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Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type (In-house, Outsourcing), By Test Type, By End-use, By Sample (Sterile Drugs, Biologics & Therapeutics), And Segment Forecasts, 2018 - 2025

Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type (In-house, Outsourcing), By Test Type, By End-use, By Sample (Sterile Drugs, Biologics & Therapeutics), And Segment Forecasts, 2018 - 2025

The global pharmaceutical sterility testing market size is expected to reach USD 2.0 billion by 2025, according to a new report by Grand View Research, Inc. The market is anticipated to expand at a healthy CAGR of 11.8% over the forecast period. Increasing number of drug launches coupled with the rising R&D expenditure across the globe is expected to be the key market growth drivers.

Technological advancements in sterility testing methods led to reduction of the procedural time and human intervention, thereby increasing the efficiency and accuracy of these tests. Latest advancements are flexible to suit the safety requirements of innovative products. The FDA also relaxed its regulatory requirements to allow the use of modern sterility tests for ensuring product safety.

Outsourcing of sterility testing is a strategy adopted by many companies in order to reduce cost. Moreover, several contract laboratories are available, which provide quality sterility testing at economic prices. Outsourcing of sterility testing also reduces the need for personnel training, equipment purchases, and manufacturing facility changes.

Regulatory framework for sterile products in pharmacies is increasingly becoming stringent owing to the several adverse events, such as meningitis outbreak (2012), associated with unsafe sterile products compounded in pharmacies. Moreover, the Drug Quality and Security Act provides the FDA authority to monitor and regulate the compounding of drugs, thereby, increasing adoption of sterility testing procedures by the compounding pharmacies.

Developing countries are harmonizing the regulatory framework with ICH standards and are also undertaking initiatives to boost the domestic production by providing incentives and tax concessions. Thus, developing nations are considered to be the future area for expansion of operations and outsourcing of sterility testing by multinational companies.

Further key findings from the study suggest:

  • The outsourcing pharmaceutical sterility testing market is anticipated to register a CAGR of 12.0% over the forecast period
  • Among end-users, the others segment includes hospitals, biopharmaceuticals, clinics, and research labs and it is anticipated to witness the maximum CAGR over the forecast period
  • Bacterial endotoxin testing segment led the global pharmaceutical sterility testing market with a market share of over 39.0% in 2016
  • The North America region is anticipated to expand at CAGR of 11.7% during the estimated period
  • Developing countries, especially India and China, are expected to witness a remarkable growth over the coming years
  • Some of the key companies in this market are SGS SA; Toxikon, Inc.; Pace Analytical Services, LLC; Boston Analytical; Charles River Laboratories International, Inc.; and Nelson Laboratories LLC.


