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PharmaPoint: Hemophilia A and B - US Drug Forecast and Market Analysis to 2022

  (January 16, 2014)

NEW YORK, Jan. 16, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

PharmaPoint: Hemophilia A and B - US Drug Forecast and Market Analysis to 2022

http://www.reportlinker.com/p01957658/PharmaPoint-Hemophilia-A-and-B---US-Drug-Forecast-and-Market-Analysis-to-2022.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology


PharmaPoint: Hemophilia A and B - US Drug Forecast and Market Analysis to 2022

Summary

The competitive landscape of hemophilia A and B recombinant therapy in the US and 5EU is dominated by the use of recombinant FVIII and FIX replacement factors, and patients with severe forms of the disease receive frequent prophylactic infusions beginning from the first one or two years of life and often continuing through adulthood. However, the burden on patients and their families to maintain the prophylactic treatment schedule is high, and there is a significant unmet need for new therapies that can reduce the number of weekly prophylactic infusions and alleviate some of this treatment burden.

The US is the largest hemophilia market, due to the high rates of disease diagnosis combined with high rates of primary rFVIII and rFIX prophylaxis among diagnosed severe hemophilia A and B patients. GlobalData anticipates that companies such as Baxter, Bayer, Novo Nordisk, CSL Behring and Biogen Idec will be able to command slight premiums over currently marketed recombinant standard of care therapies, thus contributing to overall market growth.

Scope

- Overview of Hemophilia A and B including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.- Detailed information on the key drugs in the US including product description, safety and efficacy profiles as well as a SWOT analysis.- Sales forecast for the top drugs in the US from 2012-2022.- Analysis of the impact of key events as well the drivers and restraints affecting the US Hemophilia A and B market.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return- Stay ahead of the competition by understanding the changing competitive landscape for Hemophilia A and B- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential- Make more informed business decisions from insightful and in-depth analysis of drug performance- Obtain sales forecast for drugs from 2012-2022 in the US1 Table of Contents1 Table of Contents 51.1 List of Tables 91.2 List of Figures 112 Introduction 122.1 Catalyst 122.2 Related Reports 132.3 Upcoming Related Reports 153 Disease Overview 163.1 Etiology and Pathophysiology 163.1.1 Etiology 163.1.2 Pathophysiology 173.1.3 Prognosis and Quality of Life 193.2 Symptoms 213.2.1 Hemophilia A and B 213.2.2 Inhibitors 224 Disease Management 234.1 Treatment Overview 234.1.1 Hemophilia A and B Diagnosis 244.1.2 Hemophilia A and B Treatment 244.1.3 Inhibitors Diagnosis 264.1.4 Inhibitors Treatment 264.2 US 284.2.1 Clinical Practice 285 Competitive Assessment 315.1 Overview 315.2 Strategic Competitive Assessment 325.3 Product Profiles - Major Brands, Hemophilia A 365.3.1 Advate (octocog alfa; Antihemophilic Factor [Recombinant] Plasma/Albumin-Free) 365.3.2 Kogenate FS/Helixate FS (Antihemophilic Factor (Recombinant)) 405.3.3 Xyntha/ReFacto AF (moroctocog alfa; Antihemophilic Factor [Recombinant], Plasma/Albumin-Free) 435.3.4 Recombinate (octocog alfa; Antihemophilic Factor [Recombinant] Plasma/Albumin-Free) 465.4 Product Profiles - Hemophilia B 485.4.1 BeneFIX (nonacog alfa; coagulation factor IX [recombinant]) 485.4.2 Rixubis (BAX-326) 515.5 Product Profiles - Hemophilia A and B with Inhibitors 545.5.1 NovoSeven RT (coagulation factor VIIa [recombinant]) 546 Opportunity and Unmet Need 576.1 Overview 576.2 Opportunities Analysis 586.2.1 Longer-Lasting Recombinant Factors to Reduce the Frequency of Prophylactic Injections 586.2.2 Lower-Cost Recombinant Replacement Therapies 596.2.3 Lower Risk of Inhibitor Formation in Previously Untreated Patients 606.2.4 More Convenient Drug Administration 606.2.5 Oral Formulation of Recombinant Replacement Therapies 616.3 Unmet Needs Gap Analysis 626.3.1 Long-Acting FVIII Replacement Therapies 626.3.2 Gene Therapy Treatments for Hemophilia A and B 627 Pipeline Assessment 637.1 Overview 637.2 Promising Drugs in Clinical Development - Hemophilia A 637.2.1 Eloctate (rFVIII-Fc) (recombinant factor VIII fusion protein) 667.2.2 BAY 94-9027 (octocog alfa) 727.2.3 BAX-855 757.2.4 Novoeight (turoctocog alfa; NN7008) 797.2.5 N8-GP (NN7088) 837.2.6 CSL-627 (rFVIII-SC) 867.3 Promising Drugs in Clinical Development - Hemophilia B 907.3.1 Alprolix (rFIXFc) 927.3.2 CSL-654 (rIX-FP) 967.3.3 N9-GP (NN-7999) 997.3.4 IB1001 (trenacog alfa) 1027.4 Promising Drugs in Clinical Development - Hemophilia A and B Patients with Inhibitors 1067.4.1 BAX-817 (rFVIIa BI) 1078 Market Outlook 1108.1 US 1108.1.1 Forecast 1108.1.2 Key Events 1148.1.3 Drivers and Barriers 1149 Appendix 1179.1 Bibliography 1179.2 Abbreviations 1309.3 Methodology 1339.4 Forecasting Methodology 1339.4.1 Diagnosed Hemophilia Patients 1349.4.2 Percent Drug-Treated Patients 1349.4.3 Drugs Included in Each Therapeutic Class 1349.4.4 Launch and Patent Expiry Dates 1359.4.5 General Pricing Assumptions 1359.4.6 Individual Drug Assumptions 1369.4.7 Pricing of Pipeline Agents 1399.5 Physicians and Specialists Included in this Study 1409.6 About the Authors 1429.6.1 Authors 1429.6.2 Global Head of Healthcare 1439.7 About GlobalData 1449.8 Disclaimer 144

