ポータブル血液透析の世界市場：2024年～2031年

レポート概要

世界のポータブル血液透析の市場規模は、2023年に202億米ドルに達し、2031年には353億8,000万米ドルに達し、予測期間2024年～2031年にCAGR7.4%で成長すると予測されています。

血液透析は、血液中の老廃物や余分な水分を除去する腎臓の働きを代行する治療法です。これは、ダイアライザーまたは人工腎臓と呼ばれる特殊なフィルターを用いて行われます。血液はプラスチックのチューブを通ってダイアライザーに送られ、そこで洗浄された後、患者に戻されます。各治療の最初に、2本の針がアクセスに刺されます。これらの針は、血液をダイアライザーに送るプラスチックチューブに接続されています。一度に体から出る血液はごく少量です。透析装置は血液を透析システムに送り、治療時間、温度、除水量、圧力を制御します。

ポータブル血液透析装置は、患者さんにとって有益なように、ある場所から別の場所へ簡単に移動でき、患者さんのいる場所まで装置を持ち運ぶことができる医療機器です。現在、腎臓病や腎臓疾患は憂慮すべき速度で増加しており、ポータブル血液透析製品の必要性が高まっています。

市場力学：

促進要因

慢性腎臓疾患の有病率の増加

世界のポータブル血液透析市場の需要は、複数の要因によって牽引されており、慢性腎臓病の有病率の上昇が市場成長を促進しています。

さらに、治療需要は技術の進歩の増加によって促進されます。例えば、nih.govによると、慢性腎臓病は進行性の疾患であり、全世界の一般人口の10％以上、8億人以上が罹患しています。慢性腎臓病は、高齢者、女性、人種的マイノリティ、糖尿病や高血圧の人に多く見られます。慢性腎臓病は低・中所得国において特に大きな負担となっています。

例えば、全米腎臓財団によると、現在世界中で200万人以上の人々が、生きるために透析や腎移植による治療を受けていますが、この数は、生きるために実際に治療が必要な人々の10％に過ぎません。腎不全の患者数は、高齢者が増加している中国やインドなどの発展途上国で不釣り合いに増加すると推定されています。腎不全の治療を受けている200万人のうち、大半は米国、日本、ドイツ、ブラジル、イタリアのわずか5カ国で治療を受けています。この5カ国は世界人口のわずか12％に過ぎません。世界人口の50％以上を占める約100の発展途上国では、わずか20％しか治療を受けていません。

抑制要因

手術に関連する合併症や人々の認識不足といった要因が市場の妨げになると予想されます。米国腎臓財団の統計によると、世界人口の10％が慢性腎臓病に罹患しており、死因の第12位となっています。手ごろな価格で治療を受けられないために、毎年数百万人が亡くなっています。

市場セグメンテーション分析

世界のポータブル血液透析市場は、製品、ポンプシステム、エンドユーザー、地域によって区分されます。

ポータブル機器セグメントは、世界のポータブル血液透析市場シェアの約49.7%を占める

予測期間中、ポータブル機器セグメントが最大の市場シェアを占めると予想されます。このセグメントでは、技術の進歩、民間メーカーの機器開発資金の増加がこの市場を牽引すると思われます。

例えば、2024年3月、オランダのBussumに本拠を置く医療技術企業Nextkidneyは、世界初のポータブル血液透析装置Neokidneyを開発したと発表しました。オランダの同社によると、Neokidneyは開発の最終段階にあり、2024年までにオランダで発売される予定です。

さらに2024年8月には、医療機器メーカーのSynopexが、国内で初めて独自に開発した重症患者用持続的腎代替療法（CRRT）装置の販売承認を食品医薬品安全省（MFDS）から取得しました。

