Recombinant factor C assay is a type of pyrogen test that determines the presence of endotoxin substances. Recombinant factor C assay is a new alternative to various endotoxin tests such as limulus amebocyte lysate test. Recombinant factor C is the first component in the horseshoe crab clotting cascade that is activated by endotoxin. Recombinant factor C assay is activated by endotoxin binding, which results in the generation of flurogenic compounds.
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Pyrogens are substances that cause fever after administering an injection. Increase in body ache and body temperature are harmful reactions caused due to injection of pyrogens in the body. Drug manufacturers employ a process of recombinant factor C assay to determine if the manufactured vaccine or drug is likely to cause fever on administration. Various countries are focused on preventing infectious diseases to reduce the associated health care costs, this in turn is expected to increase the demand for health care facilities. Moreover, governments are focusing on pyrogen-free medical devices and pharmaceuticals for patients.
Factors such as elimination of false-positive glucan reactions, no animal are used for testing, and predictable and reliable assay performance are the factors driving the recombinant factor C assay market during the forecast period. Globally increasing health care awareness, growing number of pharmaceutical and biotechnology companies, and shifting focus of patients toward the treatment of chronic and lifestyle diseases is propelling the recombinant factor C assay market. Increasing research & development activities in the health care industry, rise in the number of new drug approvals, and growing incidences of chronic diseases are boosting the market.
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Increasing production of cosmetic products supports the expansion of the recombinant factor C assay market owing to the cosmetic products need to be tested for pyrogens. Increasing inclination toward animal-free detection tests, rising government initiatives for the prevention of diseases to curb health care costs, and rise in pharmaceutical outsourcing are projected to boost the demand for recombinant factor C testing. However, high entry barrier for new market entrants and small players are some of the restraining factors of the global recombinant factor C assay market.
The global recombinant factor C assay market can be segmented based on product type, end-user, and region. In terms of product type, the market can be categorized into routine assay, inhibition/enhancement (INH/ENH), reference standard endotoxin/ control standard endotoxin (RSE/CSE), and initial qualification (INT. QUAL). Based on end-user, the market can be divided into pharmaceuticals industry, biotechnology industry, medical devices industry, and others.
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Key players operating in the global recombinant factor C assay market include Hyglos GmbH, Lonza, and Hawaii Biotech Inc.