Reportlinker Adds Coagulation Factors 2010 - The Portfolio Aspect as Decisive Force: A Competitive Landscape and R&D Pipeline Analysis of Hemostasis Proteins
NEW YORK, Sept. 28 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
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 12
2 Introduction: 14
2.1 Overview 14
2.2 Commercial uses of coagulation factors 15
2.3 Epidemiology of coagulation disorders 15
2.4 Market size 16
2.5 Patent expiration 22
2.6 Industrial stakeholders 24
3 Summary of Pipeline Changes since August 2009 25
4 Target Pipeline Analysis 37
4.1 Factor VIII 37
4.2 Factor IX 44
4.3 Factor VII 50
4.4 von Willebrand Factor (vWF) 55
4.5 Other Coagulation Factors 56
4.6 Topical Coagulation Factors (Hemostats) 59
4.7 Alternative Procoagulants & Adjuncts 69
4.8 Other Experimental Hemophilia Therapies 70
5 Corporate Benchmark Analysis 72
5.1 The TOP League 72
5.1.1 Baxter 72
5.1.2 Novo Nordisk 75
5.1.3 Bayer Schering Pharma 77
5.1.4 Pfizer 78
5.1.5 A Cross-Comparison 79
5.2 The Diversifying Companies 80
5.2.1 CSL 81
5.2.2 Octapharma 82
5.2.3 LFB 84
5.2.4 Talecris Biotherapeutics 85
5.3 The Emerging Companies 86
5.3.1 Zymogenetics 86
5.3.2 Biogen Idec 87
5.3.3 Swedish Orphan Biovitrum 88
5.3.4 Inspiration Biopharmaceuticals & Ipsen 89
5.3.5 Green Cross 90
5.3.6 SK Chemicals 90
5.3.7 Thrombotargets 91
5.3.8 GTC Biotherapeutics 91
5.3.9 Pharming 91
5.3.10 ProFibrix 92
5.4 The Facilitator Companies 92
5.5 The Traditional Companies 94
5.6 The Unclassified Companies 96
6 References 97
Tables in the Text
Table 1 Prevalence of rare coagulation factor disorders 17
Table 2 2009 Sales of Recombinant Factor VIII Products 18
Table 3 Growth of the recombinant Factor VIII market (US$ mln) 18
Table 4 BeneFix Sales (2000 – 2009) 19
Table 5 NovoSeven Sales (2000 – 2009) 19
Table 6 Total Sales of recombinant coagulation factors in 2009 20
Table 7 2009 Sales of selected pd coag. factors for systemic use 21
Table 8 2009 Sales of selected pd coagulation factors for topical use 21
Table 9 2009 Sales of coagulation factor product lines per company 22
Table 10 Changes of manufacturing/formulation in rec. coag. factors 23
Table 11 Approval / launches of rec coag. factors in the US and EU 23
Table 12 The TOP coag. factor companies in terms of 2009 sales 24
Table 13 Product characteristics of improved rhu F. VIII products 38
Table 14 Overview of R&D pipeline of rec factor VIII products 39
Table 15 Target profiles of rec wild-type F. VIII products in R&D 40
Table 16 Target profiles of rec long-acting F. VIII products in R&D 42
Table 17 Product characteristics of marketed wt rhu F. IX 45
Table 18 Overview of R&D pipeline of rec factor IX products 45
Table 19 Target profiles of rec wild-type F. IX products in R&D 46
Table 20 Target profiles of rec long-acting F. IX products in R&D 47
Table 21 Product characteristics of marketed wt rhu F. VII 51
Table 22 Overview of R&D pipeline of rec factor VIIa products 51
Table 23 Target profile of rec wild-type F. VIIa product in R&D 52
Table 24 Target profiles of rec long-acting F. VIIa products in R&D 54
Table 25 US prices of topical thrombin hemostats 63
