ネフローゼ症候群治療薬の世界市場：2024年～2031年

概要

世界のネフローゼ症候群治療薬市場は、2023年に4億2,370万米ドルに達し、2024-2031年の予測期間中にCAGR 5.4％で成長し、2030年には6億4,530万米ドルに達すると予測されています。

ネフローゼ症候群（NS）は、低アルブミン血症（30g/L未満）の原因となる大量の蛋白尿（1時間当たり40mg/m^2以上）によって定義される臨床症候群であり、結果として高脂血症、浮腫、様々な合併症を引き起こします。

低アルブミン血症は、腎糸球体の基底膜の損傷による透過性の亢進によって起こる。糸球体透過性の異常によって生じるが、腎臓に特異的な疾患による原発性のものと、先天性感染症、糖尿病、全身性エリテマトーデス、新生物、特定の薬物使用などによる続発性のものがあります。

微小変化型（MCD）と巣状硬化型（FSGS）の2つのタイプがあります。MCDは小児に多く、治療に反応する可能性が高いです。FSGSはより侵攻性の強い疾患で、腎障害を引き起こす可能性があります。NSに罹患したほとんどの小児は、若年成人期までに治癒します。

市場力学：

促進要因

ネフローゼ症候群の有病率の上昇

世界のネフローゼ症候群治療薬市場の需要は、複数の要因によって牽引されています。主な要因の一つは、ネフローゼ症候群の有病率の上昇です。ネフローゼ症候群はあらゆる年齢層の人々が罹患するが、小児と50歳以上の成人ではより高い罹患率が観察されます。ネフローゼ症候群の有病率は、人口の高齢化、糖尿病や高血圧（二次性ネフローゼ症候群の主な原因）の増加、診断能力の向上などの要因により、世界的に上昇しています。

2023年5月のNCBIによると、ネフローゼ症候群は小児の重要な慢性疾患です。健康な小児におけるネフローゼ症候群の推定年間発症率は、18歳未満の小児10万人あたり2～7人です。低年齢では女児よりも男児に多いが、思春期に達すると男女間に有意差はないです。アフリカ系アメリカ人とヒスパニック系アメリカ人では、罹患率の増加と重症化がみられます。

さらに、市場の主なプレーヤーはネフローゼ症候群の治療に力を入れており、現在進行中の臨床試験での研究開発がこの市場の成長を促進すると思われます。2024年5月にニューイングランド・ジャーナル・オブ・メディシン誌に掲載された調査によると、研究者らは「抗ネフリン自己抗体」を疾患進行を追跡する信頼性の高いバイオマーカーとして同定し、個別化治療アプローチの新たな道を開いた。調査チームは、新しい技術を用いてネフローゼ症候群に関連する腎疾患の新規バイオマーカーを検出しました。

また、2022年2月、Goldfinch Bio社は、FSGS、糖尿病性腎症（DN）およびネフローゼ症候群の治療薬として、ポドサイトを標的とする低分子カノニカルチャネル5（TRPC5）阻害薬GFB-887を評価する進行中の第2相臨床試験の良好な予備データを発表しました。

抑制要因

高額な治療費、限られた認識と診断、投薬による副作用、限られた治療オプションの利用可能性などの要因が、市場の妨げになると予想されます。

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
    • ネフローゼ症候群の有病率の上昇
    • 認知度の向上と治療選択肢の増加
  • 抑制要因
    • 治療費の高騰
  • 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
• DMIの見解

第6章 タイプ別

• 一次性ネフローゼ症候群治療薬
• 二次性ネフローゼ症候群治療薬

第7章 薬剤クラス別

• アンジオテンシン変換酵素（ACE）阻害薬
• 利尿薬
• スタチン
• 血液凝固薬
• 副腎皮質ステロイド薬
• その他

第8章 治療別

• 蛋白尿
• 低アルブミン血症

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
  • ロシア
  • 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
  • 中国
  • インド
  • 日本
  • 韓国
  • 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

• Aldeyra Therapeutics, Inc
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• Asahi Kasei Pharma Corp
• Manus Aktteva Biopharma LLP
• Dr. Reddy's Laboratories
• Century Pharmaceuticals Limited
• Viatris Mylan
• Alembic Pharmaceuticals
• Salvavidas Pharmaceutical Pvt. Ltd
• Rosemont Pharmaceuticals
• F. Hoffmann-La Roche Ltd

第13章 付録

Overview

The global nephrotic syndrome drugs market reached US$ 423.7 million in 2023 and is expected to reach US$ 645.3 million by 2030, growing with a CAGR of 5.4% during the forecast period 2024-2031.

Nephrotic syndrome (NS) is a clinical syndrome defined by massive proteinuria (greater than 40 mg/m^2 per hour) responsible for hypoalbuminemia (less than 30 g/L), with resulting hyperlipidemia, edema, and various complications.

