Abstract
Product description
The report “Coagulation Factors 2010 - The Portfolio Aspect as
Decisive Force: A Competitive Landscape and R&D Pipeline Analysis of
Hemostasis Proteins” provides a description, evaluation and
assessment of the recombinant and plasma-derived coagulation factor pipelines
as of September 2010. 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 factor 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:
Global sales of the five major recombinant products of coagulation factors
VIII, IX and VIIa in 2009 were US$ 5.5 bln (with $ conversion rate of
September 2, 2010). As of 2009, substance patents have commenced to expire in
the first territories and are continuing to expire over the next few years. As
a consequence, established companies have intensified their efforts to defend
or even expand their coagulation factor sales and new players have been
entered this commercially attractive field.
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
None of the established marketers of recombinant coagulation factors so far
has achieved to get a next generation coagulation factor product approved to
convert sales from the first generation product to the next generation product.
The five marketed recombinant coagulation factors (VIII, IX and VIIa) are
facing a total of more than 41 different projects among the three hemophilia
coagulation factors in the R&D pipeline: 12 projects (equally distributed
among the three factors) are in clinical stage and another 7 molecules are in
IND enabling studies or at pre-IND stage ready to enter phase I during the
next 12 months. Further 22 molecules are in preclinical R&D. The field is
moving rapidly and the next two years will see important progress in the
development of new molecules because the drug discovery phase has provided
sufficient candidates for non-clinical and clinical development.
Novo Nordisk extended its leading position in the competitive R&D landscape of
next generation coagulation factor products with a highly differentiated
portfolio approach.
In addition to differentiating the properties of a single coagulation factor,
more than 10 companies are active with more than one of the three different
coagulation factors emphasizing the importance of the portfolio aspect in the
future marketing efforts. Not only the established companies with recombinant
coagulation factors on the market are developing a differentiated portfolio,
but also newcomers to the field are developing more than one factor. Portfolio
not only means the addition of a second or even third coagulation factor, but
even within the same coagulation factor molecules with different half-life
properties or administration feature.
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
Companies mentioned in the report
- Abraxis Biosciences
- Amsterdam Molecular Therapeutics
- Amunix
- Angiotech
- Apitope
- Archemix
- Arecor
- Asklepios Biopharmaceutical
- Baxter
- Bayer Schering Pharma
- Bio Products Laboratory (BPL)
- Biogen Idec
- Biotest
- Catalyst Biosciences
- China Biologic Products
- CSL
- Ethicon (J&J)
- Fresenius Kabi
- Genavia Therapeutics
- Green Cross
- Grifols
- GTC Biotherapeutics
- Hualan Biologic Engineering
- Inspiration Biopharmaceuticals
- Intas Biopharmaceuticals
- Ipsen
- Kaketsuken
- Kamada
- Kedrion
- King Pharmaceuticals
- LFB
- Lipoxen
- Mochida Pharmaceutical
- National Bioproducts Institute (NBI)
- Novo Nordisk
- Nycomed
- Octapharma
- Origen Therapeutics
- Orthovita
- Pfizer
- Pharming
- ProFibrix
- PROLOR Biotech
- Recoly
- Sanquin
- Shanghai RAAS
- SK Chemicals
- Swedish Orphan Biovitrum
- Talecris Biotherapeutics
- Thermogenesis
- Thrombotargets
- VIRxSYS
- Vivostat
- Zymogenetics
Table of Contents
1. Executive Summary
2. Introduction:
- 2.1 Overview
- 2.2 Commercial uses of coagulation factors
- 2.3 Epidemiology of coagulation disorders
- 2.4 Market size
- 2.5 Patent expiration
- 2.6 Industrial stakeholders
3. Summary of Pipeline Changes since August 2009
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 (Hemostats)
- 4.7 Alternative Procoagulants & Adjuncts
- 4.8 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 Pfizer
- 5.1.5 A Cross-Comparison
- 5.2 The Diversifying Companies
- 5.2.1 CSL
- 5.2.2 Octapharma
- 5.2.3 LFB
- 5.2.4 Talecris Biotherapeutics
- 5.3 The Emerging Companies
- 5.3.1 Zymogenetics
- 5.3.2 Biogen Idec
- 5.3.3 Swedish Orphan Biovitrum
- 5.3.4 Inspiration Biopharmaceuticals & Ipsen
- 5.3.5 Green Cross
- 5.3.6 SK Chemicals
- 5.3.7 Thrombotargets
- 5.3.8 GTC Biotherapeutics
- 5.3.9 Pharming
- 5.3.10 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. 2009 Sales of Recombinant Factor VIII Products
- Table 3. Growth of the recombinant Factor VIII market (US$ mln)
- Table 4. BeneFix Sales (2000 - 2009)
- Table 5. NovoSeven Sales (2000 - 2009)
- Table 6. Total Sales of recombinant coagulation factors in 2009
- Table 7. 2009 Sales of selected pd coag. factors for systemic use
- Table 8. 2009 Sales of selected pd coagulation factors for topical use
- Table 9. 2009 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 2009 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. US prices of topical thrombin hemostats
- Table 26. Companies with marketed human coagulation factors
- Table 27. Companies with topical coagulation factors in R&D
- Table 28. 2009 Sales of selected topical pd coagulation factors
- Table 29. Overview on topical hemostats
- Table 30. Topical hemostat product portfolios of Ethicon and Baxter
- Table 31. Selling points of rhu thrombin products
- Table 32. Stakeholders in the topical hemostat field
- Table 33. Overview on Baxter' s R&D Pipeline in rec coag. factors
- Table 34. SWOT analysis of Baxter
- Table 35. Overview on Novo Nordisk' s R&D pipeline in coag. factors
- Table 36. SWOT analysis of Novo Nordisk
- Table 37. Overview on Bayer' s R&D pipeline in rec coag. factors
- Table 38. SWOT analysis of Bayer Schering Pharma
- Table 39. Overview on Pfizer' s R&D pipeline in rec coag. factors
- Table 40. SWOT analysis of Pfizer' s
- Table 41. Overview on TOP League' s R&D pipeline in r coag. factors
- Table 42. The largest plasma fractionation companies by plasma vol.
