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

• Datamonitor Healthcare estimates that in 2021, there were 100,200 incident cases of glioblastoma in adults aged 20 years and older worldwide, and forecasts that number to increase to 110,800 incident cases by 2030.
• Approved drugs in the glioblastoma space focus on DNA, vascular endothelial growth factor, DNA synthesis, protein synthesis, RNA synthesis, the immune system, and oncolytic virus therapy. 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 two drugs 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 II, Phase II/III, and Phase III trial results, an estimated PDUFA date for a BLA, and an expected CHMP opinion, as well as approval decisions in the US and EU.
• The overall likelihood of approval of a Phase I solid tumors asset is 5.1%, and the average probability a drug advances from Phase III is 41.6%. Drugs, on average, take 9.9 years from Phase I to approval in the solid tumors space, as well as 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 93% of trials in Phase I–II, and only 7% 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. Roche has the highest number of completed clinical trials for glioblastoma, with 81 trials.
• Roche leads industry sponsors with the highest overall number of clinical trials for glioblastoma, followed by Merck & Co.