The Pharmaceutical Sterility Testing Market Size was valued at USD 1.45 billion in 2022, and is expected to reach USD 3.68 billion by 2030, and grow at a CAGR of 12.1% over the forecast period 2023-2030.
The pharmaceutical sterility testing market consists of sales made used to verify that medical products are free of the presence of live microorganisms. Pharmaceutical sterility tests examine biological parenteral intended for human use for the presence of microorganisms. Pharmaceutical sterility testing is an essential step in the production of medicines, medical devices, and therapeutics. It evaluates the efficacy of a sterilizing process and is done at every stage of production to lower the possibility of product contamination.
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DRIVERS
The emergence of more novel drugs and the growth of the biotechnology and pharmaceutical industries
Fresh technical innovations
Increasing R&D spending on life science research
RESTRAINTS
Strict regulations that take time to comply with
Shortage of highly qualified personnel
OPPORTUNITIES
Increasing government efforts to support the biotechnology industry
CHALLENGES
Processes that take a long time could impede growth
The COVID-19 shutdown resulted from the pharmaceutical and biotech industries' race to develop a COVID-19 vaccine, which led to the market for pharmaceutical sterility testing to arise. In order to confirm that a vaccination is secure, reliable, and sanctioned by regulatory bodies, quick testing is necessary. A final product sterility test must be passed before any vaccine or injection given to patients is deemed safe. In the pandemic phase, this is anticipated to drive the pharmaceutical sterility testing industry, which will expand quickly. The 14-day sterility test, which is currently used by many vaccine producers, necessitates a two-week delay before any lot of vaccine may be distributed to the general population. The expansion of the market could be hindered by this time-consuming aspect.
By Product Type
Instruments: A wide range of gear and equipment are included in the instruments section. Each tool is essential to the accomplishment of every stage in the production process. High-temperature sterilization equipment, low-temperature sterilization equipment, ionizing radiation equipment, non-ionizing radiation equipment, and filtration sterilization equipment are all needed in the pharmaceutical sterility testing sector.
Kits and Reagents: Kits and reagents include sterile soybean casein digest medium and sterile fluid thioglycolate media. It is renowned as a quick approach for checking the sterility of pharmaceuticals and is inexpensive and simple to use. One major element fueling the expansion of the kits & reagent segment is the frequent acquisition of these items by end customers over the globe.
Services: Services are intended to deal with issues that arise at various phases of the sterility test. To diversify their product offerings and increase their market share, businesses in the pharmaceutical sterility testing industry are launching new sterility testing services. To take advantage of the pharmaceutical sterility testing market's growing potential, the corporations have introduced well-equipped services.
By Type
In-house Internal sterility testing is a crucial component of quality assurance and Good Manufacturing Practices for businesses that manufacture drugs, biologics, and medical devices. The segment can grow because every batch must pass sterility tests before being distributed.
Outsourcing Some pharmaceutical and medical device businesses do not have the infrastructure required to do high-quality sterility testing; thus, this can be done. They choose to contract out these services. Additionally, in order to save money, many businesses outsource sterility testing.
By End User
Compounding Pharmacies: The Drug Quality and Security Act gives the FDA the authority to oversee and regulate the compounding of pharmaceuticals, which encourages compounding pharmacies to employ sterility testing practices. Additionally, in order to prevent any negative outcomes, the regulatory framework for sterile products in pharmacies is becoming increasingly strict.
Medical device companies: Medical device firms offer a variety of sterile items to the end user, including equipment, machinery, apparatus, and implants. The need for pharmaceutical sterility testing for the medical device firms is driven by government backing for the industry and improvements in sterilizing technologies.
Pharmaceutical Businesses: To assess the quality of raw materials, process control, and end-product validation, pharmaceutical companies used sterility testing. Pharmaceutical businesses typically employ good manufacturing practices (GMP) regulations and "pharmacopoeia" methods to test pharmaceuticals. The market is expanding as a result of the increased number of pharmaceutical companies and drug launches across the world.
