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人工臓器とバイオニクスの世界市場-2024～2031年

Global Artificial Organs and Bionics Market - 2024-2031

出版日
ページ情報
英文 176 Pages
納期
即日から翌営業日
カスタマイズ可能
適宜更新あり
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価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=144.06円
人工臓器とバイオニクスの世界市場-2024～2031年
出版日: 2024年12月04日
発行: DataM Intelligence
ページ情報: 英文 176 Pages
納期: 即日から翌営業日
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  • 概要
  • 目次
概要

概要

世界の人工臓器とバイオニクス市場は、2023年に378億5,000万米ドルに達し、2031年には770億8,000万米ドルに達すると予測され、予測期間2024年～2031年のCAGRは9.3%で成長する見込みです。

人工臓器は、天然臓器の機能を代替、複製、拡張するために、人間の体内に移植または一体化される人間製の装置または組織です。これらの臓器は生体組織とのインターフェースを持ち、患者が正常な機能を取り戻し、生活の質を向上させることを可能にします。例としては、人工心臓、人工腎臓、人工手足などがあり、これらの臓器によって必要な身体機能を回復させたり、身体能力を向上させたりすることができます。

一方、バイオニクスは、生物学的システムを電子部品と統合するもので、多くの場合、神経系と相互作用できる装置を生み出します。バイオニック・デバイスには、神経信号で制御できる人工装具や、聴覚回復のための人工内耳など、感覚機能を回復させるインプラントが含まれます。こうした要因が、世界の人工臓器とバイオニクス市場拡大の原動力となっています。

政府による投資と資金提供の増加に伴い、人工臓器とバイオニクスの革新的ソリューションの研究開発が活発化しています。例えば、オーストラリアとカリフォルニアを拠点とする臨床段階の医療機器企業であるBiVacor社は、2024年にオーストラリア政府の医療研究未来基金（MRFF）から人工心臓フロンティアプログラム（AHFP）を通じて1,300万米ドルの助成金を獲得しました。この資金は、同社のTAH（Total Artificial Heart）プログラムと将来の製品改良をサポートします。

市場力学：

促進要因と阻害要因

臓器移植の増加

臓器移植の増加は、世界の人工臓器とバイオニクス市場の成長を大きく牽引しており、市場予測期間中も牽引していくと予想されます。糖尿病、心臓病、腎臓障害などの慢性疾患の有病率の増加は、臓器不全の発生率上昇の重要な要因です。この臓器不全症例の増加は、人工臓器とバイオニクスの需要増に直結しています。

2024年1月の米国保健社会福祉省のデータによると、2023年には、米国で、生死ドナーの両方を含む合計46,632件の臓器移植が行われました。この数字は、2022年と比較して8.7％増、臓器移植件数が初めて4万件を超えた年として注目された2021年と比較して12.7％増です。移植件数の増加は、臓器提供と移植の状況におけるいくつかの重要な動向と要因を反映しています。

臓器不全率の上昇により、従来の移植に代わる人工臓器への需要が高まっています。これらの人工臓器は、利用可能なドナーの不足による空白を埋めるのに役立ち、重度の慢性疾患を抱える患者に救命の選択肢を提供します。

規制上のハードル

規制上の課題は人工臓器とバイオニクスセクターに大きな障害をもたらし、製品開発のスピードと効率、そして参入に影響を与えます。人工臓器やバイオニックデバイスの承認プロセスは、長くて複雑なことが多いです。米国のFDAや世界中の同等の機関などの規制機関は、製品化前に製品の安全性と有効性を確立するための厳格な臨床試験を必要とします。このため、新規技術の導入が遅れ、患者がタイムリーに技術を利用できなくな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
      • 臓器移植の増加
    • 抑制要因
      • 規制上のハードル
    • 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
  • 償還分析
  • 特許分析
  • SWOT分析
  • DMIの見解

第6章 タイプ別

  • 人工臓器
    • 腎臓
    • 心臓
    • 肺
    • 肝臓
    • 手足
    • その他
  • 人工バイオニクス
    • 人工内耳
    • 外骨格
    • バイオニック・リムス
    • ビジョン・バイオニクス
    • ブレイン・バイオニクス

