The global pharmaceutical sterility testing market size is anticipated to reach USD 3.28 billion by 2030 and is projected to grow at a CAGR of 11.02% from 2024 to 2030, according to a new report by Grand View Research, Inc. A growing number of drug launches worldwide, and rising government investments are anticipated to influence the global market positively. As pharmaceutical companies are introducing an array of new drugs to the market, there is a parallel surge in the demand for rigorous sterility testing protocols. Besides, stringent regulatory requirements for pharmaceuticals products further support market growth. Thus, an upsurge in novel drug launches provided unprecedented growth opportunities to the pharmaceutical sterility testing market.

In addition, increasing emphasis on R&D activities in the pharmaceutical industry profoundly impacts the pharmaceutical sterility testing market. As pharmaceutical companies are proactively involved in the discovery and development of innovative & advanced drug formulations, there is a growing need for robust sterility testing protocols to ensure the safety and efficacy of these products. R&D activities drive the development of new pharmaceuticals, biologics, and vaccines, necessitating comprehensive sterility testing methodologies to comply with regulatory requirements.

Gather more insights about the market drivers, restrains and growth of the Global Pharmaceutical Sterility Testing Market

Furthermore, stringent regulations by regulatory bodies for pharmaceutical product approval prompt pharmaceutical companies to invest significantly in R&D to meet these evolving standards. As a result, the market experiences a surge in demand for state-of-the-art testing solutions to align with the regulatory landscape. For instance, in September 2023, Sartorius AG introduced a sterisart septum for sampling from a sterility testing unit. It is a closed system for testing based on the membrane filtration method that mitigates the risk of secondary contamination. Such service launches offered a competitive edge in the market.

Moreover, the pharmaceutical industry's commitment to addressing unmet medical needs and discovering innovative therapeutic avenues further amplifies the importance of robust sterility testing protocols. The need for accuracy & reliability in detecting any potential contaminants becomes paramount to ensure the safety and efficacy of these newly launched drugs.

Pharmaceutical Sterility Testing Market Report Highlights

• Based on type, the outsourcing segment led the market with the largest revenue share of 59.25% in 2023. The segment growth is driven by increasing requirements for Outsourcing sterility testing as attractive alternative for several small- & medium-sized pharmaceutical and medical device companies, which may lack the infrastructure to conduct quality sterility testing

• Based on product type, the kits and reagents segment held the market with the largest revenue share of 60.30% in 2023, attributing to a standardized and reliable techniques to determine the absence of live microorganisms in pharmaceutical products

• Based on test type, the bioburden testing segment led the market with the largest revenue share of 41.71% in 2023. The segment is driven by strict quality control processes and the demand for testing to quantify microbial contamination of a product at different stages of production from initial manufacturing to final distribution

• Based on sample, the pharmaceuticals segment led the market with the largest revenue share of 42.45% in 2023. The products are widely used dosage forms. The growing demand or these dosage forms globally is one of the major factors driving this segment

• Based on end-use, the pharmaceutical companies dominated the market in 2023. These companies conduct sterility tests to ensure the safety of the products, especially oral dosage forms, as most of these products are ingested by patients

• North America dominated the market with a revenue share of 49.45% in 2023. The presence of a large number of major market players in this region is expected to contribute to the market growth significantly. Stringent regulatory requirements for sterility testing of pharmaceuticals and medical devices in this region further supports market growth

Browse through Grand View Research's Clinical Diagnostics Industry Research Reports.

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Segments Covered in the Report

Grand View Research has segmented the global pharmaceutical sterility testing market based on type, product type, test type, sample, end-use, and region:

Pharmaceutical Sterility Testing Type Outlook (Revenue, USD Million, 2018 - 2030)

• In-House

• Outsourcing

Pharmaceutical Sterility Testing Product Type Outlook (Revenue, USD Million, 2018 - 2030)

• Kits & Reagents

• Instruments

• Services

Pharmaceutical Sterility Testing Test Type Outlook (Revenue, USD Million, 2018 - 2030)

• Sterility Testing

  • Membrane Filtration

  • Direct Inoculation

  • Product Flush

• Bioburden Testing

• Bacterial Endotoxin Testing

• Rapid Microbial Method

  • ATP Bioluminescence

  • Fluorescent -Based

  • Solid-phase Cytometry

  • Others

Pharmaceutical Sterility Testing Sample Outlook (Revenue, USD Million, 2018 - 2030)

• Pharmaceuticals

• Medical Devices

• Biopharmaceuticals

Pharmaceutical Sterility Testing End-use Outlook (Revenue, USD Million, 2018 - 2030)

• Compounding Pharmacies

• Medical Device Companies

• Pharmaceutical Companies

• Others

Pharmaceutical Sterility Testing Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North America

  • U.S.

  • Canada

• Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Netherlands

  • Switzerland

  • Sweden

  • Belgium

  • Russia

• Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Philippines

  • Malaysia

  • New Zealand

  • Singapore

  • Thailand

• Latin America

  • Brazil

  • Mexico

  • Argentina

  • Colombia

  • Chile

• Middle East and Africa (MEA)

  • South Africa

  • Saudi Arabia

  • Egypt

  • Israel

  • UAE

Order a free sample PDF of the Pharmaceutical Sterility Testing Market Intelligence Study, published by Grand View Research.