Coagulation Factors 2009

Target Pipeline and Corporate Benchmark Analysis

Publication Date	August 2009
Publisher	La Merie
Product Type	Report
Pages	386
ISBN Number	not applicable
Product Code	LME00088

Buy this product or for assistance call +44 20 7060 7474

PDF £2,190.00$3643 | €2451

FAX Order above formats by FAX

Summary

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

Companies mentioned in the report

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

Content

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