補体3糸球体症市場 - 市場の洞察、疫学、市場予測：2034年

補体3糸球体症という用語は、補体カスケードの調節異常によって引き起こされるまれな腎疾患群を定義するために、2013年に専門家のコンセンサスによって採用されました。補体3糸球体症の主な特徴には、尿中の高濃度蛋白（蛋白尿）、血尿（血尿）、尿量の減少、血液中の低濃度蛋白、体の数カ所の腫脹などがあります。

補体3糸球体症は糸球体疾患の一種であり、糸球体内にC3補体成分（C3）が優位に沈着し、C1qおよびC4が沈着しないことが特徴です。糸球体中に古典的補体成分やレクチン補体成分が有意に存在せずにC3が蓄積することは、基礎となる病態機序として代替補体経路の調節障害を示唆しています。糸球体腎炎の古典的な臨床的特徴を有する患者において、免疫グロブリンの沈着がない、あるいはほとんどないこの所見は、唯一の診断基準です。補体3糸球体症はまれな疾患であるため、正確な発生率や有病率を算出することは困難であるが、いくつかの小規模コホート研究によって、信頼性の低い推定値が得られています。

ほとんどの場合、補体3糸球体症の診断には、腎生検と光学顕微鏡、免疫蛍光、電子顕微鏡による注意深い検討が必要です。大まかには、補体3糸球体症は、免疫蛍光（IF）において、免疫グロブリンと比較してC3の染色が優勢（強度が2桁以上）であると定義されます。補体3糸球体障害は、電子顕微鏡所見により、緻密な膜内浸透圧沈着の有無によってDDDまたはC3GNに分類されます。しかし、補体3糸球体症の診断を確定するために選択される様々な診断検査は以下の通りである：尿検査、血液検査、糸球体濾過量（GFR）、腎生検などです。

補体3糸球体症に対する最適な治療法はまだ確立されていません。補体3糸球体症と診断されたすべての患者には、生活習慣のアドバイス、高血圧と蛋白尿をコントロールするためのアンジオテンシン変換酵素阻害薬またはアンジオテンシン受容体拮抗薬、脂質低下治療などの腎保護対策を行うべきです。このような薬物療法だけでは末期腎疾患への進行を予防することは示されていないが、免疫抑制薬の予防効果を改善する可能性はあります。補体3糸球体症に対する承認された治療法/治療薬、および補体3糸球体症の原因を攻撃できる治療法がないため、治療レジメンは補体3糸球体症による腎障害のプロセスを遅らせることに重点を置く。この治療法には、副腎皮質ステロイド（しばしば「ステロイド」と呼ばれる）、免疫抑制薬、ACE阻害薬やARB、食事療法、補体阻害薬などが含まれます。

主要7ヶ国における補体3糸球体症の市場規模は、2023年に約3,500万米ドルでした。補体3糸球体症の市場規模が最も大きいのは米国で、EU4ヶ国と英国、日本と比べても、主要7ヶ国の73%を占めています。EU4ヶ国と英国の中で、2023年の市場規模が最も大きいのはドイツで、2023年の補体3糸球体症の市場規模が最も小さいのはイタリアです。

当レポートでは、主要7ヶ国における補体3糸球体症市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2032年までの市場規模予測、および医療のアンメットニーズなどを提供しています。

目次

第1章 重要な洞察

第2章 レポートのイントロダクション

第3章 補体3糸球体症のエグゼクティブサマリー

第4章 補体3糸球体症市場の概要

第5章 主要な出来事

第6章 疫学と市場予測調査手法

第7章 疾患の背景と概要

• イントロダクション
• C3Gのよく知られた形式
• 原因と危険因子
• 臨床所見
• 組織学的パターン
• 症状
• 病態生理学
• 病因
• 診断
• 診断における課題
• 鑑別診断
• 予後

第8章 治療

• C3Gの診断と管理のためのアルゴリズム

第9章 糸球体疾患の管理のための臨床実践ガイドライン：KDIGO 2021年

• 補体3糸球体症

第10章 疫学と患者数

• 主な調査結果
• 前提条件と根拠
• 主要7ヶ国におけるC3Gと診断された有病人口の合計
• 米国
• EU4ヶ国と英国
• 日本

第11章 患者動向

第12章 新興薬剤

第13章 補体3糸球体症（C3G）：主要7ヶ国市場分析

• 主な調査結果
• 主要7ヶ国におけるC3Gの総市場規模
• 市場の見通し
• コンジョイント分析
• 主要な市場予測の前提条件
• 米国の市場規模
• EU4ヶ国と英国の市場規模
• 日本市場規模

