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1606499

全球 3D 列印器官市場 - 2024-2031

Global 3D Printed Organ 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3D列印器官市場規模達到24.1億美元，預計2031年將達到61.8億美元，2024-2031年預測期間複合年成長率為12.6%。

3D 列印器官是使用 3D 生物列印機創建的身體組織的複製品。它們由細胞生物墨水製成，並在實驗室中人工生長。生物墨水旨在幫助細胞建構其模仿的自然器官的功能和結構。

使用 3D 列印器官可以滿足個別患者獨特的解剖學和生理學需求。透過使用患者自己的細胞來建構器官，可以減少排斥的機會，從而改善結果。 3D 列印的器官可作為研究疾病和測試新藥物的模型。這項技能使研究人員能夠更好地了解疾病如何影響人體組織並設計更有效的治療方法，而無需依賴動物實驗。

市場動態：

驅動程式和限制

慢性病盛行率增加

糖尿病、高血壓和腎臟病等慢性疾病是器官衰竭的主要原因。隨著這些疾病在世界各地變得越來越普遍，尋求器官移植的患者數量也在增加。例如，目前美國全國移植等待名單上有超過 103,000 人，每八分鐘增加一人，這凸顯了迫切需要 3D 列印器官等新方法來滿足這一需求。

3D列印器官可由患者自身的細胞製成，提高生物相容性並顯著降低移植排斥的可能性。這種個人化對於患有慢性疾病的個體尤其有利，因為它使得個人化治療選擇與他們的生理需求緊密結合。透過解決相容性問題，3D 列印器官可以提高移植成功率和患者福祉。

監管挑戰

監管機構在批准新醫療項目之前需要重要的安全性和有效性證據。由於 3D 列印器官是為每位患者量身定做的，因此隨機對照試驗等典型測試方法可能無效。每個器官都是獨一無二的，因此很難預測從一個例子到下一個例子的結果，引發了對安全統計數據可靠性的質疑。植入前無法在其他人身上測試器官阻礙了監管評估。

滿足監管標準的成本可能過於昂貴，特別是對於生物列印新創公司和小型組織而言。需要進行廣泛的研究、測試和文書工作來確保遵守安全法規，這可能會阻礙投資並限制創新。監管流程的成本困難可能會限制市場參與者的數量。

Individual patients' distinct anatomical and physiological needs can be addressed using 3D-printed organs. By employing a patient's own cells to construct the organ, the chance of rejection is reduced, resulting in improved outcomes. 3D-printed organs can be used as models to research diseases and test novel medications. This skill enables researchers to gain a better understanding of how diseases affect human tissues and design more effective treatments without having to rely on animal experimentation.

Market Dynamics: Drivers & Restraints

Increasing Prevalence of Chronic Diseases

Chronic disorders such as diabetes, hypertension, and kidney disease are major causes of organ failure. As these disorders become more common around the world, the number of patients seeking organ transplants increases. For instance, there are currently over 103,000 persons on the national transplant waiting list in the United States, with one added every eight minutes, underlining the urgent need for novel approaches like 3D-printed organs to meet this demand.

3D-printed organs can be made from a patient's own cells, increasing biocompatibility and significantly reducing the possibility of transplant rejection. This personalization is especially advantageous for individuals suffering from chronic diseases since it enables individualized treatment options closely aligned with their physiological needs. By addressing compatibility difficulties, 3D-printed organs can boost transplant success rates and patient well-being.

Regulatory Challenges

Regulatory bodies require significant safety and efficacy evidence before approving new medical items. Because 3D-printed organs are custom-made for each patient, typical testing methods such as randomized controlled trials may be ineffective. Each organ is unique, making it difficult to predict outcomes from one example to the next, raising questions about the dependability of safety statistics. The inability to test organs on other people before implantation hampers regulatory evaluations.

Meeting regulatory criteria can be excessively expensive, particularly for bioprinting startups and smaller organizations. Extensive study, testing, and paperwork are required to establish compliance with safety regulations, which may discourage investment and limit innovation. The cost difficulty of navigating regulatory processes may limit the number of market participants.

Segment Analysis

The global 3D printed organ market is segmented based on type, material, fixation type, technology, end-user and region.

Type:

Kidney segment is expected to dominate the 3D-printed organ market share

The kidney segment is likely to dominate the 3D printed organ market due to several compelling factors, including increasing demand for innovative organ transplantation options, rising number of individuals with chronic kidney diseases and others. Kidney transplants account for a substantial share of organ transplant treatments worldwide. For instance, according to the United Network for Organ Sharing, in 2022, 42,887 organ transplants were performed in the United States, an increase of 3.7 percent over 2021.

The significant shortage of suitable donor kidneys is a pressing issue, with over 110,000 people on waiting lists for organ transplants in the United States. Many patients have lengthy waits for a qualified donor, which might last many years. This scarcity emphasizes the urgent requirement for alternative alternatives, such as 3D-printed kidneys, which could be an appealing choice for patients who would otherwise face long wait times or rely on dialysis treatments.

