Hemophilia Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

The Report Covers Global Hemophilia Treatment Market Insights & Statistics and it is Segmented by Disease Type (Hemophilia A, Hemophilia B, and Others), Therapy (Replacement Therapy, Gene Therapy, and Others), Product Type (Recombinant Coagulation Factor Concentrates, Plasma-derived Coagulation Factor Concentrates, and Others), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market size and forecasts are provided in terms of value (in USD million) for the above segments.

Hemophilia Market Size

Hemophilia Market Summary
Study Period 2019 - 2029
Base Year For Estimation 2023
Forecast Data Period 2024 - 2029
CAGR 5.70 %
Fastest Growing Market Asia Pacific
Largest Market North America

Major Players

Hemophilia Market Major Players

*Disclaimer: Major Players sorted in no particular order

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Hemophilia Market Analysis

The hemophilia market is expected to register a CAGR of 5.7% during the forecast period.

The outbreak of COVID-19 adversely impacted individuals with chronic medical conditions, such as hemophilia. They had to take extra precautions to minimize the risk of contracting COVID-19, as this population group was more prone to infectious diseases. In addition, according to the study published in the Journal of Dental and Medical Sciences in August 2020, the mean annualized bleed rate before the lockdown was 2.4. In contrast, it significantly increased to 8.2 during the lockdown in children who were on regular prophylaxis earlier. Among various reasons cited by them for not attending a Hemophilia treatment center, the important reasons were non-availability of transport (97.5%), fear of coronavirus infection (95%), and high cost of alternate transport (90%). It slowed down the market growth during the pandemic. However, since the pandemic restriction was eased and the rise in availability of advanced therapies for hemophilia, the studied market is likely to grow notably in the coming years.

Certain factors driving the market growth include the growing prevalence of hemophilia, favorable government initiatives, and rising research and development. For instance, according to the World Federation of Hemophilia Global Report 2021, there were 386,966 people with bleeding disorders identified globally, of which 233,577 cases were hemophilia. Such a huge prevalence of hemophilia globally will likely lead to increased adoption of therapies for hemophilia, driving market growth.

Additionally, an increase in grants for research on hemophilia is expected to contribute to the market studied over the forecast period. For instance, in March 2022, a researcher from the Indiana University School of Medicine received USD 2 million from the National Heart Lung and Blood Institute. It is for developing three major themes in a gene therapy approach that could lead to safer and potentially curative treatments for hemophilia. It will lead to the development of novel therapies for hemophilia, thereby expected to drive market growth over the forecast period. Moreover, rising product approvals for the United States Food and Drug Administration are expected to propel the market growth. For instance, in March 2022, Freeline Therapeutics Holdings plc dosed the first patient in its Phase 1/2 B-LIEVE dose-confirmation clinical trial of FLT180a for treating hemophilia B. It is a debilitating genetic bleeding disorder caused by a clotting factor IX protein deficiency.

Thus, due to the rise in hemophilia cases and the increase in product launches coupled with research and development for hemophilia therapies, the studied market is expected to witness significant market growth over the forecast period. However, the high cost of hemophilia treatment and the need for more awareness among people regarding advanced technologies is expected to hinder the studied market.

Hemophilia Market Trends

Hemophilia A is Expected to Hold Significant Market Share in the Disease Type Segment

Hemophilia A is the most common severe bleeding disorder. Replacement therapy, providing the missing coagulation factor, was the mainstay of treatment both prophylactically and to treat bleeding. Hemophilia A is expected to hold a significant market share over the forecast period owing to factors such as an increase in the prevalence of hemophilia A cases, a rise in awareness programs, and a surge in different therapies for hemophilia A. For instance, according to the World Federation of Hemophilia Report on the Annual Global Survey 2021, 233,577 people were living with hemophilia in 2021 globally, out of which 185,318 cases were hemophilia A.

Furthermore, product approval, clearance, and launches will likely increase market opportunities over the forecast period. For instance, in August 2022, the European Commission (EC) granted conditional marketing authorization to valoctocogene roxaparvovec gene therapy under ROCTAVIAN. BioMarin includes multiple clinical studies underway in its comprehensive gene therapy program for treating severe hemophilia A. Similarly, in June 2022, the FDA granted Breakthrough Therapy designation to efanesoctocog alfa (BIVV001) for treating people with hemophilia A. It is a rare, life-threatening bleeding disorder based on pivotal XTEND-1 Phase 3 study data. Sanofi and Sobi collaborated on the development and commercialization of efanesoctocog alfa.