By Sample
Sterile medications: Isotonic sterile medications must be free of any germs. Ophthalmic and parenteral formulations are examples of sterile dosage forms. Injections, transfusion fluids, sterile solids, sterile solutions, or emulsions are examples of parenteral preparations. Ophthalmic preparations include eye gels, eye drops, eye ointments, eye suspensions, eye lotions, and contact lens solutions.
Medical Devices: Manufacturers of medical equipment work hard to provide products that are safe and effective, and sterility assurance is a crucial step in that process. Medical equipment sterility is evaluated using soybean-casein digest media.
Biologics: A powerful medication that lessens the negative consequences of inflammation is known as a biologic. Both vaccinations and biosimilars are part of it.
By Sample
Sterile Drugs
Medical Devices
Biologics
By Product Type
Instruments
Kits & Reagents
Services
Sterility Testing
Bioburden Testing
Bacterial Endotoxin Testing
By Type
In-house
Outsourcing
By End User
Compounding Pharmacies
Medical Devices Companies
Pharmaceutical Companies
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Medical device companies: Medical device firms offer a variety of sterile items to the end user, including equipment, machinery, apparatus, and implants. The need for pharmaceutical sterility testing for the medical device firms is driven by government backing for the industry and improvements in sterilizing technologies.
Pharmaceutical Businesses: To assess the quality of raw materials, process control, and end-product validation, pharmaceutical companies used sterility testing. Pharmaceutical businesses typically employ good manufacturing practices (GMP) regulations and "pharmacopoeia" methods to test pharmaceuticals. The market is expanding as a result of the increased number of pharmaceutical companies and drug launches across the world.
REGIONAL COVEREGE:
North America
USA
Canada
Mexico
Europe
Germany
UK
France
Italy
Spain
The Netherlands
Rest of Europe
Asia-Pacific
Japan
south Korea
China
India
Australia
Rest of Asia-Pacific
The Middle East & Africa
Israel
UAE
South Africa
Rest of Middle East & Africa
Latin America
Brazil
Argentina
Rest of Latin America
Major key players are BioMérieux, Inc., Charles River Laboratories International, Inc., Boston Analytical, Rapid Micro Biosystems, SGS SA, Pace Analytical Services, LLC, Sotera Health, Merck KGaA, Solvias AG, Thermo Fisher Scientific, Inc., Sartorius AG, Toxikon, Inc. and other players.
| Report Attributes | Details |
|---|---|
| Market Size in 2022 | US$ 1.45 Billion |
| Market Size by 2030 | US$ 3.68 Billion |
| CAGR | CAGR of 12.1% From 2023 to 2030 |
| Base Year | 2022 |
| Forecast Period | 2023-2030 |
| Historical Data | 2020-2021 |
| Report Scope & Coverage | Market Size, Segments Analysis, Competitive Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook |
| Key Segments | • by Sample (Sterile Drugs, Medical Devices, Biologics) • By Product Type (Instruments, Kits & Reagents, Services, Sterility Testing, Bioburden Testing, Bacterial Endotoxin Testing) • By Type (In-house, Outsourcing) • By End User (Compounding Pharmacies, Medical Devices Companies, Pharmaceutical Companies) |
| Regional Analysis/Coverage | North America (USA, Canada, Mexico), Europe (Germany, UK, France, Italy, Spain, Netherlands, Rest of Europe), Asia-Pacific (Japan, South Korea, China, India, Australia, Rest of Asia-Pacific), The Middle East & Africa (Israel, UAE, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America) |
| Company Profiles | BioMérieux, Inc., Charles River Laboratories International, Inc., Boston Analytical, Rapid Micro Biosystems, SGS SA, Pace Analytical Services, LLC, Sotera Health, Merck KGaA, Solvias AG, Thermo Fisher Scientific, Inc., Sartorius AG, Toxikon, Inc. |
| Key Drivers | • Fresh technical innovations • Increasing R&D spending on life science research |
| RESTRAINTS | • Strict regulations that take time to comply with • Shortage of highly qualified personnel |
Ans. The Pharmaceutical Sterility Testing Market Size was valued at USD 1.45 billion in 2022.
