New York, USA, Oct. 09, 2023 (GLOBE NEWSWIRE) — Hemophilia A Market to Exhibit Growth at a Remarkable CAGR During the Study Period (2019-2032) | DelveInsight
The current therapeutic landscape of hemophilia A in the United States is driven by several approved therapies. The hemophilia A market is estimated to grow for the period 2019–2032. The major reason behind the hemophilia A market upsurge is the launch of the most anticipated gene therapies, which are considered as a threat to the current hemophilia A market.
DelveInsight’s Hemophilia A Market Insights report includes a comprehensive understanding of current treatment practices, hemophilia A emerging drugs, market share of individual therapies, and current and forecasted hemophilia A market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan].
Key Takeaways from the Hemophilia A Market Report
- As per DelveInsight’s analysis, the hemophilia A market size was found to be USD 8.5 billion in 2021 in the 7MM and it is anticipated to grow at a significant CAGR by 2032.
- As per DelveInsight estimates, the total prevalent population of hemophilia A in the 7MM comprised of 45K cases in 2021 and are projected to increase during the forecast period.
- Leading hemophilia A companies such as Roche (Spark Therapeutics), ApcinteX, Alnylam Pharmaceuticals, Sanofi, Novo Nordisk A/S, Pfizer, Sangamo Therapeutics, Bayer, Ultragenyx Pharmaceutical, and others are developing novel hemophilia A drugs that can be available in the hemophilia A market in the coming years.
- Some of the key therapies for hemophilia A treatment include RG6357 (SPK-8011), RG6358 (SPK-8016), SerpinPC, Concizumab (NN7415), Fitusiran (ALN-AT3, SAR-439774), BIVV001 (Efanesoctocog alfa) (rFVIIIFc-VWF-XTEN), Marstacimab (PF-06741086), NNC0365-3769 A (Mim8), Giroctocogene fitelparvovec (SB-525 or PF-07055480), BAY2599023 (DTX201 AAV FVIII), and others.
- In June 2023, BioMarin announced that the FDA had approved Roctavian as a one-time treatment for patients with severe hemophilia A.
- In February 2023, the US FDA approved ALTUVIIIO (efanesoctocog alfa) factor VIII replacement therapy for adults and children with hemophilia A. ALTUVIIIO is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as perioperative management (surgery) for adults and children with hemophilia A.
- In September 2022, Pfizer and Sangamo Therapeutics announced that the Phase III AFFINE study evaluating giroctocogene fitelparvovec, has re-opened recruitment.
Discover which therapies are expected to grab the major hemophilia A market share @ Hemophilia A Market Report
Hemophilia A Overview
Hemophilia A is a genetic disorder characterized by a deficiency or low levels of clotting factor VIII, a protein essential for proper blood clotting. In the absence of sufficient factor VIII, individuals may experience difficulty controlling bleeding. It is noteworthy that approximately one-third of cases occur without any known family history of the condition. Those with severe hemophilia A are at risk of spontaneous bleeding in various organ systems, including the kidneys, gastrointestinal tract, and even the brain. This may manifest as blood in the urine in cases of genitourinary bleeding or as black or bloody stools during gastrointestinal bleeding. Diagnosis involves both screening tests, which evaluate the blood’s clotting ability, and clotting factor tests, also known as factor assays, which are essential for identifying and determining the severity of the specific type of hemophilia.
Hemophilia A Epidemiology Segmentation
The hemophilia A epidemiology section provides insights into the historical and current hemophilia A patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders.
The hemophilia A market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into:
- Total Hemophilia A Diagnosed Prevalent Pool
- Hemophilia A Severity-specific Prevalent Pool
- Hemophilia A Inhibitor-specific Prevalent Pool
- Hemophilia A Treated Prevalent Pool
Download the report to understand which factors are driving hemophilia A epidemiology trends @ Hemophilia A Epidemiological Insights
Hemophilia A Treatment Market
Presently, a cure remains elusive, yet scientists are fervently dedicated to exploring gene therapy as a potential solution. One promising avenue involves the introduction of a functional version of the faulty blood factor gene, with the goal of enabling individuals with hemophilia to generate adequate factor levels autonomously. In the realm of treatment, Hemophilia A patients typically have two primary options: “On Demand” and “Prophylaxis,” with the latter gaining increasing significance over the former.
Many patients receive preventive infusions using third-generation products that are free of human or animal proteins. Numerous such products are currently accessible in the market, such as ADVATE by Takeda and XYNTHA by Pfizer. While there are other approved products in this category, they have been on the market for quite some time. In the meantime, newer recombinant factor therapies, not derived from human plasma, have been introduced, with ELOCTATE and JIVI emerging as popular options.
