This Market Spotlight report covers the Glioblastoma (GBM) market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Key Takeaways The analyst estimates that in 2019, there were 77,000 incident cases of glioblastoma worldwide, and forecasts that number to increase to 91,800 incident cases by 2028.
It is estimated that the majority of diagnosed cases were in males in 2019. Approved drugs in the glioblastoma space focus on DNA, vascular endothelial growth factor, DNA synthesis, protein synthesis, and RNA synthesis. These drugs are administered via the intravenous, intratumoral, and oral routes for glioblastoma.
The majority of industry-sponsored drugs in active clinical development for glioblastoma are in Phase II, with only one drug in the NDA/BLA phase.
Therapies in mid- and late-stage development for glioblastoma focus on a wide variety of targets. The majority of pipeline drugs for glioblastoma are administered via the oral and intravenous routes.
High-impact upcoming events for drugs in the glioblastoma space comprise topline Phase I trial results, topline Phase I/II trial results, topline Phase II trial results, topline Phase III trial results, Phase III updated trial results, and an expected PDUFA date.
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 vast majority of trials for glioblastoma have been in the early and mid-phases of development, with 92% of trials in Phase I–II, and only 8% in Phase III–IV.
The US has a substantial lead in the number of glioblastoma clinical trials globally. France leads the major European markets, while China has the top spot in Asia.
Clinical trial activity in the glioblastoma space is dominated by completed trials. Merck and Co has the highest number of completed clinical trials for glioblastoma, with 80 trials.
Merck and Co leads industry sponsors with the highest overall number of clinical trials for glioblastoma, closely followed by Roche.
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