Tumor lysis syndrome (TLS) comprises a group of metabolic disturbances that result from either chemotherapy or spontaneously induced tumor cell death. The release of intracellular components, including nucleic acids, electrolytes, and proteins, into the systemic circulation is triggered by tumor cytotoxicity. This may result in the development of metabolic abnormalities such as hyperkalemia, hyperphosphatemia, hyperuricemia, and hypocalcemia. Clinically, this can lead to effects on multiple organs such as cardiac arrhythmias, seizures, and acute kidney injury.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
Published: 01 November 2021
Number of pages:28
This Market Spotlight report covers the Tumor Lysis Syndrome (TLS) market, comprising key marketed drugs, clinical trials, probability of success, and a 10-year disease incidence forecast, as well as presenting drug-specific revenue forecasts.
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 8.5%, and the average probability a drug advances from Phase III is 58.5%. Drugs, on average, take 9.5 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 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.
6 KEY TAKEAWAYS
7 DISEASE BACKGROUND
8 Prophylaxis and monitoring
8 Volume expansion
8 Medical therapies
8 Renal replacement therapy
10 Incidence assumptions
19 MARKETED DRUGS
21 PROBABILITY OF SUCCESS
22 REVENUE OPPORTUNITY
23 CLINICAL TRIAL LANDSCAPE
24 Sponsors by status
25 Sponsors by phase
LIST OF FIGURES 12 Figure 1: Trends in incident cases of TLS in selected high-risk malignancies, 2017–26
21 Figure 2: Probability of success in the hematologic pipeline
23 Figure 3: Clinical trials in TLS
23 Figure 4: Top 10 drugs for clinical trials in TLS
24 Figure 5: Top 10 companies for clinical trials in TLS
24 Figure 6: Trial locations in TLS
25 Figure 7: TLS trials status
25 Figure 8: TLS trials sponsors, by phase
LIST OF TABLES
11 Table 1: Incident cases of TLS in selected high-risk malignancies, 2017–26
13 Table 2: Incidence of acute myeloid leukemia, and proportion of individuals with TLS, 2017
14 Table 3: Incident cases of TLS in acute myeloid leukemia, 2017–26
15 Table 4: Incidence of acute lymphocytic leukemia, and proportion of individuals with TLS, 2017
16 Table 5: Incident cases of TLS in acute lymphocytic leukemia, 2017–26
17 Table 6: Incidence of Burkitt’s lymphoma, and proportion of individuals with TLS, 2017
18 Table 7: Incident cases of TLS in Burkitt’s lymphoma, 2017–26
20 Table 8: Marketed drugs for TLS
22 Table 9: Historical global sales, by drug ($m), 2016–20
22 Table 10: Forecasted global sales, by drug ($m), 2021–25
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