Biological Safety Testing Market: Global Market Estimation, Dynamics, Regional Share, Trends, Competitor Analysis (2017-2021) and Forecast (2022-2028)

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Biological Safety Testing Market: By Product Type Analysis (Kits and Reagents, Services and Instruments),By Test Type Analysis(Endotoxin Tests, Sterility Tests, Cell Line Authentication and Characterization Tests, Bioburden Tests, Residual Host Contaminant Detection Tests, Adventitious Agent Detection Tests and Other Tests),By Application Analysis(Vaccine & Therapeutics Development, Blood and Blood-Related Products Testing, Cellular and Gene Therapy, Tissue and Tissue-Related Products Testing and Stem Cell Research), and Geography

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Report

Description

Biological Safety Testing Market size is valued at USD 3,520.0 million in 2021 and is expected to reach a value of USD 8,541.5 million by 2028, growing at a CAGR of 13.5% during the forecast period 2022 to 2028. The global market provides a detailed overview of the biological safety testing market and that can be segmented by product type, application type, and test type. By product type, the biological safety testing market has been segmented into kits and reagents, services, and instruments. The kits and reagents segment is likely to be the largest and fastest-growing segment in terms of product type. Based on test type, the biological safety testing market is segmented into endotoxin tests, sterility tests, cell line authentication and characterization tests, bioburden tests, residual host contaminant detection tests, adventitious agent detection tests, and other tests.  Among these, the bioburden tests segment is expected to have the fastest-growing market during the forecast period 2022-2028. On the basis of application, the market is segregated into vaccine & therapeutics development, blood and blood-related product testing, cellular and gene therapy, tissue and tissue-related product testing, and stem cell research. Vaccine & therapeutics development is likely to be the fastest-growing segment in the market.

Key Developments:

In 2021, EndoScan-V, a verified endotoxin detection and measurement software used to generate and report quantitative test data, has been released by Charles River Laboratories, Inc. (US). The software took the necessary measurements and calculations and generated test results, which could be approved with a digital signature.

Biological Safety Testing Market

MARKET SUMMARY
-
13.5%
  • Study Period– 2022-2028
  • Base Year– 2021
  • CAGR– 13.5%
  • Largest Market– Europe
  • Fastest Growing Market– Asia Pacific

Biological Safety Testing Market

  • The biological safety testing market report gives comprehensive outlook across the region with special emphasis on key regions such as North America, Europe, Asia Pacific, Latin America and Middle East and Africa.
  • The biological safety testing market is segmented based on product type, application, test type and geography.
Key Players
  • Pace Analytical Services Inc
  • Toxikon Corporation
  • Eurofins Scientific Se
  • Avance Biosciences Inc
  • Source Bioscience
Biological Safety Testing Market Drivers

Pharmaceutical companies are taking several steps to ensure the safety of focused and specific medications, as well as to avoid potential flaws and assess their outcomes. Pharmaceutical and biotechnology industries are using biological safety assessment methods in response to the rising demand for high manufacturing efficiency. For a variety of target disorders, these tools and kits provide very accurate assessments and results. Increasing regulatory authorities’ influence on biopharma companies’ implementation of safety requirements, combined with increased consumer awareness, will reinforce biological safety testing.


Asia-Pacific Got Significant Share

Biological Safety Testing Market

Asia Pacific market is expected to witness the highest market share during the forecast period. The growth is due to rising healthcare spending and increased knowledge of the products' benefits. North America held a considerable market share during the estimated period owing to increasing biotechnology investment, increased cancer research uptake, and the creation of new biologics, vaccines, and medicines Furthermore, one of the elements driving growth is the increasing quantity of R&D investments made by businesses.

Latin America
Latin-America
North-America
North-America
Europe
Europe
Asia Pacific
Asia-Pacific
Middle East
Middle East

Key

Features of the Report

  • The biological safety testing market report provides granular level information about the market size, regional market share, historic market (2017-2021) and forecast (2022-2028)
  • The biological safety testing market report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The biological safety testing market report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The biological safety testing market report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The biological safety testing market report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
Biological Safety Testing Market Segmentation


Location

GEOGRAPHY

Frequently Asked Questions

The Biological Safety Testing Market is projected to expand at a CAGR of 13.5% during the forecast period.

The major players in the global biological safety testing market are Charles River Laboratories International, Inc., Merck KGaA, Lonza Group LTD, SGS SA, Thermo Fisher Scientific Inc, Wuxi Apptec, Sartorius AG, Cytovance Biologics, Inc, Pace Analytical Services Inc, Toxikon Corporation, Eurofins Scientific Se, Avance Biosciences Inc, and Source Biosciences.

