体外肺模型市场－全球产业规模、份额、趋势、机会、预测：按类型、应用、区域和竞争格局划分，2021-2031年

全球体外肺模型市场预计将从 2025 年的 4.6766 亿美元大幅成长至 2031 年的 11.5184 亿美元，复合年增长率为 16.21%。

这些模型，包括肺晶片平台和类器官，都是实验室建构的系统，旨在模拟人类呼吸道的生理结构和细胞功能。这些先进的工具使研究人员能够在可控的体外环境中研究肺部的生物学特性、毒性和药物反应。市场成长的主要驱动力是监管机构日益增长的压力，要求以更贴近人体的替代方法取代动物试验，以及製药业对预测数据的需求，以最大限度地减少后期临床试验的失败。

对这类可靠的临床前工具的需求进一步受到严重呼吸系统疾病日益普遍的推动，使得治疗方法的发现变得迫在眉睫。根据美国肺臟协会2024年发布的数据，「预计美国将有约23.5万人被诊断出患有肺癌」。儘管如此沉重的疾病负担正在推动相关技术的应用，但阻碍市场扩张的主要挑战在于复製动态肺泡-毛细血管界面和血管灌注的生物学复杂性。在实现这些特性方面，高通量筛检的标准化仍然是一个技术上极具挑战性且高成本的问题。

市场驱动因素

监管和伦理层面向非动物调查方法的转变正在从根本上重塑全球体外肺模型市场，推动该行业摆脱对体内模型的传统依赖。这一转变主要受到鼓励在新药申请中使用替代方法数据的法律体制的影响，例如美国FDA现代化法案2.0。随着监管机构积极检验这些平台的有效性，製药公司正在加速采用人源模型，以提高安全性并减少伦理方面的担忧。该领域的一项重大进展是FDA正式将这些创新平台纳入其官方审查流程。据Emulate公司称，FDA于2024年9月将首个晶片器官技术纳入ISTAND试验计画，体现了FDA对这些系统在监管决策中预测能力的核准。

同时，肺晶片系统和3D生物列印技术的突破性进展，正透过解决肺泡界面的生物学复杂性，拓展市场潜力。创新者们正在设计能够精确模拟人类肺细胞结构、气体交换和流体动态的支架——这些特征先前在静态培养中是无法实现的。例如，Frontier Bio公司在2024年10月宣布，该公司已成功开发出利用干细胞自组装成功能性细支气管的生物列印肺组织，并实现了黏液和界面活性剂的生成。这项技术的成熟正推动着该行业巨大的商业性兴趣和投资。根据CN Bio报道，该公司在2024年4月获得了2,100万美元的B轮资金筹措，用于扩展其微生理系统，这显然显示了业界对非动物模型的日益重视。

市场挑战

全球体外肺模型市场成长的主要障碍在于，精确复製动态肺泡-毛细血管界面和血管灌注所涉及的生物复杂性。这项技术难题使得此类模型的开发成本高昂，且难以标准化，以满足製药公司所需的高通量筛检。因此，这些系统通常仅限于小众学术研究，而无法整合到大规模工业药物研发流程中，因为它们尚未具备大规模生产所需的稳定性和统一性。无法持续复製人类肺部的生理环境阻碍了市场向商业领域的拓展，而速度、成本效益和可重复性在商业领域至关重要。

缺乏标准化是一个瓶颈，阻碍了製药业有效解决药物研发效率日益扩大的问题。製药公司迫切需要预测工具来加速研发进程，但目前的肺部模型过于复杂，难以快速应用。国际药品製造商协会联合会（IFPMA）指出，「从2019年到2023年，临床试验从启动到完成患者招募的平均时间增加了26%。」 虽然这一数据凸显了临床工作流程的负担加重，但体外肺部模型技术要求高、验证成本高，因此，筛检检验以扭转这一趋势的可靠手段，从而阻碍了其市场推广。

市场趋势

三维球状体和类器官培养技术的普及，正将体外肺模型的应用范围从药物筛检扩展到环境毒理学。与静态二维培养不同，这些自组装结构能够模拟评估新型物质呼吸系统效应所需的复杂性。当研究人员检验这些系统在奈米毒理学应用中的价值，并确认其在危害识别方面的应用时，这一优势尤其显着。曼彻斯特大学于2024年4月发表的一份报告《科学家培养微型人肺作为奈米材料安全测试的动物替代模型》指出，研究人员利用人类肺类器官成功模拟了碳基奈米材料的体内反应，从而建立了一种可靠的非动物安全测试替代方案。这一趋势预示着类器官的应用前景广阔，其在工业颗粒物评估中将发挥越来越重要的作用。

