Myelofibrosis Market

Market Overview:

The 7 major myelofibrosis markets reached a value of USD 1,619 Billion in 2024. Looking forward, IMARC Group expects the 7MM to reach USD 2,508 Billion by 2035, exhibiting a growth rate (CAGR) of 4.06% during 2025-2035.

The myelofibrosis market has been comprehensively analyzed in IMARC's new report titled "Myelofibrosis Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2025-2035". Myelofibrosis (MF) is a rare, chronic blood cancer defined by overproduction of fibrosis in the bone marrow resulting in compromised production of blood cells. The disease falls under the category of myeloproliferative neoplasms (MPNs) and can occur de novo (primary myelofibrosis) or evolve out of polycythemia vera or essential thrombocythemia. Myelofibrosis is essentially caused by JAK2, CALR, and MPL gene mutations, which result in aberrant JAK-STAT signaling, out-of-control cell growth, and fibrosis. Early myelofibrosis can be asymptomatic, but with progression of the disease, patients typically present with anemia, splenomegaly, pain in the bones, night sweats, fever, loss of weight, and severe weakness. The diagnosis of myelofibrosis usually includes a combination of blood examinations, bone marrow biopsy, molecular analysis for driver mutations, and imaging methods like ultrasound or MRI to measure spleen size. The Dynamic International Prognostic Scoring System (DIPSS) is often employed to risk-stratify patients and direct treatment.

The increasing incidence of myeloproliferative neoplasms, complemented by an expanding knowledge of the molecular pathogenesis of myelofibrosis, is fueling market growth. Moreover, growing uptake of targeted therapies, including JAK inhibitors like ruxolitinib and fedratinib, is transforming the therapeutic landscape. Beyond JAK inhibitors, promising therapies, including BET inhibitors, telomerase inhibitors, and novel combination regimens, are emerging, further catalyzing market growth. Additionally, improvements in allogeneic stem cell transplantation (allo-SCT) methods, the sole potentially curative treatment for high-risk patients, are serving as another significant market driver. Additionally, the growing clinical pipeline, with therapies for anemia, bone marrow fibrosis, and disease progression, is solidifying the market scenario. Also, supportive regulatory policies and reimbursement structures are improving patient access to approved and investigational therapies, further driving market growth.

IMARC Group's new report provides an exhaustive analysis of the myelofibrosis market in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report the EU5 has the largest patient pool for myelofibrosis and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario and unmet medical needs, etc. have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the myelofibrosis market in any manner.

Recent Developments:

• In December 2024, updated results from the phase 2 RESTORE trial (NCT05037760) were presented at ASH 2024, highlighting elritercept’s potential in myelofibrosis (MF). The activin receptor type IIA-Fc fusion protein improved hemoglobin levels, reduced transfusion burden, and stabilized platelet counts, addressing anemia associated with JAK inhibitors.
• In February 2024, the NHS in England approved momelotinib (Ojjaara) for myelofibrosis patients with intermediate-2 or high-risk disease, enlarged spleen, or moderate to severe anemia. It offers an alternative to ruxolitinib, benefiting both treatment-naïve and previously treated patients. Approval is based on the SIMPLIFY trials' evidence.
• In July 2023, the FDA granted fast-track designation to selinexor for myelofibrosis, including primary, post-essential thrombocythemia, and post-polycythemia vera types. Selinexor is being evaluated with ruxolitinib in the Phase 3 SENTRY study and as monotherapy in the Phase 2 SENTRY-2 trial (NCT05980806) for JAK inhibitor–naive patients.

Key Highlights:

• Myelofibrosis is an uncommon bone marrow cancer that disrupts the body's normal production of blood cells.
• The condition is often associated with mutations in the JAK2, CALR, or MPL genes, leading to abnormal blood cell proliferation and bone marrow fibrosis.
• In the United States, myelofibrosis is diagnosed in approximately 1 to 3 out of 100,000 people annually.
• The disease is most commonly diagnosed in individuals aged 50 to 80 but can occur at any age.
• About 8% to 30% of individuals with myelofibrosis may eventually develop acute myeloid leukemia, a severe form of bone marrow cancer.

