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.
Full Research Report On Pharmaceutical Sterility Testing Market Analysis:www.grandviewresearch.com/industry-analysis/pharmaceutical-sterility-testing-market
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.
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Grand View Research has segmented the global pharmaceutical sterility testing market on the basis of type, test type, end-use, sample and region:
Pharmaceutical Sterility Testing Type Outlook (Revenue, USD Million, 2014 – 2025)
In-house
Outsourcing
Pharmaceutical Sterility Testing Test type Outlook (Revenue, USD Million, 2014 – 2025)
Sterility Testing
Bioburden Testing
Bacterial Endotoxin Testing
Pharmaceutical Sterility Testing End-use Outlook (Revenue, USD Million, 2014 – 2025)
Compounding Pharmacies
Medical Devices Companies
Pharmaceutical Companies
Others
Pharmaceutical Sterility Testing Sample Outlook (Revenue, USD Million, 2014 – 2025)
Sterile Drugs
Medical Devices
Biologics & Therapeutics
Pharmaceutical Sterility Testing Regional Outlook (Revenue, USD Million, 2014 – 2025)
North America
U.S.
Canada
Europe
U.K.
Germany
Asia Pacific
Japan
China
Latin America
Brazil
Mexico
Middle East & Africa
Saudi Arabia
South Africa
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About Grand View ResearchGrand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, we offer market intelligence studies ensuring relevant and fact-based research across a range of industries, from technology to chemicals, materials and healthcare.
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