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Global Hemophilia Treatment Market to 2024

  • 28
  • |
  • Oct, 2018
  • |
  • Biopharmaceuticals
  • |
  • Pages
  • |
  • Global

Market Overview, Key in-line Products, Market Share Distribution, Competitive Dynamics, Regulatory Outlook, Pipeline Development, Growth Catalysts & Challenges, Leading Market & R&D Trends, Partnership & Deals Analyses, Global Sales forecast of in-line and pipeline products, Fast Growing Private Companies, Management Perspectives, Commentaries, Market Outlook & Summary Conclusions
 
Global hemophilia treatment market was valued at $10.2bn in 2015 and is forecast to grow at a modest 5.4% CAGR between 2015 and 2024, culminating in 2024 global sales of $17.2bn.
 
Hemophilia is a rare inherited bleeding disorder whereby blood does not clot normally. Predominantly, hemophilia is classified as hemophilia A and hemophilia B. Hemophilia A occurs when the body is unable to produce adequate amounts of factor VIII (FVIII), while patients with hemophilia B are unable to produce adequate amounts of factor IX (FIX).  
Based on patient numbers and market opportunity, hemophilia A is the largest market, followed by hemophilia A patients that need bypassing agents to treat their disease. Hemophilia B is the third largest segment. Rare bleeding disorders, such as Von Willebrand disease, make up the remainder of the total hemophilia treatment market.  
 

Attribute
Details

Base Year 
2015

Historic Analysis 
2013 to 2014

Forecast
2016 to 2024

  
  
Global Hemophilia Treatment Market, By Types, 2013 - 2024 (USD Million)  
 
 
 
 
“Treatment Algorithm”
The current treatment paradigm for most hemophilia patients remains predominantly first generation recombinant factor replacement therapies. Recombinant products now represent two third of the market. Prior to the development of recombinant technologies, plasma derived therapies remained the standard of care. Some patients have elected to switch to extended half-life factor replacement products which have recently entered the market and are expected to gain strong adoption over the next 5 years. Shire’s Adynovate and Biogen’s Eloctate are currently approved extended half-life products.  There is also a small subset of patients, ~10% of the market who have elected to remain on plasma derived therapies.  
 
Consultants view lower inhibitor formation and less frequent infusions as the biggest unmet needs in hemophilia and are optimistic that longer-acting products that require less frequent dosing could represent an improvement.  
 
"Shire Baxalta, Baxter, Biogen, Novo Nordisk, Pfizer and CSL are some of the key players in hemophilia treatment market"
 
In June 2016, Shire merged with Baxalta, giving Shire an attractive hemophilia product portfolio. Shires’ hemophilia franchise includes a strong breadth of products such as Advate, Feiba, Rixubis, Obizur, and plasma derived factors, such as Hemofil.
 
Shire’s Advate, acquired from Baxalta reported worldwide sales of ~$2bn in sales in 2015. Shire is expected to hold market leading position for the treatment of hemophilia A over the next 5 years supported by breadth of its hemophilia product franchise.
 
Novo Nordisk holds formidable position in the hemophilia market represented by its inhibitor treatment NovoSeven followed by Pfizer’s Benefix and Xyntha/Refacto, Bayer’s Kogenate, Biogen’s Eloctate and Alprolix, and CSL’s Helixate.
 
“Reimbursement coverage and Payer Insights”
Given that recombinant factor replacement therapies to treat hemophilia command a high price (well over $100K/year for an annual cost of prophylaxis treatment) and have favorable reimbursement, these therapies take modest price increases per year. The extended half-life products that have entered the market have come in at a premium to older factor replacement therapies on an annual cost of therapy basis, despite the less frequent dosing requirements.
 
“New Product Innovations”
 
The hemophilia market has grown at a steady pace over the last 5 years and is expected to grow for next several years driven by greater prophylaxis treatment in the adult and pediatric populations, and new extended half-life factor replacement therapies entering the market.  
 
Bayer is expected to file its extended half-life FVIII product BAY94-9027 in late 2016 and Novo Nordisk is expected to file its extended half-life product N8-GP in 2018. Once approved, these products can gradually gain more share of this market over the next decade.
 
Completely new approaches to the treatment of hemophilia, such as Roche/Chugai’s bispecific FIXa/X antibody ACE910 administered subcutaneously, could ultimately change the landscape for hemophilia treatment, but more data is needed in Phase III studies to ensure optimal dosing, long-term durability of therapy, and long-term safety with this approach can be achieved.

