凝血因子（2009年）：標的產品線及競爭標竿分析 是由出版商La Merie在2009年08月所出版的。
這份英文市場調查報告書包含386 Pages 價格從美金3454起跳。
置換及取自血漿的凝血因子產品的市場總值於2008年超過75億美元。預計未來10年當中市場將變化，凝血因子產品的既有製造商及銷售企業將面臨新企業進入市場競爭的課題。
本報告書內容包括：凝血因子產品研發概要及蛋白工程、給藥技術評價、上市產品概要及分析、50家以上進入產業的企業介紹、競爭企業標竿學習等。內容綱要摘記如下：
第1章 實施概要
第2章 概要
第3章 介紹
- 凝血因子的商業利用
- 凝固疾病的流行病學
- 市場規模
- 專利的有效期限
- 業界利害關係人
第4章 標的產品線分析
- 第VIII因子
- 第IX因子
- 第VII因子
- vWF
- 其他凝固因子
- 局部凝固因子
- 其他實驗性血友病治療
第5章 企業標竿分析
- 領先企業
- Baxter
- Novo Nordisk
- Bayer Schering Pharma
- Wyeth
- 比較
- 多樣化企業
- 新興企業
- Zymogenetics
- Biogen Idec
- Biovitrum
- Inspiration Biopharmaceuticals
- Ispen
- Green Cross
- SK Chemicals
- Thrombotargets
- GTC Biotherapeutics
- Pharming
- ProFibrix
- 促進發展企業
- 傳統企業
- 未分類企業
第6章 參考資料
第7章 圖表
Abstract
The “Coagulation Factors 2009: Target Pipeline and Corporate Benchmark
Analysis” report is the most complete and up-to-date evaluation and
assessment of the recombinant and plasma-derived coagulation factor pipelines.
The authors analyze and assess the target pipeline for each of the coagulation
factors used for systemic and topical administration. Companies active in the
therapeutic coagulation business are evaluated and the strengths, weaknesses,
opportunities and threats (SWOT) in their R&D pipeline benchmarked in the
respective peer group. Technologies used for creation of next generation
coagulation factors are discussed and assessed. The report identifies
strategies to overcome weaknesses in the portfolio and suggests development
strategies
Background
The market size of recombinant and plasma-derived coagulation factor products
exceeded US$ 7.5 bln in 2008, the majority (US$ 5.5 bln) generated by
recombinant proteins. Replacement of plasma-derived coagulation factors by
marketed recombinant molecules is ongoing and will further increase by new
recombinant coagulation factors in development. In light of ongoing expiration
of substance patents, about 40 new recombinant coagulation factor projects are
in the pipeline indicating a changing marketplace over the next decade. New
players are competing and will challenge established manufacturers and
marketers of coagulation factor products.
Scope of the report
- R&D pipeline overview;
- In depth profiles of most promising coagulation factors in the pipeline
- pipeline analysis for each coagulation factor ;
- evaluation and assessment of protein engineering and drug delivery
technologies
- overview and analysis of marketed coagulation factors;
- profiles of more than 50 companies active in this business;
- corporate product portfolios and R&D pipelines
- benchmark and SWOT analysis of corporate competitors within peer group;
Highlights
Ongoing patent expirations and failed life cycle management efforts leave the
established companies vulnerable regarding the future growth perspective of
their recombinant coagulation factor business, but at the same time opens the
door to potential new market entrants.
The recombinant factor VIII pipeline consists of more than ten novel
molecules, four of them already in clinical stages, some are wild-type
constructs, but many are longer acting variants of factor VIII. The
recombinant factor IX pipeline even counts 15 developments with three in
clinical phases. In the recombinant factor VIIa pipeline, all projects except
one are modified versions, either short-acting or longer acting with four
projects in the clinic and two more shortly to follow.
All of the next generation molecules need systemic intravenous administration,
attempts to allow subcutaneous or even non-injectable administration regimes
so far have not succeeded and leave space for future optimization.
SWOT analysis revealed Novo Nordisk as well positioned in contrast to market
leader Baxter.
