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Recombinant Coagulation Factors 2015:

Maturation of recombinant clotting factor pipeline and emergence of gene therapy and alternative procoagulants

A Pipeline Landscape Analysis and Comparative Assessment of Key Players

This report provides an update of recombinant coagulation factors used for controlling bleeding of hemophilia A and B and other bleeding disorders. 2013 sales figures and 2014 nine-month sales data are analyzed to evaluate commercial development of the market under the light of a strong pipeline and entry of new competitor products into the market. The profiles of drug candidates in development are presented in details not only for recombinant coagulation factors VIII, IX and VII, but also for emerging alternative procoagulants, gene therapeutics and immune tolerance inducing agents.

The competitve landscape of classical recombinant coagulation factors and of new emerging treatment modalities of hemophilia and other severe bleeding orders is analyzed. The emergence of new treatment modalities brings many new stakeholders to the field of hemophilia. Among them are the established hemophilia portofolio companies, but also new entrants from Big Pharma and Big Biotech, specialty pharmaceutical companies, biosimilar companies, and new technology providers as half-life prolongation technologies are no longer in the focus of major interest.

A short- to mid-term outlook into the field is provided and the trends driving the future of this therapeutic segment are identified and described. Preparation of this report is based on information stored in La Merie Publishing’s proprietary data base and news archive, on scientific literature, and on corporate disclosures. The data are presented, analyzed and assessed in a comprehensive manner by an experienced author writing the fifth edition of this report series.

Benefits from the report:

- Development of product sales and recombinant coagulation factors market
- Sales performance of newly launched recombinant coagulation factors
- Drug profiles for all relevant classical as well a semerging developments
- Technologies, constructs and players in the gene therapy field of hemophilia
- Alternative procoagulants: approaches, profiles, competitive advantages
- Comparative analysis of key product features of new coagulation factors
- Corporate profiles of all relevant stakeholders including deals and pipelines
- Pipeline and technology trends

Table Of Contents

Recombinant Coagulation Factors 2015: Maturation of recombinant clotting factor pipeline and emergence of gene therapy and alternative procoagulants
Recombinant Coagulation Factors 2015:
Maturation of recombinant clotting factor pipeline and emergence of gene therapy and alternative procoagulants
A Pipeline Landscape Analysis and Comparative Assessment of Key Players
Table of Contents
1.         Executive Summary
2.         Recombinant Coagulation Factor Markets
2.1       Recombinant Factor VIII (rFVIII) Product Sales and Market Size
2.1.1    Advate/Recombinate Sales
2.1.2    Kogenate FS Sales
2.1.3    Helixate Sales
2.1.4    Xyntha / Refactor AF Sales
2.1.5    Eloctate Sales
2.1.6    2014 Performance of rFVIII Product Sales
2.1.7    rFVIII Market Size
2.2       Recombinant Factor IX (rFIX) Product Sales and Market Size
2.2.1    BeneFIX Sales
2.2.2    Alprolix Sales
2.2.3    2014 Performance of rFIX Product Sales
2.2.4    rFIX Market Size
2.3       Recombinant Factor VII (rFVII) Product Sales and Market Size
2.3.1    NovoSeven Sales
2.3.2    Coagil VII Sales
2.3.3    rFVII Market Size

2.4       Recombinant Thrombin Product Sales and Market Size

2.5       Total Recombinant Coagulation Factor Market Size

3.         Pipeline Update of Recombinant Coagulation Factors

3.1       Factor VIII Pipeline Changes and Drug Profile Updates
3.1.1    Wild-type, improved and biosimilar rFVIII
3.1.2    Long-acting rFVIII

3.2       Factor IX Pipeline Changes and Drug Profile Updates
3.2.1    Wild-type rFIX
3.2.2    Long-acting rFIX

3.3       Factor VII Pipeline Changes and Drug Profile Updates
3.3.1    Wild-type, improved and biosimilar rFVIIa
3.3.2    Long-acting rFVIIa

3.4       Pipeline Update for Other Recombinant Coagulation Factors

3.5       Pipeline Update for Alternative Procoagulants
3.5.1    Coagulation Factor Mimetics
3.5.2    Inhibitor Switch-off
3.5.3    Systemic Thrombin
3.5.4    Factor Xa Variants
3.5.5    Oral Procoagulants

3.6       Pipeline Update for Gene andamp; Cell Therapy
3.6.1    Gene andamp; Cell Therapy of Hemophilia B
3.6.2    Gene andamp; Cell Therapy of Hemophilia A
3.6.3    Gene and Cell Therapy of Hemophilia A and B

3.7       Immune Tolerance Inducing (ITI) Agents

4.         Competitive Landscape Analysis of Recombinant Coagulation Factors

4.1       rFVIII Competitive Landscape Analysis
4.1.1    Wild-type, improved and biosimilar rFVIII Landscape
4.1.2    Long-acting rFVIII Landscape
4.2       rFIX Competitive Landscape Analysis
4.3       rFVII Competitive Landscape Analysis
4.4       Competitive Landscape of Other Recombinant Coagulation Factors
4.5       Competitive Landscape of Alternative Procoagulants for Systemic Use
4.6       Competitive Landscape of Gene andamp; Cell Therapy for Hemophilia
4.7       Immune Tolerance Inducing (ITI) Agents

5.         Stakeholder Profiles

5.1       Coagulation Factor Portfolio Companies
5.1.1    Baxter
5.1.2    Novo Nordisk
5.1.3    CSL
5.1.4    Bayer HealthCare Pharmaceuticals
5.1.5    Pfizer
5.1.6    Octapharma
5.1.7    LFB
5.1.8    Biotest
5.1.9    The Medicines Company

5.2       Big Pharma andamp; Biotech as New Entrants to Bleeding Disorder Field
5.2.1    Biogen Idec
5.2.2    Roche (Chugai)
5.2.3    AstraZeneca (MedImmune)

5.3       Specialty Pharma as New Entrants to Hemophilia Field
5.3.1    Shire
5.3.2    BioMarin Pharmaceutical
5.3.3    Emergent BioSolutions
5.3.4    OPKO Health

5.4       Biosimilar Companies
5.4.1    Generium Group
5.4.2    Aryogen

5.5       Protein Engineering Companies
5.5.1    Catalyst Biosciences
5.5.2    Pharming
5.5.3    The Chemo-Sero-Therapeutic Research Institute KAKETSUKEN

5.6       Gene andamp; Cell Therapy Companies
5.6.1    uniQure
5.6.2    Spark Therapeutics
5.6.3    Dimension Therapeutics
5.6.4    Expression Therapeutics
5.6.5    Sangamo Biosciences
5.6.6    ReGenX
5.6.7    Sernova andamp; Medicyte
5.6.8    Amarna Therapeutics

5.7       RNA Companies
5.7.1    Alnylam Pharmaceuticals
5.7.2    Arcturus Therapeutics

5.8       Immunology Companies
5.8.1    Apitope
5.8.2    Selecta Biosciences
5.8.3    EpiVax

6.         Strategic Analysis

6.1       Pipeline and Technology Overview and Trends
6.2       Short- and Mid-term Perspective of Recombinant Coagulation Factors
6.3       Key Product Profiles and Differentation Factors among Novel Products
6.4       Mid- and long-term perspective of new hemophilia treatments
6.5       Key Players in the Field

7          References

8          ADDENDUM: Development and Approval Timelines

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