Myelofibrosis (MF) is a rare blood disorder, which is characterized by bone marrow fibrosis. Currently, there is only one approved drug, Incyte/Novartis Jakafi (ruxolitinib), for the treatment of MF, and other conventional therapies used in MF are off-label. However, none of these drugs are curative, and the only potentially curative intervention is allogeneic stem cell transplant (allo-SCT), which is available to a very small percentage of eligible patients because of the high risk of morbidity and mortality. Therefore, there is a huge unmet need for the treatment of MF.
This report highlights the significant unmet need for novel drug treatment for MF, both to alleviate MF-associated complications and to reverse the disease course, across the seven major markets; it also discusses the associated commercial opportunities for new market entrants to gain a foothold in the market. GlobalData anticipate the MF market to almost double, from $545.2m to $1.01 billion, over the forecast period of 2015-2025. The key drivers wills be the launch of pipeline drugs, increasing incidence and an increase in the use of drugs for splenomegaly and constitutional symptoms in the 5EU and Japan.
Key Questions Answered
- The MF market has high unmet need. What are the main unmet needs in this market? How will the drugs under development fulfil the unmet needs of the MF market?
- There are three middle- to late-stage MF pipeline drugs expected to launch during the forecast period. Will these drugs make a significant impact on the MF market? Which of these drugs will have the deepest patient penetration and highest peak sales, and why?
- The current MF market is dominated by one JAK inhibitor, Jakafi. How will the launch of pipeline drugs with novel mechanism of action change this? How will the way MF patients are treated change over the next years? What are the key drivers and barriers to this change?
- The launch of premium priced products, in particular second-line treatments for patients who are refractory to Jakafi, will be the main drivers of growth in he MF market.
- There are high unmet needs in MF. The biggest unmet need is for curative treatments. The unmet needs will only be partially addressed by the major pipeline drugs. In addition, there are currently no approved or major pipeline drugs for MF-associated anemia. Any drug that can get approved in this setting can expect a lucrative return.
- Key Opinion Leaders urged pharma companies to focus their R&D strategies on trying to reverse the disease course of MF. This will involve collaborating with academics to identify new molecular targets.
- One key R&D strategy will be developing drugs that reverse bone marrow fibrosis.
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- Overview of MF, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, treatment guidelines and disease management.
- Annualized MF therapeutics market revenue, average cost of therapy and treatment usage pattern data from 2015 and forecast for seven years to 2025.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the MF therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of middle- to late-stage pipeline drugs.
- Analysis of the current and future market competition in the global MF 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
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. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global MF therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global MF therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global MF therapeutics market from 2015-2025.
- Organize your sales and marketing efforts by identifying the market categories
Table of Contents
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
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