Benefits from the report
- Understand your position in a highly competitive environment
- Avoid costly mistakes
- Learn from your competitors
- Challenge your strategy with a view from outside the organization
- Revise weaknesses of your molecule and development plan
- Identify threats to your business plan
- Realize new opportunities suggested by the report
- Reassure and build upon your strengths
- Find applications for your technology
Target audience
- Project, product and portfolio managers
- Business development & licensing
- Research & development
- Technology evaluation
- Financial analysts
- Investment fund/venture capital managers
- Plasma fractionation companies with coagulation factor business
- Drug delivery companies
- Protein engineering companies
- Companies with surgery and wound healing business
- Companies interested in biosimilars/biogenerics
Table of Contents
1. Executive Summary
2. Overview: What you will find in the report and where
3. Introduction:
- 3.1 Commercial uses of coagulation factors
- 3.2 Epidemiology of coagulation disorders
- 3.3 Market size
- 3.4 Patent expiration
- 3.5 Industrial stakeholders
4. Target Pipeline Analysis
- 4.1 Factor VIII
- 4.2 Factor IX
- 4.3 Factor VII
- 4.4 von Willebrand Factor (vWF)
- 4.5 Other Coagulation Factors
- 4.6 Topical Coagulation Factors
- 4.7 Other Experimental Hemophilia Therapies
5. Corporate Benchmark Analysis
- 5.1 The TOP League
- 5.1.1 Baxter
- 5.1.2 Novo Nordisk
- 5.1.3 Bayer Schering Pharma
- 5.1.4 Wyeth
- 5.1.5 A Cross-Comparison
- 5.2 The Diversifying Companies
- 5.2.1 CSL
- 5.2.2 Octapharma
- 5.2.3 LFB
- 5.3 The Emerging Companies
- 5.3.1 Zymogenetics
- 5.3.2 Biogen Idec
- 5.3.3 Biovitrum
- 5.3.4 Inspiration Biopharmaceuticals
- 5.3.5 Ipsen
- 5.3.6 Green Cross
- 5.3.7 SK Chemicals
- 5.3.8 Thrombotargets
- 5.3.9 GTC Biotherapeutics
- 5.3.10 Pharming
- 5.3.11 ProFibrix
- 5.4 The Facilitator Companies
- 5.5 The Traditional Companies
- 5.6 The Unclassified Companies
6. References
7. Tables in the Text
- Table 1 Prevalence of rare coagulation factor disorders
- Table 2 2008 Sales of Recombinant Factor VIII Products
- Table 3 Growth of the recombinant Factor VIII market (US$ mln)
- Table 4 BeneFix Sales (1999 - 2008)
- Table 5 NovoSeven Sales (1999 - 2008)
- Table 6 Total Sales of recombinant coagulation factors in 2008
- Table 7 2008 Sales of selected pd coag. factors for systemic use
- Table 8 2008 Sales of selected pd coagulation factors for topical use
- Table 9 2008 Sales of coagulation factor product lines per company
- Table 10 Changes of manufacturing/formulation in rec. coag. factors
- Table 11 Approval / launches of rec coag. factors in the US and EU
- Table 12 The TOP coag. factor companies in terms of 2008 sales
- Table 13 Product characteristics of improved rhu F. VIII products
- Table 14 Overview of R&D pipeline of rec factor VIII products
- Table 15 Target profiles of rec wild-type F. VIII products in R&D
- Table 16 Target profiles of rec long-acting F. VIII products in R&D
- Table 17 Product characteristics of marketed wt rhu F. IX
- Table 18 Overview of R&D pipeline of rec factor IX products
- Table 19 Target profiles of rec wild-type F. IX products in R&D
- Table 20 Target profiles of rec long-acting F. IX products in R&D
- Table 21 Product characteristics of marketed wt rhu F. VII
- Table 22 Overview of R&D pipeline of rec factor VIIa products
- Table 23 Target profile of rec wild-type F. VIIa product in R&D
- Table 24 Target profiles of rec long-acting F. VIIa products in R&D
- Table 25 Overview on Baxter' s R&D Pipeline in rec coag. factors
- Table 26 SWOT analysis of Baxter
- Table 27 Overview on Novo Nordisk' s R&D pipeline in coag. factors
- Table 28 SWOT analysis of Novo Nordisk
- Table 29 Overview on Bayer' s R&D pipeline in rec coag. factors
- Table 30 SWOT analysis of Bayer Schering Pharma
- Table 31 Overview on Wyeth' s R&D pipeline in rec coag. factors
- Table 32 SWOT analysis of Wyeth
- Table 33 Overview on TOP League' s R&D pipeline in r coag. factors
- Table 34 The largest plasma fractionation companies by plasma vol.
