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全球人造器官和仿生市场 - 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个工作天内

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简介目录

概述

2023年，全球人造器官和仿生市场达到378.5亿美元，预计2031年将达到770.8亿美元，2024-2031年预测期间复合年增长率为9.3%。

人造器官是指植入或整合到人体内以取代、复製或增强自然器官功能的人造装置或组织。这些器官与活组织相互作用，使患者能够恢復正常功能并提高生活品质。例如人造心臟、肾臟和四肢，它们可以恢復基本的身体功能或增强身体能力。

另一方面，仿生学涉及生物系统与电子元件的集成，通常会产生可以与神经系统相互作用的设备。仿生设备包括可以透过神经讯号控制的义肢和恢復感觉功能的植入物，例如用于恢復听力的人工耳蜗。这些因素推动了全球人造器官和仿生市场的扩张。

随着政府投资和资助的增加，人造器官和仿生学创新解决方案的研究和开发不断增加。例如，2024年，总部位于澳洲和加州的临床阶段医疗器材公司BiVacor透过人工心臟前沿计画（AHFP）获得了澳洲政府医学研究未来基金（MRFF）拨款的1,300万美元。这笔资金将支持该公司的全人工心臟（TAH）计画和未来的产品改进。

市场动态：

驱动程式和限制

器官移植数量不断增加

器官移植数量的增加极大地推动了全球人造器官和仿生市场的成长，预计将在整个市场预测期内推动成长。糖尿病、心臟病和肾臟疾病等慢性疾病的盛行率不断上升，是导致器官衰竭发生率上升的重要因素。器官衰竭病例的增加与人造器官和仿生学需求的成长直接相关。

根据美国卫生与公众服务部2024年1月的资料，2023年，美国总共进行了46,632例器官移植，其中包括活体捐赠者和已故捐赠者。这一数字比 2022 年增长了 8.7%，比 2021 年增长了 12.7%，2021 年是器官移植量首次突破 4 万例的一年。移植数量的增长反映了器官捐赠和移植领域的几个重要趋势和因素。

器官衰竭率的上升增加了对人造器官作为传统移植替代品的需求。这些人造器官可以帮助填补因可用捐赠者短缺而造成的空白，为患有严重慢性疾病的患者提供挽救生命的替代方案。

监管障碍

监管挑战为人造器官和仿生学领域带来了重大障碍，影响了产品开发和进入的速度和效率。人造器官和仿生设备的审批流程通常漫长而复杂。监管机构，例如美国 FDA 和世界各地的类似组织，在产品商业化之前需要进行严格的临床试验来确定产品的安全性和有效性。这可能会延迟新技术的部署并限制患者及时获得这些技术。

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