DelveInsight’s “Myelofibrosis Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of the Myelofibrosis, historical and forecasted epidemiology and the FSGS market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
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Key Takeaways from the Myelofibrosis Market Report
- The total myelofibrosis prevalence in the 7MM were nearly ~55,900 in 2024 and is projected to increase during the study period (2020–2034).
- Among the EU4 and the UK, Germany accounted for the highest number of myelofibrosis diagnosed prevalent cases, followed by the Spain, whereas the UK accounted for the lowest number of cases in 2024.
- Based on risk, myelofibrosis cases are stratified as low risk, intermediate-1 risk, intermediate-2, and high risk. The high-risk accounted for the highest number of patients in 2024 in the US.
- Myelofibrosis can be further categorized into primary myelofibrosis and secondary myelofibrosis. In 2024, primary myelofibrosis accounted for ~75% of all cases in the US.
- In the US, based on age, myelofibrosis cases are stratified in the age group =49 years, 40-69 years, and =70 years. =70 years of age group accounted for the highest number of patients i.e. nearly ~12,100 in 2024 in the US.
- In the US, the cases of JAK2 mutations account for approximately ~60% in 2024
- The leading Myelofibrosis Companies such as PharmaEssentia, AOP Orphan Pharmaceuticals, Incyte, Karyopharm Therapeutics, Geron, Bristol Myers Squibb, Kartos Therapeutics, Novartis, Merck, Telios Pharma, Ryvu Therapeutics, Sumitomo Pharma, Syntara, Disc Medicine, Menarini Group, and others.
- Promising Myelofibrosis Therapies such as BESREMi (ropeginterferon alfa-2b-njft/P-1101), INCB057643, XPOVIO (NEXPOVIO/selinexor/KPT-330), RYTELO (imetelstat), REBLOZYL (luspatercept/ACE-536), Navtemadlin (KRT-232), Pelabresib (DAK539), Bomedemstat (IMG-7289/MK-3543), TL-895, RVU120 ( SEL-120), TP-3654 (nuvisertib), SNT-5505 (PXS-5505), DISC-0974, ELZONRIS (tagraxofusp/SL-401), and others
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Myelofibrosis Epidemiology Segmentation in the 7MM
- Total prevalent cases
- Type-specific cases
- Myelofibrosis cases based on risk stratification
- Age-specific cases
- Myelofibrosis cases based on molecular alterations
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Myelofibrosis Marketed Drugs
- JAKAFI/JAKAVI (ruxolitinib): Incyte/Novartis
Ruxolitinib belongs to the class of medications called kinase inhibitors. It works to treat myelofibrosis by blocking the signals that cause cancer cell proliferation, thereby inhibiting the spread of cancer cells. It works to treat GVHD by blocking the signals of the cells that cause GVHD. JAKAFI works by targeting JAKs, which control the production of blood cells. In doing so, JAKAFI helps reduce overactive JAK signaling to help keep the production of blood cells under control. It was approved by the United States Food and Drug Administration (US FDA) for the treatment of adults with intermediate or high-risk myelofibrosis in November 2011, and in August 2012, it was approved by the European Medicines Agency (EMA). In July 2014, it was approved in Japan.
- INREBIC (fedratinib): Bristol Myers Squibb
INREBIC is an oral kinase inhibitor with activity against wild-type and mutationally activated JAK2 and FMS-like tyrosine kinase 3 (FLT3). INREBIC is a JAK2-selective inhibitor with higher potency for JAK2 over family members JAK1, JAK3, and TYK2. Abnormal activation of JAK2 is associated with myeloproliferative neoplasms, including myelofibrosis and polycythemia vera. In cell models expressing mutationally active JAK2 or FLT3, INREBIC reduced phosphorylation of signal transducer and activator of transcription (STAT3/5) proteins, inhibited cell proliferation, and induced apoptotic cell death. On August 16, 2019, the US FDA approved INREBIC for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. In February 2021, the European Commission granted full marketing authorization for INREBIC.
Myelofibrosis Emerging Drugs
- XPOVIO (selinexor): Karyopharm Therapeutics
Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus. This re-initiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells while largely sparing normal cells. In May 2022, the US FDA granted selinexor Orphan Drug Designation (ODD) for the treatment of myelofibrosis, and in October 2022, the EC granted Orphan Medicinal Product Designation for selinexor for the treatment of myelofibrosis. In July 2023, Karyopharm Therapeutics received Fast Track Designation (FTD) from the US FDA for selinexor for the treatment of patients with myelofibrosis, including primary myelofibrosis, post-essential thrombocythemia myelofibrosis, and post-polycythemia vera myelofibrosis. In the January 2025 corporate presentation, Karyopharm Therapeutics announced plans to report preliminary data from the Phase II SENTRY-2 trial in myelofibrosis in the first half of 2025. In its January 2025 corporate presentation, Karyopharm Therapeutics stated that it expects to report top-line results from the Phase III SENTRY trial in the second half of 2025, which could represent a potentially transformative opportunity to establish a new treatment paradigm in Myelofibrosis
- RYTELO (imetelstat): Geron Corporation
RYTELO (imetelstat) is an investigational telomerase inhibitor that binds to telomerase and inhibits its activity, selectively killing the malignant stem and progenitor cells in the bone marrow that are the source of disease in blood cancers, such as myelodysplastic syndromes (MDS) and myelofibrosis. By inhibiting the proliferation of these malignant stem and progenitor cells, which enables the recovery of non-malignant bone marrow and blood cell production, this telomerase inhibitor has exhibited disease-modifying activity and clinical benefits for patients in Phase III clinical trials of myelofibrosis. In the corporate presentation held in January 2025, the company mentioned that the initial results from Part 2 of the IMproveMF study are expected in 2026.