Chapter 1 Research Methodology
1.1 Information procurement
1.2 Information or Data Analysis
1.3 Market Formulation & Validation
Chapter 2 Executive Summary
2.1 Market Snapshot
Chapter 3 Market Variables, Trends & Scope
3.1 Market segmentation& scope
3.1.1 Market Driver Analysis
3.1.1.1 Supportive government investment in the healthcare industry
3.1.1.2 Increasing R&D activities
3.1.1.3 Increasing number of drug launches
3.1.1.4 Increasing focus on quality and sterility
3.1.2 Market Restraint Analysis
3.1.2.1 Third party performance
3.2 Penetration & growth prospect mapping
3.3 Pharmaceutical Sterility Testing - SWOT Analysis, By Factor (political & legal, economic and technological)
3.4 Industry Analysis - Porter’s
Chapter 4 Type Estimates & Trend Analysis
4.1 Pharmaceutical sterility testing market: Type movement analysis
4.2 In- house pharmaceutical sterility Testing
4.2.1 In-house pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
4.3 Outsourcing pharmaceutical sterility testing
4.3.1 Outsourcing pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
Chapter 5 Test-Type Estimates & Trend Analysis
5.1 Pharmaceutical sterility testing market: Test type movement analysis
5.2 Sterility Testing
5.2.1 Sterility Testing market, 2014 - 2025 (USD Million)
5.3 Bioburden testing
5.3.1 Bioburden testing market, 2014 - 2025 (USD Million)
5.4 Bacterial Endotoxin testing
5.4.1 Bacterial Endotoxin testing market, 2014 - 2025 (USD Million)
Chapter 6 End-use Estimates & Trend Analysis
6.1 Pharmaceutical sterility testing market: End-use movement analysis
6.2 Compounding Pharmacies
6.2.1 Compounding market, 2014 - 2025 (USD Million)
6.3 Medical Devices Companies
6.3.1 Medical devices companies market, 2014 - 2025 (USD Million)
6.4 Pharmaceutical companies
6.4.1 Pharmaceutical companies market, 2014 - 2025 (USD Million)
6.5 Others
6.5.1 Others market, 2014 - 2025 (USD Million)
Chapter 7 Sample Estimates & Trend Analysis
7.1 Pharmaceutical sterility testing market: Sample movement analysis
7.2 Sterile drugs
7.2.1 Sterile drugs market, 2014 - 2025 (USD Million)
7.3 Medical devices
7.3.1 Medical devices market, 2014 - 2025 (USD Million)
7.4 Biologics & therapeutics
7.4.1 Biologics & therapeutics, 2014 - 2025 (USD Million)
Chapter 8 Regional Estimates & Trend Analysis, by Services
8.1 Pharmaceutical sterility testing market share by region, 2015 & 2025
8.2 North America
8.2.1 North America Pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
8.2.2 U.S.
8.2.2.1 U.S. Pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
8.2.3 Canada
8.2.3.1 Canada Pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
8.3 Europe
8.3.1 Europe pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
8.3.2 U.K.
8.3.2.1 U.K. pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
8.3.3 Germany
8.3.3.1 Germany pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
8.4 Asia Pacific
8.4.1 Asia Pacific pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
8.4.2 Japan
8.4.2.1 Japan pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
8.4.3 China
8.4.3.1 China pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
8.5 Latin America
8.5.1 Latin America pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
8.5.2 Brazil
8.5.2.1 Brazil pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
8.5.3 Mexico
8.5.3.1 Mexico pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
8.6 MEA
8.6.1 MEA pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
8.6.2 South Africa
8.6.2.1 South Africa pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
8.6.3 Saudi Arabia
8.6.3.1 Saudi Arabia pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
Chapter 9 Competitive Landscape
9.1 Strategy framework
9.2 Company Profile
9.2.1 Pacific Biolabs
9.2.1.1 Company overview
9.2.1.2 Financial performance
9.2.1.3 Product benchmarking
9.2.2 STERIS Corporation.
9.2.2.1 Company overview
9.2.2.2 Financial performance
9.2.2.3 Product benchmarking
9.2.2.4 Strategic initiatives
9.2.3 Boston Analytical.
9.2.3.1 Company overview
9.2.3.2 Financial performance
9.2.3.3 Product Benchmarking
9.2.3.4 Strategic initiatives
9.2.4 Gibraltar Laboratories.
9.2.4.1 Company overview
9.2.4.2 Financial performance
9.2.4.3 Service benchmarking
9.2.5 Sartorius AG.
9.2.5.1 Company overview
9.2.5.2 Financial Performance
9.2.5.3 Service benchmarking
9.2.5.4 Strategic initiatives
9.2.6 Solvias AG.
9.2.6.1 Company overview
9.2.6.2 Financial Performance
9.2.6.3 Service benchmarking
9.2.7 SGS SA
9.2.7.1 Company overview
9.2.7.2 Financial performance
9.2.7.3 Service benchmarking
9.2.7.4 Strategic initiatives
9.2.8 Toxikon, Inc.
9.2.8.1 Company overview
9.2.8.2 Financial Performance
9.2.8.3 Product benchmarking
9.2.9 Pace Analytical Services LLC.
9.2.9.1 Company overview
9.2.9.2 Financial Performance
9.2.9.3 Product benchmarking
9.2.9.4 Strategic initiatives
9.2.10 Charles River Laboratories International, Inc.
9.2.10.1 Company overview
9.2.10.2 Financial performance
9.2.10.3 Product benchmarking
9.2.10.4 Strategic initiatives
9.2.11 Thermo Fisher Scientific, Inc.
9.2.11.1 Company overview
9.2.11.2 Financial performance
9.2.11.3 Product benchmarking
9.2.11.4 Strategic initiatives
9.2.12 Nelson Laboratories, Inc.
9.2.12.1 Company overview
9.2.12.2 Financial performance
9.2.12.3 Product benchmarking
9.2.12.4 Strategic initiatives
9.2.13 Rapid Micro Biosystems, Inc.
9.2.13.1 Company overview
9.2.13.2 Financial performance
9.2.13.3 Product benchmarking
List of Tables
TABLE 1 Global Pharmaceutical Sterility Testing Market, by region, 2014 - 2025 (USD Million)
TABLE 2 Global Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 3 Global Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 4 Global Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 5 Global Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
TABLE 6 North America Pharmaceutical Sterility Testing Market, by region, 2014 - 2025 (USD Million)
TABLE 7 North America Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 8 North America Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 9 North America Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 10 North America Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
TABLE 11 U.S. pharmaceutical Sterility Testing Market, by region, 2014 - 2025 (USD Million)
TABLE 12 U.S. Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 13 U.S. Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 14 U.S. Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 15 U.S. Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
TABLE 16 Canada Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 17 Canada Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 18 Canada Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 19 Canada Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 20 Canada Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