It is caused by increased permeability through the damaged basement membrane in the renal glomerulus. It results from an abnormality of glomerular permeability that may be primary with a disease specific to the kidneys or secondary to congenital infections, diabetes, systemic lupus erythematosus, neoplasia, or certain drug use.

It has two types, minimal change disease (MCD) and focal sclerosis (FSGS). MCD is much more common in children, and likely to respond to therapy. FSGS is a more aggressive disease and may lead to kidney damage. Most children with NS outgrow it by young adulthood.

Market Dynamics: Drivers

Rising prevalence of nephrotic syndrome

The demand for the global nephrotic syndrome drugs market is driven by multiple factors. One of the primary factors is the rising prevalence of nephrotic syndrome. The nephrotic syndrome affects people of all ages, with higher incidence rates observed in children and adults over 50 years old. The prevalence of nephrotic syndrome is rising globally due to factors such as aging populations, increased rates of diabetes and hypertension (leading causes of secondary nephrotic syndrome), and improved diagnostic capabilities.

According to NCBI in May 2023, Nephrotic syndrome is an important chronic disease in children. The estimated annual incidence of nephrotic syndrome in healthy children is two to seven new cases per 100,000 children less than 18 years of age. It is more common in boys than girls at younger ages, but once adolescence is reached, there is no significant difference between genders. Increased incidence and more severe diseases are seen in African American and Hispanic populations.

Moreover, key players in the market are more focused on the treatment of nephrotic syndrome, and research & development in the ongoing clinical trials would propel this market growth. According to the study published in the New England Journal of Medicine in May 2024, the researchers identified 'anti-nephrin autoantibodies' as a reliable biomarker for tracking disease progression, opening new roads for personalized treatment approaches. Researchers have detected novel biomarkers for kidney diseases associated with nephrotic syndrome using a new technique.

Also, in February 2022, Goldfinch Bio, positive preliminary data from its ongoing Phase 2 clinical trial evaluating GFB-887, a podocyte-targeting small molecule inhibitor of Transient Receptor Potential Canonical Channel 5 (TRPC5), for the treatment of FSGS, diabetic nephropathy (DN) and nephrotic syndrome.

Restraints

Factors such as the high cost of the treatment, limited awareness & diagnosis, adverse effects of medication, and availability of limited treatment options, are expected to hamper the market.

Segment Analysis

The global nephrotic syndrome drugs are segmented based on type, drug class, application, distribution channel, treatment, end-user, and region.

The angiotensin-converting enzyme (ACE) Inhibitors segment accounted for approximately 61.2% of the global nephrotic syndrome drugs market share

The angiotensin-converting enzyme inhibitors segment is expected to hold the largest market share over the forecast period inhibitors are a major drug class used in the treatment of nephrotic syndrome, as they can help reduce proteinuria and slow the progression of kidney disease. They are considered a first-line treatment medication for the disease.

ACE inhibitors provide effective treatment for PMN. Primary membranous nephropathy (PMN) is a rare autoantibody-mediated autoimmune kidney disease and a leading cause of nephrotic syndrome (NS) in adults worldwide. Disease onset and diagnosis typically occur between 40 and 50 years of age, with 80% of patients presenting with nephrotic syndrome (i.e., edema, >3.5 g/day proteinuria, hypoalbuminemia).

Moreover, key players' research and developments, product launches, and approvals would drive this segment's growth in this region. As per Scientific Reports research study in November 2023, Budesonide was well-tolerated, and treatment-emergent adverse events were mostly mild in severity and reversible. Budesonide was effective in the treatment of patients with IgAN at high risk of progression in terms of reducing proteinuria and preserving renal function over 36 months of therapy.

Also, in October 2023, Human Immunology Biosciences (announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for felzartamab in primary membranous nephropathy (PMN).

Geographical Analysis

North America accounted for approximately 42.6% of the global nephrotic syndrome drugs market share

North America region is expected to hold the largest market share over the forecast period owing to the incidences of nephrotic syndrome, especially among children and infants and the prevalence of chronic kidney disease is increasing globally, driving the growth of the nephrotic syndrome market. According to the National Kidney Foundation, approximately 30 million people in the United States have kidney disease, and it is estimated that 50% of these individuals are unaware they have the condition.

As per NIH publication in May 2023, Chronic kidney disease (CKD) affects more than 1 in 7 U.S. adults an estimated 37 million Americans. For Americans with diabetes or high blood pressure, the two most common causes of kidney disease the risk for CKD is even greater. Nearly 1 in 3 people with diabetes and 1 in 5 people with high blood pressure have kidney disease. All these factors help to drive this market growth in this region.

The rise in diabetes and associated diseases is driving this market's growth. Diabetic nephropathy associated with nephrotic syndrome is most common, with an estimated rate of around 50 cases per million population. In the pediatric population, nephrotic syndrome could occur at a rate of 20 cases per million. In adults, approximately 30 percent of people with nephrotic syndrome have an underlying medical problem, such as diabetes. According to the CDC in May 2024, the percentage of Americans 65 and older remains high, at 29.2%, or 15.9 million seniors (diagnosed and undiagnosed). New 1.4 million Americans are diagnosed with diabetes every year.

