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.
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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.
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
o U.S.
o Canada
• Europe
o U.K.
o Germany
• Asia Pacific
o Japan
o China
• Latin America
o Brazil
o Mexico
• Middle East & Africa
o Saudi Arabia
o South Africa