Asia Pacific is the fastest-growing region for Biological Safety Testing Market


Report

Table Of Content

1. Executive Summary
2. Global Biological Safety Testing Market Introduction
2.1. Global Biological Safety Testing Market – Taxonomy
2.2. Global Biological Safety Testing Market –Definitions
2.2.1. By Product Type
2.2.2. By Application Type
2.2.3. By Test Type
2.2.4. By Region
3. Global Biological Safety Testing Market Dynamics
3.1. Drivers
3.2. Restraints
3.3. Opportunities/Unmet Needs of the Market
3.4. Trends
3.5. Global Biological Safety Testing Market Dynamic Factors – Impact Analysis
3.6. Global Biological Safety Testing Market – Competition Landscape
4. Global Biological Safety Testing Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028
4.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
4.2. Year-over-Year (Y-o-Y) Growth Analysis (%)
4.3. Market Opportunity Analysis
5. Global Biological Safety Testing Market, By Product, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
5.1. Kits and Reagents
5.1.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
5.1.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
5.1.3. Market Opportunity Analysis
5.2. Services
5.2.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
5.2.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
5.2.3. Market Opportunity Analysis
5.3. Instruments
5.3.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
5.3.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
5.3.3. Market Opportunity Analysis
6. Global Biological Safety Testing Market, By Test Type, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
6.1. Endotoxin Tests
6.1.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
6.1.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
6.1.3. Market Opportunity Analysis
6.2. Sterility Tests
6.2.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
6.2.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
6.2.3. Market Opportunity Analysis
6.3. Cell Line Authentication and Characterization Tests
6.3.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
6.3.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
6.3.3. Market Opportunity Analysis
6.4. Bioburden Tests
6.4.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
6.4.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
6.4.3. Market Opportunity Analysis
6.5. Residual Host Contaminant Detection Tests
6.5.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
6.5.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
6.5.3. Market Opportunity Analysis
6.6. Adventitious Agent Detection Tests
6.6.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
6.6.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
6.6.3. Market Opportunity Analysis
6.7. Other Tests
6.7.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
6.7.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
6.7.3. Market Opportunity Analysis
7. Global Biological Safety Testing Market, By Application, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
7.1. Vaccine & Therapeutics Development
7.1.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
7.1.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
7.1.3. Market Opportunity Analysis
7.2. Blood and Blood-Related Products Testing
7.2.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
7.2.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
7.2.3. Market Opportunity Analysis
7.3. Cellular and Gene Therapy
7.3.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
7.3.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
7.3.3. Market Opportunity Analysis
7.4. Tissue and Tissue-Related Products Testing
7.4.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
7.4.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
7.4.3. Market Opportunity Analysis
7.5. Stem Cell Research
7.5.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
7.5.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
7.5.3. Market Opportunity Analysis
8. Global Biological Safety Testing Market Forecast, By Region, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
8.1. North America
8.1.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
8.1.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
8.1.3. Market Opportunity Analysis
8.2. Europe
8.2.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
8.2.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
8.2.3. Market Opportunity Analysis
8.3. Asia-Pacific
8.3.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
8.3.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
8.3.3. Market Opportunity Analysis
8.4. Latin America
8.4.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
8.4.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
8.4.3. Market Opportunity Analysis
8.5. Middle East and Africa
8.5.1. Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
8.5.2. Year-over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%)
8.5.3. Market Opportunity Analysis
8.6. Global Biological Safety Testing Market – Opportunity Analysis Index, By Application, Application, and Region, 2022 –  2028
9. North America Biological Safety Testing Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
9.1. Product Type Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
9.1.1. Kits and Reagents
9.1.2. Services
9.1.3. Instruments
9.2. Test Type Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
9.2.1. Endotoxin Tests
9.2.2. Sterility Tests
9.2.3. Cell Line Authentication and Characterization Tests
9.2.4. Bioburden Tests
9.2.5. Residual Host Contaminant Detection Tests
9.2.6. Adventitious Agent Detection Tests
9.2.7. Other Tests
9.3. Application Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn), Y-o-Y Growth (%) and Market Share (%)
9.3.1. Vaccine & Therapeutics Development
9.3.2. Blood and Blood-Related Products Testing
9.3.3. Cellular and Gene Therapy
9.3.4. Tissue and Tissue-Related Products Testing
9.3.5. Stem Cell Research
9.4. Country Analysis 2017 –  2021 and Forecast 2022 –  2028  by Revenue (USD Mn) Y-o-Y Growth (%) and Market Share (%)
9.4.1. U.S.
9.4.2. Canada