1.1 List of Tables

Table 1: Symptoms of Hemophilia A and B 22Table 2: Most Prescribed Hemophilia A and B Drugs in the Global Markets, 2013 27Table 3: Leading Recombinant Replacement Therapies for Hemophilia A and B and Patients with Inhibitors, 2013 34Table 4: Leading Plasma-Based Replacement Therapies for Hemophilia A and B and Patients with Inhibitors, 2012 35Table 5: Product Profile - Advate (octocog alfa; Antihemophilic Factor [Recombinant] Plasma/Albumin-Free) 37Table 6: Advate SWOT Analysis, 2013 39Table 7: Product Profile - Kogenate FS/Helixate FS (Antihemophilic Factor (Recombinant)) 41Table 8: Kogenate FS/Helixate FS SWOT Analysis, 2013 43Table 9: Product Profile - Xyntha/ReFacto AF (moroctocog alfa; Antihemophilic Factor [Recombinant], Plasma/Albumin-Free) 44Table 10: Xyntha/ReFacto AF SWOT Analysis, 2013 45Table 11: Product Profile - Recombinate (octocog alfa; Antihemophilic Factor [Recombinant] Plasma/Albumin-Free) 46Table 12: Recombinate SWOT Analysis, 2013 47Table 13: Product Profile - BeneFIX (nonacog alfa; coagulation factor IX [recombinant]) 49Table 14: BeneFIX SWOT Analysis, 2013 51Table 15: Product Profile - Rixubis (BAX-326) 52Table 16: Rixubis SWOT Analysis, 2013 54Table 17: Product Profile - NovoSeven RT (coagulation factor VIIa [recombinant]) 55Table 18: NovoSeven RT SWOT Analysis, 2013 56Table 19: Overall Unmet Needs - Current Level of Attainment 58Table 20: Hemophilia A - Phase I/II Pipeline, 2013 63Table 21: Hemophilia A - Phase III Pipeline, 2013 64Table 22: Product Profile - Eloctate (rFVIII-Fc) 67Table 23: Eloctate SWOT Analysis, 2013 71Table 24: Product Profile - BAY 94-9027 72Table 25: BAY 94-9027 SWOT Analysis, 2013 75Table 26: Product Profile - BAX-855 76Table 27: BAX-855 SWOT Analysis, 2013 78Table 28: Product Profile - Novoeight (turoctocog alfa; NN7008) 79Table 29: Novoeight SWOT Analysis, 2013 82Table 30: Product Profile - N8-GP (NN7088) 83Table 31: N8-GP SWOT Analysis, 2013 86Table 32: Product Profile - CSL-627 (rFVIII-SC) 87Table 33: CSL-627 SWOT Analysis, 2013 89Table 34: Hemophilia B - Phase I/II Pipeline, 2013 90Table 35: Hemophilia B - Phase III Pipeline, 2013 90Table 36: Product Profile - Alprolix (rFIXFc) 92Table 37: Alprolix SWOT Analysis, 2013 95Table 38: Product Profile - CSL-654 96Table 39: CSL-654 SWOT Analysis, 2013 99Table 40: Product Profile - N9-GP 100Table 41: N9-GP SWOT Analysis, 2013 102Table 42: Product Profile - IB1001 103Table 43: IB1001 SWOT Analysis, 2013 106Table 44: Hemophilia A and B with Inhibitors - Phase I/II Pipeline, 2013 106Table 45: Hemophilia A and B with Inhibitors - Phase III Pipeline, 2013 106Table 46: Product Profile - BAX-817 (rFVIIa BI) 107Table 47: BAX-817 SWOT Analysis, 2013 109Table 48: Sales Forecasts ($m) for Hemophilia A and B in the US, 2012-2022 112Table 49: Key Events Impacting Sales for Hemophilia A and B in the US, 2013 114Table 50: US Hemophilia A and B Market - Drivers and Barriers, 2013 114Table 51: Product Launch Dates 135Table 52: Physicians Surveyed 140

1.2 List of Figures

Figure 1: Competitive Assessment of Late-Stage Pipeline Agents in Hemophilia A, 2012-2022 65Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Hemophilia B, 2012-2022 91Figure 3: Sales for Hemophilia A and B in the US by Drug Class, 2012-2022 113

To order this report: PharmaPoint: Hemophilia A and B - US Drug Forecast and Market Analysis to 2022 http://www.reportlinker.com/p01957658/PharmaPoint-Hemophilia-A-and-B---US-Drug-Forecast-and-Market-Analysis-to-2022.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

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