This Market Spotlight report covers the Neuroendocrine Tumors (NETs) market, comprising key marketed and pipeline drugs, clinical trials, probability of success, upcoming and regulatory events, a 10-year disease incidence and prevalence forecast, and licensing and asset acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

• Datamonitor Healthcare estimates that in 2019, there were approximately 531,400 incident cases of neuroendocrine tumors (NETs) worldwide, and forecasts that number to increase to 639,200 incident cases by 2028.
• Worldwide, the majority of NETs in 2019 were malignant carcinoid tumors or neuroendocrine carcinomas. The approved drugs in the NETs space focus on targets such as norepinephrine (noradrenaline), radiopharmaceutical, mammalian target of rapamycin/mTORC, tyrosine hydroxylase, somatostatin receptors, FMS-like tyrosine kinase 3, KIT/c-KIT, platelet-derived growth factor receptor, VEGF receptor, ganglioside GD2, tryptophan hydroxylase, cluster of differentiation 3, fibroblast growth factor receptor, and macrophage colony stimulating factor 1. 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, with one drug in the NDA/BLA stage.
• Therapies in the pipeline for NETs focus on a wide variety of targets. The largest proportion of these therapies are administered intravenously, with the remainder being oral, subcutaneous, intranasal, and intratumoral formulations.
• High-impact upcoming events for drugs in the NETs space comprise topline Phase II trial results for Fyarro, and an expected CHMP opinion as well as an estimated PDUFA date for surufatinib.
• The overall likelihood of approval of a Phase I solid tumors asset is 5.3%, and the average probability a drug advances from Phase III is 42.3%. Drugs, on average, take 9.7 years from Phase I to approval, compared to 9.6 years in the overall oncology space.
• 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 77% of trials in Phase I–II, and only 23% in Phase III–IV.
• The US has a substantial lead in the number of NETs clinical trials globally. Spain leads the major European markets, while China has the top spot in Asia.
• Novartis has the highest number of completed clinical trials for NETs, with 23 trials. Novartis also leads industry sponsors with the highest overall number of clinical trials for NETs, followed by Ipsen.