Hemophilia A and B Recombinant Factor Replacement Therapy - US Drug Forecast and Market Analysis to 2024

Home/Hemophilia A and B Recombinant Factor Replacement Therapy - US Drug Forecast and Market Analysis to 2024

Hemophilia A and B Recombinant Factor Replacement Therapy - US Drug Forecast and Market Analysis to 2024

Regulation & Policy (Pharma & Healthcare), Finance & Investment (Pharma & Healthcare), Deals & Alliances (Pharma & Healthcare), Pharma & Healthcare

Publication ID:

GDA1215631

Publication Date:

December 11, 2015

Pages:

229

Publisher:

GlobalData

Region:

USA

$4,995.00

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Description

Hemophilia A and B Recombinant Factor Replacement Therapy - US Drug Forecast and Market Analysis to 2024

Summary

Congenital Hemophilia A and B are bleeding disorders that are caused by genetic X-linked deficiencies in the blood clotting Factors VIII and IX, respectively. Hemophilia manifests as mild, moderate, or severe inability to form clots, depending upon the endogenous levels of circulating factor in an individual patient. The mainstay of treatment for hemophilia is to replace the missing FVIII or FIX, produced using plasma-derived or recombinant methods. Some patients develop inhibitors to FVIII or FIX treatment and need a bypassing agent, such as FVIIa, to resolve bleeds. Patients of hemophilia A or B often require lifelong treatment to prevent and control bleeding episodes, and this therefore represents a lucrative sales opportunity.

The US is the largest global hemophilia market, due to high rates of disease diagnosis combined with high rates of primary rFVIII and rFIX prophylaxis among diagnosed severe hemophilia A and B patients. This market growth will be driven by increasing rates of prevalent cases of hemophilia A and B, and increasing uses of recombinant replacement factors in hemophilia A and B patients over the forecast period.

*This is an on-demand report and will be delivered within 24 hrs. (excluding weekends) of the purchase.

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 2014-2024.
- 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 2014-2024 in US.

