Global Sterility Testing Market - 2021-2028
Description
Global Sterility Testing Market - 2021-2028
Market Overview
The global sterility testing market size was valued at US$ XX million in 2020 and is estimated to reach US$ XX million by 2028, growing at a CAGR of XX % during the forecast period (2021-2028).
Sterility testing is a GMP (Good Manufacturing Process) microbiology testing requirement to ensure that sterile products are free of viable microorganisms before release and patient administration.
Market Dynamics
The major factors contributing to the growth of the global sterility testing market are the increasing R&D, and the increasing number of drug approvals is expected to drive the market growth.
The increasing number of drug approvals is expected to drive the market growth in the forecast period
The development or validation of product-specific methods and reliable sterility testing are critical steps in drug development. Sterility testing is required to ensure no viable contaminating microorganisms in a product. This testing is done in an isolator or cleanroom environment using direct inoculation or membrane filtration methods. Pharmaceutical articles must be sterile tested during the sterilization validation process and routine release testing. USP requirements use sterility testing as an official test to determine the suitability of a lot.
For instance, according to the Congressional Budget Office's April 2021 report on ""Research and Development in Pharmaceutical Industry,"" there was a 60% increase in the number of new drugs approved for sale in the United States between 2010 and 2019, with 59 new drugs approved in the country in 2018. Hence, with increasing drug approvals and launches, the global sterility testing market is expected to grow in the forecast period.
The problems associated with sterility testing is expected to hamper the market growth
In addition to the significant limitation of testing sterilized products, there is also the uncertainty associated with sterility testing execution. Contamination of the test by non–product-related microorganisms is one of the issues with sterility testing. The USP describes a typical contamination rate for sterility testing of 0.1 percent or 1 per 1,000 samples. This level is likely to rise as test article size, complexity, and manipulation increase. Thus, even if one attempted to test the fully sterilized product with the massive sample size required to verify a typical SAL of 106, the test method would almost certainly fall short of the required precision. In addition to the significant limitation of testing sterilized products, there is also the uncertainty associated with sterility testing execution.
COVID-19 Impact Analysis
The COVID-19 pandemic forced most pharmaceutical and biotechnological companies to focus on research and development to identify leads that can diagnose and treat the SARS-CoV-2 infection, as well as forcing them to look beyond just conventional medicine and therapy, resulting in massive investment in research and development activities by private and government entities all over the world, significantly increasing the growth of sterility testing market.
Segment Analysis
Based on application, the pharmaceutical and biological manufacturing segment is expected to drive the market growth
Sterility testing is performed at all pharmaceutical and biological product manufacturing levels to reduce the risk of product contamination. The rapid growth of the pharmaceutical and biological industries will significantly increase the overall use of sterility testing, resulting in high demand for sterility testing products and solutions. Sterility testing is performed in the manufacturing process of any pharmaceutical or biological product for raw materials, finished product, and even before the final product is released to ensure the absence of microorganisms as per the mandated regulations of the regulatory authority or institutions, and as the demand for pharmaceutical and medical products for various health conditions increases, so does the frequency of sterility testing in the industries. Furthermore, rising investment in research and development and increasing regulatory approvals for drugs and other biologics are propelling new drugs and products, which is expected to fuel the market in the coming years.
For instance, on 22nd November 2019, Reading Scientific Services Ltd. launched a fast, responsive, and flexible sterility testing service for pharmaceutical companies.
Geographical Analysis
North America region is expected to hold the largest market share in the global sterility testing market
The increased research and innovation in the biotechnology and pharmaceutical industries in the regions increased investment in research and development activities in the life sciences and medical technology, and favorable government initiatives are expected to drive the market growth. For instance, according to Statistics Canada's May 2021 report ""The Canadian Research and Development Pharmaceutical Sector,"" in 2018, the pharmaceutical sector added nearly USD 15 billion in value-added to the Canadian economy while spending approximately USD 1.5 billion to USD 2 billion on research and development.
Furthermore, high-end research activities in academics and research institutes will drive the growth of the country's sterility testing market over the forecast period.
Global Sterility Testing Market- Competitive Landscape
The global sterility testing market is highly competitive with mergers, collaborations, and product launches. Some of the major key players in the market are BioMérieux, Charles River Laboratories, Inc., Merck KGaA, Sartorius AG, SGS S.A., Sotera Health LLC, Thermo Fisher Scientific, Alcami Corporation, Redberry, Lucideon
Redberry
Overview: Redberry company creates new platforms to avoid the culture phase of microorganisms in industrial microbiology and thus provide immediate results at previously unheard-of costs, performance, and ease-of-use. It was founded in 2017.
