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PUBLISHER: GlobalData | PRODUCT CODE: 1287898

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PUBLISHER: GlobalData | PRODUCT CODE: 1287898

Myelofibrosis Market Size and Trend Report including Epidemiology, Disease Management, Pipeline Analysis, Competitor Assessment, Unmet Needs, Clinical Trial Strategies and Forecast to 2031

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PAGES: 150 Pages
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Abstract

This report covers the 8MM (US, France, Germany, Italy, Spain, UK, Japan, and China) and includes an assessment of the disease epidemiology and 10-year patient-based forecast (PBF) across the 8MM for marketed and late-stage pipeline therapies, with a launch date assessment by market for myelofibrosis (MF).

These sales forecasts leverage data on pharmaceutical sales and drug availability from GlobalData's World Markets Healthcare (WMH) and POLI Price Intelligence databases.

MF, also called osteomyelofibrosis is a rare blood disorder that causes bone marrow (BM) fibrosis. Despite being a rare blood cancer, MF is a blockbuster market and is expected to grow from sales of $2.39 billion in 2021 to $2.89 billion in 2031 at a compound annual growth rate (CAGR) of 1.9%.

This report includes an assessment of the disease epidemiology and 10-year patient-based forecast (PBF) across the 8MM for marketed and late-stage pipeline therapies, with a launch date assessment by market for myelofibrosis (MF). These sales forecasts leverage data on pharmaceutical sales and drug availability from GlobalData's World Markets Healthcare (WMH) and POLI Price Intelligence databases.

Despite being a rare blood cancer, MF is a blockbuster market and is expected to grow from sales of $2.39 billion in 2021 to $2.89 billion in 2031, as shown in Figure 1, at a compound annual growth rate (CAGR) of 1.9%. Peak-year sales are set to be reached in 2027, driven by the approvals of several promising late-stage pipeline agents and the continued clinical dominance of Jakafi/Jakavi (ruxolitinib). In 2028, Jakafi/Jakavi is set to come off-patent in the US, which will greatly decrease its total market sales. However, the loss of total market sales will be somewhat recuperated in 2028 and beyond by the additional growth in market value of other pipeline Janus kinase (JAK) inhibitors and targeted therapies, with sales of these agents being driven by ameliorating critical unmet needs within the MF treatment paradigm.

Key Highlights

Report deliverables include Excel-based forecast model

Forecasts includes the 8MM

Forecasts covers from 2021-2031

GlobalData valued the myelofibrosis market in the 8MM at $2.39 billion and expects the market to increase to $2.89 billion by 2031

Incyte, GSK and CTI BioPharma are expected to take market-leading position in 2031

A moderate level of unmet need will remain for most myelofibrosis patient populations during the forecast period

The late-stage pipeline in myelofibrosis is robust and is likely to provide significant clinical benefit to many myelofibrosis patient populations, with fierce competition expected

Several markets across the 8MM will experience growth driven by common drivers -

  • Approvals of late-stage pipeline agents, including novel JAK inhibitors and targeted therapies, which will partially meet critical unmet clinical needs
  • Decreased reliance on generic immunomodulatory agents, androgens, and erythropoietin-stimulating agents
  • Increased utilization of novel combination regimens with premium-priced agents

Common barriers to market growth experienced across the 8MM primarily include a series of patent expiries:

  • Patent expiry of Jakafi/Jakavi
  • Patent expiry of Vonjo (pacritinib)
  • Patent expiry of Inrebic (fedratinib)

Scope

  • Overview of myelofibrosis, including epidemiology, symptoms, diagnosis, and disease management.
  • Annualized myelofibrosis therapeutics market revenue, cost of therapy per patient, and treatment usage patterns forecast from 2021 to 2031.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications of these factors for the myelofibrosis therapeutics market.
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for myelofibrosis treatment. The most promising candidates in Phase III and Phase IIb development are profiled.
  • Analysis of the current and future market competition in the global myelofibrosis therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications

Reasons to Buy

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global myelofibrosis therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global myelofibrosis therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships
Product Code: GDHC269PIDR

Table of Contents

Table of Contents

1 Myelofibrosis: Executive Summary

  • 1.2 Novel JAK inhibitors and combination therapies will provide more holistic and robust treatment for myelofibrosis patients, including underserved patient populations
  • 1.3 The level of unmet clinical need in myelofibrosis remains high during the forecast period, despite dramatic improvements by historical standards
  • 1.4 The myelofibrosis pipeline is robust, with plenty of room for new market entrants
  • 1.5 What do physicians think?

