Idiopathic Membranous Nephropathy (IMN) - Market Insights, Epidemiology and Market Forecast - 2032

Key Highlights:

• Membranous Nephropathy (MN) is a kidney disease that affects the filters of the kidney. It causes protein increase in urine, abnormal kidney function, and swelling. It is also called membranous glomerulopathy. MN is a rare disease affecting the kidney glomerulus, specifically the podocytes, which are key in controlling the kidney's permeability to proteins. Albumin and higher molecular weight proteins are minimally filtered in a healthy individual. In contrast, in nephrotic syndrome, large amounts of proteins escape into the urine, decreasing serum albumin and developing generalized edema
• In adults, primary or idiopathic MN is responsible for approximately 75-80% of cases of MN identified on kidney biopsy. The circulating autoantibodies (anti-PLA2R and anti-THSD7A) provide biomarkers with high specificity for the diagnosis of primary MN and aid in distinguishing between primary and secondary MN.
• In 2022, the market size of IMN was highest in the US, accounting for approximately USD 100 million, which is further expected to increase by 2032.
• Primary or idiopathic MN is when the disease is associated serologically with antibodies to a known antigen, such as the M-type phospholipase A2 receptor (PLA2R) or thrombospondin type-I domain-containing 7A (THSD7A). In about 70-80% of cases with primary MN, an antibody called anti-PLA2R is found in the kidney and bloodstream.
• The short-term goal of treatment is to stop protein spillage completely (known as remission) or lower the amount of protein lost in the urine as much as possible. The less protein lost in the urine, the better the individual will do. The long-term treatment goals include protein relapses in the urine and preventing the deterioration of kidney function.
• As per the Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guidelines for the Management of Glomerular Diseases, immunosuppressive therapy should be restricted to patients at risk for progressive kidney injury and patients with MN and at least one risk factor for disease progression, it is recommended to use rituximab or cyclophosphamide and alternate month glucocorticoids for 6 months or CNI-based therapy for 6 months, with the choice of treatment depending on the risk estimate.
• Due to its favorable safety profile, rituximab is now considered a first-line treatment option for MN, especially in patients at moderate and high risk of deterioration in kidney function.
• There is no cure for primary or secondary membranous nephropathy. With the patients having the condition, treatment focuses on generally adopting a symptomatic approach and strengthening the patient's immune system. Patients are started with supportive therapy regardless of underlying etiology as soon as the diagnosis is confirmed and continued for the course of the disease.
• The treatment addressable pool of IMN is not only restricted to the ones who do not undergo spontaneous remission; it also includes the patients who relapse despite having experienced spontaneous remission or after receiving treatment. Therefore, the percentage of patients lying in the addressable pool is quite high, and the companies have an opportunity to develop therapies catering to these patients.
• Improved understanding of the underlying molecular pathways responsible for MN has led to better therapies targeting novel pathways. The major pharma players currently developing therapies for MN include Hoffmann-La Roche (obinutuzumab), MorphoSys (felzartamab), Cerium Pharmaceuticals (SNP-ACTH [1-39] Gel), BeiGene (zanubrutinib), GlaxoSmithKline (belimumab), and a few others.

This “Idiopathic Membranous Nephropathy (IMN) - Market Insights, Epidemiology and Market Forecast - 2032” report delivers an in-depth understanding of historical and forecasted epidemiology as well as market trends of IMN in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, Japan, and China.

IMN market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM + China IMN market size from 2019 to 2032. The report also covers current IMN 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
• China

Study Period: 2019-2032

IMN Disease Understanding and Treatment

IMN Overview

Membranous Nephropathy (MN), also known as membranous glomerulonephritis (MGN), is a rare autoimmune disorder characterized by a pathological change in the glomerular basement membrane (GBM) due to the deposition of subepithelial immune complexes. MN causes protein increase in urine, abnormal kidney function, and swelling. It is also called membranous glomerulopathy. MN is a rare disease affecting the kidney glomerulus, specifically the podocytes, which control the kidney's permeability to proteins. Albumin and higher molecular weight proteins are minimally filtered in a healthy individual. In contrast, in nephrotic syndrome, large amounts of proteins escape into the urine, decreasing serum albumin and developing generalized edema.