9.5. North America Biological Safety Testing Market – Opportunity Analysis Index, By Product, By Test, Application, and Country, 2022 –  2028
9.6. North America Biological Safety Testing Market Dynamics – Trends
10. Europe Biological Safety Testing Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn)
10.1. Product Type Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
10.1.1. Kits and Reagents
10.1.2. Services
10.1.3. Instruments
10.2. Test Type Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
10.2.1. Endotoxin Tests
10.2.2. Sterility Tests
10.2.3. Cell Line Authentication and Characterization Tests
10.2.4. Bioburden Tests
10.2.5. Residual Host Contaminant Detection Tests
10.2.6. Adventitious Agent Detection Tests
10.2.7. Other Tests
10.3. Application Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn), Y-o-Y Growth (%) and Market Share (%)
10.3.1. Vaccine & Therapeutics Development
10.3.2. Blood and Blood-Related Products Testing
10.3.3. Cellular and Gene Therapy
10.3.4. Tissue and Tissue-Related Products Testing
10.3.5. Stem Cell Research
10.4. Country Analysis 2017 –  2021 and Forecast 2022 –  2028  by Revenue (USD Mn) Y-o-Y Growth (%) and Market Share (%)
10.4.1. Germany
10.4.2. UK
10.4.3. France
10.4.4. Spain
10.4.5. Italy
10.4.6. Russia
10.4.7. Poland
10.4.8. Rest of Europe
10.5. Europe Biological Safety Testing Market – Opportunity Analysis Index, By Product, By Test, Application, and Country, 2022 –  2028
10.6. Europe Biological Safety Testing Market Dynamics – Trends
11. Asia-Pacific Biological Safety Testing Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
11.1. Product Type Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
11.1.1. Kits and Reagents
11.1.2. Services
11.1.3. Instruments
11.2. Test Type Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
11.2.1. Endotoxin Tests
11.2.2. Sterility Tests
11.2.3. Cell Line Authentication and Characterization Tests
11.2.4. Bioburden Tests
11.2.5. Residual Host Contaminant Detection Tests
11.2.6. Adventitious Agent Detection Tests
11.2.7. Other Tests
11.3. Application Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn), Y-o-Y Growth (%) and Market Share (%)
11.3.1. Vaccine & Therapeutics Development
11.3.2. Blood and Blood-Related Products Testing
11.3.3. Cellular and Gene Therapy
11.3.4. Tissue and Tissue-Related Products Testing
11.3.5. Stem Cell Research
11.4. Country Analysis 2017 –  2021 and Forecast 2022 –  2028  by Revenue (USD Mn) Y-o-Y Growth (%) and Market Share (%)
11.4.1. Japan
11.4.2. China
11.4.3. India
11.4.4. ASEAN
11.4.5. Australia & New Zealand
11.4.6. Rest of Asia-Pacific
11.5. Asia-Pacific Biological Safety Testing Market – Opportunity Analysis Index, By Product, By Test, Application, and Country, 2022 –  2028
11.6. Asia-Pacific Biological Safety Testing Market Dynamics – Trends
12. Latin America Biological Safety Testing Market Analysis, 2017 –  2021 and Forecast, 2020 – 2026
12.1. Product Type Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
12.1.1. Kits and Reagents
12.1.2. Services
12.1.3. Instruments
12.2. Test Type Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
12.2.1. Endotoxin Tests
12.2.2. Sterility Tests
12.2.3. Cell Line Authentication and Characterization Tests
12.2.4. Bioburden Tests
12.2.5. Residual Host Contaminant Detection Tests
12.2.6. Adventitious Agent Detection Tests
12.2.7. Other Tests
12.3. Application Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn), Y-o-Y Growth (%) and Market Share (%)
12.3.1. Vaccine & Therapeutics Development
12.3.2. Blood and Blood-Related Products Testing
12.3.3. Cellular and Gene Therapy
12.3.4. Tissue and Tissue-Related Products Testing
12.3.5. Stem Cell Research
12.4. Country Analysis 2017 –  2021 and Forecast 2022 –  2028  by Revenue (USD Mn) Y-o-Y Growth (%) and Market Share (%)
12.4.1. Brazil
12.4.2. Mexico
12.4.3. Argentina
12.4.4. Rest of Latin America
12.5. Latin America Biological Safety Testing Market – Opportunity Analysis Index, By Product, By Test, Application, and Country, 2022 –  2028
12.6. Latin America Biological Safety Testing Market Dynamics – Trends
13. Middle East and Africa Biological Safety Testing Market Analysis, 2017 –  2021 and Forecast, 2022 –  2028 (Revenue, USD Mn )
13.1. Product Type Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
13.1.1. Kits and Reagents
13.1.2. Services
13.1.3. Instruments
13.2. Test Type Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn), Y-o-Y Growth (%), and Market Share (%)
13.2.1. Endotoxin Tests
13.2.2. Sterility Tests
13.2.3. Cell Line Authentication and Characterization Tests
13.2.4. Bioburden Tests
13.2.5. Residual Host Contaminant Detection Tests
13.2.6. Adventitious Agent Detection Tests
13.2.7. Other Tests
13.3. Application Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn), Y-o-Y Growth (%) and Market Share (%)
13.3.1. Vaccine & Therapeutics Development
13.3.2. Blood and Blood-Related Products Testing
13.3.3. Cellular and Gene Therapy
13.3.4. Tissue and Tissue-Related Products Testing
13.3.5. Stem Cell Research
13.4. Country Analysis 2017 –  2021 and Forecast 2022 –  2028 by Revenue (USD Mn) Y-o-Y Growth (%) and Market Share (%)
13.4.1. Gulf Cooperation Council (GCC) Countries
13.4.2. Israel
13.4.3. South Africa
13.4.4. Rest of MEA
13.5. MEA Biological Safety Testing Market – Opportunity Analysis Index, By Product, By Test, Application, and Country, 2022 –  2028
13.6. MEA Biological Safety Testing Market Dynamics – Trends
14. Competition Landscape 
14.1. Strategic Dashboard of Top Market Players
14.2. Company Profiles (Introduction, Financial Analysis, Product & Service Offerings, Key Developments, Strategies, and SWOT Analysis)
14.2.1. Charles River Laboratories International,Inc.
14.2.2. Merck KGaA
14.2.3.  Lonza Group LTD.
14.2.4.  SGS S.A.
14.2.5.  Thermo Fisher Scientific Inc.
14.2.6.  Wuxi Apptec
14.2.7.  Sartorius AG
14.2.8.  Cytovance Biologics,Inc.
14.2.9.  Pace Analytical Services Inc.
14.2.10.  Toxikon Corporation
14.2.11.  Eurofins Scientific Se
14.2.12.  Avance Biosciences Inc.
14.2.13.  Source Bioscience
14.2.14. Others
15. Research Methodology
16. Key Assumptions and Acronyms

