- Development of extended half-life therapies, siRNA, bispecific antibodies and gene therapy for the treatment of Hemophilia A shall create a positive impact on the market size in coming years
LAS VEGAS, Feb. 15, 2021 /PRNewswire/ -- DelveInsight's Hemophilia A Market Analysis report offers an integrated view of epidemiological trends, treatment approaches, unmet needs present in the treatment market, and the pipeline therapies expected to have a tremendous impact in the Hemophilia A market in the coming next decade in the 7MM (the US, EU5 (the UK, Germany, Spain, Italy, and France), and Japan).
The Hemophilia A Market report offers a detailed mapping of the key companies at the forefront of the domain, major collaborations, deals, and tie-ups taking place, as well as clinical trials, and recent happenings ongoing in the Hemophilia A market landscape.
Some of the key highlights from the Hemophilia A Market Research report:
- The mainstay treatment option has long been FVIII replacement therapy. Initially, FVIII replacement was accomplished by donated whole blood, subsequently by plasma and currently by recombinant human FVIII (rFVIII) replacement therapies, which revolutionized the treatment of Hemophilia A.
- About 30% of severe Hemophilia A patients develop neutralizing anti-FVIII alloantibodies (inhibitors), which render the FVIII replacement ineffective. The standard of care therapy for patients with inhibitors is to induce immune tolerance with high-dose, high-frequency FVIII and treatment with bypassing agents (e.g., recombinant activated factor VII such as NovoSeven, FEIBA)
- Some of the FDA-approved recombinant forms of factor VIII for the treatment of Hemophilia A, include HelixateFS, Recombinate, KogenateFS, Advate, ReFacto, Eloctate, Nuwiq, Adynovate, Kovaltry, Jivi, and Xyntha.
- FDA-approved Human plasma-derived preparations include Monarc-M, Monoclate-P, Hemofil M, and Koate-DVI.
- Hemlibra, a bispecific factor IXa- and factor X-directed antibody, got FDA approval in 2017 to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients who have developed inhibitors. Later in 2018 it was also approved in Hemophilia A without factor VIII inhibitors. Hemlibra is expected to disrupt the market mostly in the recombinant FVIII class. Owing to its strong clinical data, broad FAD label and dosing convenience expected to become a blockbuster worldwide.
- DelveInsight's analysis estimates that the Hemophilia A treatment hemisphere is mainly driven by non-inhibitors drug candidates as the development of Hemophilia A gene therapies are mainly focussed on non-inhibitors segment.
- Pharmaceutical companies such as BioMarin Pharmaceutical, Novo Nordisk, Pfizer, Sangamo Therapeutics, Sanofi/Alnylam Pharmaceuticals, Catalyst Biosciences, Roche/Spark Therapeutics, Sigilon Therapeutics, Takeda, and others, are actively exploring the waters in the Hemophilia A market with their novel therapeutic approaches.
- Launch of emerging therapies like Valoctocogene Roxaparvovec, Concizumab, Fitusiran, BIVV001, Marstacimab, SPK-8011, SB-525 and others, are anticipated during the forecast period (2021-30).
- Some of the examples of the most anticipated pipeline therapies which are expected to launch during the forecast period include gene therapies like ValoctocogeneRoxaparvovec, SPK-8011, SB-525 and Small interfering RNA agents Fitusiran.
- The Hemophilia A treatment market landscape is shifting towards extended half-life therapies as well as novel approaches, including siRNA, bispecific antibodies, and Hemophilia A gene therapy.
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Hemophilia is a group of bleeding disorders. A congenital deficiency of certain clotting factors causes Hemophilia and the main form of Hemophilia is Hemophilia A and is due to the deficiency of factor VIII.
Hemophilia A Epidemiological Analysis
Over 80% of the total patient pool of Hemophilia has Hemophilia A. The total Hemophilia A prevalent population in the7MM in 2020 was 43,243. The prevalence is further expected to rise by 2030, during the study period (2018-2030). On the basis of severity, the Hemophilia A cases can be segmented in to mild, moderate and severe. Severe Hemophilia A cases are more prominent in comparison to mild and moderate. Additionally, moderate and severe accounts for 75% of the Hemophilia A patient pool.
