Pharmaceutical Sterility Testing Market Report 2025

This Pharmaceutical Sterility Testing market report provides a comprehensive analysis of the market’s characteristics, size, and growth, including segmentation, regional and country-level breakdowns, competitive landscape, market shares, trends, and strategies. It also tracks historical and forecasted market growth across various geographies.

The pharmaceutical sterility testing market size has grown strongly in recent years. It will grow from $1.41 billion in 2024 to $1.54 billion in 2025 at a compound annual growth rate (CAGR) of 9%. The growth in the historic period can be attributed to rising demand for quality pharmaceutical products, growing emphasis on drug safety and efficacy, growing demand for biologics and biosimilar drugs, increasing prevalence of infectious diseases, and rising investments in life science research.

The pharmaceutical sterility testing market size is expected to see rapid growth in the next few years. It will grow to $3.18 billion in 2029 at a compound annual growth rate (CAGR) of 20%. The growth in the forecast period can be attributed to biopharmaceutical growth, personalized medicine, growing trend of outsourcing, quality assurance emphasis, pandemic preparedness. Major trends in the forecast period include rapid microbiological methods, combination products, data integrity and digitalization, automation and robotics, advanced analytical techniques.

Growth in the pharmaceutical sterility testing market is attributed to an upsurge in drug launches and increased investment in research and development (R&D). Maintaining sterility in drug manufacturing is crucial to prevent contamination and ensure the absence of viable microorganisms in medications. Notably, in March 2022, the UK government pledged a substantial $347 million (£260 million) towards R&D initiatives for innovative treatments and tools, signifying a commitment to advancing the pharmaceutical landscape. Additionally, IQVIA's report from December 2021 projects a significant rise in new drug introductions over the next five years, particularly in specialty, niche, and orphan drugs, accompanied by a substantial increase in spending on new products.

The rise in biologics sales is anticipated to significantly propel the growth of the pharmaceutical sterility testing market. Biologics, which are medicines derived from living organisms, encompass a wide range of products, including vaccines, blood and blood components, allergenics, somatic cells, gene therapies, tissues, and recombinant therapeutic proteins. Ensuring the sterility of these biologics is critical, as pharmaceutical sterility testing provides essential quality control to verify that these products are free from microbial contamination prior to patient administration. For example, in November 2023, the Patented Medicine Prices Review Board, a Canada-based regulatory agency, reported that sales of oncology medicines increased by 10% in 2021 and saw a more significant rise of 12% in 2022. This growing trend in biologics sales underscores the heightened demand for sterility testing services to maintain the safety and efficacy of these life-saving treatments. Consequently, the surge in biologics sales is a key driver for the pharmaceutical sterility testing market, highlighting the critical role of rigorous testing protocols in the biopharmaceutical industry.

Key players in the pharmaceutical sterility testing market are introducing technologically advanced solutions, such as the sterility test isolator workstation (STIW), to address testing challenges and minimize erroneous results. The STIW, a specialized containment system, creates a sterile environment for conducting sterility tests on pharmaceutical products. For example, AUSTAR Group unveiled the Sterility Test Isolator Workstation (STIW) in March 2022 as part of their 'Standards' product range, featuring UDAF and TURB models. This barrier isolator technology significantly reduces false positives, fostering confidence in lab results while lowering operational costs. Designed for secure sterility testing, the STIW ensures protection against contamination, adhering to stringent guidelines. Its integrated bio-decontamination system expedites processing within 30 minutes, optimizing workflow efficiency for operators.

Major companies operating in the pharmaceutical sterility testing market include Pacific Biolabs Inc., STERIS Corporation, Boston Analytical Inc., Gibraltar Laboratories Inc., Sartorius AG, Solvias AG, SGS S.A., Toxikon Inc., Pace Analytical Services LLC, Charles River Laboratories International Inc., Nelson Laboratories Inc., Rapid Micro Biosystems Inc., bioMérieux Inc., Merck KGaA, WuXi AppTec, Sotera Health LLC, Dynalabs LLC, Infinity Laboratories, Eurofins Scientific SE, Avomeen Analytical Services, Microbac Laboratories Inc., Analytical Lab Group LLC, North American Science Associates Inc., Medical Device Testing Services Inc., Microtest Laboratories Inc., BioScreen Testing Services Inc., Microchem Laboratory Inc., Bactolac Pharmaceutical Inc., Micro Quality Labs Inc., Boston Microfluidics Inc., BioPharma Services Inc., Microbiology Research Associates, BioScience Laboratories Inc.

North America was the largest region in the pharmaceutical sterility testing market in 2024. The Middle East is expected to be the fastest-growing region in the global pharmaceutical sterility testing market share during the forecast period. The regions covered in the pharmaceutical sterility testing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. The countries covered in the pharmaceutical sterility testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Spain, Canada.

Pharmaceutical sterility testing is a critical process designed to determine whether biological parenteral products intended for human use contain any extraneous, viable microorganisms. Ensuring the absence of contaminants is crucial for patient safety and the overall quality of medical products. Sterility testing guarantees that the products offered are appropriately free from harmful microorganisms.

Within pharmaceutical sterility testing, two primary types exist: in-house testing and outsourced testing. Various tests, including sterility testing, bioburden testing, and bacterial endotoxin testing, are conducted on sterile drugs, medical devices, biologics, and therapeutics. The bacterial endotoxin test, an in vitro assay, detects bacterial endotoxins by lysing blood cells from horseshoe crabs. Products utilized in this process include instruments, kits, reagents, and services.

The pharmaceutical sterility testing market research report is one of a series of new reports that provides pharmaceutical sterility testing market statistics, including pharmaceutical sterility testing industry global market size, regional shares, competitors with a pharmaceutical sterility testing market share, detailed pharmaceutical sterility testing market segments, pharmaceutical sterility testing market trends and opportunities, and any further data you may need to thrive in the pharmaceutical sterility testing industry. This pharmaceutical sterility testing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The pharmaceutical sterility testing market includes revenues earned by entities by membrane filtration, direct transfer (product immersion), and product flush. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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