Pharmaceutical Sterility Testing Market

Pharmaceutical Sterility Testing Market Size

The Pharmaceutical Sterility Testing market will see a robust CAGR of 8.7%, valued at USD 1.22 billion in 2021, and is expected to reach USD 3.06 billion by 2032.

Pharmaceutical Sterility Testing is the investigation of the microorganisms. Sterility test is conducted with the help of bacteriostatic and fungistatic testing. This test secures the antimicrobial property within the test subject that barricades the identification of microbial organisms. This test is performed under a clean environment as per the instructions or the membrane filtration methods using the isolator. In pharmaceutical manufacturing, Sterility testing is an essential process during the validation and sterilization process along with the release testing. In several industries, it is an important part of every sterilization, validation process that makes it a pivotal procedure in manufacturing industry. It is an extremely tough procedure that should be designed and executed with precision, which can be helpful in ruling out false positive results. In a clean room, planned testing should be carried out where there is minimal, or no chances of error seen.

Market Highlights

Pharmaceutical Sterility Testing Market is expected to project a notable CAGR of 8.7%

The Pharmaceutical Sterility Testing market will see a robust CAGR of 8.7%, valued at USD 1.22 billion in 2021, and is expected to reach USD 3.06 billion by 2032. The Pharmaceutical Sterility Testing market is estimated to rise soon owing to the increase in demand for sterilized items. Even the growth media should be prepared accurately and tested to make sure that the microbial growth is as efficient as possible during sterility testing. 

Pharmaceutical Sterility Testing Market: Segments

Kits and Reagent segment holds the largest market share

The global Pharmaceutical Sterility Testing Market is segmented based on the Product into Kits and Reagents, Instruments, Services. Kits and Reagent segment is dominating   the market, and it is estimated to grow significantly. This increase is due to the availability of an extensive range of products that help in minimizing the false-positive results and the risk of false-negative. Sterility testing pumps also came into existence that aid in increasing safety & streamlining workflow, which are designed to fit into all the testing facilities seamlessly.

Membrane filtration segment holds the largest market share

The global Pharmaceutical Sterility Testing Market is segmented based on the Test into Direct Inoculation, Membrane Filtration, Bioburden Testing, Bacterial Endotoxin Testing, Container Closure Integrity Testing, Antimicrobial Effectiveness Testing, Rapid Micro Test, Others. Membrane filtration is dominating the market, owing to advancements of technology in membrane filtration operations and designs, which increase the efficiency of filtration and allows the processes to operate with less energy consumption and at a low temperature.

Market Dynamics                                                     

Growth Drivers

Expanding Research and Development in Life Sciences

The expanding research and development in life sciences, together with significant private and public financing, is a major growth driver that is expanding the market of Pharmaceutical Sterility Testing. New firms are involving in the market of kit testing since it provides a constant of revenue from the clients

Innovations In Pharmaceutical and Medical Field

The need for sterility tests will increase along with developments in the pharmaceutical and medical fields. The global biotechnology industry is booming, which will help the sterility testing market grow over the forecast period. Sterility testing has benefited from new technology advancements that have improved process efficiency, which will promote market expansion.

Restraint

Stringent Government Regulations

The insufficiency of qualified sterility testing professionals and a rise in the unit price of sterility testing are obstructing the market growth due to strict government rules. Rigid regulatory frameworks, high levels of consolidation and a lengthy licensing procedure are significant hurdles to new market entrants.

Recent Developments

• On May 17, 2021, Charles River Laboratories International, Inc. announced, that it had signed a definitive agreement to acquire a leading gene therapy contract development and manufacturing organization Vigene Biosciences, Inc. that specializes gene delivery solutions based on viral vector.
• In October 2020, to allow the company to expand its capacity in the APAC region, Thermo Fisher Scientific announced plans to build two additional sterile filling lines in Singapore, for vaccine and therapy manufacturing and development.

Pharmaceutical Sterility Testing Market

Key Players

• Pacific Bio labs

Company Overview, Business Strategy, Key Product Offerings, Key Performance Indicators, Financial Performance, Risk Analysis, Recent Development, Regional Presence, SWOT Analysis

• STERIS
• Boston Analytical
• Nelson Laboratories, LLC
• Sartorius AG
• SOLVIAS AG
• Rapid Micro Biosystems, Inc.
• SGS SA
• Laboratory Corporation of America Holding
• Charles River Laboratories
• Thermo Fisher Scientific, Inc.
• Almac Group
• Pace Analytical
• Other Prominent Players

Global Pharmaceutical Sterility Testing Market: Regions

Pharmaceutical Sterility Testing Market is segmented based on regional analysis into five major regions: North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. North America had the highest share of market in pharmaceutical sterility testing. Increased investing in life sciences, favorable initiatives by the government, increment in the research & development activities of medical technology, biotechnology and pharmaceutical industries are the primary reason behind possessing the largest industry share. On contrary, the Asia-Pacific region is the fastest growing market for sterility testing during the forecasted period, which is mainly due to the increment in expenditure on life science research.

Impact of Covid-19 on Pharmaceutical Sterility Testing Market

The pharmaceutical sterility testing industry emerged globally from the COVID-19. Pharmaceutical and biotechnology indstries were in a race to develop COVID-19 vaccine. Any product, injection or vaccine provided should undergo final product sterility testing to be approved safe. Rapid testing kits use resulted in the rise of pharmaceutical sterility testing industry. The regular use of these screening procedures during the pandemic period had a positive impact on growth of the Pharmaceutical Sterility Testing industry.

Pharmaceutical Sterility Testing Market is further segmented by region into:

• North America Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – United States and Canada
• Latin America Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – Mexico, Argentina, Brazil and Rest of Latin America
• Europe Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – United Kingdom, France, Germany, Italy, Spain, Belgium, Hungary, Luxembourg, Netherlands, Poland, NORDIC, Russia, Turkey and Rest of Europe
• Asia Pacific Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – India, China, South Korea, Japan, Malaysia, Indonesia, New Zealand, Australia and Rest of APAC
• Middle East and Africa Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – North Africa, Israel, GCC, South Africa and Rest of MENA

Pharmaceutical Sterility Testing Market report also contains analysis on:

Pharmaceutical Sterility Testing Market Segments:

• By Product

  • Kits and Reagents
  •  Instruments
  •  Services
• By Test
  • Membrane Filtration
  • Direct Inoculation
  • Bioburden Testing
  • Bacterial Endotoxin Testing
  • Container Closure Integrity Testing
  • Antimicrobial Effectiveness Testing
  • Rapid Micro Test
  • Others
• By Application
  • Pharmaceutical and Biological Manufacturing
  • Medical devises Manufacturing
  • Other Applications
• Pharmaceutical Sterility Testing Market Dynamics
• Pharmaceutical Sterility Testing Market Size
• Supply & Demand
• Current Trends/Issues/Challenges
• Competition & Companies Involved in the Market
• Value Chain of the Market
• Market Drivers and Restraints

Pharmaceutical Sterility Testing Market Report Scope and Segmentation

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