Product Portfolio: Red One, a fully automated rapid microbial detection. Red One detects viable active microorganisms (bacteria, yeasts, and moulds) and eukaryotic cells. It can count samples with concentrations ranging from 10 to 5 10e5 microorganisms per cap (linear range).
Key Developments: On December 14th, 2020, Redberry launched Red One, a fully automated rapid microbial detection platform for in-process control and the release of industrial products.
Why Purchase the Report?
Visualize the composition of the global sterility testing market segmentation by product type, by test type, and application highlighting the key commercial assets and players.
Identify commercial opportunities in global sterility testing market by analyzing trends and co-development deals.
Excel data sheet with thousands of data points of global sterility testing market- level 4/5 segmentation.
PDF report with the most relevant analysis cogently put together after exhaustive qualitative interviews and in-depth market study.
Product mapping in excel for the key product of all major market players
The global sterility testing market report would provide an access to an approx. 45+market data table, 40+figures and 180 pages.
Target Audience
Service Providers/ Buyers
Industry Investors/Investment Bankers
Education & Research Institutes
Research Professionals
Emerging Companies
Manufacturers
Market Segmentation
Global Sterility Testing Market- By Product Type
Instruments
Kits and Reagents
Services
Global Sterility Testing Market- By Test Type
Membrane Filtration
Direct Inoculation
Other
Global Sterility Testing Market- By Application
Pharmaceutical and Biological Manufacturing
Medical Devices Manufacturing
Other
Global Sterility Testing Market- By Region
North America
Europe
South America
Asia Pacific
Middle East and Africa
Market Overview
The global sterility testing market size was valued at US$ XX million in 2020 and is estimated to reach US$ XX million by 2028, growing at a CAGR of XX % during the forecast period (2021-2028).
Sterility testing is a GMP (Good Manufacturing Process) microbiology testing requirement to ensure that sterile products are free of viable microorganisms before release and patient administration.
Market Dynamics
The major factors contributing to the growth of the global sterility testing market are the increasing R&D, and the increasing number of drug approvals is expected to drive the market growth.
The increasing number of drug approvals is expected to drive the market growth in the forecast period
The development or validation of product-specific methods and reliable sterility testing are critical steps in drug development. Sterility testing is required to ensure no viable contaminating microorganisms in a product. This testing is done in an isolator or cleanroom environment using direct inoculation or membrane filtration methods. Pharmaceutical articles must be sterile tested during the sterilization validation process and routine release testing. USP requirements use sterility testing as an official test to determine the suitability of a lot.
For instance, according to the Congressional Budget Office's April 2021 report on ""Research and Development in Pharmaceutical Industry,"" there was a 60% increase in the number of new drugs approved for sale in the United States between 2010 and 2019, with 59 new drugs approved in the country in 2018. Hence, with increasing drug approvals and launches, the global sterility testing market is expected to grow in the forecast period.
The problems associated with sterility testing is expected to hamper the market growth
In addition to the significant limitation of testing sterilized products, there is also the uncertainty associated with sterility testing execution. Contamination of the test by non–product-related microorganisms is one of the issues with sterility testing. The USP describes a typical contamination rate for sterility testing of 0.1 percent or 1 per 1,000 samples. This level is likely to rise as test article size, complexity, and manipulation increase. Thus, even if one attempted to test the fully sterilized product with the massive sample size required to verify a typical SAL of 106, the test method would almost certainly fall short of the required precision. In addition to the significant limitation of testing sterilized products, there is also the uncertainty associated with sterility testing execution.
COVID-19 Impact Analysis
The COVID-19 pandemic forced most pharmaceutical and biotechnological companies to focus on research and development to identify leads that can diagnose and treat the SARS-CoV-2 infection, as well as forcing them to look beyond just conventional medicine and therapy, resulting in massive investment in research and development activities by private and government entities all over the world, significantly increasing the growth of sterility testing market.
Segment Analysis
Based on application, the pharmaceutical and biological manufacturing segment is expected to drive the market growth
Sterility testing is performed at all pharmaceutical and biological product manufacturing levels to reduce the risk of product contamination. The rapid growth of the pharmaceutical and biological industries will significantly increase the overall use of sterility testing, resulting in high demand for sterility testing products and solutions. Sterility testing is performed in the manufacturing process of any pharmaceutical or biological product for raw materials, finished product, and even before the final product is released to ensure the absence of microorganisms as per the mandated regulations of the regulatory authority or institutions, and as the demand for pharmaceutical and medical products for various health conditions increases, so does the frequency of sterility testing in the industries. Furthermore, rising investment in research and development and increasing regulatory approvals for drugs and other biologics are propelling new drugs and products, which is expected to fuel the market in the coming years.
