Intermediate AMD - Market Insights, Epidemiology, and Market Forecast - 2034

Key Highlights

• Immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN) is a type of kidney disease characterized by immune complexes (antibody-antigen clusters) depositing in the glomeruli, the kidney's filtering units. These deposits trigger inflammation and damage to the glomerular structure, leading to thickening of the glomerular walls (membranoproliferative changes). This can result in proteinuria (protein in urine), reduced kidney function, and, if untreated, progressive kidney failure.
• In 2023, there were approximately 7,100 diagnosed prevalent cases of IC-MPGN across the 7MM, with the United States representing about 55% of these cases with the highest number of cases in the United States, followed by Japan.
• A substantial number of IC-MPGN cases occurred in adults, with about 90% of all cases diagnosed in patients due to chronic infections, autoimmune disorders, or underlying conditions such as hepatitis C, systemic lupus erythematosus (SLE), or monoclonal gammopathy. These conditions can lead to persistent immune complex formation, which triggers the complement system and results in kidney damage over time, making IC-MPGN more prevalent in adult populations.
• The market size of IC-MPGN in the United States was ~USD 12 million in 2023 and is expected to increase by 2034 due to an increase in the diagnosed prevalence of IC-MPGN and the entry of emerging therapies with a premium price tag.
• Since there are no approved therapies for IC-MPGN, the market is mainly dominated by the use of off-label prescription drugs. Treatments for IC-MPGN include immunosuppressants, steroids, renin-angiotensin-aldosterone system Inhibitors (RAAS), and other supportive therapies (calcineurin inhibitors, other immunosuppressive agents, and antibodies).
• Upcoming anti-complements such as iptacopan and pegcetacoplan present realistic therapeutic options for complement-related diseases.

This report delivers an in-depth understanding of Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), historical and forecasted epidemiology as well as Immune Complex Membranoproliferative Glomerulonephritis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Immune Complex Membranoproliferative Glomerulonephritis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Immune Complex Membranoproliferative Glomerulonephritis market size from 2020 to 2034. The report also covers current Immune Complex Membranoproliferative Glomerulonephritis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Immune Complex Membranoproliferative Glomerulonephritis Disease Understanding and Treatment Algorithm

Immune Complex Membranoproliferative Glomerulonephritis Overview

Membranoproliferative glomerulonephritis (MPGN) is a kidney disorder involving inflammation and kidney cell changes. It is a form of glomerulonephritis caused by an abnormal immune response.

MPGN has previously been used as an umbrella term to describe a spectrum of hypocomplementemic glomerular diseases, which are a rare cause of end-stage kidney disease (ESKD). More recently, MPGN has been reclassified into two diseases: immune-complex MPGN (IC-MPGN) and C3 glomerulopathy (C3G) based on immunofluorescence findings in kidney biopsies: predominant or exclusive C3 deposits in C3G and combined immunoglobulins and complement deposits in IC-MPGN.

Immune Complex Membranoproliferative Glomerulonephritis Diagnosis

To diagnose MPGN, several tests are typically conducted including a Urine test, Blood test, Glomerular Filtration Rate (GFR) test, Kidney biopsy, and Genetic testing. These tests collectively aid in confirming the diagnosis of MPGN, determining its specific class, understanding the extent of kidney involvement, and guiding healthcare providers in formulating the most effective treatment plan based on the underlying causes and characteristics of the disease

Immune Complex Membranoproliferative Glomerulonephritis Treatment

To date, there has not been a specific treatment devised to cure the indication completely. Besides, the market for IC-MPGN lacks approved drugs and is dominated by the use of off-label prescription medications. These include immunosuppressants, corticosteroids, renin-angiotensin-aldosterone system Inhibitors (RAAS), and other supportive therapies.

Immune Complex Membranoproliferative Glomerulonephritis Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by a total diagnosed prevalent population of IC-MPGN, gender-specific diagnosed prevalent population of IC-MPGN, and age-specific diagnosed prevalent population of IC-MPGN in the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom and Japan from 2020 to 2034.