- Table 35 The largest plasma fractionation companies by sales
- Table 36 SWOT analysis of CSL
- Table 37 SWOT analysis of Octapharma
- Table 38 SWOT analysis of LFB
- Table 39 SWOT analysis of Zymogenetics
- Table 40 SWOT analysis of Biogen Idec
- Table 41 SWOT analysis of Biovitrum
- Table 42 SWOT analysis of Inspiration Biopharmaceuticals
- Table 43 SWOT analysis of Ipsen
- Table 44 SWOT analysis of Green Cross
- Table 45 Protein engineering companies (ref. rec coagulation factors)
- Table 46 Drug delivery companies (ref. rec coagulation factors)
- Table 47 Product portfolio of traditional plasma fract. companies
- Table 48 R&D portfolio of traditional plasma fractionation companies
ADDENDUM
A) Executive Drug Profiles
- 40K PEG-rFIX
- AV513
- BAY 79-4980
- BAY 86-6150
- CSL689
- FIXFc
- GreenGene
- IB1001
- NN1731
- NN1841
- NN7008
- NN7128
- OBI-1
- Octagenate
- rVWF
B) Company Profiles
- Amsterdam Molecular Therapeutics
- Apitope
- Asklepios Biopharmaceutical
- Baxter
- Bayer Schering Pharma
- Bio Products Laboratory (BPL)
- Biogen Idec
- Biotest
- Biovitrum
- Catalyst Biosciences
- Celestial Biologicals
- China Biologic Products
- Crucell
- CSL
- Ethicon (J&J)
- Green Cross
- Grifols
- GTC Biotherapeutics
- Haemacure
- Inspiration Biopharmaceuticals
- Intas Biopharmaceuticals
- Ipsen
- Jerini (Shire)
- Kaketsuken
- Kamada
- Kedrion
- King Pharmaceuticals
- LFB
- Lipoxen
- Maxygen
- MDRNA
- MediVas
- Mochida Pharmaceutical
- National Bioproducts Institute (NBI)
- Nautilus Biotech (HanAll Pharmaceutical)
- Nektar Therapeutics
- Neose Technologies
- Novo Nordisk
- Nycomed
- Octapharma
- Oxford Biomedica
- Pharming
- ProFibrix
- ProGenetics
- PROLOR Biotech
- Recoly
- Sanquin
- Shanghai RAAS
- SK Chemicals
- Talecris Biotherapeutics
- Thrombotargets
- VIRxSYS
- Wyeth
- Zymogenetics
C) Tabulated Overviews on Profiles of Plasma Derived Coagulation Factors
- Tab I: Profile of Human Plasma-Derived Coagulation Factor VIII Concentrates
- Tab II: Profile of Highly Purified Human Plasma-Derived Coagulation Factor
IX Concentrates
- Tab III: Profile of Purified Human Plasma-Derived Prothrombin Complex
Concentrates
- Tab IV: Profile of Other Human Plasma-Derived Coagulation Factor
Concentrates
- Tab V: Profile of Topical Coagulation Factor Products & Projects
D) Tabulated Target Pipelines of Coagulation Factors
- Tab VI: Human Plasma-Derived Coagulation Factor VIII Concentrates
- Tab VII: Recombinant Coagulation Factor VIII Products
- Tab VIII: Human Plasma-Derived Coagulation Factor IX Products
- Tab IX: Recombinant Coagulation Factor IX Products
- Tab X: Human Plasma-Derived Factor VII
- Tab XI: Recombinant Coagulation Factor VII Products
- Tab XII: Human Plasma-Derived Coagulation Factor Concentrates for vWD
- Tab XIII: Recombinant Human Von Willebrand Factor Products
- Tab XIV: Human Plasma-Derived Fibrinogen (Factor I)
- Tab XV: Recombinant Human Fibrinogen Products
- Tab XVI: Human Plasma-Derived Factor V
- Tab XVII Human Plasma-Derived Factor XI
- Tab XVIII: Human Plasma-Derived Factor X
- Tab XIX: Recombinant Human Factor X
- Tab XX: Human Plasma-Derived Factor XIII
- Tab XXI: Recombinant Human Factor XIII
- Tab XXII: Other Recombinant Factors
- Tab XXIII: Other Experimental Hemophilia Therapies
- Tab XXIV: Gene Therapy
- Tab XXV: Topical Human Plasma-Derived Fibrinogen and Thrombin Products
- Tab XXVI: Topical Plasma-Derived Thrombin Products
- Tab XXVII: Human Plasma-Derived Prothrombin Complex Concentrates
E) Tabulated Corporate Product Portfolios and R&D Pipelines
- Abraxis Biosciences
- Amsterdam Molecular Therapeutics
- Angiotech
- Apitope
- Asklepios Biopharmaceutical
- Baxter
- Bayer Schering Pharma
- Bio Products Laboratory (BPL)
- Biogen Idec
- Biotest
- Biovitrum
- Catalyst Biosciences
- China Biologic Products
- Crucell
- CSL
- Ethicon (J&J)
- Genzyme
- Green Cross
- Grifols
- GTC Biotherapeutics
- Haemacure
- Inspiration Biopharmaceuticals
- Intas Biopharmaceuticals
- Ipsen
- Jerini (Shire)
- Kaketsuken
- Kamada
- Kedrion
- King Pharmaceuticals
- LFB
- Lipoxen
- Maxygen
- MDRNA
- MediVas
- Mochida Pharmaceutical
- National Bioproducts Institute (NBI)
- Nautilus Biotech (HanAll Pharmaceutical)
- Nektar Therapeutics
- Neose Technologies
- Novo Nordisk
- Nycomed
- Octapharma
- Oxford Biomedica
- Pharming
- ProFibrix
- ProGenetics
- PROLOR Biotech
- Recoly
- Roche
- Sanquin
- Shanghai RAAS
- Sinobiomed
- SK Chemicals
- Talecris Biotherapeutics
- Thrombotargets
- VIRxSYS
- Wyeth
- Zymogenetics
