Global Hemophilia A Treatment Market - 2023-2030

Overview

Global Hemophilia A Treatment Market reached US$ 9.1 billion in 2022 and is expected to reach US$ 13.3 billion by 2030 growing with a CAGR of 5% during the forecast period 2023-2030. The trend such as the shift towards gene therapy advancements that aims to correct existing gene mutations responsible for this condition is expected to dominate the global hemophilia A treatment market.

The global hemophilia A treatment market has grown significantly in recent years and is projected to continue on its upward trend. The market is undergoing a transformational period, influenced by several significant trends such shift towards extended half-life products, introduction of biosimilar and generics, and emergence of non-replacement therapies.

Furthermore, the rising prevalence of hemophilia, increasing advancements in treatments, increasing number of clinical trials are driving up the hemophilia A treatment market size. The growing research activities for treating hemophilia A and presence of establish biopharmaceutical and pharmaceutical companies are some of the factors in demand from North American regions. With significant competitors like Takeda Pharmaceutical Company Limited, SANOFI CORPORATION, Genentech USA, Inc., and others actively operating in the market.

Dynamics

The Growing Prevalence of Hemophilia A to Drive the Growth of the Hemophilia A Treatment Market

The growing global prevalence of hemophilia A is a crucial driving force in the development and transformation of the hemophilia A treatment industry. Hemophilia A is a hereditary bleeding condition characterized by a deficiency in the clotting factor VIII. Blood doesn't clot correctly to prevent bleeding when factor VIII levels are low.

For instance, according to National Librabry of Medicine 2023 article, Hemophilia A, the most common hereditary hemostasis condition, affects one in every 5,000 males and accounts for 80% of hemophilia cases. Hemophilia A affects around 400000 males worldwide, with many going undiagnosed in underdeveloped countries. Thus, many people going undiagnosed there is need of effective treatment with increased R&D efforts, including innovations such as extended half-life clotting factor products, gene therapies, and personalized treatments. Thereby, driving the market over the forecast period.

The Advancements in Gene Therapies will Drive the Hemophilia A Treatment Market Growth

Rapid advances in gene therapies are a critical driver of the hemophilia A therapy market's growth trajectory. Gene treatments, a novel approach that involves one-time infusion that use a vector to fix and replace the defective gene responsible for hemophilia A, showing a possibility of long-term or even curative solutions.

The FDA approvals for hemophilia A treatment using gene therapy will create a major impact on the market growth. For instance, in June 2023, U.S. Food and Drug Administration approved Roctavian, an adeno-associated virus vector-based gene therapy for the treatment of adults with severe hemophilia A without pre-existing antibodies to adeno-associated virus serotype 5 detected by an FDA-approved test. Thus, owing to the developing advancement undertaking in gene therapy to drive the market over the forecast period.

The High Cost Associated with the Hemophilia A Treatment Will Hamper the Growth of the Market

The high cost of medication is a significant restraint for the hemophilia A market, Considering the availability of a number of hemophilia treatment choices, each medicine maintains its individual branding, resulting in elevated price ranges. Furthermore, the lack of cost-effective biosimilar options for blood factor medications contributes to this pricing issue.

For example, the DDAVP injectable solution (4 mcg/mL) costs roughly around $864 for a 10 milliliter supply, showing the financial strain. This financial barrier may limit treatment accessibility, particularly in regions with limited healthcare budgets. Addressing these pricing problems is essential for ensuring adequate access to necessary hemophilia A medications.

Segment Analysis

The global hemophilia A treatment market is segmented based on treatment type, route of administration, severity type, distribution channel, and region.

Owing to the Proven Efficacy, the Factor Replacement Therapy Segment Accounted for Approximately 52.2% of the Hemophilia A Treatment Market Share

In treatment type, the factor replacement therapy segment is expected to dominate the market, due to proven efficacy contributing to its significance. The factor replacement therapy consist of treatment such as recombinant factor VIII and plasma-derived Factor VIII. This therapy entails the administration of synthetic clotting factor VIII to replace inadequate clotting factor in hemophilia patients leadingto increased in amount of factor in the body to levels that lead to better clotting, and therefore less bleeding.

This treatment remains a cornerstone in managing hemophilia A owing to increasing FDA approvals. For instance, in February 2023, the Food and Drug Administration approved Sanofi SA's therapy to treat hemophilia A, and is expects to launch it in the U.S in April. Moreover, this Sanofi's replacement medicine, Altuviiio, is entering a market dominated by competitors such as Takeda Pharmaceutical, Bayer AG, and Novo Nordisk, which produce factor replacement therapies that have been the conventional treatment for decades. Thus, due to better efficacy and increasing FDA approval the segment is expected to dominate over the forecast period.

