腎不全の世界市場-2023年～2030年

概要

腎不全（腎臓の機能不全または腎不全とも呼ばれる）は、腎臓が本来の役割を効率的に果たせなくなり、老廃物や余分な水分を循環からろ過する機能が低下した状態です。その結果、体内に老廃物や毒素が蓄積し、電解質の不均衡や体液貯留を引き起こす可能性があります。

慢性疾患の増加、高齢化、医療技術の進歩、意識の高まりといった要因が市場を牽引しています。市場の拡大には、腎不全の診断、治療、処置の進歩が寄与しています。透析技術の向上や新薬の開発などの技術により、患者の予後は改善しています。

ダイナミクス

活発な主要企業

2023年5月、アンメット・メディカル・ニーズが高い希少な重症慢性腎臓病に対するアンチセンス・オリゴヌクレオチド（ASO）医薬品の発見、開発、商業化のため、Chinook Therapeutics, Inc.は、Ionis Pharmaceuticals, Inc.と共同研究契約を締結しました。両社は、イオニスのRNA標的治療薬における豊富な経験と、チヌーク社の精密医療へのアプローチおよび腎臓内科における深い専門知識を活用します。

腎臓病患者の透析と移植をなくすという使命を追求する一方で、ASO治療薬の開発により、重要な遺伝的・分子的要因を標的とする能力が向上し、希少な重症慢性腎臓病に対する精密医療パイプラインの幅が広がります。

活発化する研究活動

2023年2月、チャールス・リバー・ラボラトリーズ・インターナショナル・インクと、腎臓病治療に革命を起こすことに焦点を当てた最先端の遺伝子治療事業を展開するピュアスプリング・セラピューティクス社との間で、プラスミドDNAの開発・製造受託機関（CDMO）関係が締結されました。

このプログラムは、チャールス・リバーが確立したプラスミド・プラットフォームであるeXpDNAと、当社のプラスミドDNA製造センター・オブ・エクセレンスでの数十年にわたる経験を活用し、世界人口の約10％にあたる約8億4,000万人が罹患している腎疾患をターゲットとした初の遺伝子治療プラットフォームをサポートするものです。

透析や移植を除き、Purespring社は慢性腎疾患の進行を止めたり、劇的に遅らせたりする可能性のある革新的な医薬品の創製に取り組んでいます。

主要企業間の協力関係の強化

2022年7月、ロシュはイオニス・ファーマシューティカルズの希少腎疾患治療薬候補のライセンス権5,500万米ドルを譲り受けます。ロシュは、カリフォルニア州のバイオテクノロジー企業が開発したIONIS-FB-LRxと名付けられたアンチセンス薬を、慢性腎臓病や腎不全を引き起こすことが多い希少疾患である免疫グロブリンA腎症（IgAN）を対象とした治療薬として販売しています。

今回の契約により、ロシュ社はIgAN患者を対象としたIONIS-FB-LRxの第3相試験と、同薬に関する今後の世界な開発、規制、商業化活動を担当することになります。

技術進歩

将来、慢性腎臓病（CKD）は、現在世界中で多くの人々の命を奪っていますが、他のすべての死因を追い越すと予想されています。末期腎不全（ESRD）患者は、腎臓提供者の不足と透析に関する問題の結果、最善の治療を受けていません。しかし、最近の腎臓学の進歩は、この学問分野にとって有望です。

腎機能推定技術の向上、腎臓画像診断技術の改善、装着型人工腎臓、異種移植、幹細胞由来療法、生体工学モデル、新薬などの新しい治療戦略などがその一例です。

多額の治療費

実際、急性腎障害（AKI）や慢性腎臓病（CKD）を含む腎不全の治療は、高額な治療費によって大きな制約を受けています。腎不全の治療費は、適切な治療を受けるための障壁となり、患者、ヘルスケアシステム、経済にさまざまな悪影響を及ぼします。

腎不全患者は、処方薬、定期的な医師の診察、臨床検査、時には透析や移植など、継続的な医療を必要とすることが多いです。患者は、特に健康保険に加入していない場合、これらの費用を管理しきれないと感じるかもしれません。

