Market Spotlight: Glioblastoma (GBM)
Market Spotlight: Glioblastoma (GBM)
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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.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
- Description
- Contents
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 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, 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 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/II, Phase II, and Phase III trial results, Phase III updated trial results, an estimated PDUFA date for a BLA, and an expected CHMP opinion, as well as an EU approval decision.
- 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 42.4%. Drugs, on average, take 9.7 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 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 & Co has the highest number of completed clinical trials for glioblastoma, with 84 trials.
- Merck & Co leads industry sponsors with the highest overall number of clinical trials for glioblastoma, closely followed by Roche.
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
8 Disease definition
8 Patient segmentation
8 Symptoms
8 Risk factors
9 Diagnosis
10 TREATMENT
10 Surgery
10 Radiation therapy
10 Chemotherapy
10 Tumor-treating fields (TTFs)
11 Targeted therapy
12 EPIDEMIOLOGY
16 MARKETED DRUGS
19 PIPELINE DRUGS
39 RECENT EVENTS AND ANALYST OPINION
39 DNX-2401 for Glioblastoma (November 20, 2020)
40 Omburtamab for Glioblastoma (October 16, 2020)
42 AG-881 for Glioblastoma (May 29, 2020)
43 FT-2102 for Glioblastoma (May 28, 2020)
45 KEY UPCOMING EVENTS
46 KEY REGULATORY EVENTS
46 Pioneering Japan Approval For Daiichi’s Oncolytic Virus In Glioma
46 Innovent’s Adalimumab And Bevacizumab Get New Indications In China
47 PROBABILITY OF SUCCESS
48 LICENSING AND ASSET ACQUISITION DEALS
48 Calidi Signs Licenses With Three Academic Partners In Oncolytic Virus Therapy
48 Kazia Therapeutics Enters Collaboration With Cornell University
48 Yale Unveils Research Pact With D&D Pharmatech
48 Lineage, Immunomic Partner On Brain Cancer Immunotherapy
49 UroGen, Johns Hopkins Investigate Brain Cancer Immunotherapy
49 Simcere Picks Up Kazia’s Paxalisib In China-Plus Area
49 Chimerix Pays $78m To Acquire Oncoceutics
50 Agios Sells Cancer Portfolio To Servier To Focus On Genetic Diseases
50 Connectyx Explores Use Of NCI Antibody For Brain Cancer
50 Telix Chooses China Grand In Greater China Alliance
51 REVENUE OPPORTUNITY
52 CLINICAL TRIAL LANDSCAPE
53 Sponsors by status
54 Sponsors by phase
55 Recent events
57 BIBLIOGRAPHY
59 APPENDIX
LIST OF FIGURES
14 Figure 1: Trends in incident cases of glioblastoma, 2019–28
19 Figure 2: Overview of pipeline drugs for glioblastoma in the US
19 Figure 3: Pipeline drugs for glioblastoma, by company
20 Figure 4: Pipeline drugs for glioblastoma, by drug type
20 Figure 5: Pipeline drugs for glioblastoma, by classification
40 Figure 6: DNX-2401 for Glioblastoma (November 20, 2020): Phase II – CAPTIVE/KEYNOTE-192 – w/Keytruda
42 Figure 7: Omburtamab for Glioblastoma (October 16, 2020): Phase II/III – 101 (Neuroblastoma Central Nervous System/Leptomeningeal Metastases)
44 Figure 8: FT-2102 for Glioblastoma (May 28, 2020): Phase I/II – 2101-ONC-102
45 Figure 9: Key upcoming events in glioblastoma
47 Figure 10: Probability of success in the solid tumors pipeline
52 Figure 11: Clinical trials in glioblastoma
52 Figure 12: Top 10 drugs for clinical trials in glioblastoma
53 Figure 13: Top 10 companies for clinical trials in glioblastoma
53 Figure 14: Trial locations in glioblastoma
54 Figure 15: Glioblastoma trials status
55 Figure 16: Glioblastoma trials sponsors, by phase
LIST OF TABLES
13 Table 1: Global incident cases of glioblastoma, 2019–28
15 Table 2: Incident cases of glioblastoma, by gender, 2019
17 Table 3: Marketed drugs for glioblastoma
21 Table 4: Pipeline drugs for glioblastoma in the US
39 Table 5: DNX-2401 for Glioblastoma (November 20, 2020)
41 Table 6: Omburtamab for Glioblastoma (October 16, 2020)
42 Table 7: AG-881 for Glioblastoma (May 29, 2020)
43 Table 8: FT-2102 for Glioblastoma (May 28, 2020)
51 Table 9: Historical global sales, by drug ($m), 2016–20
51 Table 10: Forecasted global sales, by drug ($m), 2021–25
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