同时，患者特异性诱导多能干细胞（iPS细胞）衍生模型的开发正在革新精准医疗，实现了基于「化身」治疗方法的预筛检。这些工具使临床医生能够在患者自身的组织中测试治疗方法，透过确保生物相容性显着提高临床试验的成功率。这项实际应用正在推动国际研究，以更有效地对患者群体进行分层。根据乌得勒支大学医学中心（UMC Utrecht）于2024年6月发表的题为「囊肿纤维化（CF）患者的独特临床试验：基于类器官的定制」的报告，患者特异性器官技术正被用于在10个欧洲国家的14个研究中心开展的囊肿纤维化临床试验中识别合格的响应者。这种与临床工作流程的整合表明，个人化模型在降低疗法研发风险方面具有日益增长的价值。

目录

第一章概述

第二章：调查方法

第三章执行摘要

第四章：客户心声

第五章：全球体外肺模型市场展望

• 市场规模及预测
  • 按金额
• 市占率及预测
  • 按类型（2D、3D）
  • 依应用领域（药物筛检、毒理学、3D模型开发、基础研究、生理研究、干细胞研究、再生医学）
  • 按地区
  • 按公司（2025 年）
• 市场地图

第六章：北美体外肺模型市场展望

• 市场规模及预测
• 市占率及预测
• 北美洲：国别分析
  • 我们
  • 加拿大
  • 墨西哥

第七章：欧洲体外肺模型市场展望

• 市场规模及预测
• 市占率及预测
• 欧洲：国别分析
  • 德国
  • 法国
  • 英国
  • 义大利
  • 西班牙

第八章：亚太地区体外肺模型市场展望

• 市场规模及预测
• 市占率及预测
• 亚太地区：国别分析
  • 中国
  • 印度
  • 日本
  • 韩国
  • 澳洲

第九章：中东和非洲体外肺部模型市场展望

• 市场规模及预测
• 市占率及预测
• 中东与非洲：国别分析
  • 沙乌地阿拉伯
  • 阿拉伯聯合大公国
  • 南非

第十章：南美洲体外肺模型市场展望

• 市场规模及预测
• 市占率及预测
• 南美洲：国别分析
  • 巴西
  • 哥伦比亚
  • 阿根廷

第十一章 市场动态

• 促进因素
• 任务

第十二章 市场趋势与发展

• 併购
• 产品发布
• 近期趋势

第十三章：全球体外肺模型市场：SWOT分析

第十四章：波特五力分析

• 产业竞争
• 新进入者的潜力
• 供应商的议价能力
• 顾客权力
• 替代品的威胁

第十五章 竞争格局

• Epithelix Sarl
• Mattek Corp.
• Lonza Group AG
• Emulate Inc.
• AlveoliX AG
• Nortis Inc.
• CN Bio Innovations Ltd.
• Mimetas BV
• InSphero AG
• ATTC Global

第十六章 策略建议

第十七章：关于研究公司及免责声明

The Global In Vitro Lung Model Market is projected to experience substantial growth, rising from USD 467.66 Million in 2025 to USD 1151.84 Million by 2031, reflecting a CAGR of 16.21%. These models, which include lung-on-a-chip platforms and organoids, are laboratory-engineered systems designed to emulate the physiological architecture and cellular functions of the human respiratory tract. Such advanced tools allow researchers to investigate pulmonary biology, toxicity, and drug responses within a controlled setting external to a living organism. The market is chiefly underpinned by increasing regulatory pressure to substitute animal testing with human-relevant alternatives, alongside the pharmaceutical industry's requirement for predictive data to minimize failures in late-stage clinical trials.

The demand for these reliable preclinical tools is further intensified by the rising prevalence of severe respiratory conditions, which necessitates accelerated therapeutic discovery. As stated by the 'American Lung Association', in '2024', 'approximately 235,000 individuals in the United States were projected to receive a lung cancer diagnosis'. Although this significant disease burden fuels adoption, a major challenge hindering market expansion is the biological complexity involved in recreating the dynamic alveolar-capillary interface and vascular perfusion. Achieving these features remains technically difficult and expensive to standardize for high-throughput screening purposes.

