+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)
Biologics Safety Testing Global Market Insights 2025, Analysis and Forecast to 2030, by Market Participants, Regions, Technology, Application, Product Type- Product Image
Biologics Safety Testing Global Market Insights 2025, Analysis and Forecast to 2030, by Market Participants, Regions, Technology, Application, Product Type- Product Image
New

Biologics Safety Testing Global Market Insights 2025, Analysis and Forecast to 2030, by Market Participants, Regions, Technology, Application, Product Type

  • PDF Icon

    Report

  • 87 Pages
  • January 2025
  • Region: Global
  • Prof Research
  • ID: 5726777
Description Jump to:
Biologics safety testing is a crucial process in the biopharmaceutical industry, ensuring that biological products are safe for human consumption. With the increasing demand for biologics, the market for safety testing is expected to grow significantly over the coming years. This review will provide an overview of the biologics safety testing market, including market size, share, trends, key players, product types, processes, applications, and forecasts for 2024 to 2029.

Market Overview

The biologics safety testing market is influenced by several factors such as stringent regulatory requirements, an increase in the number of biologics entering the market, and rising concerns regarding product safety. According to recent estimates, the global biologics safety testing market is projected to grow at a CAGR of approximately 8% to 12% from 2024 to 2029.

Market Size and Share

As of 2023, the biologics safety testing market was valued at around $3 billion. The market is anticipated to reach approximately $5 billion by the end of 2029. The growth of the market is attributed to increased R&D activities, the necessity for high-quality testing solutions, and the growth of the biopharmaceutical sector.

Trends Analysis

The following trends are shaping the biologics safety testing market:
  • Increasing Complexity of Biologics: The rise of advanced therapies such as cell and gene therapies is increasing the need for comprehensive safety testing.
  • Technological Advancements: Innovations in testing technologies, including automation and high-throughput screening, are driving market growth.
  • Outsourcing of Testing Services: Biopharmaceutical companies are increasingly outsourcing safety testing to specialized service providers to focus on their core competencies.

Market Segmentation

By Product Type

The biologics safety testing market can be segmented into the following product types:
  • Endotoxin Tests: Essential for ensuring the absence of bacterial endotoxins in biologics.
  • Sterility Tests: Used to confirm that products are free from viable contaminants.
  • Mycoplasma Tests: Detects mycoplasma contamination in cell cultures and biological products.
  • Bioburden Tests: Measures the number of viable microorganisms present in a product.
  • Residual Host-Cell Proteins & DNA Detection Tests: Identifies residual components from the manufacturing process that could affect product safety.
  • Virus Safety Tests: Ensures biological products are free from viral contamination.

By Key Players

The market is dominated by several key players, including:
  • Charles River Laboratories
  • Lonza
  • Thermo Fisher Scientific
  • Merck
  • SGS
  • Eurofins Scientific
  • Sartorius
  • Samsung BioLogics
  • WuXi Biologics

By Process

Market segmentation by process includes:
  • Raw Material Testing
  • In-Process Testing
  • Final Product Testing

By Application

Applications of biologics safety testing include:
  • Vaccine Manufacturing: Ensures the safety and efficacy of vaccines.
  • Monoclonal Antibodies Manufacturing: Critical for the development of therapeutic antibodies.
  • Cellular & Gene Therapy Products Manufacturing: Ensures the safety of innovative therapies.
  • Blood and Blood Products Manufacturing: Ensuring the safety of transfusion products.
  • Others: Including tissue products and combination products.

By End-Use

This segment includes:
  • Biopharmaceutical Companies
  • Contract Testing Organizations
  • Research Institutions

By Region

The market is analyzed across various regions:
  • North America: Dominated the market due to advanced healthcare infrastructure.
  • Europe: Significant market share driven by stringent regulatory requirements.
  • Asia-Pacific: Expected to witness the highest growth rate due to increasing investments in biotechnology.
  • Latin America and Middle East & Africa: Emerging markets with growth potential.