2 Introduction

  • 2.1 Catalyst
  • 2.2 Related reports
  • 2.3 Upcoming reports

3 Disease Overview

  • 3.1 Etiology and pathophysiology
    • 3.1.1 Etiology
    • 3.1.2 Pathophysiology
    • 3.1.3 Classification and staging systems

4 Epidemiology

  • 4.1 Disease background
  • 4.2 Risk factors and comorbidities
  • 4.3 Global and historical trends
  • 4.4 Forecast methodology
    • 4.4.1 Sources
    • 4.4.2 Forecast assumptions and methods
    • 4.4.3 Diagnosed incident cases of PMF
    • 4.4.4 Diagnosed incident cases of PET MF and PPV MF
    • 4.4.5 MIPSS70+ V2.0 risk categories among diagnosed PMF incident cases
    • 4.4.6 Mutations among the diagnosed incident cases of PMF
    • 4.4.7 Patients with/without anemia among the diagnosed incident cases of PMF
    • 4.4.8 Diagnosed prevalent cases of PMF
    • 4.4.9 Diagnosed prevalent cases of PET MF and PPV MF
  • 4.5 Epidemiological forecast of myelofibrosis (2021-31)
    • 4.5.1 Diagnosed incident cases of PMF
    • 4.5.2 Age-specific diagnosed incident cases of PMF
    • 4.5.3 Sex-specific diagnosed incident cases of PMF
    • 4.5.4 Diagnosed incident cases of PMF by MIPSS70+ V2.0 risk category
    • 4.5.5 Diagnosed incident cases of PMF by mutation
    • 4.5.6 Patients with or without anemia among diagnosed incident cases of PMF
    • 4.5.7 Diagnosed incident cases of PET MF
    • 4.5.8 Sex-specific diagnosed incident cases of PET MF
    • 4.5.9 Diagnosed incident cases of PPV MF
    • 4.5.10 Sex-specific diagnosed incident cases of PPV MF
    • 4.5.11 Diagnosed prevalent cases of PMF
    • 4.5.12 Age-specific diagnosed prevalent cases of PMF
    • 4.5.13 Sex-specific diagnosed prevalent cases of PMF
    • 4.5.14 Diagnosed prevalent cases of PET MF
    • 4.5.15 Sex-specific diagnosed prevalent cases of PET MF
    • 4.5.16 Diagnosed prevalent cases of PPV MF
    • 4.5.17 Sex-specific diagnosed prevalent cases of PPV MF
  • 4.6 Discussion
    • 4.6.1 Epidemiological forecast insight
    • 4.6.2 COVID-19 impact
    • 4.6.3 Limitations of the analysis
    • 4.6.4 Strengths of the analysis

5 Disease Management

  • 5.1 Diagnosis and Treatment Overview
  • 5.2 KOL insights on disease management
    • 5.2.1 Allogeneic hematopoietic cell transplant
    • 5.2.2 Treatment for splenomegaly and constitutional symptoms
    • 5.2.3 Treatment for anemia
    • 5.2.4 US-specific KOL insights on disease management
    • 5.2.5 EU-specific KOL Insights on Disease Management
    • 5.2.6 China- and Japan-specific KOL insights on disease management

6 Current Treatment Options

  • 6.1 Overview

7 Unmet Needs and Opportunity Assessment

  • 7.1 Overview
  • 7.2 Controlling anemia in patients on ruxolitinib
  • 7.3 Improving the Durability of Treatments
  • 7.4 Drugs that target disease progression and improve survival
  • 7.5 More patients are needed for clinical trials
  • 7.6 More Therapies for Patients with Thrombocytopenia