Moreover, research and development to advance the treatment for hemophilia A are widely carried out, which is expected to fuel the market growth over the forecast period. For instance, as per the article published in September 2022 in PubMed, various key players are working on an in vivo genome-editing program based on CRISPR/Cas9. This technique uses non-homologous end-joining to prevent the loss of the AAV vector due to hepatocyte growth. It is to enable the permanent chromosomal integration of a modified human B-domain-deleted FVIII at the albumin locus in liver cells. Young individuals with hemophilia A who are currently ineligible for traditional gene therapy may benefit greatly from such a method.

Therefore, due to the increase in hemophilia A cases and the rise in different pipeline studies and product approvals for hemophilia A, the studied segment is expected to include significant market growth over the forecast period.

Hemophilia Market: Number of Patients Identified with Hemophilia (in Thousand), By Type, Global, 2021

North America Expected to Hold Significant Share in the Market and Expected to do Same Over the Forecast Period

North America is expected to hold a significant share of the market. It is expected to do the same over the forecast period due to factors such as the rise in hemophilia cases, increasing awareness about technologically advanced products, and favorable regional government initiatives. For instance, according to the CDC update in August 2022, about 33,000 people in the US contain hemophilia. Hemophilia typically affects men and people assigned male at birth (AMAB). As per the same source, the estimated prevalence of hemophilia in the United States is 12 cases per 100,000 US males for hemophilia A and 3.7 cases per 100,000 US males for hemophilia B.

Furthermore, according to the study published in Frontiers in Immunology in April 2021, in the United States, patients with hereditary disorders, such as hemophilia B, benefited from Adeno-associated virus (AAV)-mediated gene transfer by attaining long-term expression of the therapeutic transgene. Such studies further bolster gene therapies for hemophilia, thereby driving market growth. Moreover, rising initiatives from key market players are also expected to drive market growth in this region. For instance, in February 2022, BioMarin Pharmaceutical Inc. presented positive results from a two-year Phase 3 GENEr8-1 study analysis and an overall safety update of valoctocogene roxaparvovec. It is an investigational gene therapy for treating adults with severe hemophilia A at the 15th Annual Virtual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD).

Additionally, approvals and clearances for hemophilia-related products and therapies are expected to bolster market growth over the forecast period. For instance, in October 2022, Novo Nordisk received Health Canada approval for a new indication for REBINYN (Coagulation Factor IX (Recombinant), pegylated) for the treatment of routine prophylaxis in hemophilia B patients that are <18 years of age. REBINYN is now indicated in all ages with hemophilia B (congenital factor IX deficiency or Christmas disease) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes and control and prevent bleeding in a perioperative setting.

Thus, North America is expected to include a significant market share over the forecast period due to the increase in hemophilia cases and the rise in different therapies for hemophilia coupled with research and development.

Hemophilia Market - Growth Rate by Region

Hemophilia Industry Overview

The hemophilia market is moderately competitive and consists of a few major players. The key players are also involved in various strategic alliances such as acquisitions, collaborations, and launching advanced products and research studies to secure their position in the global market. Some of the key market players in this market include Bayer AG, BioMarin, CSL Limited (CSL Behring), Novo Nordisk, Pfizer, Inc., Sanofi (Genzyme Corporation), Takeda Pharmaceutical Company Limited (Shire Plc.), among others.

Hemophilia Market Leaders

  1. Pfizer, Inc.

  2. Bayer AG

  3. Novo Nordisk A/S

  4. CSL Limited (CSL Behring)

  5. BioMarin

*Disclaimer: Major Players sorted in no particular order

Hemophilia Market Concentration
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Hemophilia Market News

  • February 2023: The US Food and Drug Administration (FDA) approved ALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl]. It is previously referred to as efanesoctocog alfa, a first-in-class, high-sustained factor VIII replacement therapy. ALTUVIIIO is the first and only hemophilia A treatment that delivers normal to near-normal factor activity levels (over 40%) for most of the week with once-weekly dosing, significantly reducing bleeds compared to prior factor VIII prophylaxis.
  • January 2023: BioMarin Pharmaceutical Inc., a global biotechnology company dedicated to transforming lives through genetic discovery, publicized positive results from more than three years of follow-up from its ongoing global Phase 3 GENEr8-1 study of ROCTAVIANTM (valoctocogene roxaparvovec). It is an investigational one-time gene therapy for treating adults with severe hemophilia A. It is the largest and longest global Phase 3 study for any gene therapy in hemophilia, with 134 participants.

