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

Publisher: La Merie Publishing
Pages: 129
Format: PDF
Product Line:
LMP Full Report
Product Code: LMFR0008
Release Date: June of 2013

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

A Technology & Pipeline Assessment and Corporate Benchmarking Analysis

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 or under regulatory review. Given this tight competition, time-to-market will be an important success factor. 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

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

A Technology & Pipeline Assessment and Corporate Benchmarking Analysis

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

4          Comparative Target Pipeline Analysis & Assessment
4.1       Recombinant Factor VIII Pipeline
4.1.1    Clinical Pipeline of Novel Recombinant Factor VIII Molecules
4.1.2    Preclinical Pipeline of Novel Recombinant Factor VIII Molecules
4.2       Recombinant Factor IX Pipeline
4.3       Recombinant Factor VII Pipeline
4.4       Recombinant Fibrinogen and Thrombin Pipeline
4.5       Recombinant von Willebrand Factor Pipeline
4.6       Recombinant Factor XIII
4.7       Alternative Procoagulants & Adjuncts Pipeline
4.8       Gene Therapy of Hemophilia

5          Corporate Benchmark Analysis
5.1       Stakeholder Overview
5.2       Stakeholders per Company
Baxter
Bayer HealthCare Pharmaceuticals
Biogen Idec
Cangene
Chugai (Roche)
CSL
Green Cross
LFB (rEVO Biologics)
Novo Nordisk
Octapharma
OPKO Health (PROLOR Biotech)
Pfizer
Pharmstandard
5.3       Key Success & Failure Factors
5.4       Opportunities

6          References

7          Tables


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

A Technology & Pipeline Assessment and Corporate Benchmarking Analysis

Tables

Table   1          Calendar Year Sales of Advate/Recombinate from Baxter
Table 2            Calendar year Sales of Kogenate (FS) from Bayer
Table 3            Calendar Year Sales of Helixate from CSL
Table 4            Calendar Year Sales of ReFacto (AF)/Xyntha from Pfizer
Table 5            Market Shares of Recombinant Factor VIII Products
Table   6          Growth of the Recombinant Factor VIII Market
Table   7          rFVIII Market and Product Growth Rates 2005-2012
Table   8          Sales of BeneFIX in US$ mln
Table   9          Sales of NovoSeven
Table   10        Total Market Size (US$ mln) of Rec Coagulation Factors in Hemophilia
Table   11        Sales of Recothrom
Table   12        Market Shares of Recombinant Coagulation Factor Classes            

Tables in the Text
Table 13          Overview of Competitive Situation of Recombinant Coagulation Factors and Novel Therapeutic Approaches for Hemophilia
Table 14          Pipeline of rFVIII Molecules in Clinical Development
Table 15          Inhibitor Formation with Clinical Stage rFVIII Molecules
Table16           Half-life and Administration Frequency of Clinical Stage rFVIII Molecules
Table 17          Clinical Success of rFVIII Treatment and Prophylaxis
Table 18          Calculation of Approval Dates of Clinical Stage rFVIII Molecules
Table 19          Approval Dates of Clinical Stage rFVIII Molecules
Table 20          Preclinical Stage recombinant Factor VIII Molecules
Table 21          Clinical Stage Recombinant Factor IX Molecules
Table 22          Inhibitor Formation with Clinical Stage rFIX Molecules
Table 23          Half-life and Administration Frequency of Clinical Stage rFIX Molecules
Table 24          Clinical Success of rFIX Treatment and Prophylaxis
Table 25          Calculation of Approval Dates of Clinical Stage rFIX Molecules
Table 26          Approval Dates of Clinical Stage rFIX Molecules
Table 27          Preclinical Stage recombinant Factor IX Molecules
Table 28          Clinical Stage Recombinant Factor VIIa Molecules
Table 29          Half-life and Administration Frequency of Clinical Stage rFVIIa Molecules
Table 30          Calculation of Approval Dates of Clinical Stage rFIX Molecules
Table 31          Preclinical Stage recombinant Factor VIIa Molecules
Table 32          Pipeline of Recombinant Fibrinogen and Thrombin
Table 33          Pipeline of Recombinant von Willebrand Factor
Table 34          Pipeline of Recombinant Factor XIII
Table 35          Alternative Procoagulants & Adjuncts
Table 36          Pipeline of Gene Therapy of Hemophilia B
Table 37          Pipeline of Gene Therapy of Hemophilia A
Table 38          Comparative Clinical Portfolio Overview of Major Stakeholders
Table 39          Baxter Coagulation Pipeline
Table 40          Bayer Coagulation Pipeline
Table 41          Biogen Idec Coagulation Pipeline
Table 42          Cangene Coagulation Pipeline
Table 43          Chugai (Roche) Coagulation Pipeline
Table 44          CSL Coagulation Pipeline
Table 45          Green Cross
Table 46          LFB (rEVO Biologics) Coagulation Pipeline
Table 47          Novo Nordisk Coagulation Pipeline
Table 48          Octapharma Coagulation Pipeline
Table 49          OPKO Health (PROLOR Biotech) Coagulation Pipeline
Table 50          Pfizer Coagulation Pipeline
Table 51          Pharmstandard Coagulation Pipeline



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