This Market Spotlight report covers the Myelofibrosis market, comprising key marketed and pipeline drugs, clinical trials, upcoming and regulatory events, probability of success, patent information, 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 2017, there were 47,000 prevalent cases of myelofibrosis in adults aged 50 years and older worldwide, and forecasts that number to increase to 58,300 prevalent cases by 2026.
• The global prevalence of myelofibrosis is estimated to be 0.0027%. Incyte’s Jakafi (ruxolitinib phosphate) is the only marketed drug for myelofibrosis. It is the first FDA-approved oral JAK1/2 inhibitor for the treatment of the disease.
• The majority of industry-sponsored drugs in active clinical development for myelofibrosis are in Phase II, with one drug each in Phase III and the NDA/BLA phase.
• Therapies in mid-to-late-stage 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 II trial results for pacritinib, topline Phase III trial results for momelotinib, and an expected PDUFA date for fedratinib.
• The overall likelihood of approval of a Phase I hematologic asset is 10.1%, and the average probability a drug advances from Phase III is 57.7%. Drugs, on average, take 8.8 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
• There have been only three licensing and asset acquisition deals involving myelofibrosis drugs during 2014–19. The largest deal was the $1,250m agreement in 2015 between Bristol-Myers Squibb and Promedior, pursuant to which Bristol-Myers Squibb was granted an exclusive right to acquire Promedior along with its lead asset PRM-151, which is in development for idiopathic pulmonary fibrosis and myelofibrosis.
• 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 88% of trials in Phase I–II, and only 12% in Phase III–IV.
• The US has a substantial lead in the number of myelofibrosis clinical trials globally. Germany leads the major EU markets, while Israel has the top spot in Asia.
• Clinical trial activity in the myelofibrosis space is dominated by completed trials. Novartis has the highest number of completed clinical trials for myelofibrosis, with 14 trials.
• Novartis leads industry sponsors with the highest number of clinical trials for myelofibrosis, followed by Incyte.