Anti-GBM Market Summary

• The US accounts for the largest Anti-Glomerular Basement Membrane (Anti-GBM) market size in the 7MM with nearly USD 15.5 million in 2023.
• Key Anti-Glomerular Basement Membrane (Anti-GBM) Companies are Hansa Biopharma, and many more.

Anti-GBM Disease Market Insight and Trends

• Anti-GBM is an ultra-rare and very severe disease that affects approximately 1−1.5 people per million, annually. Many patients lose their kidney function, requiring chronic dialysis and/or kidney transplantation. It typically affects people in two age groups – young people aged 20−30, and people 60 and older.
• The majority of patients (80-90%) are present with features of rapidly progressive glomerulonephritis. Whereas, 40 to 60% have concurrent lung hemorrhage, and a small minority of patients may present with isolated pulmonary disease.
• Standard therapy comprises plasma exchange combined with high doses of glucocorticoids and cyclophosphamide.
• In the 7MM, the US accounted for the highest number of incident cases of anti-GBM disease with more than 500 cases in 2023.
• Among EU4 and the UK, Germany accounted for the maximum number of incident cases followed by France in 2023.
• There is no approved therapy for the treatment of anti-GBM thus creating a high unmet need for new therapies for the treatment of anti-GBM disease.
• The anti-GBM disease pipeline is not so robust but possesses one potential drug i.e., IDEFIRIX (Imlifidase/HMed-IdeS) which is currently in Phase III clinical development.

Factors Affecting Anti-GBM Disease Market Growth

Low Disease Prevalence and Rare Patient Population

Anti-glomerular basement membrane (anti-GBM) disease also known as Goodpasture’s syndrome is a rare autoimmune condition, which limits the number of diagnosed cases globally. The small patient population constrains market size and reduces commercial attractiveness for therapeutic developers.

Challenges in Early Diagnosis

Anti-GBM disease often presents with symptoms similar to other autoimmune or renal disorders (e.g., hematuria, pulmonary hemorrhage). Delayed or misdiagnosis can restrict timely treatment initiation and reduce utilization of appropriate therapies. Limited access to specialized diagnostic tests (anti-GBM antibody assays, renal biopsy) in some regions further hampers early identification.

Advancements in Diagnostic Technologies

Improved laboratory assays and greater clinician awareness of specialized testing have enabled better detection of anti-GBM antibodies, supporting earlier diagnosis and treatment. Enhanced diagnostic capabilities can increase patient identification, driving demand for therapeutic interventions.

Limited Treatment Options and Unmet Medical Need

Current anti-GBM disease management primarily relies on plasmapheresis, corticosteroids, and immunosuppressive agents to suppress immune activity and remove pathogenic antibodies. There are no disease-modifying therapies uniquely approved for anti-GBM disease, representing a major unmet need. The lack of targeted treatments presents both a restraint (due to limited options) and opportunity (for innovation).

Rising Focus on Rare Disease Research

Growing interest in rare autoimmune and nephrological disorders has led to increased research funding and clinical investigations. Orphan drug incentives, special regulatory pathways, and financial support for rare disease R&D encourage therapeutic development, which may accelerate pipeline growth.

Access to Healthcare and Specialist Care

Availability of nephrology and autoimmune specialty care influences disease management. Regions with strong healthcare infrastructure and specialist networks are better equipped to diagnose and treat anti-GBM disease, whereas areas with limited access may underreport cases and have lower treatment uptake.

Economic and Reimbursement Constraints

High costs associated with intensive therapies (plasmapheresis, long-term immunosuppression) and diagnostic procedures, combined with variable insurance coverage, can limit patient access especially in developing markets. Reimbursement policies play a crucial role in treatment affordability.

Patient Education and Awareness

Lack of awareness among patients and some healthcare providers about anti-GBM disease symptoms can delay diagnosis and reduce engagement with appropriate care pathways. Enhanced education initiatives can support earlier presentations and better disease outcomes.

Competitive Rare Disease Landscape

Pharmaceutical attention, investment, and resources are often focused on more prevalent autoimmune or renal conditions (e.g., lupus nephritis), which may divert research efforts away from ultra-rare diseases like anti-GBM disease, slowing market momentum.