The most common symptom of MN is swelling, referred to as edema. This can range from mild to severe. Most people have some swelling, often the first symptom. In MN (as opposed to other diseases that cause protein in the urine and nephrotic syndrome), swelling is usually slow (over weeks to months), but it can sometimes come quickly. It typically starts in the feet, ankles, or legs but can occur anywhere in the body, including the abdomen, hands, arms, and face. It occurs due to fluid build-up in the body, specifically in different tissues.

Histologically, MN has been classified into primary and secondary types. Idiopathic or Primary MN is considered to be an antibody-mediated autoimmune disease, whereas secondary MN occurs in association with other diseases such as systemic lupus erythematosus (SLE), infections and malignancies, or exposure to toxins as well as certain medications such as non-steroidal anti-inflammatory drugs, TNF alpha-blockers, and other therapies.

IMN Diagnosis

The diagnosis of IMN is often diagnosed by evaluating protein in the urine (normally, there should not be protein in the urine). Others go to the doctor because of symptoms such as swelling, and blood and urine examinations reveal protein in the urine. The doctor may suggest examinations like urine tests, blood tests, etc. A blood test will help find protein, cholesterol, and waste levels in the blood. A kidney biopsy is a gold standard in confirming the diagnosis. In this test, a tiny kidney is removed with a special needle and looked at under a microscope. The kidney biopsy may show if you have a certain type of protein that helps the body fight infection, called an antibody. The body usually makes this antibody when you have MN. It is used either exclusively or in combination with antibody assay.

While the diagnosis of primary MN requires a kidney biopsy, recently, the availability of assays for PLA2R antibodies has dramatically changed the diagnostic strategy, owing to the very high specificity (99%) of anti-PLA2R antibodies for the diagnosis of MN.

IMN Treatment

The most severe cases of PMN are treated with immunosuppression. There is no cure for primary or secondary membranous nephropathy. With the patients having the condition, doctors focusing on the treatment generally adopt a symptomatic approach and try strengthening the patient's immune system.

Patients are started with supportive therapy regardless of underlying etiology as soon as the diagnosis is confirmed and continued for the course of the disease. It includes careful BP control, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker therapy to minimize proteinuria and enhance chances of spontaneous remission, statins for hyperlipidemia, salt restriction, and diuretics to control edema, and a low protein diet allowing for replacement of urinary protein losses. In recent studies, alkylating agents alternating with corticosteroids demonstrated favorable outcomes in patients with MN.

Some drugs/drug classes adopted to treat MN patients include immunosuppressive therapies (like steroids and alkylating agents, calcineurin inhibitors (CNIs), rituximab). The cornerstone of immunosuppression and immunosuppressive agents have been the alkylating agents plus steroids and calcineurin inhibitors (CNIs). Though they are partially successful in improving the reduction of proteinuria in MN patients, they have also been associated with higher relapse rates and major adverse reactions.

Some of the immunosuppressive therapies have received the most attention, and these include alkylating agents such as cyclophosphamide and chlorambucil, calcineurin inhibitors (CNIs) such as cyclosporine and tacrolimus, mycophenolate mofetil (MMF), rituximab, and adrenocorticotropic hormone (ACTH).

The treatment landscape of IMN is expected to change substantially and experience growth. The upcoming launch of innovative therapies such as SNP-ACTH (1-39) Gel, GAZYVA (obinutuzumab; RG7159), BRUKINSA (zanubrutinib), MOR202 (felzartamab), and others are expected to drive the market further.

IMN Epidemiology

As the market is derived using a patient-based model, the IMN epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Prevalence of Idiopathic Membranous Nephropathy (including the addressable pool) and Prevalence of Idiopathic Membranous Nephropathy by Antigens, in the 7MM and China covering the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, Japan, and China from 2019 to 2032. The total prevalent cases of Idiopathic Membranous Nephropathy in the 7MM and China comprised approximately 380,000 cases in 2022 and are projected to increase during the forecasted period.

