Focal segmental glomerulosclerosis (FSGS) is a disease in which scar tissue develops on the parts of the kidneys that filter waste from the blood (glomeruli). FSGS can be caused by a variety of conditions and may lead to ESRD. There are three types of FSGS including primary/idiopathic, secondary and genetic/familial. The purpose of this study is to describe the disease, determine diagnosis/referral/co-management patterns, understand current and future treatment options along with unmet needs, and size the patient population in the US.
Market Dynamix™: Focal Segmental Glomerulosclerosis (US) is a blend of physician survey data and patient chart audit data. In addition, qualitative interviews are conducted with KOLs and community nephrologists to better understand the future market potential for pipeline products. Market Dynamix are typically conducted once per year.
Spherix will survey 100 US nephrologists who actively manage patients with FSGS. Participants are required to be in practice between 2 and 30 years, to spend at least 50% of their time in clinical practice (vs. industry consulting/employment, research, administrative or teaching), to not be a principal investigator for FSGS products in development and to be in agreement with Spherix terms of conditions. Three participants are peer-nominated as key opinion leaders) about current and future management of FSGS including reactions to product profiles for advanced pipeline agents. Also included is demographic data for patients with FSGS captured in the RealWorld Dynamix™ Dialysis and CKD-ND audits.
Learn more about Market Dynamix™ reports here.
- How does FSGS present? What are the patient symptoms, what triggers referral to a nephrologist? What percent of patients with FSGS are classified as primary, secondary and familial? Are there differences based on these classifications?
- How is FSGS diagnosed? What are the common differential diagnoses? How comfortable are general nephrologists with managing this condition? Across what stages of CKD do the patients fall; what percent progress to ESRD (dialysis/transplant); what percent have rapid progression and how does this compare to other renal conditions? Are these patients co-managed with other specialists, including specialty nephrologists?
- What are the treatment goals and how is FSGS treated pharmacologically? What are the limitations of current therapeutic treatments? What are the unmet needs for new drugs? What non-pharmacologic interventions, if any, are common among this population?
- Which agents are in the development pipeline (Phase 1 and higher) and how promising are these agents according to KOLs? What unique attributes will each agent bring if successfully commercialized?
- Using secondary data sources and RealWorld Dynamix CKD-ND (Spherix’s proprietary patient chart audit), estimate incident and prevalent patients and understand the touchpoints with nephrology in a given year.
- Translate the above into a market size (patient based) model complete with assumptions that can be modified/adjusted according to client needs.
Complexa’s CXA-10, Retrophin’s sparsentan, Reata’s bardoxolone methyl, Aurinia’s voclosporin, Chinook’s atrasentan, Vertex’s VX-127, Pfizer’s PF-06730512, Astellas/Kyowa/Kirin’s bleselumab, and Zyversa’s VAR-200.