SYS-CON MEDIA Authors: Elizabeth White, Yeshim Deniz, Peter Silva, Liz McMillan, Pat Romanski

News Feed Item

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

LONDON, April 16, 2014 /PRNewswire/ -- Reportbuyer.com has added a new market research report:

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

http://www.reportbuyer.com/pharma_healthcare/diseases/pharmapoint_hemophilia_us_drug_forecast_market_analysis_2022.html

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 US
1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 9
1.2 List of Figures 11
2 Introduction 12
2.1 Catalyst 12
2.2 Related Reports 13
2.3 Upcoming Related Reports 15
3 Disease Overview 16
3.1 Etiology and Pathophysiology 16
3.1.1 Etiology 16
3.1.2 Pathophysiology 17
3.1.3 Prognosis and Quality of Life 19
3.2 Symptoms 21
3.2.1 Hemophilia A and B 21
3.2.2 Inhibitors 22
4 Disease Management 23
4.1 Treatment Overview 23
4.1.1 Hemophilia A and B Diagnosis 24
4.1.2 Hemophilia A and B Treatment 24
4.1.3 Inhibitors Diagnosis 26
4.1.4 Inhibitors Treatment 26
4.2 US 28
4.2.1 Clinical Practice 28
5 Competitive Assessment 31
5.1 Overview 31
5.2 Strategic Competitive Assessment 32
5.3 Product Profiles - Major Brands, Hemophilia A 36
5.3.1 Advate (octocog alfa; Antihemophilic Factor [Recombinant] Plasma/Albumin-Free) 36
5.3.2 Kogenate FS/Helixate FS (Antihemophilic Factor (Recombinant)) 40
5.3.3 Xyntha/ReFacto AF (moroctocog alfa; Antihemophilic Factor [Recombinant], Plasma/Albumin-Free) 43
5.3.4 Recombinate (octocog alfa; Antihemophilic Factor [Recombinant] Plasma/Albumin-Free) 46
5.4 Product Profiles - Hemophilia B 48
5.4.1 BeneFIX (nonacog alfa; coagulation factor IX [recombinant]) 48
5.4.2 Rixubis (BAX-326) 51
5.5 Product Profiles - Hemophilia A and B with Inhibitors 54
5.5.1 NovoSeven RT (coagulation factor VIIa [recombinant]) 54
6 Opportunity and Unmet Need 57
6.1 Overview 57
6.2 Opportunities Analysis 58
6.2.1 Longer-Lasting Recombinant Factors to Reduce the Frequency of Prophylactic Injections 58
6.2.2 Lower-Cost Recombinant Replacement Therapies 59
6.2.3 Lower Risk of Inhibitor Formation in Previously Untreated Patients 60
6.2.4 More Convenient Drug Administration 60
6.2.5 Oral Formulation of Recombinant Replacement Therapies 61
6.3 Unmet Needs Gap Analysis 62
6.3.1 Long-Acting FVIII Replacement Therapies 62
6.3.2 Gene Therapy Treatments for Hemophilia A and B 62
7 Pipeline Assessment 63
7.1 Overview 63
7.2 Promising Drugs in Clinical Development - Hemophilia A 63
7.2.1 Eloctate (rFVIII-Fc) (recombinant factor VIII fusion protein) 66
7.2.2 BAY 94-9027 (octocog alfa) 72
7.2.3 BAX-855 75
7.2.4 Novoeight (turoctocog alfa; NN7008) 79
7.2.5 N8-GP (NN7088) 83
7.2.6 CSL-627 (rFVIII-SC) 86
7.3 Promising Drugs in Clinical Development - Hemophilia B 90
7.3.1 Alprolix (rFIXFc) 92
7.3.2 CSL-654 (rIX-FP) 96
7.3.3 N9-GP (NN-7999) 99
7.3.4 IB1001 (trenacog alfa) 102
7.4 Promising Drugs in Clinical Development - Hemophilia A and B Patients with Inhibitors 106
7.4.1 BAX-817 (rFVIIa BI) 107
8 Market Outlook 110
8.1 US 110
8.1.1 Forecast 110
8.1.2 Key Events 114
8.1.3 Drivers and Barriers 114
9 Appendix 117
9.1 Bibliography 117
9.2 Abbreviations 130
9.3 Methodology 133
9.4 Forecasting Methodology 133
9.4.1 Diagnosed Hemophilia Patients 134
9.4.2 Percent Drug-Treated Patients 134
9.4.3 Drugs Included in Each Therapeutic Class 134
9.4.4 Launch and Patent Expiry Dates 135
9.4.5 General Pricing Assumptions 135
9.4.6 Individual Drug Assumptions 136
9.4.7 Pricing of Pipeline Agents 139
9.5 Physicians and Specialists Included in this Study 140
9.6 About the Authors 142
9.6.1 Authors 142
9.6.2 Global Head of Healthcare 143
9.7 About GlobalData 144
9.8 Disclaimer 144

1.1 List of Tables

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

1.2 List of Figures

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


Read the full report:
PharmaPoint: Hemophilia A and B - US Drug Forecast and Market Analysis to 2022

http://www.reportbuyer.com/pharma_healthcare/diseases/pharmapoint_hemophilia_us_drug_forecast_market_analysis_2022.html