地域別の市場分析

北米がポータブル血液透析の世界市場シェアの約42.3%を占める

予測期間中、北米が最大の市場シェアを占めると予想されます。同地域では慢性腎臓病の罹患率の上昇、技術の進歩、資金配分の増加などが市場を後押ししています。

例えば、American Kidney Fundによると、推定3,550万人のアメリカ人が腎臓病を患っています。約80万8,000人のアメリカ人が腎不全を患っており、55万7,000人以上のアメリカ人が透析を受けています。腎臓病は驚くべき速さで増加しています。現在、米国成人の7人に1人（14％）以上が罹患しており、有色人種ほど腎不全のリスクが高いです。2021年に新たに腎不全と診断されたアメリカ人は約13万5,000人です。腎臓病患者の10人中9人は自分が腎臓病であることに気づいておらず、腎機能が著しく低下している（しかしまだ透析を受けていない）人の3人に1人は自分が腎臓病であることに気づいていません。

さらに、2023年9月、AWAKテクノロジーズは、ウェアラブル透析デバイスの米国での主要臨床試験のために、シリーズBで2,000万米ドル以上の資金を獲得しました。AWAK PDは、ウルトラポータブル腹膜透析（PD）システムで、腎臓病患者が自宅や外出先で透析を受けることを可能にします。同社は今回の資金を、シンガポール総合病院との間で進行中の人間を対象としたプレピボタル臨床試験を終了させるための様々な重要な取り組みに使用する予定です。また、今回の資金調達は、2025年に開始が見込まれる米国での最終試験に向け、ウルトラポータブルPD装置の改良にも役立てられます。

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
    • 慢性疾患の増加
    • 技術の進歩
  • 抑制要因
    • 処置に伴う合併症
    • 認識不足
  • 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
• アンメットニーズ
• PESTEL分析
• 特許分析
• SWOT分析

第6章 製品タイプ別

• ポータブル機器
• 消耗品
• ソフトウェアとサービス
• その他

第7章 ポンプシステム別

• シングルポンプ
• ダブルポンプ

第8章 エンドユーザー別

• 病院
• 専門クリニック
• 透析センター
• 在宅医療
• その他

第9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
  • 韓国
  • その他アジア太平洋
• 中東・アフリカ

第10章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第11章 企業プロファイル

• NxStage Medical 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
• Quanta Dialysis Technologies
• Cantel Medical Group of Companies
• AWAK Technologies
• Medtronic
• SB Kawasumi Laboratories
• Texas Instruments Incorporated. Incorporated.
• Baxter
• Diality
• Teleflex Incorporated

第12章 付録

Report Overview

The Global Portable Hemodialysis Market reached US$ 20.2 billion in 2023 and is expected to reach US$ 35.38 billion by 2031, growing at a CAGR of 7.4% during the forecast period 2024-2031.

Hemodialysis is a treatment that replaces the work of one's kidneys to clear wastes and extra fluid from the blood. This is done using a special filter called a dialyzer or artificial kidney. The blood travels through plastic tubing to the dialyzer, where it is cleaned and then returned to the patient. At the beginning of each treatment, two needles are placed into the access. These needles are connected to the plastic tubing that carries the blood to the dialyzer. Only a small amount of blood is out from the body at any one time. The dialysis machine pumps the blood through the dialysis system and controls the treatment time, temperature, fluid removal, and pressure.

A portable hemodialysis device is a medical device, which can be moved from one location to another location easily so that it is beneficial for the patient and the device can be carried to the patient's location. Nowadays, kidney diseases and disorders are increasing at an alarming rate which is increasing the need for portable hemodialysis products.

Market Dynamics: Drivers

Increasing prevalence of chronic kidney disorders

The demand for the global portable hemodialysis market is driven by multiple factors. The rising prevalence of chronic kidney disorders propels the market growth.

Furthermore, the demand for treatment will be fueled by the increase in technological advancements. For instance, according to nih.gov, chronic kidney disease is a progressive condition that affects >10% of the general population worldwide, amounting to >800 million individuals. Chronic kidney disease is more prevalent in older individuals, women, racial minorities, and people experiencing diabetes mellitus and hypertension. Chronic kidney disease represents an especially large burden in low- and middle-income countries, which are least equipped to deal with its consequences.

