Sterility testing is a crucial process in the pharmaceutical and biotechnology industries to ensure that products are free from viable microorganisms. Companies offering sterility testing services play a vital role in maintaining the quality and safety of pharmaceutical products.
Latest Americas Sterility Testing Companies Update
Mar 2023: For the intended Phase I clinical trial of EB-373 for treating anxiety disorders, Enveric Biosciences and Australian contract research organization (CRO) Avance Clinical have inked a deal. As per the agreement, Avance Clinical will oversee the trial in collaboration with Enveric Therapeutics, the recently founded Australian branch of Enveric Biosciences. The goal of the dose-escalating, multi-cohort clinical trial is to evaluate the care and tolerability of EB-373, the company's main candidate. It is anticipated to start in the fourth quarter of this year. Using Enveric Biosciences' Psybrary drug discovery platform, the next-generation psilocin prodrug EB-373 was created with anxiety disorders in mind. Preclinical research revealed that it interacted efficiently with many serotonin receptor types, such as the serotonin 5-HT2A receptor.
Nov 2023: The debut of CliniPrime Cryopreserved Leukopaks for cell therapy creation and production marks the extension of Charles River Laboratories International, Inc.'s GMP-compliant CliniPrimeTM line of products. Regulations about the creation of clinical trials and the commercial production of cutting-edge treatments are met by all CliniPrime products. As gene-modified cell treatments progress, there is an increasing demand for dependable and consistent supplies of donor-derived, GMP-compliant cellular starting material. Cryopreserved leukopaks are now popular among many cell therapy developers and essential to research and development. The best results for cellular viability, product uniformity, and long-term availability are obtained by cryopreservation soon after leukopak collection.
The Americas Sterility Testing Market is expected to reach USD 7,632.3 Million by 2030 at 10.4% CAGR during the forecast period 2022-2030. Sterility testing is one of the important aspect in the healthcare sector. It ensures the purity and safety of a product or a substance. Sterilization of the product and devices ensures the safety of the products. The major driving factor for the growth of the market are increasing manufactures of the medical devices & products, increasing prevalence of many infectious diseases, and increasing in the R&D activities. According to the Centers for Disease Control and Prevention, in 2012, about half of all adults i.e. 117 million American had one or more chronic health problem. Increasing number of diseases has intensified the research activities, which has significantly driven the market. Furthermore, technological advances, growth of pharmaceutical industries, increasing support provided by the government and increasing R&D investment have fuelled the market growth in this region. However, time consuming approval process and strict regulatory guidelines are the key factors responsible for slow the market growth, which is expected to do so over the given period.
Market Assessment 
Source: World Health Organization (WHO, white paper, company presentation, annual report
Intended Audience
Figure 1:- Americas sterility testing market, by products (% share)
Source: World Health Organization (WHO, white paper, company presentation, annual reportÂ
On the regional basis, the Americas is segmented into North America and South America. North America holds a major share of the market owing to increasing number of approval of new drugs, increasing demand for the better quality products and increasing number of healthcare organizations like hospital, private research institute has led to increase in the market in North America. America sterility testing market is segmented into the US and Canada. The US is the major contributor to the market in this region. South America shows a steady growth in the market.Â
Key PlayersÂ
Some of the major player in the market are Charles River Laboratories International, Inc. (US), Avance Biosciences (US), Boston Scientific Corporation (US), Paragon Bioservices, Inc (US), Thermo Fisher Scientific, Inc. (U.S.), Avista Pharma Solutions (US), DYNALABS LLC. (US), and Merck KGaA (Germany)
Americas Sterility Testing Market Highlights:
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