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. An increase in R&D activities and the number of product approvals are anticipated to boost the market growth. Also, the demand for medicines and effective treatment options is constantly growing due to the prevalence of arthritis, asthma, diabetes, and other such chronic diseases.
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, the need for rapid approval and the 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 until 2022 respectively, according to an article published in FierceBiotech. These investments are anticipated to drive demand for sterility testing in the 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 the sterility testing procedure and helps in getting rapid approvals and the introduction of novel products. The adoption of new technologies has led to the 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.
The 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, the demand for sterility testing services and products is anticipated to increase over the forecast period.
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. Besides, in-house training of personnel is anticipated to incur higher costs. Therefore, companies prefer to outsource sterile pharmaceutical testing services. Also, 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.
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 a 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.
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.
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 the safety of products, especially oral dosage forms, as most of these products are ingested by patients.
With the increasing demand for pharmaceutical products, companies have to maintain a highly regulated manufacturing condition to ensure the sterility of their products. Moreover, this testing is considered essential to launch a new batch of products into the market. Thus, the demand for innovative solutions is anticipated to drive the market over the forecast period.
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 Attribute |
Details |
The market size value in 2020 |
USD 417.8 million |
The revenue forecast in 2025 |
USD 713.6 million |
Growth Rate |
CAGR of 11.3% from 2017 to 2025 |
The base year for estimation |
2016 |
Historical data |
2014 - 2015 |
Forecast period |
2017 - 2025 |
Quantitative units |
Revenue in USD million and CAGR from 2017 to 2025 |
Report coverage |
Revenue forecast, company share, competitive landscape, growth factors and trends |
Segments covered |
Type, test type, end-use, sample |
Country scope |
U.S |
Key companies profiled |
SGS SA; Toxikon, Inc.; Boston Analytical; Charles River Laboratories International, Inc.; Pacific Biolabs; STERIS; Pace Analytical; Gibraltar Laboratories; Infinity Laboratories; DYNALABS LLC |
Customization scope |
Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope. |
Pricing and purchase options |
Avail customized purchase options to meet your exact research needs. Explore purchase options |
This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2014 to 2025. For this study, Grand View Research has segmented the U.S. pharmaceutical sterility testing market report based on 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
b. The U.S. pharmaceutical sterility testing market size was estimated at USD 375.4 million in 2019 and is expected to reach USD 417.8 million in 2020.
b. The U.S. pharmaceutical sterility testing market is expected to grow at a compound annual growth rate of 11.3% from 2018 to 2025 to reach USD 713.6 million by 2025.
b. Outsourcing segment dominated the U.S. pharmaceutical sterility testing market with a share of 55.0% in 2017. This is attributable to the increasing outsourcing of sterile pharmaceutical testing services.
b. Some key players operating in the U.S. pharmaceutical sterility testing market include SGS SA; Toxikon, Inc.; Boston Analytical; Charles River Laboratories International, Inc.; Pacific Biolabs; STERIS; Pace Analytical; Gibraltar Laboratories; Infinity Laboratories; and DYNALABS LLC.
b. Key factors that are driving the market growth include increasing R&D activities, and rapid approval and launch of safe products.
This report has a service guarantee. We stand by our report quality.
We are in compliance with GDPR & CCPR norms. All interactions are confidential.
Design an exclusive study to serve your research needs.
Get your queries resolved from an industry expert.
"The quality of research they have done for us has been excellent..."
The most common concern for the governments of all Covid-19 hit nations is the excruciating need to screen for and test large numbers of patients for possible Sars-Cov-2 infection. As a result, most of them are facing major shortages in the supply for diagnostic kits to test for the virus. Diagnostics virology entities are under immense pressure to provide reliable testing kits, and there is a surge in demand for in-vitro or point-of-care testing capacities by labs across a large number of countries. The report will account for Covid19 as a key market contributor.