Global Biological Safety Testing Products and Services Market Size Study, By Product, By Application, By Test Type, and Regional Forecasts 2022-2032

Description

The global biological safety testing products and services market was valued at approximately USD 4.57 billion in 2023 and is anticipated to expand at a CAGR of 10.7% over the forecast period 2024-2032. Increasing demand for biologics, vaccines, and gene therapy products has propelled the need for stringent safety evaluations, fostering the adoption of biological safety testing solutions. As regulatory authorities impose rigorous safety standards for pharmaceutical and biopharmaceutical products, the demand for innovative testing methodologies is increasing.

Biological safety testing ensures that pharmaceutical and biologics manufacturing processes remain free from contamination. Rising government funding and private investments in drug development, coupled with the expansion of biotechnology and pharmaceutical industries, have further boosted the adoption of advanced biological safety testing methods. Companies are prioritizing regulatory compliance to mitigate risks associated with microbial contamination, residual host-cell proteins, and endotoxin levels. For instance, in 2023, Charles River Laboratories expanded its safety testing capabilities with enhanced in vitro testing solutions, catering to the evolving needs of biopharmaceutical developers.

Furthermore, the growing focus on personalized medicine and gene therapies has necessitated advanced biological safety testing protocols. The rise in cell-based therapies and monoclonal antibodies (mAbs) has heightened concerns regarding product integrity, sterility, and safety. Regulatory bodies such as the FDA, EMA, and WHO have implemented stringent guidelines requiring robust biological safety testing at various stages of development and manufacturing. Technological advancements, including CRISPR-based testing methods and next-generation sequencing (NGS), have further enhanced testing accuracy and efficiency.

Despite these positive trends, high costs associated with biological safety testing instruments and services remain a challenge for small and mid-sized biopharmaceutical firms. However, ongoing technological advancements, the emergence of AI-driven biosafety solutions, and the increasing integration of automated testing platforms are expected to reduce operational costs over time. Additionally, market players are focusing on expanding their service portfolios through acquisitions and strategic partnerships. In January 2023, Thermo Fisher Scientific acquired a major stake in a biosafety testing service provider to enhance its global presence and strengthen its regulatory compliance capabilities.

Major Market Players Included in this Report Are:

Charles River Laboratories
Thermo Fisher Scientific Inc.
Merck KGaA (MilliporeSigma)
Lonza
Eurofins Scientific
SGS Societe Generale de Surveillance SA
Samsung Biologics
Sartorius AG
BIOMERIEUX
BSL Bioservice
FUJIFILM Diosynth Biotechnologies
Nelson Labs
Wuxi AppTec
Cytovance Biologics
StemExpress

The Detailed Segments and Sub-segments of the Market are Explained Below:

By Product:

Reagents & Kits
Instruments
Services

By Application:

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

By Test Type:

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

By Region:

North America
U.S.
Canada
Europe
UK
Germany
France
Italy
Spain
Denmark
Sweden
Norway
Asia Pacific
Japan
China
India
South Korea
Australia
Thailand
Latin America
Brazil
Mexico
Argentina
Middle East & Africa
South Africa
Saudi Arabia
UAE
Kuwait

Years considered for the study are as follows:

Historical Year - 2022
Base Year - 2023
Forecast Period - 2024 to 2032

Key Takeaways:

Market Estimates & Forecast for 10 years (2022-2032)
Annualized revenues & regional-level analysis for each market segment
Geographical landscape analysis with country-level market insights
Competitive landscape with information on major market players
Key business strategies & investment recommendations
Competitive structure & demand-supply analysis
Comprehensive regulatory framework overview impacting market growth

Chapter 1. Global Biological Safety Testing Products and Services Market Executive Summary

1.1. Global Market Size & Forecast (2022-2032)
1.2. Regional Summary
1.3. Segmental Summary
- 1.3.1. By Product
- 1.3.2. By Application
- 1.3.3. By Test Type
1.4. Key Market Trends
1.5. Recession Impact Analysis
1.6. Analyst Recommendation & Conclusion

Chapter 2. Global Biological Safety Testing Products and Services Market Definition and Research Assumptions

2.1. Research Objective
2.2. Market Definition
2.3. Research Assumptions
- 2.3.1. Inclusion & Exclusion
- 2.3.2. Limitations
- 2.3.3. Supply Side Analysis
  - 2.3.3.1. Availability
  - 2.3.3.2. Infrastructure
  - 2.3.3.3. Regulatory Environment
  - 2.3.3.4. Market Competition
  - 2.3.3.5. Economic Viability (Consumer's Perspective)
- 2.3.4. Demand Side Analysis
  - 2.3.4.1. Regulatory Frameworks
  - 2.3.4.2. Technological Advancements
  - 2.3.4.3. Environmental Considerations
  - 2.3.4.4. Consumer Awareness & Acceptance
2.4. Estimation Methodology
2.5. Years Considered for the Study
2.6. Currency Conversion Rates

Chapter 3. Global Biological Safety Testing Products and Services Market Dynamics

