Coagulation Factors 2010 – The Portfolio Aspect as Decisive Force: A Competitive Landscape and R&D Pipeline Analysis of Hemostasis Proteins

Date: September 22, 2010
Pages: 446
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Publisher: La Merie Publishing
Report type: Strategic Report
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Coagulation Factors 2010 – The Portfolio Aspect as Decisive Force: A Competitive Landscape and R&D Pipeline Analysis of Hemostasis Proteins
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
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
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