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.
- The author estimates that in 2016, there were 46,000 prevalent cases of myelofibrosis in adults aged 50 years and older worldwide, and forecasts that number to increase to 57,000 prevalent cases by 2025.
- Global prevalence of myelofibrosis is estimated to be 0.0027%.
- A majority of industry-sponsored drugs in active clinical development for myelofibrosis are in Phase II.
- Therapies in mid- and late-stage development for myelofibrosis focus on targets such as JAK/STAT and hedgehog signaling pathways, FMS-like tyrosine kinase 3, IL-1 receptor-associated kinase 1, histone deacetylase, telomerase, transforming growth factor-beta receptor, Src kinase family, monocytes, interferon receptor, IL-3 receptor, and BCR-ABL fusion protein. Among these therapies, the JAK inhibitor pacritinib is the most clinically advanced. The majority of pipeline drugs in mid- to late-stage development for myelofibrosis are administered via the oral route.
- 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.
- High-impact upcoming events for drugs in the myelofibrosis space include pacritinib's topline Phase II trial results and its expected CHMP opinion.
- Licensing and asset acquisition activity involving myelofibrosis drugs has been weak during 2012-17, with only four deals. The largest deal during this period was the $1,250m agreement 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 clinical trial distribution across Phases I-IV indicates that the majority of drugs are in early and mid-phases of development, with 87% of trials in Phases I-II, and only 13% in Phases III-IV.
- The US has a substantial lead in the number of myeloproliferative neoplasms clinical trials globally, yet the forecasted prevalent cases of myelofibrosis are lower in North America as compared with Asia and Europe. Germany leads the major EU markets, while South Korea has the top spot in Asia, where the prevalent cases of myelofibrosis are the highest.
- Clinical trial activity in the myeloproliferative neoplasms space is dominated by completed trials. Novartis has the highest number of completed clinical trials for myeloproliferative neoplasms.
Key Topics Covered:
1 Key Takeaways
2 Disease Background
5 Pipeline Drugs
6 Marketed Drugs
7 Key Upcoming Events
8 Key Regulatory Events
9 Licensing And Asset Acquisition Deals
10 Parent Patents
11 Revenue Opportunity
12 Clinical Trials Landscape
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