Hemophilia Market Size
| Study Period | 2019 - 2029 |
| Market Size (2024) | USD 13.66 Billion |
| Market Size (2028) | USD 17.86 Billion |
| CAGR (2024 - 2029) | 5.50 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Hemophilia Market Analysis
The Hemophilia Market size is estimated at USD 13.66 billion in 2024, and is expected to reach USD 17.86 billion by 2028, growing at a CAGR of 5.5% during the forecast period (2024-2028).
Certain factors driving the market’s 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 2022, around 18,580 people were diagnosed with hemophilia in the United States in 2022. Hemophilia is a genetic blood disorder that damages the normal functionality of blood clotting and coagulation. Around 386,966 people with bleeding disorders were identified globally, of which 233,577 cases were hemophilia. Such a huge prevalence of hemophilia globally is expected to lead to increased adoption of therapies, driving market growth.
Additionally, an increase in grants for research on hemophilia is expected to contribute to market growth 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 to develop three major themes in a gene therapy approach that could lead to safer and potentially curative treatments for hemophilia. Such grants may lead to the development of novel therapies for hemophilia, thereby driving market growth over the forecast period.
Similarly, in 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 global Phase 3 GENEr8-1 study of ROCTAVIANTM (valoctocogene roxaparvovec). It was an investigational one-time gene therapy for treating adults with severe hemophilia A. It was the largest and longest global Phase 3 study for any gene therapy in hemophilia, with 134 participants.
Moreover, rising product approvals from the US Food and Drug Administration are expected to propel 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 market studied is expected to witness significant growth during the forecast period. However, the high cost of hemophilia treatment and the need for more awareness among people regarding advanced technologies are expected to hinder market growth.
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, as per the data published in June 2024 by the Hemophilia Foundation Australia, hemophilia occurs in one in 6,000 to 10,000 males internationally. Approximately one in 6,000 males have hemophilia A. A total of 208,997 people worldwide were affected by hemophilia A. Thus, the high burden of hemophilia A is expected to contribute to the growth of the segment over the forecast period.
Furthermore, product approvals, clearances, and launches are expected to increase market opportunities during 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 market growth over the forecast period. For instance, as per the article published in September 2022 in PubMed, various key players worked on an in vivo genome-editing program based on CRISPR/Cas9. This technique used non-homologous end-joining to prevent the loss of the AAV vector due to hepatocyte growth. It was 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 were ineligible for traditional gene therapy benefitted 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 segment is expected to witness significant growth over the forecast period.
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 United States were diagnosed with 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.
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 was an investigational gene therapy for treating adults with severe hemophilia A demonstrated 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’s approval for a new indication for REBINYN (Coagulation Factor IX [recombinant], pegylated) for the treatment of routine prophylaxis in hemophilia B patients aged less than 18 years. 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 register 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 Industry Overview
The hemophilia market is semi consolidated in nature 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), and Takeda Pharmaceutical Company Limited (Shire PLC).
Hemophilia Market Leaders
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Pfizer, Inc.
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Bayer AG
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Novo Nordisk A/S
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CSL Limited (CSL Behring)
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BioMarin
*Disclaimer: Major Players sorted in no particular order
Hemophilia Market News
- April 2024: The Food and Drug Administration approved Pfizer's Beqvez, a novel gene therapy designed for individuals with the less common "B" form of hemophilia.
- February 2023: The US Food and Drug Administration approved ALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl]. It was 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.
Hemophilia Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumption 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 Other Disease Types
5.2 By Therapy
5.2.1 Replacement Therapy
5.2.2 Gene Therapy
5.2.3 Other Therapies
5.3 By Product Type
5.3.1 Recombinant Coagulation Factor Concentrates
5.3.2 Plasma-derived Coagulation Factor Concentrates
5.3.3 Other Product Types
5.4 By 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 SpA
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 SA
6.1.11 Medexus Pharmaceuticals Inc.
6.1.12 Octapharma AG
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
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, therapy, product type, and geography. By disease type, the market is segmented as hemophilia A, hemophilia B, and other disease types. By therapy, the market is segmented as replacement therapy, gene therapy, and other therapies. By product type, the market is segmented as recombinant coagulation factor concentrates, plasma-derived coagulation factor concentrates, and other product types. By geography, the market is segmented as 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 and offers the value (USD) for the above segments.
| By Disease Type | |
| Hemophilia A | |
| Hemophilia B | |
| Other Disease Types |
| By Therapy | |
| Replacement Therapy | |
| Gene Therapy | |
| Other Therapies |
| By Product Type | |
| Recombinant Coagulation Factor Concentrates | |
| Plasma-derived Coagulation Factor Concentrates | |
| Other Product Types |
| By Geography | ||||||||
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Hemophilia Market Research FAQs
How big is the Hemophilia Market?
The Hemophilia Market size is expected to reach USD 13.66 billion in 2024 and grow at a CAGR of 5.5% to reach USD 17.86 billion by 2028.
What is the current Hemophilia Market size?
In 2024, the Hemophilia Market size is expected to reach USD 13.66 billion.
Who are the key players in Hemophilia Market?
Pfizer, Inc., Bayer AG, Novo Nordisk A/S, CSL Limited (CSL Behring) and BioMarin are the major companies operating in the Hemophilia Market.
Which is the fastest growing region in Hemophilia Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Hemophilia Market?
In 2024, the North America accounts for the largest market share in Hemophilia Market.
What years does this Hemophilia Market cover, and what was the market size in 2023?
In 2023, the Hemophilia Market size was estimated at USD 12.91 billion. The report covers the Hemophilia Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Hemophilia Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
What are the key factors driving the growth of the home-based Hemophilia Treatment Market?
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 Intelligence™ 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.
