腹膜透析装置の世界市場-2023年～2030年

概要

末期腎不全（ESRD）または重度の腎不全は、腹膜透析（PD）技術によって治療されます。腎臓が効果的に機能しなくなった場合、腹膜透析は腎代替療法の一種で、体内の老廃物や余分な水分を除去するのを助けます。手動のCAPDと自動のAPDのどちらを使用するかは、患者さんの嗜好、生活様式、医療上の必要条件によって決まります。CAPDでは1日に数回、人手による透析液交換が必要であるのに対し、APDでは夜間の透析液交換は機械で行う。

腹膜透析装置の有効性、安全性、使いやすさは、技術の進歩によって向上してきました。こうした技術開発の結果、腹膜透析を治療法として選択する患者が増加しています。また、高齢化社会の進展に伴い、腎臓疾患への罹患率が高まっていることから、腹膜透析を中心とした透析療法のニーズが高まっています。

ダイナミクス

腹膜透析の利点の増加

2023年にFrontiers in Physiologyに掲載された論文によると、血液透析（HD）は腎不全や末期腎臓病の患者にとって必ずしも適切な治療法とは限らないです。40年以上の歴史がある腹膜透析の導入は、いくつかの理由で世界的に大きく異なっています。Global Kidney Health Atlasによると、慢性腹膜透析を受けているのは平均で100万人あたり38.1人（ppm）であり、HDの世界推定普及率298.4人（ppm）よりかなり少ないです。

腹膜透析には、より優れた血圧管理、より優れた腎機能維持、患者により柔軟で自律的な治療計画など、多くの利点があります。腹膜透析は患者にとってもヘルスケアシステムにとっても負担が少ないため、患者や医療従事者の中には腹膜透析を望ましい選択肢と考える人もいると思われます。

慢性腎臓病の増加

全世界で8億人以上（全人口の10％以上）が変性疾患である慢性腎臓病を患っています。糖尿病、高血圧、高齢者、女性、有色人種は慢性腎臓病になる可能性が高いです。慢性腎臓病は、糖尿病、高血圧、高齢者、女性、有色人種に発症しやすい病気です。

米国疾病予防管理センターによると、米国の成人の14％に当たる約3,550万人がCKDに罹患していると考えられています。重度CKDの成人の3人に1人は自分の状態に気づいていないです。CKD患者は、45～64歳（12％）や18～44歳（6％）よりも65歳以上（34％）の方が多いです。女性（14％）は男性（12％）よりCKDの割合がやや高いです。非ヒスパニック系アジア人（14％）および非ヒスパニック系白人（12％）に比べ、非ヒスパニック系黒人成人（20％）はCKD有病率が高いです。

罹患者の多さと慢性腎臓病の深刻な悪影響から、より良い予防と治療のための努力が必要です。その結果、腹膜透析機器に対する市場の需要が増加します。

腹膜透析の認知度の低さ

患者や医療従事者の間で、末期腎不全（ESRD）の治療法として腹膜透析（PD）に関する知識が不足していることは、多くの影響を及ぼしかねない深刻な問題です。ESRD患者は腹膜透析が治療の選択肢であることを知らない可能性があります。知識不足のために、患者は透析治療の開始を延期したり、あるいは透析治療を完全に断念したりするかもしれないです。その結果、自分の病気を適切にコントロールするチャンスを逃してしまうかもしれません。

患者さんは、PDの存在を知らなければ、腎不全を治療する選択肢がほとんどないと考えるかもしれません。このため、PDの利点を知っていればPDを選択できたのに、より多くの患者さんが中心静脈内血液透析を選択する可能性があります。

感染リスク

腹膜透析（PD）ではカテーテルを腹部に挿入しなければならないため、感染のリスクが高くなります。最初の腹膜透析カテーテル留置術では腹壁を切開し、カテーテルを腹腔内に挿入します。どんな手術でもそうですが、この手技によって細菌が広がる可能性があります。

患者さんの腹膜透析療法は数カ月から数年続くこともあり、その間カテーテルは留置されたままになります。腹腔内への細菌の侵入は、カテーテルを留置している期間が長いほど起こりやすくなります。

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
    • 腹膜透析の利点の増加
    • 慢性腎臓病の増加
  • 抑制要因
    • 腹膜透析の認知度の低下
    • 感染リスク
  • 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意見

第6章 COVID-19分析

第7章 製品別

• システムと消耗品
  • 腹膜透析液
  • 腹膜透析トランスファーセット
  • 腹膜透析カテーテル
  • その他

第8章 治療タイプ別

• 持続的外来腹膜透析（CAPD）
• 自動腹膜透析（APD）

第9章 エンドユーザー別

• 病院
• 透析センター
• その他

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

• AWAK Technologies
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• Baxter International Inc.
• Medtronic plc
• Fresenius Medical Care North America
• Terumo Corporation
• Utah Medical Products, Inc
• Polymedicure
• Angiplast
• Merit Medical Systems
• Newsol Technologies Inc

第13章 付録

Overview

End-stage Renal Disease (ESRD) or severe kidney failure is treated with peritoneal dialysis (PD) technology. When the kidneys are no longer working effectively, peritoneal dialysis is a type of renal replacement therapy that aids in removing waste and extra fluid from the body. The patient's preferences, way of life, and medical requirements determine whether manual CAPD or automatic APD should be used. Several times a day, CAPD requires human exchanges of dialysis fluid, whereas APD employs a machine for nocturnal exchanges.

