This Market Spotlight report covers the Tumor Lysis Syndrome (TLS) market, comprising key pipeline and marketed drugs, clinical trials, patent information, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
The author estimates that in 2016, there were approximately 12,300 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 forecasted to increase to 13,400 by 2025. Marketed drugs for TLS comprise xanthine oxidase inhibitors such as Aloprim (allopurinol) and Uloric (febuxostat), as well as a recombinant urate oxidase enzyme, Elitek (rasburicase).
Uloric is the only drug in active clinical development in the US for TLS. It targets xanthine oxidase, and is administered orally. There was only one licensing agreement involving cancer chemotherapy-induced TLS drugs during 2012-17. This deal was an exclusive distribution agreement between Teijin Pharma and Menarini Group for the marketing of Teijin Pharma's febuxostat in 26 additional countries. The value of the deal was not disclosed.
The distribution of clinical trials across Phase I-IV indicates that the majority of trials for TLS have been in the late phase of development, with 66.6% in Phase III-IV and only 33.3% in Phase I-II.
The US has a substantial lead in the number of TLS clinical trials globally. Clinical trial activity in the TLS space is dominated by completed trials. Sanofi has the highest number of completed clinical trials for TLS, with six in total.
Sanofi has carried out the most clinical trials in the TLS space, with Menarini being the only other trial sponsor.
Key Topics Covered:
TREATMENT Prophylaxis and monitoring Volume expansion Medical therapies Renal replacement therapy
EPIDEMIOLOGY Incidence assumptions
MARKETED DRUGS Approvals by country
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE Sponsors by status Sponsors by phase