This Market Spotlight report covers the gastrointestinal stromal tumor (GIST) market, comprising key marketed and pipeline drugs, clinical trials, key upcoming events, key regulatory events, patent information, a 10-year disease incidence forecast, and drug-specific revenue forecasts.
- The author estimates that in 2016, there were 96,400 incident cases of gastrointestinal stromal tumor (GIST) worldwide, and expects that number to increase to 105,600 incident cases by 2025.
- Incidence (per 100,000) is highest in Asia and lowest in Northern America. The approved drugs in the GIST space target platelet-derived growth factor receptor (PDGFR), BCR-ABL fusion protein, vascular endothelial growth factor (VEGF) receptor, KIT/c-KIT, Raf kinase, and FMS-like tyrosine kinase 3. All of the marketed drugs for GIST are administered via the oral route.
- The majority of industry-sponsored drugs in active clinical development for GIST are in Phase II, with only three drugs in Phase III.
- Therapies in mid- to late-stage development for GIST focus on a variety of targets. The majority of pipeline drugs in mid- to latestage development for GIST are administered via the oral route.
- Sutent’s (sunitinib) US method of use patent is set to expire in December 2020, which will open the door to generic entry.
- Gleevec (imatinib) sales ranked highest in the GIST space during 2012-16. The distribution of clinical trials across Phases I-IV indicates that the majority of trials for GIST have been in early and midphases of development, with 82.7% of trials in Phase I-II and only 17.3% in Phase III-IV.
- The US has a substantial lead in the number of GIST clinical trials globally. The UK and France lead the major EU markets, while Japan has the top spot in Asia.
- Clinical trial activity in the GIST space is dominated by completed trials. Novartis has the highest number of completed clinical trials for GIST, followed by Pfizer. Novartis leads industry sponsors with the highest number of clinical trials for GIST.
Approvals by country
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
Blueprint Lays Out Path To Early Approval In Small GIST Population
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
List of Figures
Figure 1: Trends in incident cases of gastrointestinal stromal tumor, 2016-25
Figure 2: Pipeline drugs for gastrointestinal stromal tumor in the US
Figure 3: Pipeline drugs for gastrointestinal stromal tumor, by company
Figure 4: Pipeline drugs for gastrointestinal stromal tumor, by drug type
Figure 5: Pipeline drugs for gastrointestinal stromal tumor, by classifications
Figure 6: Key upcoming events in gastrointestinal stromal tumor
Figure 7: Parent patents in gastrointestinal stromal tumor
Figure 8: Clinical trials in gastrointestinal stromal tumor
Figure 9: Top 10 drugs for clinical trials in gastrointestinal stromal tumor
Figure 10: Top 10 companies for clinical trials in gastrointestinal stromal tumor
Figure 11: Trial locations in gastrointestinal stromal tumor
Figure 12: Gastrointestinal stromal tumor trials status
Figure 13: Gastrointestinal stromal tumor trials sponsors, by phase
List of Tables
Table 1: Incident cases of gastrointestinal stromal tumor, 2016-25
Table 2: Incidence rates of gastrointestinal stromal tumor, 2016-25
Table 3: Marketed drugs for gastrointestinal stromal tumor
Table 4: Approvals by country for gastrointestinal stromal tumor
Table 5: Pipeline drugs for gastrointestinal stromal tumor in the US
Table 6: Historical global sales, by drug ($m), 2012-16
Table 7: Forecasted global sales, by drug ($m), 2017-22