Table 26 Companies with marketed human coagulation factors 64
Table 27 Companies with topical coagulation factors in R&D 64
Table 28 2009 Sales of selected topical pd coagulation factors 65
Table 29 Overview on topical hemostats 66
Table 30 Topical hemostat product portfolios of Ethicon and Baxter 66
Table 31 Selling points of rhu thrombin products 67
Table 32 Stakeholders in the topical hemostat field 68
Table 33 Overview on Baxter's R&D Pipeline in rec coag. factors 73
Table 34 SWOT analysis of Baxter 74
Table 35 Overview on Novo Nordisk's R&D pipeline in coag. factors 75
Table 36 SWOT analysis of Novo Nordisk 76
Table 37 Overview on Bayer's R&D pipeline in rec coag. factors 77
Table 38 SWOT analysis of Bayer Schering Pharma 78
Table 39 Overview on Pfizer's R&D pipeline in rec coag. factors 79
Table 40 SWOT analysis of Pfizer's 79
Table 41 Overview on TOP League's R&D pipeline in r coag. factors 79
Table 42 The largest plasma fractionation companies by plasma vol. 80
Table 43 The largest plasma fractionation companies by sales 80
Table 44 SWOT analysis of CSL 82
Table 45 SWOT analysis of Octapharma 84
Table 46 SWOT analysis of LFB 85
Table 47 SWOT analysis of Talecris Biotherapeutics 86
Table 48 SWOT analysis of Zymogenetics 87
Table 49 SWOT analysis of Biogen Idec 88
Table 50 SWOT analysis of Swedish Orphan Biovitrum 88
Table 51 SWOT analysis of JV Ipsen & Inspiration Biopharma. 89
Table 52 SWOT analysis of Green Cross 90
Table 53 Protein engineering companies (ref. rec coagulation factors) 93
Table 54 Drug delivery companies (ref. rec coagulation factors) 94
Table 55 Product portfolio of traditional plasma fract. companies 95
ADDENDUM
A) Executive Drug Profiles 122
BAX 326 122
BAX 513 124
BAY 79-4980 128
BAY 86-6150 132
CSL654 135
CSL689 137
GreenGene 140
IB1001 142
LA-N8 144
NN1731 146
NN1810 151
NN1841 153
NN7008 157
NN7128 163
NN7129 169
NN7999 170
OBI-1 175
Octagenate 179
rFIXFc 182
rFVIIIFc 185
rVWF 187
TFPI Inhibitory Aptamer 191
B) Company Profiles
Amsterdam Molecular Therapeutics 192
Angiotech Pharmaceuticals 193
Apitope 195
Archemix 196
Arecor 197
Asklepios Biopharmaceutical 198
Baxter 199
Bayer Schering Pharma 210
Bio Products Laboratory (BPL) 216
Biogen Idec 217
Biotest 220
Catalyst Biosciences 221
Celestial Biologicals 223
China Biologic Products 224
CSL 225
Ethicon (J&J) 229
Fresenius Kabi 230
Genavia Therapeutics 231
Green Cross 232
Grifols 234
GTC Biotherapeutics 236
Hualan Biological Engineering 239
Inspiration Biopharmaceuticals 240
Intas Biopharmaceuticals 242
Ipsen 243
Jerini (Shire) 245
Kaketsuken 246
Kamada 247
Kedrion 248
King Pharmaceuticals 250
LFB 252
Lipoxen 254
Maxygen 255
Marina Biotech 257
Mochida Pharmaceutical 258
National Bioproducts Institute (NBI) 259
Nektar Therapeutics 260
Novo Nordisk 261
Novozymes 276
Nycomed 277
Octapharma 278
Origen Therapeutics 280
Pfizer 281
Pharming 285
ProFibrix 286
ProGenetics 288
PROLOR Biotech 289
Recoly 290
Sanquin 294
Shanghai RAAS 295
SK Chemicals 296
Swedish Orphan Biovitrum 297
Talecris Biotherapeutics 301
Thrombotargets 302
VIRxSYS 303
Zymogenetics 305