医薬品開発の課題

濾過、再吸収、分泌、および多数の化学物質の制御は、すべて腎臓によって行われる高度な生理学的プロセスです。腎不全は、これらのプロセスの障害によって発症し、悪化します。様々なネットワークが相互に関連しているため、標的外作用を抑えながら特定の経路を標的とする薬物を創製することは困難です。

多くの腎疾患の臨床転帰を正確に予測できる代用エンドポイントは多くありません。このため、臨床試験において実験的治療の有効性を評価することは課題です。

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
    • 活発な主要企業
    • 活発化する研究活動
    • 主要企業間の協力関係の強化
    • 技術進歩
  • 抑制要因
    • 多額の治療費
    • 医薬品開発の課題
  • 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
• DMIの見解

第6章 COVID-19分析

第7章 治療タイプ別

• 薬物療法
• 人工透析
• 腎移植
• その他

第8章 疾患のステージ別

• 慢性腎臓病（CKD）の病期
• 末期腎不全（ESRD）

第9章 販売チャネル別

• 病院薬局
  • 小売薬局
  • オンライン薬局
• エンドユーザー
  • 透析センター
  • 病院・クリニック
  • 研究・学術機関

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
  • 中国
  • インド
  • 日本
  • オーストラリア
  • その他アジア太平洋
• 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

• Healthy.io
  • 企業概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な動向
• Boehringer Ingelheim Pharmaceuticals, Inc
• Eli Lilly and Company
• Roche
• Charles River Laboratories International, Inc
• Purespring Therapeutics
• Chinook Therapeutics, Inc. Inc
• AstraZeneca
• Baxter
• Nipro Corp.

第13章 付録

Overview

A condition known as renal insufficiency, often referred to as kidney insufficiency or kidney failure, occurs when the kidneys are unable to efficiently carry out their essential tasks, which reduces their capacity to filter waste materials and extra fluids from the circulation. This may cause the body to accumulate waste and toxins, as well as electrolyte imbalances and fluid retention.

The market is driven by factors such as the increasing prevalence of chronic diseases, the aging population, advancements in medical technology, and growing awareness. Market expansion has been fueled by advancements in renal insufficiency diagnoses, therapies, and treatments. Patient outcomes have improved due to technologies like better dialysis techniques and the development of new drugs.

Dynamics

Active Major Players

In May 2023, for the discovery, development, and commercialization of an antisense oligonucleotide (ASO) medication for a rare, severe chronic kidney disease with a substantial unmet medical need, Chinook Therapeutics, Inc. Inc. inked a collaboration agreement with Ionis Pharmaceuticals, Inc. The businesses will make use of Ionis' vast experience in RNA-targeted therapies and Chinook's substantial precision medicine approach and profound expertise in nephrology.

While pursuing their mission to eliminate dialysis and transplant for those with kidney disease, the development of an ASO treatment improves their capacity to target important genetic and molecular drivers and broadens their precision medicine pipeline for rare severe chronic kidney illnesses.

The Increasing Research Activities

In February 2023, a plasmid DNA contract development and manufacturing organization (CDMO) relationship between Charles River Laboratories International, Inc. and Purespring Therapeutics, a cutting-edge gene therapy business focused on revolutionizing the treatment of kidney illnesses.

The program makes use of Charles River's established plasmid platform, eXpDNA, and decades of experience at the Company's plasmid DNA manufacturing center of excellence to support the first gene therapy platform targeting renal diseases, which affect about 840 million people, or roughly 10% of the global population.

With the exception of dialysis or transplantation, Purespring is working to create innovative medicines that have the potential to halt or dramatically slow down the progression of chronic renal disorders.

Increasing Collaboration Among Key Players

In July 2022, Roche is handing over $55 million for the licensing rights to Ionis Pharmaceuticals' rare kidney disease treatment candidate, an investigational med the Big Pharma plans to advance into a phase 3 clinical trial. Roche is taking on the California biotech's antisense medicine dubbed IONIS-FB-LRx, which takes aim at hard-to-treat disease immunoglobulin A nephropathy, or IgAN, a rare condition that often results in chronic kidney disease and renal failure.

