C3腎症治療の世界市場：2023年～2030年

概要

体液相および糸球体環境における補体調節異常は、腎生検標本にC3補体の沈着をもたらし、C3腎症として知られるまれなカテゴリーの腎臓病を特徴づける。C3腎症の2つの主要なサブグループである濃厚沈着症（DDD）とC3糸球体腎炎（C3GN）は、疾患の連続性の存在を示唆する臨床的・病理学的特徴を有しています。

終末経路の調節障害も頻度が高いが、補体代替経路の調節障害はC3腎症の徴候にとって極めて重要です。大半の患者では、C3またはC5転換酵素を標的とする自己抗体のような後天的要因が疾患を引き起こしています。

市場力学：促進要因

研究活動の活発化

IC-MPGNおよびC3Gの経過は、体内の免疫システムの構成要素である補体カスケードの抑制されない活性化によって大きく影響を受けると考えられており、腎臓にC3分解産物が過剰に蓄積すると、炎症と臓器障害が促進されます。C3G患者の約半数は診断から10年以内に末期腎不全になり、その頻度は世界全体で100万人あたり2～3人です。

例えば、2021年6月、ノバルティスは、ファースト・イン・クラスの経口標的B因子阻害薬であるイプタコパン（LNP023）が、C3腎症（C3G）患者の推定糸球体濾過量（eGFR）勾配を改善し、腎機能を安定化させたと報告しました。C3G患者を対象とした非盲検第II相試験（NCT03832114）の中間解析結果によると、イプタコパン1日2回200mgの投与により、血液が腎臓を通過し濾過される速度を示す腎クリアランス機能の重要な指標であるeGFR勾配1が変化し、腎機能が安定しました。

さらに、2022年12月、免疫介在性疾患を治療するための画期的な補体療法を開拓する世界のバイオテクノロジー企業であるキラ・ファーマシューティカルズは、IgA腎症（IgAN）および補体3糸球体症（C3G）を含む腎バスケット試験において、代替補体経路および終末補体経路を選択的に標的とするファーストインクラスの二機能性生物学的製剤であるKP104の評価について、中国国家医薬品監督管理局（NMPA）およびオーストラリア治療品庁（TGA）から第2相試験の開始が承認されたことを報告しました。

限られた標的治療

C3腎症と呼ばれる稀な腎疾患は、新たな治療法の創出や市場の拡大を困難にしています。患者数が少ないため、製薬会社は希少疾患の研究開発に投資しにくい可能性があります。補体系の根本的な調節障害に対処する標的治療法の創出は困難であるため、市場の潜在的拡大が制約される可能性があります。特に希少疾患の場合、新規治療法の創出には費用と時間がかかります。臨床試験の実施や規制当局のライセンシング取得には多額の費用がかかるため、この分野への投資は抑制される可能性があります。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • 研究活動の活発化
  • 抑制要因
    • 限られた標的治療
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析
• ロシア・ウクライナ戦争の影響分析
• SWOT分析
• 特許分析
• DMIオピニオン

第6章 COVID-19分析

第7章 薬剤クラス別

• 副腎皮質ステロイド
  • アリストコート
  • ブブリプレッド
  • セレストン
• ACE阻害薬
  • ベナゼプリル
  • カプトプリル
  • エナラプリル
• 免疫抑制療法
• その他

第8章 投与経路別

• 経口
• 非経口
• その他

第9章 流通チャネル別

• 病院薬局
• 小売薬局
• オンライン薬局

第10章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • オーストラリア
  • その他アジア太平洋地域
• 中東・アフリカ

第11章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第12章 企業プロファイル

• F. Hoffmann-La Roche Ltd.
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• Mylan N.V.
• Teva Pharmaceutical Industries Ltd.
• Sanofi
• Pfizer Inc.
• GSK plc
• Novartis AG
• Alexion Pharmaceuticals
• Omeros Corporation
• ChemoCentryx

第13章 付録

Overview

Complement dysregulation in the fluid phase and in the glomerular milieu, which results in substantial complement C3 deposition in kidney biopsy samples, characterizes the rare category of kidney illnesses known as C3 glomerulopathies. Dense deposit disease (DDD) and C3 glomerulonephritis (C3GN), the two main subgroups of C3 glomerulopathy, have clinical and pathological characteristics that point to the existence of a disease continuum.

Although terminal pathway dysregulation is also frequent, dysregulation of the complement alternative route is crucial to the signs of C3 glomerulopathy. In the majority of patients, acquired factors, such as autoantibodies that target the C3 or C5 convertases, are what cause disease.

