Market Spotlight: Gout
Market Spotlight: Gout
$1,318.00
This Market Spotlight report covers the Gout market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
- Description
- Contents
This Market Spotlight report covers the Gout market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Key Takeaways
- Datamonitor Healthcare estimates that in 2017, there were 34.5 million prevalent cases of gout in people aged 15 years and older worldwide, and forecasts that number to increase to 38.5 million prevalent cases by 2026.
- The approved drugs in the gout space focus on a wide variety of targets. These are commonly administered via the oral route, with the remainder being available in intravenous and subcutaneous formulations.
- The majority of industry-sponsored drugs in active clinical development for gout are in Phase II. Early- and mid-stage drugs in development for gout focus on targets such as uric acid, the interleukin-1 receptor, URAT1, xanthine oxidase, NLR protein-3/inflammasome, the immune system, and reactive oxygen species/free radicals. The largest proportion of pipeline drugs are administered via the oral route, with the remainder being intramuscular, intravenous, or subcutaneous formulations.
- High-impact upcoming events for drugs in the gout space comprise topline Phase IIb trial results for REV-002 and topline Phase II trial results for SEL-212 and Krystexxa.
- The overall likelihood of approval of a Phase I arthritis asset is 10.5%, and the average probability a drug advances from Phase III is 79.7%. Drugs, on average, take 8.5 years from Phase I to approval, compared to 8.8 years in the overall autoimmune/immunology space.
- There have been six licensing and asset acquisition deals involving gout drugs during 2014–19. The exclusive collaboration agreement in 2019 between Horizon Pharma and HemoShear for $500m, to discover and develop novel therapeutics for gout, was the largest deal.
- The distribution of clinical trials across Phase I–IV indicates that the majority of trials for gout have been in the early and midphases of development, with 69% of trials in Phase I–II, and 31% in Phase III–IV.
- The US has a substantial lead in the number of gout clinical trials globally. Germany leads the major EU markets, while Japan has the top spot in Asia.
- Clinical trial activity in the gout space is dominated by completed trials. AstraZeneca has the highest number of completed clinical trials for gout, with 70 trials.
- AstraZeneca leads industry sponsors with the highest overall number of clinical trials for gout.
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
8 Subtypes
9 TREATMENT
9 Non-steroidal anti-inflammatory drugs (NSAIDs)
9 Corticosteroids
9 Colchicine
9 Combination therapy
10 Prevention of chronic gout
11 EPIDEMIOLOGY
13 MARKETED DRUGS
16 PIPELINE DRUGS
21 RECENT EVENTS AND ANALYST OPINION
21 Uloric for Gout (February 21, 2019)
22 Uloric for Gout (January 11, 2019)
23 Gout Program (Horizon/HemoShear) for Gout (January 3, 2019)
23 SEL-212 for Gout (April 10, 2018)
25 Uloric for Gout (March 12, 2018)
28 KEY UPCOMING EVENTS
29 KEY REGULATORY EVENTS
29 Takeda’s Uloric Gets CV Death Warning And Restricted Indication, But No REMS
29 Uloric U-Turn: Gout Therapy Likely To Stay On Market Despite CV Safety Concern
29 Can A REMS Mitigate CV Risks? Avandia, Meridia Offer Point, Counterpoint
29 Is There A REMS In Uloric’s Future? US FDA Panelists Say Yes, Agency Says Not Likely
30 Takeda’s Uloric: CV Mortality Signal Leads US FDA To Ponder Regulatory Options
31 PROBABILITY OF SUCCESS
32 LICENSING AND ASSET ACQUISITION DEALS
32 HemoShear, Horizon Team Up To Develop Gout Therapies
32 Ironwood Pulls Plug On Struggling Gout Drug Zurampic
34 PARENT PATENTS
35 REVENUE OPPORTUNITY
36 CLINICAL TRIAL LANDSCAPE
37 Sponsors by status
38 Sponsors by phase
40 BIBLIOGRAPHY
40 Prescription information
41 APPENDIX
LIST OF FIGURES
12 Figure 1: Trends in prevalent cases of gout, 2017–26
16 Figure 2: Overview of pipeline drugs for gout in the US
16 Figure 3: Pipeline drugs for gout, by company
17 Figure 4: Pipeline drugs for gout, by drug type
17 Figure 5: Pipeline drugs for gout, by classification
25 Figure 6: SEL-212 for Gout (April 10, 2018): Phase II – Chronic Gout (Refractory)
27 Figure 7: Uloric for Gout (March 12, 2018): Phase IIIb – CARES (CVOT)
28 Figure 8: Key upcoming events in gout
31 Figure 9: Probability of success in the gout pipeline
32 Figure 10: Licensing and asset acquisition deals in gout, 2014–19
34 Figure 11: Parent patents in gout
36 Figure 12: Clinical trials in gout
36 Figure 13: Top 10 drugs for clinical trials in gout
37 Figure 14: Top 10 companies for clinical trials in gout
37 Figure 15: Trial locations in gout
38 Figure 16: Gout trials status
39 Figure 17: Gout trials sponsors, by phase
LIST OF TABLES
11 Table 1: Prevalent cases of gout, 2017–26
14 Table 2: Marketed drugs for gout
18 Table 3: Pipeline drugs for gout in the US
21 Table 4: Uloric for Gout (February 21, 2019)
22 Table 5: Uloric for Gout (January 11, 2019)
23 Table 6: Gout Program (Horizon/HemoShear) for Gout (January 3, 2019)
24 Table 7: SEL-212 for Gout (April 10, 2018)
26 Table 8: Uloric for Gout (March 12, 2018)
35 Table 9: Historical global sales, by drug ($m), 2014–18
35 Table 10: Forecasted global sales, by drug ($m), 2019–23
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