Under the most recent deal, Roche will be responsible for the phase 3 study of IONIS-FB-LRx in patients with IgAN, along with any future global development, regulatory and commercialization activities related to the med.

Technological Advancements

In the future, chronic kidney disease (CKD), which now kills a large number of people worldwide, is expected to overtake all other causes of death. Patients with end-stage renal disease (ESRD) are not receiving the best care possible as a result of the lack of available kidney donors and the problems related to dialysis. However, recent advancements in nephrology provide promise for the discipline.

Improvements in renal function estimation techniques, improvements in kidney imaging techniques, and novel therapeutic strategies such as wearable prosthetic kidneys, xenotransplantation, stem cell-derived therapies, bioengineering models, and new pharmaceuticals are some of these.

High Treatment Cost

In fact, the therapy of renal insufficiency, including acute kidney injury (AKI) and chronic kidney disease (CKD), is severely constrained by high treatment costs. Treatment costs for renal insufficiency can be a barrier to receiving appropriate care and have a variety of negative effects on patients, healthcare systems, and economies.

Renal insufficiency patients frequently need continuing medical care, which may include prescription drugs, routine doctor visits, laboratory tests, and sometimes dialysis or transplantation. Patients may find these expenses to be unmanageable, especially if they lack health insurance.

Drug Development Challenges

The filtration, reabsorption, secretion, and control of numerous chemicals are all sophisticated physiological processes carried out by the kidneys. Renal insufficiency develops and worsens as a result of disruptions in these processes. Due to the interconnection of various networks, it is difficult to create medications that target particular pathways while limiting off-target effects.

There are not many surrogate endpoints that can accurately predict clinical outcomes for many renal disorders. Due to this, evaluating the efficacy of experimental treatments during clinical trials is challenging.

Segment Analysis

The global renal insufficiency market is segmented based on treatment type, disease stage, sales channel, and region.

The Chronic Kidney Disease (CKD) Stages segment accounted for approximately 43.7% of the market share

According to the degree of kidney function, which is frequently assessed using the glomerular filtration rate (GFR), chronic kidney disease (CKD) is typically divided into stages. The severity of renal disease can be evaluated using the CKD stages, which also serve to direct therapy choices. A more general term, renal insufficiency, includes CKD and other degrees of decreased kidney function. Kidney Damage with Normal or Increased GFR is Stage 1 CKD, 90 mL/min GFR, Despite the fact that there is kidney damage, which can be shown in abnormalities in the urine or on imaging tests, the GFR is still within the normal range.

CKD stage two: Mild reduction in GFR. GFR is 60 to 89 mL/min. Kidney damage may still be evident, and kidney function has been slightly decreased. Moderate GFR Decrease in Stage 3 CKD. Stage 3 is broken down into two smaller stages: GFR = 45-59 mL/min in stage 3a., and GFR = 30-44 mL/min in stage 3b. Patients may begin to experience symptoms including fatigue and fluid retention due to the noticeably diminished kidney function. The goal of treatment is to control problems and halt progression.

Geographical Penetration

Advanced Healthcare Infrastructure and Active Major Players

North America has been a dominant force in the global Renal Insufficiency market. For instance, in January 2023, Boehringer Ingelheim and Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets, which is being researched as a potential treatment to lower the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD).

For the estimated 37 million Americans living with CKD, this application acceptance represents a significant step forward. The sNDA is predicated on findings from the historic EMPA-KIDNEY phase III trial, which showed that Jardiance significantly decreased the risk of kidney disease progression or cardiovascular death in individuals with CKD by 28% (ARR: 3.8%) compared with placebo, both in addition to standard of treatment.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global renal insufficiency market. Healthcare services were interrupted as a result of the COVID-19 pandemic, including non-urgent medical procedures and appointments that were postponed or canceled. This might have an impact on how quickly renal insufficiency is managed.

