This Market Spotlight report covers the Neuroendocrine Tumors market, comprising key pipeline and marketed drugs, clinical trials, upcoming events, patent information, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
- The author estimates that in 2016, there were approximately 450,300 incident cases of neuroendocrine tumors (NETs) worldwide, and forecasts that number to increase to 543,800 incident cases by 2025.
- Worldwide, the majority of NETs were malignant carcinoid tumors or neuroendocrine carcinomas. The approved drugs in the NETs target somatostatin receptors, tyrosine hydroxylase, mammalian target of rapamycin/mTORC, FMS-like tyrosine kinase 3, KIT/c-KIT, platelet-derived growth factor receptor, VEGF receptor, and ganglioside GD2. These drugs are administered via the oral, intravenous, and subcutaneous routes, however, one product is available in intramuscular formulation.
- Two therapies are currently in NDA/BLA phase for NETs. Therapies in the pipeline for NETs focus on a wide variety of targets. The majority of pipeline drugs in development are administered intravenously, with a few drugs being tested in oral, subcutaneous, intranasal, intramuscular and intratumoral formulations.
- High-impact upcoming events in the NETs space include topline Phase III trial results for sulfatinib, and estimated PDUFAs for Lutathera and Azedra.
- There were only five licensing and asset acquisition activities involving NETs drugs during 2012-17. The $115m exclusive licensing agreement (in November 2017) between Nanocarrier and VBL therapeutics, for the development, commercialization, and supply of VB-111 (ofranergene obadenovec) in Japan, was the only deal with disclosed deal value during the period.
- Somatuline Autogel's composition patent, and Sutent's method of use patent are set to expire in 2020 and 2021, respectively, which will open the door to generic entry.
- Afinitor sales ranked highest in the NETs space during 2012-16, however, its sales are forecasted to plummet during 2017-22 to reach $305m by 2021.
- The clinical trials distribution across Phase I-IV indicates that the majority of trials for NETs have been in early and mid-phases of development, with 79% of trials in Phase I-II, and only 21% in Phase III-IV.
- The US has a substantial lead in the number of NETs clinical trials globally. The UK leads the major EU markets. Clinical trial activity in the NETs space is dominated by completed trials. Ipsen has the highest number of completed clinical trials for NETs, with eight completed trials, followed by Novartis and Pfizer with five completed trials each.
- Novartis leads industry sponsors with the highest number of clinical trials for NETs, followed by Ipsen and Pfizer.
Key Topics Covered:
Neuroendocrine Tumors Subtypes
Hepatic artery embolization
KEY UPCOMING EVENTS
LICENSING AND ASSET ACQUISITION DEALS
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CLINICAL TRIAL LANDSCAPE
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