Market News and Policies

Regulatory bodies like the FDA and EMA have been tightening guidelines for the safe testing of biologics, encouraging companies to adopt the latest testing protocols. Furthermore, generous funding opportunities from governments to promote R&D in biotechnology are likely to impact the market positively.

Key Segment Forecasts (2024 - 2029)

Based on market trends and expected growth drivers, forecasts for key segments include:
  • Endotoxin Test Market: Expected to grow at a CAGR of 6% to 9%.
  • Sterility Test Market: Anticipated growth of 7% to 10% due to increased focus on product safety.
  • Mycoplasma Tests Segment: Projected CAGR of 8% to 11%.
  • Virus Safety Test Market: Expected to grow at an CAGR of 9% to 12%.

Conclusion

The biologics safety testing market is poised for significant growth in the coming years, driven by the increasing demand for biologics and stringent regulatory requirements. Key players are strategizing to leverage technology advancements and expand their services, which will contribute to the overall market expansion. Stakeholders should remain alert to innovations and emerging trends within this dynamic sector to harness opportunities effectively.

This product will be delivered within 1-3 business days.

Table of Contents

Chapter 1 Executive SummaryChapter 2 Abbreviation and Acronyms
Chapter 3 Preface
3.1 Research Scope
3.2 Research Sources
3.2.1 Data Sources
3.2.2 Assumptions
3.3 Research Method
Chapter 4 Market Landscape
4.1 Market Overview
4.2 Classification/Types
4.3 Application/End Users
Chapter 5 Market Trend Analysis
5.1 Introduction
5.2 Drivers
5.3 Restraints
5.4 Opportunities
5.5 Threats
Chapter 6 Industry Chain Analysis
6.1 Upstream/Suppliers Analysis
6.2 Biologics Safety Testing Analysis
6.2.1 Technology Analysis
6.2.2 Cost Analysis
6.2.3 Market Channel Analysis
6.3 Downstream Buyers/End Users
Chapter 7 Latest Market Dynamics
7.1 Latest News
7.2 Merger and Acquisition
7.3 Planned/Future Project
7.4 Policy Dynamics
Chapter 8 Historical and Forecast Biologics Safety Testing Market in North America (2020-2030)
8.1 Biologics Safety Testing Market Size
8.2 Biologics Safety Testing Market by End Use
8.3 Competition by Players/Suppliers
8.4 Biologics Safety Testing Market Size by Type
8.5 Key Countries Analysis
8.5.1 United States
8.5.2 Canada
8.5.3 Mexico
Chapter 9 Historical and Forecast Biologics Safety Testing Market in South America (2020-2030)
9.1 Biologics Safety Testing Market Size
9.2 Biologics Safety Testing Market by End Use
9.3 Competition by Players/Suppliers
9.4 Biologics Safety Testing Market Size by Type
9.5 Key Countries Analysis
9.5.1 Brazil
9.5.2 Argentina
9.5.3 Chile
9.5.4 Peru
Chapter 10 Historical and Forecast Biologics Safety Testing Market in Asia & Pacific (2020-2030)
10.1 Biologics Safety Testing Market Size
10.2 Biologics Safety Testing Market by End Use
10.3 Competition by Players/Suppliers
10.4 Biologics Safety Testing Market Size by Type
10.5 Key Countries Analysis
10.5.1 China
10.5.2 India
10.5.3 Japan
10.5.4 South Korea
10.5.5 Southeast Asia
10.5.6 Australia
Chapter 11 Historical and Forecast Biologics Safety Testing Market in Europe (2020-2030)
11.1 Biologics Safety Testing Market Size
11.2 Biologics Safety Testing Market by End Use
11.3 Competition by Players/Suppliers
11.4 Biologics Safety Testing Market Size by Type
11.5 Key Countries Analysis
11.5.1 Germany
11.5.2 France
11.5.3 United Kingdom
11.5.4 Italy
11.5.5 Spain
11.5.6 Belgium
11.5.7 Netherlands
11.5.8 Austria
11.5.9 Poland
11.5.10 Russia
Chapter 12 Historical and Forecast Biologics Safety Testing Market in MEA (2020-2030)
12.1 Biologics Safety Testing Market Size
12.2 Biologics Safety Testing Market by End Use
12.3 Competition by Players/Suppliers
12.4 Biologics Safety Testing Market Size by Type
12.5 Key Countries Analysis
12.5.1 Egypt
12.5.2 Israel
12.5.3 South Africa
12.5.4 Gulf Cooperation Council Countries
12.5.5 Turkey
Chapter 13 Summary For Global Biologics Safety Testing Market (2020-2025)
13.1 Biologics Safety Testing Market Size
13.2 Biologics Safety Testing Market by End Use
13.3 Competition by Players/Suppliers
13.4 Biologics Safety Testing Market Size by Type
Chapter 14 Global Biologics Safety Testing Market Forecast (2025-2030)
14.1 Biologics Safety Testing Market Size Forecast
