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LAS VEGAS, Dec. 3, 2025
The dynamics of the hemophilia A market are expected to change mainly due to the increase in prevalence and the launch of upcoming therapies such as Mim8 (Novo Nordisk), DTX201 (Pebocotocogene camaparvovec, BAY2599023 [Ultragenyx Pharmaceutical]), giroctocogene fitelparvovec (SB-525 [Sangamo Therapeutics]), and others during the forecast period.
LAS VEGAS, Dec. 3, 2025 /PRNewswire/ -- 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 market size from 2020 to 2034, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Hemophilia A Market Summary
Discover the new hemophilia A treatment @ Hemophilia A Treatment Market
Key Factors Driving the Growth of the Hemophilia A Market
Rising Hemophilia A Target Patient Pool
The diagnosed prevalence of Hemophilia A is expected to rise from 49K in 2024 to 50K by 2034. Improved diagnostic capabilities and increased disease awareness mainly drive this increase in cases.
Advancements in Gene Therapy
Gene therapy has emerged as a transformative approach in hemophilia A treatment. Notably, BioMarin's ROCTAVIAN has been approved in the U.S. and EU, offering a one-time infusion that provides long-term correction of the factor VIII deficiency. Pfizer's gene therapy giroctocogene fitelparvovec for hemophilia A has also demonstrated promising results in late-stage trials, significantly reducing bleeding episodes and outperforming traditional treatments.
Regulatory Approvals and Hemophilia A Market Expansion
Recent regulatory approvals have bolstered the availability of hemophilia A treatments. For instance, the U.S. FDA approved Pfizer's once-weekly injection, HYMPAVZI (in October 2024), for hemophilia A patients aged 12 and above, aiming to prevent or reduce bleeding episodes. Similarly, Sanofi's QFITLIA (in March 2025), a subcutaneous treatment administered every two months, was approved for patients with Hemophilia A or B aged 12 and older.
Emergence of Non-Factor Hemophilia A Therapies
Expanding beyond traditional therapies, hemophilia A care now includes two cutting-edge non-factor approaches: anti-TFPI therapies (Pfizer's HYMPAVZI and Novo Nordisk's ALHEMO) and siRNA therapies (Sanofi's QFITLIA).
Robust Hemophilia A Clinical Trial Activity
Several hemophilia A companies are actively developing emerging therapies, including Novo Nordisk (Mim8, ALHEMO), Sangamo Therapeutics (Giroctocogene fitelparvovec), Roche/Chugai (NXT007), ASC Therapeutics (ASC-618), Ultragenyx (DTX201), and others.
Hemophilia A Market Analysis
The primary goal of current treatment strategies for hemophilia A is to minimize complications caused by bleeding into joints, tissues, or organs. With ongoing technological advancements and improved medical understanding, patients now have access to a range of therapeutic options. Treatment is typically administered either "on-demand" or as "prophylaxis", with prophylactic therapy increasingly becoming the preferred approach.
The U.S. FDA has approved several recombinant Factor VIII products for hemophilia A management, including HELIXATE FS, RECOMBINATE, KOGENATE FS, ADVATE, REFACTO, ELOCTATE, NUWIQ, ADYNOVATE, KOVALTRY, JIVI, and XYNTHA. Additionally, plasma-derived Factor VIII products, such as MONARC-M, MONOCLATE-P, HEMOFIL M, and KOATE-DVI, remain available.
The latest addition, QFITLIA (fitusiran), a siRNA-based therapy approved in 2025, works by lowering antithrombin levels to enhance clot formation. It offers the convenience of only six injections per year and is effective for both inhibitor and non-inhibitor patients.
HEMLIBRA has emerged as a first-line prophylactic therapy for Hemophilia A patients with inhibitors, although immune tolerance induction (ITI) therapy continues to be the gold standard. For those who encounter difficulties with ITI, HEMLIBRA provides an alternative, requiring less frequent FVIII dosing during ITI.
Looking ahead, hemophilia management is shifting toward extended half-life factor therapies and cutting-edge modalities, including siRNA agents, bispecific antibodies, and gene therapy. The competitive landscape is expected to expand with the introduction of new long-acting factor products and next-generation therapeutic technologies.
Hemophilia A Competitive Landscape
The hemophilia A clinical trial landscape features several drugs in mid- and late-stage development that are expected to be approved in the near future. The emerging landscape offers a diverse range of therapeutic alternatives for treatment, including Mim8 (Novo Nordisk), DTX201 (Pebocotocogene camaparvovec, BAY2599023 [Ultragenyx Pharmaceutical]), giroctocogene fitelparvovec (SB-525 [Sangamo Therapeutics]), and others.
