Biological Safety Testing Products and Services Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product, By Application, By Test Type, By Region and Competition, 2020-2030F

Description

The Global Biological Safety Testing Products and Services Market, valued at USD 4.77 Billion in 2024, is projected to experience a CAGR of 9.32% to reach USD 8.14 Billion by 2030. The Global Biological Safety Testing Products and Services Market encompasses assays, reagents, instruments, and contract testing services crucial for ensuring the purity, potency, and safety of biological products such as vaccines, gene therapies, and biopharmaceuticals throughout their development and manufacturing lifecycle. The market's growth is primarily driven by the increasing complexity of advanced therapeutic modalities, stringent global regulatory mandates for biopharmaceutical approval, and the expanding pipeline of new biologics and biosimilars.

Market Overview
Forecast Period	2026-2030
Market Size 2024	USD 4.77 Billion
Market Size 2030	USD 8.14 Billion
CAGR 2025-2030	9.32%
Fastest Growing Segment	Reagents & Kits
Largest Market	North America

Key Market Drivers

The expanding pipeline of cell and gene therapies and stringent global regulatory requirements for biologics represent two pivotal drivers for the Global Biological Safety Testing Products and Services Market. The increasing proliferation of novel advanced therapeutic modalities, particularly cell and gene therapies, inherently demands extensive and specialized safety assessments throughout their development and manufacturing. These therapies involve complex biological constructs that necessitate rigorous testing to ensure product purity, potency, and freedom from adventitious agents. According to the Alliance for Regenerative Medicine's annual Cell & Gene State of the Industry Briefing, in January 2024, seven cell and gene therapies received FDA approval in the U. S. in 2023, with predictions for up to 17 approvals in the U.S. and EU in 2024.

Key Market Challenges

The substantial capital expenditure required for establishing and maintaining advanced testing infrastructure presents a significant impediment to the growth of the Global Biological Safety Testing Products and Services Market. This financial barrier limits the ability of new service providers to enter the market and hinders existing firms from expanding their capabilities or upgrading to the latest technologies. Developing and equipping laboratories with advanced assays, reagents, and instruments for complex biological product analysis demands considerable upfront investment, directly constraining the overall capacity available to meet increasing industry demand for safety assessments.

Key Market Trends

The Global Biological Safety Testing Products and Services Market is significantly shaped by advancements in rapid and high-throughput testing technologies. These innovations address the critical industry need for accelerated development timelines and increased efficiency in assessing biological product safety. The integration of advanced platforms, such as next-generation sequencing and automated systems, allows for faster detection of contaminants and more comprehensive characterization of complex biologics.

Key Market Players

Charles River Laboratories International, Inc.
BSL Bioservice Scientific Laboratories Munich GmbH
Merck KGaA
Samsung Biologics
Sartorius AG
Eurofins Scientific (Ireland) Limited
SGS Societe Generale de Surveillance SA
Thermo Fisher Scientific Inc.
BIOMERIEUX SA
Lonza Group Ltd.

Report Scope:

In this report, the Global Biological Safety Testing Products and Services Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Biological Safety Testing Products and Services Market, By Product:

Reagents & Kits
Services
Instruments

Biological Safety Testing Products and Services Market, By Application:

Vaccines & Therapeutics
Gene Therapy
Monoclonal Antibodies
Recombinant Protein
Blood & Blood-based Products
Tissue & Tissue-based Products
Stem Cells

Biological Safety Testing Products and Services Market, By Test Type:

Endotoxin Tests
Sterility Tests
Cell Line Authentication & Characterization Tests
Bioburden Tests
Adventitious Agent Detection Tests
Residual Host Contamination Detection Tests
Others

Biological Safety Testing Products and Services Market, By Region:

North America
- United States
- Canada
- Mexico
Europe
- France
- United Kingdom
- Italy
- Germany
- Spain
Asia Pacific
- China
- India
- Japan
- Australia
- South Korea
South America
- Brazil
- Argentina
- Colombia
Middle East & Africa
- South Africa
- Saudi Arabia
- UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Biological Safety Testing Products and Services Market.

Available Customizations:

Global Biological Safety Testing Products and Services Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

1. Product Overview

1.1. Market Definition
1.2. Scope of the Market
- 1.2.1. Markets Covered
- 1.2.2. Years Considered for Study
- 1.2.3. Key Market Segmentations

2. Research Methodology

2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations

3. Executive Summary

3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Biological Safety Testing Products and Services Market Outlook

5.1. Market Size & Forecast
- 5.1.1. By Value
5.2. Market Share & Forecast
- 5.2.1. By Product (Reagents & Kits, Services, Instruments)
- 5.2.2. By Application (Vaccines & Therapeutics, Gene Therapy, Monoclonal Antibodies, Recombinant Protein, Blood & Blood-based Products, Tissue & Tissue-based Products, Stem Cells)
- 5.2.3. By Test Type (Endotoxin Tests, Sterility Tests, Cell Line Authentication & Characterization Tests, Bioburden Tests, Adventitious Agent Detection Tests, Residual Host Contamination Detection Tests, Others)
- 5.2.4. By Region
- 5.2.5. By Company (2024)
5.3. Market Map

