This 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.
- The author 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, 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 Krystexxa.
- The overall likelihood of approval of a Phase I arthritis asset is 10.8%, and the average probability a drug advances from Phase III is 79.2%. Drugs, on average, take 8.2 years from Phase I to approval, compared to 8.7 years in the overall autoimmune/immunology space.
- There have been nine 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 during the period.
- 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 68% of trials in Phase I-II, and 32% 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 69 trials.
AstraZeneca leads industry sponsors with the highest number of
clinical trials for gout.
Key Topics Covered
Non-steroidal anti-inflammatory drugs (NSAIDs)
Prevention of chronic gout
RECENT EVENTS AND ANALYST OPINION
Uloric for Gout (January 11, 2019)
SEL-212 for Gout (April 10, 2018)
Uloric for Gout (March 12, 2018)
SEL-212 for Gout (November 7, 2017)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
Uloric U-Turn: Gout Therapy Likely To Stay On Market Despite CV Safety Concern
Can A REMS Mitigate CV Risks? Avandia, Meridia Offer Point, Counterpoint
Is There A REMS In Uloric's Future? US FDA Panelists Say Yes, Agency Says Not Likely
Takeda's Uloric: CV Mortality Signal Leads US FDA To Ponder Regulatory Options
LIST OF FIGURES
Waiting For Next Regulatory Shoe To Drop For Takeda's Gout Drug Uloric
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
HemoShear, Horizon Team Up To Develop Gout Therapies
Ironwood Pulls Plug On Struggling Gout Drug Zurampic
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
Figure 1: Trends in prevalent cases of gout, 2017-26
Figure 2: Overview of pipeline drugs for gout in the US
Figure 3: Pipeline drugs for gout, by company
Figure 4: Pipeline drugs for gout, by drug type
Figure 5: Pipeline drugs for gout, by classification
Figure 6: SEL-212 for Gout (April 10, 2018): Phase II - Chronic Gout (Refractory)
Figure 7: Uloric for Gout (March 12, 2018): Phase IIIb - CARES (CVOT)
Figure 8: SEL-212 for Gout (November 7, 2017): Phase II - Chronic Gout (Refractory)
Figure 9: Key upcoming events in gout
Figure 10: Probability of success in the gout pipeline
Figure 11: Licensing and asset acquisition deals in gout, 2014-19
Figure 12: Parent patents in gout
Figure 13: Clinical trials in gout
Figure 14: Top 10 drugs for clinical trials in gout
Figure 15: Top 10 companies for clinical trials in gout
Figure 16: Trial locations in gout
Figure 17: Gout trials status
Figure 18: Gout trials sponsors, by phase
LIST OF TABLES
Table 1: Prevalent cases of gout, 2017-26
Table 2: Marketed drugs for gout
Table 3: Pipeline drugs for gout in the US
Table 4: Uloric for Gout (January 11, 2019)
Table 5: SEL-212 for Gout (April 10, 2018)
Table 6: Uloric for Gout (March 12, 2018)
Table 7: SEL-212 for Gout (November 7, 2017)
Table 8: Historical global sales, by drug ($m), 2013-17
Table 9: Forecasted global sales, by drug ($m), 2019-23
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