Chicago, Aug. 26, 2024 (GLOBE NEWSWIRE) -- The "Sterility Testing Market Size, Share & Trends by Product (Kits & Reagents, Instrument, Services), Test (Membrane Filtration, Direct Inoculation), Application (Pharma, Biological Manufacturing, Medical Device Manufacturing), End User (Pharma, Biotech) & Region - Global Forecasts to 2028" report highlights substantial growth projections. It anticipates the market to escalate from $1.1 billion in 2023 to $1.9 billion by 2028, at a notable CAGR of 10.5%. The growth of the sterility testing market is driven by the expansion of pharmaceutical and biopharmaceutical production capacities, increased development of novel products, and rising investments in life science research. However, the market faces constraints from the adoption of single-use technology, which reduces the need for sterility testing by eliminating the need for labor-intensive cleaning and sterilization. Emerging markets, particularly in Brazil, India, and China, present significant growth opportunities due to increased R&D funding and expanding contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs). Challenges include a shortage of skilled professionals essential for effective sterility testing. In 2022, the market was led by the consumables segment, with membrane filtration being the dominant test type. North America held the largest market share, bolstered by high drug approvals, increasing disease prevalence, and significant R&D investments. Key players in the market include Charles River Laboratories, Merck KGaA, bioMérieux, SGS, WuXi AppTec, Nelson Laboratories, Pacific BioLabs, Sartorius, Thermo Fisher Scientific, and Samsung Biologics.
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Charles River Laboratories (US): Key Player in Sterility Testing
Charles River Laboratories is a leading entity in the sterility testing market, operating as a service-oriented and early-stage contract research organization (CRO). The company provides a comprehensive range of discovery and safety assessment services, supporting clients' manufacturing processes with a diverse portfolio of products and services. Charles River focuses on expanding its sterility testing offerings to bolster its market position, including customized assays and Fast Track Testing for expedited results. Recent acquisitions, such as JADE Biomedical and Cognate BioServices, have enhanced the company’s service capabilities and geographical reach.
bioMérieux SA (France): Leader in Alternative Sterility Testing Methods
bioMérieux is a prominent player in alternative sterility testing methods, with a strong focus on inorganic growth strategies to maintain and expand its market leadership. The company’s acquisition of Specific Diagnostics in May 2022 enhances its position in antimicrobial resistance and global clinical microbiology. bioMérieux’s innovative products, including BACT/ALERT and SCANRDI, are pioneers in rapid microbiological methods, reducing sterility testing timelines from the traditional 11-14 days to just 4 hours.
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Product & Service Segmentation in the Sterility Testing Market
The sterility testing market is segmented into kits & reagents, instruments, and services. In 2022, the kits & reagents segment dominated with a 49.1% market share and is projected to experience the highest growth due to the need for recurring purchases and a growing preference for kit-based testing.
Test Type Insights for Sterility Testing
The market is divided into membrane filtration, direct inoculation, and other test types. The membrane filtration segment held the largest share in 2022 and is expected to continue leading due to the increasing demand for testing drugs in liquid dosage forms.
Application Trends in Sterility Testing
Sterility testing applications include pharmaceutical & biologics manufacturing, medical device manufacturing, and other uses. The pharmaceutical and biologics manufacturing segment held the largest share in 2022 and is anticipated to grow the fastest, driven by expanding capacities in pharmaceutical and biopharmaceutical companies. For example, Novartis invested USD 300 million in 2022 to enhance bio-therapeutic production capabilities.
End User Trends in Sterility Testing
The market is segmented into pharmaceutical companies, biotechnology companies, and other end users. In 2022, pharmaceutical companies represented the largest share, driven by the need for sterility testing in preclinical, clinical, and commercial drug production stages. The robust drug pipeline and increasing production capacities are expected to further boost this segment.
Regional Market Dynamics
The sterility testing market is divided into North America, Europe, Asia, and the Rest of the World. North America held the largest market share in 2022. However, Asia is expected to see the highest growth during the forecast period, driven by increased investment in life science research and a growing trend of pharmaceutical outsourcing to countries like India and China.
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