U.S. Pharmaceutical Sterility Testing Market Size, Share & Trends Report

U.S. Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type (In-house, Outsourced), By Test Type (Bacterial Endotoxin, Sterility), By End Use, By Sample, And Segment Forecasts, 2018 - 2025

  • Published Date: Jul, 2018
  • Base Year for Estimate: 2016
  • Report ID: GVR-2-68038-403-1
  • Format: Electronic (PDF)
  • Historical Data: 2014 - 2015
  • Number of Pages: 68

Industry Insights

The U.S. pharmaceutical sterility testing market size was estimated at USD 302.2 million in 2017. It is expected to register a CAGR of 11.3% over the forecast period. Increase in R&D activities and in number of product approvals is anticipated to boost the market growth. In addition, demand for medicines and effective treatment options is constantly growing due to prevalence of arthritis, asthma, diabetes, and other such chronic diseases.

U.S. pharmaceutical sterility testing market

In 2017, the U.S. Food and Drug Administration (FDA) approved 43 drugs, projected to generate a combined sale of approximately USD 32.0 billion over the next 5 years. Thus, need for rapid approval and launch of safe products is anticipated to impel market growth over the forecast period.

Rising R&D investment by innovator companies is expected to increase the number of product launches over the forecast period. This, in turn, is anticipated to drive the demand for sterility testing solutions. Celgene and Boehringer Ingelheim are expected to increase their R&D expenses by 13.0% and 6.0% per year till 2022 respectively, according to an article published in FierceBiotech. These investments are anticipated to drive demand for sterility testing in U.S.

The FDA published a standardized document for sterility testing of various products. The International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines have clear instructions to be followed. This provides clarity in sterility testing procedure and helps in getting rapid approvals and introduction of novel products. Adoption of new technologies has led to harmonization of quality and standards in the healthcare industry. This has further created a need for not only aseptic manufacturing techniques, but also for efficient, reliable, and effective terminal sterilization processes.

Government in developing economies such as India and China are increasingly focusing on providing cost-effective and quality medications. They are increasingly becoming U.S. FDA compliant.Hence, demand for sterility testing services and products is anticipated to increase over the forecast period.

Type Insights

Based on type, the market is segmented into in-house and outsourcing. The outsourcing segment is anticipated to drive the market over the forecast period. Outsourcing is, usually, considered cost-effective for manufacturing companies as compared to in-house sterile pharmaceutical testing.

In-house sterile pharmaceutical testing is perceived as an expensive strategy, as it adversely affects operational costs including building and maintaining the cleanroom and need for an isolator that requires expensive consumables. In addition, in-house training of personnel is anticipated to incur higher costs. Therefore, companies prefer to outsource sterile pharmaceutical testing services. In addition, there is a cost advantage by outsourcing to regions such as India and China due to the positive exchange rate. Hence, outsourcing is anticipated to grow lucratively at a CAGR of 11.4% over the forecast period.

Test Type Insights

By test type, the market is divided into sterility tests, bioburden testing, and bacterial endotoxin testing. In 2016, bacterial endotoxin tests dominated the market in terms of revenue, followed by sterility testing. The sterility testing segment is anticipated to witness maximum CAGR over the forecast period. Bacterial endotoxin testing services require comparatively sophisticated instruments, hence these services are more expensive compared to other tests.

Data generated during sterility tests is vital and provides assurance of quality required for approval. Hence, these tests are a pre-requisite for the launch of any product or product batch. This is anticipated to drive market growth over the forecast period.

Sample Insights

The sample segment is divided into sterility drugs, medical devices, and biologics and therapeutics. The sterility drugs segment dominated the U.S. pharmaceutical sterility testing market in 2016 in terms of revenue. This trend is estimated to continue over the forecast period, due to increasing product launches and R&D investment.

End-use Insights

Based on end use, the market is segmented into compounding pharmacies, medical device and pharmaceutical companies, and others. Pharmaceutical companies held the largest market share in terms of revenue in 2016. These companies conduct sterility tests to ensure safety of products, especially oral dosage forms, as most of these products are ingested by patients.

U.S. pharmaceutical sterility testing market

With increasing demand for pharmaceutical products, companies have to maintain a highly regulated manufacturing condition to ensure sterility of their products. Moreover, this testing is considered essential to launch a new batch of products into the market. Thus, demand for innovative solutions is anticipated to drive the market over the forecast period.

U.S. Pharmaceutical Sterility Testing Market Share Insights 

Some of the key players in the market are SGS SA; Toxikon, Inc.; Boston Analytical; Charles River Laboratories International, Inc.; Pacific Biolabs; STERIS; Pace Analytical; Gibraltar Laboratories; Infinity Laboratories; and DYNALABS LLC.

Regional and service portfolio expansions and mergers and acquisitions are key strategic undertakings adopted by these players. For instance, in September 2016, Charles River Laboratories acquired Agilux Laboratories, Inc., a U.S.-based contract research organization (CRO) that provides integrated discovery and bioanalytical testing services. This acquisition helped the company enhance its bioanalytical capabilities.

Report Scope



Base year for estimation


Actual estimates/Historical data

2014 - 2015

Forecast period

2017 - 2025

Market representation

Revenue in USD Million & CAGR from 2017 to 2025

Regional scope


Report coverage  

Revenue forecast, company share, competitive landscape, growth factors and trends

Country Scope


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Segments Covered in the Report

This report forecasts revenue growth at country level and provides an analysis of latest industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the U.S. pharmaceutical sterility testing market report on the basis of type, test type, end use, and sample:

  • Type Outlook (Revenue, USD Million, 2014 - 2025)

    • In-house

    • Outsourced

  • Test Type Outlook (Revenue, USD Million, 2014 - 2025)

    • Sterility Test

    • Bioburden Testing

    • Bacterial Endotoxin Test

  • End-use Outlook (Revenue, USD Million, 2014 - 2025)

    • Compounding Pharmacies

    • Medical device Companies

    • Pharmaceutical Companies

    • Others

  • Sample Outlook (Revenue, USD Million, 2014 - 2025)

    • Sterility Drugs

    • Medical Devices

    • Biologics & Therapeutics

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