NEW YORK, Sept. 28 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

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

http://www.reportlinker.com/p0304778/Coagulation-Factors-2010-–-The-Portfolio-Aspect-as-Decisive-Force-A-Competitive-Landscape-and-RD-Pipeline-Analysis-of-Hemostasis-Proteins.html

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

Biopharmaceutical Business News

More  Market Research Report

Check our  Company Profile, SWOT and Revenue Analysis!

SOURCE Reportlinker

Back to top

RELATED LINKS
http://www.reportlinker.com