• The total IMN cases in the US were approximately 29,000 in 2022 and are projected to increase during the forecast period (2023-2032).
• China contributed to the largest prevalent population of Idiopathic Membranous Nephropathy, acquiring ~82% of the 7MM and China in 2022. Whereas EU4 and the UK, and Japan accounted for around 5% of the total population share, each in 2022.
• In 2022, the US accounted for approximately 19,000 cases in the addressable pool of IMN.
• Among the EU4 countries, Germany accounted for the largest number of Idiopathic Membranous Nephropathy cases, followed by the UK, whereas France accounted for the lowest number of cases in 2022.
• The estimates that around 23,000, 800, and 5,000 cases of PLA2R antigen, THSD7A antigen, and other antigens were observed in the US in 2022. The cases are projected to increase during the forecast period.
• In 2022, total IMN cases in Japan were approximately 16,000, estimated to increase during the forecast period (2023-2032).

IMN Drug Chapters

The drug chapter segment of the IMN report encloses a detailed analysis of IMN-marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the IMN clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Emerging Drugs

GAZYVA (Hoffmann-La Roche)
GAZYVA (obinutuzumab) is a humanized and glycoengineered type II anti-CD20 monoclonal antibody with superior in vitro B-cell cytotoxicity than rituximab. Obinutuzumab is directed at a different epitope on CD20 than that recognized by rituximab and can evoke a greater B-cell apoptotic response. Modifying the glycan tree structure at the Fc fragment of obinutuzumab leads to an increased affinity to FcgRIII, thereby potentiating antibody-dependent cellular cytotoxicity via natural killer cells' antibody-dependent cellular phagocytosis via macrophages.

MOR202 (MorphoSys)
MOR202/TJ202 (felzartamab) is a therapeutic human monoclonal antibody derived from MorphoSys' HuCAL antibody library and directed against CD38. In Membranous Nephropathy, long-lived plasma cells drive pathogenic antibody production, contributing to functional damage to the glomeruli in the kidney. By targeting CD38, Felzartamab has the potential to deplete the CD38-positive plasma cells, which may ultimately improve the patient's kidney functions.

Note: Detailed emerging therapies assessment will be provided in the final report.

Drug Class Insights

The current treatment of IMN consists of off-label therapies consisting of background therapies such as ACE inhibitors, ARB inhibitors, etc., and immunosuppressive therapies such as CNIs, rituximab, cyclophosphamide, etc.

Some of the immunosuppressive therapies have received the most attention, and these include alkylating agents such as cyclophosphamide and chlorambucil, calcineurin inhibitors (CNIs) such as cyclosporine and tacrolimus, mycophenolate mofetil (MMF), rituximab, and adrenocorticotropic hormone (ACTH). Among the calcineurin inhibitors (CNIs), cyclosporine is an established treatment option for iMN patients at moderate or high risk of disease progression. Another CNI that acts as an alternative treatment is tacrolimus.

IMN Market Outlook

There is no cure for membranous nephropathy. With the patients having the condition, doctor's focus on the treatment, generally, adopt a symptomatic approach, and try strengthening the patient's immune system. Patients are started with supportive therapy regardless of underlying etiology as soon as the diagnosis is confirmed and continued for the course of the disease.

Treatment includes careful BP control, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker therapy to minimize proteinuria and enhance chances of spontaneous remission, statins for hyperlipidemia, salt restriction, and diuretics to control edema, and a low protein diet allowing for replacement of urinary protein losses. In recent studies, alkylating agents alternating with corticosteroids demonstrated favorable outcomes in patients with MN. The 2012 Kidney Disease Improving Global Outcomes (KDIGO) guidelines rate this treatment regimen as the first line.

Because of the role of B cells in autoantibody production in membranous nephropathy combined with adverse effects of alkylating agents, corticosteroids, and calcineurin inhibitors, increasing amounts of observational data have emerged about the effectiveness of rituximab. However, a lack of randomized, controlled trials precluded consideration of rituximab as a first-line agent.

This has changed with the MENTOR study and will have implications for future guidelines and patient access to this drug. Some drugs/drug classes adopted to treat MN patients include immunosuppressive therapies (like steroids and alkylating agents, calcineurin inhibitors (CNIs), rituximab). The cornerstone of immunosuppression and immunosuppressive agents have been the alkylating agents plus steroids and calcineurin inhibitors (CNIs). Though they are partially successful in improving the reduction of proteinuria in MN patients, they have also been associated with higher relapse rates and major adverse reactions.