People with renal insufficiency are thought to be at a high risk of experiencing severe COVID-19 outcomes, especially those who are on dialysis or have advanced CKD. To protect these patients, healthcare organizations had to put in place stringent infection control procedures.

Patients' access to healthcare institutions and ability to obtain in-person care were hindered by lockdowns and limitations. Although virtual consultations and telemedicine have become more popular, not all facets of renal treatment can be handled remotely.

Russia-Ukraine War Impact Analysis

The healthcare system in conflict-affected areas can be under strain if there is a major rise in casualties or displaced people, which could have an impact on the resources available for treating renal insufficiency. Access to basic renal treatment, such as routine dialysis, medication, and doctor's appointments, could be hampered by population displacement, destruction of healthcare facilities, and general instability.

The dispute may have an immediate impact on healthcare workers, which could result in a potential scarcity of qualified personnel for delivering renal care.

By Treatment Type

• Medications
• Dialysis
• Kidney Transplantation
• Others

By Disease Stage

• Chronic Kidney Disease (CKD) Stages
• End-Stage Renal Disease (ESRD)

• Sales Channel

• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

• By End-users
  • Dialysis Centres
  • Hospital & Clinics
  • Research & Academic Institutes

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

Key Developments

• In May 2023, Healthy.io, the global leader in transforming the smartphone camera into a medical device, launched a program with Boehringer Ingelheim Pharmaceuticals, Inc, a leading research-driven pharmaceutical company, that will support at-home testing and offer educational information for patients at risk of chronic kidney disease.

Competitive Landscape

The major global players in the market include: Healthy.io, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Roche, Charles River Laboratories International, Inc., Purespring Therapeutics, Chinook Therapeutics, Inc. Inc, AstraZeneca, Baxter, and Nipro Corp.

Why Purchase the Report?

• To visualize the global renal insufficiency market segmentation based on treatment type, disease stage, sales 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 Renal Insufficiency 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 Renal Insufficiency 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 Treatment Type
• 3.2. Snippet by Disease Stage
• 3.3. Snippet by Sales Channel
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Active Major Players
    • 4.1.1.2. The Increasing Research Activities
    • 4.1.1.3. Increasing Collaboration Among Key Players
    • 4.1.1.4. Technological Advancements
  • 4.1.2. Restraints
    • 4.1.2.1. High Treatment Cost
    • 4.1.2.2. Drug Development Challenges
  • 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. 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 Treatment Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 7.1.2. Market Attractiveness Index, By Treatment Type
• 7.2. Medications*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Dialysis
• 7.4. Kidney Transplantation
• 7.5. Others

8. By Disease Stage

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Stage
  • 8.1.2. Market Attractiveness Index, By Disease Stage
• 8.2. Chronic Kidney Disease (CKD) Stages*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. End-Stage Renal Disease (ESRD)

9. By Sales Channel

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sales Channel
  • 9.1.2. Market Attractiveness Index, By Sales Channel
• 9.2. Hospital Pharmacies*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.2.3. Retail Pharmacies
  • 9.2.4. Online Pharmacies
• 9.3. End-user
  • 9.3.1. Dialysis Centres*
  • 9.3.2. Hospital & Clinics
  • 9.3.3. Research & Academic Institutes

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 Treatment Type
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Stage
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sales Channel
  • 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 Treatment Type
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Stage
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sales Channel
  • 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 Treatment Type
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Stage
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sales Channel
  • 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 Treatment Type
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Stage
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sales Channel
  • 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 Treatment Type
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Stage
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sales Channel

11. Competitive Landscape

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

12. Company Profiles

• 12.1. Healthy.io*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. Boehringer Ingelheim Pharmaceuticals, Inc
• 12.3. Eli Lilly and Company
• 12.4. Roche
• 12.5. Charles River Laboratories International, Inc
• 12.6. Purespring Therapeutics
• 12.7. Chinook Therapeutics, Inc. Inc
• 12.8. AstraZeneca
• 12.9. Baxter
• 12.10. Nipro Corp.

LIST NOT EXHAUSTIVE

13. Appendix

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