The effectiveness, safety, and usability of peritoneal dialysis apparatus have been enhanced by technological advances. As a result of these technical developments, more patients are opting for peritoneal dialysis as a form of treatment. The need for dialysis treatments, particularly peritoneal dialysis, has increased due to an aging population's greater susceptibility to kidney-related disorders.

Dynamics

Increasing Advantages of Peritoneal Dialysis

As per the article published in Frontiers in Physiology in 2023, hemodialysis (HD) is not always an appropriate therapy option for those with kidney failure or end-stage kidney disease. The adoption of peritoneal dialysis, which has been around for more than 40 years, has varied greatly globally for several reasons. According to the Global Kidney Health Atlas, 38.1 per million individuals (pmp) on average undergo chronic PD treatment, which is significantly less than the 298.4 pmp estimated global prevalence of HD.

Peritoneal dialysis has a number of benefits, including better blood pressure management, better renal function maintenance, and a more flexible and autonomous treatment plan that gives patients more autonomy. Some patients and providers may find PD to be a desirable alternative because it can have lower expenses for both patients and the healthcare system.

The Rising Prevalence of Chronic Kidney Disease

More than 800 million people worldwide-more than 10% of the overall population-have chronic kidney disease, which is a degenerative disorder. Persons with diabetes mellitus, hypertension, elderly persons, women, and people of color are more likely to develop chronic kidney disease. Because they are least prepared to handle its effects, low- and middle-income countries bear a disproportionately heavy burden from chronic kidney disease.

According to the Centers for Disease Control and Prevention, approximately 35.5 million US adults, or 14%, are believed to have CKD.† Up to 90% of persons with CKD are unaware of their condition. One in three adults with severe CKD is unaware of their condition. People with CKD are more likely to be over 65 (34%) than between 45 and 64 (12%) or between 18 and 44 (6%). Women (14%) have CKD at a somewhat higher rate than males (12%). Compared to non-Hispanic Asian (14%) and non-Hispanic White (12%) adults, non-Hispanic Black adults (20%) had a higher prevalence of CKD.

Increased efforts for better prevention and treatment should be made as a result of the large number of afflicted people and the serious negative effects of chronic renal disease. Results in increasing demand for peritoneal dialysis equipment in the market.

Limited Awareness of Peritoneal Dialysis

The lack of knowledge of peritoneal dialysis (PD) as a treatment option for end-stage renal disease (ESRD) among patients and healthcare providers is a serious problem that can have numerous effects. It is possible that patients with ESRD are unaware that PD is a therapy option. Due to a lack of knowledge, patients may postpone starting their dialysis treatment or perhaps decide against it altogether. As a result, people might pass up the chance to properly control their disease.

Patients may believe they have few options for treating their renal failure if they are unaware of PD. Because of this, more patients may choose in-center hemodialysis when they could have opted for PD had they known about its advantages.

Infection Risks

Catheter must be inserted into the abdomen during peritoneal dialysis (PD), and doing so increases the risk of infection. An abdominal wall incision is made during the initial PD catheter placement surgery, and the catheter is then introduced into the peritoneal cavity. Like with any operation, there is a chance that this technique will spread bacteria.

The patient's peritoneal dialysis therapy may last months or even years, during which time the catheter is left in place. Bacterial invasion into the peritoneal cavity is more likely the longer the catheter is in place.

Segment Analysis

The global peritoneal dialysis equipment market is segmented based on product, treatment type, end-users and region.

The Automated Peritoneal Dialysis (APD) segment accounted for approximately 45.6% of the market share

APD is a form of PD that involves employing a dialysis machine to deliver and drain the dialysate automatically and with a minimum of human involvement. APD exchanges can be completed overnight while you sleep and normally take between 8 and 12 hours. One of the kidney functions that dialysis treatment substitutes is ultrafiltration, which is the evacuation of fluid from the patient's body. Ultrafiltration is used in peritoneal dialysis (PD) to remove fluid via the peritoneal membrane.

