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.

Key Takeaways

• Datamonitor Healthcare estimates that in 2021, there were approximately 446,300 incident cases of sarcoma worldwide, and forecasts that number to increase to 503,700 incident cases by 2028.
• Worldwide in 2019, 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, rectal, and subcutaneous formulations.
• High-impact upcoming events for drugs in the sarcoma space comprise topline Phase II trial results for ZN-c3, RAIN-32, and APX005M, as well as topline Phase III trial results for envafolimab and RAIN-32.
• The overall likelihood of approval of a Phase I sarcoma asset is 9.6%, and the average probability a drug advances from Phase III is 45.5%. Drugs, on average, take 10.2 years from Phase I to approval, compared to 9.7 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 95% of trials in Phase I–II, and only 5% in Phase III–IV.
• The US has a substantial lead in the number of sarcoma clinical trials globally. The UK leads the major European markets, while China 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 82 trials.
• Merck & Co leads industry sponsors with the highest overall number of clinical trials for sarcoma, followed by Novartis and Roche.