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.

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.

recombinant factor c assay market infographic

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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.

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.

recombinant factor c assay market segmentation

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Analysts’ Viewpoint

Gaining FDA approval for drugs is essential in the recombinant factor C assay market. Advantages of rFC are grabbing the attention of commercial innovators in the field of recombinant technology to explore untapped business potentials.

rFC is ensuring the sustainable evolution of horseshoe crab species. However, it is still unsure whether rFC-based tests outshine LAL assays and other robust test systems. Hence, pharmaceutical test users should increase their efficacy in long-term research studies that validate the efficiency of rFC involving unknown samples and inter-laboratory, -operator, and -lot changes. They should increase research in comparative studies of rFC involving kinetic chromogenic LAL assays that help companies to boost their credibility in the market landscape.

Recombinant Factor C Assay Market: Overview

  • The global recombinant factor C assay market was valued at ~US$ 13 Mn in 2018 and is projected to expand at a considerable CAGR from 2019 to 2027. Endotoxin detection is a crucial step before the launch of pharmaceutical drugs, medical devices, and biotechnology products for human use. Recombinant factor C assay has been accepted as an alternative to LAL tests, which are widely employed for endotoxin testing. This growing acceptance as an alternative to LAL tests and its inclusion in the regulatory pharmacopoeias would contribute to the growth of the recombinant factor C assay market.   
  • Significant advantages offered by recombinant factor C assays, including cost advantages by aiding in reducing the operator risks by lowering the rate of invalid results and reduction of over 50% of the processing time as compared to the conventional microplate-based LAL tests, contribute to the growth of the recombinant factor C assays market
  • Productivity of the pharmaceutical industry has been significantly high, with an increase in the number of drugs approved annually. According to the U.S. FDA, in 2018, over 59 new drugs were approved in the U.S. Additionally, increase in demand for personalized medicine aids in the rise in the product approvals. This contributes to the growth of the recombinant factor C assays market.

Recombinant Factor C Assay Market: Segmentation

  • The global recombinant factor C assay market has been segmented based on brand, end user, and region
  • In terms of brand, the global recombinant factor C assay market has been categorized into PyroGene and EndoNext. The PyroGene brand is sub-segmented into PyroGene Bulk rFC (2,880 tests) and PyroGene rFC (192 tests). The EndoNext brand is sub-segmented into EndoZyme II, EndoZyme II GO, and EndoLisa. 
  • Based on end user, the global recombinant factor C assay market has been segregated into pharmaceutical companies, biotechnology companies, medical device companies, and contract research organizations (CROs). The pharmaceutical companies segment dominated the market in 2018, and is likely to remain dominant during the forecast period. Growth of the segment can be attributed to increase in approvals of pharmaceutical drugs globally. In addition, rise in demand for personalized medicines contributes to increase in manufacturing of pharmaceuticals, thereby leading to rise in the number of endotoxin detection tests conducted. This would contribute to the growth of the pharmaceutical companies segment in the recombinant factor C assay market.

Recombinant Factor C Assay Market: Regional Segmentation

  • In terms of region, the global recombinant factor C assay market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa
  • North America dominated the global recombinant factor C assay market in 2018 and the trend is expected to continue throughout the forecast period
  • The recombinant factor C assay market in Asia Pacific is anticipated to expand at a high CAGR during the forecast period. Incorporation of recombinant factor C as a recognized endotoxin detection test by pharmacopoeias, and focus on conservation of the Limulus species in Asia Pacific contributes to the growth of the recombinant factor C assay market in the region.

Recombinant Factor C Assay Market: Major Players

  • Key players operating in the global recombinant factor C assay market are Lonza Group and Hyglos GmbH – a bioMérieux Company 
  • These players are focused on adopting inorganic growth strategies and product launches to strengthen their product portfolio. In June 2018, bioMérieux launched rapid ENDOZYME II GO, a new endotoxin test in the bioMérieux ENDONEXT range of recombinant horseshoe crab factor C assays. bioMérieux entered the market in 2016, through the acquisition of Hyglos, a company engaged in the development of recombinant factor C assays for endotoxin testing.