Market Driver

The regulatory and ethical transition toward animal-free testing methodologies is fundamentally reshaping the Global In Vitro Lung Model Market, shifting the industry away from its traditional reliance on in vivo models. This change is heavily influenced by legislative frameworks such as the U.S. FDA Modernization Act 2.0, which encourages the use of data from alternative methods for investigational new drug applications. As regulatory bodies actively validate these platforms, pharmaceutical developers are increasingly adopting human-relevant models to enhance safety profiles and mitigate ethical concerns. A pivotal development in this area was the FDA's formal integration of these innovative platforms into its official review process; according to Emulate, Inc., in September 2024, the FDA accepted the first Organ-on-a-Chip technology into its ISTAND Pilot Program, validating the predictive capability of these systems for regulatory decision-making.

Simultaneously, technological breakthroughs in lung-on-chip systems and 3D bioprinting are expanding market capabilities by resolving the biological complexity of the alveolar interface. Innovators are now engineering scaffolds that accurately mimic the cellular architecture, gas exchange, and fluid dynamics of human lungs, features that were previously impossible to replicate in static cultures. For instance, according to Frontier Bio, in October 2024, the company reported the development of bioprinted lung tissue that successfully produces mucus and surfactant, utilizing stem cells to self-organize into functional bronchioles. This technical maturation is driving significant commercial interest and facilitating investment in the sector; according to CN Bio, in April 2024, the company secured $21 million in Series B financing to scale its microphysiological systems, explicitly citing the growing industry adoption of non-animal models.

Market Challenge

The primary obstacle impeding the growth of the Global In Vitro Lung Model Market is the biological complexity associated with accurately recreating the dynamic alveolar-capillary interface and vascular perfusion. This technical intricacy makes the development of these models prohibitively expensive and difficult to standardize for the high-throughput screening required by pharmaceutical companies. Consequently, because these systems are not yet sufficiently robust or uniform for mass production, they are frequently confined to niche academic studies rather than being integrated into large-scale industrial drug discovery pipelines. The inability to consistently replicate the physiological environment of the human lung restricts market expansion into the commercial sector, where speed, cost-efficiency, and reproducibility are paramount.

This lack of standardization creates a bottleneck that prevents the industry from effectively addressing the widening efficiency gap in drug development. Pharmaceutical firms are in urgent need of predictive tools to accelerate timelines, yet current lung models remain too complex to be deployed rapidly. According to the 'International Federation of Pharmaceutical Manufacturers and Associations', in '2024', 'the average time from clinical trial start to patient enrollment close increased by 26% from 2019 to 2023'. This statistic highlights the growing burden on clinical workflows; however, because in vitro lung models remain technically demanding and expensive to validate, they cannot yet be reliably used to screen candidates early enough to reverse this trend, thereby stalling their broader market adoption.

Market Trends

The widespread adoption of 3D spheroid and organoid cultures is expanding the utility of in vitro lung models beyond pharmaceutical screening into the realm of environmental toxicology. Unlike static 2D cultures, these self-organizing structures recapitulate the complexity required to accurately assess the respiratory impact of novel materials. This capability was highlighted when researchers validated these systems for nanotoxicology applications, confirming their value in hazard identification. According to The University of Manchester, April 2024, in the 'Scientists grow human mini-lungs as animal alternative for nanomaterial safety testing' report, researchers successfully utilized human lung organoids to mimic in vivo responses to carbon-based nanomaterials, establishing a robust animal-free alternative for safety testing. This trend signifies a broadening market scope where organoids are becoming increasingly essential for evaluating industrial particulates.

Simultaneously, the development of patient-specific iPSC-derived models is revolutionizing precision medicine by enabling the "avatar-based" pre-screening of therapies. These tools allow clinicians to test treatments on a patient's own tissue, significantly optimizing clinical trial success rates by ensuring biological compatibility. This practical application is driving international research efforts to stratify patient populations more effectively. According to UMC Utrecht, June 2024, in the 'Unique trial patients with CF: customisation with organoids' announcement, a cystic fibrosis clinical trial is utilizing patient-specific organoid technology across 14 centres in 10 European countries to identify eligible responders. This integration into clinical workflows highlights the growing value of personalized models in de-risking therapeutic development.

