Market Spotlight: Myelofibrosis (MF)
Market Spotlight: Myelofibrosis (MF)
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This Market Spotlight report covers the Myelofibrosis (MF) market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
- Description
- Contents
This Market Spotlight report covers the Myelofibrosis (MF) market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Key Takeaways
- Datamonitor Healthcare estimates that in 2019, there were 49,500 prevalent cases of myelofibrosis in adults aged 50 years and older worldwide, and forecasts that number to increase to 60,700 prevalent cases by 2028.
- Bristol Myers Squibb’s Inrebic and Incyte’s Jakafi are the only marketed drugs for myelofibrosis. These drugs are administered via the oral route.
- The majority of industry-sponsored drugs in active clinical development for myelofibrosis are in Phase II, with one drug in the NDA/BLA stage.
- Therapies in development for myelofibrosis focus on a wide variety of targets. The majority of the pipeline drugs are administered via the oral route.
- High-impact upcoming events for drugs in the myelofibrosis space comprise topline Phase I/II trial results for Jakafi; topline Phase IIa trial results for GB2064; topline Phase III trial results for pacritinib, Reblozyl, Inrebic, Jakafi, momelotinib, navitoclax, imetelstat, INCB057643, and INCB000928; and an estimated PDUFA date for pacritinib.
- The overall likelihood of approval of a Phase I hematologic asset is 8.7%, and the average probability a drug advances from Phase III is 58.5%. Drugs, on average, take 9.6 years from Phase I to approval, compared to 9.7 years in the overall oncology space.
- The distribution of clinical trials across Phase I–IV indicates that the vast majority of trials for myelofibrosis have been in the early and mid-phases of development, with 81% of trials in Phase I–II, and only 19% in Phase III–IV.
- The US has a substantial lead in the number of myelofibrosis clinical trials globally. Italy leads the major European markets, while South Korea has the top spot in Asia.
- Novartis has the highest number of completed clinical trials for myelofibrosis, with 15 trials.
- Novartis leads industry sponsors with the highest overall number of clinical trials for myelofibrosis, followed by Incyte.
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
9 TREATMENT
9 Anemia
9 Splenomegaly
10 Curative Treatment
12 EPIDEMIOLOGY
15 MARKETED DRUGS
17 PIPELINE DRUGS
23 RECENT EVENTS AND ANALYST OPINION
23 Bomedemstat for Myelofibrosis (December 5, 2020)
24 Momelotinib for Myelofibrosis (December 5, 2020)
25 Pelabresib for Myelofibrosis (December 5, 2020)
27 KEY UPCOMING EVENTS
28 KEY REGULATORY EVENTS
28 BioCryst & Celgene Suffer English Funding Setback For Rare Disease Drugs
28 BMS Buoyed By EU Approval Of Myelofibrosis Drug
28 EU Approvals Beckon For Inrebic & Novel Adalimumab Biosimilar
30 PROBABILITY OF SUCCESS
31 LICENSING AND ASSET ACQUISITION DEALS
31 Merck’s $11.5bn Acceleron Buy Partially Fills Future Keytruda Revenue Gap
31 CTI BioPharma Enters Into Royalty Sales Agreement With DRI Healthcare
31 Sierra Oncology Signs Global License Agreement with AstraZeneca for AZD5153
31 MorphoSys Hits Refresh Button On Pipeline With Constellation Buy
32 Nippon Shinyaku Licenses Menarini’s Tagraxofusp For Japan
33 REVENUE OPPORTUNITY
34 CLINICAL TRIAL LANDSCAPE
35 Sponsors by status
36 Sponsors by phase
38 BIBLIOGRAPHY
39 APPENDIX
LIST OF FIGURES
14 Figure 1: Trends in prevalent cases of myelofibrosis, 2019–28
17 Figure 2: Overview of pipeline drugs for myelofibrosis in the US
17 Figure 3: Pipeline drugs for myelofibrosis, by company
18 Figure 4: Pipeline drugs for myelofibrosis, by drug type
18 Figure 5: Pipeline drugs for myelofibrosis, by classification
27 Figure 6: Key upcoming events in myelofibrosis
30 Figure 7: Probability of success in the hematologic pipeline
34 Figure 8: Clinical trials in myelofibrosis
34 Figure 9: Top 10 drugs for clinical trials in myelofibrosis
35 Figure 10: Top 10 companies for clinical trials in myelofibrosis
35 Figure 11: Trial locations in myelofibrosis
36 Figure 12: Myelofibrosis trials status
37 Figure 13: Myelofibrosis trials sponsors, by phase
LIST OF TABLES
13 Table 1: Prevalent cases of myelofibrosis, 2019–28
16 Table 2: Marketed drugs for myelofibrosis
19 Table 3: Pipeline drugs for myelofibrosis in the US
23 Table 4: Bomedemstat for Myelofibrosis (December 5, 2020)
24 Table 5: Momelotinib for Myelofibrosis (December 5, 2020)
25 Table 6: Pelabresib for Myelofibrosis (December 5, 2020)
33 Table 7: Historical global sales, by drug ($m), 2016–20
33 Table 8: Forecasted global sales, by drug ($m), 2021–25
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