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Myelofibrosis (MF) - Market Insight, Epidemiology And Market Forecast - 2032

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    Report

  • 225 Pages
  • September 2022
  • Region: Global
  • DelveInsight
  • ID: 5524013
This Myelofibrosis - Market Insights, Epidemiology, and Market Forecast - 2032 report delivers an in-depth understanding of the Myelofibrosis, historical and forecasted epidemiology as well as the Myelofibrosis market trends in the United States, the EU-5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

The Myelofibrosis market report provides current treatment practices, emerging drugs, Myelofibrosis market share of the individual therapies, current and forecasted Myelofibrosis market size from 2019 to 2032 segmented by seven major markets. The Report also covers the current Myelofibrosis treatment practice/algorithm, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

  • The United States
  • EU-5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan
Study Period: 2019-2032

Myelofibrosis: Disease Understanding and Treatment Algorithm

Myelofibrosis Overview

Myelofibrosis is a rare type of blood cancer characterized by the buildup of scar tissue, called “fibrosis,” in the bone marrow. The bone marrow cannot make enough healthy blood cells due to increased scar tissue. It is one of the related groups of blood cancers known as “myeloproliferative neoplasms (MPNs)” in which blood cells produced by bone marrow cells develop and function abnormally. When myelofibrosis develops on its own (and not as the result of another bone marrow disease), it is called primary myelofibrosis. In other cases, another type of MPN, such as polycythemia vera (PV) or essential thrombocythemia (ET), can transform into MF. In these cases, it is known as secondary MF, which may also be referred to as a post-PV MF or post-ET MF.

Myelofibrosis usually develops slowly, and it often does not cause early symptoms and may be found during a routine blood test. When fibrosis develops in the bone marrow, the bone marrow is unable to produce enough normal blood cells. The lack of blood cells causes many signs and symptoms of myelofibrosis. Several specific gene mutations have been identified in people with myelofibrosis. The most common is the Janus kinase 2 (JAK2) gene mutation, and other less common mutations include CALR and MPL. Some people with myelofibrosis do not have any identifiable gene mutations.

Prominent clinical features in myelofibrosis include anemia, hepatosplenomegaly, and constitutional symptoms including fatigue, night sweats, low-grade fever, and progressive cachexia with loss of muscle mass, bone pain, splenic infarct, pruritus, nonhepatosplenic EMH, thrombosis, and bleeding.

Myelofibrosis Diagnosis

Myelofibrosis can be diagnosed by using a series of tests such as blood tests, bone marrow tests, molecular testing, and mutation-enhanced morphologic diagnosis. In order to confirm the diagnosis, the doctor tests the bone marrow. Bone marrow testing involves two steps usually performed at the same time in a doctor's office or a hospital: a bone marrow aspiration removes a liquid marrow sample, and a bone marrow biopsy removes a small amount of bone filled with marrow. Molecular tests are used for diagnosis and treatment planning look for abnormal changes in the genes, chromosomes, proteins, or other molecules within the patient's cancer cells.

Myelofibrosis Treatment

No drug therapy can cure myelofibrosis. The only potential cure for myelofibrosis is allogeneic stem cell transplantation, but this procedure is risky for older patients and those with other health problems. As MF primarily affects older adults, stem cell transplantation is not a treatment option for most MF patients. For most people with myelofibrosis, treatment remains aimed at controlling disease symptoms and complications, enhancing the quality of life, and extending survival.

For patients with low-risk symptoms, treatment options include Ruxolitinib (Jakafi), Interferon alfa (Intron A, Roferon-A, and Pegasys), although the best use of these medications may be in a clinical trial, and Hydroxyurea (Hydrea).

Patients with Intermediate and high-risk treatment may include Pacritinib (Vonjo), Ruxolitinib (Jakafi), Fedratinib (Inrebic), and allogeneic stem cell transplantation.

Myelofibrosis Epidemiology

The Myelofibrosis epidemiology division provides insights about the historical and current Myelofibrosis patient pool and forecasted trends for seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of The report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings

The disease epidemiology covered in the report provides historical as well as forecasted Myelofibrosis epidemiology [segmented as total prevalent cases, total diagnosed prevalent cases, type-specific cases, based on risk stratification, age-specific cases, based on molecular alterations, treatment eligible pool of myelofibrosis, and transplant eligible/ineligible pool of myelofibrosis] in the 7MM covering the United States, EU-5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2019 to 2032.