8 R&D Strategies

  • 8.1 Overview
    • 8.1.1 Novel JAK inhibitors
    • 8.1.2 Combination Therapies
    • 8.1.3 Monotherapies
  • 8.2 Clinical trials design
    • 8.2.1 Primary and secondary endpoints of pivotal trials
    • 8.2.2 Study inclusion and exclusion criteria
    • 8.2.3 Future directions for myelofibrosis clinical trials

9 Pipeline Assessment

  • 9.1 Overview
  • 9.2 Promising drugs in clinical development

10 Pipeline Valuation Analysis

  • 10.1 Overview
  • 10.2 Competitive assessment

11 Current and Future Players

  • 11.1 Overview
  • 11.2 Deal-making trends

12 Market Outlook

  • 12.1 Global Markets
    • 12.1.1 Forecast
    • 12.1.2 Drivers and barriers - global issues
  • 12.2 US
    • 12.2.1 Forecast
    • 12.2.2 Key events
    • 12.2.3 Drivers and barriers
  • 12.3 5EU
    • 12.3.1 Forecast
    • 12.3.2 Key events
    • 12.3.3 Drivers and barriers
  • 12.4 Japan
    • 12.4.1 Forecast
    • 12.4.2 Key events
    • 12.4.3 Drivers and barriers
  • 12.5 China
    • 12.5.1 Forecast
    • 12.5.2 Key events
    • 12.5.3 Drivers and barriers

13 Appendix

  • 13.1 Bibliography
  • 13.2 Abbreviations
  • 13.3 Methodology
    • 13.3.1 Forecasting methodology
  • 13.4 Primary research - KOLs interviewed for this report
    • 13.4.1 KOLs
  • 13.5 Primary research - prescriber survey
  • 13.6 About the authors
    • 13.6.1 Analyst
    • 13.6.2 Therapy Area Director
    • 13.6.3 Epidemiologist
    • 13.6.4 Managing Epidemiologist
    • 13.6.5 Global Director of Therapy Analysis and Epidemiology
    • 13.6.6 Global Head and EVP of Healthcare Operations and Strategy
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Product Code: GDHC269PIDR

List of Tables

List of Tables

  • Table 1: Myelofibrosis: key metrics in the 8MM
  • Table 2: Risk factors for PMF patient survival scoring systems
  • Table 3: Risk factors and comorbid conditions associated with MF
  • Table 4: 8MM, diagnosed incident cases of PMF by MIPSS70+ v2.0 risk category, N, men and women, ages ≥40 years, 2021
  • Table 5: treatment guidelines for myelofibrosis across the 8MM
  • Table 6: Comparison of the efficacies of marketed JAK inhibitors
  • Table 8: Top 10 deals by value, 2017-22
  • Table 9: Myelofibrosis market - global drivers and barriers, 2021-31
  • Table 10: Key events impacting sales for myelofibrosis in the US, 2021-2031
  • Table 11: Myelofibrosis market - drivers and barriers in the US, 2021-2031
  • Table 12: Key events impacting sales for myelofibrosis in the 5EU, 2021-31
  • Table 13: Myelofibrosis market - drivers and barriers in the 5EU, 2021-31
  • Table 14: Key events impacting sales for myelofibrosis in Japan, 2021-31
  • Table 15: Myelofibrosis market - drivers and barriers in Japan, 2021-31
  • Table 16: Key events impacting sales for myelofibrosis in China, 2021-31
  • Table 17: Myelofibrosis market - drivers and barriers in China, 2021-31
  • Table 18: High-prescribing physicians (non-KOLs) surveyed, by country

