Recombinant Factor C Assay Market: Introduction

According to the report, the global recombinant factor C assay market was valued at ~US$ 13 Mn in 2018 and is projected to expand at a considerable CAGR during the forecast period. Recombinant factor C (rFC) assay can be defined as an alternative to LAL tests employed for endotoxin testing of the products for pyrogens. These tests are performed on all the pharmaceutical products and medical devices in batches prior to their release for human use. This method of endotoxin testing employs a single enzymatic step compared to multiple steps enzymatic process needed for LAL assays. Rise in need for alternative endotoxin detection tests drives the global recombinant factor C assay market. Commonly used tests for the detection of endotoxins include limulus amoebocyte lysate (LAL) test and rabbit pyrogen test. However, decline in horseshoe crab population and increasing threat of their extinction have led to the development of newer tests such as the recombinant factor C (rFC) test that employs the recombinant factor C, which is one of the major components of the cascade of proteins tested during the LAL detection tests.

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North America dominated the global recombinant factor C assay market in 2018 and the trend is anticipated to continue during the forecast period. Strong growth of the market in the region can be attributed to incorporation of the rFC assays in the U.S. pharmacopoeia, strong presence of market players in the region, and increase in adoption of rFC assays by the pharmaceutical companies in the region.

Advantages of Recombinant Factor C Assay

Recombinant factor C (rFC) assays are being considered to be replacements for the most employed endotoxin detection method, the LAL test. This can be attributed to the higher specificity, greater sensitivity, and lesser variability of recombinant factor C tests compared to other endotoxin detection methods. Advantages offered by the recombinant factor C tests include the ability to perform comparably or better than LAL/TAL-based methods for various applications, lot-to-lot consistency, ease-of-use & a suitable sensitivity range, and enhanced endotoxin specificity. These advantages would encourage the pharmaceutical product manufacturers to employ alternative tests such as the recombinant factor C assays. In addition, the adoption of this assays will contribute significantly in the conservation of horseshoe crabs, which are considered as “living fossils”. This, in turn, is likely to boost the growth of the global market.

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PyroGene to Lead Global Market

In terms of brand segment, the PyroGene brand is likely to account for a major share of the global recombinant factor C assay market during the forecast period. The growth of the segment can be attributed to it being the first marketed recombinant Factor C assay product employed as an alternative to LAL tests. It is one of the major products tested as an alternative to LAL tests with an aim of conserving the Limulus species, which is considered as a “Living Fossil”.

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Recombinant Factor C Assay Market: Prominent Regions

The global recombinant factor C assay market has been segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global recombinant factor C assay market in 2018. The expansion of the recombinant factor C assay market in the region can be attributed to well-established presence of the market players, changing government regulations, and introduction of recombinant factor C as an alternative assay for LAL endotoxin detection. In addition, increase in product approvals by the U.S. FDA is likely to create a demand for recombinant factor C assays, owing to the fact that endotoxin detection is the mandatory process prior to the launch of the products for human use.

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The recombinant factor C assay market in Asia Pacific is likely to expand at a high CAGR from 2019 to 2027. Growth of the market in the region can be attributed to changing regulations, inclusion of recombinant factor C assays in global pharmacopoeias, growing pharmaceutical and biotechnology industries, and rise in medical tourism.

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