第14章 アンメットニーズ

第15章 SWOT分析

第16章 KOLの見解

第17章 市場アクセスと償還

• 米国
• EU4ヶ国と英国
• 日本
• 補体3糸球体症（C3G）：市場アクセスと償還

第18章 付録

第19章 DelveInsightのサービス内容

第20章 免責事項

第21章 DelveInsightについて

List of Tables

• Table 1: Summary of C3 Glomerulopathy (C3G) Market, and Epidemiology (2020-2034)
• Table 2: Factor-H-related Fusion Proteins in Familial C3G
• Table 3: Acquired Drivers of C3G
• Table 4: Diagnostic Procedure for Patients Suspected of C3G
• Table 5: Total Diagnosed Prevalent Population of C3G in the 7MM (2020-2034)
• Table 6: Total Diagnosed Prevalent Population of C3G in the United States (2020-2034)
• Table 7: Type-specific Diagnosed Prevalent Population of C3G in the United States (2020-2034)
• Table 8: Age-specific Diagnosed Prevalent Population of C3G in the United States (2020-2034)
• Table 9: Total Diagnosed Prevalent Population of C3G in EU4 and the UK (2020-2034)
• Table 10: Type-specific Diagnosed Prevalent Population of C3G in EU4 and the UK (2020-2034)
• Table 11: Age-specific Diagnosed Prevalent Population of C3G in EU4 and the UK (2020-2034)
• Table 12: Total Diagnosed Prevalent Population of C3G in Japan (2020-2034)
• Table 13: Type-specific Diagnosed Prevalent Population of C3G in Japan (2020-2034)
• Table 14: Age-specific Diagnosed Prevalent Population of C3G in Japan (2020-2034)
• Table 15: Comparison of Emerging Drugs Under Development
• Table 16: Iptacopan, Clinical Trial Description, 2024
• Table 17: Pegcetacoplan (APL-2), Clinical Trial Description, 2024
• Table 18: ARO-C3, Clinical Trial Description, 2024
• Table 19: KP104, Clinical Trial Description, 2024
• Table 20: AMY-101, Clinical Trial Description, 2024
• Table 21: NM8074, Clinical Trial Description, 2024
• Table 22: Market Size of C3G in the 7MM in USD million (2020-2034)
• Table 23: Key Market Forecast Assumption of C3G in the United States
• Table 24: Key Market Forecast Assumption of C3G in EU4 and the UK
• Table 25: Key Market Forecast Assumption of C3G in Japan
• Table 26: Market Size of C3G in the US, USD million (2020-2034)
• Table 27: Market Size of C3G by Therapies in the US, USD million (2020-2034)
• Table 28: Market Size of C3G in EU4 and the UK, USD million (2020-2034)
• Table 29: Market Size of C3G by therapies in EU4 and the UK, USD million (2020-2034)
• Table 30: Market Size of C3G in Japan, USD million (2020-2034)
• Table 31: Market Size of C3G by Therapies in Japan, USD million (2020-2034)

List of Figures

• Figure 1: C3-dominant Glomerulonephritis Disease Classification
• Figure 2: Algorithm for Diagnosis and Management of C3G
• Figure 3: Algorithm for Clinical Management of C3G or IC-MPGN
• Figure 4: Total Diagnosed Prevalent Population of C3G in the 7MM (2020-2034)
• Figure 5: Total Diagnosed Prevalent Population of C3G in the United States (2020-2034)
• Figure 6: Type-specific Diagnosed Prevalent Population of C3G in the United States (2020-2034)
• Figure 7:Age-specific Diagnosed Prevalent Population of C3G in the United States (2020-2034)
• Figure 8: Total Diagnosed Prevalent Population of C3G in EU4 and the UK (2020-2034)
• Figure 9: Type-specific Diagnosed Prevalent Population of C3G in EU4 and the UK (2020-2034)
• Figure 10: Age-specific Diagnosed Prevalent Population of C3G in EU4 and the UK (2020-2034)
• Figure 11: Total Diagnosed Prevalent Population of C3G in Japan (2020-2034)
• Figure 12: Type-specific Diagnosed Prevalent Population of C3G in Japan (2020-2034)
• Figure 13: Age-specific Diagnosed Prevalent Population of C3G in Japan (2020-2034)
• Figure 14: Market Size of C3G in the 7MM in USD million (2020-2034)
• Figure 15: Market Size of C3G in the US, USD million (2020-2034)
• Figure 16: Market Size of C3G by Therapies in the US, USD million (2020-2034)
• Figure 17: Market Size of C3G in EU4 and the UK, USD million (2020-2034)
• Figure 18: Market Size of C3G by Therapies in EU4 and the UK, USD million (2020-2034)
• Figure 19: Market Size of C3G in Japan, USD million (2020-2034)
• Figure 20: Market Size of C3G by Therapies in Japan, USD million (2020-2034)
• Figure 21: Health Technology Assessment
• Figure 22: Reimbursement Process in Germany
• Figure 23: Reimbursement Process in France
• Figure 24: Reimbursement Process in Italy
• Figure 25: Reimbursement Process in Spain
• Figure 26: Reimbursement Process in the United Kingdom
• Figure 27: Reimbursement Process in Japan
• Figure 28: Complement Activation is Implicated in Numerous Diseases