The hemophilia A treatment market offers numerous recombinant factor VIII (FVIII) products with highly specific activities, alongside plasma-derived clotting factor options. However, recombinant third-generation and second-generation products currently dominate the market. Despite the variety of available products, none offer a complete cure or management solution for this condition.
The landscape of hemophilia treatment is evolving, with a growing emphasis on extended half-life therapies and innovative approaches like siRNA, bispecific antibodies, and gene therapy. Looking ahead, we can expect increased competition, as more extended half-life factor products enter the market, alongside the emergence of novel technologies such as gene therapies and bi-specific antibodies.
Learn more about the FDA-approved drugs for hemophilia A @ Drugs for Hemophilia A Treatment
Key Hemophilia A Therapies and Companies
- RG6357 (SPK-8011): Roche (Spark Therapeutics)
- RG6358 (SPK-8016): Roche (Spark Therapeutics)
- SerpinPC: ApcinteX
- Concizumab (NN7415): Novo Nordisk
- Fitusiran (ALN-AT3, SAR-439774): Sanofi (Genzyme)/Alnylam Pharmaceuticals
- BIVV001 (Efanesoctocog alfa) (rFVIIIFc-VWF-XTEN): Sanofi
- Marstacimab (PF-06741086): Pfizer
- NNC0365-3769 A (Mim8): Novo Nordisk A/S
- Giroctocogene fitelparvovec (SB-525 or PF-07055480): Pfizer/Sangamo Therapeutics
- BAY2599023 (DTX201 AAV FVIII): Bayer/Ultragenyx Pharmaceutical
To know more about hemophilia A clinical trials, visit @ Hemophilia A Treatment Drugs
Hemophilia A Market Dynamics
The dynamics of the hemophilia A market are expected to change in the coming years. Being an orphan condition may lead to expedited approval timelines, a seven-year period of market exclusivity, subsidies for clinical trials, and reduced regulatory fees, among other benefits. In the severe disease category, treatment options are extremely scarce, creating promising opportunities in the hemophilia market.
Furthermore, potential therapies are being investigated for the treatment of hemophilia A, and it is safe to predict that the treatment space will significantly impact the hemophilia A market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the hemophilia A market in the 7MM.
However, several factors are impeding the growth of the hemophilia A market. Numerous choices exist within the realm of recombinant factor VIII, and as time progresses, this area is likely to become increasingly saturated. This saturation is poised to influence the adoption of new medications employing a similar strategy. Hemophilia A treatment is notorious for its exorbitant costs, and forthcoming options such as gene therapies and extended half-life products are also anticipated to come with steep price tags. Healthcare authorities are expected to implement measures to limit both the pricing and utilization of these high-cost treatments.
Furthermore, the hemophilia A market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the hemophilia A market growth.
Hemophilia A Report Metrics | Details |
Study Period | 2019–2032 |
Hemophilia A Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
Hemophilia A Market Size in 2021 | USD 8.5 Billion |
Key Hemophilia A Companies | Roche (Spark Therapeutics), ApcinteX, Alnylam Pharmaceuticals, Sanofi, Novo Nordisk A/S, Pfizer, Sangamo Therapeutics, Bayer, Ultragenyx Pharmaceutical, and others |
Key Hemophilia A Therapies | RG6357 (SPK-8011), RG6358 (SPK-8016), SerpinPC, Concizumab (NN7415), Fitusiran (ALN-AT3, SAR-439774), BIVV001 (Efanesoctocog alfa) (rFVIIIFc-VWF-XTEN), Marstacimab (PF-06741086), NNC0365-3769 A (Mim8), Giroctocogene fitelparvovec (SB-525 or PF-07055480), BAY2599023 (DTX201 AAV FVIII), and others |
Scope of the Hemophilia A Market Report
- Therapeutic Assessment: Hemophilia A current marketed and emerging therapies
- Hemophilia A Market Dynamics: Attribute Analysis of Emerging Hemophilia A Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, Hemophilia A Market Access and Reimbursement
Discover more about hemophilia A drugs in development @ Hemophilia A Clinical Trials
Table of Contents
1. | Hemophilia A Market Key Insights |
2. | Hemophilia A Market Report Introduction |
3. | Hemophilia A Market Overview at a Glance |
4. | Hemophilia A Market Executive Summary |
5. | Disease Background and Overview |
6. | Hemophilia A Treatment and Management |
7. | Hemophilia A Epidemiology and Patient Population |
8. | Patient Journey |
9. | Hemophilia A Marketed Drugs |
10. | Hemophilia A Emerging Drugs |
11. | Seven Major Hemophilia A Market Analysis |
12. | Hemophilia A Market Outlook |
13. | Potential of Current and Emerging Therapies |
14. | KOL Views |
15. | Unmet Needs |
16. | SWOT Analysis |
17. | Appendix |
18. | DelveInsight Capabilities |
19. | Disclaimer |
20. | About DelveInsight |
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