Hemophilia A Market to Exhibit Growth at a CAGR of 2.9% During the Forecast Period (2025-2034) Owing to the Rising Hemophilia Prevalence, Strong Uptake of New Drugs, and Emergence of High-cost Gene Therapies | DelveInsight

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

• The market size for hemophilia A was found to be USD 12.2 billion in the leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] in 2024.
• The United States accounted for the largest hemophilia A treatment market size, approximately 48% of the total market size in the 7MM in 2024, compared to other major markets, including the EU4 countries, the United Kingdom, and Japan.
• HEMLIBRA's growth curve (US Q1 2025 year-over-year sales) in the United States was flat, indicating increased competition from newer therapies.
• The total number of diagnosed prevalent cases of Hemophilia A in the 7MM was around 49,500 in 2024.
• Leading hemophilia A companies, such as Novo Nordisk, Ultragenyx Pharmaceutical, Sangamo Therapeutics, ASC Therapeutics, Roche, Chugai, and others, are developing new hemophilia A treatment drugs that can be available in the hemophilia A market in the coming years. 
• The promising hemophilia A therapies in clinical trials include Mim8, DTX201 (Peboctocogene camaparvovec, BAY2599023), Giroctocogene fitelparvovec (SB-525), ASC618, NXT007/RG6512, and others.

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

• In July 2025, Novo Nordisk announced that the FDA has approved ALHEMO injection for once-daily prophylactic use to prevent or reduce bleeding episodes in adults and children aged 12 years and older with hemophilia A or B (HA/HB) without inhibitors. This approval broadens the drug's indication beyond its initial December 2024 approval for patients with HA/HB with inhibitors.
• In June 2025, Pfizer Inc. reported positive topline findings from its Phase 3 BASIS trial (NCT03938792), which evaluated HYMPAVZI (marstacimab) in adults and adolescents with hemophilia A or B who have inhibitors.
• In May 2025, the FDA approved Antihemophilic factor (recombinant), PEGylated-aucl (Jivi; Bayer) for treating pediatric patients aged 7 and older with hemophilia A. The approval was supported by results from the Alfa-PROTECT and PROTECT Kids trials.
• In March 2025, Alnylam Pharmaceuticals announced the FDA's approval of Qfitlia™ (fitusiran), the sixth Alnylam-discovered RNAi therapeutic approved in the U.S. It is the first and only treatment to lower antithrombin (AT), aiming to promote thrombin generation, rebalance hemostasis, and prevent bleeds.

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:

• Total Diagnosed Prevalent Cases of Hemophilia A
• Diagnosed Prevalent Cases of Hemophilia A with Inhibitors or without Inhibitors 
• Age-Specific Diagnosed Prevalent Cases of Hemophilia A 
• Severity-specific Diagnosed Prevalent Cases of Hemophilia A

Scope of the Hemophilia A Market Report

• Therapeutic Assessment: Hemophilia A current marketed and emerging therapies
• Hemophilia A Market Dynamics: Key Market Forecast Assumptions of Emerging Hemophilia A Drugs and Market Outlook
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL's views, Analyst's views, Hemophilia A Market Access and Reimbursement

Download the report to evaluate the hemophilia A treatment company HEMLIBRA on hemophilia in women @ Royal Hemophilia A or B

Table of Contents

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