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基因重組凝血因子:重組的凝血因子開發平台的成熟及基因治療·替代凝血催化劑的出現

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

出版商 La Merie Publishing 商品編碼 274454
出版日期 內容資訊 英文 210 Pages
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基因重組凝血因子:重組的凝血因子開發平台的成熟及基因治療·替代凝血催化劑的出現 Recombinant Coagulation Factors 2015: Maturation of Recombinant Clotting Factor Pipeline and Emergence of Gene Therapy and Alternative Procoagulants
出版日期: 2014年12月22日 內容資訊: 英文 210 Pages
簡介

本報告提供全球基因重組凝血因子市場現狀與未來趨勢相關分析,為您彙整至今的市場趨勢與今後的預測,主要的開發平台藥物的開發·臨床實驗·認證情形,開發企業各公司簡介與產品開發情形等資料。

第1章 摘要整理

第2章 基因重組凝血因子的市場

  • 基因重組第八凝血因子(rFVIII)產品銷售額·市場規模
    • Advate/重組的產品的銷售額
    • Helixate的銷售額
    • Xyntha / Refactor AF的銷售額
    • Eloctate的銷售額
    • rFVIII產品的銷售額實際成果
    • rFVIII市場規模
  • 基因重組第九凝血因子(rFIX)產品的銷售額·市場規模
    • BeneFIX 銷售額
    • Alprolix的銷售額
    • rFIX產品的銷售額實際成果
    • rFIX市場規模
  • 基因重組第VII因子(rFVII)產品的銷售額·市場規模
    • NovoSeven的銷售額
    • Coagil VII的銷售額
    • rFVII市場規模
  • 基因重組凝血酶產品的銷售額·市場規模
  • 基因重組凝血因子的整體市場規模

第3章 基因重組凝血因子的開發平台更新

  • 基因重組第八凝血因子的變化和藥物簡介的更新
  • 基因重組第九凝血因子的變化和藥物簡介的更新
  • 基因重組第VII因子的變化和藥物簡介的更新
  • 其他基因重組凝血因子的開發平台更新
  • 替代凝固催化劑的開發平台更新
  • 遺傳基因&細胞療法的開發平台提高資料
  • 免疫耐受性誘導(ITI)劑

第4章 基因重組凝血因子的競爭情形分析

  • 基因重組第八凝血因子(rFVIII)的競爭情形分析
  • 基因重組第九凝血因子(rFIX)的競爭情形分析
  • 基因重組第VII因子(rFVII)的競爭情形分析
  • 其他基因重組凝血因子的競爭情形
  • 全身用替代凝固催化劑的競爭情形
  • 血友病用遺傳基因&細胞療法的競爭情形
  • 免疫耐受性誘導(ITI)劑

第5章 相關利益者簡介

  • 凝血因子組合企業
    • Baxter
    • Novo Nordisk
    • CSL
    • Bayer HealthCare Pharmaceuticals
    • Pfizer
    • Octapharma
    • LFB
    • Biotest
    • The Medicines Company
  • 出血性疾病領域的新加入廠商者的大型製藥公司&生物科技企業
    • Biogen Idec
    • Roche (中外製藥)
    • AstraZeneca (MedImmune)
  • 血友病領域的新加入廠商──專門限定公司
    • Shire
    • BioMarin Pharmaceutical
    • Emergent BioSolutions
    • OPKO Health
  • 生技仿製藥企業
    • Generium Group
    • Aryogen
  • 蛋白質工程企業
    • Catalyst Biosciences
    • Pharming
    • 一般財團法人化學和血清療法學會:化血研
  • 遺傳基因&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
  • 免疫學企業
    • Apitope
    • Selecta Biosciences
    • EpiVax

第6章 策略分析

  • 開發平台及技術概要與趨勢
  • 基因重組凝血因子的短·中期展望
  • 主要產品簡介及新藥的差異化要素
  • 新的血友病治療中·長期的展望
  • 該領域的主要企業

第7章 參照

第8章 附錄:開發·核准計劃

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目錄
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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