Novo Nordisk's Mim8 is an advanced FVIIIa-mimicking bispecific antibody designed to provide sustained hemostatic control with convenient once-weekly or once-monthly prophylactic dosing for individuals with Hemophilia A, regardless of inhibitor status. Delivered subcutaneously, Mim8 functions by bridging activated Factors IXa and X (FIXa/FX) upon activation, effectively compensating for the absence of FVIII. This restores normal thrombin generation and promotes effective blood clotting.
Ultragenyx Pharmaceutical's DTX201 represents the first clinical-stage gene therapy for Hemophilia A utilizing an Adeno-associated Virus (AAV) vector derived from the AAVhu37 serotype. It is a non-replicating AAV vector carrying a single-stranded DNA genome that encodes a B-domain–deleted FVIII, driven by a liver-specific promoter and enhancer sequence optimized for strong transgene expression. The AAVhu37 capsid, part of the hepatotropic clade E family, was chosen for its demonstrated ability in preclinical studies to enable efficient liver-targeted FVIII gene delivery, optimal biodistribution, and long-lasting FVIII expression.
The anticipated launch of these emerging therapies are poised to transform the hemophilia A market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the hemophilia A market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about the FDA approved gene therapy hemophilia A @ FDA Approved AAV Gene Therapy Hemophilia A
Recent Developments in the Hemophilia A Market
What is Hemophilia A?
Hemophilia A is an inherited bleeding disorder caused by a deficiency or low levels of clotting factor VIII. For many years, the standard treatment has been replacement therapy with FVIII. This began with FVIII obtained from donated whole blood, later advanced to plasma-derived FVIII, and is now primarily managed with recombinant human FVIII (rFVIII) products that have transformed hemophilia care. While the condition is typically diagnosed at birth, it can also be acquired later in life when the immune system develops antibodies that neutralize clotting factors, a rare condition known as acquired hemophilia.
Hemophilia A Epidemiology Segmentation
The hemophilia A epidemiology forecast section provides insights into the historical and current hemophilia A patient pool and forecasted trends for the leading markets. In the 7MM, the highest diagnosed prevalent cases of Hemophilia A were in the United States, accounting for nearly 14,900 cases in 2024. These cases are anticipated to increase in the upcoming years.
The hemophilia A treatment market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets, segmented into:
Hemophilia A Market Report Metrics
Details
Study Period
2020–2034
Coverage
7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Hemophilia A Market CAGR
2.9 %
Hemophilia A Market Size in 2024
USD 12.2 Billion
Key Hemophilia A Companies
Novo Nordisk, Ultragenyx Pharmaceutical, Sangamo Therapeutics, ASC Therapeutics, Roche, Chugai, Sanofi, Alnylam Pharmaceuticals, Pfizer, Genentech, BioMarin Pharmaceutical, HEMA Biologics, LFB Pharmaceuticals, Octapharma, CSL Behring, Octapharma, Bayer, Takeda, and others
Key Hemophilia A Therapies
Mim8, DTX201 (Peboctocogene camaparvovec, BAY2599023), Giroctocogene fitelparvovec (SB-525), ASC618, NXT007/RG6512, QFITLIA, HYMPAVZI, ALHEMO, HEMLIBRA, ALTUVIIIO, ROCTAVIAN, SEVENFACT/CEVENFACTA, ESPEROCT, WILATE, JIVI, ADYNOVATE, AFSTYLA, NUWIQ, FEIBA, KOVALTRY, OBIZUR, ELOCTATE/Elocta, XYNTHA, and others
Scope of the Hemophilia A Market Report
Download the report to evaluate the hemophilia A treatment company HEMLIBRA on hemophilia in women @ Royal Hemophilia A or B
Table of Contents
1
Hemophilia A Market Key Insights
2
Hemophilia A Market Report Introduction
3
Executive Summary
4
Key Events
5
Epidemiology and Market Forecast Methodology
6
Hemophilia A Market Overview at a Glance
6.1
Market Share (%) Distribution of Hemophilia A by Therapy in 2020
6.2
Market Share (%) Distribution of Hemophilia A by Therapy in 2034
6.3
Market Share (%) Distribution of Hemophilia A by Inhibitor in 2020
6.4
