Recombinant Coagulation Factors 2015: Maturation of recombinant clotting factor pipeline and emergence of gene therapy and alternative procoagulants
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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 with an independent view 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
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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
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 & Cell Therapy
3.6.1 Gene & Cell Therapy of Hemophilia B
3.6.2 Gene & 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 & 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 & 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 & 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 & 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
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
Tables
Table 1 Sales of Advate/Recombinate
Table 2 Sales of Kogenate (FS)
Table 3 Sales of Helixate (NexGen)
Table 4 Sales of ReFacto (AF)/Xyntha
Table 5 Growth of the Recombinant Factor VIII Market
Table 6 Market Shares of Recombinant Factor VIII Products
Table 7 Sales of BeneFIX / Growth of rFIX Market
Table 8 Sales of NovoSeven
Table 9 Sales of Coagil VII
Table 10 Growth of Recombinant Factor VIIa Market
Table 11 Sales of Recothrom
Table 12 Total Market Size of Recombinant Coagulation Factors in Hemophilia
Table 13 The US/EU Clinical Trial Program of GreenGene F
Table 14 The Clinical Trial Program of Nuwiq (simoctocog alfa)
Table 15 The LEOPOLD Clinical Trial Program of BAY 81-8973
Table 16 The AFFINITY Clinical Trial Program of CSL627
Table 17 The Clinical Trial Program of Eloctate
Table 18 The Clinical Trial Program of BAX 855
Table 19 The Clinical Trial Program of damoctocog alfa pegol
Table 20 The PATHFINDER Clinical Trial Program of turoctocog alfa pegol
Table 21 The Clinical Trial Program of nonacog gamma
Table 22 The Clinical Trial Program of trenonacog alfa
Table 23 The Clinical Trial Program of Alprolix
Table 24 The PROLONG-9FP Clinical Trial Program of CSL654
Table 25 The PARADIGM Clinical Trial Program of nonacog beta pegol
Table 26 The Clinical Trial Program of BAX 817
Table 27 The PERSEPT Clinical Trial Program of LR769
Table 28 The PROLONG-7FP Clinical Trial Program of CSL689
Table 29 R&D Stage and Timeline of wild-type, improved and biosimilar rFVIII
Table 30 Inhibitor Formation by wild-type and improved rFVIII
Table 31 Half-Life and Dosing Frequency of wild-type and improved rFVIII
Table 32 Efficacy of wild-type and improved rFVIII
Table 33 R&D Stage and Timeline of Long-Acting rFVIII
Table 34 Inhibitor Formation by Long-Acting rFVIII
Table 35 Half-Life and Dosing Frequency of Long-Acting rFVIII
Table 36 Efficacy of Long-Acting rFVIII
Table 37 R&D Stage and Timeline of wild-type, biosimilar and long-acting rFIX
Table 38 Inhibitor Formation by rFIX
Table 39 Half-Life and Dosing Frequency of rFIX
Table 40 Efficacy of rFIX
Table 41 R&D Stage and Timeline of wild-type, biosimlar and long-acting rFVII
Table 42 Inhibitor Formation by wild-type and long-acting rFVII
Table 43 Half-Life and Dosing Frequency of wild-type and long-acting rFVII
Table 44 Other Recombinant Coagulation Factors
Table 45 R&D Stage and Timelines of Alternative Procoagulants
Table 46 Product Profiles of Systemic Alternative Procoagulants
Table 47 R&D Stage and Timeline of Gene Therapy of Hemophilia B
Table 48 R&D Stage and Timeline of Gene & Cell Therapy of Hemophilia A
Table 49 R&D Stage and Timeline of Gene Therapy of Hemophilia A and B
Table 50 Immune Tolerance Inducing (ITI) Agents
Table 51 Baxter Hemophilia Recombinant Product Portfolio and R&D Pipeline
Table 52 Novo Nordisk Bleeding Disorder Product Portfolio and R&D Pipeline
Table 53 CSL Hemophilia Recombinant Product Portfolio and R&D Pipeline
Table 54 Bayer Hemophilia Product Portfolio and R&D Pipeline
Table 55 Pfizer Bleeding Disorder Recombinant Products and R&D Pipeline
Table 56 Octapharma Hemophilia Recombinant Product Portfolio
Table 57 LFB Hemophilia Recombinant R&D Pipeline
Table 58 The Medicines Company Bleeding Disorder Product and R&D Pipeline
Table 59 Biogen Idec Hemophilia Recombinant Products and R&D Pipeline
Table 60 AstraZeneca Hemophilia & Bleeding Disorder R&D Pipeline
Table 61 Shire and Sangamo Biosciences Bleeding Disorder R&D Pipeline
Table 62 BioMarin Pharmaceutical Hemophilia R&D Pipeline
Table 63 Emergent BioSolutions Hemophilia R&D Pipeline
Table 64 OPKO Health Hemophilia R&D Pipeline
Table 65 Generium Hemophilia Product Portfolio and R&D Pipeline
Table 66 Catalyst Biosciences Bleeding Disorder Recombinant R&D Pipeline
Table 67 Pharming Hemophilia & Bleeding Disorder R&D Pipeline
Table 68 uniQure Hemophilia R&D Pipeline
Table 69 Spark Therapeutics Hemophilia R&D Pipeline
Table 70 Dimension Therapeutics Hemophilia R&D Pipeline
Table 71 Expression Therapeutics Hemophilia R&D Pipeline
Table 72 ReGenX Biosciences Hemophilia R&D Pipeline
Table 73 Sernova & Medicyte Hemophilia R&D Pipeline
Table 74 Pipeline Overview and R&D Trends
Table 75 Target Launch Years for Novel rFVIII Molecules by Company Names
Table 76 Target Launch Years for Novel rFIX Molecules by Company Names
Table 77 Major Players and Hemophilia Portfolio Coverage
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
Alnylam Pharmaceuticals
Alphamab
Alteogen
Amarna Therapeutics
Apitope
Arcturus Therapeutics
Aryogen
AstraZeneca
Baxter
Bayer HealthCare Pharmaceuticals
Biogen Idec
Biotest
Catalyst Biosciences
Chia Tai Tiangqing Pharma Group
Chiesi Farmaceutici
CSL
Dimension Therapeutics
Dong-A Pharmaceutical
Emergent BioSolutions
EpiVax
Expression Therapeutics
Generium Group
Green Cross
ISU Abxis
Nektar Therapeutics
Novo Nordisk
Octapharma
Opus Bio (Lentigen)
Pfizer
Pharming
Pharmstandard
REGENX Biosciences
Roche (Chugai)
Sangamo Biosciences
Sanofi (Genzyme)
Selecta Biosciences
Shanghai Institute for Pharmaceutical Industry (SIPI, a Sinopharma company)
Shire
Spark Therapeutics
Swedish Orphan Biovitrum (Sobi)
Teijin Pharma
The Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN),
The Medicines Company
UCB
uniQure
Xenetic Biosciences