14.2 Biologics Safety Testing Application Forecast
14.3 Competition by Players/Suppliers
14.4 Biologics Safety Testing Type Forecast
Chapter 15 Analysis of Global Key Vendors
15.1 Charles River Laboratories
15.1.1 Company Profile
15.1.2 Main Business and Biologics Safety Testing Information
15.1.3 SWOT Analysis of Charles River Laboratories
15.1.4 Charles River Laboratories Biologics Safety Testing Revenue, Gross Margin and Market Share (2020-2025)
15.2 Lonza
15.2.1 Company Profile
15.2.2 Main Business and Biologics Safety Testing Information
15.2.3 SWOT Analysis of Lonza
15.2.4 Lonza Biologics Safety Testing Revenue, Gross Margin and Market Share (2020-2025)
15.3 Thermo Fisher Scientific
15.3.1 Company Profile
15.3.2 Main Business and Biologics Safety Testing Information
15.3.3 SWOT Analysis of Thermo Fisher Scientific
15.3.4 Thermo Fisher Scientific Biologics Safety Testing Revenue, Gross Margin and Market Share (2020-2025)
15.4 Merck
15.4.1 Company Profile
15.4.2 Main Business and Biologics Safety Testing Information
15.4.3 SWOT Analysis of Merck
15.4.4 Merck Biologics Safety Testing Revenue, Gross Margin and Market Share (2020-2025)
15.5 SGS
15.5.1 Company Profile
15.5.2 Main Business and Biologics Safety Testing Information
15.5.3 SWOT Analysis of SGS
15.5.4 SGS Biologics Safety Testing Revenue, Gross Margin and Market Share (2020-2025)
15.6 Eurofins Scientific
15.6.1 Company Profile
15.6.2 Main Business and Biologics Safety Testing Information
15.6.3 SWOT Analysis of Eurofins Scientific
15.6.4 Eurofins Scientific Biologics Safety Testing Revenue, Gross Margin and Market Share (2020-2025)
15.7 Sartorius
15.7.1 Company Profile
15.7.2 Main Business and Biologics Safety Testing Information
15.7.3 SWOT Analysis of Sartorius
15.7.4 Sartorius Biologics Safety Testing Revenue, Gross Margin and Market Share (2020-2025)
15.8 Samsung BioLogics
15.8.1 Company Profile
15.8.2 Main Business and Biologics Safety Testing Information
15.8.3 SWOT Analysis of Samsung BioLogics
15.8.4 Samsung BioLogics Biologics Safety Testing Revenue, Gross Margin and Market Share (2020-2025)
15.9 WuXi Biologics
15.9.1 Company Profile
15.9.2 Main Business and Biologics Safety Testing Information
15.9.3 SWOT Analysis of WuXi Biologics
15.9.4 WuXi Biologics Biologics Safety Testing Revenue, Gross Margin and Market Share (2020-2025)
List of Tables and Figures
Table Abbreviation and Acronyms
Table Research Scope of Biologics Safety Testing Report
Table Data Sources of Biologics Safety Testing Report
Table Major Assumptions of Biologics Safety Testing Report
Figure Market Size Estimated Method
Figure Major Forecasting Factors
Figure Biologics Safety Testing Picture
Table Biologics Safety Testing Classification
Table Biologics Safety Testing Applications
Table Drivers of Biologics Safety Testing Market
Table Restraints of Biologics Safety Testing Market
Table Opportunities of Biologics Safety Testing Market
Table Threats of Biologics Safety Testing Market
Table COVID-19 Impact For Biologics Safety Testing Market
Table Raw Materials Suppliers
Table Different Production Methods of Biologics Safety Testing
Table Cost Structure Analysis of Biologics Safety Testing
Table Key End Users
Table Latest News of Biologics Safety Testing Market
Table Merger and Acquisition
Table Planned/Future Project of Biologics Safety Testing Market
Table Policy of Biologics Safety Testing Market
Table 2020-2030 North America Biologics Safety Testing Market Size
Figure 2020-2030 North America Biologics Safety Testing Market Size and CAGR
Table 2020-2030 North America Biologics Safety Testing Market Size by Application
Table 2020-2025 North America Biologics Safety Testing Key Players Revenue
Table 2020-2025 North America Biologics Safety Testing Key Players Market Share
Table 2020-2030 North America Biologics Safety Testing Market Size by Type
Table 2020-2030 United States Biologics Safety Testing Market Size
Table 2020-2030 Canada Biologics Safety Testing Market Size
Table 2020-2030 Mexico Biologics Safety Testing Market Size
Table 2020-2030 South America Biologics Safety Testing Market Size
Figure 2020-2030 South America Biologics Safety Testing Market Size and CAGR
Table 2020-2030 South America Biologics Safety Testing Market Size by Application
Table 2020-2025 South America Biologics Safety Testing Key Players Revenue