3.1. Market Drivers
- 3.1.1. Rising demand for biologics and biosimilars
- 3.1.2. Stringent regulatory policies for pharmaceutical safety
- 3.1.3. Growing investment in biopharmaceutical R&D
3.2. Market Challenges
- 3.2.1. High costs associated with biological safety testing
- 3.2.2. Complexities in biologics testing and regulatory approvals
3.3. Market Opportunities
- 3.3.1. Advancements in genetic and cell-based assays
- 3.3.2. Emerging markets in Asia-Pacific driving demand

Chapter 4. Global Biological Safety Testing Products and Services Market Industry Analysis

4.1. Porter's Five Forces Model
- 4.1.1. Bargaining Power of Suppliers
- 4.1.2. Bargaining Power of Buyers
- 4.1.3. Threat of New Entrants
- 4.1.4. Threat of Substitutes
- 4.1.5. Competitive Rivalry
- 4.1.6. Futuristic Approach to Porter's Five Forces Model
- 4.1.7. Porter's Five Forces Impact Analysis
4.2. PESTEL Analysis
- 4.2.1. Political Factors
- 4.2.2. Economic Factors
- 4.2.3. Social Factors
- 4.2.4. Technological Factors
- 4.2.5. Environmental Factors
- 4.2.6. Legal Factors
4.3. Top Investment Opportunities
4.4. Top Winning Strategies
4.5. Disruptive Trends in Biological Safety Testing
4.6. Industry Expert Perspectives
4.7. Analyst Recommendation & Conclusion

Chapter 5. Global Biological Safety Testing Products and Services Market Size & Forecasts by Product (2022-2032)

5.1. Segment Dashboard
5.2. Global Market: Product Revenue Trend Analysis (2022 & 2032)
- 5.2.1. Reagents & Kits
- 5.2.2. Instruments
- 5.2.3. Services

Chapter 6. Global Biological Safety Testing Products and Services Market Size & Forecasts by Application (2022-2032)

6.1. Segment Dashboard
6.2. Global Market: Application Revenue Trend Analysis (2022 & 2032)
- 6.2.1. Vaccines & Therapeutics
  - 6.2.1.1. Vaccines
  - 6.2.1.2. Monoclonal Antibodies
  - 6.2.1.3. Recombinant Protein
- 6.2.2. Blood & Blood-based Products
- 6.2.3. Gene Therapy
- 6.2.4. Tissue & Tissue-based Products
- 6.2.5. Stem Cell Therapy

Chapter 7. Global Biological Safety Testing Products and Services Market Size & Forecasts by Test Type (2022-2032)

7.1. Segment Dashboard
7.2. Global Market: Test Type Revenue Trend Analysis (2022 & 2032)
- 7.2.1. Endotoxin Tests
- 7.2.2. Sterility Tests
- 7.2.3. Cell Line Authentication & Characterization Tests
- 7.2.4. Bioburden Tests
- 7.2.5. Adventitious Agent Detection Tests
- 7.2.6. Residual Host Contamination Detection Tests
- 7.2.7. Others

Chapter 8. Global Biological Safety Testing Products and Services Market Size & Forecasts by Region (2022-2032)

8.1. North America Market
- 8.1.1. U.S. Market
- 8.1.2. Canada Market
8.2. Europe Market
- 8.2.1. UK Market
- 8.2.2. Germany Market
- 8.2.3. France Market
- 8.2.4. Italy Market
- 8.2.5. Spain Market
- 8.2.6. Denmark Market
- 8.2.7. Sweden Market
- 8.2.8. Norway Market
8.3. Asia-Pacific Market
- 8.3.1. Japan Market
- 8.3.2. China Market
- 8.3.3. India Market
- 8.3.4. South Korea Market
- 8.3.5. Australia Market
- 8.3.6. Thailand Market
8.4. Latin America Market
- 8.4.1. Brazil Market
- 8.4.2. Mexico Market
- 8.4.3. Argentina Market
8.5. Middle East & Africa Market
- 8.5.1. South Africa Market
- 8.5.2. Saudi Arabia Market
- 8.5.3. UAE Market
- 8.5.4. Kuwait Market

Chapter 9. Competitive Intelligence

9.1. Key Company SWOT Analysis
- 9.1.1. Charles River Laboratories
- 9.1.2. Merck KGaA
- 9.1.3. Thermo Fisher Scientific Inc.
9.2. Top Market Strategies
9.3. Company Profiles
- 9.3.1. Charles River Laboratories
- 9.3.2. BSL Bioservice
- 9.3.3. Merck KGaA (MilliporeSigma)
- 9.3.4. Samsung Biologics
- 9.3.5. Sartorius AG
- 9.3.6. Eurofins Scientific
- 9.3.7. SGS Societe Generale de Surveillance SA
- 9.3.8. Thermo Fisher Scientific Inc.
- 9.3.9. BIOMERIEUX
- 9.3.10. Lonza

Chapter 10. Research Process

10.1. Research Process Overview
- 10.1.1. Data Mining
- 10.1.2. Analysis
- 10.1.3. Market Estimation
- 10.1.4. Validation
- 10.1.5. Publishing
10.2. Research Attributes