Country Wise- Myelofibrosis Epidemiology

  • The total prevalent population of myelofibrosis in the 7MM comprised of 39,735 cases in 2021 and is projected to increase during the study period (2019-2032).
  • In the United States, the total number of prevalent cases of Myelofibrosis were 19,815 cases in the year 2021 which are expected to grow during the study period, i.e., 2019-2032.
  • Among the EU-5 countries, Germany accounted for the highest number of myelofibrosis diagnosed prevalent cases, followed by the UK, whereas Spain accounted for the lowest cases in 2021.
  • The total diagnosed prevalent cases of myelofibrosis in the Japan is 5,391 in 2021 and is projected to increase during the forecast period.
  • In the US, based on risk, myelofibrosis cases are stratified in the low risk, intermediate-1 risk, intermediate-2, and high-risk. The high-risk accounted for the highest number of patients in 2021 in the US.
  • Myelofibrosis can be further categorized into primary myelofibrosis and secondary myelofibrosis. In 2021, 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 ≤ 40 years, 41−60 years, and > 60 years. The >60 years accounted for the highest number of patients i.e. 10,275 in 2021 in the US.
  • In 2021, treatment eligible pool of myelofibrosis accounted for 9,511 cases in the United States.
  • The epidemiology model of myelofibrosis suggests that there are two broad classification based on the molecular enhancement in myelofibrosis, one that includes patients who driver harbor mutations which suggests that highest mutation is observed in JAK2 mutations followed by CALR mutation and MLR mutation. Second category includes patients with triple negative mutations. In the US, JAK2 mutations account for approximately 60% of cases.
  • In 2021, transplant ineligible pool of myelofibrosis accounted for 8,980 cases in the United States.

Drug Chapters

The drug chapter segment of the Myelofibrosis report encloses the detailed analysis of Myelofibrosis late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Myelofibrosis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Myelofibrosis Marketed Drugs

JAKAFI (Ruxolitinib): Incyte/Novartis

Ruxolitinib belongs to the class of medications called kinase inhibitors. It works to treat myelofibrosis and PV by blocking the signals that cause cancer cell proliferation, thereby inhibiting the spread of cancer cells. JAKAFI is the first medicine approved by the FDA for patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis and PPV-MF/PET-MF. The drug is approved in the US, Europe, and Japan. The starting dose of Jakafi is 20 mg given orally twice daily for patients with a platelet count greater than 200 × 109/L, and 15 mg twice daily for patients with a platelet count between 100 × 109/L and 200 × 109/L. Novartis is expecting the data readout of Phase I/II (ADORE) by 2024. The ADORE trial aims to investigate the safety, pharmacokinetics, and preliminary efficacy of combination treatment of ruxolitinib with five novel compounds: siremadlin, crizanlizumab, sabatolimab, LTT462, and NIS793 in myelofibrosis subjects.

INREBIC (Fedratinib): Impact Biomedicines/Celgene

INREBIC (fedratinib) is an oral kinase inhibitor with activity against wild-type and mutationally activated JAK2 and FMS-like tyrosine kinase 3 (FLT3). On August 16, 2019, the FDA approved fedratinib for adults with intermediate-2 or high-risk primary or secondary myelofibrosis. In February 2021, the European Commission granted full marketing authorization for fedratinib (INREBIC). The recommended dosage for fedratinib is 400 mg orally once daily with or without food for patients with a baseline platelet count of ≥50 × 109/L. Fedratinib received Orphan Drug Designation from the FDA and EMA to treat myelofibrosis. INREBIC has a Boxed Warning for serious and fatal encephalopathy, including Wernicke's.

VONJO (Pacritinib): CTI BioPharma

VONJO is an inhibitor of JAK2 and IRAK1 while sparing JAK1. Indicated for treating adults with myelofibrosis with platelet counts below 50 × 109/L. In February 2022, FDA approved VONJO and recommendations include first- and second-line usage: Treatment for all high-risk myelofibrosis patients (first- and second-line) with platelet counts < 50 × 109/L, candidates not for transplant and second-line treatment for lower-risk and higher-risk myelofibrosis patients with platelet counts ≥50 × 109/L, candidates not for transplant. VONJO is the only approved JAK inhibitor recommended by NCCN for myelofibrosis patients regardless of platelet counts. The recommended dosage is 200 mg orally twice daily with or without food.

Myelofibrosis Emerging Drugs

Momelotinib: Sierra Oncology

Momelotinib (CYT387/GS-0387) is a novel, orally bioavailable inhibitor of three key signaling pathways: JAK1, JAK2, and ACVR1/ALK2. This combined profile is unique amongst currently approved and emerging JAK inhibitor-based therapeutics. In 2019, FDA granted Fast Track Designation to momelotinib for the treatment of patients with intermediate/high-risk myelofibrosis who have previously received a JAK inhibitor. The drug also has Orphan drug designation from FDA and EMA. In June 2022, the company presented Phase III data in ASCO 2022 and at the European Hematology Association Hybrid Congress 2022. Based on the positive results, the company submitted an NDA to FDA in the second quarter of 2022. Data from MOMENTUM, along with data from more than 820 myelofibrosis patients previously treated with momelotinib, is the basis of the global registration strategy for momelotinib. The FDA has accepted the NDA and has assigned a PDUFA date of 16 June 2023. The company is expecting the US approval and launch in the first half of 2023.

