- 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 for 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, ganglioside GD2, and tryptophan hydroxylase. These drugs are predominantly administered via the oral, intravenous, and subcutaneous routes, while one product is available in an intramuscular formulation.
- The majority of industry-sponsored drugs in active clinical development for NETs are in Phase II. 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 smaller number being tested in oral, subcutaneous, intranasal, intramuscular, and intratumoral formulations.
- High impact upcoming events in the NETs space comprise topline Phase III trial results for sulfatinib, and a PDUFA date for Azedra.
- There have been five licensing and asset acquisition deals involving NETs drugs during 2013-18. 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 a disclosed value.
- 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 for drugs in the NETs space during 2012-16; however, its sales are forecasted to plummet during 2017-22 to reach $314m by 2022.
- The distribution of clinical trials across Phase I-IV indicates that the majority of trials for NETs have been in the early and midphases of development, with 79.4% of trials in Phase I-II, and only 20.6% in Phase III-IV.
- The US has a substantial lead in the number of NETs clinical trials globally, while the UK leads the major EU markets. Clinical trial activity in the NETs space is dominated by ongoing trials. Novartis has the highest number of ongoing clinical trials for NETs, with 11 trials.
- Novartis leads industry sponsors with the highest number of clinical trials for NETs, followed by Ipsen and Pfizer
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KEY UPCOMING EVENTS
LICENSING AND ASSET ACQUISITION DEALS
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CLINICAL TRIAL LANDSCAPE
List of Figures
Figure 1: Trends in incident cases of neuroendocrine tumors, 2016-25
Figure 2: Incident cases of neuroendocrine tumors, by age, 2016
Figure 3: Incident cases of neuroendocrine tumors, by tumor type, 2016
Figure 4: Overview of pipeline drugs for neuroendocrine tumors in the US
Figure 5: Pipeline drugs for neuroendocrine tumors, by company
Figure 6: Pipeline drugs for neuroendocrine tumors, by drug type
Figure 7: Pipeline drugs for neuroendocrine tumors, by classifications
Figure 8: Key upcoming events in neuroendocrine tumors
Figure 9: Licensing and asset acquisition deals in neuroendocrine tumors, 2013-18
Figure 10: Parent patents in neuroendocrine tumors
Figure 11: Clinical trials in neuroendocrine tumors
Figure 12: Top 10 drugs for clinical trials in neuroendocrine tumors
Figure 13: Top 10 companies for clinical trials in neuroendocrine tumors
Figure 14: Trial locations in neuroendocrine tumors
Figure 15: Neuroendocrine tumors trials status
Figure 16: Neuroendocrine tumors trials sponsors, by phase
List of Tables
Table 1: Incident cases of neuroendocrine tumors, 2016-25
Table 2: Marketed drugs for neuroendocrine tumors
Table 3: Approvals by country for neuroendocrine tumors
Table 4: Pipeline drugs for neuroendocrine tumors in the US
Table 5: Historical global sales, by drug ($m), 2012-16
Table 6: Forecasted global sales, by drug ($m), 2017-22