Table of Contents

1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Related Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.1.3 Prognosis and Quality of Life
3.2 Symptoms
3.2.1 Hemophilia A and B
3.2.2 Inhibitors
4 Disease Management
4.1 Treatment Overview
4.1.1 Hemophilia A and B Diagnosis
4.1.2 Hemophilia A and B Treatment
4.1.3 Diagnosis of Inhibitors
4.1.4 Treatment of Inhibitors
4.2 US
4.2.1 Clinical Practice
5 Competitive Assessment
5.1 Overview
5.2 Strategic Competitive Assessment
5.3 Product Profiles - Hemophilia A
5.3.1 Advate (Octocog Alfa)
5.3.2 Kogenate FS/Helixate FS (Octocog Alfa)
5.3.3 Xyntha/ReFacto AF (Moroctocog Alfa)
5.3.4 Recombinate (Octocog Alfa)
5.3.5 Eloctate (Efmoroctocog Alfa)
5.3.6 NovoEight (Turoctocog Alfa)
5.3.7 Nuwiq (Simoctocog Alfa)
5.4 Product Profiles - Hemophilia B
5.4.1 BeneFIX (Nonacog Alfa)
5.4.2 Alprolix (Eftrenonacog Alfa)
5.4.3 Rixubis (Nonacog Gamma)
5.4.4 IXinity (Trenonacog Alfa)
5.5 Product Profiles - Hemophilia A and B with Inhibitors
5.5.1 NovoSeven RT (Eptacog Alfa)
6 Unmet Need and Opportunity
6.1 Overview
6.2 Opportunity Analysis
6.2.1 Longer-Lasting Recombinant Factors
6.2.2 Lower-Cost Recombinant Replacement Therapies
6.2.3 Lower Risk of Inhibitor Formation in Previously Untreated Patients
6.2.4 More Convenient Drug Administration
6.3 Unmet Needs Gap Analysis
6.3.1 Long-Acting FVIII Replacement Therapies
6.3.2 Gene Therapy Treatments for Hemophilia A and B
7 Pipeline Assessment
7.1 Overview
7.2 Late-Stage Development Candidates - Hemophilia A
7.2.1 Kovaltry (Octocog Alfa; BAY 81-8973)
7.2.2 Adynovate (BAX-855)
7.2.3 BAY 94-9027 (Damoctocog Alfa Pegol)
7.2.4 N8-GP (Turoctocog Alfa Pegol)
7.2.5 CSL-627 (rFVIII-SC)
7.2.6 GreenGene F (Beroctocog Alfa; GC1101C)
7.3 Late-Stage Development Candidates - Hemophilia B
7.3.1 CSL-654 (rIX-FP; Albutrepenonacog Alfa)
7.3.2 N9-GP (NN-7999; Nonacog Beta Pegol)
7.4 Late-Stage Development Candidates - Hemophilia A and B Bypassing Agents (Patients with Inhibitors)
7.4.1 BAX-817 (rFVIIa BI)
7.4.2 LR-769 (rhFVIIa)
7.4.3 CSL-689 (rVIIa-FP)
7.5 Promising Drugs in Early-Stage Development
7.5.1 Alternative Coagulation Promoters
7.5.2 Gene Therapies
8 Market Outlook
8.1 US
8.1.1 Forecast
8.1.2 Key Events
8.1.3 Drivers and Barriers
9 Appendix
9.1 Bibliography
9.2 Abbreviations
9.3 Methodology
9.4 Forecasting Methodology
9.4.1 Diagnosed Hemophilia Patients
9.4.2 Percent Drug-Treated Patients
9.4.3 Drugs Included in Each Therapeutic Class
9.4.4 Launch Dates
9.4.5 General Pricing Assumptions
9.4.6 Individual Drug Assumptions
9.4.7 Pricing of Pipeline Agents
9.5 Primary Research - KOLs Interviewed for this Report
9.6 Primary Research - Prescriber Survey
9.7 Real-World Data
9.8 About the Authors
9.8.1 Analyst
9.8.2 Therapy Area Director
9.8.3 Epidemiologists
9.8.4 Global Head of Healthcare
9.9 About GlobalData
9.10 Disclaimer