Key Highlights:

• The market size of Complement 3 Glomerulopathy in the 7MM was ~USD 35 million in 2023 and is expected to increase by 2034 due to an increase in the diagnosed prevalence of Complement 3 Glomerulopathy and the entry of emerging therapies with a premium price tag.
• Since there are no approved therapies for Complement 3 Glomerulopathy, the market is mainly dominated by the use of off-label prescription drugs. Treatments for Complement 3 Glomerulopathy 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 a realistic therapeutic option for complement-related diseases.
• Adult population is more prevalent towards Complement 3 Glomerulopathy compared to the pediatric population. Approximately ~15% of the population of Complement 3 Glomerulopathy in Japan are pediatric and ~85% are adults.
• The emerging pipeline of C3G holds a few significant products in development by prominent key players such as Apellis Pharmaceuticals, Novartis, Arrowhead Pharmaceuticals, coming up with interventions such as pegcetacoplan (APL-2), iptacopan (LNP023), ARO-C3, respectively. These therapies are expected to create an upward shift in the C3G treatment market, after their launch in the coming years, in the 7MM.

DelveInsight's "Complement 3 Glomerulopathy (C3G) - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Complement 3 Glomerulopathy, historical and forecasted epidemiology as well as Complement 3 Glomerulopathy market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Complement 3 Glomerulopathy market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Complement 3 Glomerulopathy market size from 2020 to 2034. The report also covers current Complement 3 Glomerulopathy 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.

Complement 3 Glomerulopathy Disease Understanding and Treatment Algorithm

Complement 3 Glomerulopathy Overview

The term complement 3 glomerulopathy was adopted by expert consensus in 2013 to define a group of rare kidney diseases driven by dysregulation of the complement cascade. The major features of Complement 3 Glomerulopathy include high levels of protein in the urine (proteinuria), blood in the urine (hematuria), reduced amounts of urine, low levels of protein in the blood, and swelling in several areas of the body.

Complement 3 Glomerulopathy is a type of glomerular disease, characterized by predominant C3 complement component (C3) deposits in the glomeruli in the absence of a significant amount of immunoglobulin and without deposition of C1q and C4. The accumulation of C3 without a significant amount of classical or lectin complement component in the glomeruli suggests dysregulation of the alternative complement pathway as the underlying pathogenetic mechanism. This finding, in the absence or near absence of immunoglobulin deposits in a patient with the classic clinical features of glomerulonephritis, is the single diagnostic criterion. The rarity of Complement 3 Glomerulopathy makes it challenging to derive precise incidence and prevalence of the indication; however, several small cohort studies have generated estimates of limited reliability.

Complement 3 Glomerulopathy Diagnosis

In most cases, diagnosis of Complement 3 Glomerulopathy requires a renal biopsy and careful review of light microscopy, immunofluorescence, and electron microscopy. Broadly, Complement 3 Glomerulopathy is defined as the predominant staining of C3 on immunofluorescence (IF) when compared to immunoglobulin (intensity >2 orders of magnitude). Complement 3 Glomerulopathy is classified by electron microscopy findings into DDD or C3GN, depending on the presence or absence of dense osmiophilic intramembranous deposits. However, the various diagnostic tests opted for establishing a Complement 3 Glomerulopathy diagnosis are as follows: Urine test, Blood test, Glomerular filtration rate (GFR), and Kidney biopsy.