Market Dynamics: Drivers

The Increasing Research Activities

The course of IC-MPGN and C3G is thought to be significantly influenced by unchecked activation of the complement cascade, a component of the body's immune system, where excessive buildup of C3 breakdown products in the kidney promotes inflammation and organ damage.1-4 Up to 8,000 people in Europe and 5,000 people in the United States are thought to have IC-MPGN or C3G, and 50% of those patients have renal failure within five to ten years of diagnosis. Around half of persons with C3G have end-stage renal disease within ten years of diagnosis, with a global frequency of 2-3 per million.

For instance, in June 2021, Novartis reported that Iptacopan (LNP023), a first-in-class oral, targeted factor B inhibitor, improved estimated glomerular filtration rate (eGFR) slope and stabilized kidney function in patients with C3 glomerulopathy (C3G). According to the interim analysis results from the open-label Phase II study (NCT03832114) in patients with C3G, twice-daily 200mg of iptacopan stabilized kidney function as indicated by a change in eGFR slope1, a crucial indicator of kidney clearance function that gauges the rate at which blood passes through and is filtered by the kidneys.

In addition, in December 2022, Kira Pharmaceuticals, a global biotechnology company that pioneers transformational complement therapies to treat immune-mediated diseases reported that the Chinese National Medical Products Administration (NMPA) and the Australian Therapeutic Goods Administration (TGA) have approved the start of Phase 2 studies for the evaluation of KP104, a first-in-class bifunctional biologic that selectively targets the alternative and terminal complement pathways, in a renal basket study including IgA nephropathy (IgAN) and complement 3 glomerulopathy (C3G).

Limited Targeted Therapies

A rare kidney condition called C3 glomerulopathy can make it difficult to create new treatments and expand the market. Due to the small patient population, pharmaceutical companies may be less likely to invest in research and development for rare diseases. It has been difficult to create targeted treatments that address the underlying dysregulation of the complement system; hence, the market's potential expansion may be constrained. Creating novel treatments can be expensive and time-consuming, especially for rare disorders. Investment in this field may be discouraged by the significant expenses involved with carrying out clinical trials and obtaining regulatory licenses.

Segment Analysis

The global C3 glomerulopathy treatment market is segmented based on drug class, route of administration, distribution channel, and region.

The corticosteroids segment accounted for approximately 47.3% of the market share

Some patients continue to have a high risk of developing progressive CKD even with the best supportive therapy. In addition to conventional therapy, these patients could require immunosuppressive therapy. The therapy also aims to improve hematuria and stabilize renal function. Patients with IgAN are considered to be at high risk of disease development and may be eligible for immunosuppressive medication if they continue to have proteinuria of less than 1 g/day after three to six months of optimal supportive care.

According to BMC Nephrology, in 2023, there are no known treatments for C3G, in contrast to immune-complex mediated MPGN, where treatment focuses on underlying disorders, such as chronic infections, autoimmune diseases, or cancer. In tiny patient cohorts, immunosuppressive therapies such as plasma infusion or plasmapheresis (calcineurin inhibitors, cyclophosphamide, mycophenolate mofetil, or rituximab) have had erratic results.

Geographical Analysis

North America accounted for approximately 40.1% of the market share

North America has been a dominant force in the global C3 glomerulopathy treatment market. According to estimates, there are between 0.5 and 3 instances of C3G per million people in the US, with a point prevalence of 14 to 40 cases per million people.1 DDD is typically diagnosed in childhood or early adulthood and seems to be less prevalent than C3GN. Patients typically have proteinuria and hematuria when they first present, which can range from asymptomatic abnormalities in the urine to classic acute glomerulonephritis with kidney failure and hypertension.

For instance, ChemoCentryx, Inc. developed Tavneos and is continuing to do so for the treatment of patients with hidradenitis suppurativ (HS) and C3 Glomerulopathy (C3G). Tavneos has been given orphan medical product classification by Swissmedic for the adjunctive treatment of MPA and GPA (formerly known as Wegener's granulomatosis), two types of ANCA-associated vasculitis, as well as C3G.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global C3 glomerulopathy treatment market. Treatment options for C3 glomerulopathy, an uncommon and complicated kidney condition, have historically been scarce. Immunosuppressive medications are frequently used in conjunction with blood pressure control, proteinuria treatment, and other management strategies.

The complement system-targeting drug eculizumab has showed potential in some patients, but it is not always efficient. In 2021, efforts were made in research and development to find more specialized treatments for C3 glomerulopathy. These initiatives intended to treat the disease's characteristic complement dysregulation, which was at the root of these efforts. Clinical trials for novel therapeutics were ongoing, and their success might increase the range of available treatments.

