US Pharmaceutical Sterility Testing Market

US Pharmaceutical Sterility Testing Market Outlook 2031

The US pharmaceutical sterility testing market size was valued at USD 515.24 Million in 2022 and is estimated to reach USD 1.30 Billion by 2031 expand at a substantial CAGR 10.9% during the forecast period, 2023–2031. The growth of the market is attributed to the rising number of diagnostic kits or pharmaceutical devices approvals and increase in R&D activities.

Pharmaceutical sterility testing involves a screening process to make all devices, equipment, or other products related to pharmaceutical and biologics safe and sterile for the use of diseases treatment. One key aspect of the market growth in the US is due to the easy approval of biologic devices by regulatory bodies.

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For instance, the US Food and Drug Administration (FDA) approved 43 drugs in 2017 and the introduction of several products were made possible as a consequence of the existing favorable policies from government agencies. The FDA set a standardized guideline for product sterility testing and the regional players are actively engaged in several market strategies to enhance their product portfolio by following the agencies guidelines.

Another key factor for propelling the US market is due to the presence of key global pharmaceutical players and their massive investment on various product development research and study.

US Pharmaceutical Sterility Testing Market​ Trends, Drivers, Restraints, and Opportunities

• Growing number of chronic illness such as arthritis, diabetes, and cancer as well as infectious diseases globally is driving the market growth.
• Favorable government policies especially in developed countries that encourage the development of various pharmaceutical clinical products for diseases treatment are projected to boost the market.   
• Introduction of various innovative technology for effective functioning of sterility testing devices is expected to fuel the market expansion in the coming years.
• Increasing R&D activities and increasing approvals for products from regulatory bodies are estimated to create several opportunities for the market growth during the forecast period.

Scope of Pharmaceutical Sterility Testing Market Report

The report on the global US pharmaceutical sterility testing market analysis includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Pharmaceutical Sterility Testing Market Segment Insights

Outsourced segment is projected to constitute a key market share

Based on types, the US pharmaceutical sterility testing market analysis is bifurcated into in-house and outsourced. The outsourced segment is expected to constitute a key share of the market during the forecast period due to certain advantages such as cost-effective and wide availability of the platform as compared to in-house sterile pharmaceutical testing.

In-house sterile pharmaceutical testing is an expensive and high cost technique as it takes into account for operating costs such as cleanroom construction and maintenance as well as the need for an isolator, which are costly consumables. As a result, US pharmaceutical companies are consistently outsourcing their businesses in emerging economies such as India and China.

Sterility testing segment is anticipated to expand at a rapid CAGR

On the basis of test types, the market is segregated into bacterial endotoxin, bioburden, and sterility. The sterility testing segment is expected to expand at a rapid CAGR during the forecast period due to wide adoption of the testing type across the globe.  The information gathered during sterility tests is crucial for further treatment of disease, as it provides the assurance of consistency needed for treatment approval.

However, the bacterial endotoxin testing segment is expected to constitute a key share of the market during the forecast period as it offers accurate results due to the use of more advanced instruments than other studies. However, it is costly techniques as compared to sterility testing.

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Sterility drugs segment dominated the market

Based on samples, the US pharmaceutical sterility testing market analysis is segregated into sterility drugs, medical devices, and biologics & therapeutics. The sterility drugs segment dominated the market in 2020 and the trend is expected to continue in the coming years due to increasing development of new products and ongoing R&D spending for the drugs discovery.

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Pharmaceutical companies segment to hold a major market share

In terms of end-users, the market is divided into compounding pharmacies, medical device companies, pharmaceutical companies, and others. The pharmaceutical companies segment is anticipated to hold a major market share in the coming years these companies are widely engaged in the activities to ensure the safety of their products, especially oral dosage forms for human use.​​​​​​​

Segments

The US pharmaceutical sterility testing market has been segmented on the basis of

Types

• In-house
• Outsourced

Test Types

• Bacterial Endotoxin
• Bioburden
• Sterility

End-Users

• Compounding Pharmacies
• Medical device Companies
• Pharmaceutical companies
• Others

Samples

• Sterility drugs
• Medical devices
• Biologics & therapeutics

Regions

• Asia Pacific
• North America
• Latin America
• Europe
• Middle East & Africa

Key Players

• SGS SA.
• Toxikon, Inc.
• Boston Analytical.
• Charles River Laboratories International, Inc.
• Pacific Biolabs.
• STERIS
• Pace Analytical
• Gibraltar Laboratories
• Infinity Laboratories
• DYNALABS LLC

Competitive Landscape

Key players competing in the US pharmaceutical sterility testing 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.

These companies have adopted several strategic initiatives including regional and service portfolio expansions, mergers, and acquisitions. For example, a Massachusetts-based contract research organisation, Agilux Laboratories, Inc., was acquired by Charles River Laboratories in September 2016 with an aim to expand its business operation that offers integrated drug discovery and bio-analytical testing services.