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U.S. Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type (In-house, Outsourced), By Test Type (Bacterial Endotoxin, Sterility), By End Use, By Sample, And Segment Forecasts, 2018 - 2025

U.S. Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type (In-house, Outsourced), By Test Type (Bacterial Endotoxin, Sterility), By End Use, By Sample, And Segment Forecasts, 2018 - 2025

The U.S. pharmaceutical sterility testing market size is expected to reach USD 713.6 million by 2025, according to a new report by Grand View Research, Inc. It is anticipated to expand at a CAGR of 11.3% over the forecast period. Supportive government investment in healthcare industry, increasing R&D activities, and drug launches are the key factors driving market growth.

The government is keen on bringing down healthcare costs which is anticipated to encourage the U.S. Food and Drug Administration (FDA) to promote fast approvals of generic pharmaceuticals. Faster approvals drive the need for newer sterility testing methods. This is anticipated to encourage market participants to spend more on sterility solutions and in turn, expand the market. With increasing demand for drugs, companies are launching newer drugs with different routes of administration, dosage, and indication. These launches require thorough sterility testing and thus, are anticipated to drive market growth.

On the basis of type, the U.S. pharmaceutical sterility testing market is segmented into in-house and outsourcing. Most market players prefer outsourcing sterility testing services, as it is economically viable. Companies shortlist and select outsourcing firms based on their experience, expertise, and quality of service. Hence, it is difficult for new players to enter into this area.

Companies active in the U.S. pharmaceutical sterility testing market are Charles River Laboratories, Pace Analytical Series LLC, DynaLabs, Infinity, Boston Analytical, and others. Market players employ various growth strategies such as mergers, capacity expansion, and venturing into new regions. For instance, in April 2018, Charles River Labs completed acquisition of MPI Research, a non-clinical Contract Research Organization (CRO) providing detailed services to medical device and biopharmaceutical companies. This acquisition is anticipated to expand biotechnology client base of the former and to provide the company access to MPI’s scientific expertise and quality services.

Further key findings from the report suggest:

  • U.S. pharmaceutical sterility testing market was valued at USD 302.2 million in 2017 and is expected to grow lucratively over the forecast period
  • In terms of revenue, outsourcing segment is anticipated to grow at a lucrative rate during the forecast period.
  • Sterility testing segment was valued at USD 97.6 million in 2016 and is anticipated to witness swift growth over the forecast period.


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 U.S. Pharmaceutical Sterility Testing Market Snapshot
Chapter 3 U.S. Pharmaceutical Sterility Testing Market: Variables, Trends & Scope
3.1 U.S. Pharmaceutical Sterility Testing 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 U.S. Pharmaceutical Sterility Testing Market - SWOT Analysis, By Factor (political & legal, economic and technological)
3.4 Industry Analysis - Porter’s
Chapter 4 U.S. Pharmaceutical Sterility Testing Market: Type Estimates & Trend Analysis
4.1 U.S. 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 Outsourced pharmaceutical sterility testing
4.3.1 Outsourced pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
Chapter 5 U.S. Pharmaceutical Sterility Testing Market: Test Type Estimates & Trend Analysis
5.1 U.S. 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 U.S. Pharmaceutical Sterility Testing Market: End-use Estimates & Trend Analysis
6.1 U.S. pharmaceutical sterility testing market: End-use movement analysis
6.2 Compounding pharmacies
6.2.1 Compounding pharmacies market, 2014 - 2025 (USD Million)
6.3 Medical device companies
6.3.1 Medical device 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 U.S. Pharmaceutical Sterility Testing Market: Sample Estimates & Trend Analysis
7.1 U.S. pharmaceutical sterility testing market: Sample movement analysis
7.2 Sterility drugs
7.2.1 Sterility 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 market, 2014 - 2025 (USD Million)
Chapter 8 Regional Estimates & Trend Analysis, by Type, Test type, Sample, End-use
8.1 U.S. Pharmaceutical Sterility Testing Market 2014 & 2025
8.1.1 U.S. Pharmaceutical Sterility Testing Market, 2014 - 2025 (USD Million)
Chapter 9 Competitive Landscape
9.1 Strategy framework
9.2 Company Profiles
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 Infinity Laboratories
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 Dynalabs
9.2.6.1 Company Overview
9.2.6.2 Financial Performance
9.2.6.3 Product Benchmarking
9.2.6.4 Strategic Initiatives
9.2.7 SGS SA
9.2.7.1 Company Overview
9.2.7.2 Financial Performance
9.2.7.3 Product Benchmarking
9.2.7.4 Strategic Initiatives
9.2.8 Toxikon, Inc.
9.2.8.1 Company Overview
9.2.8.2 Financial Performance
9.2.9 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
List of Tables
TABLE 1 U.S. Pharmaceutical Sterility Testing Market, by region, 2014 - 2025 (USD Million)
TABLE 2 U.S. Pharmaceutical Sterility Testing Market, by type, 2014 - 2025 (USD Million)
TABLE 3 U.S. Pharmaceutical Sterility Testing Market, by test type, 2014 - 2025 (USD Million)
TABLE 4 U.S. Pharmaceutical Sterility Testing Market, by end-use, 2014 - 2025 (USD Million)
TABLE 5 U.S. 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 U.S. pharmaceutical sterility testing market: Segmentation & scope
FIG. 10 Market driver relevance analysis (Current & future impact)
FIG. 11 FDA drug approval in 2016 vs 2017.
FIG. 12 Market restraint relevance analysis (Current & future impact)
FIG. 13 Penetration & growth prospect mapping
FIG. 14 SWOT Analysis, By Factor (political & legal, economic and technological)
FIG. 15 Porter’s Five Forces Analysis
FIG. 16 U.S. pharmaceutical sterility testing market: Type outlook & key takeaways
FIG. 17 U.S. pharmaceutical sterility testing market: Type movement analysis
FIG. 18 In-house pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 19 Outsourced pharmaceutical sterility testing market, 2014 - 2025 (USD Million)
FIG. 20 U.S. pharmaceutical sterility testing market: Test type outlook & key takeaways
FIG. 21 U.S. pharmaceutical sterility testing market: Test type movement analysis
FIG. 22 Sterility testing market, 2014 - 2025 (USD Million)
FIG. 23 Bioburden testing market, 2014 - 2025 (USD Million)
FIG. 24 Bacterial endotoxin testing market, 2014 - 2025 (USD Million)
FIG. 25 U.S. pharmaceutical sterility testing market: End-use outlook & key takeaways
FIG. 26 U.S. pharmaceutical sterility testing market: End-use movement analysis
FIG. 27 Compounding pharmacies market, 2014 - 2025 (USD Million)
FIG. 28 Medical device companies market, 2014 - 2025 (USD Million)
FIG. 29 Pharmaceutical companies market, 2014 - 2025 (USD Million)
FIG. 30 Others market, 2014 - 2025 (USD Million)
FIG. 31 U.S. pharmaceutical sterility testing market: Sample outlook & key takeaways
FIG. 32 U.S. pharmaceutical sterility testing market: Test type movement analysis
FIG. 33 Sterility drugs market, 2014 - 2025 (USD Million)
FIG. 34 Medical devices market, 2014 - 2025 (USD Million)
FIG. 35 Biologics & therapeutics market, 2014 - 2025 (USD Million)
FIG. 36 U.S. Pharmaceutical Sterility Testing Market, 2014 - 2025 (USD Million)
FIG. 37 Strategy framework

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