Global Sterility Testing Market Growth Forecast 2023-2028: Key Drivers and Restraints


The global sterility testing market is poised for significant growth, with projections indicating an impressive surge from USD 1.1 billion in 2023 to USD 1.9 billion in 2028, at a compelling Compound Annual Growth Rate (CAGR) of 10.5%. In this article, we will delve into the factors driving this remarkable growth and explore the challenges that the market faces.

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Factors Fueling Market Growth:

  1. Pharmaceutical & Biopharmaceutical Expansion: A pivotal driver of this growth is the continuous expansion of pharmaceutical and biopharmaceutical production capacities. This expansion is fueled by the ever-growing demand for high-quality pharmaceutical products on a global scale.
  2. Novel Biopharmaceutical Development: The market is further propelled by the increasing development of innovative biopharmaceutical products. This surge in novel product development has created a need for robust sterility testing to ensure the safety and efficacy of these cutting-edge therapies.
  3. Investments in Life Science Research: The healthcare and life sciences sectors have witnessed a surge in investments. These investments are directed towards groundbreaking research and development initiatives, thus creating a heightened demand for sterility testing solutions.

Challenges Hindering Market Growth:

  1. Rise of Single-Use Technology: One significant challenge faced by the sterility testing market is the growing adoption of single-use technology. While this trend is environmentally friendly and cost-effective, it poses a threat to traditional sterility testing methods.

Key Market Player

Prominent players operating in the biomarkers market are Charles River Laboratories, Inc. (US), Merck KGaA (Germany), bioMérieux SA (France), SGS SA (Switzerland), WuXi AppTec (China), Nelson Laboratories, LLC (US), Pacific BioLabs (US), Sartorius AG (Germany), Thermo Fisher Scientific Inc. (US), Samsung Biologics (South Korea). The study includes an in-depth competitive analysis of these key players in the modular data center market with their company profiles, recent developments, and key market strategies. The players in this market have embraced different strategies to expand their global presence and increase their market shares. New product launches and enhancements, partnerships, acquisitions, and collaborations have been the most dominating strategies adopted by the major players.

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The kits & reagents segment accounted for the largest share of the product & service segment in 2022

On the basis of product & service, the sterility testing market is segmented into kits & reagents, instruments, and services. In 2022, the kits & reagents segment accounted for the largest market share in sterility testing. Kits & reagents are widely used in the pharmaceutical and biotechnology industries as it is easy to use. Moreover, the long shelf life of these products is contributing to their rising adoption in academic institutions and contract research organizations.

 By test-type segment, membrane filtration accounted for the largest market share in 2022

Based on the test type, the sterility testing market is divided into membrane filtration, direct inoculation, and other tests. The membrane filtration segment accounted for the biggest share of the sterility testing market in 2022. Factors such as the growing demand for sterility testing of liquid dose formulations and the utility of such tests in samples containing preservatives and bacteriostatic & fungistatic compounds will boost segmental growth.

In 2022, the Asia region accounted as the fastest-growing region in the market

In 2022, the Asia region accounted for the fastest-growing region of the sterility testing market. Factors responsible for the growth of this region include the rising trend of outsourcing pharmaceutical activities to CROs and CDMOs coupled with growing demand from emerging markets such as China and India.Moreover, growing public and private investments in pharmaceutical and biopharmaceutical R&D activities in the region will also propel the growth of Asian sterility testing market over the forecast period.

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Recent Development:

  • In November 2022, Merck KGaA (Switzerland) invested USD 306.5 million in expanding its biosafety testing capacity at Rockville, Maryland, US. This site will provide biosafety testing and analytical development services in the US.
  • In September 2022, Merck KGaA (Switzerland) opened its viral clearance (VC) laboratory as the first phase of the China Biologics Testing Center. This site is set to operate in China and will locally conduct viral clearance studies across pre-clinical development to commercialization.
  • In June 2022, Charles River Laboratories, Inc. (US) opened a new facility of High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, UK. The 16,000 sq. ft facility will provide plasmid DNA manufacturing services.
  • In May 2022, bioMerieux SA (France) acquired Specific Diagnostics (US). With this acquisition, bioMerieux will improve its presence in antimicrobial resistance while expanding its market-leading position globally in clinical microbiology.

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