Hemophilia Market Report - Table of Contents

1. INTRODUCTION

  • 1.1 Study Assumptions and Market Definition
  • 1.2 Scope of the Study

2. RESEARCH METHODOLOGY

3. EXECUTIVE SUMMARY

4. MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Growing Prevalence of Hemophilia
    • 4.2.2 Favorable Government Initiatives
    • 4.2.3 Rising R&D and New Product Development
  • 4.3 Market Restraints
    • 4.3.1 High Cost of Treatment
    • 4.3.2 Lack of Awareness Regarding Advanced Technologies
  • 4.4 Porter's Five Forces Analysis
    • 4.4.1 Bargaining Power of Suppliers
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Threat of New Entrants
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5. MARKET SEGMENTATION (Market Size by Value - USD)

  • 5.1 By Disease Type
    • 5.1.1 Hemophilia A
    • 5.1.2 Hemophilia B
    • 5.1.3 Others
  • 5.2 By Therapy
    • 5.2.1 Replacement Therapy
    • 5.2.2 Gene Therapy
    • 5.2.3 Others
  • 5.3 By Product Type
    • 5.3.1 Recombinant Coagulation Factor Concentrates
    • 5.3.2 Plasma-derived Coagulation Factor Concentrates
    • 5.3.3 Others
  • 5.4 Geography
    • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
    • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
    • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
    • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6. COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 Bayer AG
    • 6.1.2 BioMarin
    • 6.1.3 CSL Limited (CSL Behring)
    • 6.1.4 Kedrion S.p.A
    • 6.1.5 Novo Nordisk A/S
    • 6.1.6 Pfizer, Inc.
    • 6.1.7 F. Hoffmann-La Roche AG (Chugai Pharmaceutical Co.)
    • 6.1.8 Sanofi (Genzyme Corporation)
    • 6.1.9 Takeda Pharmaceutical Company Limited (Shire Plc.)
    • 6.1.10 Grifols, S.A
    • 6.1.11 Medexus Pharmaceuticals, Inc.
    • 6.1.12 Octapharma AG
  • *List Not Exhaustive

7. MARKET OPPORTUNITIES AND FUTURE TRENDS

** Subject To Availablity
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**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments
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Hemophilia Industry Segmentation

As per the scope of the report, hemophilia is a genetic bleeding disorder that prevents the blood from clotting normally due to a lack of enough blood-clotting proteins (clotting factors). People with hemophilia contain low levels of either factor VIII (8) or factor IX (9). The primary symptom is uncontrolled, often spontaneous bleeding in different body areas. The amount of bleeding depends on the severity of hemophilia. The Hemophilia Market is segmented by disease type (Hemophilia A, Hemophilia B, and others), therapy (replacement therapy, gene therapy, and others), product type (recombinant coagulation factor concentrates, plasma-derived coagulation factor concentrates, and others), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD) for the above segments.

By Disease Type Hemophilia A
Hemophilia B
Others
By Therapy Replacement Therapy
Gene Therapy
Others
By Product Type Recombinant Coagulation Factor Concentrates
Plasma-derived Coagulation Factor Concentrates
Others
Geography North America United States
Canada
Mexico
Geography Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Geography Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Geography Middle East and Africa GCC
South Africa
Rest of Middle East and Africa
Geography South America Brazil
Argentina
Rest of South America
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Hemophilia Market Research FAQs

The Global Hemophilia Market is projected to register a CAGR of 5.70% during the forecast period (2024-2029)

Pfizer, Inc., Bayer AG, Novo Nordisk A/S, CSL Limited (CSL Behring) and BioMarin are the major companies operating in the Global Hemophilia Market.

Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).

In 2024, the North America accounts for the largest market share in Global Hemophilia Market.

The report covers the Global Hemophilia Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Global Hemophilia Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.

The key factors driving the growth of the home-based Hemophilia Treatment Market are a) Advancements in self-administration technologies b) Patient preference for home care c) Impact on treatment adherence

Hemophilia Industry Report

The hemophilia industry is experiencing significant growth, driven by the increasing prevalence of the disorder and heightened awareness of genetic abnormalities. Advances in gene and replacement therapy are introducing innovative treatments, promising better management and potential cures. The industry benefits from robust investments in R&D, leading to novel therapies for hemophilia A and B patients. Supportive government initiatives and specialized treatment centers are enhancing care access and patient outcomes, with the prophylaxis treatment segment leading the market. This shift towards proactive management, coupled with a focus on improving patients' quality of life and reducing treatment frequency, characterizes the industry's evolution. The sector is buoyed by a strong pipeline of gene therapy products and an emphasis on early detection and treatment, signaling a new era of care. According to Mordor Intelligenceā„¢ Industry Reports, the market is poised for continued expansion and innovation, with detailed statistics on market share, size, and revenue growth rates available in a free report PDF download, offering a comprehensive forecast outlook and historical overview of the hemophilia market.

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Hemophilia Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)