Navitoclax (ABT-263): AbbVie

Navitoclax, a BCL-XL/BCL-2 inhibitor being investigated to treat myelofibrosis. Navitoclax is a known BH3 mimetic drug and potently binds to the BH3 domain of BCL-2 anti-apoptotic members. In 2019, FDA and EMA granted Orphan Drug Designation to navitoclax for the treatment of myelofibrosis. The company anticipated the regulatory submission and regulatory approval of navitoclax in 2023 as first-line therapy and relapsed/refractory myelofibrosis. The company is also expecting Phase II data readout in relapsed/refractory myelofibrosis in 2022 and Phase III data readout as the first line of therapy in myelofibrosis patients by 2023. At the American Association of Cancer Research (AACR) 2022 annual meeting, AbbVie presented positive results from a Phase II trial evaluating navitoclax in combination with ruxolitinib in myelofibrosis patients that previously had a suboptimal response or disease progression with ruxolitinib monotherapy.

Parsaclisib (INCB050465): Incyte

Parsaclisib is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). Parsaclisib has demonstrated potency and selectivity in preclinical studies and has potential therapeutic utility in treating patients. The PI3Kδ pathway mediates oncogenic signaling in B-cell malignancies. Based on positive Phase II data, the company has started two pivotal ongoing trials of ruxolitinib in combination with parsaclisib (PI3Kδ) in first-line myelofibrosis (LIMBER-313) and myelofibrosis patients with a suboptimal response to ruxolitinib monotherapy (LIMBER-304). The top-line data from the trials are anticipated by 2023. At EHA 2022, Incyte presented the subgroup analysis of efficacy and safety data from the Phase II INCB 50465-201 trial (NCT02718300).

REBLOZYL (Luspatercept/ACE-536): Celgene/Bristol Myers Squibb

Luspatercept-aamt (ACE-536), 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. In 2020, EMA and FDA granted Orphan Drug Designation to luspatercept for myelofibrosis treatment. In 2020, the drug received approval from the US FDA and the European Commission for treating transfusion-dependent anemia in patients with Myelodysplastic Syndrome and is sold under the brand name REBLOZYL. It is also approved for anemia in adult patients with beta-thalassemia who require regular red blood cell (RBC) transfusions. The drug is currently in Phase III INDEPENDENCE trial for myelofibrosis patients requiring RBC transfusions; the data from this trial is expected by 2023/2024.

Pelabresib: MorphoSys

Pelabresib (CPI-0610) is an investigational selective small molecule designed to promote antitumor activity by inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decreasing the expression of abnormally expressed genes in cancer. In November 2018, FDA granted Fast Track Designation to the pelabresib for myelofibrosis treatment. The drug also has Orphan drug designation from FDA and EMA. The drug is currently in Phase III (MANIFEST-2) pivotal trial for first-line myelofibrosis patients, and the primary analysis data from this trial is expected by 1H 2024. The latest data from the MANIFEST study was presented at EHA 2022.

Note: Detailed emerging therapies assessment will be provided in the final report.

Myelofibrosis Market Outlook

Myelofibrosis has limited treatment options, and only a few patients received allogeneic hematopoietic cell transplantation, the only curative therapy. Myelofibrosis has a wide range of clinical manifestations, and the best treatment frequently involves managing many symptoms, such as anemia, splenomegaly, constitutional symptoms, bone pain, and bleeding. 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.

Ruxolitinb was the sole drug approved to treat intermediate- or high-risk myelofibrosis for a long time until the approval of a second JAK inhibitor, fedratinib, in August 2019. In February 2022, 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.

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.

Future myelofibrosis treatment options may include combination therapy as a crucial component, maybe in conjunction with an immunotherapeutic drug. Vonjo boasts the distinction of being the first approved therapy to specifically address the needs of patients with cytopenic (platelet count below 50 × 109/L) myelofibrosis. Ruxolitinib and fedratinib are not yet approved in this patient segment. To fill the patient unmet needs, NS Pharma (Ilginatinib), and Roche (Zinpentraxin alfa) are developing their candidates for thrombocytopenia.

Coming therapies are focusing on different mechanisms other than JAK inhibitors, such as imetelstat (telomerase inhibitor), navitoclax (BCL-XL/BCL-2 inhibitor), GB2064 (LOXL2 protein inhibitors), navtemadlin (MDM2 protein inhibitor), pelabresib (BET inhibitor), and others which may cover the patient need in refractory and relapse to JAK inhibitor and provide an alternative treatment for the patients.

Key Findings

The Myelofibrosis market size in the 7MM is expected to change during the study period 2019-2032. The therapeutic market of Myelofibrosis in the seven major markets is expected to increase during the study period (2019-2032) with a CAGR of 7.3%. According to the estimates, the highest market size of Myelofibrosis is found in the United States followed by Japan.

The United States Market Outlook

The total market size of Myelofibrosis therapies in the United States is expected to increase with a CAGR of 8.0% in the study period (2019-2032).

EU-5 Countries: Market Outlook

The total market size of Myelofibrosis therapies in EU-5 countries is expected to increase with a CAGR of 5.0% in the study period (2019-2032).

Japan Market Outlook

The total market size of Myelofibrosis therapies in Japan is expected to increase with a CAGR of 3.6% in the study period (2019-2032).