Key players such as Cerium Pharmaceuticals (SNP-ACTH [1-39] Gel), Hoffmann-La Roche (GAZYVA [obinutuzumab; RG7159]), BeiGene (BRUKINSA [zanubrutinib]), MorphoSys/ Human Immunology Biosciences (HI-Bio)/I-Mab Biopharma (MOR202 [felzartamab]), and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of IMN.

• The total market size of Idiopathic Membranous Nephropathy in the 7MM and China is approximately USD 220 million in 2022 and is projected to increase during the forecast period (2023-2032).
• The market size in the 7MM and China will increase at a CAGR of 12% due to increasing awareness of the disease and the launch of emerging therapies.
• China contributed to the largest market share of Idiopathic Membranous Nephropathy, acquiring ~40% of the 7MM and China in 2022. Whereas EU4 and the UK, and Japan accounted for around 15% and 5% of the total market share, respectively, in 2022.
• In 2022, the US captured the highest market share (60%) of all the 7MM countries.
• Among EU4 countries, Germany accounts for the maximum market size in 2022, while France occupies the bottom of the ladder 2022.
• In Japan, the IMN market size is expected to increase at a CAGR of ~4% during the study period (2019-2032).

IMN Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019-2032. For example, for MOR202 (felzartamab), which is expected to be launched in the US in 2028, the drug uptake is expected to be medium, with a probability-adjusted peak patient share of ~20% in the US, expected to peak at 6 years from the year of launch.

Further detailed analysis of emerging therapies drug uptake in the report…

IMN Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. 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 IMN emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SME's opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on IMN evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, and drug uptake, along with challenges related to accessibility, include Medical/scientific writers and Professors from renowned universities in the US, Europe, the UK, Japan, and China.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM and China. Centers like the Medicine Department of Ohio State University, the Department of Medicine, and Fred Hutchinson Cancer Research Center were contacted. Their opinion helped understand and validate current and emerging therapy treatment patterns of IMN market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

The publisher performs Qualitative and Market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. 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.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in trials for IMN, one of the most important primary endpoints is efficacy in reducing the intensity of IMN over time percentage of patients that respond to treatment. Based on these, the overall efficacy is evaluated.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The cost of newly approved medications is usually high, and because of it, patients escape from proper treatment or opt for off-label and cheap medications. It affects market access to newly launched medications, and reimbursement is crucial. Often, the decision to reimburse comes down to the 'drug's price relative to the benefit it produces in treated patients. Market access and reimbursement options can differ depending on regulatory status, target population size, the setting of care, unmet needs, the magnitude of incremental benefit claims, and costs.

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

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of IMN, explaining the definition of IMN, risk factors involved in IMN, pathophysiology, and the treatment of IMN.
• Comprehensive insights into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have 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 IMN 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 + China 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 + China IMN market.

IMN Report Insights

• Patient Population
• Therapeutic Approaches
• IMN Pipeline Analysis
• IMN Market Size and Trends
• Existing and Future Market Opportunity

IMN Report Key Strengths

• Ten years Forecast
• 7MM + China Coverage
• IMN Epidemiology Segmentation
• Key Cross Competition
• Attribute Analysis
• Drugs Uptake and Key Market Forecast Assumptions

IMN Report Assessment

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

Key Questions Answered

Market Insights

• What was the IMN total market size, the market size by therapies, market share (%) distribution in 2019, and what would it look like in 2032? What are the contributing factors for this growth?
• What kind of uptake the new therapies approved will witness in IMN patients in the coming years?
• Which therapy is going to be the largest contributor in 2032?
• 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?

Epidemiology Insights

• What are the disease risk, burdens, and unmet needs of IMN? What will be the growth opportunities across the 7MM + China with respect to the patient population pertaining to IMN?
• What is the historical and forecasted IMN patient pool in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, Japan, and China?
• What is the treatment eligibility pattern of IMN?
• Which clinical factors will affect IMN?
• Which factors will affect the increase in the diagnosis of chronic IMN?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of IMN? What are the current treatment guidelines for the treatment of IMN in the US, Europe, the UK, Japan, and China?
• How many companies are developing therapies for the treatment of IMN?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of IMN?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?
• What is the 7MM + China historical and forecasted market of IMN?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the IMN market.
• Insights on patient burden/disease prevalence and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunity 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, Spain) and the United Kingdom, Japan, and China.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• 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 need of the existing market so that the upcoming players can strengthen their development and launch strategy.