For instance, on 22nd November 2019, Reading Scientific Services Ltd. launched a fast, responsive, and flexible sterility testing service for pharmaceutical companies.
Geographical Analysis
North America region is expected to hold the largest market share in the global sterility testing market
The increased research and innovation in the biotechnology and pharmaceutical industries in the regions increased investment in research and development activities in the life sciences and medical technology, and favorable government initiatives are expected to drive the market growth. For instance, according to Statistics Canada's May 2021 report ""The Canadian Research and Development Pharmaceutical Sector,"" in 2018, the pharmaceutical sector added nearly USD 15 billion in value-added to the Canadian economy while spending approximately USD 1.5 billion to USD 2 billion on research and development.
Furthermore, high-end research activities in academics and research institutes will drive the growth of the country's sterility testing market over the forecast period.
Global Sterility Testing Market- Competitive Landscape
The global sterility testing market is highly competitive with mergers, collaborations, and product launches. Some of the major key players in the market are BioMérieux, Charles River Laboratories, Inc., Merck KGaA, Sartorius AG, SGS S.A., Sotera Health LLC, Thermo Fisher Scientific, Alcami Corporation, Redberry, Lucideon
Redberry
Overview: Redberry company creates new platforms to avoid the culture phase of microorganisms in industrial microbiology and thus provide immediate results at previously unheard-of costs, performance, and ease-of-use. It was founded in 2017.
Product Portfolio: Red One, a fully automated rapid microbial detection. Red One detects viable active microorganisms (bacteria, yeasts, and moulds) and eukaryotic cells. It can count samples with concentrations ranging from 10 to 5 10e5 microorganisms per cap (linear range).
Key Developments: On December 14th, 2020, Redberry launched Red One, a fully automated rapid microbial detection platform for in-process control and the release of industrial products.
Why Purchase the Report?
Visualize the composition of the global sterility testing market segmentation by product type, by test type, and application highlighting the key commercial assets and players.
Identify commercial opportunities in global sterility testing market by analyzing trends and co-development deals.
Excel data sheet with thousands of data points of global sterility testing market- level 4/5 segmentation.
PDF report with the most relevant analysis cogently put together after exhaustive qualitative interviews and in-depth market study.
Product mapping in excel for the key product of all major market players
The global sterility testing market report would provide an access to an approx. 45+market data table, 40+figures and 180 pages.
Target Audience
Service Providers/ Buyers
Industry Investors/Investment Bankers
Education & Research Institutes
Research Professionals
Emerging Companies
Manufacturers
Market Segmentation
Global Sterility Testing Market- By Product Type
Instruments
Kits and Reagents
Services
Global Sterility Testing Market- By Test Type
Membrane Filtration
Direct Inoculation
Other
Global Sterility Testing Market- By Application
Pharmaceutical and Biological Manufacturing
Medical Devices Manufacturing
Other
Global Sterility Testing Market- By Region
North America
Europe
South America
Asia Pacific
Middle East and Africa
Table of Contents
165 Pages
- 1. Global Sterility Testing Market Methodology and Scope
- 1.1. Research Methodology
- 1.2. Research Objective and Scope of the Report
- 2. Global Sterility Testing Market– Market Definition and Overview
- 3. Global Sterility Testing Market– Executive Summary
- 3.1. Market Snippet By Product Type
- 3.2. Market Snippet By Test Type
- 3.3. Market Snippet By Application
- 3.4. Market Snippet By Region
- 4. Global Sterility Testing Market-Market Dynamics
- 4.1. Market Impacting Factors
- 4.1.1. Drivers:
- 4.1.1.1. The increasing number of drug approvals
- 4.1.2. Restraints:
- 4.1.2.1. The problems associated with sterility testing
- 4.1.3. Opportunity
- 4.1.4. Impact Analysis
- 5. Global Sterility Testing Market– Industry Analysis
- 5.1. Porter's Five Forces Analysis
- 5.2. Supply Chain Analysis
- 5.3. Pricing Analysis
- 5.4. Regulatory Analysis
- 5.5. Unmet Needs
