Home / Biotechnology / Biological Safety Testing Market By Product (Reagents And Kits, Instruments, Services), By Test (Sterility Test, Endotoxin Tests, Cell Line Authentication And Characterization Tests, Residual Host Contaminant Detection Tests, Bioburden Tests, Adventitious Agent Detection Tests), By Application (Gene And Cellular Therapy, Tissue & Tissue-Based Products, Vaccines & Therapeutics, Stem Cell Research) - Growth, Future Prospects And Competitive Analysis, 2017 - 2025

Biological Safety Testing Market By Product (Reagents And Kits, Instruments, Services), By Test (Sterility Test, Endotoxin Tests, Cell Line Authentication And Characterization Tests, Residual Host Contaminant Detection Tests, Bioburden Tests, Adventitious Agent Detection Tests), By Application (Gene And Cellular Therapy, Tissue & Tissue-Based Products, Vaccines & Therapeutics, Stem Cell Research) - Growth, Future Prospects And Competitive Analysis, 2017 - 2025

Published: Sep 2017 | Report Code: 58705-09-17

Biological safety testing is mandatory procedure in most biological, pharmaceutical products including vaccines, drugs and others in the different stages during the manufacturing process. Well defined guidelines ensuring the safety of developed vaccines with unaltered therapeutic value and reduced toxicity, which may result from constituent materials and pharmacodynamic action of the vaccine and drugs are driving the global biological safety testing market.

The report titled “Global Biological Safety Testing Market- Growth, Future Prospects and Competitive Analysis, 2017–2025” offers strategic insights into the overall biological safety testing market along with the market size and estimates for the duration 2017 to 2025. The research study covers in-depth analysis of market segments based on product type, test type, application and different geographical region.

In order to help strategic decision makers, the report also includes competitive profiling of the leading players in global biological safety testing market, attractive investment proposition and market positioning of key manufacturers sections. Geographically, the global biological safety testing market is studied for the following regional markets:

  • North America
    • U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East and Africa
    • GCC
    • Rest of Middle East and Africa

Market size and forecast for these regional and country level markets are presented in this study for the period 2015-2025. Market growth rates for the forecast period 2015-2025 are also included in this report, considering 2016 as the base year.

Along with quantitative information, qualitative information sets and assessment tools are provided in this study for better analysis of the overall market scenario and future prospects. Information such as market inclination insights and drivers, challenges and opportunities assists the readers for understanding the ongoing trends in the global biological safety testing market. Tools such as market positioning of key players and attractive investment proposition provide the readers with insights on the competitive scenario of the global biological safety testing market. This report concludes with company profiles section that highlights major information about the key players engaged in global biological safety testing market. In-depth competitive environment analysis and historical years (2015) market size data are also provided in the report. 

Thus, the research study provides a holistic view of the global biological safety testing market, offering market size and estimates for the period from 2015 to 2025, keeping in mind the above-mentioned factors.

 Biological Safety Testing Market

Chapter 1 Preface
1.1 Report Description
1.1.1 Purpose of the Report
1.1.2 Target Audience
1.1.3 USP and Key Offerings
1.2 Research Scope
1.3 Research Methodology
1.3.1 Phase I – Secondary Research
1.3.2 Phase II – Primary Research
1.3.3 Phase III – Expert Panel Review
1.3.4 Assumptions

Chapter 2 Executive Summary
2.1 Biological Safety Testing Market Portraiture
2.2 Biological Safety Testing Market, by Product Type, 2016 (US$ Mn)
2.3 Biological Safety Testing Market, by Test Type, 2016 (US$ Mn)
2.4 Biological Safety Testing Market, by Application Type, 2016 (US$ Mn)
2.5 Biological Safety Testing Market, by Geography, 2016 (Value %)

Chapter 3 Global Biological Safety Testing Market Analysis
3.1 Global Biological Safety Testing Market Overview
3.2 Market Dynamics
3.2.1 Market Drivers
3.2.2 Challenges
3.2.3 Opportunities
3.3 Mergers, Acquisition and Business Strategies
3.4 Porter’s Analysis
3.5 Attractive Investment Proposition
3.6 Competitive Analysis: Global Biological Safety Testing Market, 2016 (Value %)

Chapter 4 Global Biological Safety Testing Market Analysis, By
Product Type
4.1 Overview
4.1.1 Market Attractive Proposition of Biological Safety Testing Market, by
Product Type, 2016
4.2 Reagents and Kits
4.3 Instruments
4.4 Services

