Myelofibrosis Market Size, Drug Analysis, Epidemiology, Disease Management, Pipeline Assessment, Unmet Needs and Forecast to 2031

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Published: March 30, 2023 Report Code: GDHC269PIDR-ST

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Myelofibrosis Market Overview

The Myelofibrosis market size across the 8MM was valued at $2.39 billion in 2021 and is expected to achieve a CAGR of more than 1% during 2021-2031. 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).

Incyte was the first company to capitalize on the clinical and commercial potential of the MF market with the landmark approval of its blockbuster JAK inhibitor Jakafi/Jakavi directly into the first-line setting in 2011, making it the first targeted therapy available specifically to treat MF. It also was, and still remains, the most effective therapy available to treat MF by far. Incyte markets Jakafi in the US and Novartis markets Jakavi in the five major European markets (5EU) (France, Germany, Italy, Spain, and UK), Japan, and China.

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 the market value of other pipelines Janus kinase (JAK) inhibitors and targeted therapies, with sales of these agents being driven by ameliorating critical unmet needs within the Myelofibrosis treatment paradigm.

Myelofibrosis Market Outlook, 2021-2031 ($ Billion)

Myelofibrosis Market Outlook, 2021-2031 ($ Billion)

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Myelofibrosis Market Drivers

The Myelofibrosis market in the 8MM is expected to be driven by the approvals of late-stage pipeline agents, including novel JAK inhibitors and targeted therapies over the forecast period. It will partially meet critical unmet clinical needs. In addition, decreased reliance on generic immunomodulatory agents, androgens, and erythropoietin-stimulating agents will also propel the market growth in the coming years.

Increased utilization of novel combination regimens with premium-priced agents is also expected to drive the growth of the market in the forecast period.

Myelofibrosis Market Segmentation by Countries

Some of the major countries in the Myelofibrosis market are the US, France, Germany, Italy, Spain, the UK, Japan, and China. The US led the Myelofibrosis market in 2021 in terms of the value of sales.

Incyte markets Jakafi in the US and Novartis markets Jakavi in the five major European markets (5EU) (France, Germany, Italy, Spain, and UK), Japan, and China. Jakafi/Jakavi sales are forecast to diminish slowly to moderately until 2028 when it comes off-patent in the US, with sales being eroded by novel pipeline agents capturing patient share in the second-line setting.

Myelofibrosis Market Analysis by Countries, 2021 (%)

Myelofibrosis Market Analysis by Countries (%)

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Myelofibrosis Market Segmentation by Class

The World Health Organization (WHO) classification system for tumors of the hematopoietic and lymphoid tissues classifies Myelofibrosis as a JAK2/CALR/MPL mutation-associated MPN negative for BCR-ABL1 oncogene or Philadelphia chromosome. Under this classification, PMyelofibrosis is subdivided into prefibrotic PMyelofibrosis and overt PMyelofibrosis, primarily differentiated by the histological grading of fibrosis. There are several Myelofibrosis scoring systems used to stratify patient risk and estimate prognosis.

The National Comprehensive Cancer Network recommends the Mutation and Karyotype-Enhanced International Prognosis Scoring System (MIPSS70) Plus Version 2, which encompasses a broad range of symptoms and incorporates genetic risk factors.

For more class insights into the Myelofibrosis market, download a free report sample

Myelofibrosis Market - Competitive Landscape

Some of the leading players in the UC market are Bristol Myers Squib, Novartis, GSK, Incyte, Zelgen, AbbVie, and CTi among others. Several late-stage pipeline agents are geared towards partially meeting these unmet needs, such as GSK’s momelotinib, a novel JAK inhibitor that targets the second line of therapy and has demonstrated promising anemia efficacy, and CTI BioPharma’s JAK inhibitor Vonjo (pelabresib), which is now available in the US under FDA accelerated approval for patients with thrombocytopenia who cannot receive conventional JAK inhibitors.

Scope

This report provides:

  • 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 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 a qualitative analysis of its implications.

Key Highlights

Report deliverables include a PowerPoint report and 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

Reasons to Buy

The report will enable you to:

  • 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 counterstrategies 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

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

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 Us

Table

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

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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