Market Overview, Key in-line Products, Market Share Distribution, Competitive Dynamics, Regulatory Outlook, Pipeline Development, Growth Catalysts & Challenges, Leading Market & R&D Trends, Partnership & Deals Analyses, Global Sales forecast of in-line and pipeline products, Fast Growing Private Companies, Management Perspectives, Commentaries, Market Outlook & Summary Conclusions
 
Global hemophilia treatment market was valued at $10.2bn in 2015 and is forecast to grow at a modest 5.4% CAGR between 2015 and 2024, culminating in 2024 global sales of $17.2bn.
 
Hemophilia is a rare inherited bleeding disorder whereby blood does not clot normally. Predominantly, hemophilia is classified as hemophilia A and hemophilia B. Hemophilia A occurs when the body is unable to produce adequate amounts of factor VIII (FVIII), while patients with hemophilia B are unable to produce adequate amounts of factor IX (FIX).  
Based on patient numbers and market opportunity, hemophilia A is the largest market, followed by hemophilia A patients that need bypassing agents to treat their disease. Hemophilia B is the third largest segment. Rare bleeding disorders, such as Von Willebrand disease, make up the remainder of the total hemophilia treatment market.  
 

Attribute
Details

Base Year 
2015

Historic Analysis 
2013 to 2014

Forecast
2016 to 2024

  
  
Global Hemophilia Treatment Market, By Types, 2013 - 2024 (USD Million)  
 
 
 
 
“Treatment Algorithm”
The current treatment paradigm for most hemophilia patients remains predominantly first generation recombinant factor replacement therapies. Recombinant products now represent two third of the market. Prior to the development of recombinant technologies, plasma derived therapies remained the standard of care. Some patients have elected to switch to extended half-life factor replacement products which have recently entered the market and are expected to gain strong adoption over the next 5 years. Shire’s Adynovate and Biogen’s Eloctate are currently approved extended half-life products.  There is also a small subset of patients, ~10% of the market who have elected to remain on plasma derived therapies.  
 
Consultants view lower inhibitor formation and less frequent infusions as the biggest unmet needs in hemophilia and are optimistic that longer-acting products that require less frequent dosing could represent an improvement.  
 
"Shire Baxalta, Baxter, Biogen, Novo Nordisk, Pfizer and CSL are some of the key players in hemophilia treatment market"
 
In June 2016, Shire merged with Baxalta, giving Shire an attractive hemophilia product portfolio. Shires’ hemophilia franchise includes a strong breadth of products such as Advate, Feiba, Rixubis, Obizur, and plasma derived factors, such as Hemofil.
 
Shire’s Advate, acquired from Baxalta reported worldwide sales of ~$2bn in sales in 2015. Shire is expected to hold market leading position for the treatment of hemophilia A over the next 5 years supported by breadth of its hemophilia product franchise.
 
Novo Nordisk holds formidable position in the hemophilia market represented by its inhibitor treatment NovoSeven followed by Pfizer’s Benefix and Xyntha/Refacto, Bayer’s Kogenate, Biogen’s Eloctate and Alprolix, and CSL’s Helixate.
 
“Reimbursement coverage and Payer Insights”
Given that recombinant factor replacement therapies to treat hemophilia command a high price (well over $100K/year for an annual cost of prophylaxis treatment) and have favorable reimbursement, these therapies take modest price increases per year. The extended half-life products that have entered the market have come in at a premium to older factor replacement therapies on an annual cost of therapy basis, despite the less frequent dosing requirements.
 
“New Product Innovations”
 
The hemophilia market has grown at a steady pace over the last 5 years and is expected to grow for next several years driven by greater prophylaxis treatment in the adult and pediatric populations, and new extended half-life factor replacement therapies entering the market.  
 
Bayer is expected to file its extended half-life FVIII product BAY94-9027 in late 2016 and Novo Nordisk is expected to file its extended half-life product N8-GP in 2018. Once approved, these products can gradually gain more share of this market over the next decade.
 
Completely new approaches to the treatment of hemophilia, such as Roche/Chugai’s bispecific FIXa/X antibody ACE910 administered subcutaneously, could ultimately change the landscape for hemophilia treatment, but more data is needed in Phase III studies to ensure optimal dosing, long-term durability of therapy, and long-term safety with this approach can be achieved.


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