ID: MRFR/HC/9236-HCR | 120 Pages | Published By Rahul Gotadki on March 2023
The global pharmaceutical sterility testing market is expected to cross USD 900 million by 2030 at a CAGR of 6.10%.
$900 million
6.10%
North America
2022- 2030
The pharmaceutical sterility testing market is expected to cross USD 900 Million by 2030 at a CAGR of 6.10%. Sterility is the non-appearance of viable microorganisms, dust, fibers, foreign particles, and other biological agents. Pharmaceutical sterility testing is a major aspect of good manufacturing practice (GMP) microbiology and is crucial for tissue materials, pharmaceutical preparations, and medical devices, all of which must be sterile due to their intended use. Moreover, it is also used for cell banks, raw materials, and pharmacological finished goods. According to the laws of the European Pharmacopoeia and United States Pharmacopoeia, pharmaceutical preparations and substances must be made sterile. For instance, all parenteral biological formulations intended for human use must be sterile; hence sterility testing is required. The major factors driving the pharmaceutical sterility testing market include an increasing number of drug launches, expansion of the biotechnology & pharmaceutical industry, and increasing R&D in life science research. Moreover, new technological development and improving focus on quality control in accordance with regulatory requirements further contribute to the market growth. However, time-consuming and stringent regulatory policies are the factors that may hamper market growth.
COVID-19 Analysis
The global pharmaceutical sterility testing market emerged from the COVID-19 shut down due to the pharmaceutical and biotech companies' race to discover a vaccine for the COVID-19. Speedy testing is essential to verify that a vaccine is safe, effective, and approved by regulatory agencies. Every vaccine and injection given to patients must pass final product sterility testing to be considered safe. This will drive the pharmaceutical sterility testing market and is expected to grow at a rapid pace during the pandemic period. However, many vaccine manufacturers currently utilize a 14-day sterility test, which means each lot of vaccine must wait two weeks before being released to the public. Due to this time-consuming factor, market growth may be hampered.
Market Dynamics
Growing government initiatives towards the biotechnology sector
Report Attribute/Metric | Details |
---|---|
Market Size | 2027: USD 1,285.8 Million |
CAGR | 6.6% |
Base Year | 2020 |
Forecast Period | 2021-2027 |
Historical Data | 2018-2019 |
Forecast Units | Value (USD Million) |
Report Coverage | Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
Segments Covered | Sample, Product Type, Type, Test Type, and End User |
Geographies Covered | North America, Europe, Asia-Pacific, and Rest of the World (RoW) |
Key Vendors | • Merck KGaA (Germany) • Rapid Micro Biosystems (US) • Sartorius AG (Germany) • Solvias AG (Switzerland) • SGS SA (Switzerland) • Boston Analytical (US) • bioMérieux, Inc. (France) • Charles River Laboratories International, Inc. (US) • Thermo Fisher Scientific, Inc. (US) • Pace Analytical Services, LLC (US) • Toxikon, Inc. (US) • Sotera Health (US) • Pacific Biolabs Inc. (US) • STRERIS Corporation (US) • WuXi AppTec (China) |
Key Market Opportunities | • Growing government initiatives towards the biotechnology sector |
Key Market Drivers | • Increasing number of drug approvals and new drug launches • Increasing cases of patients suffering from cardiovascular diseases and cancer • New technological developments |
The pharmaceutical sterility testing market is expected to cross USD 900 million by 2030 at a CAGR of 6.10%.
Merck KGaA (Germany), Rapid Micro Biosystems (US), Sartorius AG (Germany), Solvias AG (Switzerland), SGS SA (Switzerland), Boston Analytical (US), bioMérieux, Inc. (France), Charles River Laboratories International, Inc. (US), Thermo Fisher Scientific, Inc. (US), Pace Analytical Services, LLC (US), Toxikon, Inc. (US), Sotera Health (US), Pacific Biolabs Inc. (US), STRERIS Corporation (US), and WuXi AppTec (China) are the key players in the market of pharmaceutical sterility testing
North America is predicted to lead the the market of pharmaceutical sterility testing
Increasing number of new drug launches and expansion of the biotechnology & pharmaceutical industry are the major market driver of pharmaceutical sterility testing
Time-consuming and stringent regulatory policies may limit the market growth of pharmaceutical sterility testing