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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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    Drug Pipelines

  • 150 Pages
  • March 2023
  • Region: Global
  • GlobalData
  • ID: 5821008
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 the publisher'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 the publisher'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
The publisher 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

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
  • Contact the Publisher
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
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 the publisher 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 the publisher 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 the publisher 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

Companies Mentioned (Partial List)

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

  • Abbvie
  • Acceleron Pharma
  • Bristol Myers Squibb
  • Constellation Pharmaceuticals
  • CTI BioPharma
  • Geron
  • GSK
  • Hangzhou Bangshun Pharmaceutical
  • Huadong Medicine
  • Impact Biomedicines
  • Incyte
  • Kartos Therapeutics
  • Morphosys
  • Novartis
  • Sierra Oncology
  • Suzhou Zelgen Pharmaceuticals