List of Figures

List of Figures

  • Figure 1: Global sales forecast by country for myelofibrosis in 2021 and 2031
  • Figure 2: Analysis of the company portfolio gap in myelofibrosis during the forecast period
  • Figure 3: Competitive assessment of the late-stage monotherapy pipeline agents that GlobalData expects to be licensed for the treatment of myelofibrosis during the forecast period
  • Figure 4: Competitive assessment of the late-stage combination pipeline agents that GlobalData expects to be licensed for the treatment of myelofibrosis during the forecast period
  • Figure 5: JAK/STAT signaling in myelofibrosis
  • Figure 6: 8MM, diagnosed incidence of PMF (cases per 100,000 population), men and women, ages ≥40 years, 2021
  • Figure 7: 8MM, diagnosed prevalence of PMF (%), men and women, ages ≥40 years, 2021
  • Figure 8: 8MM, sources used and not used to forecast the diagnosed incident cases of PMF
  • Figure 9: 8MM, sources used to forecast the diagnosed incident cases of PET MF and PPV MF
  • Figure 10: 8MM, sources used to forecast the diagnosed incident cases of PMF by MIPSS70+ v2.0 risk categories
  • Figure 11: 8MM, sources used to forecast the diagnosed incident cases of PMF by JAK2V617F mutation
  • Figure 12: 8MM, sources used to forecast the diagnosed incident cases of PMF by CALR mutation
  • Figure 13: 8MM, sources used to forecast the diagnosed incident cases of PMF by MPL mutation
  • Figure 14: 8MM, sources used to forecast the diagnosed incident cases of PMF by anemia
  • Figure 15: 8MM, sources used to forecast the diagnosed prevalent cases of PMF
  • Figure 16: 8MM, sources used to forecast the diagnosed prevalent cases of PET MF and PPV MF
  • Figure 17: 8MM, diagnosed incident cases of PMF, N, men and women, ages ≥40 years, 2021
  • Figure 18: 8MM, diagnosed incident cases of PMF by age, N, men and women, 2021
  • Figure 19: 8MM, diagnosed incident cases of PMF by sex, N, ages ≥40 years, 2021
  • Figure 20: 8MM, diagnosed incident cases of PMF by mutation, N, men and women, ages ≥40 years, 2021
  • Figure 21: 8MM, patients with or without anemia among diagnosed incident cases of PMF, N, men and women, ages ≥40 years, 2021
  • Figure 22: 8MM, diagnosed incident cases of PET MF, N, men and women, ages ≥40 years, 2021
  • Figure 23: 8MM, diagnosed incident cases of PET MF by sex, N, ages ≥40 years, 2021
  • Figure 24: 8MM, diagnosed incident cases of PPV MF, N, men and women, ages ≥40 years, 2021
  • Figure 25: 8MM, diagnosed incident cases of PPV MF by sex, N, ages ≥40 years, 2021
  • Figure 26: 8MM, diagnosed prevalent cases of PMF, N, men and women, ages ≥40 years, 2021
  • Figure 27: 8MM, diagnosed prevalent cases of PMF by age, N, men and women, 2021
  • Figure 28: 8MM, diagnosed prevalent cases of PMF by sex, N, ages ≥40 years, 2021
  • Figure 29: 8MM, diagnosed prevalent cases of PET MF, N, men and women, ages ≥40 years, 2021
  • Figure 30: 8MM, diagnosed prevalent cases of PET MF by sex, N, ages ≥40 years, 2021
  • Figure 31: 8MM, diagnosed prevalent cases of PPV MF, N, men and women, ages ≥40 years, 2021
  • Figure 32: 8MM, diagnosed prevalent cases of PPV MF by sex, N, ages ≥40 years, 2021
  • Figure 33: Treatment algorithm for myelofibrosis-associated anemia
  • Figure 34: Treatment algorithm for splenomegaly and constitutional symptoms
  • Figure 35: Unmet needs and opportunities in myelofibrosis
  • Figure 36: Overview of the development pipeline in myelofibrosis
  • Figure 37: Key late-stage trials for the promising pipeline agents that GlobalData expects be licensed for myelofibrosis in the 8MM during the forecast period
  • Figure 38: Competitive assessment of the marketed and pipeline drugs benchmarked against the standard of care, Jakafi/Jakavi
  • Figure 39: Competitive assessment of the Jakafi/Jakavi combination therapies
  • Figure 40: Analysis of the company portfolio gap in myelofibrosis during the forecast period
  • Figure 41: Global (8MM) sales forecast by country for myelofibrosis in 2021 and 2031
  • Figure 42: Sales forecast by class for myelofibrosis in the US in 2021 and 2031
  • Figure 43: Sales forecast by class for myelofibrosis in the 5EU in 2021 and 2031
  • Figure 44: Sales forecast by class for myelofibrosis in Japan in 2021 and 2031
  • Figure 45: Sales forecast by class for myelofibrosis in China in 2021 and 2031
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