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Global Haemophilia Therapeutics Market

  • April 2015
  • -
  • Frost & Sullivan
  • -
  • 105 pages

Increased use of recombinant and prophylaxis therapies drives growth

This research service focuses on the global haemophilia therapeutics market, with a particular focus on recently FDA-approved drugs and late-stage compounds for the treatment of haemophilia A, haemophilia B, inhibitors, and von Willebrand Disease. Pipeline analysis outlines the major FDA-approved haemophilia products, which include those submitted for regulatory review and those in Phase I, II, and III of clinical development. The study also provides an overview of the major clinical trials of recently approved or late-stage pipeline candidates. Novel technologies to extend product half-life and potential future therapies for haemophilia patients have also been discussed.

Executive Summary—Key Findings

- 2014 turned out to be a flagship year in the development of recombinant factor replacement therapies for haemophilia.
o Biogen Idec got Food and Drug Administration (FDA) approval for two of its recombinant therapies, FVIII (Eloctate) and FIX (Alprolix), in 2014.
o Baxter’s Obizur, which is a novel recombinant porcine FVIII product used to treat patients with acquired haemophilia A (a rare bleeding disorder) and inhibitors, gained FDA approval in October 2014.
o Biological License Application (BLA) was submitted for four recombinant FVII therapies, including BAX 111 (Baxter), BAX 855 (Baxter), BAY 81-8973 (Bayer), and Nuwiq® (Octapharma), as well as one recombinant FIX therapy, namely rIX-FP (CSL Behring).
- Within the next two years (2015 and 2016), in the United States alone nearly seven new products are expected to enter the haemophilia recombinant therapeutics market.
o The new products are likely to offer significant efficacy and moderate convenience benefits to patients, providing considerable incentives to switch to newer therapies, especially in the rFIX segment.
- The global haemophilia therapeutics market was valued at $ billion in 2014 and is projected to grow at a CAGR of % to reach $ billion in 2019.
o Increased uptake of recombinant therapies and prophylactic use, coupled with improved diagnosis of the disease, is expected to drive the growth of the global haemophilia therapeutics market.
o Recombinant therapies are likely to command a premium price and drive growth in the developed markets, while increased access to treatment and volumes per patient are likely to contribute to growth in the emerging markets.
o However, with several new recombinant products in the market, an increase in price pressure is anticipated, and negotiated discounts in emerging markets may drive down growth.
- Newer recombinant therapies are likely to gradually capture the share of the current leading participants, posing more of a long-term threat than a short-term one.
o Compelling convenience benefits are required for patients to switch therapies. None of the new rFVIII therapies has shown to extend half-life by more than %.
o The new market entrants such as Biogen Idec do not have well-established marketing/sales teams or good relationships with haematologists unlike the global big pharma companies.
o Moreover, global participants such as Bayer, Baxter, and Novo Nordisk have their own franchise of modified recombinant therapies in the pipeline to defend their market position.
- While the pipeline of recombinant replacement factors are maturing, other newer approaches are in the early phase of clinical development.
o Early proof-of-concept studies have shown that gene therapy can be a cost-effective alternative to treat haemophilia B patients.
o Companies such as Chatham Therapeutics and Amsterdam Molecular Therapeutics/uniQure are currently investigating new compounds in Phase I trials.
o Other novel therapeutics in early-stage pipeline include concizumab, a monoclonal antibody from Novo Nordisk, and ALN-AT3, an RNA interference therapeutic from Alnylam Pharmaceuticals.

Table Of Contents

Global Haemophilia Therapeutics Market
1. EXECUTIVE SUMMARY

Executive Summary
Executive Summary—Key Findings
Haemophilia Drugs Market—Game-changing Strategies
Key Merger, Acquisition, and Partnership Assessment
Methodology and Scope

2. INTRODUCTION

Introduction
Introduction
Classification of Haemophilia
Treatment Guidelines for Haemophilia Therapy—Prophylactic or On-demand
Market Overview—Segmentation

3. HAEMOPHILIA THERAPEUTICS MARKET—EPIDEMIOLOGY AND PATIENT FORECASTS

Haemophilia Therapeutics Market—Epidemiology and Patient Forecasts
Haemophilia—Prevalence and Incidence
Haemophilia—Global Prevalence and Treatment Rates