1.1 List of Tables
Table 1: Symptoms of Hemophilia A and B
Table 2: Most Prescribed Hemophilia A and B Drugs in the Global Markets, 2015
Table 3: Country Profile - US, 2014
Table 4: Leading Recombinant Replacement Therapies for Hemophilia A and B and Patients with Inhibitors, 2015
Table 5: Product Profile - Advate
Table 6: Advate SWOT Analysis, 2015
Table 7: Global Sales Forecast ($m) for Advate, 2014-2024
Table 8: Product Profile - Kogenate FS/Helixate FS
Table 9: Kogenate FS/Helixate FS SWOT Analysis, 2015
Table 10: Global Sales Forecast ($m) for Kogenate FS/Kogenate Bayer, 2014-2024
Table 11: Global Sales Forecast ($m) for Helixate FS/Helixate NexGen, 2014-2024
Table 12: Product Profile - Xyntha/ReFacto AF
Table 13: Xyntha/ReFacto AF SWOT Analysis, 2015
Table 14: Global Sales Forecast ($m) for Xyntha/ReFacto AF, 2014-2024
Table 15: Product Profile - Recombinate
Table 16: Recombinate SWOT Analysis, 2015
Table 17: Global Sales Forecast ($m) for Recombinate, 2014-2024
Table 18: Product Profile - Eloctate
Table 19: Eloctate SWOT Analysis, 2015
Table 20: Global Sales Forecast ($m) for Eloctate, 2014-2024
Table 21: Product Profile - NovoEight
Table 22: NovoEight SWOT Analysis, 2015
Table 23: Global Sales Forecast ($m) for NovoEight, 2014-2024
Table 24: Product Profile - Nuwiq
Table 25: Nuwiq SWOT Analysis, 2015
Table 26: Global Sales Forecast ($m) for Nuwiq, 2014-2024
Table 27: Product Profile - BeneFIX
Table 28: BeneFIX SWOT Analysis, 2015
Table 29: Global Sales Forecast ($m) for BeneFIX, 2014-2024
Table 30: Product Profile - Alprolix
Table 31: Alprolix SWOT Analysis, 2015
Table 32: Global Sales Forecast ($m) for Alprolix, 2014-2024
Table 33: Product Profile - Rixubis
Table 34: Rixubis SWOT Analysis, 2015
Table 35: Global Sales Forecast ($m) for Rixubis, 2014-2024
Table 36: Product Profile - IXinity
Table 37: IXinity SWOT Analysis, 2015
Table 38: Global Sales Forecast ($m) for IXinity, 2014-2024
Table 39: Product Profile - NovoSeven RT
Table 40: NovoSeven RT SWOT Analysis, 2015
Table 41:
Table 42: Overall Unmet Needs - Current Level of Attainment
Table 43: Hemophilia A - Phase III Pipeline, 2015
Table 44: Product Profile - Kovaltry
Table 45: Kovaltry SWOT Analysis, 2015
Table 46: Global Sales Forecast ($m) for Kovaltry, 2014-2024
Table 47: Product Profile - Adynovate
Table 48: Adynovate SWOT Analysis, 2015
Table 49: Global Sales Forecast ($m) for Adynovate, 2014-2024
Table 50: Product Profile - BAY 94-9027
Table 51: Efficacy of BAY 94-9027 in the PROTECT VIII study
Table 52: BAY 94-9027 SWOT Analysis, 2015
Table 53: Global Sales Forecast ($m) for BAY 94-9027, 2014-2024
Table 54: Product Profile - N8-GP
Table 55: N8-GP SWOT Analysis, 2015
Table 56: Global Sales Forecast ($m) for N8-GP, 2014-2024
Table 57: Product Profile - CSL-627
Table 58: CSL-627 SWOT Analysis, 2015
Table 59: Global Sales Forecast ($m) for CSL-627, 2014-2024
Table 60: Product Profile - GreenGene F
Table 61: GreenGene F SWOT Analysis, 2015
Table 62: Global Sales Forecast ($m) for GreenGene F, 2014-2024
Table 63: Hemophilia B - Phase III Pipeline, 2015
Table 64: Product Profile - CSL-654
Table 65: CSL-654 SWOT Analysis, 2015
Table 66: Global Sales Forecast ($m) for CSL-654, 2014-2024
Table 67: Product Profile - N9-GP
Table 68: N9-GP SWOT Analysis, 2015
Table 69: Global Sales Forecast ($m) for N9-GP, 2014-2024
Table 70: Hemophilia A and B with Inhibitors - Phase III Pipeline, 2015
Table 71: Product Profile - BAX-817
Table 72: BAX-817 SWOT Analysis, 2015
Table 73: Global Sales Forecast ($m) for BAX-817, 2014-2024
Table 74: Product Profile - LR-769
Table 75: LR-769 SWOT Analysis, 2015
Table 76: Global Sales Forecast ($m) for LR-769, 2014-2024
Table 77: Product Profile - CSL-689
Table 78: CSL-689 SWOT Analysis, 2015
Table 79: Global Sales Forecast ($m) for CSL-689, 2014-2024
Table 80: Alternative Coagulation Promoters - Early-Stage Pipeline, 2015
Table 81: Hemophilia A and B Gene Therapies - Early-Stage Pipeline, 2015
Table 82: Sales Forecast ($m) for Hemophilia A and B Recombinant Therapies in the US, 2014-2024
Table 83: Key Events Impacting Sales for Hemophilia A and B in the US, 2014-2024
Table 84: US Hemophilia A and B Market - Drivers and Barriers, 2014-2024
Table 85: Key Launch Dates
Table 86: Physicians Surveyed

1.2 List of Figures
Figure 1: Competitive Assessment of Late-Stage Pipeline Agents in Hemophilia A, 2014-2024
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Hemophilia B, 2014-2024
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents for Hemophilia A and B Patients with Inhibitors, 2014-2024
Figure 4: Sales for Hemophilia A and B recombinant therapies in the US by Drug Class, 2014-2024

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