Myelofibrosis Pipeline Development Activities

The drugs which are in forecast include:
1. Momelotinib (Sierra Oncology)
2. Parsaclisib (Incyte)
3. Lusatercept (BMS/Celgene)
4. Pelabresib (MorphoSys)
5. Bomedemstat (Imago Biosciences)
6. Selinexor (Karyopharm Therapeutics)
7. Navitoclax (AbbVie)
8. Navtemadlin (Kartos Therapeutics)
9. Imetelstat (Geron Corperation)
10. Zinpentraxin alfa (Roche)
The report provides insights into different therapeutic candidates in Phase II, Phase III and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for Myelofibrosis emerging therapies.

Note: Detailed emerging therapies assessment will be provided in the final report.

Analyst Commentary

  • According to the estimates, the highest market size in Myelofibrosiss will be contributed from the United States owing to the higher patient pool and higher treatment cost.
  • JAK inhibitors, the only approved therapy for myelofibrosis, have successfully reduced spleen and symptom burden. However, they do not impact disease progression. Patients who are refractory to JAK inhibition also have a dismal survival.
  • The companies are enhancing their strategies to improve symptom and spleen reductions with JAKi in the first line setting. Currently, combination therapy is being evaluated with multiple agents, including pelabresib, parsaclisib, and navitoclax, with ongoing Phase III clinical trials in the upfront setting.

NRG1 fusion Drugs Uptake

  • This section focuses on the rate of uptake of the potential drugs expected to get launched in the market during the study period 2019-2032. The analysis covers Myelofibrosis market uptake by drugs; patient uptake by therapies; and sales of each drug. For example- Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Currently, the company is conducting two trials for imetelstat - Phase III (IMpactMF) and Phase I (frontline myelofibrosis) to treat primary and secondary myelofibrosis. The drug is expected to launch in the US in 2026. As per our analysis, Imetelstat drug uptake in the US is expected to be medium with an estimated probability adjusted peak share of 4%.

KOL-Views

To keep up with current market trends, we take KOLs and SME's opinion working in the Myelofibrosis domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Myelofibrosis market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

The publisher performs Competitive and Market Intelligence analysis of the Myelofibrosis Market by using various Competitive Intelligence tools that includes - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

  • The report covers the descriptive overview of Myelofibrosis, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies.
  • Comprehensive insight has been provided into the Myelofibrosis epidemiology and treatment in the 7MM.
  • Additionally, an all-inclusive account of both the current and emerging therapies for Myelofibrosis is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
  • A detailed review of the Myelofibrosis market; historical and forecasted is included in the report, covering drug outreach in the 7MM.
  • The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Myelofibrosis market.

Report Highlights

  • In the coming years, the Myelofibrosis market is set to change due to the rising awareness of the disease and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Myelofibrosis R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition and address the current unmet needs.
  • Major players are involved in developing therapies for Myelofibrosis. The launch of emerging therapies will significantly impact the Myelofibrosis market.
  • A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Myelofibrosis.
  • This in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Myelofibrosis Report Insights

  • Patient Population
  • Therapeutic Approaches
  • Myelofibrosis Pipeline Analysis
  • Myelofibrosis Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies

Myelofibrosis Report Key Strengths

  • 11 Years Forecast
  • 7MM Coverage
  • Myelofibrosis Epidemiology Segmentation
  • Key Cross Competition
  • Highly Analyzed Market
  • Drugs Uptake

Myelofibrosis Report Assessment

  • SWOT Analysis
  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Attribute Analysis
  • Market Attractiveness

Key Questions Answered

Market Insights:

  • What was the Myelofibrosis Market share (%) distribution in 2019 and how it would look like in 2032?
  • What would be the Myelofibrosis total market size as well as market size by therapies across the 7MM during the study period (2019-2032)?
  • What are the key findings of the market across the 7MM and which country will have the largest Myelofibrosis market size during the study period (2019-2032)?
  • At what CAGR, the Myelofibrosis market is expected to grow in the 7MM during the study period (2019-2032)?
  • What would be the Myelofibrosis market outlook across the 7MM during the study period (2019-2032)?
  • What would be the Myelofibrosis market growth till 2032 and what will be the resultant market size in the year 2032?
  • How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
  • Myelofibrosis patient types/pool where unmet need is more and whether emerging therapies will be able to address the residual unmet need?
  • How emerging therapies are performing on the parameters like efficacy, safety, route of administration (RoA), treatment duration, and frequencies based on their clinical trial results?
  • Among the emerging therapies, what are the potential therapies which are expected to disrupt the Myelofibrosis market?

Epidemiology Insights:

  • What are the disease risks, burdens, and unmet needs of the Myelofibrosis?
  • What is the historical Myelofibrosis patient pool in the seven major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
  • What would be the forecasted patient pool of Myelofibrosis in the 7 major markets covering the United States, the EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
  • What will be the growth opportunities in the 7MM concerning the patient population about Myelofibrosis?
  • Out of all the 7MM countries, which country would have the highest prevalent population of Myelofibrosis during the study period (2019-2032)?
  • Which mutation and age-group accounts for the highest prevalent population of Myelofibrosis during the study period (2019-2032) and stratification of myelofibrosis patient pool based on the risk.
  • What is the treatment eligible pool of myelofibrosis in the 7MM and the transplant eligible/ineligible pool of myelofibrosis in the 7MM?
  • At what CAGR the population is expected to grow in the 7MM during the study period (2019-2032)?
  • What are the various recent and upcoming events which are expected to improve the diagnosis of Myelofibrosis?

