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 targets such as microtubules, URAT1, xanthine oxidase, interleukin-1, and uric acid. These drugs are commonly administered via the oral route, with the remainder being available in intravenous and subcutaneous formulations.
- The largest proportion 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, URAT1, xanthine oxidase, and NLR protein-3/inflammasome. The largest proportion of pipeline drugs are administered via the oral route, with the remainder being intravenous, intramuscular, and topical formulations.
- High-impact upcoming events for drugs in the gout space comprise topline Phase II trial results for Krystexxa and SEL-212. The overall likelihood of approval of a Phase I arthritis asset is 9.6%, and the average probability a drug advances from Phase III is 78.3%. Drugs, on average, take 8.6 years from Phase I to approval, compared to 9.0 years in the overall autoimmune/immunology space.
- There have been nine licensing and asset acquisition deals involving gout drugs during 2015–20. The exclusive collaboration agreement in 2019 between Horizon Therapeutics and HemoShear for $502m, 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 70% of trials in Phase I–II, and 30% 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
20 RECENT EVENTS AND ANALYST OPINION
20 URC102 for Gout (September 27, 2019)
20 Uloric for Gout (February 21, 2019)
21 Uloric for Gout (January 11, 2019)
25 Gout Program (Horizon/HemoShear) for Gout (January 3, 2019)
26 KEY UPCOMING EVENTS
27 KEY REGULATORY EVENTS
27 Takeda’s Uloric Gets CV Death Warning And Restricted Indication, But No REMS
27 Uloric U-Turn: Gout Therapy Likely To Stay On Market Despite CV Safety Concern
27 Can A REMS Mitigate CV Risks? Avandia, Meridia Offer Point, Counterpoint
27 Is There A REMS In Uloric’s Future? US FDA Panelists Say Yes, Agency Says Not Likely
28 Takeda’s Uloric: CV Mortality Signal Leads US FDA To Ponder Regulatory Options
29 PROBABILITY OF SUCCESS
30 LICENSING AND ASSET ACQUISITION DEALS
30 Simcere Picks Up JW’s Investigational Gout Drug For China
30 HemoShear, Horizon Team Up To Develop Gout Therapies
32 PARENT PATENTS
33 REVENUE OPPORTUNITY
34 CLINICAL TRIAL LANDSCAPE
35 Sponsors by status
36 Sponsors by phase
38 BIBLIOGRAPHY
38 Prescription information
40 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
26 Figure 6: Key upcoming events in gout
29 Figure 7: Probability of success in the gout pipeline
30 Figure 8: Licensing and asset acquisition deals in gout, 2015–20
32 Figure 9: Parent patents in gout
34 Figure 10: Clinical trials in gout
34 Figure 11: Top 10 drugs for clinical trials in gout
35 Figure 12: Top 10 companies for clinical trials in gout
35 Figure 13: Trial locations in gout
36 Figure 14: Gout trials status
37 Figure 15: 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
20 Table 4: URC102 for Gout (September 27, 2019)
21 Table 5: Uloric for Gout (February 21, 2019)
22 Table 6: Uloric for Gout (January 11, 2019)
25 Table 7: Gout Program (Horizon/HemoShear) for Gout (January 3, 2019)
33 Table 8: Historical global sales, by drug ($m), 2014–18
33 Table 9: Forecasted global sales, by drug ($m), 2020–24
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