Recombinant Factor C Assay Market - Scope of the Report

TMR’s report on the global recombinant factor C assay market studies the past as well as current growth trends and opportunities to gain valuable insights of these indicators for the global market during the forecast period i.e. from 2019 to 2027. The report provides the overall revenue of the global recombinant factor C assay market for the 2017–2027 period, considering 2018 as the base year and 2027 as the forecast year. The report also provides the compounded annual growth rate (CAGR) for the global recombinant factor C assay market for the forecast period.

The report has been prepared after an extensive research. Primary research involved bulk of research efforts, wherein analysts carried out interviews with market leaders and opinion makers. Extensive secondary research involved referring to key players’ product literature, annual reports, press releases, and relevant documents to understand the global recombinant factor C assay market.

Secondary research also included Internet sources, statistical data from government agencies, websites, and trade associations. Analysts also employed a combination of top-down and bottom-up approaches to study various phenomena in the global recombinant factor C assay market.

The report includes an elaborate executive summary, along with a snapshot of the growth pattern of various segments and sub-segments included in the scope of the study. Additionally, the report sheds light on the changing competition dynamics in the global recombinant factor C assay market. These indices serve as valuable tools for existing market players as well as for entities interested in participating in the global recombinant factor C assay market. The next section of the report highlights the USPs, which include value chain analysis, key industry developments, patent analysis, regulatory scenario, and institutes involved in research studies using horseshoe crabs in the global recombinant factor C assay market.

The report delves into the competition landscape of the global recombinant factor C assay market. Key players operating in the global recombinant factor C assay market have been identified and each one of these has been profiled for its distinguishing business attributes. Company overview, financial standings, recent developments, and SWOT are some of the attributes of players profiled in the global recombinant factor C assay market report.

Key Questions Answered in Global Recombinant Factor C Assay Market Report

  • How much sales revenue would be generated by recombinant factor C assay across all regions during the forecast period?
  • What are key trends in the global recombinant factor C assay market?
  • What are major drivers, restraints, and opportunities in the global recombinant factor C assay market?
  • Which regional market is set to expand at the most rapid CAGR during the forecast period?
  • Which end user segment would generate the maximum revenue by 2027 and which brand segment would expand at the most rapid CAGR during the forecast period?

Recombinant Factor C Assay Market - Research Objectives and Research Approach

The comprehensive report on the global recombinant factor C assay market begins with an overview of the market, followed by the scope and objectives of the study. Following this, the report provides detailed explanation of the objectives of the study and health care compliances laid down by accredited agencies in the purview of research in the global recombinant factor C assay market. It is followed by market introduction, market dynamics, and an overview of the global recombinant factor C assay market, which includes TMR’s analysis of market drivers, restraints, and trends affecting the market. Furthermore, Y-o-Y growth analysis with elaborate insights has been provided to understand the Y-o-Y growth trends of the global market. The next section of the global recombinant factor C assay market report highlights the USPs, which include regulatory scenarios for recombinant factor C assay globally, market value chain analysis, and developments in the global market.

For reading comprehensibility, the report has been compiled in a chapter-wise layout, with each section further divided into small sections. The entire report comprises an exhaustive collection of graphs and tables that are appropriately interspersed in the entire compilation. Pictorial representation of actual and projected values of key segments is visually appealing to readers. This also allows comparison of market shares of key segments in the past and at the end of the forecast period.

Revenue generated by key players in the global recombinant factor C assay market has been mapped to ascertain the size of the global recombinant factor C assay market, in terms of value. The forecast presented here assesses the total revenue generated in the global recombinant factor C assay market. In order to provide an accurate forecast, we initiated by sizing up the current recombinant factor C assay market with the help of the parent market.

The report analyzes the global recombinant factor C assay market in terms of brand, end user, and region. Key segments under each criteria have been studied at length and the market share for each of these by the end of 2027 has been provided. These valuable insights would help market stakeholders in making informed business decisions for investments in the global recombinant factor C assay market.

Global Recombinant Factor C Assay Market – Segmentation

Brand

PyroGene

  • PyroGene Bulk rFC (2,880 tests)
  • PyroGene rFC (192 tests)

EndoNext

  • EndoZyme II
  • EndoZyme II GO
  • EndoLisa

End User

Pharmaceutical Companies

Biotechnology Companies

Medical Device Companies

Contract Research Organizations (CROs)

Region

North America

Europe

Asia Pacific

Latin America

Middle East & Africa

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