By Drug Class

• Corticosteroids
  • Aristocort
  • Bubbli-Pred
  • Celestone
• ACE Inhibitors
  • Benazepril
  • Captopril
  • Enalapril
• Immunosuppressive Therapy
• Others

By Route of Administration

• Oral
• Parenteral
• Others

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
• Middle East and Africa

Competitive Landscape

major global players in the market include: Hoffmann-La Roche Ltd., Mylan N.V., Teva Pharmaceutical Industries Ltd., Sanofi, Pfizer Inc., GSK plc Novartis AG Alexion Pharmaceuticals, Omeros Corporation, and ChemoCentryx among others.

Key Developments

• In June 2022, Apellis Pharmaceuticals, Inc. and Sobi stated that The Phase 3 VALIANT study, which is examining pegcetacoplan, a targeted C3 therapy, in patients with primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G), two rare and debilitating kidney diseases with related underlying causes and no approved treatment, has dosed its first patient.

Why Purchase the Report?

• To visualize the global C3 glomerulopathy treatment market segmentation based on drug class, route of administration, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of C3 glomerulopathy treatment market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global C3 glomerulopathy treatment market report would provide approximately 61 tables, 58 figures, and 186 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Drug Class
• 3.2. Snippet by Route of Administration
• 3.3. Snippet by Distribution Channel
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing Research Activities
  • 4.1.2. Restraints
    • 4.1.2.1. Limited Targeted Therapies
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. Russia-Ukraine War Impact Analysis
• 5.6. SWOT Analysis
• 5.7. Patent Analysis
• 5.8. DMI Opinion

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID
  • 6.1.2. Scenario During COVID
  • 6.1.3. Scenario Post COVID
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Drug Class

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 7.1.2. Market Attractiveness Index, By Drug Class
• 7.2. Corticosteroids*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.2.3. Aristocort
  • 7.2.4. Bubbli-Pred
  • 7.2.5. Celestone
• 7.3. ACE Inhibitors
  • 7.3.1. Benazepril
  • 7.3.2. Captopril
  • 7.3.3. Enalapril
• 7.4. Immunosuppressive Therapy
• 7.5. Others

8. By Route of Administration

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 8.1.2. Market Attractiveness Index, By Route of Administration
• 8.2. Oral*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Parenteral
• 8.4. Others

9. By Distribution Channel

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.1.2. Market Attractiveness Index, By Distribution Channel
• 9.2. Hospital Pharmacies*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Retail Pharmacies
• 9.4. Online Pharmacies

10. By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 10.1.2. Market Attractiveness Index, By Region
• 10.2. North America
  • 10.2.1. Introduction
  • 10.2.2. Key Region-Specific Dynamics
  • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.6.1. U.S.
    • 10.2.6.2. Canada
    • 10.2.6.3. Mexico
• 10.3. Europe
  • 10.3.1. Introduction
  • 10.3.2. Key Region-Specific Dynamics
  • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.6.1. Germany
    • 10.3.6.2. UK
    • 10.3.6.3. France
    • 10.3.6.4. Italy
    • 10.3.6.5. Spain
    • 10.3.6.6. Rest of Europe
• 10.4. South America
  • 10.4.1. Introduction
  • 10.4.2. Key Region-Specific Dynamics
  • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.6.1. Brazil
    • 10.4.6.2. Argentina
    • 10.4.6.3. Rest of South America
• 10.5. Asia-Pacific
  • 10.5.1. Introduction
  • 10.5.2. Key Region-Specific Dynamics
  • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.6.1. China
    • 10.5.6.2. India
    • 10.5.6.3. Japan
    • 10.5.6.4. Australia
    • 10.5.6.5. Rest of Asia-Pacific
• 10.6. Middle East and Africa
  • 10.6.1. Introduction
  • 10.6.2. Key Region-Specific Dynamics
  • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration

11. Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Market Positioning/Share Analysis
• 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

• 12.1. F. Hoffmann-La Roche Ltd.*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. Mylan N.V.
• 12.3. Teva Pharmaceutical Industries Ltd.
• 12.4. Sanofi
• 12.5. Pfizer Inc.
• 12.6. GSK plc
• 12.7. Novartis AG
• 12.8. Alexion Pharmaceuticals
• 12.9. Omeros Corporation
• 12.10. ChemoCentryx

LIST NOT EXHAUSTIVE

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us