6. North America Biological Safety Testing Products and Services Market Outlook

6.1. Market Size & Forecast
- 6.1.1. By Value
6.2. Market Share & Forecast
- 6.2.1. By Product
- 6.2.2. By Application
- 6.2.3. By Test Type
- 6.2.4. By Country
6.3. North America: Country Analysis
- 6.3.1. United States Biological Safety Testing Products and Services Market Outlook
  - 6.3.1.1. Market Size & Forecast
    - 6.3.1.1.1. By Value
  - 6.3.1.2. Market Share & Forecast
    - 6.3.1.2.1. By Product
    - 6.3.1.2.2. By Application
    - 6.3.1.2.3. By Test Type
- 6.3.2. Canada Biological Safety Testing Products and Services Market Outlook
  - 6.3.2.1. Market Size & Forecast
    - 6.3.2.1.1. By Value
  - 6.3.2.2. Market Share & Forecast
    - 6.3.2.2.1. By Product
    - 6.3.2.2.2. By Application
    - 6.3.2.2.3. By Test Type
- 6.3.3. Mexico Biological Safety Testing Products and Services Market Outlook
  - 6.3.3.1. Market Size & Forecast
    - 6.3.3.1.1. By Value
  - 6.3.3.2. Market Share & Forecast
    - 6.3.3.2.1. By Product
    - 6.3.3.2.2. By Application
    - 6.3.3.2.3. By Test Type

7. Europe Biological Safety Testing Products and Services Market Outlook

7.1. Market Size & Forecast
- 7.1.1. By Value
7.2. Market Share & Forecast
- 7.2.1. By Product
- 7.2.2. By Application
- 7.2.3. By Test Type
- 7.2.4. By Country
7.3. Europe: Country Analysis
- 7.3.1. Germany Biological Safety Testing Products and Services Market Outlook
  - 7.3.1.1. Market Size & Forecast
    - 7.3.1.1.1. By Value
  - 7.3.1.2. Market Share & Forecast
    - 7.3.1.2.1. By Product
    - 7.3.1.2.2. By Application
    - 7.3.1.2.3. By Test Type
- 7.3.2. France Biological Safety Testing Products and Services Market Outlook
  - 7.3.2.1. Market Size & Forecast
    - 7.3.2.1.1. By Value
  - 7.3.2.2. Market Share & Forecast
    - 7.3.2.2.1. By Product
    - 7.3.2.2.2. By Application
    - 7.3.2.2.3. By Test Type
- 7.3.3. United Kingdom Biological Safety Testing Products and Services Market Outlook
  - 7.3.3.1. Market Size & Forecast
    - 7.3.3.1.1. By Value
  - 7.3.3.2. Market Share & Forecast
    - 7.3.3.2.1. By Product
    - 7.3.3.2.2. By Application
    - 7.3.3.2.3. By Test Type
- 7.3.4. Italy Biological Safety Testing Products and Services Market Outlook
  - 7.3.4.1. Market Size & Forecast
    - 7.3.4.1.1. By Value
  - 7.3.4.2. Market Share & Forecast
    - 7.3.4.2.1. By Product
    - 7.3.4.2.2. By Application
    - 7.3.4.2.3. By Test Type
- 7.3.5. Spain Biological Safety Testing Products and Services Market Outlook
  - 7.3.5.1. Market Size & Forecast
    - 7.3.5.1.1. By Value
  - 7.3.5.2. Market Share & Forecast
    - 7.3.5.2.1. By Product
    - 7.3.5.2.2. By Application
    - 7.3.5.2.3. By Test Type

8. Asia Pacific Biological Safety Testing Products and Services Market Outlook

8.1. Market Size & Forecast
- 8.1.1. By Value
8.2. Market Share & Forecast
- 8.2.1. By Product
- 8.2.2. By Application
- 8.2.3. By Test Type
- 8.2.4. By Country
8.3. Asia Pacific: Country Analysis
- 8.3.1. China Biological Safety Testing Products and Services Market Outlook
  - 8.3.1.1. Market Size & Forecast
    - 8.3.1.1.1. By Value
  - 8.3.1.2. Market Share & Forecast
    - 8.3.1.2.1. By Product
    - 8.3.1.2.2. By Application
    - 8.3.1.2.3. By Test Type
- 8.3.2. India Biological Safety Testing Products and Services Market Outlook
  - 8.3.2.1. Market Size & Forecast
    - 8.3.2.1.1. By Value
  - 8.3.2.2. Market Share & Forecast
    - 8.3.2.2.1. By Product
    - 8.3.2.2.2. By Application
    - 8.3.2.2.3. By Test Type
- 8.3.3. Japan Biological Safety Testing Products and Services Market Outlook
  - 8.3.3.1. Market Size & Forecast
    - 8.3.3.1.1. By Value
  - 8.3.3.2. Market Share & Forecast
    - 8.3.3.2.1. By Product
    - 8.3.3.2.2. By Application
    - 8.3.3.2.3. By Test Type
- 8.3.4. South Korea Biological Safety Testing Products and Services Market Outlook
  - 8.3.4.1. Market Size & Forecast
    - 8.3.4.1.1. By Value
  - 8.3.4.2. Market Share & Forecast
    - 8.3.4.2.1. By Product
    - 8.3.4.2.2. By Application
    - 8.3.4.2.3. By Test Type
- 8.3.5. Australia Biological Safety Testing Products and Services Market Outlook
  - 8.3.5.1. Market Size & Forecast
    - 8.3.5.1.1. By Value
  - 8.3.5.2. Market Share & Forecast
    - 8.3.5.2.1. By Product
    - 8.3.5.2.2. By Application
    - 8.3.5.2.3. By Test Type

