Global Pharmaceutical Sterility Testing Market Report, 2018-2025 - Increasing Number of Drug Launches Coupled with Rising R&D Expenditure
DUBLIN, Nov. 15, 2018 /PRNewswire/ --
The "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" report has been added to ResearchAndMarkets.com's offering.
The global pharmaceutical sterility testing market size is expected to reach USD 2.0 billion by 2025
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.
Key Topics Covered:
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
4.3 Outsourcing pharmaceutical sterility testing
Chapter 5 Test-Type Estimates & Trend Analysis
5.1 Pharmaceutical sterility testing market: Test type movement analysis
5.2 Sterility Testing
5.3 Bioburden testing
5.4 Bacterial Endotoxin testing
Chapter 6 End-use Estimates & Trend Analysis
6.1 Pharmaceutical sterility testing market: End-use movement analysis
6.2 Compounding Pharmacies
6.3 Medical Devices Companies
6.4 Pharmaceutical companies
6.5 Others
Chapter 7 Sample Estimates & Trend Analysis
7.1 Pharmaceutical sterility testing market: Sample movement analysis
7.2 Sterile drugs
7.3 Medical devices
7.4 Biologics & therapeutics
Chapter 8 Regional Estimates & Trend Analysis, by Services
Chapter 9 Competitive Landscape
- Pacific Biolabs
- STERIS Corporation
- Boston Analytical
- Gibraltar Laboratories
- Sartorius AG
- Solvias AG
- SGS SA
- Toxikon, Inc
- Pace Analytical Services LLC
- Charles River Laboratories International, Inc
- Thermo Fisher Scientific, Inc.
- Nelson Laboratories, Inc.
- Rapid Micro Biosystems, Inc.
For more information about this report visit https://www.researchandmarkets.com/research/k63vn5/global?w=5
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