Sterility Testing Market to Surpass 469 Million by 2030 Drives Due to Rising Demand for Quality Assurance in Pharmaceutical and Medical Industries

SkyQuest projects that the sterility testing market will attain a value of USD 469 million by 2030, with a CAGR of 12.6% over the forecast period (2023-2030). The sterility testing market is anticipated to grow substantially owing to the increasing investments and funding. One such example is the announcement recently made by Thermo Fisher Scientific Inc., where they planned to invest more than US$ 50 million in expanding their global bioproduction capabilities. This investment aimed to provide additional capacity for manufacturing single-use bioprocess container (BPC) systems, crucial for sterile liquid-handling applications in the biopharmaceutical industry.


Westford, USA, July 30, 2023 (GLOBE NEWSWIRE) -- According to SkyQuest, the demand for sterility testing market is expected to experience a significant growth with continuous advancements in the pharmaceutical and medical fields. The flourishing biotechnology industry worldwide is another factor that will contribute to expanding the market during the forecast period. Furthermore, as safety concerns related to biological medicinal products continue to increase, there is a growing emphasis on ensuring the sterility and quality of these products.

Browse in-depth TOC on "Sterility Testing Market"

  • Pages - 219
  • Tables - 86
  • Figures – 76

Sterility is a crucial concept in the pharmaceutical industry and refers to the absence of viable microorganisms. In pharmaceutical practice, a container is deemed sterile when the probability of being contaminated with replicating microorganisms is less than one out of one million in sterility testing market.

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Prominent Players in Sterility Testing Market

  • Merck KGaA
  • Charles River Laboratories International, Inc.
  • SGS S.A.
  • WuXi AppTec Inc.
  • Thermo Fisher Scientific Inc.
  • bioMérieux SA
  • Sartorius AG
  • Pacific Biolabs
  • Nelson Laboratories, LLC
  • Bio-Rad Laboratories, Inc.
  • Becton, Dickinson and Company
  • Sigma-Aldrich Corporation
  • Pace Analytical Services LLC
  • Eurofins Scientific SE
  • ATS Labs, Inc.
  • MilliporeSigma
  • Cytovance Biologics, Inc.
  • North American Science Associates, Inc. (NAMSA)
  • Toxikon Corporation
  • Nelson Laboratories (Europe) B.V.

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Membrane Filtration Sterility Testing Segment is Expected to Dominating the Market Due to the Testing Samples

The membrane filtration sterility testing segment has emerged as the dominant player, holding the largest sterility testing market share. This segment is also projected to witness significant growth at a considerable CAGR during the forecast period. Membrane filtration sterility testing is a widely adopted method that involves passing test samples through conventional membranes capable of capturing bacteria. This technique is particularly suited for testing samples that contain adjuvant gels and other general-purpose items such as vaccines.

The markets in North America have emerged as the dominant region in the global sterility testing market. The presence of leading biopharmaceutical and biotechnology companies in the region and ongoing research and development efforts focused on finding cures for chronic diseases have contributed to the market's growth.

Pharmaceutical and Biotechnology Segment is Expected to Grow in the Market Due to the Increasing Demand for Sterility Testing Services

The pharmaceutical and biotechnology segment has emerged as the leader in the sterility testing market, holding the largest market share. Sterility testing is a critical process in this industry as it is conducted to detect the presence of pyrogenic compounds or any foreign materials that can impact the quality and safety of the final product. In particular, parenteral products, which are administered through injection or infusion, undergo rigorous sterility testing to ensure they are free from pyrogens.

Regional markets in the Asia Pacific are witnessing a significant growth in the sterility testing market, emerging as the fastest-growing market globally. One of the key drivers for this growth is the presence of many pathology labs, diagnostics labs, and research and development facilities in the region. These facilities contribute to the increasing demand for sterility testing services, as they play a crucial role in ensuring the safety and efficacy of medical products.

A comprehensive analysis of the major players in the sterility testing market has been recently conducted in a report. The report encompasses various aspects, including collaborations, mergers, innovative business policies, and strategies, providing valuable insights into key trends and breakthroughs in the market. Furthermore, the report scrutinizes the market share of the top segments and presents a detailed geographic analysis. Lastly, the report highlights the major players in the industry and their endeavours to develop innovative solutions to cater to the growing demand.

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Key Developments in Sterility Testing Market

  • STEMart introduced a comprehensive microbiology and sterility testing service designed for sterile and non-pyrogenic medical devices in 2022. This new offering aims to ensure the safety and effectiveness of these devices by conducting rigorous testing to detect the presence of microorganisms or pyrogenic compounds.
  • Berkshire Sterile Manufacturing marked a significant milestone by introducing a sterility testing isolator in 2022. This isolator enables the company to conduct onsite sterility testing for its Good Manufacturing Practice (GMP) batches. Berkshire Sterile Manufacturing specializes in the sterile filling of injectable medicines, focusing on products involved in clinical trials or those with limited commercial demand.

Key Questions Answered in Sterility Testing Market Report

  • What specific growth drivers are projected to impact the market during the forecast period?
  • List the top companies in the market and explain how they have achieved their positions of influence?
  • In what ways do regional trends and patterns differ within the global market, and how these differences shape the market's future growth?

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