Recent advancements in bioprinting technologies are focused on tackling the complex structures of kidneys, which improves the chances of successfully creating these engineered organs for transplantation. Researchers are consistently improving methods to accurately replicate the intricate functions of kidneys, which is essential for developing organs that can perform the necessary biological tasks effectively.

Geographical Analysis

North America is expected to hold a significant position in the 3D-printed organ market share

North America is at the forefront of the 3D printed organ market, driven by a combination of a strong healthcare system, significant investments in research and development, and an increasing demand for organ transplants. The region has a well-established healthcare infrastructure that supports advanced medical research and innovation, facilitating the integration of cutting-edge technologies like 3D printing into clinical practice. This environment enables rapid advancements in the fabrication of organs.

Moreover, substantial investments from both government and private sectors are directed towards advancing bioprinting technologies in North America. These investments are crucial for developing innovative solutions to address the complexities involved in organ printing, including enhancing bioink formulations and refining printing techniques.

Rising government initiatives to meet the rising demand for organs are also contributing to the overall region's market growth. For instance, In March 2024, the Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), announced the Personalized Regenerative Immunocompetent Nanotechnology Tissue (PRINT) program. The PRINT program aims to create a process to enable biofabrication of the kidney, heart, and liver by leveraging 3D bioprinting, cell manufacturing, biomaterials, modeling, and tissue engineering. The goal is to use patient cells or a biobank to quickly produce immune matched replacement organs and restore normal organ function. These factors are expected to contribute to the region's market growth.

Asia-Pacific is growing at the fastest pace in the 3D-printed organ market

Asia-Pacific is expected to experience the fastest growth in the global 3D-printed organ market. This is due to rising technological advancement, increasing research and capabilities, and rising funding from the government.

The region faces a significant demand for organ transplants. For instance, according to the publication by Taipei Times in 2022, organ donor registrations dropped by 48 percent during the COVID-19 pandemic, Taiwan Organ Sharing Registry and Patient Autonomy Promotion Center data show. As of the end of June, more than 10,000 people were waiting to receive an organ transplant, including 8,254 people waiting for a kidney, 1,002 people waiting for a liver, 217 people waiting for a heart, 93 people waiting for a lung, and 89 people waiting for a pancreas. Thus, the above factors are rising the region's growth.

Competitive Landscape

The major global players in the 3D-printed organ market include CELLINK, Organovo Holdings Inc., CYFUSE BIOMEDICAL K.K., 3D Systems, Inc., Stratasys, United Therapeutics Corporation, Prellis Biologics, CollPlant Biotechnologies Ltd., Aspect Biosystems Ltd. and Materialise among others.

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 3D printed organ 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 Organ Type
3.2. Snippet by Technology
3.3. Snippet by Application
3.4. Snippet by End-User
3.5. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Increasing Prevalence of Chronic Diseases
- 4.1.2. Restraints
  - 4.1.2.1. Regulatory Challenges
- 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 Organ Type

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Organ Type
- 6.1.2. Market Attractiveness Index, By Organ Type
6.2. Heart*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Liver
6.4. Kidney
6.5. Lung
6.6. Skin
6.7. Bone

7. By Technology

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 7.1.2. Market Attractiveness Index, By Technology
7.2. Extrusion-Based 3D Printing*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Laser-Assisted Printing
7.4. Inkjet Printing
7.5. Magnetic Levitation

8. By Application

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 8.1.2. Market Attractiveness Index, By Application
8.2. Tissue Engineering*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Regenerative Medicine
8.4. Drug Discovery
8.5. Surgical Planning

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 and Clinics*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Research Institutes and Laboratories
9.4. Pharmaceutical Companies
9.5. Academic Institutions

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 Organ Type
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.2.7.1. The U.S.
  - 10.2.7.2. Canada
  - 10.2.7.3. 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 Organ Type
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.3.7.1. Germany
  - 10.3.7.2. UK
  - 10.3.7.3. France
  - 10.3.7.4. Italy
  - 10.3.7.5. Spain
  - 10.3.7.6. 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 Organ Type
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.4.7.1. Brazil
  - 10.4.7.2. Argentina
  - 10.4.7.3. 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 Organ Type
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.5.7.1. China
  - 10.5.7.2. India
  - 10.5.7.3. Japan
  - 10.5.7.4. South Korea
  - 10.5.7.5. 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 Organ Type
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.6.6. 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. CELLINK*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio and Description
- 12.1.3. Financial Overview
- 12.1.4. Key Developments
12.2. SynCOrganovo Holdings Inc.
12.3. CYFUSE BIOMEDICAL K.K.
12.4. 3D Systems, Inc.
12.5. Stratasys
12.6. United Therapeutics Corporation
12.7. Prellis Biologics
12.8. CollPlant Biotechnologies Ltd.
12.9. Aspect Biosystems Ltd.
12.10. Materialise

LIST NOT EXHAUSTIVE