Research estimates that the MF market in the 7MM in 2015 to be valued at $545.2m. The market is defined as sales from approved branded drugs as well as off-label drugs used for the treatment of MF. The majority of 2015 sales, $405.5m (74.4%), were generated in the US, while sales in the 5EU and Japan were estimated to be $133.2m (24.4%) and $6.5m (1.2%), respectively.
By 2025, the MF market is expected to grow to $1.02 billion across the 7MM at a Compound Annual Growth Rate (CAGR) of 6.4%. At the end of the forecast period, the majority of sales, $737m (72.5%), will still be generated in the US, and sales in the 5EU and Japan are forecast to be $265.6m (26.1%) and $13.4m (1.3%), respectively.
Major drivers of the growth of the MF market in the 7MM over the forecast period will include:
- The launch of pipeline agents, including Gilead’s momelotinib, Promedior’s PRM-151, and Johnson & Johnson(J&J)/Geron’s imetelstat. These pipeline drugs are expected to command a premium price compared to existing products and off-label drugs, and their uptake is expected to drive the overall growth of the MF market. The availability of new drugs will also increase the number of lines of therapy that MF patients receive.
- An increase in the incidence of MF from 3,791 new cases in 2015 to just over 4,300 new cases in 2025, at an Annual Growth Rate (AGR) of 1.5%, as forecast by GlobalData’s epidemiology team. This increase, coupled with an anticipated increase in branded therapy prescription, will drive growth of the global MF market over the forecast period.
- An increase in the use of drugs for the treatment of splenomegaly and constitutional symptoms in the 5EU and Japan over the forecast period. GlobalData’s primary research showed that this market segment has not been saturated in the base year.
Major barriers to the growth of the MF market in the 7MM over the forecast period will include:
- The low incidence of MF and consequent small market size, compared to other oncology indications. This makes it less attractive to drug developers. In fact, this is shown by the fact that there are only three promising Phase II–III products in the MF pipeline, and only one of them is in Phase III development.
- The lack of development in the treatment of MF-associated anemia. All the current drug therapies for anemia are off-label drugs, and there are no promising pipeline agents in this area, leading to a stagnant market segment throughout the forecast period.
- The high cost of treatment for MF, especially Jakafi (ruxolitinib). Pressure for cost control in healthcare will limit the reimbursement of new market entrants, particularly in the EU. In addition, payers in the US are also getting more cost-conscious in the expensive oncology market.
Table of Content: Key Points
1 Table of Contents 9
1.1 List of Tables 14
1.2 List of Figures 17
2 Introduction 19
2.1 Catalyst 19
2.2 Related Reports 19
2.3 Upcoming Related Reports 20
3 Disease Overview 21
3.1 Etiology and Pathophysiology 21
3.1.1 Etiology 22
3.1.2 Pathophysiology 23
3.2 Classification and Prognosis 25
3.3 Symptoms 27
3.4 Quality of Life 30
4 Epidemiology 31
4.1 Risk Factors and Comorbidities 32
4.2 Global Trends 34
4.2.1 US 35
4.2.2 5EU 37
4.2.3 Japan 37
4.3 Forecast Methodology 37
4.3.1 Sources Used 37
4.3.2 Forecast Assumptions and Methods 48
4.3.3 Sources Not Used 61
4.4 Epidemiological Forecast of Myelofibrosis (2015-2025) 62
4.4.1 Diagnosed Incident Cases 62
4.4.2 Diagnosed Prevalent Cases 77
4.5 Discussion 90
4.5.1 Epidemiological Forecast Insight 90
4.5.2 Limitations of the Analysis 91
4.5.3 Strengths of the Analysis 92
5 Current Treatment Options 93
5.1 Overview 93
5.2 Diagnosis and Treatment 94
5.2.1 Diagnosis 94
5.2.2 Treatment Guidelines and Leading Prescribed Drugs 99
5.2.3 Clinical Practice 100
5.3 Major Brands – JAK Inhibitors 108
5.3.1 Jakafi (Ruxolitinib) 108
5.4 Conventional Medical Therapy (Off-Label) 120
5.4.1 Cytoreductive Drugs 120
5.4.2 Androgen Therapies 121
5.4.3 Erythropoiesis-Stimulating Agents 124
5.4.4 Immunomodulatory Imide Drugs 124
5.4.5 Anti-fibrotic Agents 126
6 Unmet Needs Assessment and Opportunity Analysis 127
6.1 Overview 127
6.2 Development of Curative Treatments 128
6.2.1 Unmet Need 128
6.2.2 Gap Analysis 129
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