- REBLOZYL (luspatercept/ACE-536): Bristol Myers Squibb
Luspatercept, an erythroid maturation agent, is a recombinant fusion protein consisting of a modified form of the extracellular domain (ECD) of the human activin receptor Type IIB (ActRIIB) linked to the human immunoglobin G1 (IgG1) Fc domain. ActRIIB receptor and its ligands are members of the transforming growth factor-ß (TGF-ß) superfamily. Members of the TGF-ß superfamily ligands bind to activin receptors and are involved in modulating the differentiation of late-stage erythrocyte precursors (normoblasts) in the bone marrow. In January 2020, the US FDA granted ODD to luspatercept for the treatment of myelofibrosis. In February 2020, the EMA granted ODD to luspatercept for the treatment of primary myelofibrosis. In the Q3 2024 presentation, the company highlighted that the anticipated data readout for Phase III (NCT04717414) in the treatment of 1L TD associated with myelofibrosis-related anemia is expected in 2025.
Myelofibrosis Market Outlook
Myelofibrosis has limited treatment options, and only a few patients received allogeneic hematopoietic cell transplantation, the only curative therapy. JAKAFI (ruxolitinib) was the sole drug approved to treat intermediate- or high-risk myelofibrosis for a long time until the approval of a second JAK inhibitor, INREBIC (fedratinib), in August 2019. Research indicates that fedratinib and ruxolitinib, have similar efficacy in myelofibrosis patients. However, their toxicity profiles differ, with fedratinib having a risk of encephalopathy, leading to a black box warning on the label. Later, in February 2022, VONJO (pacritinib) was approved for the treatment of adults with intermediate or high-risk primary or secondary myelofibrosis with a platelet count below 50 × 109/L in which no other JAK inhibitor was approved. Then in September 2023, the US FDA approved OJJAARA (momelotinib). To date, it is the only approved agent for both newly diagnosed and previously treated patients with myelofibrosis and anemia that addresses the key manifestations of the disease, namely anemia, constitutional symptoms, and splenomegaly.
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Myelofibrosis Companies
PharmaEssentia, AOP Orphan Pharmaceuticals, Incyte, Karyopharm Therapeutics, Geron, Bristol Myers Squibb, Kartos Therapeutics, Novartis, Merck, Telios Pharma, Ryvu Therapeutics, Sumitomo Pharma, Syntara, Disc Medicine, Menarini Group, and others.
Myelofibrosis Therapeutics Market
There are currently only four US FDA-approved drugs for the treatment of myelofibrosis. They are OJJAARA/OMJJARA (momelotinib), VONJO (pacritinib), INREBIC (fedratinib), and JAKAFI/JAKAVI (ruxolitinib). The only targeted treatments for MPNs at this time are JAK inhibitors, which were created in response to the identification of the JAK2 V617F mutation as the most frequent recurrent mutation in MPNs. JAK inhibitors have emerged as the centerpiece of pharmacologic therapy for patients with myelofibrosis, providing unprecedented benefits in terms of spleen shrinkage, symptom improvement, and quality of life that can enhance longevity in patients with advanced disease. However, JAK inhibitor therapy is linked with certain complications. Ruxolitinib-related anemia and thrombocytopenia that are dose-dependent in some patients may result in cessation. Anemia and thrombocytopenia can be reduced with dosing techniques, although this could lead to less-than-ideal clinical results. Coming therapies are focusing on different mechanisms other than JAK inhibitors, such as imetelstat (telomerase inhibitor), navtemadlin (MDM2 protein inhibitor), pelabresib (BET inhibitor), and others which may cover the patient need and provide an alternative treatment for the patients.
Scope of the Myelofibrosis Market Report
- Coverage- 7MM
- Study Period- 2020-2034
- Myelofibrosis Companies- PharmaEssentia, AOP Orphan Pharmaceuticals, Incyte, Karyopharm Therapeutics, Geron, Bristol Myers Squibb, Kartos Therapeutics, Novartis, Merck, Telios Pharma, Ryvu Therapeutics, Sumitomo Pharma, Syntara, Disc Medicine, Menarini Group, and others.
- Myelofibrosis Therapies- BESREMi (ropeginterferon alfa-2b-njft/P-1101), INCB057643, XPOVIO (NEXPOVIO/selinexor/KPT-330), RYTELO (imetelstat), REBLOZYL (luspatercept/ACE-536), Navtemadlin (KRT-232), Pelabresib (DAK539), Bomedemstat (IMG-7289/MK-3543), TL-895, RVU120 ( SEL-120), TP-3654 (nuvisertib), SNT-5505 (PXS-5505), DISC-0974, ELZONRIS (tagraxofusp/SL-401), and others
- Myelofibrosis Therapeutic Assessment: Myelofibrosis current marketed and Myelofibrosis emerging therapies
- Myelofibrosis Market Dynamics: Myelofibrosis market drivers and Myelofibrosis market barriers
- Myelofibrosis Unmet Needs, KOL’s views, Analyst’s views, Myelofibrosis Market Access and Reimbursement
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Table of Content
1 Key Insights
2 Myelofibrosis Market Report Introduction
3 Myelofibrosis Market Overview by Therapies
4 Methodology of Myelofibrosis Epidemiology and Market
5 Executive Summary of Myelofibrosis
6 Key Events
7 Disease Background and Overview: Myelofibrosis
8 Epidemiology and Patient Population
9 Patient Journey
10 Marketed Drugs
11 Emerging Drugs
12 Myelofibrosis Market Analysis
13 Key Opinion Leaders’ Views
14 SWOT Analysis
15 Unmet Needs
16 Market Access and Reimbursement
17 Appendix
18 Report Methodology
19 DelveInsight Capabilities
20 Disclaimer
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