Key Market Players

• Epithelix Sarl
• Mattek Corp.
• Lonza Group AG
• Emulate Inc.
• AlveoliX AG
• Nortis Inc.
• CN Bio Innovations Ltd.
• Mimetas BV
• InSphero AG
• ATTC Global

Report Scope

In this report, the Global In Vitro Lung Model Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

In Vitro Lung Model Market, By Type

• 2D
• 3D

In Vitro Lung Model Market, By Application

• Drug Screening
• Toxicology
• 3D Model Development
• Basic Research
• Physiologic Research
• Stem Cell Research
• Regenerative Medicine

In Vitro Lung Model Market, By Region

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global In Vitro Lung Model Market.

Available Customizations:

Global In Vitro Lung Model Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global In Vitro Lung Model Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Type (2D, 3D)
  • 5.2.2. By Application (Drug Screening, Toxicology, 3D Model Development, Basic Research, Physiologic Research, Stem Cell Research, Regenerative Medicine)
  • 5.2.3. By Region
  • 5.2.4. By Company (2025)
• 5.3. Market Map

6. North America In Vitro Lung Model Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Type
  • 6.2.2. By Application
  • 6.2.3. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States In Vitro Lung Model Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Type
      • 6.3.1.2.2. By Application
  • 6.3.2. Canada In Vitro Lung Model Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Type
      • 6.3.2.2.2. By Application
  • 6.3.3. Mexico In Vitro Lung Model Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Type
      • 6.3.3.2.2. By Application

7. Europe In Vitro Lung Model Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Type
  • 7.2.2. By Application
  • 7.2.3. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany In Vitro Lung Model Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Type
      • 7.3.1.2.2. By Application
  • 7.3.2. France In Vitro Lung Model Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Type
      • 7.3.2.2.2. By Application
  • 7.3.3. United Kingdom In Vitro Lung Model Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Type
      • 7.3.3.2.2. By Application
  • 7.3.4. Italy In Vitro Lung Model Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Type
      • 7.3.4.2.2. By Application
  • 7.3.5. Spain In Vitro Lung Model Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Type
      • 7.3.5.2.2. By Application

8. Asia Pacific In Vitro Lung Model Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Type
  • 8.2.2. By Application
  • 8.2.3. By Country
• 8.3. Asia Pacific: Country Analysis
  • 8.3.1. China In Vitro Lung Model Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Type
      • 8.3.1.2.2. By Application
  • 8.3.2. India In Vitro Lung Model Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Type
      • 8.3.2.2.2. By Application
  • 8.3.3. Japan In Vitro Lung Model Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Type
      • 8.3.3.2.2. By Application
  • 8.3.4. South Korea In Vitro Lung Model Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Type
      • 8.3.4.2.2. By Application
  • 8.3.5. Australia In Vitro Lung Model Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Type
      • 8.3.5.2.2. By Application

9. Middle East & Africa In Vitro Lung Model Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Type
  • 9.2.2. By Application
  • 9.2.3. By Country
• 9.3. Middle East & Africa: Country Analysis
  • 9.3.1. Saudi Arabia In Vitro Lung Model Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Type
      • 9.3.1.2.2. By Application
  • 9.3.2. UAE In Vitro Lung Model Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Type
      • 9.3.2.2.2. By Application
  • 9.3.3. South Africa In Vitro Lung Model Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Type
      • 9.3.3.2.2. By Application

10. South America In Vitro Lung Model Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Type
  • 10.2.2. By Application
  • 10.2.3. By Country
• 10.3. South America: Country Analysis
  • 10.3.1. Brazil In Vitro Lung Model Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Type
      • 10.3.1.2.2. By Application
  • 10.3.2. Colombia In Vitro Lung Model Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Type
      • 10.3.2.2.2. By Application
  • 10.3.3. Argentina In Vitro Lung Model Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Type
      • 10.3.3.2.2. By Application

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Global In Vitro Lung Model Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Products

15. Competitive Landscape

• 15.1. Epithelix Sarl
  • 15.1.1. Business Overview
  • 15.1.2. Products & Services
  • 15.1.3. Recent Developments
  • 15.1.4. Key Personnel
  • 15.1.5. SWOT Analysis
• 15.2. Mattek Corp.
• 15.3. Lonza Group AG
• 15.4. Emulate Inc.
• 15.5. AlveoliX AG
• 15.6. Nortis Inc.
• 15.7. CN Bio Innovations Ltd.
• 15.8. Mimetas BV
• 15.9. InSphero AG
• 15.10. ATTC Global

16. Strategic Recommendations

17. About Us & Disclaimer