Chapter 5 Global Biological Safety Testing Market Analysis, By Test
Type
5.1 Overview
5.1.1 Market Attractive Proposition of Biological Safety Testing Market, by Test
Type, 2016
5.2 Sterility Test
5.3 Endotoxin Tests
5.4 Cell Line Authentication and Characterization Tests
5.5 Residual Host Contaminant Detection Tests
5.6 Bioburden Tests
5.7 Adventitious Agent Detection Tests
5.8 Others

Chapter 6 Global Biological Safety Testing Market Analysis, By
Application Type
6.1 Overview
6.1.1 Market Attractive Proposition of Biological Safety Testing Market, by
Application Type, 2016
6.2 Gene and Cellular Therapy
6.3 Tissue & tissue-based products
6.4 Vaccines & therapeutics
6.5 Stem Cell Research
6.6 Others

Chapter 7 Global Biological Safety Tests Market, By Geography
7.1 Preface
7.2 North America (U.S. & Canada)
7.2.1 North America Biological Safety Tests Market, by Product Type, 2015-
2025 (US$ Mn)
7.2.2 North America Biological Safety Tests Market, by Test Type, 2015-2025
(US$ Mn)
7.2.3 North America Biological Safety Tests Market, by Application Type, 2015-
2025 (US$ Mn)
7.2.4 North America Biological Safety Tests Market, by Country, 2015 – 2025
(US$ Mn)
7.3 Europe (U.K., Germany & Rest of Europe)
7.3.1 Europe Biological Safety Tests Market, by Product Type, 2015-2025 (US$
Mn)
7.3.2 Europe Biological Safety Tests Market, by Test Type, 2015-2025 (US$ Mn)
7.3.3 Europe Biological Safety Tests Market, by Application Type, 2015-2025
(US$ Mn)
7.3.4 Europe Biological Safety Tests Market, by Country, 2015 – 2025 (US$ Mn)
7.4 Asia-Pacific (China, Japan & Rest of Asia-Pacific)
7.4.1 Asia Pacific Biological Safety Tests Market, by Product Type, 2015-2025
(US$ Mn)
7.4.2 Asia Pacific Biological Safety Tests Market, by Test Type, 2015-2025 (US$
Mn)
7.4.3 Asia Pacific Biological Safety Tests Market, by Application Type, 2015-
2025 (US$ Mn)
7.4.4 Asia - Pacific Biological Safety Tests Market, by Country, 2015 – 2025 (US$
Mn)
7.5 Latin America (Brazil, Mexico and Rest of LATAM)
7.5.1 Latin America Biological Safety Tests Market, by Product Type, 2015-2025
(US$ Mn)
7.5.2 Latin America Biological Safety Tests Market, by Test Type, 2015-2025
(US$ Mn)
7.5.3 Latin America Biological Safety Tests Market, by Application Type, 2015-
2025 (US$ Mn)
7.5.4 Latin America Biological Safety Tests Market, by Country, 2015 – 2025
(US$ Mn)
7.6 Middle East and Africa
7.6.1 Middle East and Africa Biological Safety Tests Market, by Product Type,
2015-2025 (US$ Mn)
7.6.2 Middle East and Africa Biological Safety Tests Market, by Test Type, 2015-
2025 (US$ Mn)
7.6.3 Middle East and Africa Biological Safety Tests Market, by Application
Type, 2015-2025 (US$ Mn)
7.6.4 Middle East and Africa Biological Safety Tests Market, by Country, 2015 –
2025 (US$ Mn)

Chapter 8 Company Profiles
8.1 BSL Bioservice Scientific Laboratories GmbH
8.2 Charles River Laboratories International, Inc.
8.3 Lonza Group
8.4 Cytovance Biologics
8.5 Sigma Aldrich Corporation
8.6 Merck Mellipore
8.7 SGS S.A.
8.8 Toxikon, Inc.
8.9 Wuxi Pharmatech (Cayman) Inc.
8.10 Avance Biosciences
8.11 Thermo Fisher Scientific, Inc.

List of Tables :