Complement 3 Glomerulopathy Treatment

Optimal treatment for Complement 3 Glomerulopathy has not been established yet since no treatment has proven effective and beneficial for Complement 3 Glomerulopathy. All patients diagnosed with Complement 3 Glomerulopathy should be treated with renoprotective measures, including lifestyle advice, an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker to control hypertension and proteinuria, and lipid-lowering treatment. Such medication alone has not been shown to protect against progression to end-stage renal disease but may improve the protective effect of immunosuppressive medication. Due to the absence of approved treatment/therapies for Complement 3 Glomerulopathy as well as therapies that can attack the cause of Complement 3 Glomerulopathy, the treatment regimen focuses on slowing the process of kidney damage from Complement 3 Glomerulopathy. This treatment regimen may include corticosteroids (often called "steroids"), immunosuppressive drugs, ACE inhibitors and ARBs, diet changes, and complement inhibitors.

Further details related to treatment are provided in the report…

Complement 3 Glomerulopathy Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent population of Complement 3 Glomerulopathy, type-specific diagnosed prevalent population of Complement 3 Glomerulopathy, and age-specific diagnosed prevalent population of Complement 3 Glomerulopathy 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 Complement 3 Glomerulopathy in the 7MM was found to be ~5,700 in 2023.
• The diagnosed prevalent population of Complement 3 Glomerulopathy, in the United States, was found to be 3,300 in 2023.
• In EU4 and the UK, the diagnosed prevalent population of Complement 3 Glomerulopathy 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 in Complement 3 Glomerulopathy compared to pediatrics.

Complement 3 Glomerulopathy Drug Chapters

The drug chapter segment of the Complement 3 Glomerulopathy report encloses a detailed analysis of the marketed and the late-stage (Phase III and Phase II) pipeline drugs. Furthermore, the current key players for emerging drugs and their respective drug candidates include Novartis Pharmaceuticals (Iptacopan), Apellis Pharmaceuticals (pegcetacoplan), and others. The drug chapter also helps understand the Complement 3 Glomerulopathy 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

Novartis Pharmaceuticals is developing Iptacopan, which is an oral small-molecule inhibitor of complement factor B (FB) with potential immunomodulatory activity. Upon administration, FB inhibitor LNP023 binds to FB and prevents the formation of the alternative pathway (AP) C3-convertase (C3bBb). This limits the cleavage of C3 to the active fragment C3b and may prevent C3b-mediated extravascular hemolysis in certain complement-driven disorders such as Complement 3 Glomerulopathy, paroxysmal nocturnal hemoglobinuria (PNH), etc. The company is expecting data read-out in 2025 from the Phase II study (NCT03955445).

Furthermore, data read-out from the Phase III study (NCT03955445) is expected by 2025. Novartis plans to submit the drug by 2024, aiming to bring it to market promptly and meet the needs of patients. Iptacopan is expected to have a first-mover advantage in the Complement 3 Glomerulopathy market space.

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. The Phase III VALIANT study investigating pegcetacoplan in adolescent and adult patients with native and post-transplant recurrence of IC-MPGN and Complement 3 Glomerulopathy is ongoing, with top-line results expected by 2024. In terms of efficacy, pegcetacoplan is better than Iptacopan based on the Phase II trial.

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

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 Complement 3 Glomerulopathy. 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 Complement 3 Glomerulopathy. 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 Complement 3 Glomerulopathy therapy. Complement inhibitors Pegcetacoplan and Iptacopan perform well in Complement 3 Glomerulopathy in terms of safety and effectiveness.

Note: Detailed insights will be provided in the final report.

Complement 3 Glomerulopathy Market Outlook

According to the National Kidney Foundation (NKF), Complement 3 Glomerulopathy stands for complement 3 glomerulopathy. The "C3" refers to a blood protein that plays a key role in normal immunity and the development of this disease whereas the "G" is for glomerulopathy, meaning damage to the glomeruli in the kidney. In addition, Complement 3 Glomerulopathy includes dense deposit disease (DDD) and C3 glomerulonephritis (C3GN), which represent the two different patterns of damage and inflammation in the glomeruli. In other words, the damage and inflammation in the kidney tissue in DDD look different from that in C3GN when seen under a microscope.

Since there are no approved therapies for Complement 3 Glomerulopathy, the market is mainly dominated by the use of off-label prescription drugs. Treatments for Complement 3 Glomerulopathy include Immunosuppressants in combination with corticosteroids, Renin-angiotensin-aldosterone system Inhibitors (RAAS), and other supportive therapies (calcineurin inhibitors, anti-complement therapies with eculizumab).

