Meeting Quality Standards: Driving the Growth of Pharmaceutical Sterility Testing Market is Likely to Set a CAGR of 11.8% by 2033 | FMI  

Pharmaceutical Sterility Testing Market

In 2023, it is projected that the global Pharmaceutical Sterility Testing Market will create US$ 1,250.7 million in sales revenue. Demand is anticipated to grow at a CAGR of 11.8% to reach US$ 3,815.6 million in value by 2033.

The demand for effective medications is predicted to rise as the prevalence of chronic diseases rises. This drives the requirement for sterility testing of products before their release onto the market and supports global market expansion.

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To reduce the possibility of product contamination, pharmaceutical sterility testing is done at every stage of the production of pharmaceutical and biological goods. The frequency of sterility testing in industries is rising, along with the demand for pharmaceutical and medical products for various health issues.

Potential Market Opportunity

An increase in research and development expenditures in the biopharmaceutical industry contributed to the market’s expansion. For instance, in December 2021, the pharmaceutical industry’s annual research and development spending was 7.3 times higher than that of the aerospace and defense industries. Moreover, it was 6.5 times higher than that of the chemicals industry and 1.5 times higher than that of the software industry.

Key Takeaways:

  • By 2033, the pharmaceutical sterility testing market in the United Kingdom is likely to expand at a CAGR of 9.5%.
  • In 2022, the United States dominated the pharmaceutical sterility testing sector, with a share of 41.5%.
  • The pharmaceutical sterility testing market was significantly expanding, with a size of US$ 1,124.7 million in 2022.
  • By 2033, the pharmaceutical sterility testing industry in China is likely to expand, with a CAGR of 12.1%.
  • By 2033, Australia is projected to expand in the pharmaceutical sterility testing business, with an expected CAGR of 10.4%.
  • The market is expected to grow to US$ 1,747. 75 million valuations by 2026, with rising automated techniques.
  • By 2033, India is projected to expand significantly in the pharmaceutical sterility testing sector, with a share of 12.8%.
  • Japan’s pharmaceutical sterility testing market share expanded significantly, with a 5.1% share in 2022.
  • In 2022, the outsourced segment dominated the market with a share of 54.1%. It is anticipated to control the market by 2033 in terms of services.
  • Based on product type, kits, and reagents dominated the market with a share of 39.7% in 2022.

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Key Players Operating in the Pharmaceutical Sterility Testing Market:

  • Merck KGaA
  • bioMerieux SA
  • Thermo Fisher Scientific Inc.
  • Charles River Laboratories International Inc.
  • Others

Recent Developments

  • In June 2022

For its GMP batches, Berkshire Sterile Manufacturing opened a sterility testing isolator and conducted sterility testing. It provides sterile filling of injectable medications, the bulk of which are undergoing clinical trials or have little commercial need.

STEMart has started conducting thorough sterility and microbial tests for sterile, non-pyrogenic medical equipment.

  • Thermo Fisher Scientific announced plans to build two new sterile filling lines in Singapore in October 2020. To increase capacity for producing and developing vaccines and treatments in the APAC region.

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Key Segments:

By Product:

  • Kits and Reagents
  • Instruments

By Application:

  • Sterile Drugs
  • Biologics and Therapeutics
  • Medical Devices

By Test Type:

  • Sterility Testing
    • Membrane Filtration
    • Direct Inoculation
  • Bacterial Endotoxin Testing
  • Rapid Micro Test
  • Container Closure Integrity Testing
  • Electrical Resistance
  • Bioburden Testing
  • ATP Bioluminescence
  • Fluorescent Labeling
  • Others

By Services:

  • In-House
  • Outsourced

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By End Use:

  • Compounding Pharmacies
  • Medical Devices Companies
  • Pharmaceutical Companies

By Region:

  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia
  • Oceania
  • The Middle East & Africa (MEA)

About Future Market Insights (FMI)

Future Market Insights, Inc. (ESOMAR certified, Stevie Award – recipient market research organization and a member of Greater New York Chamber of Commerce) provides in-depth insights into governing factors elevating the demand in the market. It discloses opportunities that will favor the market growth in various segments on the basis of Source, Application, Sales Channel and End Use over the next 10-years.

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About the Author

Ronak Shah

Associate Vice President at Future Market Insights is deeply committed to uncovering actionable insights for consumer and food and beverage players. She brings a unique blend of analysis, industry trends, and consumer behavior to put data into perspective.

What she makes out of data becomes a delight to read. She has authored many opinions, including for publications like Process Industry Informer and Spinal Surgery News, as she understands the market pulse and consumers' shifting preferences.

She likes to bring experts to a roundtable to weigh the impact of a trend on an industry. Catch up with her discussion on the impact of AI in packaging.

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