Table 2020-2025 South America Biologics Safety Testing Key Players Market Share
Table 2020-2030 South America Biologics Safety Testing Market Size by Type
Table 2020-2030 Brazil Biologics Safety Testing Market Size
Table 2020-2030 Argentina Biologics Safety Testing Market Size
Table 2020-2030 Chile Biologics Safety Testing Market Size
Table 2020-2030 Peru Biologics Safety Testing Market Size
Table 2020-2030 Asia & Pacific Biologics Safety Testing Market Size
Figure 2020-2030 Asia & Pacific Biologics Safety Testing Market Size and CAGR
Table 2020-2030 Asia & Pacific Biologics Safety Testing Market Size by Application
Table 2020-2025 Asia & Pacific Biologics Safety Testing Key Players Revenue
Table 2020-2025 Asia & Pacific Biologics Safety Testing Key Players Market Share
Table 2020-2030 Asia & Pacific Biologics Safety Testing Market Size by Type
Table 2020-2030 China Biologics Safety Testing Market Size
Table 2020-2030 India Biologics Safety Testing Market Size
Table 2020-2030 Japan Biologics Safety Testing Market Size
Table 2020-2030 South Korea Biologics Safety Testing Market Size
Table 2020-2030 Southeast Asia Biologics Safety Testing Market Size
Table 2020-2030 Australia Biologics Safety Testing Market Size
Table 2020-2030 Europe Biologics Safety Testing Market Size
Figure 2020-2030 Europe Biologics Safety Testing Market Size and CAGR
Table 2020-2030 Europe Biologics Safety Testing Market Size by Application
Table 2020-2025 Europe Biologics Safety Testing Key Players Revenue
Table 2020-2025 Europe Biologics Safety Testing Key Players Market Share
Table 2020-2030 Europe Biologics Safety Testing Market Size by Type
Table 2020-2030 Germany Biologics Safety Testing Market Size
Table 2020-2030 France Biologics Safety Testing Market Size
Table 2020-2030 United Kingdom Biologics Safety Testing Market Size
Table 2020-2030 Italy Biologics Safety Testing Market Size
Table 2020-2030 Spain Biologics Safety Testing Market Size
Table 2020-2030 Belgium Biologics Safety Testing Market Size
Table 2020-2030 Netherlands Biologics Safety Testing Market Size
Table 2020-2030 Austria Biologics Safety Testing Market Size
Table 2020-2030 Poland Biologics Safety Testing Market Size
Table 2020-2030 Russia Biologics Safety Testing Market Size
Table 2020-2030 MEA Biologics Safety Testing Market Size
Figure 2020-2030 MEA Biologics Safety Testing Market Size and CAGR
Table 2020-2030 MEA Biologics Safety Testing Market Size by Application
Table 2020-2025 MEA Biologics Safety Testing Key Players Revenue
Table 2020-2025 MEA Biologics Safety Testing Key Players Market Share
Table 2020-2030 MEA Biologics Safety Testing Market Size by Type
Table 2020-2030 Egypt Biologics Safety Testing Market Size
Table 2020-2030 Israel Biologics Safety Testing Market Size
Table 2020-2030 South Africa Biologics Safety Testing Market Size
Table 2020-2030 Gulf Cooperation Council Countries Biologics Safety Testing Market Size
Table 2020-2030 Turkey Biologics Safety Testing Market Size
Table 2020-2025 Global Biologics Safety Testing Market Size by Region
Table 2020-2025 Global Biologics Safety Testing Market Size Share by Region
Table 2020-2025 Global Biologics Safety Testing Market Size by Application
Table 2020-2025 Global Biologics Safety Testing Market Share by Application
Table 2020-2025 Global Biologics Safety Testing Key Vendors Revenue
Figure 2020-2025 Global Biologics Safety Testing Market Size and Growth Rate
Table 2020-2025 Global Biologics Safety Testing Key Vendors Market Share
Table 2020-2025 Global Biologics Safety Testing Market Size by Type
Table 2020-2025 Global Biologics Safety Testing Market Share by Type
Table 2025-2030 Global Biologics Safety Testing Market Size by Region
Table 2025-2030 Global Biologics Safety Testing Market Size Share by Region
Table 2025-2030 Global Biologics Safety Testing Market Size by Application
Table 2025-2030 Global Biologics Safety Testing Market Share by Application
Table 2025-2030 Global Biologics Safety Testing Key Vendors Revenue
Figure 2025-2030 Global Biologics Safety Testing Market Size and Growth Rate
Table 2025-2030 Global Biologics Safety Testing Key Vendors Market Share
Table 2025-2030 Global Biologics Safety Testing Market Size by Type
Table 2025-2030 Biologics Safety Testing Global Market Share by Type

