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1606501

全球人造器官和仿生市場 - 2024-2031

Global Artificial Organs and Bionics Market - 2024-2031

出版日期: 2024年12月04日 | 出版商:

DataM Intelligence | 英文 176 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

概述

2023年，全球人造器官和仿生市場達到378.5億美元，預計2031年將達到770.8億美元，2024-2031年預測期間複合年成長率為9.3%。

人造器官是指植入或整合到人體內以取代、複製或增強自然器官功能的人造裝置或組織。這些器官與活組織相互作用，使患者能夠恢復正常功能並提高生活品質。例如人造心臟、腎臟和四肢，它們可以恢復基本的身體功能或增強身體能力。

另一方面，仿生學涉及生物系統與電子元件的整合，通常會產生可以與神經系統相互作用的設備。仿生設備包括可以透過神經訊號控制的義肢和恢復感覺功能的植入物，例如用於恢復聽力的人工耳蝸。這些因素推動了全球人造器官和仿生市場的擴張。

隨著政府投資和資助的增加，人造器官和仿生學創新解決方案的研究和開發不斷增加。例如，2024年，總部位於澳洲和加州的臨床階段醫療器材公司BiVacor透過人工心臟前沿計畫（AHFP）獲得了澳洲政府醫學研究未來基金（MRFF）撥款的1,300萬美元。這筆資金將支持該公司的全人工心臟（TAH）計畫和未來的產品改進。

市場動態：

驅動程式和限制

器官移植數量不斷增加

器官移植數量的增加極大地推動了全球人造器官和仿生市場的成長，預計將在整個市場預測期內推動成長。糖尿病、心臟病和腎臟疾病等慢性疾病的盛行率不斷上升，是導致器官衰竭發生率上升的重要因素。器官衰竭病例的增加與人造器官和仿生學需求的成長直接相關。

根據美國衛生與公眾服務部2024年1月的資料，2023年，美國總共進行了46,632例器官移植，其中包括活體捐贈者和已故捐贈者。這一數字比 2022 年成長了 8.7%，比 2021 年成長了 12.7%，2021 年是器官移植量首次突破 4 萬例的一年。移植數量的成長反映了器官捐贈和移植領域的幾個重要趨勢和因素。

器官衰竭率的上升增加了對人造器官作為傳統移植替代品的需求。這些人造器官可以幫助填補因可用捐贈者短缺而造成的空白，為患有嚴重慢性疾病的患者提供挽救生命的替代方案。

監管障礙

監管挑戰為人造器官和仿生學領域帶來了重大障礙，影響了產品開發和進入的速度和效率。人造器官和仿生設備的核准流程通常漫長而複雜。監管機構，例如美國 FDA 和世界各地的類似組織，在產品商業化之前需要進行嚴格的臨床試驗來確定產品的安全性和有效性。這可能會延遲新技術的部署並限制患者及時獲得這些技術。

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.

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