ヒト肝臓モデルの世界市場：2025年～2033年

世界のヒト肝臓モデルの市場規模は、2024年に13億7,000万米ドルとなりました。同市場は、2033年には37億6,000万米ドルに達すると予測され、2025年から2033年の予測期間中に12.3％のCAGRで拡大する見込みです。

ヒト肝臓モデルは、ヒト肝臓の生理的・機能的特性を模倣するように設計された高度な構築物です。これらのモデルは主に、薬物毒性、肝疾患、肝臓解剖の複雑な空間動態の研究に利用されています。洗練されたヒト肝臓モデルには、オルガノイド、3Dバイオプリント組織、肝臓チップシステムなど様々な形式があり、いずれもヒト肝臓の生理機能を分子レベル以上から再現しようと努めています。

肝疾患の有病率の上昇は、世界のヒト肝臓モデル市場拡大の主な要因です。この罹患率の上昇は、肝機能、疾患プロセス、薬物相互作用の理解を向上させる高度な研究ツールに対する緊急のニーズを生み出しています。

2022年3月のBMC Endocrine Disorders調査発表によると、非アルコール性脂肪性肝疾患（NAFLD）、ウイルス性肝炎、肝硬変、肝がんを含む慢性肝疾患の世界的有病率は著しく上昇しています。例えば、NAFLDは欧米諸国で最も有病率の高い慢性肝疾患として浮上しており、世界人口の約25％が罹患しています。

さらに、提携や共同研究、啓発プログラム、革新的な製品の発売など、主要企業の戦略がこの市場の成長を促進すると思われます。例えば、2024年2月、薬物毒性スクリーニング用肝臓オルガノイドを開発するための共同研究は、医薬品開発プロセスにおける新薬の安全性と有効性の向上を目指した重要な取り組みです。Cincinnati Children's HospitalのCuSTOMアクセラレーターラボが主導するこのプロジェクトは、Danaher Corporationの「ビーコン」プログラムの一環で、前臨床試験のツールとしてヒト肝臓オルガノイドの可能性を活用することに焦点を当てています。

同様に、2023年2月、CN Bioは、創薬における予測的ヒト肝臓モデルの使用を改善することを目的としたPhysio Mimix Single-organ Higher Throughput（HT）Systemを発表しました。この革新的なシステムは、これらのモデルの普及を妨げている既存の課題に取り組むもので、研究者はより大規模な比較試験を実施し、開発プロセスの早い段階で薬剤候補の有効性、体内動態、安全性を評価することができます。

世界のヒト肝臓モデル市場が直面している主な課題のひとつは、高度なモデルの開発と維持に伴うコストの高さです。3Dバイオプリンティング、オルガノイド、臓器チップシステムなどの技術は技術革新の最前線にありますが、高度なインフラと特殊な装置を必要とします。これらのプラットフォームは、調達コストが高いだけでなく、高度な材料や消耗品、高度な精度を必要とするため、運用や維持にもコストがかかります。そのため、多くの小規模研究機関や新興企業、新興市場の施設にとっては、資金的に手が届きにくいものとなっています。

加えて、ヒト由来細胞、特に一次ヒト肝細胞を調達し、使用するコストは著しく高いです。これらの細胞は、倫理的制約、入手可能なドナーの制限、厳格な品質管理基準のために入手が困難です。培養中の細胞の生存能と機能を維持するためには、濃縮培地、成長因子、厳密に制御された環境条件が必要であるため、さらに費用がかかります。

当レポートでは、世界のヒト肝臓モデル市場について調査し、市場の概要とともに、製品タイプ別、用途別、エンドユーザー別、地域別動向、競合情勢、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 市場のイントロダクションと範囲

第2章 経営者の洞察と重要なポイント

第3章 市場力学

• 影響要因
  • 促進要因
  • 抑制要因
  • 機会
  • 影響分析

第4章 戦略的洞察と業界展望

• 市場のリーダーとパイオニア
• 最新の開発とブレークスルー
• 規制と償還の情勢
• 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
• 特許分析
• SWOT分析
• アンメットニーズとギャップ
• 市場参入と拡大のための推奨戦略
• シナリオ分析ベストケース、ベースケース、ワーストケースの予測
• 価格分析と価格動向
• キーオピニオンリーダー

第5章 ヒト肝臓モデル市場（製品タイプ別）

• 2Dモデル
• 3Dモデル

第6章 ヒト肝臓モデル市場（用途別）

• ADME研究
• 創薬
• 毒性試験
• 疾患モデル化
• その他

第7章 ヒト肝臓モデル市場（エンドユーザー別）

• 学術調研究関
• 製薬・バイオテクノロジー企業
• CRO

第8章 ヒト肝臓モデル市場、地域別市場分析と成長機会

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • スペイン
  • イタリア
  • その他
• 南米
  • ブラジル
  • アルゼンチン
  • その他
• アジア太平洋
  • 中国
  • インド
  • 日本
  • 韓国
  • その他
• 中東・アフリカ

第9章 競合情勢と市場ポジショニング

• 競合状況の概要と主要市場参入企業
• 市場シェア分析とポジショニングマトリックス
• 戦略的パートナーシップ、合併・買収
• 製品ポートフォリオとイノベーションにおける主な発展
• 企業ベンチマーク

第10章 企業プロファイル

• Corning Incorporated
• 会社概要
• 製品ポートフォリオ
• 財務概要
• 主な発展
• SWOT分析
• BioIVT LLC
• Emulate Inc.
• InSphero
• Organovo Holdings Inc.
• MIMETAS BV
• CN Bio Innovations Ltd
• CELLINK
• Visikol, Inc.
• Cyprotex PLC

第11章 仮定と調査手法

第12章 付録

The global human liver models market reached US$ 1.37 billion in 2024 and is expected to reach US$ 3.76 billion by 2033, growing at a CAGR of 12.3% during the forecast period of 2025-2033.

A human liver model is an advanced construct designed to imitate the physiological and functional attributes of the human liver. These models are mainly utilized for investigating drug toxicity, liver diseases, and the intricate spatial dynamics of liver anatomy. Sophisticated human liver models can exist in various formats, such as organoids, 3D bioprinted tissues, and liver-on-a-chip systems, all striving to replicate human liver physiology from the molecular level and beyond.

Market Dynamics: Drivers & Restraints

Increasing Prevalence of Liver Diseases

The growing prevalence of liver diseases is a key driver behind the expansion of the global human liver models market. This rising incidence generates an urgent need for sophisticated research tools that can improve our understanding of liver function, disease processes, and drug interactions.

According to a BMC Endocrine Disorders research publication in March 2022, the global prevalence of chronic liver conditions, including non-alcoholic fatty liver disease (NAFLD), viral hepatitis, cirrhosis, and liver cancer, is increasing significantly. For example, NAFLD has emerged as the most prevalent chronic liver disorder in Western countries, affecting roughly 25% of the global population.

Furthermore, key players' strategies, such as partnerships & collaborations, awareness programs, and innovative product launches, would drive this market growth. For instance, in February 2024, the collaboration to develop liver organoids for drug toxicity screening is a significant initiative aimed at improving the safety and efficacy of new medications during the drug development process. This project, led by the CuSTOM Accelerator Lab at Cincinnati Children's Hospital, is part of Danaher Corporation's "Beacons" program and focuses on harnessing the potential of human liver organoids as a tool for preclinical testing.

Similarly, in February 2023, CN Bio introduced the Physio Mimix Single-organ Higher Throughput (HT) System, aimed at improving the use of predictive human liver models in drug discovery. This innovative system tackles existing challenges that hinder the widespread adoption of these models, allowing researchers to perform larger-scale comparative studies to evaluate the efficacy, disposition, and safety of drug candidates at earlier stages in the development process.

High Costs of Human Liver Models

One of the primary challenges facing the global human liver models market is the high cost associated with developing and maintaining advanced models. Technologies such as 3D bioprinting, organoids, and organ-on-a-chip systems are at the forefront of innovation but require sophisticated infrastructure and specialized equipment. These platforms are not only expensive to procure but also to operate and maintain, involving advanced materials, consumables, and a high degree of precision. This makes them financially inaccessible for many smaller research institutions, startups, and facilities in emerging markets.

In addition, the cost of sourcing and using human-derived cells, particularly primary human hepatocytes, is remarkably high. These cells are difficult to obtain due to ethical constraints, limited donor availability, and strict quality control standards. Maintaining their viability and function in culture adds further expenses, as it requires enriched media, growth factors, and tightly regulated environmental conditions.

Segment Analysis

The global human liver models market is segmented based on product type, application, end-user, and region.

Product Type:

The 3D models segment in product type is expected to dominate the global human liver models market with the highest market share

Conventional 2D cell cultures, which frequently do not accurately mimic the intricate architecture and microenvironment of human tissues, 3D liver models offer a more authentic representation of in vivo conditions. These models integrate various cell types and structural elements that are crucial for effectively studying liver function and drug responses. Recent developments in 3D bioprinting methods have enhanced the viability and functionality of liver cells in these models. For instance, researchers have effectively printed liver tissues that incorporate vascular structures, facilitating improved delivery of nutrients and oxygen, which is essential for sustaining cell health and function over extended periods.

Moreover, key players in the industry are more focused on the ongoing research studies on liver cells and investments that would propel this segment's growth in the market. For instance, in June 2024, Mini liver models, particularly the development of 3D liver spheroids, are set to improve the effectiveness of drug testing significantly. Researchers at King's College London (KCL) have developed a laboratory-grown Mini liver model that integrates liver cells with a synthetic nano scaffold. This novel approach enables the mini liver to more accurately replicate the structure and function of the human liver compared to conventional 2D cell culture models.

Similarly, in April 2024, Bayland Capital and CN Innovations Holdings Ltd, the founding shareholders, are set to invest $10 million and $5.5 million, respectively. This funding will support the expansion of product development and scaling efforts within the organization to meet the growing demand for Organ-on-a-Chip (OOC) solutions. These factors have solidified the segment's position in the global human liver models market.

Geographical Analysis

North America is expected to hold a significant position in the global human liver models market with the highest market share

The increasing prevalence of liver diseases, including non-alcoholic fatty liver disease (NAFLD), hepatitis, cirrhosis, and liver cancer, is a major factor driving the growth of the human liver model market. According to the American Liver Foundation, in September 2023, around 4.5 million adults in the U.S. were affected by liver disease. This rising incidence underscores the urgent need for advanced human liver models that can offer deeper insights into liver function and disease mechanisms, ultimately enhancing the drug discovery process.

Advancements in 3D bioprinting and organ-on-a-chip technologies have greatly enhanced the precision and effectiveness of human liver models. These innovations enable researchers to develop models that are more physiologically relevant and accurately replicate human liver conditions. Moreover, in this region, key players' strategies such as partnerships & collaboration, well-advanced healthcare infrastructure, R&D activities, government initiatives & regulatory bodies' support are driving this market growth.

For instance, in January 2024, CN Bio and Altis Biosystems entered into a strategic partnership to create a next-generation human Gut/Liver in vitro model aimed at improving ADME (Absorption, Distribution, Metabolism, and Excretion) studies. This collaboration combines Altis' RepliGut Planar-Jejunum model with CN Bio's PhysioMimix Liver-on-a-Chip, resulting in a comprehensive microphysiological system (MPS) that simulates inter-organ communication and accurately reflects the oral drug administration process.

Additionally, in September 2023, UC Davis Health introduced a new liver transplant program, representing a significant advancement in its transplant services. This program is set to resume operations after being temporarily closed, with plans to begin accepting patients in the spring of 2023. Thus, the above factors are consolidating the region's position as a dominant force in the global human liver models market.

Competitive Landscape

The major global players in the human liver models market include Corning Incorporated, BioIVT LLC, Emulate Inc., InSphero, Organovo Holdings Inc., MIMETAS B.V., CN Bio Innovations Ltd, CELLINK, Visikol, Inc., and Cyprotex PLC, among others.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials and product pipelines and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzed 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: This covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyze 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 human liver models market report delivers a detailed analysis with 62 key tables, more than 53 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

• 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. Market Introduction and Scope

• 1.1. Objectives of the Report
• 1.2. Report Coverage & Definitions
• 1.3. Report Scope

2. Executive Insights and Key Takeaways

• 2.1. Market Highlights and Strategic Takeaways
• 2.2. Key Trends and Future Projections
• 2.3. Snippet by Product Type
• 2.4. Snippet by Application
• 2.5. Snippet by End-User
• 2.6. Snippet by Region

3. Dynamics

• 3.1. Impacting Factors
  • 3.1.1. Drivers
    • 3.1.1.1. Increasing Prevalence of Liver Diseases
    • 3.1.1.2. Growth of Organ-on-a-Chip Technology and Advanced 3D Bioprinting
  • 3.1.2. Restraints
    • 3.1.2.1. High Costs of Human Liver Models
    • 3.1.2.2. Shortage of Skilled Professionals
  • 3.1.3. Opportunity
    • 3.1.3.1. Expansion of Virtual Clinical Trials
  • 3.1.4. Impact Analysis

4. Strategic Insights and Industry Outlook

• 4.1. Market Leaders and Pioneers
  • 4.1.1. Emerging Pioneers and Prominent Players
  • 4.1.2. Established leaders with the largest-selling Brand
  • 4.1.3. Market leaders with established Product
• 4.2. Latest Developments and Breakthroughs
• 4.3. Regulatory and Reimbursement Landscape
  • 4.3.1. North America
  • 4.3.2. Europe
  • 4.3.3. Asia Pacific
  • 4.3.4. South America
  • 4.3.5. Middle East & Africa
• 4.4. Porter's Five Forces Analysis
• 4.5. Supply Chain Analysis
• 4.6. Patent Analysis
• 4.7. SWOT Analysis
• 4.8. Unmet Needs and Gaps
• 4.9. Recommended Strategies for Market Entry and Expansion
• 4.10. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
• 4.11. Pricing Analysis and Price Dynamics
• 4.12. Key Opinion Leaders

5. Human Liver Models Market, By Product Type

• 5.1. Introduction
  • 5.1.1. Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 5.1.2. Market Attractiveness Index, By Product Type
• 5.2. 2D Models*
  • 5.2.1. Introduction
  • 5.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 5.3. 3D Models
  • 5.3.1. Liver-on-a-Chip
  • 5.3.2. Liver Organoids
  • 5.3.3. Spheroids
  • 5.3.4. 3D Bioprinting

6. Human Liver Models Market, By Application

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 6.1.2. Market Attractiveness Index, By Application
• 6.2. ADME Studies*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Drug Discovery
• 6.4. Toxicology Testing
• 6.5. Disease Modelling
• 6.6. Others

7. Human Liver Models Market, By End-User

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 7.1.2. Market Attractiveness Index, By End-User
• 7.2. Academic & Research Institutes*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Pharmaceutical & Biotechnology Companies
• 7.4. Contract Research Organizations

8. Human Liver Models Market, By Regional Market Analysis and Growth Opportunities

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 8.1.2. Market Attractiveness Index, By Region
• 8.2. North America
  • 8.2.1. Introduction
  • 8.2.2. Key Region-Specific Dynamics
  • 8.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 8.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 8.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 8.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.2.6.1. U.S.
    • 8.2.6.2. Canada
    • 8.2.6.3. Mexico
• 8.3. Europe
  • 8.3.1. Introduction
  • 8.3.2. Key Region-Specific Dynamics
  • 8.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 8.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 8.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 8.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.3.6.1. Germany
    • 8.3.6.2. U.K.
    • 8.3.6.3. France
    • 8.3.6.4. Spain
    • 8.3.6.5. Italy
    • 8.3.6.6. Rest of Europe
• 8.4. South America
  • 8.4.1. Introduction
  • 8.4.2. Key Region-Specific Dynamics
  • 8.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 8.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 8.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 8.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.4.6.1. Brazil
    • 8.4.6.2. Argentina
    • 8.4.6.3. Rest of South America
• 8.5. Asia-Pacific
  • 8.5.1. Introduction
  • 8.5.2. Key Region-Specific Dynamics
  • 8.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 8.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 8.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 8.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.5.6.1. China
    • 8.5.6.2. India
    • 8.5.6.3. Japan
    • 8.5.6.4. South Korea
    • 8.5.6.5. Rest of Asia-Pacific
• 8.6. Middle East and Africa
  • 8.6.1. Introduction
  • 8.6.2. Key Region-Specific Dynamics
  • 8.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 8.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 8.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

9. Competitive Landscape and Market Positioning

• 9.1. Competitive Overview and Key Market Players
• 9.2. Market Share Analysis and Positioning Matrix
• 9.3. Strategic Partnerships, Mergers & Acquisitions
• 9.4. Key Developments in Product Portfolios and Innovations
• 9.5. Company Benchmarking

10. Company Profiles

• 10.1. Corning Incorporated*
  • 10.1.1. Company Overview
  • 10.1.2. Product Portfolio
    • 10.1.2.1. Product Description
    • 10.1.2.2. Product Key Performance Indicators (KPIs)
    • 10.1.2.3. Historic and Forecasted Product Sales
    • 10.1.2.4. Product Sales Volume
  • 10.1.3. Financial Overview
    • 10.1.3.1. Company Revenue
    • 10.1.3.2. Geographical Revenue Shares
    • 10.1.3.3. Revenue Forecasts
  • 10.1.4. Key Developments
    • 10.1.4.1. Mergers & Acquisitions
    • 10.1.4.2. Key Product Development Activities
    • 10.1.4.3. Regulatory Approvals, etc.
  • 10.1.5. SWOT Analysis
• 10.2. BioIVT LLC
• 10.3. Emulate Inc.
• 10.4. InSphero
• 10.5. Organovo Holdings Inc.
• 10.6. MIMETAS B.V.
• 10.7. CN Bio Innovations Ltd
• 10.8. CELLINK
• 10.9. Visikol, Inc.
• 10.10. Cyprotex PLC

LIST NOT EXHAUSTIVE

11. Assumptions and Research Methodology

• 11.1. Data Collection Methods
• 11.2. Data Triangulation
• 11.3. Forecasting Techniques
• 11.4. Data Verification and Validation

12. Appendix

• 12.1. About Us and Services
• 12.2. Contact Us