Myelofibrosis Market Poised for Strong Growth, Fueled by FDA Designations and Promising Clinical Outcomes | DelveInsight

The myelofibrosis treatment market is going to witness robust growth owing to the launch of emerging therapies by key players such as AbbVie, Morphosys, Geron, Bristol Myers Squibb, Kartos Therapeutics, Karyopharm Therapeutics, Ns Pharma, Galecto Biotech, Actuate Therapeutics, Merck, Menarini Group, Telios Pharma, Disc Medicine, Syntara, Sumitomo Pharma, and Incyte, among others, which are advancing myelofibrosis research to address unmet needs.
DelveInsight's "Myelofibrosis Market Insight, Epidemiology And Market Forecast - 2034 [https://www.delveinsight.com/report-store/myelofibrosis-mf-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr]" report provides an in-depth understanding of Myelofibrosis, historical and forecasted epidemiology, as well as the Myelofibrosis market trends in the 7MM which include the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The myelofibrosis market size, valued at USD 2.2 billion in 2024, is projected to expand at a rapid CAGR over the forecasted period (2025-2034). This growth is fueled by rising myelofibrosis prevalence, improved diagnostic capabilities, and the launch of novel therapies targeting diverse patient subgroups. Among the 7MM, the US captured the largest market share with USD 1,700 million in 2024. Furthermore, among all the therapies, JAKAFI/JAKAVI (ruxolitinib) accounted for the largest myelofibrosis market size in 2024, with USD 1.5 billion.

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The report provides a comprehensive epidemiological analysis and forecasts extending to 2034. This analysis is segmented by total myelofibrosis prevalent cases, type-specific cases, myelofibrosis cases based on risk stratification, age-specific myelofibrosis cases, and myelofibrosis cases based on molecular alterations in the 7MM.

According to DelveInsight's analysis, the total myelofibrosis prevalence in the 7MM was nearly 56K in 2024. High-risk myelofibrosis accounted for the largest patient population in the US, with primary myelofibrosis making up approximately 75% of all cases. This trend is expected to continue in the forecasted period (2025-2034).

For most people with myelofibrosis, treatment remains aimed at controlling disease symptoms and complications, enhancing the quality of life, and extending survival. Key marketed therapies include JAKAFI (ruxolitinib) and INREBIC (fedratinib), which have dominated the landscape as JAK inhibitors provide unprecedented benefits to myelofibrosis patients in terms of spleen shrinkage and symptom improvement. However, the patent for JAKAFI is expected to go off in 2027 for Novartis and in 2028 for Incyte, opening up opportunities for emerging therapies.

As JAK inhibitor therapy is linked with certain complications, new treatments for myelofibrosis are focusing on mechanisms other than JAK inhibitors. These include imetelstat (telomerase inhibitor), navtemadlin (MDM2 protein inhibitor), pelabresib (BET inhibitor), and others that may meet the patient's needs and provide an alternative myelofibrosis treatment.

According to DelveInsight's analysis, the myelofibrosis competitive landscape is further enriched by several companies initiating clinical trials for new options. The pipeline includes drugs such as BESREMi (PharmaEssentia and AOP Orphan Pharmaceuticals), INCB057643 (Incyte), XPOVIO (Karyopharm Therapeutics), RYTELO (Geron), REBLOZYL (Bristol Myers Squibb and Merck), Navtemadlin (Kartos Therapeutics), Pelabresib (Novartis), Bomedemstat (Merck), TL-895 (Telios Pharma), RVU120 (Ryvu Therapeutics), TP-3654 (Sumitomo Pharma), SNT-5505 (Syntara), DISC-0974 (Disc Medicine), and ELZONRIS (Menarini Group), among others.

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Other than JAKAFI and INREBIC, the current myelofibrosis treatment landscape also includes approved drugs like VONJO (CTI BioPharma), a JAK2/IRAK1 inhibitor, approved back in 2022 for the treatment of adults with the intermediate or high-risk primary or secondary myelofibrosis. OJJAARA (GSK), a JAK1/2 and ACVR1 inhibitor targeting anemia, which is the only approved agent for both newly diagnosed and previously treated patients with myelofibrosis and anemia, was approved in 2023. Omjjara's unique mechanism addressing hepcidin dysregulation positions it to reshape the secondary myelofibrosis treatment market, particularly for anemic patients who face limited options.

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The myelofibrosis treatment clinical trial pipeline is currently active, with notable recent breakthroughs. In January 2025, the BOREAS phase 3 trial demonstrated that navtemadlin, an MDM2 inhibitor, offers clinical benefits as a single agent in JAK inhibitor-refractory myelofibrosis, showing durable spleen volume reductions and symptom improvements. In March 2025, a Phase 3 trial showed that adding pelebresib to ruxolitinib was more effective than ruxolitinib alone in treating myelofibrosis, with significant spleen shrinkage and no substantial increase in side effects. These recent findings indicate a strong upward trend in the myelofibrosis treatment market.

In May 2025, the FDA approved belzutifan for adult and pediatric patients aged 12 years and older with von Hippel-Lindau disease-associated tumors, including myelofibrosis-associated lesions.

In June 2025, Syntara Limited announced FDA Fast Track designation for SNT-5505, targeting myelofibrosis patients with inadequate response to JAK inhibitors. This designation enables more frequent FDA interactions and eligibility for accelerated approval pathways

Karyopharm's Phase 3 SENTRY trial in JAK inhibitor-naive myelofibrosis passed its futility analysis in May 2025. Full enrollment of 350 patients is expected by July 2025, with top-line results anticipated in late 2025/early 2026.

Despite these advancements, challenges persist. Long-term JAK inhibitor use is linked to cytopenias and infections, while high treatment costs and accessibility barriers limit global reach. DelveInsight's analysis emphasizes the need for cost-effective therapies and personalized approaches leveraging genetic profiling.

Looking ahead, the myelofibrosis treatment market is poised for diversification with a robust developmental pipeline, including BET inhibitors, PI3K inhibitors, and immunomodulators. The integration of biomarkers and combination regimens is expected to enhance response durability and address resistance.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary Of Myelofibrosis

4. Myelofibrosis Epidemiology And Market Methodology

5. Key Events

6. Myelofibrosis Market Overview At A Glance

7. Myelofibrosis Background And Overview

8. Myelofibrosis Treatment And Management

9. Myelofibrosis Treatment Guidelines

10. Myelofibrosis Epidemiology And Patient Population

11. Myelofibrosis Patient Journey

12. Myelofibrosis Clinical Trials Key Endpoints

13. Myelofibrosis Marketed Drugs

14. Myelofibrosis Emerging Therapies

15. Myelofibrosis Market Analysis (7MM)

16. Market Access And Reimbursement

17. SWOT Analysis

18. Myelofibrosis Unmet Needs

19. KOL Views

20. Appendix

21. Delveinsight Capabilities

22. Disclaimer

23. About Delveinsight

Related Report

Myelofibrosis Pipeline Insight [https://www.delveinsight.com/report-store/myelofibrosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr]

Myelofibrosis Pipeline Insight provides comprehensive insights about the Myelofibrosis pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the Myelofibrosis companies, including Geron Corporation, Merck, Telios Pharma, Inc., Ryvu Therapeutics SA, Taiga Biotechnologies, Inc., Morphic Therapeutic, iOnctura, Pharmaxis, Nippon Shinyaku, Active Biotech, Incyte Corporation, and Sumitomo Pharma America, Inc., among others.

About DelveInsight

DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.

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