Companies Mentioned

  • Charles River Laboratories
  • Lonza
  • Thermo Fisher Scientific
  • Merck
  • SGS
  • Eurofins Scientific
  • Sartorius
  • Samsung BioLogics
  • WuXi Biologics

Related Topics

Related Reports

Biologics Safety Testing Market by Product & Service (Consumables, Instrument, Services), Test Type (Mycoplasma, Sterility, Endotoxin, Bioburden, Virus Safety), Application (Vaccines, mAbs, Cell & Gene Therapy, Blood Products) - Forecast to 2029 - Product Image

Biologics Safety Testing Market by Product & Service (Consumables, Instrument, Services), Test Type (Mycoplasma, Sterility, Endotoxin, Bioburden, Virus Safety), Application (Vaccines, mAbs, Cell & Gene Therapy, Blood Products) - Forecast to 2029

  • Report
  • 387 Pages
  • Global
From
Biologics Safety Testing Market by Product, Test Type, Application, End-User - Global Forecast 2025-2030 - Product Image

Biologics Safety Testing Market by Product, Test Type, Application, End-User - Global Forecast 2025-2030

  • Report
  • 187 Pages
  • Global
From
Biologics Safety Testing - Global Strategic Business Report - Product Image

Biologics Safety Testing - Global Strategic Business Report

  • Report
  • 182 Pages
  • Global
From
Biologics Testing Global Market Report 2024 - Product Image

Biologics Testing Global Market Report 2024

  • Report
  • 200 Pages
  • Global
From
Biologics Safety Testing Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2031 - By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa) - Product Image

Biologics Safety Testing Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2031 - By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa)

  • Report
  • 170 Pages
  • Global
From
Copyright © 2002-2025 Research and Markets. All Rights Reserved.