Ans: The Pharmaceutical Sterility Testing Market is to grow at a CAGR of 12.1% over the forecast period 2023-2030.
Ans. Key drivers of the Pharmaceutical Sterility Testing Market is Fresh technical innovations, and Increasing R&D spending on life science research
Ans. BioMérieux, Inc., Charles River Laboratories International, Inc., Boston Analytical, Rapid Micro Biosystems, SGS SA, are the key plyer of Pharmaceutical Sterility Testing Market.
Ans. Top-down, bottom-up, Quantitative, Qualitative Research, Descriptive, Analytical, Applied, Fundamental Research.
Table of Contents
1. Introduction
1.1 Market Definition
1.2 Scope
1.3 Research Assumptions
2. Research Methodology
3. Market Dynamics
3.1 Drivers
3.2 Restraints
3.3 Opportunities
3.4 Challenges
4. Impact Analysis
4.1 COVID-19 Impact Analysis
4.2 Impact of Ukraine- Russia War
4.3 Impact of Ongoing Recession
4.3.1 Introduction
4.3.2 Impact on major economies
4.3.2.1 US
4.3.2.2 Canada
4.3.2.3 Germany
4.3.2.4 France
4.3.2.5 United Kingdom
4.3.2.6 China
4.3.2.7 Japan
4.3.2.8 South Korea
4.3.2.9 Rest of the World
5. Value Chain Analysis
6. Porter’s 5 forces model
7. PEST Analysis
8. Pharmaceutical Sterility Testing Market Segmentation, By Sample
8.1 Sterile Drugs
8.2 Medical Devices
8.3 Biologics
9. Pharmaceutical Sterility Testing Market Segmentation, By Product Type
9.1 Instruments
9.2 Kits & Reagents
9.3 Services
9.4 Sterility Testing
9.5 Bioburden Testing
9.6 Bacterial Endotoxin Testing
10. Pharmaceutical Sterility Testing Market Segmentation, By Type
10.1 In-house
10.2 Outsourcing
11. Pharmaceutical Sterility Testing Market Segmentation, By End User
11.1 Compounding Pharmacies
11.2 Medical Devices Companies
11.3 Pharmaceutical Companies
12. Regional Analysis
12.1 Introduction
12.2 North America
12.2.1 USA
12.2.2 Canada
12.2.3 Mexico
12.3 Europe
12.3.1 Germany
12.3.2 UK
12.3.3 France
12.3.4 Italy
12.3.5 Spain
12.3.6 The Netherlands
12.3.7 Rest of Europe
12.4 Asia-Pacific
12.4.1 Japan
12.4.2 South Korea
12.4.3 China
12.4.4 India
12.4.5 Australia
12.4.6 Rest of Asia-Pacific
12.5 The Middle East & Africa
12.5.1 Israel
12.5.2 UAE
12.5.3 South Africa
12.5.4 Rest
12.6 Latin America
12.6.1 Brazil
12.6.2 Argentina
12.6.3 Rest of Latin America
13. Company Profiles
13.1 BioMérieux, Inc.
13.1.1 Financial
13.1.2 Products/ Services Offered
13.1.3 SWOT Analysis
13.1.4 The SNS view
13.2 Charles River Laboratories International, Inc.
13.3 Boston Analytical
13.4 Rapid Micro Biosystems
13.5 SGS SA
13.6 Pace Analytical Services, LLC
13.7 Sotera Health
13.8 Merck KGaA
13.9 Solvias AG
13.10 Thermo Fisher Scientific, Inc.
14. Competitive Landscape
14.1 Competitive Benchmark
14.2 Market Share Analysis
14.3 Recent Developments
15. Conclusion
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