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Factor VIII Inhibitors, Potential Market Opportunity & Clinical Pipeline Insights, 2019

  • OI-94
  • |
  • Published date: Apr, 2019
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  • Life Sciences & Healthcare
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  • 0 Pages

Factor VIII was also known, as an antihemophilic factor is referred as essential blood-clotting protein. Factor VIII is said to be produced outside the liver in liver sinusoidal cells and endothelial cells of the body. It is mixed in the bloodstream in an inactive form and binds to another molecule (von Willebrand factor) until the occurrence of damage to blood vessels. By injury, coagulation factor VIII responses by getting activated and it separates from von Willebrand factor. The formation of an FVIII inhibitor is said to be a T-cell dependent event, which involves antigen-presenting cells, T- and B-helper lymphocytes. The antibodies in inhibitor patients can simultaneously target multiple FVIII epitopes, and these epitope targeting will change over time. FVIII inhibitors are classified on the basis of kinetics and extent of inhibition into Type I inhibitors, which are more common in severe hemophilia and Type II inhibitors, which are common in inhibitor patients having mild hemophilia or in patients without hemophilia and developed an acquired FVIII inhibitor.


Market Overview


FVIII inhibitors interfere with the infused factor concentrates, thereby making them ineffective and inevitably using the most costly and less effective alternative hemostatic agents.  Currently, inhibitor development comes under the most significant treatment complication in hemophilia patients, which is associated with substantial morbidity and with decreased quality of life. Thus, FVIII inhibitor development results from a complex interaction existing between the patient’s immune system, environmental and genetic risk factors. The main purpose of the treatment is the eradication of the inhibitor by immune tolerance.


Several studies are under different stages of drug development in clinical trials of factor VIII inhibitors, which are majorly applicable for treating hemophilia condition. Among them, the studies in phase 3 stage of drug development includes drugs like turoctocog alfa, BAX802, Emicizumab, Fitusiran (ALN-AT3SC), Rituximab, Cyclophosphamide that is going very vast that will add to the market growth and only a few numbers of studies are under phase 2, phase 1, and early phases of drug development including drugs like Bortezomib, BAY1093884, Concizumab, MOD-5014. Thus further factor VIII inhibitors have to be designed to increase the market growth.


The major factors that is responsible for the market segment’s growth is the increasing incidence of hemophilia A, the increase in adoption of prophylactic treatment, and the development of novel drugs with extended action. Additionally, increase in demand for novel recombinant products with extended half-life, introducing plasma-derived products for recombinant factor VIII products at lower costs, and the appearance of monoclonal antibodies and gene therapy drug products are further driving the growth of the factor VIII inhibitors market.


Key Developments



  • In Feb 2019, the U.S. FDA has approved Cablivi (caplacizumab) in combination with plasma exchange and immunosuppression for treating acquired thrombotic thrombocytopenic purpura (aTTP) in adults. Cablivi is the first FDA approved therapy specifically indicated for the treatment of aTTP.

  • In Feb 2019, CHMP recommends EU approval of Roche's Hemlibra ® (emicizumab) for people with severe haemophilia A without factor VIII inhibitors.


Segmentation


This pipeline analysis report segments the Factor VIII inhibitors based on therapies employed (monotherapy and undisclosed), RoA (oral and undisclosed), therapeutic modalities (small molecules and disclosed), drugs under development (discovery, pre-clinical, phase I, phase I/II, phase II, and phase III), and recruitment status (recruiting, active not recruiting, enrolling by invitation, and undisclosed).


By Application: Neurology, Immunology, Hematology, Critical Care, Pulmonology, Hemato-Oncology, and Rheumatology.


The key players involved in the development of Factor VIII Inhibitors are Bayer, Bioverativ therapeutics, Baxalta Innovations, Chugai Pharmaceuticals, CSL Behring, Hoffmann-La Roche, Novo Nordisk, Octapharma, and the Shire.

Report Description: The report covers in-depth analysis on Factor VIII Inhibitors Pipeline Insights, 2019. The report assesses the Factor VIII Inhibitors pipeline by stage of development (early development, pre-clinical, clinical and in approval), by application (Neurology, Immunology, Hematology, and others). In addition, the report includes key insights on other development activities, including (but not limited to) – licensing (In and Out), collaborations, acquisitions, reimbursement, patent, and regulatory designations.


The report includes in-depth company profiles of key players in Factor VIII Inhibitors Pipeline. The company profile includes key information on overview, financial highlights, product portfolio, business strategies, and key recent developments.


The report highlights information on emerging companies with potentially disruptive technologies and new market entrants.


Scope:



  • Provides detailed analysis of the product pipeline structure along with forecast of the various segments and sub-segments of the Factor VIII InhibitorsPipeline.

  • Provides a comparative analysis of key marketed products and pipeline Factor VIII Inhibitors

  • Provides key information on players involved on the Factor VIII Inhibitors Pipeline.

  • Provides a complete overview of market segments and the regional outlook of Factor VIII Inhibitors Pipeline.

  • Provides in-depth coverage of key news related toFactor VIII Inhibitors Pipeline, including major mergers and acquisitions and product development updates such as clinical trial progression updates and regulatory updates

Our research works on a holistic 360° approach to deliver high quality, validated and reliable information in our market reports. The Market estimation and forecasting involve the following steps:




  • Data Collation (Primary & Secondary)




  • In-house Estimation (Based on proprietary databases and Models)




  • Market Triangulation




  • Forecasting




  • Market-related information is assembled from both primary and secondary sources. 






  • Primary sources involved participants from all global stakeholders such as experts from several related industries and suppliers that have been interviewed to obtain and verify critical information as well as to assess prospects of the market. The participants included are CXOs, VPs, and managers. Plus, our in-house industry experts having decades of industry experience contribute their consulting and advisory services. 





  • Secondary sources include public sources such as regulatory frameworks, government IT spending, government demographic indicators, industry association statistics, and company publications annual reports press releases along with paid sources such as Factiva, OneSource, Bloomberg among others. 





  • Top-down and bottom-up approaches: The overall market size was used in the top-down approach to estimate the sizes of other individual submarkets (mentioned in the market segmentation by product, type of manufacturing, and disease) through percentage splits from secondary and primary research. The bottom-up approach was also implemented (wherever applicable) for data extracted from secondary research to validate the market segment revenues obtained. 




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