Drugs:

Jakafi (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the FDA in 2011 for myelofibrosis. It disrupts the JAK-STAT pathway, reducing abnormal blood cell proliferation and thrombotic risks. By targeting dysregulated cytokine signaling, Jakafi helps manage symptoms and improve outcomes in patients with myelofibrosis, a myeloproliferative neoplasm characterized by bone marrow fibrosis.

Inrebic (fedratinib) is a tyrosine kinase inhibitor approved by the FDA on August 16, 2019, for treating intermediate-2 and high-risk primary and secondary myelofibrosis. An anilinopyrimidine derivative, Inrebic targets dysregulated signaling pathways to reduce disease symptoms and improve patient outcomes in myelofibrosis management.

Vonjo (pacritinib) is a JAK2 and FLT3 inhibitor approved by the FDA in February 2022 for myelofibrosis (MF) patients with severe thrombocytopenia (platelet counts < 50 x 10⁹/L). It addresses hematopoietic abnormalities and splenomegaly, offering a critical option for high-risk MF patients with limited treatment alternatives.

Ojjaara (momelotinib) is a JAK1/JAK2 inhibitor approved by the FDA on September 15, 2023, for myelofibrosis. It targets abnormal hematopoietic stem cell proliferation by blocking the JAK-STAT pathway, reducing cytokine release. Ojjaara addresses key MF manifestations, including anemia and thrombocytosis, benefiting patients with primary, post-PV, and post-ET myelofibrosis.

Time Period of the Study

•  Base Year: 2024
•  Historical Period: 2019-2024
•  Market Forecast: 2025-2035

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan

Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the myelofibrosis market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the myelofibrosis market
• Reimbursement scenario in the market
• In-market and pipeline drugs

Competitive Landscape:

This report also provides a detailed analysis of the current myelofibrosis marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report

Key Questions Answered in this Report:

Market Insights

• How has the myelofibrosis market performed so far and how will it perform in the coming years?
• What are the markets shares of various therapeutic segments in 2024 and how are they expected to perform till 2035?
• What was the country-wise size of the myelofibrosis market across the seven major markets in 2024 and what will it look like in 2035?
• What is the growth rate of the myelofibrosis market across the seven major markets and what will be the expected growth over the next ten years?
• What are the key unmet needs in the market?
   

Epidemiology Insights

• What is the number of prevalent cases (2019-2035) of myelofibrosis across the seven major markets?
• What is the number of prevalent cases (2019-2035) of myelofibrosis by age across the seven major markets?
• What is the number of prevalent cases (2019-2035) of myelofibrosis by gender across the seven major markets?
• How many patients are diagnosed (2019-2035) with myelofibrosis across the seven major markets?
• What is the size of the myelofibrosis patient pool (2019-2024) across the seven major markets?
• What would be the forecasted patient pool (2025-2035) across the seven major markets?
• What are the key factors driving the epidemiological trend of myelofibrosis?
• What will be the growth rate of patients across the seven major markets?
   

Myelofibrosis: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

• What are the current marketed drugs and what are their market performance?
• What are the key pipeline drugs and how are they expected to perform in the coming years?
• How safe are the current marketed drugs and what are their efficacies?
• How safe are the late-stage pipeline drugs and what are their efficacies?
• What are the current treatment guidelines for myelofibrosis drugs across the seven major markets?
• Who are the key companies in the market and what are their market shares?
• What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the myelofibrosis market?
• What are the key regulatory events related to the myelofibrosis market?
• What is the structure of clinical trial landscape by status related to the myelofibrosis market?
• What is the structure of clinical trial landscape by phase related to the myelofibrosis market?
• What is the structure of clinical trial landscape by route of administration related to the myelofibrosis market?