Hemophilia Treatment Market Size, Share, and Trends 2024 to 2033

Hemophilia Treatment Market Size and Growth

The global hemophilia treatment market size was USD 16.40 billion in 2023, calculated at USD 18.42 billion in 2024 and is expected to reach around USD 52.36 billion by 2033. The market is expanding at a solid CAGR of 12.31% over the forecast period 2024 to 2033. The growth of the hemophilia treatment market share is driven by an increase in the prevalence of hemophilia.

Hemophilia Treatment Market Key Takeaways

• The North America hemophilia treatment market size reached USD 7.38 billion in 2023 and is expected to attain around USD 23.82 billion by 2033, poised to grow at a CAGR of 12.43% between 2024 and 2033.
• North America registered the largest revenue share of the hemophilia treatment market in 2023.
• Europe is considered the fastest-growing market in the forecasted years.
• By region, Asia Pacific is expected to witness notable growth in the market in the forecasted years.
• By type, the hemophilia A segment dominated the market in 2023 and is expected to grow further over the forecast period.
• By drug therapy, in 2023, the recombinant coagulation factor segment dominated the market.
• By drug therapy, the non-factor replacement therapy segment is expected to grow at the fastest rate in the market over the forecast period.

U.S. Hemophilia Treatment Market Size and Growth 2024 to 2033

The U.S. hemophilia treatment market size was exhibited at USD 5.54 billion in 2023 and is projected to be worth around USD 17.19 billion by 2033, poised to grow at a CAGR of 12.49% from 2024 to 2033.

North America registered the largest revenue share of the hemophilia treatment market in 2023. This dominance is fueled by the rising prevalence of blood-related disorders as a result of changing lifestyles and environmental stressors, among many other factors. This has stimulated the governments to conduct awareness campaigns and support plans regarding the treatment of conditions such as hemophilia. The resultant rise in R&D studies for treatment options is further supported by growing investments in the development of widely accepted prophylactic treatments and novel drug delivery systems.

Europe is considered the fastest-growing hemophilia treatment market in the forecasted years. This growth is attributed to the surge in research activities for hemophilia treatment in Europe, driven by recent technological advancements, increased demand for early diagnosis due to rising disease awareness, and established medical facilities.  Within Europe, Germany holds the largest share of the market, while the UK is expected to grow at the fastest rate. The government's initiatives in these countries contribute to the hemophilia treatment market expansion further.

• In February 2023, the European Commission granted conditional marketing authorization for etranacogene dezaparvovec (Hemgenix), the first and only one-time gene therapy for the treatment of severe and moderately severe hemophilia B (congenital factor IX deficiency) in adults without a history of factor IX inhibitors.

Asia Pacific is expected to witness notable growth in the hemophilia treatment market in the forecasted years. The region has seen significant advancements in healthcare infrastructure, improved accessibility to healthcare services, and increased awareness about hemophilia. Additionally, the growing population and improving economic conditions in countries like China and India are driving market expansion in the Asia Pacific. Government initiatives to improve healthcare facilities and increase healthcare expenditure further boost the growth of the hemophilia treatment market in this region.

Increasing gene therapy research and favorable government support driving market growth in China. With a rapidly growing population, rising prevalence of hemophilia, and supportive government initiatives, the hemophilia treatment market in China is set to expand smoothly during the forecast period. Also, advancements in genetic research, new product launches and approvals, increased health awareness, and a surge in diagnostic screenings are expected to boost the demand for hemophilia treatment in China.

• In January 2024, the first patient was dosed in China in a registrational clinical trial of BBM-H803, a one-time investigational gene therapy that Belief BioMed is developing to prevent bleeding in hemophilia A. The Phase 1/2/3 clinical trial is testing how safe and well-tolerated BBM-H803 is as a single into-the-vein (intravenous) infusion for adults with severe hemophilia A.

Market Overview

Hemophilia is a group of bleeding disorders characterized by prolonged blood clotting. It primarily includes hemophilia A and hemophilia B, caused by the deficiency of clotting factor VIII or IX, respectively. Hemophilia is usually inherited and predominantly affects male children.

The main symptom is bleeding, with mild cases often going undetected until excessive bleeding occurs after surgery or injury. Severe cases may experience spontaneous bleeding, including internal bleeding and joint hemorrhages. Diagnosis typically follows an abnormal bleeding episode or can be confirmed through a blood test if there is a family history. Treatment involves replacing the missing clotting factor via intravenous infusions. Special precautions are necessary during surgery for individuals with this disorder.

Hemophilia Treatment Market Growth Factors

• The rise in R&D studies regarding treatment therapies is expected to drive the growth of the hemophilia treatment market.
• A rise in prophylactic treatment for hemophilia can fuel the hemophilia treatment market growth soon.
• The government's initiatives to conduct awareness campaigns and support plans regarding the treatment of hemophilia can contribute to the hemophilia treatment market expansion further.
• Increasing the utilization of injectable drug delivery will likely help in the hemophilia treatment market expansion.

Hemophilia Treatment Market Scope

Hemophilia Treatment Market Dynamics

Driver

The rising case of bleeding disorders

The increasing prevalence of hemophilia is anticipated to drive demand for treatments in the forecast period. The diversity of available therapies and medications also contributes to market expansion. Additionally, emerging economies like India have a growing need for effective therapies to treat Factor VIII deficiency, which can further boost the market growth. Common treatments include antifibrinolytic drugs, gene therapy, inhibitor therapy, home remedies, free factor replacement therapy, and physical therapy. These factors have a substantial positive impact on the hemophilia treatment market's growth.