However, the current emerging market of Complement 3 Glomerulopathy possesses an intermediate pipeline. There are no emerging therapies in their phase III developmental stage; however, a few potential emerging players are investigating their product candidates in the late- and mid-phase of the developmental stage, namely, Apellis Pharmaceuticals (pegcetacoplan), and Novartis Pharmaceuticals (iptacopan). Other actively developing early-stage players are Amyndas Pharma and Arrowhead Pharmaceuticals.

• The market size of Complement 3 Glomerulopathy in the 7MM was approximately USD 35 million in 2023.
• The United States accounts for the largest market size of Complement 3 Glomerulopathy, in comparison to EU4 and the UK, and Japan, i.e., ~73% of the 7MM.
• Among the EU4 and the UK, Germany had the highest market size in 2023, while Italy had the lowest market size for Complement 3 Glomerulopathy in 2023.
• The current emerging market of Complement 3 Glomerulopathy possesses an intermediate pipeline. There are two emerging therapies in the Phase III developmental stage i.e., Novartis Pharmaceuticals (Iptacopan (LNP023)) and Apellis Pharmaceuticals (Pegcetacoplan); however, a few potential emerging players are investigating their product candidates in Phase II clinical developmental stage, namely, Amyndas Pharmaceuticals (AMY-101) and Arrowhead Pharmaceuticals (ARO-C3).

Complement 3 Glomerulopathy 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 is planning to file the drug in 2024. The drug is expected to launch in the US in 2025. In terms of safety, iptacopan is better than Pegcetacoplan.

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

Complement 3 Glomerulopathy 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 Complement 3 Glomerulopathy 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.

DelveInsight's 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 Complement 3 Glomerulopathy 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 main cost savings driver was the maintenance-year complement inhibitor drug cost reduction. After treatment initiation, the mean annual maintenance-year costs of ravulizumab were at least 10% lower than those of eculizumab. Eculizumab maintenance-year costs grew over the model's time horizon, owing to a cumulative incidence of BTH events resulting in up-dosing and associated higher drug costs. The improved benefit was due to reduced treatment burden and improved outcomes. No evidence was found to determine whether prophylactic use of eculizumab is effective and safe for preventing the recurrence of C3 glomerulopathy after kidney transplantation. Unsurprisingly, given the challenges of performing studies in rare diseases, the evidence for using eculizumab to treat C3 glomerulopathy in people who had experienced a recurrence of the condition post-transplant is confined to 10 case reports. Eculizumab improved or stabilized signs of C3 glomerulopathy in seven cases. A partial response was seen in one case and ineffective in two cases. More evidence is needed to assess better the safety and efficacy of eculizumab in this heterogeneous condition and to determine which patients are most likely to respond to treatment.

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of Complement 3 Glomerulopathy, 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 Complement 3 Glomerulopathy 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 Complement 3 Glomerulopathy market.

Complement 3 Glomerulopathy Report Insights

• Patient Population
• Therapeutic Approaches
• Complement 3 Glomerulopathy Pipeline Analysis
• Complement 3 Glomerulopathy Market Size and Trends
• Existing and future Market Opportunity

Report Key Strengths

• 11 Years Forecast
• The 7MM Coverage
• Complement 3 Glomerulopathy Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Complement 3 Glomerulopathy 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 Complement 3 Glomerulopathy patient pool in the United States, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan?
• What was the Complement 3 Glomerulopathy 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 Complement 3 Glomerulopathy?
• 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 Complement 3 Glomerulopathy Market.
• 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.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Complement 3 Glomerulopathy

4. Complement 3 Glomerulopathy Market Overview at a Glance

• 4.1. Market Share by Therapies (%) Distribution of C3G in 2023 in the 7MM
• 4.2. Market Share by Therapies (%) Distribution of C3G in 2034 in the 7MM

5. Key Events

6. Epidemiology and Market Forecast Methodology

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Familiar forms of C3G
  • 7.2.1. CFHR5 nephropathy
  • 7.2.2. Other Familiar Forms of C3G
  • 7.2.3. Dense Deposit Disease (DDD)
  • 7.2.4. Complement 3 Glomerulonephritis (C3GN)
• 7.3. Causes and Risk Factors
  • 7.3.1. Genetic or Hereditary Risk Factors
  • 7.3.2. Acquired Risk Factors
• 7.4. Clinical Presentation
• 7.5. Histological Patterns
• 7.6. Symptoms
• 7.7. Pathophysiology
• 7.8. Pathogenesis
• 7.9. Diagnosis
• 7.10. Challenges in Diagnosis
  • 7.10.1. Immune Complex Glomerulonephritis
  • 7.10.2. Post-infectious glomerulonephritis
  • 7.10.3. Predictors of Progression
• 7.11. Differential Diagnosis
• 7.12. Prognosis