Current Treatment Scenario and Emerging Therapies:

  • What are the current options for the treatment of Myelofibrosis?
  • What are the current treatment guidelines for the treatment of Myelofibrosis in the US, Europe and Japan?
  • How many companies are developing therapies for the treatment of Myelofibrosis?
  • How many therapies are developed by each company for the treatment of Myelofibrosis?
  • How many emerging therapies are in the mid-stage and late stages of development for the treatment of Myelofibrosis?
  • What are the key collaborations (Industry-Industry, Industry-Academic), Mergers and acquisitions, licensing activities related to the Myelofibrosis therapies?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Myelofibrosis and their status?
  • What are the key designations that have been granted for the emerging therapies for Myelofibrosis?
  • What is the global historical and forecasted market of Myelofibrosis?

Reasons to Buy

  • The report will help in developing business strategies by understanding trends shaping and driving the Myelofibrosis market.
  • To understand the future market competition in the Myelofibrosis market and Insightful review of the key market drivers and barriers.
  • Organize sales and marketing efforts by identifying the best opportunities for Myelofibrosis in the US, Europe (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
  • Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
  • Organize sales and marketing efforts by identifying the best opportunities for the Myelofibrosis market.
  • To understand the future market competition in the Myelofibrosis market.

Table of Contents

1. Key Insights2. Report Introduction
3. Myelofibrosis Market Overview at a Glance
3.1. Market Share (%) Distribution of Myelofibrosis by Therapies in 2019
3.2. Market Share (%) Distribution of Myelofibrosis by Therapies in 2032
3.3. Market Share (%) Distribution of Myelofibrosis by Class in 2019
3.4. Market Share (%) Distribution of Myelofibrosis by Class in 2032
4. Executive Summary5. Epidemiology and Market Methodology6. Key Events
7. Disease Background and Overview
7.1. Introduction
7.2. Subtypes
7.3. Signs and Symptoms
7.4. Causes
7.5. Diagnosis
7.5.1. Blood test
7.5.2. Bone marrow tests
7.5.3. Molecular testing
7.5.4. Mutation-enhanced morphologic diagnosis
7.6. Pathogenesis
7.7. Prognosis
7.8. Risk Factor
8. Treatment and Management9. Risk-based Scoring in Myelofibrosis
10. Guidelines
10.1. NCCN Guidelines
10.1.1. Treatment for lower-risk myelofibrosis
10.1.2. Treatment for higher-risk myelofibrosis
10.1.3. Management of myelofibrosis-associated anemia
10.1.4. Risk stratification for patients with primary myelofibrosis
10.2. NICE Guidelines
10.3. ESMO Guidelines (Post PV and Post ET)
11. Epidemiology and Patient Population
11.1. Key Findings
11.2. Assumptions and Rationale
11.3. Total Prevalent Population of Myelofibrosis in the 7MM
11.4. The United States
11.4.1. Total Prevalent Population of Myelofibrosis in the United States
11.4.2. Total Diagnosed prevalent cases of Myelofibrosis in the United States
11.4.3. Type-specific Cases of Myelofibrosis in the United States
11.4.4. Myelofibrosis cases Based on Risk Stratification in the United States
11.4.5. Age-specific Cases of Myelofibrosis in the United States
11.4.6. Myelofibrosis Cases Based on Molecular Alterations in the United States
11.4.7. Treatment Eligible Pool of Myelofibrosis in the United States
11.4.8. Transplant Eligible/Ineligible Pool of Myelofibrosis in the US
11.5. EU-5
11.5.1. Total Prevalent Population of Myelofibrosis in the EU-5
11.5.2. Total Diagnosed Prevalent Cases of Myelofibrosis in the EU-5
11.5.3. Type-specific Cases of Myelofibrosis in the EU-5
11.5.4. Myelofibrosis cases Based on Risk Stratification in the EU-5
11.5.5. Age-specific Cases of Myelofibrosis in the EU-5
11.5.6. Myelofibrosis Cases Based on Molecular Alterations in the EU-5
11.5.7. Treatment Eligible Pool of Myelofibrosis cases in the EU-5
11.5.8. Transplant Eligible/Ineligible Pool of Myelofibrosis cases in the EU-5
11.6. Japan
11.6.1. Total Prevalent Population of Myelofibrosis in Japan
11.6.2. Total Diagnosed Prevalent Cases of Myelofibrosis in Japan
11.6.3. Type-specific Cases of Myelofibrosis in Japan
11.6.4. Myelofibrosis cases Based on Risk Stratification in Japan
