This Market Spotlight report covers the Sarcoma market, comprising key marketed and pipeline drugs, clinical trials, upcoming and regulatory events, 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 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, topical, and subcutaneous formulations.
High-impact upcoming events for drugs in the sarcoma space comprise topline Phase II trial results for SM-88, ADP-A2M4, and RAIN-32; topline Phase Ib/II trial results for ABI-009; and topline Phase III trial results for envafolimab and RAIN-32.
The overall likelihood of approval of a Phase I sarcoma asset is 9.7%, and the average probability a drug advances from Phase III is 50%. Drugs, on average, take 9.5 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 sarcoma have been in the early and mid-phases of development, with 90% of trials in Phase I-II, and only 10% 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 and South Korea share the top spot in Asia.
Clinical trial activity in the sarcoma space is dominated by completed trials. Merck & Co and Novartis have the highest number of completed clinical trials for sarcoma, with 22 trials each.
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
- Xpovio for Sarcoma (November 2, 2020)
- Keytruda for Sarcoma (September 20, 2020)
- ADP-A2M4 for Sarcoma (May 29, 2020)
- Tazverik for Sarcoma (December 18, 2019)
- Tazverik for Sarcoma (December 16, 2019)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
- Tazverik Accelerated Approval: Disease Rarity And Unmet Need Won Out Over Efficacy Concerns
- Takara Bio's Mipetresgene Autoleucel Receives Orphan Regenerative Medicine Designation For Synovial Sarcoma
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- Aadi Licenses Greater China Rights For Cancer Therapy To EOC
- PharmaMar Licenses Yondelis To TTY In Three Asian Markets
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: Xpovio for Sarcoma (November 2, 2020): Phase II/III - SEAL
- Figure 9: Keytruda for Sarcoma (September 20, 2020): Phase II - AcSe
- Figure 10: Key upcoming events in sarcoma
- Figure 11: Probability of success in the sarcoma pipeline
- Figure 12: Clinical trials in sarcoma
- Figure 13: Top 10 drugs for clinical trials in sarcoma
- Figure 14: Top 10 companies for clinical trials in sarcoma
- Figure 15: Trial locations in sarcoma
- Figure 16: Sarcoma trials status
- Figure 17: 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: Xpovio for Sarcoma (November 2, 2020)
- Table 5: Keytruda for Sarcoma (September 20, 2020)
- Table 6: ADP-A2M4 for Sarcoma (May 29, 2020)
- Table 7: Tazverik for Sarcoma (December 18, 2019)
- Table 8: Tazverik for Sarcoma (December 16, 2019)
- Table 9: Historical global sales, by drug ($m), 2016-20
- Table 10: Forecasted global sales, by drug ($m), 2021-25