DelveInsight’s “Hemophilia B Market” report provides a thorough comprehension of the Hemophilia B historical and forecasted epidemiology and the Hemophilia B market trends in the 7MM [the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan]. The Hemophilia B market report also proffers an analysis of the current Hemophilia B treatment algorithm/practice, market drivers, market barriers, and unmet medical needs.
Some of the necessary takeaways from the Hemophilia B Market Research Report
BeneFIX, a recombinant factor IX indicated for treating Hemophilia B patients, was authorized in 1997 and is marketed by Pfizer. In 2016, the US FDA approved Idelvion, a factor IX-albumin fusion product marketed by CSL Behring.
A novel agent from Sobi and Bioverativ Therapeutics, Alprolix for Hemophilia B individuals, is an approved recombinant DNA-derived coagulation factor IX concentrate. Alprolix was authorized in 2014 and is marketed by Sanofi Aventis and Swedish Orphan Biovitrum (SOBI – in Europe, Russia, North Africa, and the Middle East).
Rebinyn/Refixia, a modified form of factor IX, was approved by the US FDA in 2017 in the United States. Rebinyn is approved for on-demand therapy and control of bleeding episodes, and perioperative bleeding management. In 2017, the European Commission approved the BLA application for Rebinyn to treat adults and children with Hemophilia B. In 2018, the Japanese regulatory authority granted a green signal to Rebinyn/Refixia.
Rixubis by Baxter is another efficient replacement factor therapy widely used in treating Hemophilia B and can reduce the number of bleeding episodes (prophylaxis).
Ixinity is a replacement therapy developed by Aptevo Therapeutics for adults and children 12 or older with Hemophilia B; the US FDA approved the medication in 2015. In March 2020, Medexus Pharmaceuticals acquired Ixinity from Aptevo.
Three of the bypassing agents that have been approved to date are Feiba, Novoseven, and Sevenfact. In April 2020, the US FDA approved Sevenfact as the first new bypassing agent in over 20 years for adults and adolescents (12 years of age and older) with hemophilia A and B with inhibitors. In January 2017, the US FDA accepted the BLA for coagulation factor VIIa (recombinant), activated eptacog beta.
Several key pharmaceutical companies, including HEMA Biologics, LFB Pharmaceuticals, Novo Nordisk, CSL Behring, Bioverativ Therapeutics, Sobi, Medexus Pharmaceuticals, Aptevo Therapeutics, Takeda, Pfizer, Spark Therapeutics, Sanofi, Alnylam Pharmaceuticals, uniQure, Freeline Therapeutics, ApcinteX, Sangamo Therapeutics, and others, are developing novel products to improve the Hemophilia B treatment outlook.
Hemophilia B market will observe growth due to the popularity of gene therapy, development of novel treatments with an extended half-life, and increased focus on prophylactic treatment. Nevertheless, the high cost of treatment, inconvenience and scheduling barriers, and lack of skilled healthcare professionals will nosedive the growth of Hemophilia B.
For further information on Market Impact by Therapies, visit: Hemophilia B Drugs Market Analysis
Hemophilia B is a rare genetic bleeding disorder in which affected individuals have insufficient blood protein levels called factor IX.
DelveInsight estimates that the totalHemophilia B prevalent population in 7MM was 10,739 cases in 2020 and is expected to rise by 2030 during the study period [2018–2030]. Also, in the same year, the highest prevalent population of Hemophilia B was in the United States, with 4,134 cases.
The Hemophilia B Market Analysis Report provides historical as well as forecasted epidemiological analysis segmented into:
Total diagnosed cases of Hemophilia B
Severity-specific cases of Hemophilia B
Hemophilia B cases by inhibitors and non-inhibitors
Treated Population of Hemophilia B
Get a complete epidemiological segmentation breakdown @ Hemophilia B Epidemiological Analysis
Hemophilia B Treatment Market
Currently, there is no cure for Hemophilia B; however, the disease can be managed with the help of available treatment choices. To achieve sufficient blood clotting and avoid complications associated with the disease, the basic treatment of Hemophilia B is the replacement of factor IX. At present, recombinant products or products extracted from human blood or plasma are widely used to replace factor IX to meet an adequate amount. Apart from this, fresh frozen plasma is also used for treatment purposes. It is extracted from human blood and is utilized only when factor IX concentrate is unavailable for treating IX deficiency patients. Currently, recombinant factor IX concentrates such as Alprolix, Benefix, Idelvion, Ixinity, Rebinyn, and Rixubis are licensed in the United States for Hemophilia B treatment. Besides these, bypassing agents such as Feiba, Novoseven, and Sevenfact and human plasma-derived coagulation factor IX – AlphaNine SD and Mononine – have secured FDA approval as well.
The future of Hemophilia treatment is continuing to incline toward extended half-life therapies and more novel approaches, including siRNA, bispecific antibodies, and gene therapy.
Despite the widespread availability of safe and effective replacement therapy, Hemophilia B patients continue to experience a tremendous burden of treatment, breakthrough bleeding, progressive joint disease, and significant rates of inhibitor development. Very limited treatment options are available for the severe segment (~35% of total hemophilia B), and there is a substantial unmet need in this setting. Also, once the inhibitors are formed, it is associated with reducing factor IX efficacy in blood coagulation, which hampers patients’ health and quality of life and considerably increases Hemophilia B treatment costs. These factors suggest that there is still a significant unmet need in the treatment of Hemophilia B patients.
