Biological Safety Testing Market Analysis By Product, By Application, By Test And Segment Forecasts To 2024

  • ID: 3934154
  • Report
  • 106 pages
  • Grand View Research
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The biological safety testing market is expected to reach USD 5.54 billion by 2024. The biological safety testing market is primarily driven by exponential growth in the production of biologics and medical devices that demand stringent safety requirements. The growing disease burden is anticipated to be the major cause for high production of biologics thus contributing toward market growth.

The overwhelming adoption rate of unhealthy lifestyles has resulted in the high prevalence of chronic diseases, such as cancer and diabetes, which is serving as a key contributing factor toward increasing drug development and their subsequent commercialization. This is presumed to raise the need to scrutinize and ensure the safety of targeted and specialized therapies, evaluate their outcomes, and circumvent probable shortcomings.

As a consequence of the high manufacturing intensity, pharmaceutical and biotechnology companies are increasingly incorporating biological safety testing tools to produce highly potent and contamination-free biologics to cater to the large population suffering from target diseases.

In addition, stringent regulations issued by healthcare organizations globally are presumed to be responsible for the high uptake of biological safety testing tools, thus resulting in a wider scope for the biological safety testing market

For instance, the European Medical Device Directives are believed to have a higher influence on the implementation of the defined imperative regulations to meet the growing safety requirements, thus translating into improved biological safety and contributing to overall growth of this vertical.

Further Key Findings From the Study Suggest:

Reagents & kits held a substantial share of the product segment of over 42.0% in 2015 as it forms an indispensable part of the overall testing process and the high dependency of the testing results on the quality of reagents employed to perform the tests.

In 2015, vaccine and therapeutics accounted for the largest market share in the application segment owing to the rising development of vaccines that are highly vulnerable to adventitious agents and necessitate stringent safety measures to prevent potential contamination due to unspecified agents

The endotoxin tests held the largest share of 24.0% in the tests segment as of 2015. This large share is attributed to the high clinical urgency to reduce the threat of endotoxins during the development of bio-pharmaceuticals

In 2015, North America dominated the regional biological safety testing vertical with a share of over 36.0%. The dominant share is a consequence of high investment in the biotechnology sector, its increasing adoption in cancer research, and for the development of new biologics, vaccines, and drugs.

Asia Pacific is expected to witness growth at an exponential CAGR of over 13.0% during the forecast period. The exponential growth rate can be attributed to the increasing healthcare spending, the demand for better infrastructure quality in laboratory & clinical research, and the adoption of compact and low cost techniques in clinical research.