The total Hemophilia A cases can be further bifurcated into with or without non-inhibitors, where the prevalent pool with non-inhibitors accounts for a higher number of Hemophilia A cases. In the 7MM, approximately 30% of severe Hemophilia A cases develop inhibitors; and the remaining 70% of the Hemophilia A cases were observed without inhibitors in 2020. The number of cases for both categories will increase during the study period.
The Hemophilia A Market report puts forward epidemiology division in the 7MM for the study period 2018-30 segmented into:
- Total Diagnosed Hemophilia A Prevalent Pool
- Severity-specific Hemophilia A Prevalent Pool
- Inhibitor-specific Hemophilia A Prevalent Pool
- Total Treated Hemophilia A Prevalent Pool
Hemophilia A Therapeutics Market Landscape
The Hemophilia A treatment landscape provides "On Demand" and "Prophylaxis" treatment options to the patients. However, the Prophylaxis treatment option has gained much absorption in the market as compared to the On-demand treatment option.
The treatment consists of replacing the missing clotting protein (factor VIII) and preventing the complications associated with the disorder. Replacement of this protein may be obtained through recombinant factor VIII, which is artificially created in a lab. Several recombinant forms of factor VIII are also approved for in the Hemophilia A treatment market.
The present Hemophilia A therapy market offers Factor Replacement Concentrates, and Bypassing agents as major treatment options. The market has several recombinant factor VIII (FVIII) products available with high specific activities. Plasma-derived clotting factors products are also present in the Hemophilia A treatment market. Furthermore, in adjunctive therapies, antifibrinolytic and supportive measures, which include icing, immobilization and others are also available. Besides, the market presence of approved treatment regimes, off-label products are also available for Hemophilia A.
However, the market is currently dominated by the recombinants of several generations (recombinant third-generation, and recombinant second generation).
Know more about the present market landscape @ Hemophilia A Drug Market Landscape
Hemophilia A Marketed Therapies
- Jivi (formerly BAY94-9027): Bayer
- Hemlibra (Emicizumab-kxwh): Roche (Chugai/ Genentech)
- Esperoct (N8-GP; Turoctocog alfa pegol): Novo Nordisk
- Sevenfact [coagulation factor VIIa (recombinant)-jncw]: HEMA Biologics/LFB Pharmaceuticals
And others.
Undoubtedly, there are several safe and effective treatment options, such as replacement therapy, available in the Hemophilia A treatment market. However, the main goal of the present Hemophilia A treatment options is to reduce complications arising from blood accumulating in joint spaces and/or other tissues & organs; and not to cure the disease. Hemophilia A continues to form a huge burden on the healthcare domain. Patients continue to fight this progressive bleeding disease, with high chances of inhibitor development.
Further, the formation of inhibitors is associated to reduce FVIII efficacy in blood coagulation, which as a consequence hampers patients' health and quality of life, adding significantly to the Hemophilia A treatment costs.
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Hemophilia A Market Forecast
To bridge the gap, and meet the unmet needs in the Hemophilia A market domain, the scientific community, academia, and pharmaceutical companies are actively, and collaboratively seeking novel approaches, taking advantage of advanced technologies, and developing new pipeline therapies.
Pharmaceutical companies like BioMarin Pharmaceutical, Novo Nordisk, Pfizer, Sangamo Therapeutics, Sanofi/Alnylam Pharmaceuticals, Catalyst Biosciences, Roche/Spark Therapeutics, Sigilon Therapeutics, Takeda, and others are busy investigating different candidates in Hemophilia A treatment market.
