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Market Spotlight: Myelofibrosis (MF)

  • Report

  • 44 Pages
  • June 2021
  • Region: Global
  • Citeline
  • ID: 4421371
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
  • The publisher 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 III trial results for pacritinib, Reblozyl, momelotinib, and imetelstat, as well as an estimated PDUFA date for pacritinib.
  • The overall likelihood of approval of a Phase I hematologic asset is 8.6%, and the average probability a drug advances from Phase III is 59.1%. Drugs, on average, take 9.5 years from Phase I to approval, compared to 9.6 years in the overall oncology space
  • The distribution of clinical trials across Phase I–IV indicates that the majority of trials for myelofibrosis have been in the early and mid-phases of development, with 80% of trials in Phase I–II, and only 20% in Phase III–IV.
  • The US has a substantial lead in the number of myelofibrosis clinical trials globally. Germany leads the major European markets, while Israel 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.

Table of Contents

OVERVIEWKEY TAKEAWAYSDISEASE BACKGROUND
TREATMENT
  • Anemia
  • Splenomegaly
  • Curative treatment

EPIDEMIOLOGYMARKETED DRUGSPIPELINE DRUGS
RECENT EVENTS AND ANALYST OPINION
  • Bomedemstat for Myelofibrosis (December 5, 2020)
  • Momelotinib for Myelofibrosis (December 5, 2020)
  • Pelabresib for Myelofibrosis (December 5, 2020)
  • Momelotinib for Myelofibrosis (May 6, 2020)
  • Navitoclax for Myelofibrosis (December 9, 2019)
  • Reblozyl for Myelofibrosis (November 6, 2019)

KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
  • BMS Buoyed By EU Approval Of Myelofibrosis Drug
  • EU Approvals Beckon For Inrebic & Novel Adalimumab Biosimilar
  • CTI’s Pacritinib Rolls Toward A Return
  • Winners & Losers: A Deep-Dive Into The EMA’s PRIME Scheme

PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
  • Nippon Shinyaku Licenses Menarini’s Tagraxofusp For Japan
  • Bristol Acquisition Of Forbius Driven By TGF-beta Assets

REVENUE OPPORTUNITY
CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase

BIBLIOGRAPHYAPPENDIX
LIST OF FIGURES
Figure 1: Trends in prevalent cases of myelofibrosis, 2019–28
Figure 2: Overview of pipeline drugs for myelofibrosis in the US
Figure 3: Pipeline drugs for myelofibrosis, by company
Figure 4: Pipeline drugs for myelofibrosis, by drug type
Figure 5: Pipeline drugs for myelofibrosis, by classification
Figure 6: Momelotinib for Myelofibrosis (May 6, 2020): Phase III - Simplify 2 (vs Best Available Therapy)
Figure 7: Reblozyl for Myelofibrosis (November 6, 2019): Phase II - MF-001
Figure 8: Key upcoming events in myelofibrosis
Figure 9: Probability of success in the hematologic pipeline
Figure 10: Clinical trials in myelofibrosis
Figure 11: Top 10 drugs for clinical trials in myelofibrosis
Figure 12: Top 10 companies for clinical trials in myelofibrosis
Figure 13: Trial locations in myelofibrosis
Figure 14: Myelofibrosis trials status
Figure 15: Myelofibrosis trials sponsors, by phase
LIST OF TABLES
Table 1: Prevalent cases of myelofibrosis, 2019–28
Table 2: Marketed drugs for myelofibrosis
Table 3: Pipeline drugs for myelofibrosis in the US
Table 4: Bomedemstat for Myelofibrosis (December 5, 2020)
Table 5: Momelotinib for Myelofibrosis (December 5, 2020)
Table 6: Pelabresib for Myelofibrosis (December 5, 2020)
Table 7: Momelotinib for Myelofibrosis (May 6, 2020)
Table 8: Navitoclax for Myelofibrosis (December 9, 2019)
Table 9: Reblozyl for Myelofibrosis (November 6, 2019)
Table 10: Historical global sales, by drug ($m), 2016–20
Table 11: Forecasted global sales, by drug ($m), 2021–25