Geographical Penetration

North America Accounted for Approximately 39.2% of the Market Share in 2022, Owing to the Increasing Number of Clinical Trials

North America, particularly the U.S., dominates the global hemophilia A treatment market due to growing number of clinical trials, and increasing research activities by major organization in the region is expected to create a major impact on this market. For instance, in May 2023, Pfizer Inc. stated that the pivotal Phase 3 BASIS clinical trial testing marstacimab (NCT03938792) accomplished its primary objectives, demonstrating statically significant and clinically relevant results.

Furthermore, Marstacimab, a novel, investigational anti-tissue factor pathway inhibitor (anti-TFPI) being studied for the treatment of hemophilia A or B in people who do not have inhibitors to Factor VIII (FVIII) or Factor IX (FIX), was administered weekly in the trial as a subcutaneous 300 mg loading dose followed by 150 mg once weekly. Thus, owing to above factors the region is expected to grow over the forecast period.

Competitive Landscape

The major global players in the hemophilia A treatment market include: Takeda Pharmaceutical Company Limited, SANOFI CORPORATION, Genentech USA, Inc., Novo Nordisk, Pfizer Inc., CSL Behring LLC., Grifols, Sagent Pharmaceuticals, Octapharma USA Inc., UBI Pharma Inc., and among others.

COVID-19 Impact Analysis

The COVID-19 pandemic has had a significant impact on the hemophilia A treatment market, revealing the connection between the virus and the disorder through increased factor VIII activity in critically ill COVID-19 patients. This connection has resulted in an increase in hospitalizations and bleeding rates in people with hemophilia A and COVID-19, demanding careful attention to bleeding episode therapy. Additionally, COVID-19 management methods such as thromboprophylaxis might come into use in hemophilia A treatment. COVID-19-induced inflammatory response complicates factor VIII levels in mild hemophilia A cases, altering replacement therapy considerations.

Adaptable approaches must be developed to address the pandemic's broader healthcare implications on hemophilia A care. Particularly, rare occurrences of acquired Hemophilia A following COVID-19 infection and immunization indicate the importance of continued monitoring for hemophilia A patients. In the complex interplay between COVID-19 and hemophilia A, a comprehensive approach is required to handle both problems and potential opportunities.

By Treatment Type

• Factor Replacement Therapy
  • Recombinant Factor VIII
  • Plasma-derived Factor VIII

• Non-Factor Replacement Therapy
  • Emicizumab
  • Desmopressin
  • Aminocaproic Acid

• Gene Therapy

By Route of Administration

• Intravenous
• Oral
• Nasal

By Severity Type

• Mild Hemophilia A
• Moderate Hemophilia A
• Severe Hemophilia A

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region

• North America
  • U.S.
  • Canada
  • Mexico

• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe

• South America
  • Brazil
  • Argentina
  • Rest of South America

• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific

• Middle East and Africa

Key Developments

• On July 4, 2023, Chugai Pharmaceutical Co., Ltd. launched Hemlibra, a medication developed by Chugai for routine prophylaxis of bleeding episodes in individuals with hemophilia A who do not use factor VIII inhibitors.
• On June 30, 2023, The U.S. FDA approved BioMarin Pharmaceutical's (BMRN.O) gene therapy for severe hemophilia A, This will patients with inherited bleeding disorder an option for regular injections of missing blood proteins.
• On March 1, 2023, 2seventy bio, Inc., a leading immuno-oncology cell therapy company, announced a $15 million preclinical milestone as part of a joint research and development collaboration focusing on an in vivo gene editing treatment for hemophilia A.

DMI Opinion

The global hemophilia A treatment market is being driven by trends such as the growing importance of gene therapy advancements that focus on fixing the genetic mutations that cause this condition. This market is undergoing a transformation, with longer half-life drugs, biosimilars, generics, and non-replacement therapies all becoming accessible.

The increasing global prevalence of hemophilia A is a major problem, with approximately 1 in 5,000 males affected by this genetic bleeding illness, emphasizing the need for improved therapies, especially considering the high number of untreated cases. Gene treatments, such as Roctavian, that have received FDA approval, provide therapeutic potential. Despite this growth, the market faces the difficulty of high treatment costs as a result of branding and a lack of cost-effective options.

The treatment landscape is driven by the dominance of factor replacement therapy, particularly recombinant factor VIII and plasma-derived Factor VIII, with North America, particularly the United States, commanding significant shares due to clinical trials and research initiatives. The link between the virus and hemophilia A becomes evident in the course of the COVID-19 pandemic, demanding precise management techniques and emphasizing the need for extensive and adaptable ways to address both challenges and potential.

Why Purchase the Report?

• To visualize the global hemophilia A treatment market segmentation based on treatment type, route of administration, severity type, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of hemophilia A treatment market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in excel consisting of key products of all the major players.

The global hemophilia A treatment market report would provide approximately 53 tables, 54 figures and 195 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies