Market Spotlight: Myelofibrosis
Market Spotlight: Myelofibrosis
This Market Spotlight report covers the Myelofibrosis market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, 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
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.
- 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.
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
10 Curative treatment
15 MARKETED DRUGS
17 PIPELINE DRUGS
25 RECENT EVENTS AND ANALYST OPINION
25 CPI-0610 for Myelofibrosis (June 3, 2019)
27 Fedratinib for Myelofibrosis (June 3, 2019)
29 KEY UPCOMING EVENTS
30 KEY REGULATORY EVENTS
30 Celgene Takes Important Regulatory Step Ahead Of Bristol Merger With Fedratinib Filing
30 Pacritinib MAA Withdrawal
30 Patients Speak Up On Pacritinib
30 Four Drugs Set For EU Approval, EMA Holds Fire On Pacritinib
30 Moment Of Truth For Pacritinib And Other EU Approval Hopefuls
32 PROBABILITY OF SUCCESS
33 LICENSING AND ASSET ACQUISITION DEALS
33 Deals Shaping The Medical Industry, January 2019
33 Geron Has Cash, But Does It Have The Imetelstat Data To Push On Without Janssen?
34 Sierra Believes It Can Do Better Than Gilead With JAK Inhibitor Momelotinib
35 PARENT PATENTS
36 REVENUE OPPORTUNITY
37 CLINICAL TRIAL LANDSCAPE
38 Sponsors by status
39 Sponsors by phase
41 Prescription information
LIST OF FIGURES
14 Figure 1: Trends in prevalent cases of myelofibrosis, 2017–26
17 Figure 2: Overview of pipeline drugs for myelofibrosis in the US
18 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: CPI-0610 for Myelofibrosis (June 3, 2019): Phase I/II – MANIFEST (+/- Ruxolitinib)
29 Figure 7: Key upcoming events in myelofibrosis
32 Figure 8: Probability of success in the myelofibrosis pipeline
33 Figure 9: Licensing and asset acquisition deals in myelofibrosis, 2014–19
35 Figure 10: Parent patents in myelofibrosis
37 Figure 11: Clinical trials in myelofibrosis
37 Figure 12: Top 10 drugs for clinical trials in myelofibrosis
38 Figure 13: Top 10 companies for clinical trials in myelofibrosis
38 Figure 14: Trial locations in myelofibrosis
39 Figure 15: Myelofibrosis trials status
40 Figure 16: Myelofibrosis trials sponsors, by phase
LIST OF TABLES
13 Table 1: Prevalent cases of myelofibrosis, 2017–26
16 Table 2: Marketed drugs for myelofibrosis
20 Table 3: Pipeline drugs for myelofibrosis in the US
25 Table 4: CPI-0610 for Myelofibrosis (June 3, 2019)
28 Table 5: Fedratinib for Myelofibrosis (June 3, 2019)
36 Table 6: Historical global sales, by drug ($m), 2014–18
36 Table 7: Forecasted global sales, by drug ($m), 2019–23
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