Market Spotlight:  Gastrointestinal Stromal Tumor (GIST)

 This Market Spotlight report covers the gastrointestinal stromal tumor (GIST) market, comprising key pipeline and marketed drugs, clinical trials, key regulatory events, patent information, a 10-year disease prevalence forecast, and drug-specific revenue forecasts.

Key Takeaways

Datamonitor Healthcare 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 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 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 two 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 clinical trials distribution across Phases I–IV indicates that the majority of trials for GIST have been in early and mid-phases 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. The UK leads 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 and Pfizer have the highest number of completed clinical trials for this condition, with 55 and 30, respectively. Novartis leads industry sponsors with the highest number of clinical trials for GIST

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Major TOC Market:

  KEY TAKEAWAYS

  DISEASE BACKGROUND

  TREATMENT
  Surgery
  Targeted therapy
  Other treatments

  EPIDEMIOLOGY

  MARKETED DRUGS
  Approvals by country

  PIPELINE DRUGS IN THE US

  KEY REGULATORY EVENTS
  Blueprint Lays Out Path To Early Approval In Small GIST Population

  PARENT PATENTS

  REVENUE OPPORTUNITY

  CLINICAL TRIAL LANDSCAPE
  Sponsors by status
  Sponsors by phase

  BIBLIOGRAPHY
  Prescription information:

  APPENDIX

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: Parent patents in gastrointestinal stromal tumor
  Figure 7: Clinical trials in gastrointestinal stromal tumor
  Figure 8: Top 10 drugs for clinical trials in gastrointestinal stromal tumor
  Figure 9: Top 10 companies for clinical trials in gastrointestinal stromal tumor
  Figure 10: Trial locations in gastrointestinal stromal tumor
  Figure 11: Gastrointestinal stromal tumor trials status
  Figure 12: 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

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