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, 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, the company offers market intelligence studies ensuring relevant and fact-based research across a range of industries including technology, chemicals, materials, healthcare and energy.
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