In some cases, APD may have a stronger ultrafiltration effect, allowing for more fluid to be evacuated during each exchange and lowering edema brought on by an excess of fluid. Patients would only need to attach and disconnect their catheter from the APD machine once per day because APD exchange is typically performed overnight. Patients would then need to connect and disconnect their catheter from the dialysate bags numerous times during the day, which can dramatically increase their risk of infection. CAPD exchanges are typically performed three to four times throughout the day.

Geographical Penetration

North America segment accounted for approximately 45.7% of the market share

North America has been a dominant force in the global peritoneal dialysis equipment market. It has long proven difficult to administer kidney dialysis to little, vulnerable neonates because the majority of dialysis devices are made for adults. However, the Children's Hospital of Los Angeles is now able to offer this life-saving treatment to infants thanks to a unique system designed especially for them.

The technology, known as the Carpediem Cardio-Renal young Dialysis Machine, is recognized by the Food and Drug Administration and offers young patients as small as 2.5 kilos (about 5 pounds) with continuous renal replacement therapy.

For instance, in November 2022, the nation's top manufacturer of dialysis equipment, Fresenius Medical Care North America (FMCNA), announced that its Liberty Select Cycler has received FDA 510(k) approval, enabling remote therapy management using the Kinexus Therapy Management Platform. The goal of this improvement is to improve the home therapy experience for PD patients and medical professionals.

Clinicians for home dialysis are helped by Liberty Select and Kinexus to make crucial decisions based on timely, reliable treatment data summaries. To help evaluate the efficacy of the program, Care Teams will also have access to up to 90 days' worth of treatment data history. The dialysis clinician can modify the therapy plan as necessary to provide quick, data-driven interventions. Market-available Liberty Select cyclers can be upgraded to support remote therap management.

COVID-19 Impact Analysis:

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global peritoneal dialysis equipment market. Since patients getting in-center hemodialysis frequently have comorbid conditions that place them at an increased risk for serious illness, COVID-19 raised questions about the safety of these individuals. As a result, peritoneal dialysis and other home-based dialysis techniques gained popularity. To lessen virus exposure, a lot of patients and medical professionals looked for methods that let patients practice dialysis at home.

Due to worries about COVID-19, some patients may have put off starting peritoneal dialysis or switching to it. The adoption of peritoneal dialysis was dependent on how carefully healthcare professionals and patients weighed the risks and advantages of various treatment alternatives.

Key Developments

• In June 2023, AWAK Technologies (AWAK) and Singapore General Hospital (SGH) stated the beginning of a pre-pivotal clinical trial with the enrollment of their first patient to examine the safety and effectiveness of an upgraded Automated Wearable Artificial Kidney Peritoneal Dialysis (AWAK PD) device.

Competitive Landscape

The major global players in the market include AWAK Technologies, Baxter International Inc., Medtronic plc, Fresenius Medical Care North America, Terumo Corporation, Utah Medical Products, Inc., Polymedicure, Angiplast, Merit Medical Systems, and Newsol Technologies Inc.

Why Purchase the Report?

• To visualize the global peritoneal dialysis equipment market segmentation based on product, treatment type, end-users 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 peritoneal dialysis equipment 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 peritoneal dialysis equipment market report would provide approximately 61 tables, 54 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 Product
• 3.2. Snippet by Treatment Type
• 3.3. Snippet by End-user
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing Advantages of Peritoneal Dialysis
    • 4.1.1.2. The Rising Prevalence of Chronic Kidney Disease
  • 4.1.2. Restraints
    • 4.1.2.1. Limited Awareness of Peritoneal Dialysis
    • 4.1.2.2. Infection Risks
  • 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 Product

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 7.1.2. Market Attractiveness Index, By Product
• 7.2. Systems And Consumables*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.2.3. Peritoneal Dialysis Solution
  • 7.2.4. Peritoneal Dialysis Transfer Sets
  • 7.2.5. Peritoneal Dialysis Catheters
  • 7.2.6. Others

8. By Treatment Type

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 8.1.2. Market Attractiveness Index, By Treatment Type
• 8.2. Continuous Ambulatory Peritoneal Dialysis (CAPD)*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Automated Peritoneal Dialysis (APD)

9. By End-user

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user
  • 9.1.2. Market Attractiveness Index, By End-User
• 9.2. Hospitals*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Dialysis Centres
• 9.4. Others

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 Product
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user
  • 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 Product
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user
  • 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 Product
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user
  • 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 Product
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user
  • 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 Product
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user

11. Competitive Landscape

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

12. Company Profiles

• 12.1. AWAK Technologies*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. Baxter International Inc.
• 12.3. Medtronic plc
• 12.4. Fresenius Medical Care North America
• 12.5. Terumo Corporation
• 12.6. Utah Medical Products, Inc
• 12.7. Polymedicure
• 12.8. Angiplast
• 12.9. Merit Medical Systems
• 12.10. Newsol Technologies Inc

LIST NOT EXHAUSTIVE

13. Appendix

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