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

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:

• Services

o Sterility Testing Services

Mycoplasma Testing Services

Endotoxin Testing Services

Bioburden Testing Services

Virus Safety Testing Services

Others

• Consumables

o Reagents and Kits

• Instruments

By Application:

• Vaccines & Therapeutics
• Cellular & Gene Therapy
• Blood & Blood-based Therapy
• Others

By End-user:

• Pharmaceutical & Biopharmaceutical Companies
• Research Institutions
• Others

By Region:

• North America

o U.S.

Canada

• Europe

o Germany

U.K.

France

Russia

Italy

Spain

Netherlands

Rest of Europe

• Asia Pacific

o China

India

Japan

Australia

Indonesia

Malaysia

South Korea

Rest of Asia Pacific

• Latin America

o Brazil

Mexico

Argentina

Rest of Latin America

• Middle East & Africa

o GCC

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.

FAQs:

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