MarketVue® Report
Membranous Nephropathy (U.S.), 2023

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Membranous Nephropathy (U.S.), April 2023

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The MarketVue®: Membranous Nephropathy 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®: Membranous Nephropathy report is supported by 5 qualitative interviews with key opinion leaders, a quantitative survey with 26 U.S. physicians and secondary research.

Geographies covered:
United States plus epidemiology for EU5 (France, Germany, Italy, Spain, United Kingdom)

 
Key companies mentioned:
  • Hoffman-La Roche
  • Cerium Pharmaceuticals
  • BeiGene
  • argenx
  • Apellis Pharmaceuticals
  • HI-Bio / Biogen
  • Reistone Biopharma
  • ACELYRIN
  • Alpine Immune Sciences
  • Alexion / AstraZeneca
  • Cabaletta Bio

Key drugs mentioned:

  • Rituximab (Rituxan)
  • Cyclophosphamide
  • Prednisone
  • Cyclosporine
  • Tacrolimus
  • Obinutuzumab (Gazyva)
  • SNP-ACTH
  • Zanubrutinib (Brukinsa)
  • Efgartigimod (Vyvgart)
  • Pegcetacoplan (Empaveli)
  • Felzartamab / MOR202
  • SHR1459
  • VB119
  • Povetacicept / ALPN-303
  • Gefurulimab / ALXN1720
  • PLA2R-CAART

Key takeaways from the report:
Membranous nephropathy (MN) is a rare, autoimmune nephropathy characterized by thickening of the glomerular capillary walls. Most patients are diagnosed with an antigen-specific form of MN, with 70% testing positive for PLA2R. Symptoms include proteinuria, low albumin levels, and edema. MN is the most common cause of nephrotic syndrome and when left untreated or poorly managed, complications include:

  • Hypertension
  • Thromboembolic events
  • Cardiovascular events
  • End-stage kidney disease
Although there are no FDA-approved therapies for MN, the treatment approach is relatively standard, with patients receiving a combination of supportive and immunosuppressive therapy. According to REACH Market Research’s MarketVue® assessment, nephrologists rely on rituximab as the preferred immunosuppressive therapy, reporting that approximately two-thirds of patients achieve some form of remission with rituximab. However, experts REACH spoke to say the time to onset of action and durability of remission with rituximab are less than ideal.
 
Nephrologist, U.S.: “Rituximab works extremely well. I don’t think I’ve had a patient fail rituximab, although I do have patients that don’t achieve complete or durable response to rituximab.”
 
Nephrologists interviewed by REACH desire new therapies that can induce complete and durable remission in the majority of patients, particularly those at high risk for progression to end-stage kidney disease. In MN there is a direct correlation between PLA2R antibody levels and disease severity and progression. Accordingly, nephrologists report frequently measuring antibody titers in PLA2R+ patients to monitor response to treatment, especially in high-risk patients.
 
Pooja Patel, Analyst at REACH: “There is a need for more treatment options, particularly for high-risk and refractory patients. Because auto-antibody levels do correlate well with clinical response as defined by proteinuria, physicians hope that the emerging widespread availability of antibody testing will allow for future therapies to achieve accelerated approval on the basis of this endpoint.”
1. DISEASE OVERVIEW
An autoimmune nephropathy characterized by thickening glomerular capillary walls and proteinuria
Figure 1.1. Percentage of antigen-specific MN type among patients
Table 1.1. Rule of thirds patient outcomes
Nephrotic syndrome in membranous nephropathy
Underlying pathology dictates current and future targets for therapy
Figure 1.2. Targets for monoclonal antibody treatments
2. EPIDEMIOLOGY & PATIENT POPULATIONS
Disease definition
Figure 2.1. Range of prevalent cases of primary MN by region
Table 2.1 Diagnosed Incident and Prevalent Populations of Primary MN in the U.S. and EU5
3. DIAGNOSIS & CURRENT TREATMENT
Diagnosis overview
Figure 3.1. Diagnostic pathway for membranous nephropathy patients
Diagnostic testing for antibodies is replacing the old gold-standard kidney biopsy
Figure 3.2. Percentage of MN patients by risk category according to surveyed nephrologists
Table 3.1. KDIGO 2021 clinical criteria for assessing risk of progressive loss of kidney function
Treatment flow for primary membranous nephropathy
Immunosuppressive therapy is the mainstay of treatment for moderate, high, and very high-risk MN patients
Figure 3.3. Percentage of MN patients in each risk category treated with immunosuppressive therapy
Figure 3.4. Nephrologist-reported current treatment share for immunosuppressive-treated MN patients
Achieving partial or complete remission is the ultimate goal of treatment
Table 3.2. Treatment goals for MN
Table 3.3. Key terms to know for MN
Immunologic remission precedes clinical remission
Figure 3.5. Percentage of nephrologists monitoring antibody levels in PLA2R+ pts throughout treatment
Figure 3.6. Nephrologist-reported proportion of MN patients achieving different disease responses
Figure 3.7. Time to remission and proportion of patients who relapse following complete remission according to surveyed nephrologists
Upsides and downsides of current membranous nephropathy treatments
Physician perspectives on current treatment regimens
Table 3.4. KOL insights on current regimens
Key treatment dynamics that will shape disease management and drug use in MN
Table 3.5. Must-know membranous nephropathy treatment dynamics
Figure 3.8. Important dynamics of membranous nephropathy market evolution
4. UNMET NEED
Overview
Figure 4.1. Nephrologist-reported unmet needs in membranous nephropathy
Physician insights on the most urgent unmet needs for membranous nephropathy
5. PIPELINE ANALYSIS
Overview
Figure 5.1. Nephrologist-reported most important outcomes for a pivotal trial in MN
The MN pipeline is active with various mechanisms being studied
Table 5.1. Comparison of ongoing trials of therapies for MN
Active trials for anti-CD38 monoclonal antibody Felzartamab
Figure 5.2. M-PLACE study design
Figure 5.3. Results of Ph 1b/2a Trial of 9 IV doses of Felzartamab in Patients with anti-PLA2R antibody-positive MN (M-PLACE™)
Physician insights on data from the MPLACE study
Physician insights on emerging therapeutic targets in MN
6. VALUE & ACCESS
Overview
Table 6.1. MN therapy pricing, U.S.
Figure 6.1. Membranous nephropathy patients by insurance type
7. METHODOLOGY
Primary market research approach
Epidemiology methodology
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