Recombinant Factor C Assay a Sustainable Endotoxin Testing Solution
Recombinant factor C (rFC) assay is a synthetic equivalent of Factor C and is the first component of the horseshoe crab clotting cascade, which is activated in response to endotoxins. Moreover, the horseshoe crab blood can be collected only during a short time frame, thus limiting its supply considerably. Hence, healthcare companies in the recombinant factor C assay market are increasing their focus on rFC methods to help alleviate this challenge and improve outcomes.
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Novel rFC methods are benefitting healthcare companies, as these companies can limit their reliance on animals or any other source materials. Hence, recombinant factor C assay is acquiring popularity as a sustainable solution for endotoxin testing. Such advancements have led to the growth of the recombinant factor C assay market, where the market is estimated to reach a revenue of ~US$ 28 Mn by the end of 2027. Analysts of Transparency Market Research (TMR) opine that rFC will gain recognition in the endotoxin testing industry for its accuracy and specificity, which is as good as the LAL (Limulus Amebocyte Lysate) assay.
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PyroGene rFC Benefits Pharmaceutical Companies Due to Single-step Enzymatic Process
PyroGene™ recombinant factor C assay is gaining market prominence as a single-step enzymatic process as opposed to LAL assay that involves multiple procedural steps. As such, the PyroGene brand is anticipated to dictate the highest revenue as compared to EndoNext in the recombinant factor C assay market where the market is predicted to grow at a favorable CAGR of ~9% during the forecast period. Monitoring samples for contaminants play a pivotal role in pharmaceutical and medical device industries. This explains why the revenue of pharmaceutical companies is estimated to be the highest among all end users in the market landscape.
Traditional LAL testing is largely dependent on the blood of the horseshoe crab namely Limulus polyphemus. However, multiple enzymatic steps associated with LAL assay is majorly dependent on the availability of horseshoe crabs. Hence, companies in the recombinant factor C assay market are increasing their research spending in PyroGene recombinant factor C assay that can be associated with innovative software systems to gain a read-incubate-read sequence within the workflow.
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Consolidated Nature of Market to Attract Attention of Healthcare Giants
LAL assays are considered as the gold standard for endotoxin testing. However, advantages of recombinant factor C assay are transforming the market landscape, which is dictated by only two major companies. Lonza Group— a leading Swiss multinational biotechnology company is increasing efforts to make its PyroGeneTM recombinant factor C assay a compendial method in Europe by collaborating with the European Pharmacopoeia. On the other hand, Hyglos GmbH— a bioMérieux company, which is a global player in in vitro diagnostics, is increasing efforts to reduce the incidence of false positives from ß-Glucan or interference due to colored or turbid samples. Thus, healthcare companies worldwide should tap opportunities in rFC, since the recombinant factor C assay market is consolidated.
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Companies in the recombinant factor C assay market are reducing the pressure on LAL assays for innovations in monitoring samples for contaminants in pharmaceutical products. However, lack of long-term studies that validate rFC for combination testing of unknown samples, inter-laboratory, -operator, and -lot changes poses a barrier for market growth. Hence, pharmaceutical test users are increasing their efficacy in research studies to validate successful outcomes of rFC in specific products.
Effective FDA-approved Drug Builds Credibility of Healthcare Companies
Companies in the recombinant factor C assay market are gaining competitive edge over other players by introducing FDA-approved drugs using rFC. They are increasing efforts to experiment with humanized monoclonal antibodies such as galcanezumab for the prevention of migraine in adults. Novel rFC methods are being highly publicized as non-animal alternatives for the assessment of contaminating endotoxins in drugs. Though LAL is considered as the gold standard for endotoxin testing, official declarations by the FDA are validating the efficiency of PyroGene in the recombinant factor C assay market landscape. Thus, accuracy, sensitivity, and specificity of recombinant factor C assay is being considered at par with LAL methods.
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