The prominent players are involved in undertaking new product development and collaborative strategies to gain a higher share of the vertical. For instance, in June 2016, Charles River acquired Blue Stream Laboratories, Inc., an analytical contract research organization. This acquisition was carried out to enhance its existing capabilities in safety assessment and manufacturing of biologics.
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1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions
1.3. List of Data Sources
2. Executive Summary
3. Market Snapshot
4. Market Variables, Trends & Scope
4.1. Market segmentation & scope
4.2. Market Driver Analysis
4.2.1. Rising number of government initiatives and recommendations
4.2.2. Increasing production of new biologics due to high disease burden
4.2.3. Rising number of pharmaceutical and biotechnological companies
4.2.4. High R&D investments in clinical research and life sciences research
4.3. Market Restraint Analysis
4.3.1. Time consuming approval process
4.4. Penetration & growth prospect mapping
4.5. Biological Safety Testing - SWOT Analysis, By Factor (political & legal, economic and technological)
4.6. Industry Analysis - Porter's
5. Market Categorization 1: Product Estimates & Trend Analysis
5.1. Biological safety testing market: Product movement analysis
5.2. Reagents & kits
5.2.1. Reagents & kits market estimates and forecasts, 2013 - 2024 (USD Million)
5.3. Instruments
5.3.1. Instruments market estimates and forecasts, 2013 - 2024 (USD Million)
5.4. Others
5.4.1. Others market estimates and forecasts, 2013 - 2024 (USD Million)
6. Market Categorization 2: Application Estimates & Trend Analysis
6.1. Biological safety testing market: Application movement analysis
6.2. Stem cell
6.2.1. Stem cell market estimates and forecasts, 2013 - 2024 (USD Million)
6.3. Tissue & tissue-based products
6.3.1. Tissue & tissue-based products market estimates and forecasts, 2013 - 2024 (USD Million)
6.4. Gene therapy
6.4.1. Gene therapy market estimates and forecasts, 2013 - 2024 (USD Million)
6.5. Blood & blood-based products
6.5.1. Blood and blood-based products market estimates and forecasts, 2013 - 2024 (USD Million)
6.6. Vaccines & therapeutics
6.6.1. Vaccines & therapeutics market estimates and forecasts, 2013 - 2024 (USD Million)
7. Market Categorization 3: Test Estimates & Trend Analysis
7.1. Biological safety testing market: Test movement analysis
7.2. Sterility tests
7.2.1. Sterility tests market estimates and forecasts, 2013 - 2024 (USD Million)
7.3. Cell line authentication & characterization tests
7.3.1. Cell line authentication & characterization tests market estimates and forecasts, 2013 - 2024 (USD Million)
7.4. Bioburden tests
7.4.1. Bioburden test market estimates and forecasts, 2013 - 2024 (USD Million)
7.5. Adventitious agent detection tests
7.5.1. Adventitious agent detection tests market estimates and forecasts, 2013 - 2024 (USD Million)
7.6. Residual host contamination detection tests
7.6.1. Residual host contamination detection tests market estimates and forecasts, 2013 - 2024 (USD Million)
7.7. Others
7.7.1. Others market estimates and forecasts, 2013 - 2024 (USD Million)
8. Market Categorization 4: Regional Estimates & Trend Analysis, By Product, Application & Test
8.1. Biological safety testing market share by region, 2015 & 2024
8.2. North America
8.2.1. North America market estimates and forecasts, by product, 2013 - 2024 (USD Million)
8.2.1.1. U.S. market estimates and forecasts
8.2.1.2. Canada market estimates and forecasts
8.2.2. North America market estimates and forecasts, by application, 2013 - 2024 (USD Million)
8.2.2.1. U.S. market estimates and forecasts
8.2.2.2. Canada market estimates and forecasts
8.2.3. North America market estimates and forecasts, by test, 2013 - 2024 (USD Million)
8.2.3.1. U.S. market estimates and forecasts
8.2.3.2. Canada market estimates and forecasts
8.3. Europe
8.3.1. Europe market estimates and forecasts, by product, 2013 - 2024 (USD Million)
8.3.1.1. UK market estimates and forecasts
8.3.1.2. Germany market estimates and forecasts
8.3.2. Europe market estimates and forecasts, by application, 2013 - 2024 (USD Million)
8.3.2.1. UK market estimates and forecasts
8.3.2.2. Germany market estimates and forecasts
8.3.3. Europe market estimates and forecasts, by test, 2013 - 2024 (USD Million)
8.3.3.1. UK market estimates and forecasts
8.3.3.2. Germany market estimates and forecasts
8.4. Asia Pacific
8.4.1. Asia Pacific market estimates and forecasts, by product, 2013 - 2024 (USD Million)
8.4.1.1. Japan market estimates and forecasts
8.4.1.2. China market estimates and forecasts
8.4.1.3. India market estimates and forecasts
8.4.2. Asia Pacific market estimates and forecasts, by application, 2013 - 2024 (USD Million)
8.4.2.1. Japan market estimates and forecasts
8.4.2.2. China market estimates and forecasts
8.4.2.3. India market estimates and forecasts
8.4.3. Asia Pacific market estimates and forecasts, by test, 2013 - 2024 (USD Million)
8.4.3.1. Japan market estimates and forecasts
8.4.3.2. China market estimates and forecasts
8.4.3.3. India market estimates and forecasts
8.5. Latin America
8.5.1. Latin America market estimates and forecasts, by product, 2013 - 2024 (USD Million)
8.5.1.1. Brazil market estimates and forecasts
8.5.1.2. Mexico market estimates and forecasts
8.5.2. Latin America market estimates and forecasts, by application, 2013 - 2024 (USD Million)
8.5.2.1. Brazil market estimates and forecasts
8.5.2.2. Mexico market estimates and forecasts
8.5.3. Latin America market estimates and forecasts, by test, 2013 - 2024 (USD Million)
8.5.3.1. Brazil market estimates and forecasts
8.5.3.2. Mexico market estimates and forecasts
8.6. MEA
8.6.1. MEA market estimates and forecasts, by product, 2013 - 2024 (USD Million)
8.6.1.1. South Africa market estimates and forecasts
8.6.2. MEA market estimates and forecasts, by application, 2013 - 2024 (USD Million)
8.6.2.1. South Africa market estimates and forecasts
8.6.3. MEA market estimates and forecasts, by test, 2013 - 2024 (USD Million)
8.6.3.1. South Africa market estimates and forecasts
9. Competitive Landscape
9.1. Strategy framework
9.2. Market participation categorization
9.3. Company Profiles
9.3.1. Charles River Laboratories International, Inc.
9.3.1.1. Company overview
9.3.1.2. Financial performance
9.3.1.3. Product benchmarking
9.3.1.4. Strategic initiatives
9.3.2. BSL Bioservice Scientific Laboratories GmbH
9.3.2.1. Company overview
9.3.2.2. Financial performance
9.3.2.3. Product benchmarking
9.3.2.4. Strategic initiatives
9.3.3. Lonza
9.3.3.1. Company overview
9.3.3.2. Financial performance
9.3.3.3. Product benchmarking
9.3.3.4. Strategic initiatives
9.3.4. Cytovance Biologics
9.3.4.1. Company overview
9.3.4.2. Financial performance
9.3.4.3. Product benchmarking
9.3.4.4. Strategic initiatives
9.3.5. Sigma Aldrich Corporation
9.3.5.1. Company overview
9.3.5.2. Financial performance
9.3.5.3. Product benchmarking
9.3.5.4. Strategic initiatives
9.3.6. Merck Mellipore
9.3.6.1. Company overview
9.3.6.2. Financial performance
9.3.6.3. Product benchmarking
9.3.6.4. Strategic initiatives
9.3.7. SGS S.A.
9.3.7.1. Company overview
9.3.7.2. Financial performance
9.3.7.3. Product benchmarking
9.3.7.4. Strategic initiatives
9.3.8. Toxikon, Inc.
9.3.8.1. Company overview
9.3.8.2. Financial performance
9.3.8.3. Product benchmarking
9.3.8.4. Strategic initiatives
9.3.9. Wuxi Pharmatech (Cayman) Inc.
9.3.9.1. Company overview
9.3.9.2. Financial performance
9.3.9.3. Product benchmarking
9.3.9.4. Strategic initiatives
9.3.10. Avance Biosciences
9.3.10.1. Company overview
9.3.10.2. Financial performance
9.3.10.3. Product benchmarking
9.3.10.4. Strategic initiatives

