Market Spotlight: Tumor Lysis Syndrome (TLS)
Market Spotlight: Tumor Lysis Syndrome (TLS)
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This Market Spotlight report covers the Tumor Lysis Syndrome (TLS) market, comprising key marketed and pipeline drugs, clinical trials, patent information, and a 10-year disease incidence forecast, as well as presenting drug-specific revenue forecasts.
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This Market Spotlight report covers the Tumor Lysis Syndrome (TLS) market, comprising key marketed and pipeline drugs, clinical trials, patent information, and a 10-year disease incidence forecast, as well as presenting drug-specific revenue forecasts.
Key Takeaways
- Datamonitor Healthcare 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. 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 around 67% in Phase III–IV and only 33% 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.
CONTENTS
5 OVERVIEW
6 KEY TAKEAWAYS
7 DISEASE BACKGROUND
8 TREATMENT
8 Prophylaxis and monitoring
8 Volume expansion
8 Medical therapies
8 Renal replacement therapy
10 EPIDEMIOLOGY
10 Incidence assumptions
19 MARKETED DRUGS
21 Approvals by country
23 PIPELINE DRUGS
26 PARENT PATENTS
27 REVENUE OPPORTUNITY
28 CLINICAL TRIAL LANDSCAPE
29 Sponsors by status
30 Sponsors by phase
31 BIBLIOGRAPHY
31 Prescription information
32 APPENDIX
LIST OF FIGURES
12 Figure 1: Trends in incident cases of TLS in selected high-risk malignancies, 2016–25
23 Figure 2: Overview of pipeline drugs for TLS in the US
23 Figure 3: Pipeline drugs for TLS, by company
23 Figure 4: Pipeline drugs for TLS, by drug type
24 Figure 5: Pipeline drugs for TLS, by classifications
28 Figure 6: Clinical trials in TLS
28 Figure 7: Top 10 drugs for clinical trials in TLS
28 Figure 8: Top 10 companies for clinical trials in TLS
29 Figure 9: Trial locations in TLS
30 Figure 10: TLS trials status
30 Figure 11: TLS trials sponsors, by phase
LIST OF TABLES
11 Table 1: Incident cases of TLS in selected high-risk malignancies, 2016–25
13 Table 2: Incidence of acute myeloid leukemia, and proportion of individuals with TLS, 2016
14 Table 3: Incident cases of TLS in acute myeloid leukemia, 2016–25
15 Table 4: Incidence of acute lymphocytic leukemia, and proportion of individuals with TLS, 2016
16 Table 5: Incident cases of TLS in acute lymphocytic leukemia, 2016–25
17 Table 6: Incidence of Burkitt’s lymphoma, and proportion of individuals with TLS, 2016
18 Table 7: Incident cases of TLS in Burkitt’s lymphoma, 2016–25
20 Table 8: Marketed drugs for TLS
22 Table 9: Approvals by country for TLS
25 Table 10: Pipeline drugs for TLS in the US
26 Table 11: Parent patents in TLS
27 Table 12: Historical global sales, by drug ($m), 2012–16
27 Table 13: Forecasted global sales, by drug ($m), 2017–22
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