Product Code: DMKC0185529
This Market Spotlight report covers the Sarcoma market, comprising key marketed and pipeline drugs, clinical trials, upcoming and regulatory events, patent information, probability of success, recent events and analyst opinion, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
- Datamonitor Healthcare estimates that in 2019, there were approximately 430,300 incident cases of sarcoma worldwide, and forecasts that number to increase to 503,700 incident cases by 2028. Worldwide, the majority of sarcoma cases were soft tissue and other extraosseous sarcomas (85%), while a smaller proportion were osteosarcomas and other malignant bone tumors (15%).
- The approved drugs in the sarcoma space focus on a wide variety of targets. These drugs are administered via the intravenous and oral routes.
- The majority of industry-sponsored drugs in active clinical development for sarcoma are in Phase II. Therapies in development for sarcoma focus on a wide variety of targets. The majority of these therapies are administered via the oral and intravenous routes, with the remainder being intraocular/subretinal/subconjunctival, intradermal, intramuscular, intraarterial, intratumoral, and topical formulations.
- Topline Phase II trial results for ADP-A2M4CD8 is the only high-impact upcoming event for drugs in the sarcoma space. The overall likelihood of approval of a Phase I sarcoma asset is 11.1%, and the average probability a drug advances from Phase III is 50%. Drugs, on average, take 9.6 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
- There have been 16 licensing and asset acquisition deals involving sarcoma drugs during 2015-20. The largest deal was the $1,119m exclusive licensing agreement signed in 2016 between Exelixis and Ipsen, pursuant to which Ipsen received exclusive commercialization rights to Exelixis's current and potential future cabozantinib indications outside the US, Canada and Japan, including Cometriq.
- The distribution of clinical trials across Phase I-IV indicates that the vast majority of trials for sarcoma have been in the early and mid-phases of development, with 89% of trials in Phase I-II, and only 11% in Phase III-IV.
- The US has a substantial lead in the number of sarcoma clinical trials globally. France leads the major European markets, while Israel has the top spot in Asia.
- Clinical trial activity in the sarcoma space is dominated by completed trials. Merck & Co has the highest number of completed clinical trials for sarcoma, with 21 trials.
- Merck & Co leads industry sponsors with the highest overall number of clinical trials for sarcoma, followed by Bristol Myers Squibb and Novartis
TABLE OF CONTENTS
- Radiation therapy
- Targeted therapies
- Epidemiological disease definition
RECENT EVENTS AND ANALYST OPINION
- Tazverik for Sarcoma (December 18, 2019)
- Tazverik for Sarcoma (December 16, 2019)
- Bempegaldesleukin for Sarcoma (June 3, 2019)
- Tazverik for Sarcoma (June 3, 2019)
- Lartruvo for Sarcoma (June 2, 2019)
- Hensify for Sarcoma (April 4, 2019)
- Lartruvo for Sarcoma (January 18, 2019)
- Beleodaq for Sarcoma (January 17, 2019)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
- Tazverik Nabs Accelerated Approval Despite FDA Concerns About Confirmatory Trial
- Adaptimmune SPEARs An RMAT For Synovial Sarcoma
- Epizyme Banks On ORR For Tazemetostat Accelerated Approval
- Celgene Eyes Late 2019 Kaposi Sarcoma Submission For Pomalyst Following BTD
- Nanobiotix's Hensify Earns CE Mark For Soft-Tissue Sarcoma
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- Deals Shaping The Medical Industry, February 2020
- STA Acquires Australian, Asian Rights To Yondelis
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
LIST OF FIGURES
- Figure 1: Trends in incident cases of sarcoma, 2019-28
- Figure 2: Incident cases of sarcoma, by age, 2019
- Figure 3: Incident cases of sarcoma, by tumor type, 2019
- Figure 4: Overview of pipeline drugs for sarcoma in the US
- Figure 5: Pipeline drugs for sarcoma, by company
- Figure 6: Pipeline drugs for sarcoma, by drug type
- Figure 7: Pipeline drugs for sarcoma, by classification
- Figure 8: Bempegaldesleukin for Sarcoma (June 3, 2019): Phase II - w/Nivolumab
- Figure 9: Tazverik for Sarcoma (June 3, 2019): Phase II - INI1-Negative Tumors
- Figure 10: Lartruvo for Sarcoma (June 2, 2019): Phase III - ANNOUNCE (w/Doxorubicin)
- Figure 11: Key upcoming events in sarcoma
- Figure 12: Probability of success in the sarcoma pipeline
- Figure 13: Licensing and asset acquisition deals in sarcoma, 2015-20
- Figure 14: Parent patents in sarcoma
- Figure 15: Clinical trials in sarcoma
- Figure 16: Top 10 drugs for clinical trials in sarcoma
- Figure 17: Top 10 companies for clinical trials in sarcoma
- Figure 18: Trial locations in sarcoma
- Figure 19: Sarcoma trials status
- Figure 20: Sarcoma trials sponsors, by phase
LIST OF TABLES
- Table 1: Incident cases of sarcoma, 2019-28
- Table 2: Marketed drugs for sarcoma
- Table 3: Pipeline drugs for sarcoma in the US
- Table 4: Tazverik for Sarcoma (December 18, 2019)
- Table 5: Tazverik for Sarcoma (December 16, 2019)
- Table 6: Bempegaldesleukin for Sarcoma (June 3, 2019)
- Table 7: Tazverik for Sarcoma (June 3, 2019)
- Table 8: Lartruvo for Sarcoma (June 2, 2019)
- Table 9: Hensify for Sarcoma (April 4, 2019)
- Table 10: Lartruvo for Sarcoma (January 18, 2019)
- Table 11: Beleodaq for Sarcoma (January 17, 2019)
- Table 12: Historical global sales, by drug ($m), 2014-18
- Table 13: Forecasted global sales, by drug ($m), 2020-24