8. Treatment

• 8.1. Algorithm for Diagnosis and Management of C3G

9. Clinical Practice Guideline for the Management of Glomerular Diseases: KDIGO 2021

• 9.1. Complement 3 Glomerulopathy

10. Epidemiology and Patient Population

• 10.1. Key Findings
• 10.2. Assumptions and Rationales
• 10.3. Total Diagnosed Prevalent Population of C3G in the 7MM
• 10.4. The United States
  • 10.4.1. Total Diagnosed Prevalent Population of C3G in the United States
  • 10.4.2. Type-specific Diagnosed Prevalent Population of C3G in the United States
  • 10.4.3. Age-specific Diagnosed Prevalent Population of C3G in the United States
• 10.5. EU4 and the UK
  • 10.5.1. Total Diagnosed Prevalent Population of C3G in EU4 and the UK
  • 10.5.2. Type-specific Diagnosed Prevalent Population of C3G in EU4 and the UK
  • 10.5.3. Age-specific Diagnosed Prevalent Population of C3G in EU4 and the UK
• 10.6. Japan
  • 10.6.1. Total Diagnosed Prevalent Population of C3G in Japan
  • 10.6.2. Type-specific Diagnosed Prevalent Population of C3G in Japan
  • 10.6.3. Age-specific Diagnosed Prevalent Population of C3G in Japan

11. Patient Journey

12. Emerging Therapies

• 12.1. Key Cross
• 12.2. Iptacopan (LNP023): Novartis Pharmaceuticals
  • 12.2.1. Product Description
  • 12.2.2. Other Developmental Activities
  • 12.2.3. Clinical Development
  • 12.2.4. Safety and Efficacy
• 12.3. Pegcetacoplan (APL-2): Apellis Pharmaceuticals
  • 12.3.1. Product Description
  • 12.3.2. Other Developmental Activities
  • 12.3.3. Clinical Development
  • 12.3.4. Safety and Efficacy
• 12.4. ARO-C3: Arrowhead Pharmaceuticals
  • 12.4.1. Product Description
  • 12.4.2. Other Developmental Activities
• 12.5. KP104: Kira Pharmaceuticals
  • 12.5.1. Product Description
  • 12.5.2. Clinical Development
• 12.6. AMY-101: Amyndas Pharmaceuticals
  • 12.6.1. Product Description
  • 12.6.2. Other Developmental Activities
  • 12.6.3. Clinical Development
  • 12.6.4. Safety and Efficacy
• 12.7. NM8074: NovelMed Therapeutics
  • 12.7.1. Product Description
  • 12.7.2. Other Development Activities
  • 12.7.3. Clinical Development

13. Complement 3 Glomerulopathy (C3G): Seven Major Market Analysis

• 13.1. Key Findings
• 13.2. Total Market Size of C3G in the 7MM
• 13.3. Market Outlook
• 13.4. Conjoint Analysis
• 13.5. Key Market Forecast Assumptions
• 13.6. The United States Market Size
  • 13.6.1. Total Market Size of C3G in the United States
  • 13.6.2. Market Size of C3G by Therapies in the United States
• 13.7. EU4 and the UK Market Size
  • 13.7.1. Total Market Size of C3G in EU4 and the UK
  • 13.7.2. Market Size of C3G by Therapies in EU4 and the UK
• 13.8. Japan Market Size
  • 13.8.1. Total Market Size of C3G in Japan
  • 13.8.2. Market Size of C3G by Therapies in Japan

14. Unmet Needs

15. SWOT Analysis

16. KOL Views

17. Market Access and Reimbursement

• 17.1. United States
  • 17.1.1. Centre for Medicare and Medicaid Services (CMS)
• 17.2. EU4 and the UK
  • 17.2.1. Germany
  • 17.2.2. France
  • 17.2.3. Italy
  • 17.2.4. Spain
  • 17.2.5. United Kingdom
• 17.3. Japan
  • 17.3.1. MHLW
• 17.4. Complement 3 Glomerulopathy (C3G): Market Access and Reimbursement
  • 17.4.1. Patient Access Programs
  • 17.4.2. HTA Decisions

18. Appendix

• 18.1. Bibliography
• 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight