3Dプリント臓器の世界市場-2024～2031年

概要

世界の3Dプリント臓器市場は、2023年に24億1,000万米ドルに達し、2031年には61億8,000万米ドルに達すると予測され、予測期間2024年～2031年のCAGRは12.6%で成長する見込みです。

3Dプリント臓器は、3Dバイオプリンターで作成された体組織のレプリカです。臓器は細胞バイオインクで作られ、研究室で人工的に培養されます。バイオインクは、模倣する天然臓器の機能と構造を細胞が構築するのを助けるように設計されています。

3Dプリント臓器を使って、個々の患者の異なる解剖学的・生理学的ニーズに対応することができます。臓器を構築するために患者自身の細胞を使用することで、拒絶反応の可能性が減少し、治療成績が向上します。3Dプリント臓器は、病気の調査や新薬の試験にモデルとして使用することができます。この技術により、研究者は病気が人間の組織にどのような影響を与えるかについて理解を深め、動物実験に頼ることなく、より効果的な治療法を設計することができます。

市場力学：

促進要因と阻害要因

慢性疾患の増加

糖尿病、高血圧、腎臓病などの慢性疾患は、臓器不全の主な原因です。これらの疾患が世界中で一般的になるにつれて、臓器移植を希望する患者数は増加しています。例えば、米国では現在10万3,000人を超える移植待機者がおり、8分に1人が追加されています。この需要に応えるためには、3Dプリント臓器のような新しいアプローチが緊急に必要であることを強調しています。

3Dプリント臓器は、患者自身の細胞から作ることができるため、生体適合性が高まり、移植拒絶反応の可能性を大幅に減らすことができます。このパーソナライゼーションは、患者の生理学的ニーズに密接に沿った個別化治療が可能になるため、慢性疾患に苦しむ人々にとって特に有利です。適合性の問題に対処することで、3Dプリント臓器は移植の成功率と患者の幸福を高めることができます。

規制上の課題

規制機関は、新しい医療品目を承認する前に、安全性と有効性に関する重要な証拠を要求します。3Dプリント臓器は患者ごとにカスタムメイドされるため、ランダム化比較試験などの一般的な試験方法は効果がない可能性があります。臓器はそれぞれユニークであるため、1つの例から次の例までの結果を予測することが難しく、安全性統計の信頼性に疑問が生じる。臓器を移植する前に、他の人を使って試験することができないため、規制当局の評価にも支障をきたします。

規制基準を満たすには、特にバイオプリンティングの新興企業や小規模な組織にとっては、過剰なコストがかかる可能性があります。安全規制への準拠を確立するためには、広範な調査、試験、書類作成が必要であり、これが投資を抑制し、技術革新を制限する可能性があります。規制プロセスを通過するためのコストの難しさは、市場参入企業の数を制限す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
    • 慢性疾患の増加
  • 抑制要因
    • 規制上の課題
  • 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 臓器の種類別

• 心臓
• 肝臓
• 腎臓
• 肺
• 肌
• 骨

第7章 技術別

• 押し出しベースの3Dプリント
• レーザーアシスト印刷
• インクジェット印刷
• 磁気浮上

第8章 用途別

• 組織工学
• 再生医療
• 創薬
• 手術計画

第9章 エンドユーザー別

• 病院と診療所
• 調査機関および研究所
• 製薬会社
• 学術機関

第10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11章 競合情勢

• 競合シナリオ
• 市況・シェア分析
• M&A分析

第12章 企業プロファイル

• CELLINK
  • 会社概要
  • 製品ポートフォリオと概要
  • 財務概要
  • 主な発展
• SynCOrganovo Holdings Inc.
• CYFUSE BIOMEDICAL K.K.
• 3D Systems, Inc.
• Stratasys
• United Therapeutics Corporation
• Prellis Biologics
• CollPlant Biotechnologies Ltd.
• Aspect Biosystems Ltd.
• Materialise

第13章 付録

Overview

The global 3D printed organ market reached US$ 2.41 billion in 2023 and is expected to reach US$ 6.18 billion by 2031, growing at a CAGR of 12.6% during the forecast period 2024-2031.

A 3D-printed organ is a replica of body tissue created with a 3D bioprinter. They're made out of cellular bio-inks and are artificially grown in a lab. The bioink is designed to help cells build the function and structure of the natural organ it mimics.

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.

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 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

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us