For instance, according to the National Kidney Foundation, over 2 million people worldwide currently receive treatment with dialysis or a kidney transplant to stay alive, yet this number may only represent 10% of people who actually need treatment to live. It is estimated that the number of cases of kidney failure will increase disproportionately in developing countries, such as China and India, where the number of elderly people is increasing. Of the 2 million people who receive treatment for kidney failure, the majority are treated in only five countries - the United States, Japan, Germany, Brazil, and Italy. These five countries represent only 12% of the world's population. Only 20% are treated in about 100 developing countries that make up over 50% of the world population.

Restraints

Factors such as complications linked with the procedure and lack of awareness among people are expected to hamper the market. According to statistics from the National Kidney Foundation in the United States, 10 percent of the world's population is affected by chronic kidney disease and it is the 12th most common cause of death. Millions die annually due to a lack of access to affordable treatment.

Market Segment Analysis

The global portable hemodialysis market is segmented based on product, pumping system, end-user, and region.

The segment portable devices accounted for approximately 49.7% of the global portable hemodialysis market share

The portable devices segment is expected to hold the largest market share over the forecast period. In this segment, the technological advancements, and rising funds for private manufacturers for device development would drive this market.

For instance, in March 2024, Bussum, the Netherlands-based Nextkidney, a medtech company, announced that it has developed the world's first portable hemodialysis device, Neokidney. According to the Dutch company, Neokidney is in the final development phase and is expected to launch in the Netherlands by 2024.

Moreover, in August 2024, Synopex, a medical device manufacturer, obtained marketing authorization from the Ministry of Food and Drug Safety (MFDS) for the nation's first independently developed continuous renal replacement therapy (CRRT) device for critical care patients.

Market Geographical Analysis

North America accounted for approximately 42.3% of the global portable hemodialysis market share

North America region is expected to hold the largest market share over the forecast period. The rising incidence of chronic kidney diseases, technological advancements, and increase in fund allotment in this region, help to propel the market.

For instance, according to American Kidney Fund, An estimated 35.5 million Americans have kidney disease. About 808,000 Americans are living with kidney failure. More than 557,000 Americans are on dialysis. Kidney disease is growing at an alarming rate. It currently affects more than 1 in 7 (or 14%) of American adults, with people of color at greater risk for kidney failure. There were about 135,000 Americans newly diagnosed with kidney failure in 2021. 9 out of 10 people with kidney disease are unaware they have it, and 1 in 3 of those with severely reduced kidney function (but not yet on dialysis) are unaware they have kidney disease.

Moreover, in September 2023, AWAK Technologies obtained more than $20m in Series B funding for the US-based pivotal trial of its wearable dialysis device. AWAK PD, the ultra-portable peritoneal dialysis (PD) system allows kidney disease patients to undergo dialysis at home and anywhere on the go. The company will use the proceeds for various crucial initiatives to conclude its ongoing human pre-pivotal clinical study with Singapore General Hospital. The funding will also help the company improve the ultraportable PD device for the final pivotal trial in the US, anticipated to begin in 2025.

Market Segmentation

By Product

Portable Devices

Consumables

Blood Lines

Dialyzer and Dialysate

Software and Services

Others

By Pumping System

Single Pump

Double Pump

By End-User

Hospitals

Specialty Clinics

Dialysis Centers

Homecare

Others

By Region

North America

U.S.

Canada

Mexico

Europe

Germany

U.K.

France

Spain

Italy

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

Market Competitive Landscape

The major global players in the global portable hemodialysis market include NxStage Medical Inc., Quanta Dialysis Technologies, Cantel Medical Group of Companies, AWAK Technologies, Medtronic, SB Kawasumi Laboratories, Texas Instruments Incorporated., Baxter, Diality, and Teleflex Incorporated. among others.

Key Developments

In April 2023, AWAK Technologies, a Singapore-based medical technology company, recently received FDA Breakthrough Device designation for their wearable and portable dialysis device. The AWAK Peritoneal Dialysis device, or AWAK PD, uses AWAK's patented sorbent technology and offers a convenient means of dialysis for renal disease patients.