To accomplish and meet these unmet needs, the companies such as Novo Nordisk, Sanofi, Pfizer, Sangamo Therapeutics, Catalyst Biosciences, uniQure, and others, are coming up with novel therapeutic approaches that can entirely change the Hemophilia B treatment landscape.
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The current standard of care treatment for severe hemophilia B is the prophylactic intravenous replacement of coagulation factor IX (FIX) to inhibit spontaneous bleeding. It is forecasted that the future of hemophilia care will trend toward more innovative forthcoming approaches such as antibodies, siRNA, and gene therapies. In the upcoming years, the increase in hemophilia B market size is primarily driven by the introduction of pipeline candidates such as Fidanacogene elaparvovec (SPK 9001/PF- 06838435), Etranacogene dezaparvovec (AMT-061), Fitusiran, Marstacimab (PF- 06741086), Concizumab, FLT180a, and AMT-060 (AAV5-hFIX) during the forecast period (2021–2030). Important areas of unmet medical need are addressed by new therapies, such as decreasing the requirement for intravenous infusions and alleviating the risk of producing neutralizing antibodies or inhibitors. If these treatments are eventually successfully commercialized, it will change the current standard of care for Hemophilia B patients. Pfizer/Spark Therapeutics’ Fidanacogene elaparvovec, uniQure’s Etranacogene dezaparvovec, and Sanofi (Genzyme)/Alnylam’s Fitusiran for hemophilia B are leading towards regulatory approval.
Currently, the Hemophilia B treatment hemisphere is mainly driven by non-inhibitors drug candidates. Emerging potential candidates pose an adverse threat to current Hemophilia B pharmaceuticals giants using their potential to transform the standard of care for Hemophilia B patients. The Hemophilia treatment landscape continues to evolve, and several companies are furiously working toward the development of new treatments that could potentially cure and change the treatment landscape of Hemophilia B. Companies are focused on the development of gene therapies that bispecific antibodies for the treatment, and this shall create a positive impact on the Hemophilia B market size of disease in coming years.
Scope of the Hemophilia B Market Insight Report
Geography Covered: The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
Study Period: 3-year historical and 10-year forecasted analysis (2018-2030).
Hemophilia B Markets Segmentation: By Geographies and By Hemophilia B Therapies (Historical and Forecasted, Current and Upcoming)
Dominant Market Companies investigating its candidates for Hemophilia B: HEMA Biologics, LFB Pharmaceuticals, Novo Nordisk, CSL Behring, Bioverativ Therapeutics, Sobi, Medexus Pharmaceuticals, Aptevo Therapeutics, Takeda, Pfizer, Spark Therapeutics, Sanofi, Alnylam Pharmaceuticals, uniQure, Freeline Therapeutics, ApcinteX, Sangamo Therapeutics, and several others.
Analysis: Comparative and conjoint analysis of emerging therapies.
Table of Contents
Hemophilia B Key Insights
Executive Summary of Hemophilia B
SWOT Analysis of Hemophilia B
Hemophilia B Market Share (%) Distribution Overview at a Glance: By Country
Hemophilia B Epidemiology and Market Methodology
Hemophilia B Disease Background and Overview
Hemophilia B Epidemiology and Patient Population
The United States
The United Kingdom
Hemophilia B Current Treatment Practices
Hemophilia B Unmet Needs
Hemophilia B Patient Journey
Hemophilia B Marketed Therapies
Sevenfact (coagulation factor VIIa [recombinant]-jncw): HEMA Biologics/LFB Pharmaceuticals
Rebinyn (Nonacog beta pegol): Novo Nordisk
Idelvion: CSL Behring
Alprolix: Bioverativ Therapeutics/Sobi
Ixinity (Trenonacog alfa): Medexus Pharmaceuticals/ Aptevo Therapeutics
Rixubis: Takeda (Shire/Baxter)
Hemophilia B Emerging Therapies
Marstacimab (PF-06741086): Pfizer
Fidanacogene elaparvovec (SPK-9001/PF-06838435): Pfizer/Spark Therapeutics
Fitusiran (ALN-AT3, SAR-439774): Sanofi (Genzyme)/Alnylam Pharmaceuticals
Etranacogene dezaparvovec (AMT-061): CSL Behring/uniQure
Concizumab (NN-7415): Novo Nordisk
Verbrinacogene setparvovec (FLT-180a): Freeline Therapeutics
SerpinPC (AP-0101): ApcinteX
AMT-060 (AAV5-hFIX): UniQure
SB-FIX: Sangamo Therapeutics
Hemophilia B 7MM Market Analysis
The United States Hemophilia B Market Size
EU-5 Hemophilia B Market Size
Germany Market Size
France Market Size
Italy Market Size
Spain Market Size
The United Kingdom Market Size
Japan Hemophilia B Market Size
Hemophilia B Market Access and Reimbursement
Hemophilia B Market Drivers
Hemophilia B Market Barriers
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