第7章 素材別

  • プラスチック
  • 金属
  • コラーゲン
  • ゼラチン
  • フィブリン
  • 多糖類
  • 合成ポリマー
  • その他

第8章 固定タイプ別

  • 一時的
  • 永続

第9章 技術別

  • 機械的バイオニクス
  • 電子的バイオニクス

第10章 エンドユーザー別

  • 病院
  • 専門クリニック
  • 学術調査機関

第11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
    • その他欧州地域
  • 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
    • 韓国
    • その他アジア太平洋地域
  • 中東・アフリカ

第12章 競合情勢

  • 競合シナリオ
  • 市況・シェア分析
  • M&A分析

第13章 企業プロファイル

  • Abiomed Inc（Johnson & Johnson Services, Inc.）
    • 会社概要
    • 製品ポートフォリオと概要
    • 財務概要
    • 主な発展
  • SynCardia Systems, LLC
  • Medtronic
  • Boston Scientific Corporation
  • Zimmer Biomet.
  • Edwards Lifesciences Corporation.
  • Jarvik Heart, Inc.
  • Cochlear Ltd.
  • Berlin Heart
  • Ekso Bionics

第14章 付録

目次
Product Code: MD8809

Overview

The global artificial organs and bionics market reached US$ 37.85 billion in 2023 and is expected to reach US$ 77.08 billion by 2031, growing at a CAGR of 9.3% during the forecast period 2024-2031.

Artificial organs are human-made devices or tissues that are implanted or integrated into a person's body to replace, duplicate, or augment the function of a natural organ. These organs interface with living tissue, allowing patients to regain normal functionality and improve their quality of life. Examples include artificial hearts, kidneys, and limbs, which can restore essential bodily functions or enhance physical capabilities.

Bionics, on the other hand, involves the integration of biological systems with electronic components, often resulting in devices that can interact with the nervous system. Bionic devices include prosthetics that can be controlled by neural signals and implants that restore sensory functions, such as cochlear implants for hearing restoration. These factors have driven the global artificial organs and bionics market expansion.

With the growing investments and the rising funding by the government, there is growing research and development of innovative solutions for artificial organs and bionics. For instance, in 2024, BiVacor, a clinical-stage medical device company based in Australia and California, received an award of US$13 million from the Australian Government's Medical Research Future Fund (MRFF) grant through the Artificial Heart Frontiers Program (AHFP). The funding will support the company's Total Artificial Heart (TAH) program and future product enhancements.

Market Dynamics: Drivers & Restraints

Increasing number of organ transplants

The increasing number of organ transplants is significantly driving the growth of the global artificial organs and bionics market and is expected to drive throughout the market forecast period. The increasing prevalence of chronic diseases such as diabetes, heart disease, and kidney disorders is a significant factor contributing to the rising incidence of organ failure. This escalation in organ failure cases directly correlates with the growing demand for artificial organs and bionics.

According to U.S. Department of Health & Human Services data in January 2024, in 2023, a total of 46,632 organ transplants were performed in the United States, encompassing both living and deceased donors. This figure represents an 8.7% increase compared to 2022 and a 12.7% increase from 2021, which was notable for being the first year to exceed 40,000 organ transplants. The growth in transplant numbers reflects several important trends and factors within the organ donation and transplantation landscape.

The rising rates of organ failure are increasing the demand for artificial organs as substitutes for traditional transplants. These artificial organs can help fill the void caused by the shortage of available donors, offering life-saving alternatives for patients with severe chronic illnesses.

Regulatory hurdles

Regulatory challenges impose significant obstacles on the artificial organs and bionics sector, affecting the speed and efficiency of product development and entrance. The approval processes for artificial organs and bionic devices are frequently lengthy and complex. Regulatory bodies, such as the FDA in the United States and comparable organizations around the world, need rigorous clinical trials to establish product safety and efficacy before it is commercialized. This can delay the deployment of novel technology and limit patients' timely access to them.

