MarketVue® Report
Gout (Chronic Refractory) (U.S.), 2024

Syndicated market assessment report driven by primary market research

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Gout (Chronic Refractory) (U.S.), February 2024

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The MarketVue®: Chronic Refractory Gout market landscape report combines primary (KOL interviews and survey data) and secondary market research to empower strategic decision-making and provide a complete view of the market.
 
Every MarketVue® includes a disease overview, epidemiology (US and EU5), current treatment, unmet needs, pipeline and access and reimbursement chapter.
 
Topics covered in this report:
  • Disease overview: Review the disease pathophysiology and potential druggable targets
  • Epidemiology: Understand prevalence, diagnosed and drug-treated prevalence of the population and key market segments
  • Current treatment: Understand the treatment decision tree and strengths and weaknesses of current on-label and off-label treatment
  • Unmet needs: Identify opportunities to address treatment or disease management gaps
  • Pipeline analysis: Compare current and emerging therapy clinical development strategy; their performance on efficacy, safety, and delivery metrics; and their potential to address unmet needs
  • Value and access: Gain insights into the drug pricing landscape and payer controls within the disease market or analogous markets
 
Methodology:
Research for the MarketVue®: Chronic Refractory Gout report is supported by 6 qualitative interviews with key opinion leaders, a quantitative survey with 20 U.S. physicians and secondary research.
 
Geographies covered:
United States plus epidemiology for EU5 (France, Germany, Italy, Spain, United Kingdom)
 
Key companies mentioned:
  • LG Chem
  • Jiangsu Hengrui Pharmaceuticals
  • JW Group/Simcere
  • Selecta / Cartesian Therapeutics
  • Sobi Biosciences
  • Teijin America
  • InventisBio
  • Arthrosi Therapeutics
  • Shanton Pharma
  • Atom Bioscience
  • Horizon Therapeutics / Amgen
  • Nippon Chemiphar
  • Protalix BioTherapeutics
  • Arrowhead Pharmaceuticals
  • Hinova Pharmaceuticals
 
Key drugs mentioned:
  • Colchicine (Colcrys, Mitigare)
  • Allopurinol (Zyloprim)
  • Febuxostat (Uloric)
  • Probenecid (Probalan)
  • Pegloticase (Krystexxa)
  • Tigulixostat / LC350189
  • Ruzinurad / SHR4640
  • Epaminurad / URC102
  • SEL-212
  • TMX-049
  • D-0120
  • AR882
  • SAP-001
  • ABP-671
  • HZN-003
  • HZN-007
  • NC-2500
  • PRX-115
  • HZN-457
  • HP501
1. DISEASE OVERVIEW
A treatment-resistant inflammatory arthritis causing flares of severe joint pain and inflammation
Figure 1.1. Gout pathophysiology
Numerous risk factors for severe gout, but few truly refractory cases
Table 1.1 Gout risk factors
2. EPIDEMIOLOGY & PATIENT POPULATIONS
Disease Definition
Figure 2.1. G6 diagnosed prevalent cases of refractory gout by region
Table 2.1 Diagnosed prevalent populations of gout and refractory gout in the U.S. and EU5
Annualized incidence
Figure 2.2. Amgen/Horizon uncontrolled gout epidemiology funnel for U.S.
Table 2.2. Diagnosed annualized incident cases of gout and refractory gout in the U.S. and EU5
3. DIAGNOSIS & CURRENT TREATMENT
Overview
Figure 3.1. Referral and diagnostic pathway for gout patients
The vast majority of patients achieve flare control with available treatment options
Table 3.1. Treatment goals for chronic refractory gout
Table 3.2. Types of urate lowering therapies
Treatment flow for gout
Figure 3.2. Treatment algorithm for gout
Krystexxa (pegloticase)
Figure 3.3. Krystexxa safety and efficacy w/ and w/o methotrexate
Physician perspectives on Krystexxa
Figure 3.4. Pegloticase – upsides and downsides
Figure 3.5 Surveyed rheumatologist-estimated Krystexxa share and discontinuation rate
Physician perspectives on Krystexxa (cont)
Key treatment dynamics that will shape disease management and drug use in gout
Table 3.3 Must-know treatment dynamics in chronic refractory gout
Improved uricase and uricosuric formulations may vastly change the gout treatment landscape
Figure 3.6. Important dynamics of chronic refractory gout market evolution
4. UNMET NEED
Overview
Figure 4.1. Top unmet needs in chronic refractory gout
Physician perspectives on unmet needs in chronic refractory gout
5. PIPELINE ANALYSIS
Overview
Table 5.1. Urate lowering therapies in late-stage development
Results from Sobi and Selecta’s Phase III trial of SEL-212 uricase therapy rivals Krystexxa with methotrexate
Figure 5.1. SEL-212 Phase 3 safety and efficacy
Uricosuric agents dominate the late-stage pipeline, but there are novel uricases in early development
Table 5.2. Urate lowering therapies in early-stage development
6. VALUE & ACCESS
Overview
Table 6.1. Current pricing of gout therapies, U.S.
Table 6.2. Typical U.S. commercial payer prior authorization criteria for Krystexxa
Payer financial burden of chronic refractory gout
Figure 6.1. Mean annual healthcare costs per patient by healthcare resource for refractory gout
Horizon has developed a number of programs to increase access and affordability of Krystexxa
7. METHODOLOGY
Primary market research approach
Epidemiology methodology
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