Pharmaceutical Sterility Testing Industry Overview

The global pharmaceutical sterility testing market size was estimated at USD 1.59 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 11.02% from 2024 to 2030.

Increasing government investments, RD activities, a growing number of drug launches, and a rising focus on quality sterility are expected to drive the market growth. The development of comprehensive sterility testing procedures is regulated with stringent policies and quality control standards.

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

In addition, several government initiatives play a pivotal role in shaping the healthcare landscape, and their financial support significantly influences the development implementation of advanced sterility testing procedures within the pharmaceutical sector. Increasing government funding for enhanced RD activities for novel therapeutics, especially vaccines, biologics, and sterile products, which need sterility testing to ensure safety efficacy. This leads to the introduction of cutting-edge technologies and innovative solutions in the sterility testing market. For instance, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA), total healthcare RD expenditure in the European Union (EU) was around USD 48.5 billion in 2022 compared to USD 46.4 billion in 2021.

Global Pharmaceutical Sterility Testing Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global pharmaceutical sterility testing market report based on the type, product type, test type, sample, end-use, and region:

Type Outlook (Revenue, USD Million, 2018 - 2030)

• In-House
• Outsourcing

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

• Kits Reagents
• Instruments
• Services

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

Sample Outlook (Revenue, USD Million, 2018 - 2030)

• Pharmaceuticals
• Medical Devices
• Biopharmaceuticals

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

• Compounding Pharmacies
• Medical Device Companies
• Pharmaceutical Companies
• Others

Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North America
  • US
  • 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

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Key Pharmaceutical Sterility Testing Company Insights

Several key players are acquiring various strategic initiatives to strengthen their market position offering diverse services to customers. The prominent strategies adopted by companies are service launches, mergers acquisitions/joint ventures merger, partnership agreements, expansions, and others to increase market presence revenue and gain a competitive edge drives the market growth.

Key Pharmaceutical Sterility Testing Companies:

The following are the leading companies in the pharmaceutical sterility testing market. These companies collectively hold the largest market share and dictate industry trends. Financials, strategy maps products of these pharmaceutical sterility testing companies are analyzed to map the supply network

• Pacific Biolabs
• Steris Plc
• Boston Analytical
• Sotera Health Company (Nelson Labs)
• Sartorius Ag
• Solvias Ag
• SGS SA
• Labcorp
• Pace Analytical
• Charles River Laboratories
• Thermo Fisher Scientific, Inc.
• Rapid Micro Biosystems, Inc.
• Almac Group
• Labor LS SE Co. KG

Recent Developments

In January 2024, Rapid Micro Biosystems, Inc. company announced the launch of the Growth Direct Rapid Sterility application by mid-2024

In August 2023, Pace Analytical Services improved its capabilities by adding advanced hydrocarbon analytical support and expanded sediment tissue testing with the acquisition of Alpha Analytical

In May 2023, Thermo Fisher Scientific, Inc. announced the launch of a sterile drug facility in Singapore. It would help deliver new vaccines and medicines in the Asia Pacific market

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