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

North-America

Europe

Asia-Pacific

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

By Product Type

Kits and Reagents,
Services and Instruments

By Test Type

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

Vaccine & Therapeutics Development,
Blood and Blood-Related Products Testing,
Cellular and Gene Therapy,
Tissue and Tissue-Related Products Testing and
Stem Cell Research

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

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

Description

Key Developments:

Biological Safety Testing Market

Biological Safety Testing Market

Features of the Report

By Product Type

By Test Type

By Application

GEOGRAPHY

Frequently Asked Questions

Table Of Content

Company Profile

Description

Key Developments:

Reviews

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