List of Tables

Table 1 Country share estimation
Table 2 North America biological safety testing market, by product, 2013 - 2024 (USD Million)
Table 3 North America biological safety testing market, by application, 2013 - 2024 (USD Million)
Table 4 North America biological safety testing market, by test, 2013 - 2024 (USD Million)
Table 5 U.S. biological safety testing market, by product, 2013 - 2024 (USD Million)
Table 6 U.S. biological safety testing market, by application, 2013 - 2024 (USD Million)
Table 7 U.S. biological safety testing market, by test, 2013 - 2024 (USD Million)
Table 8 Canada biological safety testing market, by product, 2013 - 2024 (USD Million)
Table 9 Canada biological safety testing market, by application, 2013 - 2024 (USD Million)
Table 10 Canada biological safety testing market, by test, 2013 - 2024 (USD Million)
Table 11 Europe biological safety testing market, by product, 2013 - 2024 (USD Million)
Table 12 Europe biological safety testing market, by application, 2013 - 2024 (USD Million)
Table 13 Europe biological safety testing market, by test, 2013 - 2024 (USD Million)
Table 14 Germany biological safety testing market, by product, 2013 - 2024 (USD Million)
Table 15 Germany biological safety testing market, by application, 2013 - 2024 (USD Million)
Table 16 Germany biological safety testing market, by test, 2013 - 2024 (USD Million)
Table 17 UK biological safety testing market, by product, 2013 - 2024 (USD Million)
Table 18 UK biological safety testing market, by application, 2013 - 2024 (USD Million)
Table 19 UK biological safety testing market, by test, 2013 - 2024 (USD Million)
Table 20 Asia Pacific biological safety testing market, by product, 2013 - 2024 (USD Million)
Table 21 Asia Pacific biological safety testing market, by application, 2013 - 2024 (USD Million)
Table 22 Asia Pacific biological safety testing market, by test, 2013 - 2024 (USD Million)
Table 23 Japan biological safety testing market, by product, 2013 - 2024 (USD Million)
Table 24 Japan biological safety testing market, by application, 2013 - 2024 (USD Million)
Table 25 Japan biological safety testing market, by test, 2013 - 2024 (USD Million)
Table 26 China biological safety testing market, by product, 2013 - 2024 (USD Million)
Table 27 China biological safety testing market, by application, 2013 - 2024 (USD Million)
Table 28 China biological safety testing market, by test, 2013 - 2024 (USD Million)
Table 29 India biological safety testing market, by product, 2013 - 2024 (USD Million)
Table 30 India biological safety testing market, by application, 2013 - 2024 (USD Million)
Table 31 India biological safety testing market, by test, 2013 - 2024 (USD Million)
Table 32 Latin America biological safety testing market, by product, 2013 - 2024 (USD Million)
Table 33 Latin America biological safety testing market, by application, 2013 - 2024 (USD Million)
Table 34 Latin America biological safety testing market, by test, 2013 - 2024 (USD Million)
Table 35 Brazil biological safety testing market, by product, 2013 - 2024 (USD Million)
Table 36 Brazil biological safety testing market, by application, 2013 - 2024 (USD Million)
Table 37 Brazil biological safety testing market, by test, 2013 - 2024 (USD Million)
Table 38 Mexico biological safety testing market, by product, 2013 - 2024 (USD Million)
Table 39 Mexico biological safety testing market, by application, 2013 - 2024 (USD Million)
Table 40 Mexico biological safety testing market, by test, 2013 - 2024 (USD Million)
Table 41 MEA biological safety testing market, by product, 2013 - 2024 (USD Million)
Table 42 MEA biological safety testing market, by application, 2013 - 2024 (USD Million)
Table 43 MEA biological safety testing market, by test, 2013 - 2024 (USD Million)
Table 44 South Africa biological safety testing market, by product, 2013 - 2024 (USD Million)
Table 45 South Africa biological safety testing market, by application, 2013 - 2024 (USD Million)
Table 46 South Africa biological safety testing market, by test, 2013 - 2024 (USD Million)