- 6. Global Sterility Testing Market– COVID-19 Analysis
- 6.1. Analysis of Covid-19 on the Market
- 6.1.1. Before COVID-19 Market Scenario
- 6.1.2. Present COVID-19 Market Scenario
- 6.1.3. After COVID-19 or Future Scenario
- 6.2. Pricing Dynamics Amid Covid-19
- 6.3. Demand-Supply Spectrum
- 6.4. Government Initiatives Related to the Market During Pandemic
- 6.5. Manufacturers Strategic Initiatives
- 6.6. Conclusion
- 7. Global Sterility Testing Market– By Product Type
- 7.1. Introduction
- 7.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
- 7.3. Market Attractiveness Index, By Product Type
- 7.3.1. Instruments
- 7.3.1.1.1. Introduction
- 7.3.1.1.2. Market Size Analysis, US$ Mn, 2019-2028 and Y-o-Y Growth Analysis (%), 2020-2028
- 7.2.2. Kits and Reagents
- 7.2.3. Services
- 8. Global Sterility Testing Market– By Test Type
- 8.1. Introduction
- 8.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
- 8.3. Market Attractiveness Index, By Test Type
- 8.3.2. Membrane Filtration
- 8.3.2.1.1. Introduction
- 8.3.2.1.2. Market Size Analysis, US$ Mn, 2019-2028 and Y-o-Y Growth Analysis (%), 2020-2028
- 8.3.3. Direct Inoculation
- 8.3.4. Other
- 9. Global Sterility Testing Market– By Application
- 9.1. Introduction
- 9.1.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 9.1.3. Market Attractiveness Index, By Application
- 9.2. Pharmaceutical and Biological Manufacturing*
- 9.2.2. Introduction
- 9.2.3. Market Size Analysis, US$ Million, 2019-2028 and Y-o-Y Growth Analysis (%), 2020-2028
- 9.3. Medical Devices Manufacturing
- 9.4. Other
- 10. Global Sterility Testing Market– By Region
- 10.1. Introduction
- 10.1.2. Market Size Analysis, US$ Million, 2019-2028 and Y-o-Y Growth Analysis (%), 2020-2028, By Region
- 10.1.3. Market Attractiveness Index, By Region
- 10.2. North America
- 10.2.2. Introduction
- 10.2.3. Key Region-Specific Dynamics Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
- 10.2.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
- 10.2.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 10.2.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
- 10.2.6.1. U.S.
- 10.2.6.2. Canada
- 10.2.6.3. Mexico
- 10.3. Europe
- 10.3.2. Introduction
- 10.3.3. Key Region-Specific Dynamics
- 10.3.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
- 10.3.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
- 10.3.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 10.3.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
- 10.3.7.1. Germany
- 10.3.7.2. U.K.
- 10.3.7.3. France
- 10.3.7.4. Italy
- 10.3.7.5. Spain
- 10.3.7.6. Rest of Europe
- 10.4. South America
- 10.4.2. Introduction
- 10.4.3. Key Region-Specific Dynamics Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
- 10.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
- 10.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 10.4.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
- 10.4.6.1. Brazil
- 10.4.6.2. Argentina
- 10.4.6.3. Rest of South America
- 10.5. Asia Pacific
- 10.5.2. Introduction
- 10.5.3. Key Region-Specific Dynamics Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
- 10.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
- 10.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 10.5.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
- 10.5.6.1. China
- 10.5.6.2. India
- 10.5.6.3. Japan
- 10.5.6.4. Australia
- 10.5.6.5. Rest of Asia Pacific
- 10.6. Middle East and Africa
- 10.6.2. Introduction
- 10.6.3. Key Region-Specific Dynamics Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
- 10.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
- 10.6.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 11. Global Sterility Testing Market– Competitive Landscape
- 11.1. Key Developments and Strategies
- 11.2. Company Share Analysis
- 11.3. Product Benchmarking
- 12. Global Sterility Testing Market- Company Profiles
- 12.1. Redberry*
- 12.1.2. Company Overview
- 12.1.3. Product Portfolio and Description
- 12.1.4. Key Highlights
- 12.1.5. Financial Overview
- 12.2. BioMérieux
- 12.2. Charles River Laboratories, Inc.
- 12.3. Merck KGaA
- 12.4. Sartorius AG
- 12.5. SGS S.A.
- 12.6. Sotera Health LLC
- 12.7. Thermo Fisher Scientific
- 12.8. Alcami Corporation
- 12.9. Lucideon
- LIST NOT EXHAUSTIVE
- 13. Global Sterility Testing Market– DataM
- 13.1.2. Appendix
- 13.1.3. About Us and Services
- 13.1.4. Contact Us
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