For more information:
Sarah Smith
Research Advisor at Reportbuyer.com
Email: [email protected]
Tel: +44 208 816 85 48
Website: www.reportbuyer.com

SOURCE ReportBuyer

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that WSM International (WSM), the world’s leading cloud and server migration services provider, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. WSM is a solutions integrator with a core focus on cloud and server migration, transformation and DevOps services.
The Workspace-as-a-Service (WaaS) market will grow to $6.4B by 2018. In his session at 16th Cloud Expo, Seth Bostock, CEO of IndependenceIT, will begin by walking the audience through the evolution of Workspace as-a-Service, where it is now vs. where it going. To look beyond the desktop we must understand exactly what WaaS is, who the users are, and where it is going in the future. IT departments, ISVs and service providers must look to workflow and automation capabilities to adapt to growing ...
The speed of product development has increased massively in the past 10 years. At the same time our formal secure development and SDL methodologies have fallen behind. This forces product developers to choose between rapid release times and security. In his session at DevOps Summit, Michael Murray, Director of Cyber Security Consulting and Assessment at GE Healthcare, examined the problems and presented some solutions for moving security into the DevOps lifecycle to ensure that we get fast AND ...
SYS-CON Events announced today that SafeLogic has been named “Bag Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. SafeLogic provides security products for applications in mobile and server/appliance environments. SafeLogic’s flagship product CryptoComply is a FIPS 140-2 validated cryptographic engine designed to secure data on servers, workstations, appliances, mobile devices, and in the Cloud....
SYS-CON Events announced today that Akana, formerly SOA Software, has been named “Bronze Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Akana’s comprehensive suite of API Management, API Security, Integrated SOA Governance, and Cloud Integration solutions helps businesses accelerate digital transformation by securely extending their reach across multiple channels – mobile, cloud and Internet of Thi...
There has been a lot of discussion recently in the DevOps space over whether there is a unique form of DevOps for large enterprises or is it just vendors looking to sell services and tools. In his session at DevOps Summit, Chris Riley, a technologist, discussed whether Enterprise DevOps is a unique species or not. What makes DevOps adoption in the enterprise unique or what doesn’t? Unique or not, what does this mean for adopting DevOps in enterprise size organizations? He also explored differe...
In his session at DevOps Summit, Tapabrata Pal, Director of Enterprise Architecture at Capital One, will tell a story about how Capital One has embraced Agile and DevOps Security practices across the Enterprise – driven by Enterprise Architecture; bringing in Development, Operations and Information Security organizations together. Capital Ones DevOpsSec practice is based upon three "pillars" – Shift-Left, Automate Everything, Dashboard Everything. Within about three years, from 100% waterfall, C...
SYS-CON Events announced today that Plutora, Inc., the leading global provider of enterprise release management and test environment management SaaS solutions, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Headquartered in Mountain View, California, Plutora provides enterprise release management and test environment SaaS solutions to clients in North America, Europe and Asia Pacific. Leading companies ...
SYS-CON Events announced today that Open Data Centers (ODC), a carrier-neutral colocation provider, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Open Data Centers is a carrier-neutral data center operator in New Jersey and New York City offering alternative connectivity options for carriers, service providers and enterprise customers.
Skeuomorphism usually means retaining existing design cues in something new that doesn’t actually need them. However, the concept of skeuomorphism can be thought of as relating more broadly to applying existing patterns to new technologies that, in fact, cry out for new approaches. In his session at DevOps Summit, Gordon Haff, Senior Cloud Strategy Marketing and Evangelism Manager at Red Hat, will discuss why containers should be paired with new architectural practices such as microservices ra...
Thanks to Docker, it becomes very easy to leverage containers to build, ship, and run any Linux application on any kind of infrastructure. Docker is particularly helpful for microservice architectures because their successful implementation relies on a fast, efficient deployment mechanism – which is precisely one of the features of Docker. Microservice architectures are therefore becoming more popular, and are increasingly seen as an interesting option even for smaller projects, instead of bein...
SYS-CON Events announced today that Dyn, the worldwide leader in Internet Performance, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Dyn is a cloud-based Internet Performance company. Dyn helps companies monitor, control, and optimize online infrastructure for an exceptional end-user experience. Through a world-class network and unrivaled, objective intelligence into Internet conditions, Dyn ensures...
SYS-CON Events announced today that Blue Box has been named “Bronze Sponsor” of SYS-CON's DevOps Summit New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Blue Box delivers Private Cloud as a Service (PCaaS) to a worldwide customer base. Built on a technology platform leveraging decades of operational expertise in cloud and distributed systems, Blue Box Cloud is a managed private cloud product available in both hosted and on-prem versions. Each Blue Box ...
SYS-CON Events announced today that Vicom Computer Services, Inc., a provider of technology and service solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. They are located at booth #427. Vicom Computer Services, Inc. is a progressive leader in the technology industry for over 30 years. Headquartered in the NY Metropolitan area. Vicom provides products and services based on today’s requirements...
This builds on Puppet Labs' first class Windows support, including native .MSI packages for x32 and x64 operating systems, modules to extend common Windows server management tools, including Powershell, and integrations with Microsoft Azure and Visual Studio. By automating common Windows administration tasks, Puppet Labs is enabling users to adopt DevOps practices, thereby reducing the time needed to deploy applications from weeks to hours.