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Recombinant Coagulation Factors 2013 - The Race to Market and for Market Shares

Press Release   •   Dec 05, 2013 10:34 IST

Dec 5, 2013 : Bharat Book Bureau presents the new report, on ''Recombinant Coagulation Factors 2013 - The Race to Market and for Market Shares" describes a market forecast based on growth of historical sales of recombinant coagulation factors.

The report “Recombinant Coagulation Factors 2013 – The Race to Market and for Market Shares: Technology & Pipeline Assessment and Corporate Benchmarking Analysis” of June 2013 describes a market forecast based on growth of historical sales of recombinant coagulation factors. The report evaluates reasons for failures of novel recombinant coagulation factors and provides detailed profiles of active recombinant coagulation factors in clinical development. Preclinical projects are valued on the basis of the underlying technologies. Emerging alternative therapeutic approaches are described and assessed. The detailed target pipeline assessments put emphasis on the competitive situation regarding stage of development, inhibitor profile, half-life, administration frequency, clinical success and especially time to approval/market. The pipelines of the clinically active companies are described and their competitive position assessed in light of the key success factors. Sources of information are LMP’s proprietary database, scientific literature (abstracts, papers), corporate information (press releases, presentations, reports, SEC filings). All information is referenced.

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.

Table of Contents:

1 Executive Summary

2 Recombinant Coagulation Factor Markets
2.1 Recombinant Factor VIII (rFVIII) Market
2.1.1 rFVIII Product Sales
2.1.2 rFVIII Market Dynamic
2.2 Recombinant Factor IX (rFIX) Product Sales and Market Dynamics
2.3 Recombinant Factor VII (rFVII) Product Sales and Market Dynamics
2.4 Market Size & Dynamics of Recombinant Coagulation Factors in Hemophilia
2.5 Total Recombinant Coagulation Factors Market

3 Pipeline Changes & Drug Profiles
3.1 Discontinued Development of Recombinant Coagulation Factors
3.1.1 BAY 86-6150
3.1.2 Vatreptacog alfa; NN1731; NNC 0078-0000-0007; rFVIIa-DVQ
3.1.3 N7-GP; NN7128 (SC) / NN7129 (IV); NNC 0128-0000-2011; LA-rFVIIa
3.1.4 BAX 499; ARC19499
3.2 Active Clinical Development of Recombinant Coagulation Factors
3.2.1 Recombinant factor XIII
3.2.2 Recombinant von Willebrand factor
3.2.3 Wild-type and Biosimilar Recombinant Factor VIII
3.2.4 Long-acting Recombinant factor VIII
3.2.5 Wild-type and Biosimilar Recombinant Factor IX
3.2.6 Long-acting Recombinant Factor IX
3.2.7 Wild-type Recombinant factor VIIa
3.2.8 Long-acting Recombinant factor VIIa
3.3 Non-Clinical Development of Recombinant Coagulation Factors
3.4 Technologies and preclinical stage recombinant coagulation factors
3.4.1 Conjugation Technologies
3.4.2 Drug Delivery
3.4.3 Fusion Protein Technologies
3.4.4 Protein Engineering Technologies
3.4.5 Manufacturing & Cell Line Technologies
3.4.6 Biosimilar Recombinant Coagulation Factors
3.5 Alternative Procoagulants & Adjuncts
3.5 Gene & Cell Therapy of Hemophilia
3.5.1 Hemophilia B Gene Therapy
3.5.2 Hemophilia A Gene Therapy

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