• The total diagnosed prevalent population of IC-MPGN in the 7MM was found to be approximately 7,000 in 2023.
• The diagnosed prevalent population of IC-MPGN, in the United States, was found to be approximately 3,770 in 2023.
• In EU4 and the UK, the diagnosed prevalent population of IC-MPGN was found to be the maximum in Germany, followed by Spain in 2023. While the lowest number of cases were found in Italy.
• In Japan, adults are more prevalent towards IC-MPGN compared to the pediatric group.

Immune Complex Membranoproliferative Glomerulonephritis Drug Chapters

The drug chapter segment of the Immune Complex Membranoproliferative Glomerulonephritis report encloses a detailed analysis of the marketed and the late-stage (Phase III and Phase II) pipeline drug. Furthermore, the current key players for emerging drugs and their respective drug candidates include Novartis Pharmaceuticals (Iptacopan) and Apellis Pharmaceuticals (pegcetacoplan). The drug chapter also helps understand the Immune Complex Membranoproliferative Glomerulonephritis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.

Emerging Drugs

Iptacopan (LNP023): Novartis Pharmaceuticals

Iptacopan is an investigational, first-in-class, orally administered factor B inhibitor of the alternative complement pathway, targeting one of the key drivers of CDRDs8-10. It is the most advanced asset in the Novartis nephrology pipeline and has the potential to become the first targeted therapy to delay progression to dialysis in C3G9. Discovered at the Novartis Institutes for BioMedical Research, iptacopan is currently in development for several CDRDs where significant unmet needs exist, including IC-MPGN. Currently, the drug is being investigated in Phase III of the clinical development.

Novartis intends to seek regulatory approval for the drug by 2026, with the preliminary findings from the Phase III APPARENT trials expected to be available by the same year.

Pegcetacoplan (APL-2): Apellis Pharmaceuticals

Apellis’ Pegcetacoplan (APL-2) is an investigational, targeted C3 inhibitor designed to regulate excessive complement activation, which can lead to the onset and progression of many serious diseases. It is a15-amino acid cyclic peptide conjugated to each end of a linear polyethylene glycol molecule that binds to C3 and C3b, directly preventing activation of C3, C5, and the alternative pathway. Pegcetacoplan (marketed as EMPAVELI) is approved in the United States for the treatment of adults with paroxysmal nocturnal hemoglobinuria.

In October 2020, the company initiated the Phase II (NOBLE) trial in up to 12 patients with post-kidney transplant recurrence of C3G or IC-MPGN. In September 2021, the first patients dosed in the NOBLE trial. In June 2023, the first patient was dosed in the VALIANT Phase III study investigating pegcetacoplan in C3G or IC-MPGN. Currently, the drug is evaluated in a Phase III trial for IC-MPGN patients.

In August 2024, Apellis Pharmaceuticals and Sobi announced positive topline results from the Phase III VALIANT study investigating systemic pegcetacoplan in patients with C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are rare kidney diseases with no approved treatments.

Drug Class Insights

Renin-angiotensin-aldosterone system inhibitors: Angiotensin receptor blocker (ARB) and angiotensin-converting enzyme (ACE) inhibitors both are used to treat hypertension in C3G. Combination use of RAAS inhibitors showed higher efficiency compared with monotherapy and was associated with a higher incidence of adverse events.

Immunosuppressants: Corticosteroids, calcineurin inhibitors, corticosteroids in combination with mycophenolate mofetil (MMF), and others are used for the treatment of C3G. Among all nonspecific immunosuppressive therapies, MMF-based treatment is promising compared with others concerning clinical remission and renal survival.

Complement inhibitors are the primary class in the emerging pipeline for C3G therapy. Complement inhibitors Pegcetacoplan and Iptacopan perform well in C3G in terms of safety and effectiveness.