Segment Analysis

The global artificial organs and bionics market is segmented based on type, material, fixation type, technology, end-user and region.

Type:

Artificial Organs segment is expected to dominate the artificial organs and bionics market share

The artificial organs segment is expected to dominate the global artificial organs and bionics market. The artificial organs segment will continue to dominate the artificial organs and bionics market, owing to many compelling factors driving demand and growth in this field. The global prevalence of chronic diseases such as heart disease, diabetes, and kidney failure is rising, resulting in an increased risk of organ failure. This tendency creates a considerable need for artificial organs to replace failing natural organs, driving up demand for this segment.

Furthermore, the aging population contributes to an increase in chronic diseases and organ failures among older persons, raising the demand for artificial organ solutions because these people frequently require replacements for deteriorating organs.

Companies are conducting advanced research and development of artificial organs and are introducing new organs to meet the rising demand. For instance, in January 2022, IIT-Kanpur launched the Hridyantra project, aimed at developing an advanced Left Ventricular Assist Device (LVAD) in collaboration with several hospitals. This initiative is particularly significant for patients suffering from end-stage heart failure, a condition where the heart can no longer pump blood effectively, leading to severe health complications.

Geographical Analysis

North America is expected to hold a significant position in the artificial organs and bionics market share

North America holds a substantial position in the global artificial organs and bionics market and is expected to hold most of the market share. The rising number of organ transplants significantly influences the demand for artificial organs. In the U.S., there are over 104,234 people on the national waiting list as of 2023, with a new person added every ten minutes. This urgent need for organ replacements drives the demand for artificial medical devices as alternatives.

The companies are receiving approvals for a wide range of organs and devices that are being developed innovatively. For instance, in March 2022, Edwards Lifesciences received FDA approval for the MITRIS RESILIA valve, a tissue valve replacement designed for the heart's mitral position. This valve is notable for its innovative design and advanced materials, which aim to improve patient outcomes in mitral valve replacement surgeries. Thus, the above are expected to hold the region in the dominant position in the global artificial organs and bionics market.

Asia-Pacific is growing at the fastest pace in the artificial organs and bionics market

The Asia-Pacific (APAC) region is experiencing the fastest growth rate in the artificial organs and bionics market, owing to the rising research and development of innovative artificial organs and bionics, increasing incidence of chronic diseases, and the rising number of organ failures. For instance, according to the National Institute of Health, India experiences 17,000-18,000 solid organ transplants performed every year. This increase in the number of organ failures increases the need for artificial organs solutions for transplantions.

Competitive Landscape

The major global players in the artificial organs and bionics market include Abiomed Inc. (Johnson & Johnson Services, Inc.), SynCardia Systems, LLC, Medtronic, Boston Scientific Corporation, Zimmer Biomet., Edwards Lifesciences Corporation., Jarvik Heart, Inc., Cochlear Ltd., Berlin Heart and Ekso Bionics among others.

Key Developments

  • In October 2023, Edwards received the CE [Conformite Europeenne] mark for the valve for mitral replacement surgeries. It was approved by the US Food and Drug Administration (FDA) in March 2022.

Why Purchase the Report?

  • Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
  • Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
  • Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
  • Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
  • Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
  • Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
  • Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
  • Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
  • Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
  • Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
  • Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
  • Post-market Surveillance: Uses post-market data to enhance product safety and access.
  • Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global artificial organs and bionics market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2023

  • Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
  • Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
  • Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
  • Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
  • Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
  • Supply Chain: Distribution and Supply Chain Managers.
  • Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
  • Academic & Research: Academic Institutions.