4. HAEMOPHILIA THERAPEUTICS MARKET—TRENDS AND REVENUE FORECASTS

Haemophilia Therapeutics Market—Trends and Revenue Forecasts
Forecast Assumptions and Definitions
Haemophilia Therapeutics Market—Revenue Forecast
Revenue Forecast Discussion
Increasing Use of Recombinant and Prophylactic Treatment
Variation in Adoption of Prophylactic Therapy by Region
Annual Switching Rates in Haemophilia
Global Haemophilia A and vWD Therapeutics Market Revenue Forecast
Revenue Forecast Discussion
Haemophilia B Therapeutics Market—Revenue Forecast
Revenue Forecast Discussion
Inhibitors (Bypassing Agents) Market—Revenue Forecast
Revenue Forecast Discussion

5. HAEMOPHILIA THERAPEUTICS MARKET—MARKETED PRODUCT ANALYSIS

Haemophilia Therapeutics Market—Marketed Product Analysis
Product Analysis—F VIII (Haemophilia A) and FVIII/vWF (vWD)
Product Analysis—Factor IX (Haemophilia B)
Product Analysis—Factor VIIa (Inhibitors)

6. HAEMOPHILIA THERAPEUTICS MARKET—PIPELINE ANALYSIS

Haemophilia Therapeutics Market—Pipeline Analysis
Haemophilia Drugs—Competitive Landscape of Products in Development
Haematological Drugs—Pipeline Analysis
Pipeline Analysis—F VIII (Haemophilia A) and FVIII/VWF (VWD)
Pipeline Analysis—F IX (Haemophilia B)
Pipeline Analysis—F VIIa (Inhibitors)

7. HAEMOPHILIA THERAPEUTICS MARKET—MAJOR CLINICAL MILESTONES

Haemophilia Therapeutics Market—Major Clinical Milestones
Haemophilia Therapeutics Market—Major Ongoing/Recently Completed Clinical Trials

8. HAEMOPHILIA THERAPEUTICS MARKET—PRODUCT DASHBOARD OF RECENTLY APPROVED AND LATE-STAGE PIPELINE DRUG CANDIDATES

Haemophilia Therapeutics Market—Product Dashboard of Recently Approved and Late-stage Pipeline Drug Candidates
Eloctate—Biogen Idec/SOBI
NovoEight (Turoctocog alfa)—Novo Nordisk
BAX 111—Baxter
BAX 855—Baxter
BAY81-8973—Bayer
Nuwiq/Human-cl rhFVIII (simotocog alfa)—Octapharma
BAY94-9027—Bayer
N8-GP (turoctocog alfa pegol)—Novo Nordisk
rVIII-Single Chain—CSL Behring
Alprolix—Biogen Idec/SOBI
Rixubis—Baxter
rIX-FP—CSL Behring
IB1001—Cangene (Emergent Biosolutions)
N9-GP (nonacog beta pegol)—Novo Nordisk
Obizur—Baxter
BAX 817—Baxter
LR769—rEVO Biologics/LFB

9. HAEMOPHILIA THERAPEUTICS MARKET—FUTURE THERAPIES AND NOVEL TECHNOLOGIES TO EXTEND HALF-LIFE

Haemophilia Therapeutics Market—Future Therapies and Novel Technologies to Extend Half-life
Novel Technologies that Extend Half-life of Factor Concentrates
Novel Pipeline Therapies—Gene Therapy
Novel Pipeline Therapies—RNA Interference
Novel Pipeline Therapies—Tissue Factor Pathway Inhibitor

10. HAEMOPHILIA THERAPEUTICS MARKET—TIMELINE OF KEY EVENTS

Haemophilia Therapeutics Market—Timeline of Key Events
Haemophilia A Therapeutics (FVIII) Market—Timeline of Key Events
Haemophilia B Therapeutics (FIX) Market—Timeline of Key Events
Inhibitors (Bypassing Agents) (FVIIa) Market—Timeline of Key Events

11. HAEMOPHILIA THERAPEUTICS MARKET—KEY COMPANIES TO WATCH

Haemophilia Therapeutics Market—Key Companies to Watch
Leading Big Pharma Companies—SWOT Analysis Bayer
Leading Big Pharma Companies—SWOT Analysis Baxter
Leading Big Pharma Companies—SWOT Analysis Novo Nordisk
Leading Big Pharma Companies—SWOT Analysis Pfizer
Key Companies to Watch—SWOT Analysis Biogen Idec
Key Companies to Watch—SWOT Analysis CSL Behring
Comparative Product Analysis of Key Market Participants

12. CONCLUSIONS

Conclusions
Conclusions and Recommendations
Legal Disclaimer

13. APPENDIX

Appendix
List of Abbreviations

14. THE FROST and SULLIVAN STORY

The Frost and Sullivan Story
Value Proposition
Global Perspective
Industry Convergence
360º Research Perspective
Implementation Excellence
Our Blue Ocean Strategy

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