DelveInsight's “Anti-GBM Market Insight, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of Anti-GBM, historical and forecasted epidemiology as well as the Anti-GBM market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

Anti-GBM market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Anti-GBM market size from 2020 to 2034. The Anti-GBM treatment market report also covers current Anti-GBM treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Anti-GBM Disease Understanding

Anti-GBM Overview, Country-Specific Treatment Guidelines and Diagnosis

Anti-GBM disease is a rare but serious autoimmune disease that causes inflammation in the kidneys and lungs. Anti-GBM disease may affect only the kidneys; however, when it causes both kidney and lung disease, it is called Goodpasture’s syndrome. In anti-GBM disease, the immune system mistakenly makes “anti-GBM antibodies” that attack the lungs and kidneys, leading to bleeding and inflammation in the organs. It is also characterized by the inflammation of the filtering structures (glomeruli) of the kidneys (glomerulonephritis) and excessive bleeding into the lungs (pulmonary hemorrhaging).

The diagnosis of anti-GBM disease usually relies on a blood test to identify anti-GBM antibodies. Often a kidney biopsy (taking a small sample of kidney tissue with a needle) is required to demonstrate that the kidneys are involved. This may also confirm the diagnosis, by showing deposition of anti-GBM antibodies in the kidney. Other tests such as X-rays or CT scans are often used to show if the lungs are involved. Patients are tested for serum anti-GBM antibodies by indirect immunofluorescence testing or, when available, direct enzyme-linked immunosorbent assay (ELISA) with recombinant or human NC-1 alpha3. The presence of these antibodies confirms the diagnosis.

Further details related to country-based variations in diagnosis are provided in the report

Anti-GBM Treatment

Treatment requires a process called plasma exchange, which involves using a machine to remove anti-GBM antibodies from the bloodstream. This is often done daily for 2 weeks. In addition, immunosuppressive drugs such as steroids and cyclophosphamide, are used to suppress inflammation and stop further antibody production. Treatment usually continues for 6 months after the diagnosis is made.

Anti-GBM Epidemiology

The anti-GBM disease epidemiology chapter in the Anti-GBM treatment market report provides historical as well as forecasted epidemiology in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034. The anti-GBM disease epidemiology is segmented with detailed insights into total incident cases of anti-GBM disease and age-specific incident cases of anti-GBM disease.

• In the 7MM, the highest number of incident cases of anti-GBM disease was observed in the US with more than 500 cases in 2023.
• In EU4 and the UK, the highest number of incident cases of anti-GBM disease was observed in Germany, followed by France. Whereas, Spain occupied the bottom of the ladder.
• It typically affects people in two age groups – young people aged 20−30, and people 60 and older.

Anti-GBM Drugs Analysis

The drug chapter segment of the anti-GBM disease treatment market report encloses a detailed analysis of anti-GBM disease pipeline drugs. It also deep dives into the anti-GBM clinical trial details, expected market approvals, patent details, the latest news, and recent deals and collaborations.

Emerging Anti-GBM Drugs

IDEFIRIX (Imlifidase/HMed-IdeS): Hansa Biopharma

Imlifidase is a unique intravenous antibody-cleaving enzyme originating from Streptococcus pyogenes. It specifically targets IgG and inhibits IgG-mediated immune response and is being developed by Hansa Biopharma for the treatment of transplant rejection and rare IgG-mediated autoimmune conditions. Using imlifidase is a novel approach to eliminate pathogenic IgG. It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their reactivity within hours after intravenous administration. In 2018, Hansa Biopharma was granted orphan drug designation for imlifidase for anti-GBM antibody disease in both Europe and the US. The drug is currently in Phase III.

The GOOD-IDES-02 Phase III study in anti-GBM disease has now enrolled more than 70 percent of patients and the company is expecting to complete enrollment and deliver data in 2025.

