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

Key Takeaways

• Datamonitor Healthcare estimates that in 2017, there were approximately 12,400 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.
• The overall likelihood of approval of a Phase I hematologic asset is 9.4%, and the average probability a drug advances from Phase III is 60.3%. Drugs, on average, take 9.2 years from Phase I to approval, compared to 9.4 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 67% of trials in Phase III–IV, and 33% in Phase II.
• The US leads in terms of the number of TLS clinical trials globally, while Italy and Spain lead the major European markets. Clinical trial activity in the TLS space is dominated by completed trials. Sanofi has the highest number of completed clinical trials for TLS, with eight in total.
• Sanofi has carried out the most clinical trials in the TLS space, with Menarini being the only other trial sponsor.