges and high-potential investment areas.
- Data-Driven Business Strategies: Expert recommendations tailored to key market segments, backed by precise market evaluations.
- Competitive Intelligence: Mapping of prevailing industry trends and competitor strategies to identify growth opportunities.
- Detailed Company Profiles: In-depth analysis of major players, including their business strategies, financial performance, and recent developments.
- Supply Chain Innovations: Insights into the latest technological advancements and trends shaping supply chain efficiency.
Key Questions Answered in the Report.
What was the Biologics Safety Testing Market size in 2025?
What is projected growth rate of the Biologics Safety Testing Market during 2025-2035?
What are the key factors driving the Biologics Safety Testing Market growth?
What are leading players in the Biologics Safety Testing Market ?
What are the key regions analyzed in the Biologics Safety Testing Market ?
Which region is dominating in the Biologics Safety Testing Market
Table of Contents
165 Pages
- Biologics Safety Testing Table of Contents
- Research Objective and Assumption
- Research Objectives
- Assumptions
- Abbreviations
- Market Preview
- Report Description
- Market Definition and Scope
- Executive Summary
- Market Snippet, By Offering
- Market Snippet, By Application
- Market Snippet, By End-user
- Market Snippet, By Region
- Opportunity Map Analysis
- Market Dynamics, Regulations, and Trends Analysis
- Market Dynamics
- Drivers
- Restraints
- Market Opportunities
- Market Trends
- Offering Launch
- Merger and Acquisitions
- Impact Analysis
- PEST Analysis
- Porter’s Analysis
- Safety Standard Characterization Services
- Market Segmentation, By Offering, Forecast Period up to 10 Years, (USD Bn)
- Overview
- Market Value and Forecast (USD Bn), and Share Analysis (%), Forecast Period up to 10 Years
- Y-o-Y Growth Analysis (%), Forecast Period up to 10 Years
- Segment Trends
- Services
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Sterility Testing Services
- Mycoplasma Testing Services
- Endotoxin Testing Services
- Bioburden Testing Services
- Virus Safety Testing Services
- Others
- Consumables
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Reagents and Kits
- Instruments
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Market Segmentation, By Application, Forecast Period up to 10 Years, (USD Bn)
- Overview
- Market Value and Forecast (USD Bn), and Share Analysis (%), Forecast Period up to 10 Years
- Y-o-Y Growth Analysis (%), Forecast Period up to 10 Year
- Segment trend
- Vaccines and Therapeutics
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Cellular & Gene Therapy
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Blood & Blood-based Therapy
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Others
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Market Segmentation, By End-user, Forecast Period up to 10 Years, (USD Bn)
- Overview
- Market Value and Forecast (USD Bn), and Share Analysis (%), Forecast Period up to 10 Years
- Y-o-Y Growth Analysis (%), Forecast Period up to 10 Year
- Segment trend
- Pharmaceutical & Biopharmaceutical Companies
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Research Institutions
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Others
- Overview
- Market Size and Forecast (USD Bn), and Y-o-Y Growth (%), Forecast Period up to 10 Years
- Market Segmentation, By Region, Forecast Period up to 10 Years, (USD Bn)
- Overview
- Market Value and Forecast (USD Bn), and Share Analysis (%), Forecast Period up to 10 Years
- Y-o-Y Growth Analysis (%), Forecast Period up to 10 Years
- Regional Trends
- North America
- Market Size and Forecast (USD Bn), By Offering, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By Application, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By End-user, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By Country, Forecast Period up to 10 Years
- U.S
- Canada
- Asia Pacific
- Market Size and Forecast (USD Bn), By Offering, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By Application, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By End-user, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By Country, Forecast Period up to 10 Years
- China
- India
- Japan
- Australia
- Indonesia
- Malaysia
- South Korea
- Rest of Asia Pacific
- Europe
- Market Size and Forecast (USD Bn), By Offering, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By Application, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By End-user, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By Country, Forecast Period up to 10 Years
- Germany
- U.K.
- France
- Russia
- Italy
- Spain
- Netherlands
- Rest of Europe
- Latin America
- Market Size and Forecast (USD Bn), By Offering, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By Application, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By End-user, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By Country, Forecast Period up to 10 Years
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- Middle East and Africa
- Market Size and Forecast (USD Bn), By Offering, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By Application, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By End-user, Forecast Period up to 10 Years
- Market Size and Forecast (USD Bn), By Country, Forecast Period up to 10 Years
- GCC
- Israel
- South Africa
- Rest of Middle East and Africa
Pricing
Currency Rates
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