TABLE 1 Global Biological Safety Testing Market, By Product Type (US$ Mn), 2015– 2025 (Value)
TABLE 1 Global Biological Safety Testing Market, By Test Type (US$ Mn), 2015– 2025 (Value)
TABLE 2 Global Biological Safety Testing Market, By Application Type (US$ Mn), 2015– 2025
(Value)
TABLE 3 Global Biological Safety Tests Market, by Geography, 2015 – 2025 (US$ Mn)
TABLE 4 North America Biological Safety Tests Market, by Product Type, 2015 – 2025 (US$ Mn)
TABLE 5 North America Biological Safety Tests Market, by Test Type, 2015 – 2025 (US$ Mn)
TABLE 6 North America Biological Safety Tests Market, by Application Type, 2015 – 2025 (US$
Mn)
TABLE 7 North America Biological Safety Tests Market, by Country, 2015 – 2025 (US$ Mn)
TABLE 8 Europe Biological Safety Tests Market, by Product Type, 2015 – 2025 (US$ Mn)
TABLE 9 Europe Biological Safety Tests Market, by Test Type, 2015 – 2025 (US$ Mn)
TABLE 10 Europe Biological Safety Tests Market, by Application Type, 2015 – 2025 (US$ Mn)
TABLE 11 Europe Biological Safety Tests Market, by Country, 2015 – 2025 (US$ Mn)
TABLE 12 Asia Pacific Biological Safety Tests Market, by Product Type, 2015 – 2025 (US$ Mn)
TABLE 13 Asia Pacific Biological Safety Tests Market, by Test Type, 2015 – 2025 (US$ Mn)
TABLE 14 Asia Pacific Biological Safety Tests Market, by Application Type, 2015 – 2025 (US$ Mn)
TABLE 15 Asia - Pacific Biological Safety Tests Market, by Country, 2015 – 2025 (US$ Mn)
TABLE 16 Latin America Biological Safety Tests Market, by Product Type, 2015 – 2025 (US$ Mn)
TABLE 17 Latin America Biological Safety Tests Market, by Test Type, 2015 – 2025 (US$ Mn)
TABLE 18 Latin America Biological Safety Tests Market, by Application Type, 2015 – 2025 (US$ Mn)
TABLE 19 Latin America Biological Safety Tests Market, by Country, 2015 – 2025 (US$ Mn)
TABLE 20 Middle East and Africa Biological Safety Tests Market, by Product Type, 2015 – 2025
(US$ Mn)
TABLE 21 Middle East and Africa Biological Safety Tests Market, by Test Type, 2015 – 2025 (US$
Mn)
TABLE 22 Middle East and Africa Biological Safety Tests Market, by Applications Type, 2015 – 2025
(US$ Mn)
TABLE 23 Middle East and Africa Biological Safety Tests Market, by Country, 2015 – 2025 (US$ Mn)
Credence Research, Inc. 10
TABLE 24 BSL Bioservice Scientific Laboratories GmbH: Company Snapshot (Business Description;
Financial Performance; Product Position/Portfolio; News Coverage)
TABLE 25 Charles River Laboratories International, Inc.: Company Snapshot (Business Description;
Financial Performance; Product Position/Portfolio; News Coverage)
TABLE 26 Lonza Group: Company Snapshot (Business Description; Financial Performance; Product
Position/Portfolio; News Coverage)
TABLE 27 Cytovance Biologics: Company Snapshot (Business Description; Financial Performance;
Product Position/Portfolio; News Coverage)
TABLE 28 Sigma Aldrich Corporation: Company Snapshot (Business Description; Financial
Performance; Product Position/Portfolio; News Coverage)
TABLE 29 Merck Mellipore: Company Snapshot (Business Description; Financial Performance;
Product Position/Portfolio; News Coverage)
TABLE 30 SGS S.A.: Company Snapshot (Business Description; Financial Performance; Product
Position/Portfolio; News Coverage)
TABLE 31 Toxikon, Inc.: Company Snapshot (Business Description; Financial Performance; Product
Position/Portfolio; News Coverage)
TABLE 32 Wuxi Pharmatech (Cayman) Inc.: Company Snapshot (Business Description; Financial
Performance; Product Position/Portfolio; News Coverage)
TABLE 33 Avance Biosciences: Company Snapshot (Business Description; Financial Performance;
Product Position/Portfolio; News Coverage)
TABLE 34 Thermo Fisher Scientific, Inc.: Company Snapshot (Business Description; Financial
Performance; Product Position/Portfolio; News Coverage)

List of Figures :