11.6.5. Age-specific Cases of Myelofibrosis in Japan
11.6.6. Myelofibrosis Cases Based on Molecular Alterations in Japan
11.6.7. Treatment Eligible Pool of Myelofibrosis in Japan
11.6.8. Transplant Eligible/Ineligible Pool of Myelofibrosis in Japan
12. Patient Journey13. Key Endpoints in Myelofibrosis Clinical Trials
14. Marketed Drugs
14.1. Key Cross
14.2. JAKAFI (Ruxolitinib): Incyte/Novartis
14.2.1. Product description
14.2.2. Regulatory Milestones
14.2.3. Other developmental activities
14.2.4. Current pipeline activity
14.2.5. Safety and efficacy
14.2.6. Product profile
14.3. INREBIC (Fedratinib): Impact Biomedicines/Celgene
14.3.1. Product description
14.3.2. Regulatory milestones
14.3.3. Other developmental activities
14.3.4. Current pipeline activity
14.3.5. Safety and efficacy
14.3.6. Product profile
14.4. VONJO (Pacritinib): CTI BioPharma
14.4.1. Product description
14.4.2. Regulatory milestone
14.4.3. Other developmental activities
14.4.4. Current pipeline activity
14.4.5. Safety and efficacy
14.4.6. Product profile
15. Emerging Therapies
15.1. Key Cross
15.2. Imetelstat (GRN163L): Geron Corporation
15.2.1. Product description
15.2.2. Other developmental activities
15.2.3. Clinical development
15.2.4. Safety and efficacy
15.3. Navitoclax (ABT-263): AbbVie
15.3.1. Product description
15.3.2. Other developmental activities
15.3.3. Clinical development
15.3.4. Safety and efficacy
15.4. Momelotinib: Sierra Oncology
15.4.1. Product description
15.4.2. Other developmental activity
15.4.3. Clinical development
15.4.4. Safety and efficacy
15.5. GB2064: Galecto Biotech
15.5.1. Product description
15.5.2. Other developmental activities
15.5.3. Clinical development
15.6. Elraglusib (9-ING-41): Actuate Therapeutics
15.6.1. Product description
15.6.2. Clinical development
15.7. Navtemadlin (KRT-232): Kartos Therapeutics
15.7.1. Product description
15.7.2. Other developmental activities
15.7.3. Clinical Development
15.7.4. Safety and efficacy
15.8. TL-895: Telios Pharma
15.8.1. Product description
15.8.2. Clinical development
15.9. Tagraxofusp (ELZONRIS/SL-401): Menarini Group
15.9.1. Product description
15.9.2. Other developmental activity
15.9.3. Clinical development
15.9.4. Safety and efficacy
15.10. Smac Mimetic LCL161: Novartis Pharmaceuticals
15.10.1. Product description
15.10.2. Clinical development
15.10.3. Safety and Efficacy
15.11. Ilginatinib (NS-018): NS Pharma
15.11.1. Product description
15.11.2. Clinical development
15.11.3. Safety and efficacy
15.12. Selinexor: Karyopharm Therapeutics
15.12.1. Product description
15.12.2. Other developmental activity
15.12.3. Clinical development
15.12.4. Safety and efficacy
15.13. Itacitinib (INCB039110): Incyte Corporation
15.13.1. Product profile
15.13.2. Other developmental activity
15.13.3. Clinical development
15.13.4. Safety and efficacy
15.14. Parsaclisib (INCB050465): Incyte
15.14.1. Product description
15.14.2. Other developmental activities
15.14.3. Clinical development
15.14.4. Safety and efficacy
15.15. REBLOZYL (Luspatercept/ACE-536): Celgene/Bristol Myers Squibb
15.15.1. Product description
15.15.2. Other developmental activities
15.15.3. Clinical development
15.15.4. Safety and efficacy
15.16. Pelabresib: MorphoSys
15.16.1. Product description
15.16.2. Other developmental activities
15.16.3. Clinical development
15.16.4. Safety and efficacy
15.17. Bomedemstat: Imago BioSciences
15.17.1. Product description
15.17.2. Other developmental activities
15.17.3. Clinical Development
15.17.4. Safety and efficacy
15.18. Zinpentraxin alfa: Roche
15.18.1. Product description
15.18.2. Other developmental activities
15.18.3. Clinical development
15.18.4. Safety and efficacy
16. Myelofibrosis: 7 Major Market Analysis
16.1. Key Findings
16.2. Market Outlook
16.3. Key Market Forecast Assumptions
16.4. Attribute Analysis
16.5. Total Market Size of Myelofibrosis in the 7MM
16.6. United States Market Size
16.6.1. Total Market Size of Myelofibrosis in the United States
16.6.2. Market Size of Myelofibrosis by Therapies in the United States
16.7. EU-5 Market Size
16.7.1. Total Market size of Myelofibrosis in the EU-5
16.7.2. Market Size of Myelofibrosis by Therapies in the EU-5
16.8. Japan Market Size
16.8.1. Total Market Size of Myelofibrosis in Japan
16.8.2. Market Size of Myelofibrosis by Therapies in Japan
