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Biological Safety Testing Market Size, Share & Trends Analysis Report By Product, By Application (Vaccines & Therapeutics, Gene Therapy, Stem Cell), By Test, By Region, And Segment Forecasts, 2018 - 2024

Biological Safety Testing Market Size, Share & Trends Analysis Report By Product, By Application (Vaccines & Therapeutics, Gene Therapy, Stem Cell), By Test, By Region, And Segment Forecasts, 2018 - 2024

The global biological safety testing market size is expected to reach USD 5.54 billion by 2024, according to a new report by Grand View Research, Inc., registering a CAGR of 12.2% during the forecast period. The market is predominantly driven by increasing influx of biologics, which raises the requirements of highly efficient biological safety testing tools. Rising disease burden is expected to be a major cause for high production of biologics, thereby contributing toward market growth.

Increasing prevalence of lifestyle-associated chronic diseases such as cancer and diabetes serves as a key contributing factor toward increasing drug development and their subsequent commercialization. This is presumed to raise the need to scrutinize and ensure safety of targeted and specialized therapies, evaluate their outcomes, and circumvent probable shortcomings. As a consequence of 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.

Viral safety testing is proving to be one of the primary concerns of most companies as it is a critical component of chemistry, manufacturing, and control of biologics. This presents the market with several potential growth opportunities in future.

Laboratory-based contaminations have stimulated the development and refinement of workstations by incorporating biological safety tools. Need to work with tissue cultures, maintain sterility of cell lines, and minimize cross-contamination has contributed to concerns regarding product integrity. The aforementioned factors are responsible for raising concerns of public organizations. Consistent intervention by government healthcare organizations to implement good manufacturing practices and subsequent testing and control at every production stage is believed to widen the growth opportunities of the market.

Further key findings from the study suggest:

  • By product, reagents and kits accounted for the largest share of over 42.0% in 2015 as they form major components and are extensively used in research and clinical laboratories
  • The instruments segment, on the other hand, is expected to witness a lucrative CAGR of 13.2% during the forecast period due to rising demand from various clinical and research laboratories
  • Based on application, the vaccine segment is expected to exhibit a CAGR of 12.9% during the forecast period, which can be predominantly attributed to significant increase in disease outbreaks over the years
  • Bioburden tests are expected to grow at a lucrative rate throughout the forecast period owing to high adoption rate to determine bioburden limits in wide-ranging biologics and medical devices
  • North America dominated the global market with over 36.0% in 2015 owing to high R&D investments in biotechnology
  • The Asia Pacific regional market is anticipated to exhibit a strong CAGR of over 13.1% during the forecast period.

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

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