항사구체기저막(항GBM) : 시장 인사이트, 역학, 시장 예측(-2034년)

Key Highlights:

• The US accounts for the largest Anti-GBM market size in the 7MM with nearly USD 15.5 million in 2023.
• 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.

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

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

Anti-GBM Treatment Market

Anti-glomerular Basement Membrane (Anti-GBM) Disease 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.

Anti-glomerular Basement Membrane (Anti-GBM) Disease 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-glomerular Basement Membrane (Anti-GBM) Disease Epidemiology

The anti-GBM disease epidemiology chapter in the 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-glomerular Basement Membrane (Anti-GBM) Disease Drug Chapter

The drug chapter segment of the anti-GBM disease market report encloses a detailed analysis of anti-GBM disease pipeline drugs. It also deep dives into the anti-GBM disease pivotal 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.

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. Treatment opportunities are likely to evolve as for the first time, some exciting therapy, is heading down the pipeline. At present, key players such as Hansa Biopharma (imlifidase) have commenced clinical trials that investigate new treatment options for the management of anti-GBM disease.

• 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 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-glomerular Basement Membrane (Anti-GBM) Disease Drugs Uptake

This section focuses on the uptake rate of potential Anti-GBM drugs expected to be launched in the 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.

Anti-glomerular Basement Membrane (Anti-GBM) Disease Activities

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

Pipeline Development Activities

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

Anti-GBM KOL Views

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 market and the unmet needs.

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 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 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 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 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 market.

Anti-GBM Disease Market Report Insights

• Anti-GBM Patient Population
• Anti-GBM Therapeutic Approaches
• Anti-glomerular Basement Membrane (Anti-GBM) Disease Pipeline Analysis
• Anti-glomerular Basement Membrane (Anti-GBM) Disease 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-glomerular Basement Membrane (Anti-GBM) Disease 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)

FAQs:

• What is the growth rate of the 7MM anti-GBM disease treatment market?
• What was the anti-GBM disease 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/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, mechanisms of action, and technologies developed to overcome the limitations of existing 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 market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the anti-GBM disease 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 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 players can strengthen their development and launch strategy

Table of Contents

1 Key Insights

2 Anti-GBM Market Report Introduction

3 Anti-glomerular Basement Membrane (anti-GBM) Disease Market Overview at a Glance

• 3.1 Market Share (%) Distribution of anti-GBM disease in 2023
• 3.2 Market Share (%) Distribution of anti-GBM disease in 2034

4 Executive Summary of Anti-Glomerular Basement Membrane (Anti-GBM) Disease

5 Key Events

6 Anti-GBM Epidemiology and Market Methodology

7 Disease Background and Overview

• 7.1 Introduction
• 7.2 Risk Factors and Causes of Anti-GBM Disease
• 7.3 Signs and Symptoms of Anti-GBM Disease
• 7.4 Pathophysiology of Anti-GBM Disease
• 7.5 Clinical Manifestations of Anti-GBM Disease
• 7.6 Complications of Anti-GBM Disease
• 7.7 Diagnosis of Anti-GBM Disease
  • 7.7.1 Diagnostic Algorithm
  • 7.7.2 Diagnostic Tests
  • 7.7.3 Physical Examination
  • 7.7.4 Blood and Urine Testing
  • 7.7.5 Anti-GBM Antibody Testing
  • 7.7.6 Anti-Neutrophil Cytoplasmic Antibody (ANCA) Testing
  • 7.7.7 Renal Biopsy
  • 7.7.8 Alveolar Hemorrhage
  • 7.7.9 Chest Radiograph
• 7.8 Differential Diagnosis
• 7.9 Diagnostic Guidelines
  • 7.9.1 Diagnostic Guideline by KDIGO
  • 7.9.2 KDIGO Diagnostic Guideline for Kidney Biopsy

8 Treatment of Anti-GBM disease

• 8.1 KDIGO Treatment Algorithm of Anti-GBM Disease
• 8.2 Treatment Guidelines
• 8.3 KDIGO Treatment Guidelines

9 Anti-GBM Epidemiology and Patient Population

• 9.1 Key Findings
• 9.2 Assumptions and Rationale
• 9.3 Total Incident Cases of Anti-GBM in the 7MM
• 9.4 The United States
  • 9.4.1 Total Incident Cases of Anti-GBM in the US
  • 9.4.2 Age-specific Incident Cases of Anti-GBM in the US
• 9.5 EU4 and the UK
  • 9.5.1 Total Incident Cases of Anti-GBM in EU4 and the UK
  • 9.5.2 Age-specific Incident Cases of Anti-GBM in EU4 and the UK
• 9.6 Japan
  • 9.6.1 Total Incident Cases of Anti-GBM in Japan
  • 9.6.2 Age-specific Incident Cases of Anti-GBM in Japan

10 Patient Journey of Anti-GBM

11 Emerging Anti-GBM Therapies

• 11.1 IDEFIRIX (Imlifidase/HMed-IdeS): Hansa Biopharma
  • 11.1.1 Drug Description
  • 11.1.2 Other Developmental Activities
  • 11.1.3 Clinical Development
  • 11.1.4 Safety and Efficacy

12 Anti-GBM Disease Market: 7 Major Market Analysis

• 12.1 Key Findings
• 12.2 Anti-GBM Market Outlook
• 12.3 Conjoint Analysis
• 12.4 Key Anti-GBM Market Forecast Assumptions
  • 12.4.1 Cost Assumptions and Rebate
  • 12.4.2 Pricing Trends
  • 12.4.3 Analogue Assessment
  • 12.4.4 Launch Year and Therapy Uptake
• 12.5 Total Market Size of Anti-GBM Disease in the 7MM
• 12.6 Market Size of Anti-GBM by Therapies in the 7MM
• 12.7 The United States Anti-GBM Market Size
  • 12.7.1 Total Market Size of Anti-GBM Disease in the US
  • 12.7.2 Market Size of Anti-GBM by Therapies in the US
• 12.8 EU4 and the UK Anti-GBM Market Size
  • 12.8.1 Total Market Size of Anti-GBM Disease in EU4 and the UK
  • 12.8.2 Market Size of Anti-GBM by Therapies in EU4 and the UK
• 12.9 Japan Anti-GBM Market Size
  • 12.9.1 Total Market Size of Anti-GBM Disease in Japan
  • 12.9.2 Market Size of Anti-GBM by Therapies in Japan

13 Anti-GBM KOL Views

14 Anti-GBM SWOT Analysis

15 Anti-GBM Unmet Needs

16 Anti-GBM Market Access and Reimbursement

• 16.1 Key HTA decisions for NMOSD (as a reference for anti-GBM)
• 16.2 Reimbursement

17 Appendix

• 17.1 Bibliography
• 17.2 Report Methodology

18 DelveInsight Capabilities

19 Disclaimer

20 About DelveInsight