TABLE 21 Europe Pharmaceutical Sterility Testing Market, by region, 2014 - 2025 (USD Million)
TABLE 22 Europe Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 23 Europe Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 24 Europe Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 25 Europe Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
TABLE 26 U.K. Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million))
TABLE 27 U.K. Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 28 U.K. Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 29 U.K. Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
TABLE 30 Germany Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 31 Germany Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 32 Germany Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 33 Germany Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
TABLE 34 Asia Pacific Pharmaceutical Sterility Testing Market, by region, 2014 - 2025 (USD Million)
TABLE 35 Asia Pacific Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 36 Asia Pacific Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 37 Asia Pacific Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 38 Asia Pacific Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
TABLE 39 Japan Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 40 Japan Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 41 Japan Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 42 Japan Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
TABLE 43 China Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 44 China Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 45 China Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 46 China Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
TABLE 47 Latin America Pharmaceutical Sterility Testing Market, by region, 2014 - 2025 (USD Million)
TABLE 48 Latin America Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 49 Latin America Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 50 Latin America Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 51 Latin America Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
TABLE 52 Brazil Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 53 Brazil Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 54 Brazil Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 55 Brazil Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
TABLE 56 Mexico Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 57 Mexico Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 58 Mexico Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 59 Mexico Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
TABLE 60 MEA Pharmaceutical Sterility Testing Market, by region, 2014 - 2025 (USD Million)
TABLE 61 MEA Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 62 MEA Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 63 MEA Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 64 MEA Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
TABLE 65 South Africa Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 66 South Africa Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 67 South Africa Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 68 South Africa Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
TABLE 69 Saudi Arabia Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 70 Saudi Arabia Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 71 Saudi Arabia Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 72 Saudi Arabia Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 73 Saudi Arabia Pharmaceutical Sterility Testing Market, by sample, 2014 - 2025 (USD Million)
List of Figures
FIG. 1 Market research process
FIG. 2 Information Procurement
FIG. 3 Primary research pattern
FIG. 4 Market research approaches
FIG. 5 Value chain-based sizing & forecasting
FIG. 6 QFD modelling for market share assessment
FIG. 7 Market summary (USD Million), 2016
FIG. 8 Market trends & outlook
FIG. 9 Market segmentation & scope
FIG. 10 Market driver relevance analysis (Current & future impact)
FIG. 11 Market restraint relevance analysis (Current & future impact)
FIG. 12 Penetration & growth prospect mapping
FIG. 13 SWOT Analysis, By Factor (political & legal, economic and technological)
FIG. 14 Porter’s Five Forces Analysis
FIG. 15 Pharmaceutical sterility testing market type outlook key takeaways
FIG. 16 Pharmaceutical sterility testing market: Type movement analysis
FIG. 17 In house pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 18 Outsourcing pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 19 Pharmaceutical sterility testing market test type outlook key takeaways
FIG. 20 Pharmaceutical sterility testing market: Test -type movement analysis
FIG. 21 Sterility testing market, 2014 - 2025 (USD Million)
FIG. 22 Bioburden testing market, 2014 - 2025 (USD Million)
FIG. 23 Bacterial Endotoxin testing market, 2014 - 2025 (USD Million)
FIG. 24 Pharmaceutical sterility testing market End -use outlook key takeaways
FIG. 25 Pharmaceutical sterility testing market: End use movement analysis
FIG. 26 Compounding pharmacies market, 2014 - 2025 (USD Million)
FIG. 27 Medical devices companies market, 2014 - 2025 (USD Million)
FIG. 28 Pharmaceutical companies market, 2014 - 2025 (USD Million)
FIG. 29 Others market, 2014 - 2025 (USD Million)
FIG. 30 Pharmaceutical sterility testing market sample outlook key takeaways
FIG. 31 Pharmaceutical sterility testing market: Sample movement analysis
FIG. 32 Sterile drugs market, 2014 - 2025 (USD Million)
FIG. 33 Medical devices market, 2014 - 2025 (USD Million)
FIG. 34 Biologics & therapeutics market, 2014 - 2025 (USD Million)
FIG. 35 Regional market place: Key takeaways
FIG. 36 Regional outlook, 2016 & 2025
FIG. 37 North America Pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 38 U.S. Pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 39 Canada Pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 40 Europe pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 41 U.K. Pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 42 Germany pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 43 Asia Pacific pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 44 Japan Pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 45 China pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 46 Latin America pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 47 Brazil Pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 48 Mexico pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 49 MEA pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 50 South Africa pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 51 Saudi Arabia pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 52 Strategy framework

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