In June 2022, NextKidney recently announced that it had acquired Dialyss Pte. Ltd. to boost the development of its portable Neokidney hemodialysis device. NextKidney officials boast that the Neokidney will be a small, user-friendly, home hemodialysis device, using only 4 liters of fluid per session. In addition, they say that it can run entirely independent of water supply and drain, enabling people to use it anytime and anywhere.

Why Purchase the Report?

To visualize the global portable hemodialysis market segmentation based on product, pumping system, end-user, 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 global portable hemodialysis market level with all segments.

PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.

Product mapping is available in Excel consisting of key products of all the major players.

The global portable hemodialysis market report would provide approximately 51 tables, 54 figures, and 181 Pages.

Target Audience 2024

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 Pumping System
• 3.2. Snippet by Product
• 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 Prevalence of Chronic Diseases
    • 4.1.1.2. Technological Advancements
  • 4.1.2. Restraints
    • 4.1.2.1. Complications Linked With Procedure
    • 4.1.2.2. Lack of Awareness
  • 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. Unmet Needs
• 5.6. PESTEL Analysis
• 5.7. Patent Analysis
• 5.8. SWOT Analysis

6. By Product Type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 6.1.2. Market Attractiveness Index, By Product Type
• 6.2. Portable Devices*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Consumables
• 6.4. Software and Services
• 6.5. Others

7. By Pumping System

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Pumping System
  • 7.1.2. Market Attractiveness Index, By Pumping System
• 7.2. Single Pump*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Double Pump

8. By End-User

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 8.1.2. Market Attractiveness Index, By End-User
• 8.2. Hospitals*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Specialty Clinics
• 8.4. Dialysis Centers
• 8.5. Homecare
• 8.6. Others

9. By Region

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 9.1.2. Market Attractiveness Index, By Region
• 9.2. North America
  • 9.2.1. Introduction
  • 9.2.2. Key Region-Specific Dynamics
  • 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Pumping System
  • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.2.6.1. The U.S.
    • 9.2.6.2. Canada
    • 9.2.6.3. Mexico
• 9.3. Europe
  • 9.3.1. Introduction
  • 9.3.2. Key Region-Specific Dynamics
  • 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Pumping System
  • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.3.6.1. Germany
    • 9.3.6.2. UK
    • 9.3.6.3. France
    • 9.3.6.4. Italy
    • 9.3.6.5. Spain
    • 9.3.6.6. Rest of Europe
• 9.4. South America
  • 9.4.1. Introduction
  • 9.4.2. Key Region-Specific Dynamics
  • 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Pumping System
  • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.4.6.1. Brazil
    • 9.4.6.2. Argentina
    • 9.4.6.3. Rest of South America
• 9.5. Asia-Pacific
  • 9.5.1. Introduction
  • 9.5.2. Key Region-Specific Dynamics
  • 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Pumping System
  • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.5.6.1. China
    • 9.5.6.2. India
    • 9.5.6.3. Japan
    • 9.5.6.4. South Korea
    • 9.5.6.5. Rest of Asia-Pacific
• 9.6. Middle East and Africa
  • 9.6.1. Introduction
  • 9.6.2. Key Region-Specific Dynamics
  • 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Pumping System
  • 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

10. Competitive Landscape

• 10.1. Competitive Scenario
• 10.2. Market Positioning/Share Analysis
• 10.3. Mergers and Acquisitions Analysis

11. Company Profiles

• 11.1. NxStage Medical Inc. *
  • 11.1.1. Company Overview
  • 11.1.2. Product Portfolio and Description
  • 11.1.3. Financial Overview
  • 11.1.4. Key Developments
• 11.2. Quanta Dialysis Technologies
• 11.3. Cantel Medical Group of Companies
• 11.4. AWAK Technologies
• 11.5. Medtronic
• 11.6. SB Kawasumi Laboratories
• 11.7. Texas Instruments Incorporated. Incorporated.
• 11.8. Baxter
• 11.9. Diality
• 11.10. Teleflex Incorporated. (*LIST NOT EXHAUSTIVE)

12. Appendix

• 12.1. About Us and Services
• 12.2. Contact Us