Moreover, a major number of key player's presence, well-established healthcare infrastructure, and a rising number of clinical trials and FDA approvals would drive this market growth. For instance, in February 2023, Travere Therapeutics announced FDA accelerated approval of FILSPARI (sparsentan), the first and only non-immunosuppressive therapy for the reduction of Proteinuria in IgA nephropathy.

Market Segmentation

By Type

• Primary Nephrotic Syndrome
• Secondary Nephrotic Syndrome

By Drug Class

• Angiotensin-converting enzyme (ACE) Inhibitors
• Diuretics
• Statins
• Blood Coagulants
• Corticosteroids
• Others

By Application

• Proteinuria
• Hypoalbuminemia

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region

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

Competitive Landscape

The major global players in the nephrotic syndrome drugs market include Aldeyra Therapeutics, Inc., Asahi Kasei Pharma Corp., Manus Aktteva Biopharma LLP, Dr. Reddy's Laboratories, Century Pharmaceuticals Limited, Viatris Mylan, Alembic Pharmaceuticals, Salvavidas Pharmaceutical Pvt. Ltd., Rosemont Pharmaceuticals, Hoffmann-La Roche among others.

Key Developments

• In February 2023, Aldeyra Therapeutics, Inc. announced the initiation of Phase 2 clinical trials evaluating the safety and efficacy of ADX-629, a novel, internally developed, investigational oral RASP modulator, for the treatment of minimal change disease and Sjogren-Larsson Syndrome. Aldeyra also announced the expansion of the minimal change disease clinical trial to encompass idiopathic nephrotic syndrome, a broad group of rare immune-mediated kidney disorders that includes minimal change disease.
• In November 2022, Alembic Pharmaceuticals received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cyclophosphamide Capsules, 25 mg and 50 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cyclophosphamide Capsules, 25 mg and 50 mg, of Hikma Pharmaceuticals USA Inc. Cyclophosphamide Capsules is an alkylating drug indicated for the treatment of malignant disease and minimal change nephrotic syndrome drugs in pediatric patients.

Why Purchase the Report?

• To visualize the global nephrotic syndrome drugs market segmentation based on type, drug class, application, 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 the nephrotic syndrome drugs market 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 nephrotic syndrome drugs market report would provide approximately 70 tables, 63 figures, and 183 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 Type
• 3.2. Snippet by Drug Class
• 3.3. Snippet by Application
• 3.4. Snippet by Distribution Channel
• 3.5. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Rising Prevalence of Nephrotic Syndrome
    • 4.1.1.2. Rising Awareness and Treatment Options
  • 4.1.2. Restraints
    • 4.1.2.1. High Cost of The Treatment
  • 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. DMI Opinion

6. By Type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 6.1.2. Market Attractiveness Index, By Type
• 6.2. Primary Nephrotic syndrome drugs*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Secondary Nephrotic Syndrome

7. Drug Class

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 7.1.2. Market Attractiveness Index, By Indication
• 7.2. Angiotensin-converting enzyme (ACE) Inhibitors *
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Diuretics
• 7.4. Statins
• 7.5. Blood Coagulants
• 7.6. Corticosteroids
• 7.7. Others

8. By Treatment

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 8.1.2. Market Attractiveness Index, By Treatment
• 8.2. Proteinuria *
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Hypoalbuminemia

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 Type
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.7.1. U.S.
    • 10.2.7.2. Canada
    • 10.2.7.3. 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 Type
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.7.1. Germany
    • 10.3.7.2. UK
    • 10.3.7.3. France
    • 10.3.7.4. Italy
    • 10.3.7.5. Russia
    • 10.3.7.6. 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 Type
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.7.1. Brazil
    • 10.4.7.2. Argentina
    • 10.4.7.3. 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 Type
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.7.1. China
    • 10.5.7.2. India
    • 10.5.7.3. Japan
    • 10.5.7.4. South Korea
    • 10.5.7.5. 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 Type
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.6.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country

11. Competitive Landscape

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

12. Company Profiles

• 12.1. Aldeyra Therapeutics, Inc*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. Asahi Kasei Pharma Corp
• 12.3. Manus Aktteva Biopharma LLP
• 12.4. Dr. Reddy's Laboratories
• 12.5. Century Pharmaceuticals Limited
• 12.6. Viatris Mylan
• 12.7. Alembic Pharmaceuticals
• 12.8. Salvavidas Pharmaceutical Pvt. Ltd
• 12.9. Rosemont Pharmaceuticals
• 12.10. F. Hoffmann-La Roche Ltd

LIST NOT EXHAUSTIVE

13. Appendix

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