9. Middle East & Africa Biological Safety Testing Products and Services Market Outlook

9.1. Market Size & Forecast
- 9.1.1. By Value
9.2. Market Share & Forecast
- 9.2.1. By Product
- 9.2.2. By Application
- 9.2.3. By Test Type
- 9.2.4. By Country
9.3. Middle East & Africa: Country Analysis
- 9.3.1. Saudi Arabia Biological Safety Testing Products and Services Market Outlook
  - 9.3.1.1. Market Size & Forecast
    - 9.3.1.1.1. By Value
  - 9.3.1.2. Market Share & Forecast
    - 9.3.1.2.1. By Product
    - 9.3.1.2.2. By Application
    - 9.3.1.2.3. By Test Type
- 9.3.2. UAE Biological Safety Testing Products and Services Market Outlook
  - 9.3.2.1. Market Size & Forecast
    - 9.3.2.1.1. By Value
  - 9.3.2.2. Market Share & Forecast
    - 9.3.2.2.1. By Product
    - 9.3.2.2.2. By Application
    - 9.3.2.2.3. By Test Type
- 9.3.3. South Africa Biological Safety Testing Products and Services Market Outlook
  - 9.3.3.1. Market Size & Forecast
    - 9.3.3.1.1. By Value
  - 9.3.3.2. Market Share & Forecast
    - 9.3.3.2.1. By Product
    - 9.3.3.2.2. By Application
    - 9.3.3.2.3. By Test Type

10. South America Biological Safety Testing Products and Services Market Outlook

10.1. Market Size & Forecast
- 10.1.1. By Value
10.2. Market Share & Forecast
- 10.2.1. By Product
- 10.2.2. By Application
- 10.2.3. By Test Type
- 10.2.4. By Country
10.3. South America: Country Analysis
- 10.3.1. Brazil Biological Safety Testing Products and Services Market Outlook
  - 10.3.1.1. Market Size & Forecast
    - 10.3.1.1.1. By Value
  - 10.3.1.2. Market Share & Forecast
    - 10.3.1.2.1. By Product
    - 10.3.1.2.2. By Application
    - 10.3.1.2.3. By Test Type
- 10.3.2. Colombia Biological Safety Testing Products and Services Market Outlook
  - 10.3.2.1. Market Size & Forecast
    - 10.3.2.1.1. By Value
  - 10.3.2.2. Market Share & Forecast
    - 10.3.2.2.1. By Product
    - 10.3.2.2.2. By Application
    - 10.3.2.2.3. By Test Type
- 10.3.3. Argentina Biological Safety Testing Products and Services Market Outlook
  - 10.3.3.1. Market Size & Forecast
    - 10.3.3.1.1. By Value
  - 10.3.3.2. Market Share & Forecast
    - 10.3.3.2.1. By Product
    - 10.3.3.2.2. By Application
    - 10.3.3.2.3. By Test Type

11. Market Dynamics

11.1. Drivers
11.2. Challenges

12. Market Trends & Developments

12.1. Merger & Acquisition (If Any)
12.2. Product Launches (If Any)
12.3. Recent Developments

13. Global Biological Safety Testing Products and Services Market: SWOT Analysis

14. Porter's Five Forces Analysis

14.1. Competition in the Industry
14.2. Potential of New Entrants
14.3. Power of Suppliers
14.4. Power of Customers
14.5. Threat of Substitute Products

15. Competitive Landscape

15.1. Charles River Laboratories International, Inc.
- 15.1.1. Business Overview
- 15.1.2. Products & Services
- 15.1.3. Recent Developments
- 15.1.4. Key Personnel
- 15.1.5. SWOT Analysis
15.2. BSL Bioservice Scientific Laboratories Munich GmbH
15.3. Merck KGaA
15.4. Samsung Biologics
15.5. Sartorius AG
15.6. Eurofins Scientific (Ireland) Limited
15.7. SGS Societe Generale de Surveillance SA
15.8. Thermo Fisher Scientific Inc.
15.9. BIOMERIEUX SA
15.10. Lonza Group Ltd.