Market Share (%) Distribution of Hemophilia A by Inhibitor in 2034
6.5
Market Share (%) Distribution of Hemophilia A by Noninhibitor in 2020
6.6
Market Share (%) Distribution of Hemophilia A by Noninhibitor in 2034
7
Hemophilia A: Disease Background and Overview
7.1
Introduction
7.2
Hemophilia A Signs and Symptoms
7.3
Hemophilia A Inheritance Pattern
7.4
Hemophilia A Molecular Pathogenesis
7.5
Hemophilia A Pathophysiology
7.6
Hemophilia A Risk Factors
7.7
Hemophilia A Diagnosis of Hemophilia A
8
Hemophilia A Treatment Algorithm, Current Treatment, and Medical Practices
9
Epidemiology and Patient Population
9.1
Key Findings
9.2
Assumptions and Rationale: 7MM
9.3
Total Diagnosed Prevalent Cases of Hemophilia A in the 7MM
9.4
United States
9.4.1
Total Diagnosed Prevalent Cases of Hemophilia A in the United States
9.4.2
Diagnosed Prevalent Cases of Hemophilia A With Inhibitors and Without Inhibitors in the United States
9.4.3
Age-Specific Diagnosed Prevalent Cases of Hemophilia A in the United States
9.4.4
Severity-specific Prevalent Cases of Hemophilia A in the United States
9.5
EU4 and the UK
9.6
Japan Epidemiology
10
Hemophilia A Patient Journey
11
Marketed Hemophilia A Therapies
11.1
Key Cross of Marketed Therapies
11.2
QFITLIA (fitusiran): Sanofi/Alnylam Pharmaceuticals
11.2.1
Product Description
11.2.2
Regulatory Milestones
11.2.3
Other Developmental Activities
11.2.4
Clinical Development
11.2.4.1
Clinical Trials Information
11.2.5
Safety and Efficacy
11.3
HYMPAVZI (marstacimab-hncq): Pfizer
11.4
ALHEMO (concizumab): Novo Nordisk
11.5
HEMLIBRA (emicizumab-kxwh): Chugai/Genentech/Roche
11.6
ALTUVIIIO (antihemophilic factor [recombinant], Fc-VWF-XTEN fusion protein-ehtl): Sanofi/Sobi
11.7
ROCTAVIAN (valoctocogene roxaparvovec): BioMarin Pharmaceutical
11.8
SEVENFACT/CEVENFACTA [coagulation factor VIIa (recombinant)-jncw]: HEMA Biologics/LFB Pharmaceuticals
11.9
ESPEROCT (N8-GP; Turoctocog alfa pegol): Novo Nordisk
11.10
WILATE: Octapharma
11.11
JIVI (BAY94-9027): Bayer
11.12
ADYNOVATE (Adynovi; BAX 855): Takeda Pharmaceutical
11.13
AFSTYLA (Lonoctocog alfa): CSL Behring
11.14
NUWIQ (simoctocog alfa): Octapharma
11.15
FEIBA: Takeda
11.16
KOVALTRY (BAY 81-8973): Bayer
11.17
OBIZUR (susoctocog alfa): Takeda
11.18
ELOCTATE/Elocta (efmoroctocog alfa): Sanofi/Sobi
11.19
XYNTHA (ReFacto AF): Pfizer
12
Emerging Hemophilia A Drugs
12.1
Key Cross Competition
12.2
Mim8: Novo Nordisk
12.2.1
Product Description
12.2.2
Other Development Activities
12.2.3
Clinical Development
12.2.3.1
Clinical Trial Information
12.2.4
Safety and Efficacy
12.2.5
Analyst View
12.3
DTX201 (Peboctocogene camaparvovec, BAY2599023): Ultragenyx Pharmaceutical
12.4
Giroctocogene fitelparvovec (SB-525): Sangamo Therapeutics
12.5
ASC618: ASC Therapeutics
12.6
NXT007/RG6512: Roche/Chugai
13
Hemophilia A Market: 7MM Analysis
13.1
Key Findings
13.2
Hemophilia A Market Outlook
13.3
Key Hemophilia A Market Forecast Assumptions
13.4
Conjoint Analysis
13.5
Total Market Size of Hemophilia A by Country in the 7MM
13.6
United States Hemophilia A Market Size
13.6.1
Total Market Size of Hemophilia A in the United States
13.6.2
Market Size of Hemophilia A by Therapies in the United States
13.7
EU4 and the UK Hemophilia A Market Size
13.8
Japan Hemophilia A Market Size
14
Hemophilia A Market Unmet Needs
15
Hemophilia A Market SWOT Analysis
16
KOL Views on Hemophilia A
17
Hemophilia A Market Access and Reimbursement
17.1
United States
17.2
EU4 and the UK
17.3
Japan
17.4
Market Access and Reimbursement of Hemophilia A
18
Bibliography
19
Hemophilia A Market Report Methodology
Related Reports
Hemophilia A Clinical Trial Analysis
Hemophilia A Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Hemophilia A companies, including Jiangsu Gensciences Inc., Takeda, Gritgen Therapeutics Co., Ltd., Suzhou Alphamab Co., Ltd., Novo Nordisk, Pfizer, SK Plasma Co., Ltd., Hoffmann-La Roche, Shanghai Belief-Delivery BioMed Co., Ltd, ASC Therapeutics, Biocad, Expression Therapeutics, LLC, GCBiopharma, Amarna Therapeutics, Cabaletta Bio, among others.
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