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

Anti-GBM Disease Market Outlook

There is a high unmet need for new therapies for the treatment of anti-GBM disease, which is apparent by the unavailability of any approved drugs in the anti-GBM disease market. Nevertheless, recently some developmental activities have been initiated toward the management of anti-GBM disease. Anti-GBM Treatment opportunities are likely to evolve as for the first time, some exciting therapy, is heading down the pipeline. At present, key Anti-GBM companies such as Hansa Biopharma (imlifidase) have commenced Anti-GBM clinical trials that investigate new treatment options for the management of anti-GBM disease.

Key findings from the Anti-GBM Disease Market Forecast

• Standard treatment for anti-GBM disease includes plasmapheresis, to rapidly remove pathogenic autoantibody, along with cyclophosphamide and corticosteroids, to inhibit further autoantibody production and to ameliorate end-organ inflammation.
• In the US, the Anti-GBM market size comprised nearly USD 15.5 million in 2023. The treatment space is expected to experience a substantial impact in the coming years due to the improvement in healthcare spending across the world.
• A few potential Anti-GBM therapies are being investigated for the management of anti-GBM disease. Even though it is too soon to comment for the above-mentioned promising candidate to enter the Anti-GBM market during the forecast period (2024–2034), it is safe to assume that the future of this market is bright, and eventually, the drug shall create a significant difference in the landscape of anti-GBM disease in coming years.

Anti-GBM Drugs Uptake

This section focuses on the uptake rate of potential Anti-GBM drugs expected to be launched in the Anti-GBM treatment market during 2024–2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key Anti-GBM companies 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.

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

Anti-GBM Clinical Trials Activities

The Anti-GBM treatment market report provides insights into different therapeutic candidates in different stages. It also analyzes key Anti-GBM companies involved in developing targeted therapeutics.

Anti-GBM Pipeline Developmental Activities

The Anti-GBM treatment market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for anti-GBM disease emerging therapies.

Latest KOL Views from Anti-GBM

To keep up with the real-world scenario in current and emerging Anti-GBM 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 were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.

DelveInsight’s analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging treatment patterns of anti-GBM disease. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the Anti-GBM market and the unmet needs.

Anti-GBM Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging Anti-GBM 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.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and 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 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 Anti-GBM therapies are decided.

Anti-GBM Market Access and Reimbursement

The Anti-GBM market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used 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 Anti-GBM Market Report

• The Anti-GBM treatment market report covers a segment of key events, an executive summary, descriptive overview of anti-GBM disease, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country-specific treatment guidelines.
• Additionally, an all-inclusive account of emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the anti-GBM disease 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 Anti-GBM treatment market 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 in shaping and driving the 7MM anti-GBM disease treatment market.

Anti-GBM Disease Market Report Insights

• Anti-GBM Patient Population
• Anti-GBM Therapeutic Approaches
• Anti-GBM Pipeline Analysis
• Anti-GBM Market Size
• Anti-GBM Market Trends
•  Existing and future Anti-GBM Market Opportunity

Anti-GBM Disease Market Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage
• Anti-GBM Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL’s feedback on approved and emerging Anti-GBM therapies
• Key Cross Competition
• Conjoint analysis
• Anti-GBM Drugs Uptake
• Key Anti-GBM Market Forecast Assumptions

Anti-GBM Disease Market Report Assessment

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

Frequently Asked Question from Anti-GBM Disease Market

• What is the growth rate of the 7MM anti-GBM disease treatment market?
• What was the anti-GBM 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/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• 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 Anti-GBM market dynamics and subsequent analysis of the associated trends? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
• What are the current and emerging options for the treatment of anti-GBM disease?
• How many Anti-GBM companies are developing therapies for the treatment of anti-GBM disease?
• What are the recent novel therapies, targets, Anti-GBM mechanisms of action, and technologies developed to overcome the limitations of existing Anti-GBM therapies?
• Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved Anti-GBM therapies?

Reasons to buy the Anti-GBM Disease Market Report

• The Anti-GBM market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the anti-GBM disease treatment market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing Anti-GBM market opportunities in varying geographies and the growth potential over the coming years.
• Identifying strong upcoming Anti-GBM companies in the Anti-GBM drugs market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging Anti-GBM therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies, 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 Anti-GBM market so that the upcoming Anti-GBM companies can strengthen their development and launch strategy