 


Report

Company Profile

  • Charles River Laboratories International,Inc
  • Merck KGaA
  • Lonza Group LTD
  • SGS SA
  • Thermo Fisher Scientific Inc
  • Wuxi Apptec
  • Sartorius AG
  • Cytovance Biologics,Inc
  • Pace Analytical Services Inc
  • Toxikon Corporation
  • Eurofins Scientific Se
  • Avance Biosciences Inc
  • Source Bioscience
  • Others

Description

Biological Safety Testing Market size is valued at USD 3,520.0 million in 2021 and is expected to reach a value of USD 8,541.5 million by 2028, growing at a CAGR of 13.5% during the forecast period 2022 to 2028. The global market provides a detailed overview of the biological safety testing market and that can be segmented by product type, application type, and test type. By product type, the biological safety testing market has been segmented into kits and reagents, services, and instruments. The kits and reagents segment is likely to be the largest and fastest-growing segment in terms of product type. Based on test type, the biological safety testing market is segmented into endotoxin tests, sterility tests, cell line authentication and characterization tests, bioburden tests, residual host contaminant detection tests, adventitious agent detection tests, and other tests.  Among these, the bioburden tests segment is expected to have the fastest-growing market during the forecast period 2022-2028. On the basis of application, the market is segregated into vaccine & therapeutics development, blood and blood-related product testing, cellular and gene therapy, tissue and tissue-related product testing, and stem cell research. Vaccine & therapeutics development is likely to be the fastest-growing segment in the market.

Key Developments:

In 2021, EndoScan-V, a verified endotoxin detection and measurement software used to generate and report quantitative test data, has been released by Charles River Laboratories, Inc. (US). The software took the necessary measurements and calculations and generated test results, which could be approved with a digital signature.

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