This Market Spotlight report covers the Glioblastoma market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, patent information, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
- The author estimates that in 2017, there were approximately 70,000 incident cases of glioblastoma worldwide, and forecasts that number to increase to 87,100 incident cases by 2026.
- It is estimated that the majority of diagnosed cases were in males in 2017.
- The incidence of glioblastoma is highest among older individuals aged 75–84 years. 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 GBM.
- The majority of industry-sponsored drugs in active clinical development for glioblastoma are in Phase II. 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 trial results for naxitamab and GDC0084, topline Phase III trial results for DCVax-Brain and Trans Sodium Crocetinate (TSC), topline Phase Ib/IIa trial results for INO5401, and Phase III safety and efficacy analysis for Toca 511.
- The overall likelihood of approval of a Phase I solid tumors asset is 5.6%, and the average probability a drug advances from Phase III is 40%. Drugs, on average, take 9.5 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
- There have been 41 licensing and asset acquisition deals involving glioblastoma drugs during 2014–19. The largest deal during the period was the $548m licensing agreement between I-Mab Biopharma and Genexine in 2017, to develop and commercialize a proprietary long-acting immuno-oncology drug (HyLeukin) in the Greater China territories.
- The distribution of clinical trials across Phase I–IV indicates that the 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. The UK leads the major EU markets, while Japan has the top spot in Asia.
- Clinical trial activity in the glioblastoma space is dominated by completed trials. Merck & Co has the highest number of completed clinical trials for glioblastoma, with 78 trials.
- Merck & Co leads industry sponsors with the highest overall number of clinical trials for glioblastoma, followed by Roche and Novartis.
- Disease definition
- Patient segmentation
- Risk factors
- Radiation therapy
- Tumor-treating fields (TTFs)
- Targeted therapy
RECENT EVENTS AND ANALYST OPINION
- Opdivo for Glioblastoma (September 5, 2019)
- Mvasi for Glioblastoma (June 25, 2019)
- Ripretinib for Glioblastoma (June 11, 2019)
- AG-881 for Glioblastoma (June 3, 2019)
- Multiple Drugs for Glioblastoma (June 3, 2019)
- Opdivo for Glioblastoma (May 9, 2019)
- MDNA55 for Glioblastoma (October 31, 2018)
- DCVax-Brain for Glioblastoma (May 29, 2018)
- VB-111 for Glioblastoma (March 8, 2018)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
- Pfizer Could Launch US Bevacizumab This Year Despite Patent Thicket
- Approval of SonoCloud-9 Ultrasound Device
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- Tech Transfer Roundup: Mustang, Nationwide Children’s Hospital Collaborate In Pediatric Glioblastoma
- IST Bio, twoXAR Join Hands To Discover, Develop GBM Treatment
- Troubled MabVax To Merge With Oncotelic
- FUJIFILM Licenses Oncology Radiopharmaceutical To Novartis Affiliate
- Pascal Licenses Cannabinoid-Based Cancer Therapy From U Of Washington
- Oblato Gets GBM Candidate From Oklahoma Medical Research Foundation
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
- Prescription information
LIST OF FIGURES
Figure 1: Trends in incident cases of glioblastoma, 2017–26
Figure 2: Overview of pipeline drugs for glioblastoma in the US
Figure 3: Pipeline drugs for glioblastoma, by company
Figure 4: Pipeline drugs for glioblastoma, by drug type
Figure 5: Pipeline drugs for glioblastoma, by classification
Figure 6: Opdivo for Glioblastoma (September 5, 2019): Phase III – CheckMate-548
Figure 7: Opdivo for Glioblastoma (May 9, 2019): Phase III – CheckMate 498 (vs. Temozolomide)
Figure 8: MDNA55 for Glioblastoma (October 31, 2018): Phase IIb – MDNA55-05 (rGBM)
Figure 9: VB-111 for Glioblastoma (March 8, 2018): Phase III – GLOBE
Figure 10: Key upcoming events in glioblastoma
Figure 11: Probability of success in the glioblastoma pipeline
Figure 12: Licensing and asset acquisition deals in glioblastoma, 2014–19
Figure 13: Parent patents in glioblastoma
Figure 14: Parent patents in glioblastoma [continued]
Figure 15: Clinical trials in glioblastoma
Figure 16: Top 10 drugs for clinical trials in glioblastoma
Figure 17: Top 10 companies for clinical trials in glioblastoma
Figure 18: Trial locations in glioblastoma
Figure 19: Glioblastoma trials status
Figure 20: Glioblastoma trials sponsors, by phase
LIST OF TABLES
Table 1: Global incident cases of glioblastoma, 2017–26
Table 2: Incident cases of glioblastoma, by gender, 2017
Table 3: Marketed drugs for glioblastoma
Table 4: Pipeline drugs for glioblastoma in the US
Table 5: Opdivo for Glioblastoma (September 5, 2019)
Table 6: Mvasi for Glioblastoma (June 25, 2019)
Table 7: Ripretinib for Glioblastoma (June 11, 2019)
Table 8: AG-881 for Glioblastoma (June 3, 2019)
Table 9: Multiple Drugs for Glioblastoma (June 3, 2019)
Table 10: Opdivo for Glioblastoma (May 9, 2019)
Table 11: MDNA55 for Glioblastoma (October 31, 2018)
Table 12: DCVax-Brain for Glioblastoma (May 29, 2018)
Table 13: VB-111 for Glioblastoma (March 8, 2018)
Table 14: Historical global sales, by drug ($m), 2014–18
Table 15: Forecasted global sales, by drug ($m), 2019–23