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 Material
  • 3.3. Snippet by Fixation Type
  • 3.4. Snippet by Technology
  • 3.5. Snippet by End-User
  • 3.6. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Increasing number of organ transplants
    • 4.1.2. Restraints
      • 4.1.2.1. Regulatory hurdles
    • 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. Reimbursement Analysis
  • 5.6. Patent Analysis
  • 5.7. SWOT Analysis
  • 5.8. 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. Artificial Organs*
    • 6.2.1. Introduction
    • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
    • 6.2.3. Kidney
    • 6.2.4. Heart
    • 6.2.5. Lungs
    • 6.2.6. Liver
    • 6.2.7. Limbs
    • 6.2.8. Others
  • 6.3. Artificial Bionics
    • 6.3.1. Cochlear Implant
    • 6.3.2. Exoskeleton
    • 6.3.3. Bionic Limbs
    • 6.3.4. Vision Bionics
    • 6.3.5. Brain Bionics

7. By Material

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
    • 7.1.2. Market Attractiveness Index, By Material
  • 7.2. Plastics*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Metals
  • 7.4. Collagen
  • 7.5. Gelatin
  • 7.6. Fibrin
  • 7.7. Polysaccharides
  • 7.8. Synthetic polymers
  • 7.9. Others

8. By Fixation Type

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Fixation Type
    • 8.1.2. Market Attractiveness Index, By Fixation Type
  • 8.2. Temporary*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Permanent

9. By Technology

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 9.1.2. Market Attractiveness Index, By Technology
  • 9.2. Mechanical Bionics*
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Electronic Bionics

10. By End-User

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 10.1.2. Market Attractiveness Index, By End-User
  • 10.2. Hospitals*
    • 10.2.1. Introduction
    • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 10.3. Specialty Clinics
  • 10.4. Academic & Research Institutes

11. By Region

  • 11.1. Introduction
    • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 11.1.2. Market Attractiveness Index, By Region
  • 11.2. North America
    • 11.2.1. Introduction
    • 11.2.2. Key Region-Specific Dynamics
    • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
    • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Fixation Type
    • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 11.2.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.2.8.1. The U.S.
      • 11.2.8.2. Canada
      • 11.2.8.3. Mexico
  • 11.3. Europe
    • 11.3.1. Introduction
    • 11.3.2. Key Region-Specific Dynamics
    • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
    • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Fixation Type
    • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 11.3.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.3.8.1. Germany
      • 11.3.8.2. UK
      • 11.3.8.3. France
      • 11.3.8.4. Italy
      • 11.3.8.5. Spain
      • 11.3.8.6. Rest of Europe
  • 11.4. South America
    • 11.4.1. Introduction
    • 11.4.2. Key Region-Specific Dynamics
    • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
    • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Fixation Type
    • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 11.4.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.4.8.1. Brazil
      • 11.4.8.2. Argentina
      • 11.4.8.3. Rest of South America
  • 11.5. Asia-Pacific
    • 11.5.1. Introduction
    • 11.5.2. Key Region-Specific Dynamics
    • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
    • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Fixation Type
    • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 11.5.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.5.8.1. China
      • 11.5.8.2. India
      • 11.5.8.3. Japan
      • 11.5.8.4. South Korea
      • 11.5.8.5. Rest of Asia-Pacific
  • 11.6. Middle East and Africa
    • 11.6.1. Introduction
    • 11.6.2. Key Region-Specific Dynamics
    • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
    • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Fixation Type
    • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 11.6.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

12. Competitive Landscape

  • 12.1. Competitive Scenario
  • 12.2. Market Positioning/Share Analysis
  • 12.3. Mergers and Acquisitions Analysis

13. Company Profiles

  • 13.1. Abiomed Inc (Johnson & Johnson Services, Inc.) *
    • 13.1.1. Company Overview
    • 13.1.2. Product Portfolio and Description
    • 13.1.3. Financial Overview
    • 13.1.4. Key Developments
  • 13.2. SynCardia Systems, LLC
  • 13.3. Medtronic
  • 13.4. Boston Scientific Corporation
  • 13.5. Zimmer Biomet.
  • 13.6. Edwards Lifesciences Corporation.
  • 13.7. Jarvik Heart, Inc.
  • 13.8. Cochlear Ltd.
  • 13.9. Berlin Heart
  • 13.10. Ekso Bionics

LIST NOT EXHAUSTIVE

14. Appendix

  • 14.1. About Us and Services
  • 14.2. Contact Us