This Market Spotlight report covers the Tumor Lysis Syndrome (TLS) market, comprising key marketed and pipeline drugs, clinical trials, probability of success, and a 10-year disease incidence forecast, as well as presenting drug-specific revenue forecasts.

Key Takeaways

• Datamonitor Healthcare estimates that in 2021, there were approximately 13,000 incident cases of tumor lysis syndrome (TLS) worldwide among individuals with high-risk malignancies (acute myeloid leukemia, acute lymphocytic leukemia, and Burkitt’s lymphoma).
• The number of incident cases is forecast to increase to 13,600 by 2026. The marketed drugs for TLS comprise the xanthine oxidase inhibitors Aloprim (allopurinol) and Uloric (febuxostat), and a recombinant urate-oxidase enzyme, Elitek (rasburicase). These therapies are administered via the intravenous and oral routes.
• There are currently no pipeline candidates in development for TLS. The overall likelihood of approval of a Phase I hematologic cancer asset is 7.7%, and the average probability a drug advances from Phase III is 56%. Drugs, on average, take 9.6 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 majority of trials for TLS have been in the late phases of development, with 60% of trials in Phase III–IV, and 40% in Phase II.
• The US leads in terms of the number of TLS clinical trials globally. Italy leads the major European markets, while Japan has the top spot in Asia.
• Clinical trial activity in the TLS space is dominated by completed trials. Sanofi has the highest number of completed clinical trials for TLS, with 11 in total.
• Sanofi leads industry sponsors with the highest overall number of clinical trials for TLS