FIG. 1 Biological Safety Testing Market: Research Methodology
FIG. 2 Biological Safety Testing Market, by Product Type, 2016 (US$ Mn)
FIG. 3 Biological Safety Testing Market, by Test Type, 2016 (US$ Mn)
FIG. 4 Biological Safety Testing Market, by Application Type, 2016 (US$ Mn)
FIG. 5 Biological Safety Testing Market, by Geography, 2016 (Value %)
FIG. 6 Attractive Investment Proposition
FIG. 7 Competitive Analysis: Global Biological Safety Testing Market, 2016 (Value %)
FIG. 8 Global Reagents and Kits Market(US$ Mn), 2015-2025
FIG. 9 Global Instruments Market(US$ Mn), 2015-2025
FIG. 10 Global Services Market (US$ Mn), 2015-2025
FIG. 11 Global Sterility Test Market(US$ Mn), 2015-2025
FIG. 12 Global Endotoxin Tests Market(US$ Mn), 2015-2025
FIG. 13 Global Cell Line Authentication and Characterization Tests Market (US$ Mn), 2015-2025
FIG. 14 Global Residual Host Contaminant Detection Tests Market (US$ Mn), 2015-2025
FIG. 15 Global Bioburden Tests Market (US$ Mn), 2015-2025
FIG. 16 Global Adventitious Agent Detection Tests Market(US$ Mn), 2015-2025
FIG. 17 Global Others Tests Market(US$ Mn), 2015-2025
FIG. 18 Global Gene and Cellular Therapy Market(US$ Mn), 2015-2025
FIG. 19 Global Tissue & tissue-based products Market(US$ Mn), 2015-2025
FIG. 20 Global Vaccines & therapeutics Market (US$ Mn), 2015-2025
FIG. 21 Global Stem Cell Research Market (US$ Mn), 2015-2025
FIG. 22 Global Others Applications Market(US$ Mn), 2015-2025

Based on the type of product and services, the biological safety testing market is segmented into:

  • Reagents & Kits
  • Instruments
  • Services

Biological safety testing is a mandatory process in pharmaceutical and biotechnology companies for quality control measure for biological and drug manufacturing process. On the basis of products and services the biological safety testing market is segmented into reagents & kits, instruments and services. The reagents & kits held the largest market in the product segment due to repeated use of necessary reagents in the biological safety process. Hence, leading to the higher purchase of reagents and kits. Moreover, introduction of more advanced and modified reagents formulations serving the purpose better are further driving the market. The manufacturing companies are introducing the kits for particular application which has increased the better adaptability of these products in the laboratory setting and toxicology testing making it a more organized market.

Biological Safety Testing Market

Based on the type of test, the biological safety testing market is segmented into:

  • Sterility Tests
  • Endotoxin Tests
  • Cell Line Authentication and Characterization Tests
  • Residual Host Contaminant Detection Tests
  • Bioburden Tests
  • Adventitious Agent Detection Tests
  • Others Tests

Biological safety testing is mandatory procedure in most biological, pharmaceutical products including vaccines, drugs and others in the different stages during the manufacturing process. The most common tests elucidated in this study include sterility tests, endotoxin tests, cell line authentication and characterization tests, residual host contaminant detection tests, bioburden tests, adventitious agent detection tests and others. Sterility testing held the largest market in the overall biological safety testing market due to its wide application in pharmaceutical and biotechnology process. The constant efforts for ensuring drug product quality and safety, health authorities in many countries have implemented, or are considering implementing, quality control (QC) testing requirements for pharmaceuticals, biological/biotechnology, and/or vaccine products entering the market which would drive the biological safety testing market during the forecast period.

 Biological Safety Testing Market

Based on the type of application, the biological safety testing market is segmented into:

  • Gene and Cellular Therapy
  • Tissue & tissue-based products
  • Vaccines & therapeutics
  • Stem Cell Research
  • Others

Biological safety testing is mandatory procedure in most biological, pharmaceutical products including vaccines, drugs and others in the different stages during the manufacturing process. The applications mentioned in the biological safety testing market are gene and cellular therapy, tissue & tissue-based products, vaccines & therapeutics, stem cell research and other tests. Vaccines & therapeutics held the largest share in the application segment. Vaccines and therapeutics administered by the parenteral route are required to be tested for sterility at the final container and also at various stages during manufacture according to the guidelines issued by the FDA and respective authority to prevent toxicity and contaminations. Thus, defined guidelines ensuring the safety of developed vaccines with unaltered therapeutic value and reduced toxicity, which may result from constituent materials and pharmacodynamic action of the vaccine, are presumed to be responsible for the heightened demand of this segment during the forecast period.

 Biological Safety Testing Market

For the purpose of this study, the global biological safety testing market is categorized as follows:

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa

Biological Safety Testing Market

For the purpose of this study, the global biological safety testing is segmented into regional markets viz., North America, Europe, Asia Pacific, Latin America, Middle East and Africa. In the base year 2016, North America dominated the global biological safety testing market which was followed by Europe. The major factors leading to the dominance of North America are the presence of prominent players in the region with continuous market expansion and evolution. Heightened R&D activities undertaken by the companies with the initiatives by the government further drive the market. Asia Pacific is anticipated to be the fastest growing region the biological safety testing market due to growing healthcare infrastructure resulting in growing R&D investments from the major pharmaceutical giants. Moreover, lower cost of contract research has led to the paradigm shift towards Asia Pacific. In addition, favourable regulatory policies enforced by the healthcare organizations to improve safety, as well as the improving healthcare infrastructure quality is further expected to widen the growth opportunities in the future.

 

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