17. Market Access and Reimbursement
17.1. Incyte Cares for Jakafi
17.2. Jakafi Medicare Programme
17.3. BMS Financial Support Options for Fedratinib
17.4. NICE UK
17.5. HAS France
17.6. IQWIG Germany
17.7. AIFA Italy
17.8. MHLW Japan
18. SWOT Analysis19. Unmet Needs
20. Appendix
20.1. Bibliography
20.2. Report Methodology
21. Publisher Capabilities22. Disclaimer23. About the Publisher
List of Tables
Table 1: Summary of Myelofibrosis Market, and Epidemiology (2019-2032)
Table 2: Key events
Table 3: List of the Available Risk Score for Myelofibrosis and Their Prognostic Relevance
Table 4: Mutation and karyotype-enhanced IPSS (MIPSS-70+ VERSION 2.0) for patients with primary myelofibrosis
Table 5: Total Prevalent Population of Myelofibrosis in the 7MM (2019-2032)
Table 6: Total Prevalent Population of Myelofibrosis in the US (2019-2032)
Table 7: Total Diagnosed Prevalent Cases of Myelofibrosis in the US (2019-2032)
Table 8: Type-specific Cases of Myelofibrosis in the US (2019-2032)
Table 9: Myelofibrosis Cases Based on Risk Stratification in the US (2019 -2032)
Table 10: Age-specific Cases of Myelofibrosis in the US (2019-2032)
Table 11: Myelofibrosis Cases Based on Molecular Alterations in the US (2019-2032)
Table 12: Treatment Eligible Pool of Myelofibrosis in the US (2019-2032)
Table 13: Transplant Eligible Pool of Myelofibrosis in the US (2019-2032)
Table 14: Total Prevalent Population of Myelofibrosis in the EU-5 (2019-2032)
Table 15: Total Diagnosed Prevalent Cases of Myelofibrosis in the EU-5 (2019-2032)
Table 16: Type-specific Cases of Myelofibrosis in the EU-5 (2019-2032)
Table 17: Myelofibrosis cases Based on Risk Stratification in the EU-5 (2019-2032)
Table 18: Age-specific Cases of Myelofibrosis in the EU-5 (2019-2032)
Table 19: Myelofibrosis Cases Based on Molecular Alterations in the EU-5 (2019-2032)
Table 20: Treatment Eligible Pool of Myelofibrosis cases in the EU-5 (2019-2032)
Table 21: Treatment Eligible/Ineligible Pool of Myelofibrosis in the EU-5 (2019-2032)
Table 22: Total Prevalent Population of Myelofibrosis in Japan (2019-2032)
Table 23: Total Diagnosed Prevalent Cases of Myelofibrosis in Japan (2019-2032)
Table 24: Type-specific Cases of Myelofibrosis in Japan (2019-2032)
Table 25: Myelofibrosis Cases Based on Risk Stratification in Japan (2019 -2032)
Table 26: Age-specific Cases of Myelofibrosis in Japan (2019-2032)
Table 27: Myelofibrosis Cases Based on Molecular Alterations in the Japan (2019-2032)
Table 28: Treatment Eligible Pool of Myelofibrosis in Japan (2019-2032)
Table 29: Transplant Eligible Pool of Myelofibrosis in Japan (2019-2032)
Table 30: Comparison of marketed drugs
Table 31: Jakafi, Clinical Trial Description, 2022
Table 32: INREBIC, Clinical Trial Description, 2022
Table 33: VONJO, Clinical Trial Description, 2022
Table 34: Comparison of emerging drugs
Table 35: Imetelstat, Clinical Trial Description, 2022
Table 36: Navitoclax, Clinical Trial Description, 2022
Table 37: Momelotinib, Clinical Trial Description, 2022
Table 38: GB2064, Clinical Trial Description, 2022
Table 39: 9-ING-41, Clinical Trial Description, 2022
Table 40: Navtemadlin, Clinical Trial Description, 2022
Table 41: TL-895, Clinical Trial Description, 2022
Table 42: Tagraxofusp, Clinical Trial Description, 2022
Table 43: Smac Mimetic LCL161, Clinical Trial Description, 2022
Table 44: Ilginatinib, Clinical Trial Description, 2022
Table 45: Selinexor, Clinical Trial Description, 2022
Table 46: Itacitinib, Clinical Trial Description, 2022
Table 47: Parsaclisib, Clinical Trial Description, 2022
Table 48: Luspatercept, Clinical Trial Description, 2022
Table 49: Pelabresib, Clinical Trial Description, 2022
Table 50: Bomedemstat, Clinical Trial Description, 2022
Table 51: Zinpentraxin alfa, Clinical Trial Description, 2022
Table 52: Key Market Forecast Assumptions for Imetelstat
Table 53: Key Market Forecast Assumptions for Navitoclax
Table 54: Key Market Forecast Assumptions for Momelotinib
Table 55: Key Market Forecast Assumptions for Parsaclisib
Table 56: Key Market Forecast Assumptions for Luspatercept-aamt (ACE-536)
Table 57: Key Market Forecast Assumptions for Pelabresib (CPI-0610)
Table 58: Key Market Forecast Assumptions for Bomedemstat (IMG-7289)
Table 59: Key Market Forecast Assumptions for Zinpentraxin alfa