• In October 2023, Sanofi took a deep dive into the lives of hemophilia patients, caregivers, and providers. Working with The Harris Poll, the French drugmaker surveyed 2,700 people in 11 countries to understand how the rare bleeding disorder affects people and identify opportunities to address unmet needs.

Restraint

Challenging approval and regulation processes for hemophilia treatments

The approval and regulation processes in the hemophilia treatment market can be challenging and time-consuming. Companies developing new therapies may encounter difficulties due to stringent rules and requirements for clinical trials, manufacturing, and quality control. This can limit the availability of advanced treatment options. Complications from hemophilia can include joint damage, chronic pain, and bleeding into vital organs. Managing these issues and potential comorbidities, given the chronic nature of the disease, presents additional challenges.

Opportunity

Development of safe and effective gene therapy solutions

Overcoming the challenges in the hemophilia treatment market would quickly establish this new treatment option. Developing gene therapies for hemophilia A and B presents different challenges, with hemophilia A being more difficult to address. Therefore, biotech companies have primarily focused on hemophilia B, while larger pharmaceutical companies have targeted the more extensive hemophilia A market.

Recently, molecular genetic information has been successfully utilized to deliver human hemophilia gene therapy. Several hemophilia gene therapies are set to enter late-stage clinical trials soon. The promising prospects of personalized medicine are expected to greatly contribute to the hemophilia treatment market's growth.

• In June 2023, BioMarin’s Roctavian finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder. The FDA has cleared Roctavian as a one-time therapy for adults with severe hemophilia A. It’s also setting up an outcomes-based warranty program.

Type Insights

The hemophilia A segment dominated the hemophilia treatment market in 2023 and is expected to grow further over the forecast period. Hemophilia A, also known as classic hemophilia, is the most prevalent form of the disorder, caused by a deficiency of factor VIII, a protein essential for blood clotting. Increased diagnostic rates and growing awareness of hemophilia A treatments are expected to drive segment growth during the forecast period. As the most common type of hemophilia, it accounts for most cases worldwide, resulting in the Hemophilia A segment holding a significant market share due to the larger patient population requiring treatment.

• In April 2024, Avenacy launches generic DDAVP for bleeding in mild hemophilia A. Single-dose vials are to be administered by injection. A generic version of DDAVP (desmopressin acetate), a therapy approved to control bleeding episodes in people with mild hemophilia A, is available in the U.S.

Drug Therapy Insights

The recombinant coagulation factor segment dominated the hemophilia treatment market in 2023. The growth in recombinant technology products available for treatment has contributed significantly. Recombinant coagulation factors, which are plasma derivatives, are used to treat infections caused by viruses like hepatitis C and HIV. Additionally, recombinant factors have a low risk of transmitting infectious agents.

• In February 2023, Efanesoctocog alfa, Sobi, and Sanofi’s first-in-class, long-lasting recombinant or man-made factor VIII (FVIII) replacement therapy was approved by the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia A. It will be marketed under the brand name Altuviiio.

The non-factor replacement therapy segment is expected to grow at the fastest rate in the hemophilia treatment market over the forecast period. This is due to the increase in the target population and the rise in research and development (R&D) activities for treatment therapies are key drivers. Moreover, in hemophilia, a crucial clotting factor is missing, disrupting the hemostatic balance and leading to excessive bleeding. Non-factor replacement products aim to prevent bleeds by enhancing hemostatic potential (the likelihood of blood clotting if a blood vessel is injured) rather than by increasing factor levels.

Hemophilia Treatment Market Companies

• Pfizer Inc. (U.S.)
• Novo Nordisk A/S (Denmark)
• F. Hoffmann-La Roche Ltd (Switzerland)
• Bayer AG (Germany)
• Shire (Ireland)
• CSL Behring (Australia)
• Grifols, S.A. (Spain)
• Biogen Inc. (U.S.)
• Sanofi S.A. (France)
• BioMarin Pharmaceutical Inc. (U.S.)
• Takeda Pharmaceutical Company Limited (Japan)
• Octapharma AG (Switzerland)
• Sobi (Sweden)
• Pfizer Inc. (U.S.)

Recent Developments

• In November 2023, Japan approved a new Novo Nordisk hemophilia drug that will launch in 2024. Novo Nordisk itself has identified the candidate as a potential blockbuster.
• In March 2022, in its Phase 1/2 B-LIEVE dose-confirmation clinical trial of FLT180a for the treatment of hemophilia B, a crippling genetic bleeding illness brought on by a lack in the clotting factor IX protein, Freeline Therapeutics Holdings plc dosed the first patient.
• In February 2022, at the 15th Annual Virtual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), BioMarin Pharmaceutical Inc. presented encouraging findings from a two-year analysis of the Phase 3 GENEr8-1 study and an overall safety update of valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A.

Segments Covered in the Report

By Type

• Hemophilia A
• Hemophilia B

By Drug Therapy

• Recombinant Coagulation Factor Concentrates Therapy
• Plasma-derived Coagulation Factor Concentrates Therapy
• Non-factor Replacement Therapy
• Others

By Geography

• North America
• Asia Pacific
• Europe
• Latin America
• Middle East & Africa