Immune Complex Membranoproliferative Glomerulonephritis Market Outlook

Immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN) is an ultrarare, chronic, and progressive nephropathy, which is characterized by significant immunoglobulin deposition and is assumed to involve dysregulation of both the classical and alternative pathways of complement (AP).

IC-MPGN lacks approved medications, creating a significant demand for treatments addressing the root cause. Kidney failure, necessitating dialysis or transplantation, can occur within 5-10 years of diagnosis. Current strategies involve supportive measures with or without traditional immunosuppression, showing limited effectiveness in slowing disease progression. Considering the diseases’ pathophysiology, a logical approach involves targeted complement inhibition.

The utilization of off-label prescription medications predominantly characterizes the market. IC-MPGN treatments encompass immunosuppressants, steroids, inhibitors of renin-angiotensin-aldosterone system (RAAS), and other supportive therapies like calcineurin inhibitors, additional immunosuppressive agents, and antibodies.

The current evolving landscape of IC-MPGN treatment exhibits a mid-level pipeline. Two promising therapies, Iptacopan (Novartis Pharmaceutical) and Pegcetacoplan (Apellis Pharmaceuticals), are in the advanced Phase III developmental stage.

Immune Complex Membranoproliferative Glomerulonephritis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake. Iptacopan is an oral small-molecule inhibitor of complement factor B with potential immunomodulatory activity. Novartis intends to seek regulatory approval for the drug by 2026. The drug is expected to launch in the US in 2027.

Immune Complex Membranoproliferative Glomerulonephritis Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III and II. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Immune Complex Membranoproliferative Glomerulonephritis emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient’s therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, nephrologists, Consultant Nephrologists, and Honorary Associate Professor at University Hospitals of Leicester NHS Trust, and others.

The analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapy treatment patterns or Immune Complex Membranoproliferative Glomerulonephritis market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Market Access and Reimbursement

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

The development of drugs targeting the complement system is picking up speed, but it comes with several challenges. While the general role of complement in the body is acknowledged, how it contributes to disease and its impact on pathogenesis remains unclear. The complement system is intricate, comprising numerous pathways with regulatory functions. Even if one pathway is blocked, the system can adapt by "redirecting" to another, using regulatory mechanisms to safeguard the body from pathogens. This adaptability poses a challenge in achieving the desired clinical effects of complement inhibitors.

Developing drugs that can successfully block the complement pathway presents a significant challenge. This encompasses choosing appropriate indications, screening potential targets within the complement system, and determining drug types (such as monoclonal antibodies, small molecules, peptides, etc.). When discussing reimbursement for complement inhibitors, there is a possibility that drugs being researched for IC-MPGN might receive reimbursement in certain countries without encountering obstacles, especially when the same drugs are already reimbursed for other indications.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of Immune Complex Membranoproliferative Glomerulonephritis, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Immune Complex Membranoproliferative Glomerulonephritis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Immune Complex Membranoproliferative Glomerulonephritis market.

Immune Complex Membranoproliferative Glomerulonephritis Report Insights

• Patient Population
• Therapeutic Approaches
• Immune Complex Membranoproliferative Glomerulonephritis Pipeline Analysis
• Immune Complex Membranoproliferative Glomerulonephritis Market Size and Trends
• Existing and future Market Opportunity

Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage
• Immune Complex Membranoproliferative Glomerulonephritis Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Immune Complex Membranoproliferative Glomerulonephritis Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What is the historical and forecasted Immune Complex Membranoproliferative Glomerulonephritis patient pool in the United States, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan?
• What was the Immune Complex Membranoproliferative Glomerulonephritis total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors for this growth?
• What are the advantages of complement inhibitors over immunosuppressants?
• What will be the impact on market size after the launch of pegcetacoplan and iptacopan in Immune Complex Membranoproliferative Glomerulonephritis?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• Which complement inhibitor generated the highest revenue by 2034?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Immune Complex Membranoproliferative Glomerulonephritis.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.