This Market Spotlight report covers the Gastrointestinal Stromal Tumor (GIST) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, regulatory events, probability of success, a 10-year disease incidence forecast, and drug-specific revenue forecasts.
Key Takeaways
Key Takeaways
- The publisher estimates that in 2019, there were 100,200 incident cases of gastrointestinal stromal tumor (GIST) worldwide, and expects that number to increase to 109,000 incident cases by 2028.
- The approved drugs in the GIST space target BCR-ABL fusion protein, KIT/c-KIT, platelet-derived growth factor receptor, plateletderived growth factor alpha, PPAR gamma, Raf kinase, VEGF receptor, and FMS-like tyrosine kinase 3. These therapies are administered via the oral route.
- Industry-sponsored drugs in active clinical development for GIST are spread evenly across Phase I and Phase II, with one drug in Phase III.
- Therapies in development for GIST focus on a wide variety of targets. The majority of pipeline drugs in development are administered orally, with the remainder being tested in intratumoral and intravenous formulations.
- The only high-impact upcoming event in the GIST space is topline Phase III trial results for Qinlock. 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 42.8%. 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 GIST have been in the early and midphases of development, with 83% of trials in Phase I–II, and only 17% in Phase III–IV.
- The US has a substantial lead in the number of GIST clinical trials globally. France leads the major European markets, while China 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, with 65 trials.
- Novartis leads industry sponsors with by far the highest overall number of clinical trials for GIST.
Table of Contents
OVERVIEWKEY TAKEAWAYSDISEASE BACKGROUNDEPIDEMIOLOGYMARKETED DRUGSPIPELINE DRUGSKEY UPCOMING EVENTSPROBABILITY OF SUCCESSREVENUE OPPORTUNITYBIBLIOGRAPHYAPPENDIX
TREATMENT
RECENT EVENTS AND ANALYST OPINION
KEY REGULATORY EVENTS
CLINICAL TRIAL LANDSCAPE
LIST OF FIGURES
LIST OF TABLES