Sterility Testing Market Size, Company Revenue Share, Key Drivers & Trend Analysis, 2023–2032

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The global sterility testing market size was USD 990 Million in 2022 and is expected to register a revenue CAGR of 10.5% over the forecast period, according to the latest report by Reports and Data.

Sterility testing is utilized for bulk and final drug products, cell banks, and raw materials. It is an essential requirement throughout various stages of biologic or viral vaccine production processes. The market revenue growth is driven by multiple factors, including the rise of pharmaceutical and biotechnology companies, an increasing number of drug launches, government support for the pharmaceutical and biotechnology sectors, and higher investments in Research and Development (R&D) within the life sciences field. Governments in emerging markets acknowledge the crucial role of biopharmaceuticals in improving healthcare outcomes and actively promote innovative methods to meet the growing demand for such products. The North American market takes the lead in the sterility monitoring industry, thanks to the U.S. government’s amplified healthcare investments aimed at fostering biopharmaceutical research endeavors.

Increasing R&D in life sciences, along with considerable public and private finance, is a key driver driving the sterility testing market’s revenue growth. To keep ahead of the competition, major industry players are focusing on business methods such as mergers, acquisitions, partnerships, and the development of new products. Furthermore, new companies are entering the kit testing business since it delivers a consistent source of money from clients. Furthermore, rising demand for pharmaceutical sterility testing and the need for various types of sterility testing, such as Bacteriostasis and Fungistasis (B/F) testing sterility, sterility testing medical devices, SGS sterility testing, hypothesis testing, Vaporized Hydrogen Peroxide (VHP) Ingress Testing, and so on, is driving revenue growth.

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Some of the prominent players profiled in the global sterility testing market include Merck KGaA, Charles River Laboratories, BIOMÉRIEUX, SGS Société Générale de Surveillance SA, Danaher Corporation, Nelson Laboratories, LLC, Thermo Fisher Scientific Inc., Sartorius AG, WuXi AppTec, and Eurofins Scientific.

Some Key Highlights from the Report

  • In 2022, the kits & reagents segment held the largest share of revenue in the sterility testing market. Reagent kits refer to test kits that are utilized in laboratory settings or even in the field to detect specific compounds. These test kits are commonly used to screen for the presence of illegal substances. Reagent testing kits are known for their user-friendly nature and often incorporate color changes as indicators of drug presence. The high demand for kits & reagents, driven by these characteristics, is expected to fuel the revenue growth of this segment.
  • The segment of membrane filtration emerged as the dominant contributor to the revenue share in the year 2022. By effecting the segregation of molecules possessing distinct sizes and characteristics, membrane filtration facilitates a physical partitioning process. The partitioning process is propelled by the divergent pressure levels exerted on both sides of the membrane. Membrane technology enhances the quality of products while simultaneously reducing overall production costs. A solitary feed stream is directed through a sophisticated membrane system, wherein it is bifurcated into two streams, namely retentate and permeate. These streams are meticulously separated by means of an advanced physical barrier known as a membrane, which selectively allows specific defined components from the feed stream to traverse through. Membrane filtering finds application in diverse processes, encompassing the treatment of Dairy Products, wastewater management, and beer brewing. The separation process offers numerous advantages, including adaptability, diminished energy requirements, cost-effective production, the capability to sterilize materials sensitive to heat, and the eradication of up to 100% of microorganisms. These benefits are fostering a high demand for membrane filtration, particularly for sterility testing, and are projected to propel the revenue growth of this segment.
  • In 2022, the pharmaceutical and biological production category generated the most revenue. Pharmaceutical goods used on patients by medical personnel must be of the greatest quality and exceedingly safe; otherwise, the patients may be harmed. Sterility testing confirms that the given product is suitable for sterility. As a result, it may be transferred for future use. These tests are critical for assuring thorough sterility and quality control of the product. It is difficult to assess the sterility of items without the proper sterility testing techniques. Analyzing a sample for sterility can assist identify whether or not it is completely sterile. It also aids in assessing the effectiveness of the sterilization process. This heightened demand for sterility testing in pharmaceutical and biological manufacturing is expected to drive revenue growth in this sector.
  • In 2022, the North American market had the highest revenue share. The presence of important players in this area is driving market revenue growth. The prevalence of critical illnesses, as well as the recent COVID-19 pandemic, highlight the significance of establishing additional onsite sterility testing laboratories in this region. Manufacturers are urged to establish additional facilities in order to provide more testing facilities.
  • Merck announced the release of their Ultimus Single-Use Process Container Film on April 24, 2023, which is designed to provide extraordinary durability and leak resistance for single-use assemblies primarily utilized in bioprocessing liquid applications. Ultimus film has a unique woven nylon structure that improves bag strength, durability, and resistance against leaks, abrasions, rips, and material fatigue.

For the purpose of this report, Reports and Data has segmented the global sterility testing market on the basis of Product Outlook, Test Outlook, Application Outlook, and Regional Outlook:

Product Outlook (Revenue, USD Million; 2022 – 2032)

  • Kits & Reagents
  • Services
  • Instruments

Test Outlook (Revenue, USD Million; 2022 – 2032)

  • Membrane Filteration
  • Direct Inoculation
  • Other Tests

Application Outlook (Revenue, USD Million; 2022 – 2032)

  • Pharmaceutical and Biological Manufacturing
  • Medical Device Manufacturing
  • Other Applications

Regional Outlook (Revenue, USD Million; 2022-2032)

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Sweden
    • BENELUX
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • South Korea
    • Rest of APAC
  • Latin America
    • Brazil
    • Rest of LATAM
  • Middle East & Africa
    • Saudi Arabia
    • UAE
    • South Africa
    • Israel
    • Rest of MEA

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