SNS Insider Black Friday Offer
Pharmaceutical Sterility Testing Market

Pharmaceutical Sterility Testing Market Size, Share & Segment 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), by Regions and Global Forecast 2022-2028

Report Id: SNS/HC/2520 | July 2022 | Region: Global | 134 Pages

Report Scope & Overview:

The Pharmaceutical Sterility Testing Market Size was valued at USD 1298.8 million in 2021, and is expected to reach USD 2889.2 million by 2028, and grow at a CAGR of 12.1% over the forecast period 2022-2028.

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.

Pharmaceutical Sterility Testing Market

MARKET DYNAMICS

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

IMPACT OF COVID-19

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.

COMPETITIVE LANDSCAPE

Some of the major key players are as follows: 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 MARKET 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

Pharmaceutical Sterility Testing Market

REGIONAL ANALYSIS

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

 

Pharmaceutical Sterility Testing Market Report Scope:
Report Attributes Details
Market Size in 2021 US$ 2889.2 Million
Market Size by 2028 US$ 1298.8 Million
CAGR CAGR of 12.1% From 2022 to 2028
Base Year 2021
Forecast Period 2022-2028
Historical Data 2017-2020
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


Frequently Asked Questions (FAQ) :

Ans. Pharmaceutical Sterility Testing Market Size was valued at USD 1298.8 million in 2021, and expected to reach USD 2889.2 million by 2028, and grow at a CAGR of 12.1% over the forecast period.

Ans. In-house, and Outsourcing are the sub segment of by type.

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 ware

 

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

 

An accurate research report requires proper strategizing as well as implementation. There are multiple factors involved in the completion of a good and accurate research report and selecting the best methodology to complete the research is the toughest part. Since the research reports, we provide play a crucial role in any company’s decision-making process, therefore we at SNS Insider always believe that we should choose the best method which gives us results closer to reality. This allows us to reach a stage wherein we can provide our clients best and most accurate investment to output ratio.

Each report that we prepare takes a timeframe of 350-400 business hours for production. Starting from the selection of titles through a couple of in-depth brainstorming sessions to the final QC process before uploading our titles on our website we dedicate around 350 working hours. The titles are selected based on their current market cap and the foreseen CAGR and growth.

 

The 5 steps process:

Step 1: Secondary Research:

Secondary Research or Desk Research as the name suggests is a research process wherein, we collect data through readily available information. In this process, we use various paid and unpaid databases to which our team has access and gather data through the same. This includes examining listed companies’ annual reports, Journals, SEC filling, etc. Apart from this, our team has access to various associations across the globe across different industries. Lastly, we have exchange relationships with various universities as well as individual libraries.

Secondary Research

Step 2: Primary Research

When we talk about primary research, it is a type of study in which the researchers collect relevant data samples directly, rather than relying on previously collected data.  This type of research is focused on gaining content-specific facts that can be sued to solve specific problems. Since the collected data is fresh and first-hand therefore it makes the study more accurate and genuine.

We at SNS Insider have divided Primary Research into 2 parts.

Part 1 wherein we interview the KOLs of major players as well as the upcoming ones across various geographic regions. This allows us to have their view over the market scenario and acts as an important tool to come closer to accurate market numbers. As many as 45 paid and unpaid primary interviews are taken from both the demand and supply sides of the industry to make sure we land an accurate judgment and analysis of the market.

This step involves the triangulation of data wherein our team analyses the interview transcripts, online survey responses, and observation of on-field participants. The below-mentioned chart should give a better understanding of part 1 of the primary interview.

Part 2: In this part of the primary research the data collected via secondary research and part 1 of the primary research is validated with the interviews with individual consultants and subject matter experts.

Consultants are those set of people who have at least 12 years of experience and expertise within the industry whereas Subject Matter Experts are those with at least 15 years of experience behind their back within the same space. The data with the help of two main processes i.e., FGDs (Focused Group Discussions) and IDs (Individual Discussions). This gives us a 3rd party nonbiased primary view of the market scenario making it a more dependable one while collation of the data pointers.

Step 3: Data Bank Validation

Once all the information is collected via primary and secondary sources, we run that information for data validation. At our intelligence center, our research heads track a lot of information related to the market which includes the quarterly reports, the daily stock prices, and other relevant information. Our data bank server gets updated every fortnight and that is how the information which we collected using our primary and secondary information is revalidated in real-time.

Step 4: QA/QC Process

After all the data collection and validation our team does a final level of quality check and quality assurance to get rid of any unwanted or undesired mistakes. This might include but is not limited to getting rid of the many typos, duplication of numbers, or missing any important information. The people involved in this process include technical content writers, research heads, and graphics people. Once this process is completed the title gets uploaded on our platform for our clients to read it.

Step 5: Final QC/QA Process:

This is the last process and comes when the client has ordered the study. In this process a final QA/QC is done before the study is emailed to the client. Since we believe in giving our clients a good experience of our research studies, therefore, to make sure that we do not lack at our end in any way humanly possible we do a final round of quality check and then dispatch the study to the client.