List of Figures

Figure 1 Market summary (USD Million)
Figure 2 Market trends & outlook
Figure 3 Market segmentation & scope
Figure 4 Market driver relevance analysis (Current & future impact)
Figure 5 Market restraint relevance analysis (Current & future impact)
Figure 6 Penetration & growth prospect mapping
Figure 7 SWOT Analysis, By Factor (political & legal, economic and technological)
Figure 8 Porter’s Five Forces Analysis
Figure 9 Biological safety testing market product outlook key takeaways
Figure 10 Biological safety testing market: Product movement analysis
Figure 11 Global reagents & kits market, 2013 - 2024 (USD Million)
Figure 12 Global instruments market, 2013 - 2024 (USD Million)
Figure 13 Global services market, 2013 - 2024 (USD Million)
Figure 14 Biological safety testing market application outlook: Key takeaways
Figure 15 Biological safety testing market: Application movement analysis
Figure 16 Global stem cell market, 2013 - 2024 (USD Million)
Figure 17 Global tissue & tissue-based products market, 2013 - 2024 (USD Million)
Figure 18 Global gene therapy market, 2013 - 2024 (USD Million)
Figure 19 Global blood & blood-based products market, 2013 - 2024 (USD Million)
Figure 20 Global vaccines & therapeutics market, 2013 - 2024 (USD Million)
Figure 21 Biological safety testing market test outlook: Key takeaways
Figure 22 Biological safety testing market: Test movement analysis
Figure 23 Global sterility tests market, 2013 - 2024 (USD Million)
Figure 24 Global cell line authentication & characterization tests market, 2013 - 2024 (USD Million)
Figure 25 Global bioburden tests market, 2013 - 2024 (USD Million)
Figure 26 Global endotoxin tests market, 2013 - 2024 (USD Million)
Figure 27 Global adventitious agent detection tests market, 2013 - 2024 (USD Million)
Figure 28 Global residual host contamination detection tests market, 2013 - 2024 (USD Million)
Figure 29 Global others market, 2013 - 2024 (USD Billion)
Figure 30 Regional market place: Key takeaways
Figure 31 Regional outlook, 2015 & 2024
Figure 32 North America biological safety testing market, 2013 - 2024 (USD Million)
Figure 33 U.S. biological safety testing market, 2013 - 2024 (USD Million)
Figure 34 Canada biological safety testing market, 2013 - 2024 (USD Million)
Figure 35 Europe biological safety testing market, 2013 - 2024 (USD Million)
Figure 36 Germany biological safety testing market, 2013 - 2024 (USD Million)
Figure 37 UK biological safety testing market, 2013 - 2024 (USD Million)
Figure 38 Asia Pacific biological safety testing market, 2013 - 2024 (USD Million)
Figure 39 Japan biological safety testing market, 2013 - 2024 (USD Million)
Figure 40 China biological safety testing market, 2013 - 2024 (USD Million)
Figure 41 India biological safety testing market, 2013 - 2024 (USD Million)
Figure 42 Latin America biological safety testing market, 2013 - 2024 (USD Million)
Figure 43 Brazil biological safety testing market, 2013 - 2024 (USD Million)
Figure 44 Mexico biological safety testing market, 2013 - 2024 (USD Million)
Figure 45 MEA biological safety testing market, 2013 - 2024 (USD Million)
Figure 46 South Africa biological safety testing market, 2013 - 2024 (USD Million)
Figure 47 Strategy framework
Figure 48 Participant categorization
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