To accomplish and meet these unmet needs the future of Hemophilia treatment is continuing to incline toward extended half-life therapies as well as more novel approaches which include siRNA, bispecific antibodies, and gene therapy. The emerging therapies are expected to affirmatively challenge the presently Hemophilia A marketed therapies by snatching their market share. Although the Hemophilia A treatment market is already packed with many recombinant factor VIII therapy approaches, and upcoming treatment options based on similar MoA shall further cramp up space, it is going to affect the drug uptake without the strain of doubt.
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In essence, an increasing observable trend of Hemophilia A prevalence is expected to soar the demand for effective treatment options that are curative in nature, which is lacking in the market at the moment. The advent of premium-priced agents shall dominate the Hemophilia A market in the upcoming years. However, it is not to lose sight of the fact that Hemophilia A gene therapies are heavier than expected on pockets. Thus, healthcare authorities will seek to restrict the pricing and usage of the high-cost agents. Further, the rarity of the disease facilitates accelerated approval, market exclusivity, clinical trials subsidies, and reduced regulatory fees, orphan drug designations, and several other leverages.
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Hemophilia A Pipeline Therapies
- Valoctocogene Roxaparvovec (BMN 270): Biomarin Pharmaceutical
- Concizumab: Novo Nordisk
- Fitusiran: Sanofi/Alnylam Pharmaceuticals
- BIVV001: Sanofi
- Marstacimab: Pfizer
- Marzeptacog alfa: Catalyst Biosciences
- Giroctocogene fitelparvovec (SB-525/PF-07055480): Pfizer/Sangamo Therapeutics
- RG6357 (SPK-8011): Roche/Spark Therapeutics
- RG6358 (SPK-8016): Roche/Spark Therapeutics
- SIG-001: Sigilon Therapeutics
- NNC0365-3769 A (Mim8): Novo Nordisk A/S
- TAK-754 (BAX 888/SHP654): Takeda (Shire)
And others.
Rich insights @ Hemophila A Market Forecast and Pipeline Therapies
Scope of the Report
- Coverage: 7MM (The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan
- Study Period: 2018-2030
- Key Companies: Biomarin Pharmaceutical, Novo Nordisk, Sanofi, Alnylam Pharmaceuticals, Pfizer, Catalyst Biosciences, Sangamo Therapeutics, Roche, Spark Therapeutics, Sigilon Therapeutics, Takeda (Shire) and several others.
- Hemophilia A Pipeline Therapies: Valoctocogene Roxaparvovec (BMN 270), Concizumab, Fitusiran, BIVV001, Marstacimab, Marzeptacog alfa, Giroctocogene fitelparvovec (SB-525/PF-07055480), RG6357 (SPK-8011), RG6358 (SPK-8016), SIG-001, NNC0365-3769 A (Mim8), TAK-754 (BAX 888/SHP654) and others.
- Analysis: Comparative and conjoint analysis of Hemophilia A Emerging therapies
- Tools used: SWOT analysis, Porter's Five Forces, PESTLE analysis, BCG Matrix
- Analysis methods.
- Case Studies
- KOL's Views
- Analyst's Views
Table of Contents
1 | Key Insights |
2 | Executive Summary of Hemophilia A |
3 | Competitive Intelligence Analysis for Hemophilia A |
4 | Hemophilia A: Market Overview at a Glance |
5 | Hemophilia A: Disease Background and Overview |
6 | Hemophilia A Patient Journey |
7 | Hemophilia A Epidemiology and Patient Population |
8 | Hemophilia A Treatment Algorithm, Current Treatment, and Medical Practices |
9 | Unmet Needs |
10 | Key Endpoints of Hemophilia A Treatment |
11 | Hemophilia A Marketed Products |
12 | Hemophilia A Emerging Therapies |
13 | Hemophilia A: Seven Major Market Analysis |
14 | Conjoint analysis |
15 | Hemophilia A 7MM: Market Outlook |
16 | Access and Reimbursement Overview of Hemophilia A |
17 | KOL Views |
18 | Hemophilia A Market Drivers |
19 | Hemophilia A Market Barriers |
20 | Appendix |
21 | DelveInsight Capabilities |
22 | Disclaimer |
23 | About DelveInsight |
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