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遺伝子組換え血液凝固因子:組み換え凝固因子パイプラインの成熟および遺伝子治療・代替凝血促進剤の出現

Recombinant Coagulation Factors 2015: Maturation of Recombinant Clotting Factor Pipeline and Emergence of Gene Therapy and Alternative Procoagulants

発行 La Merie Publishing 商品コード 274454
出版日 ページ情報 英文 210 Pages
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遺伝子組換え血液凝固因子:組み換え凝固因子パイプラインの成熟および遺伝子治療・代替凝血促進剤の出現 Recombinant Coagulation Factors 2015: Maturation of Recombinant Clotting Factor Pipeline and Emergence of Gene Therapy and Alternative Procoagulants
出版日: 2014年12月22日 ページ情報: 英文 210 Pages
概要

当レポートでは、世界の遺伝子組換え血液凝固因子市場の現状と将来動向について分析し、これまでの市場動向と今後の見通し、主なパイプライン薬剤の開発・治験・認証状況、開発企業各社のプロファイルと製品開発状況などをまとめ、お届けします。

第1章 エグゼクティブサマリー

第2章 遺伝子組換え血液凝固因子の市場

  • 遺伝子組換え第VIII因子(rFVIII)製品売上・市場規模
    • Advate/組み換え製品の売上高
    • Helixateの売上高
    • Xyntha / Refactor AFの売上高
    • Eloctateの売上高
    • rFVIII製品の売上実績
    • rFVIII市場規模
  • 遺伝子組換え第IX因子(rFIX)製品の売上高・市場規模
    • BeneFIX の売上高
    • Alprolixの売上高
    • rFIX製品の売上実績
    • rFIX市場規模
  • 遺伝子組換え第VII因子(rFVII)製品の売上高・市場規模
    • NovoSevenの売上高
    • Coagil VIIの売上高
    • rFVII市場規模
  • 遺伝子組換えトロンビン製品のの売上高・市場規模
  • 遺伝子組換え血液凝固因子の総市場規模

第3章 遺伝子組換え血液凝固因子のパイプラインアップデート

  • 遺伝子組換え第VIII因子の変化と薬剤プロファイルのアップデート
  • 遺伝子組換え第IX因子の変化と薬剤プロファイルのアップデート
  • 遺伝子組換え第VII因子の変化と薬剤プロファイルのアップデート
  • その他の遺伝子組換え血液凝固因子のパイプラインアップデート
  • 代替凝固促進剤のパイプラインアップデート
  • 遺伝子&細胞療法のパイプラインアップデータ
  • 免疫寛容誘導(ITI)剤

第4章 遺伝子組換え血液凝固因子の競合情勢分析

  • 遺伝子組換え第VIII因子(rFVIII)の競合情勢分析
  • 遺伝子組換え第IX因子(rFIX)の競合情勢分析
  • 遺伝子組換え第VII因子(rFVII)の競合情勢分析
  • その他の遺伝子組換え血液凝固因子の競合情勢
  • 全身用代替凝固促進剤のの競合情勢
  • 血友病向け遺伝子&細胞療法の競合情勢
  • 免疫寛容誘導(ITI)剤

第5章 ステークホルダーのプロファイル

  • 血液凝固因子ポートフォリオ企業
    • Baxter
    • Novo Nordisk
    • CSL
    • Bayer HealthCare Pharmaceuticals
    • Pfizer
    • Octapharma
    • LFB
    • Biotest
    • The Medicines Company
  • 出血性疾患分野の新規参入者としての大手製薬会社&バイオテクノロジー企業
    • Biogen Idec
    • Roche (中外製薬)
    • AstraZeneca (MedImmune)
  • 血友病分野の新規参入者としての専門制約会社
    • Shire
    • BioMarin Pharmaceutical
    • Emergent BioSolutions
    • OPKO Health
  • バイオシミラー企業
    • Generium Group
    • Aryogen
  • タンパク質工学企業
    • Catalyst Biosciences
    • Pharming
    • 一般財団法人化学及血清療法研究所:化血研
  • 遺伝子&細胞療法企業
    • uniQure
    • Spark Therapeutics
    • Dimension Therapeutics
    • Expression Therapeutics
    • Sangamo Biosciences
    • ReGenX
    • Sernova & Medicyte
    • Amarna Therapeutics
  • RNA企業
    • Alnylam Pharmaceuticals
    • Arcturus Therapeutics
  • 免疫学企業
    • Apitope
    • Selecta Biosciences
    • EpiVax

第6章 戦略分析

  • パイプラインおよび技術概要と動向
  • 遺伝子組換え血液凝固因子の短・中期的展望
  • 主要製品のプロファイルおよび新薬の差別化要因
  • 新しい血友病治療の中・長期的展望
  • 同分野の主要企業

第7章 参照

第8章 付録:開発・承認スケジュール

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目次
Product Code: LMFR0014

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

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

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