C) Tabulated Overviews on Profiles of Plasma Derived Coagulation Factors
Tab I: Profile of Human Plasma-Derived Coagulation Factor VIII
Concentrates
307
Tab II: Profile of Highly Purified Human Plasma-Derived Coagulation Factor
IX Concentrates
308
Tab III: Profile of Purified Human Plasma-Derived Prothrombin Complex
Concentrates
309
Tab IV: Profile of Other Human Plasma-Derived Coagulation Factor
Concentrates
310
Tab V: Profile of Topical Coagulation Factor Products & Projects 311
D) Tabulated Target Pipelines of Coagulation Factors
Tab VI: Human Plasma-Derived Coagulation Factor VIII Concentrates 313
Tab VII: Recombinant Coagulation Factor VIII Products 322
Tab VIII: Human Plasma-Derived Coagulation Factor IX Products 328
Tab IX: Recombinant Coagulation Factor IX Products 333
Tab X: Human Plasma-Derived Factor VII 337
Tab XI: Recombinant Coagulation Factor VII Products 338
Tab XII: Human Plasma-Derived Coagulation Factor Concentrates for vWD 343
Tab XIII: Recombinant Human Von Willebrand Factor Products 345
Tab XIV: Human Plasma-Derived Fibrinogen (Factor I) 346
Tab XV: Recombinant Human Fibrinogen Products 348
Tab XVI: Human Plasma-Derived Factor XI 349
Tab XVII: Human Plasma-Derived Factor X 349
Tab XVIII: Recombinant Human Factor X 350
Tab XIX: Human Plasma-Derived Factor XIII 350
Tab XX: Recombinant Human Factor XIII 351
Tab XXI: Other Recombinant Factors 352
Tab XXII: Other Experimental Hemophilia Therapies 353
Tab XXIII: Gene Therapy 354
Tab XXIV: Topical Human Plasma-Derived Fibrinogen and Thrombin Products 355
Tab XXV: Topical Plasma-Derived Thrombin Products 363
Tab XXVI: Topical Recombinant Thrombin Products 367
Tab XXVII: Human Plasma-Derived Prothrombin Complex Concentrates 368
E) Tabulated Corporate Product Portfolios and R&D Pipelines
Abraxis Biosciences 373
Amsterdam Molecular Therapeutics 373
Amunix 374
Angiotech 375
Apitope 375
Archemix 376
Arecor 376
Asklepios Biopharmaceutical 377
Baxter 378
Bayer Schering Pharma 386
Bio Products Laboratory (BPL) 389
Biogen Idec 390
Biotest 391
Catalyst Biosciences 392
China Biologic Products 393
CSL 394
Ethicon (J&J) 399
Fresenius Kabi 401
Genavia Therapeutics 402
Green Cross 403
Grifols 404
GTC Biotherapeutics 406
Hualan Biologic Engineering 407
Inspiration Biopharmaceuticals 408
Intas Biopharmaceuticals 409
Ipsen 410
Kaketsuken 411
Kamada 412
Kedrion 413
King Pharmaceuticals 415
LFB 417
Lipoxen 421
Mochida Pharmaceutical 421
National Bioproducts Institute (NBI) 422
Novo Nordisk 423
Nycomed 427
Octapharma 428
Origen Therapeutics 431
Orthovita 431
Pfizer 432
Pharming 433
ProFibrix 434
PROLOR Biotech 434
Recoly 435
Sanquin 436
Shanghai RAAS 438
SK Chemicals 440
Swedish Orphan Biovitrum 441
Talecris Biotherapeutics 442
Thermogenesis 443
Thrombotargets 444
To order this report:
Biopharmaceutical Industry: Coagulation Factors 2010 – The Portfolio Aspect as Decisive Force: A Competitive Landscape and R&D Pipeline Analysis of Hemostasis Proteins
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Nicolas Bombourg |
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Reportlinker |
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