- Table 43. The largest plasma fractionation companies by sales
- Table 44. SWOT analysis of CSL
- Table 45. SWOT analysis of Octapharma
- Table 46. SWOT analysis of LFB
- Table 47. SWOT analysis of Talecris Biotherapeutics
- Table 48. SWOT analysis of Zymogenetics
- Table 49. SWOT analysis of Biogen Idec
- Table 50. SWOT analysis of Swedish Orphan Biovitrum
- Table 51. SWOT analysis of JV Ipsen & Inspiration Biopharma.
- Table 52. SWOT analysis of Green Cross
- Table 53. Protein engineering companies (ref. rec coagulation factors)
- Table 54. Drug delivery companies (ref. rec coagulation factors)
- Table 55. Product portfolio of traditional plasma fract. companies
ADDENDUM
A) Executive Drug Profiles
- BAX 326
- BAX 513
- BAY 79-4980
- BAY 86-6150
- CSL654
- CSL689
- GreenGene
- IB1001
- LA-N8
- NN1731
- NN1810
- NN1841
- NN7008
- NN7128
- NN7129
- NN7999
- OBI-1
- Octagenate
- rFIXFc
- rFVIIIFc
- rVWF
- TFPI Inhibitory Aptamer
B) Company Profiles
- Amsterdam Molecular Therapeutics
- Angiotech Pharmaceuticals
- Apitope
- Archemix
- Arecor
- Asklepios Biopharmaceutical
- Baxter
- Bayer Schering Pharma
- Bio Products Laboratory (BPL)
- Biogen Idec
- Biotest
- Catalyst Biosciences
- Celestial Biologicals
- China Biologic Products
- CSL
- Ethicon (J&J)
- Fresenius Kabi
- Genavia Therapeutics
- Green Cross
- Grifols
- GTC Biotherapeutics
- Hualan Biological Engineering
- Inspiration Biopharmaceuticals
- Intas Biopharmaceuticals
- Ipsen
- Jerini (Shire)
- Kaketsuken
- Kamada
- Kedrion
- King Pharmaceuticals
- LFB
- Lipoxen
- Maxygen
- Marina Biotech
- Mochida Pharmaceutical
- National Bioproducts Institute (NBI)
- Nektar Therapeutics
- Novo Nordisk
- Novozymes
- Nycomed
- Octapharma
- Origen Therapeutics
- Pfizer
- Pharming
- ProFibrix
- ProGenetics
- PROLOR Biotech
- Recoly
- Sanquin
- Shanghai RAAS
- SK Chemicals
- Swedish Orphan Biovitrum
- Talecris Biotherapeutics
- Thrombotargets
- VIRxSYS
- 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 XI
- Tab XVII: Human Plasma-Derived Factor X
- Tab XVIII: Recombinant Human Factor X
- Tab XIX: Human Plasma-Derived Factor XIII
- Tab XX: Recombinant Human Factor XIII
- Tab XXI: Other Recombinant Factors
- Tab XXII: Other Experimental Hemophilia Therapies
- Tab XXIII: Gene Therapy
- Tab XXIV: Topical Human Plasma-Derived Fibrinogen and Thrombin Products
- Tab XXV: Topical Plasma-Derived Thrombin Products
- Tab XXVI: Topical Recombinant Thrombin Products
- Tab XXVII: Human Plasma-Derived Prothrombin Complex Concentrates
E) Tabulated Corporate Product Portfolios and R&D Pipelines
- Abraxis Biosciences
- Amsterdam Molecular Therapeutics
- Amunix
- Angiotech
- Apitope
- Archemix
- Arecor
- Asklepios Biopharmaceutical
- Baxter
- Bayer Schering Pharma
- Bio Products Laboratory (BPL)
- Biogen Idec
- Biotest
- Catalyst Biosciences
- China Biologic Products
- CSL
- Ethicon (J&J)
- Fresenius Kabi
- Genavia Therapeutics
- Green Cross
- Grifols
- GTC Biotherapeutics
- Hualan Biologic Engineering
- Inspiration Biopharmaceuticals
- Intas Biopharmaceuticals
- Ipsen
- Kaketsuken
- Kamada
- Kedrion
- King Pharmaceuticals
- LFB
- Lipoxen
- Mochida Pharmaceutical
- National Bioproducts Institute (NBI)
- Novo Nordisk
- Nycomed
- Octapharma
- Origen Therapeutics
- Orthovita
- Pfizer
- Pharming
- ProFibrix
- PROLOR Biotech
- Recoly
- Sanquin
- Shanghai RAAS
- SK Chemicals
- Swedish Orphan Biovitrum
- Talecris Biotherapeutics
- Thermogenesis
- Thrombotargets
- VIRxSYS
- Vivostat
- Zymogenetics
Coagulation Factors 2010 - The Portfolio Aspect as Decisive Force: A Competitive Landscape and R&D Pipeline Analysis of Hemostasis Proteins published by La Merie Publishing in September 7, 2010. This report price starts from US $ 3346.
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