Table 60: Key Market Forecast Assumptions for Navtemadlin
Table 61: Key Market Forecast Assumptions for Selinexor
Table 62: Market Size of Myelofibrosis in the 7MM, USD million (2019-2032)
Table 63: Market Size of Myelofibrosis in the US, USD million (2019-2032)
Table 64: Market Size of Myelofibrosis by Therapies in the US, in USD million (2019-2032)
Table 65: Market Size of Myelofibrosis in the EU-5, in USD million (2019-2032)
Table 66: Market Size of Myelofibrosis by Therapies in Germany, in USD million (2019-2032)
Table 67: Market Size of Myelofibrosis by Therapies in France, in USD million (2019-2032)
Table 68: Market Size of Myelofibrosis by Therapies in Italy, in USD million (2019-2032)
Table 69: Market Size of Myelofibrosis by Therapies in Spain, in USD million (2019-2032)
Table 70: Market Size of Myelofibrosis by Therapies in the UK, in USD million (2019-2032)
Table 71: Market Size of Myelofibrosis by Therapies in the EU-5, in USD million (2019-2032)
Table 72: Market Size of Myelofibrosis in Japan, USD million (2019-2032)
Table 73: Market Size of Myelofibrosis by Therapies in Japan, in USD million (2019-2032)
List of Figures
Figure 1: Diagrammatic representation of JAK2 signaling in hematological malignancies
Figure 2: Signaling Pathways Involved in the Pathogenesis of Myeloproliferative Neoplasms (MPNs)
Figure 3: Diagrammatic Representation of Treatment Options for Patients With Myelofibrosis
Figure 4: Total Prevalent Population of Myelofibrosis in the 7MM (2019-2032)
Figure 5: Total Prevalent Population of Myelofibrosis in the US (2019-2032)
Figure 6: Total Diagnosed Prevalent Cases of Myelofibrosis in the US (2019-2032)
Figure 7: Type-specific Cases of Myelofibrosis in the US (2019-2032)
Figure 8: Myelofibrosis cases Based on Risk Stratification in the US (2019-2032)
Figure 9: Age-specific Cases of Myelofibrosis in the US (2019-2032)
Figure 10: Myelofibrosis Cases Based on Molecular Alterations in the US (2019-2032)
Figure 11: Treatment Eligible Pool of Myelofibrosis in the US (2019-2032)
Figure 12: Transplant Eligible/Ineligible Pool of Myelofibrosis in the US (2019-2032)
Figure 13: Total Prevalent Population of Myelofibrosis in the EU-5 (2019-2032)
Figure 14: Total Diagnosed Prevalent Cases of Myelofibrosis in the EU-5 (2019-2032)
Figure 15: Type-specific Cases of Myelofibrosis in the EU-5 (2019-2032)
Figure 16: Myelofibrosis cases Based on Risk Stratification in the EU-5 (2019-2032)
Figure 17: Age-specific Cases of Myelofibrosis in the EU-5 (2019-2032)
Figure 18: Myelofibrosis Cases Based on Molecular Alterations in the EU-5 (2019-2032)
Figure 19: Treatment Eligible Pool of Myelofibrosis in the EU-5 (2019-2032)
Figure 20: Treatment Eligible/Ineligible Pool of Myelofibrosis in the EU-5 (2019-2032)
Figure 21: Total Prevalent Population of Myelofibrosis in Japan (2019-2032)
Figure 22: Total Diagnosed Prevalent Cases of Myelofibrosis in Japan (2019-2032)
Figure 23: Type-specific Cases of Myelofibrosis in Japan (2019-2032)
Figure 24: Myelofibrosis cases Based on Risk Stratification in Japan (2019-2032)
Figure 25: Age-specific Cases of Myelofibrosis in Japan (2019-2032)
Figure 26: Myelofibrosis Cases Based on Molecular Alterations in the Japan (2019-2032)
Figure 27: Treatment Eligible Pool of Myelofibrosis in Japan (2019-2032)
Figure 28: Transplant Eligible/Ineligible Pool of Myelofibrosis in Japan (2019-2032)
Figure 29: Market Size of Myelofibrosis in the 7MM, USD million (2019-2032)
Figure 30: Market Size of Myelofibrosis in the US, USD millions (2019-2032)
Figure 31: Market Size of Myelofibrosis by Therapies in the US, USD million (2019-2032)
Figure 32: Market Size of Myelofibrosis in the EU-5, in USD million (2019-2032)
Figure 33: Market Size of Myelofibrosis by Therapies in the EU-5, USD million (2019-2032)
Figure 34: Market Size of Myelofibrosis in Japan, USD millions (2019-2032)
Figure 35: Market Size of Myelofibrosis by Therapies in Japan, USD million (2019-2032)

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Geron Corporation
  • AbbVie
  • Sierra Oncology
  • Galecto Biotech
  • Actuate Therapeutics
  • Kartos Therapeutics
  • Menarini Group
  • Telios Pharma
  • Novartis Pharmaceuticals
  • NS Pharma
  • Karyopharm Therapeutics
  • Incyte Corporation
  • Incyte
  • Celgene/Bristol Myers Squibb
  • MorphoSys
  • Imago BioSciences
  • Roche