Combined product sales of the three classes olf recombinant coagulation factors used in hemophilia were US$ 7.172 mln in 2012. The pipeline of new recombinant coagulation factors is maturing and the first molecules are under regulatory review by the FDA and the EMA and many have entered pivotal clinical studies. There are 46 different molecules and R&D approaches for novel recombinant coagulation factors for hemophilia A and B in the pipeline of which 24 are in clinical development of under regulatory review. Given this tight competition, time-to-market will be an important success. This report will explain the potential development and approval timelines of each of the advanced molecules.
What will you find in this report?
- Historical sales data of the recombinant coagulation factors VIII, IX, VIIa and II;
- Historical growth rates and a 5-year sales forecast of each class of recombinant factors;
- Reasons for failure and profiles of failed recombinant coagulation factors;
- Detailed profiles of clinical stage recombinant coagulation factors;
- Technologies used for creation of novel recombinant coagulation factors;
- Preclinical stage recombinant coagulation factors;
- New approaches: alternative procoagulants / adjuncts and gene therapy;
- Pipeline analysis and assessment for each recombinant coagulation factor class;
- Comparative data on clinical inhibitor formation and discussion of its relevance;
- Comparison of half-life prolongation and its impact on administration frequency;
- Comparison of the time to approval for each clinical stage recombinant coagulation factor;
- Company pipeline and competitive position of each major player in the field