In Vitro Lung Model Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (2D, 3D), By Application (Drug Screening, Toxicology, 3D Model Development, Basic Research, Physiologic Research, Stem Cell Research, Regenerative Medicine), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 467.66 Million
CAGR (2026-2031)	16.21%
Fastest Growing Segment	Drug Screening
Largest Market	North America
Market Size (2031)	USD 1151.84 Million

Market Overview

The Global In Vitro Lung Model Market will grow from USD 467.66 Million in 2025 to USD 1151.84 Million by 2031 at a 16.21% CAGR. In vitro lung models are laboratory-engineered systems, including organoids and lung-on-a-chip platforms, designed to replicate the physiological architecture and cellular function of the human respiratory tract. These advanced tools enable researchers to study pulmonary biology, toxicity, and drug responses in a controlled environment outside a living organism. The market is primarily supported by the increasing regulatory pressure to replace animal testing with human-relevant alternatives and the pharmaceutical industry’s need for more predictive data to reduce late-stage clinical trial failures.

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

Key Market Drivers

The regulatory and ethical shift towards animal-free testing methodologies is fundamentally reshaping the Global In Vitro Lung Model Market, moving the industry away from traditional in vivo reliance. This transition is heavily influenced by legislative frameworks like the U.S. FDA Modernization Act 2.0, which now encourages 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 improve safety profiles and reduce ethical concerns. A significant development in this domain occurred when the FDA began formally integrating 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.

Technological breakthroughs in 3D bioprinting and lung-on-chip systems are simultaneously expanding market capabilities by resolving the biological complexity of the alveolar interface. Innovators are now creating scaffolds that accurately mimic the gas exchange, cellular architecture, and fluid dynamics of human lungs, features previously impossible to replicate in static cultures. 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 the capitalization of 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.

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Key Market Challenges

The primary challenge hampering the growth of the Global In Vitro Lung Model Market is the biological complexity involved in 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. Because these systems are not yet robust or uniform enough for mass production, they are frequently relegated to niche academic studies rather than being integrated into large-scale industrial drug discovery pipelines. The inability to consistently replicate the human lung’s physiological environment restricts the market's 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 desperate for predictive tools to speed up timelines, yet the current lung models are 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.

Key Market Trends

The widespread adoption of 3D organoid and spheroid cultures is expanding the utility of in vitro lung models beyond pharmaceutical screening into environmental toxicology. Unlike static 2D cultures, these self-organizing structures recapitulate the complexity needed to accurately assess the respiratory impact of novel materials. This capability was highlighted when researchers validated these systems for nanotoxicology applications, proving 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 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.

Segmental Insights

The Drug Screening segment is positioned as the fastest-growing category within the Global In Vitro Lung Model Market. This expansion is primarily driven by the enactment of the FDA Modernization Act 2.0, which authorizes the use of human-relevant in vitro alternatives to animal testing for investigational new drug applications. Pharmaceutical companies are rapidly integrating these models to mitigate the high failure rates historically associated with respiratory clinical trials. By utilizing these physiologically accurate platforms, researchers can assess compound toxicity and efficacy with greater precision, thereby streamlining the validation process for novel therapeutics.

Regional Insights

North America leads the Global In Vitro Lung Model Market, primarily driven by the extensive presence of major pharmaceutical and biotechnology firms in the region. This market dominance is significantly strengthened by the United States Food and Drug Administration (FDA), which actively promotes alternative testing methods following the passage of the FDA Modernization Act 2.0. This supportive regulatory landscape encourages the industry to replace animal testing with human-relevant in vitro models for drug development. Additionally, substantial investment in research for respiratory diseases further consolidates the region's status as the primary market for these technologies.

Recent Developments

• In April 2025, CN Bio established a strategic partnership with Pharmaron, a global R&D service provider, to integrate and validate its PhysioMimix Organ-on-a-Chip technology within Pharmaron’s drug discovery workflows. This collaboration focused on deploying CN Bio's microphysiological systems, which include their validated lung-on-a-chip models, across Pharmaron's laboratories to support disease modelling and toxicology studies. The agreement highlighted the growing adoption of alternative testing methods in the Global In Vitro Lung Model Market, as the partners aimed to provide pharmaceutical clients with more accurate human-relevant data to de-risk therapeutic development and accelerate regulatory submissions.
• In January 2025, MIMETAS announced the commercial launch of its OrganoPlate UniFlow technology, a significant innovation designed to advance the capabilities of in vitro modelling. This new pumpless, gravity-driven system was explicitly integrated into the company’s existing portfolio of organ models, including their lung, liver, and brain platforms. The launch addressed a critical need in the Global In Vitro Lung Model Market for systems that replicate physiological fluid flow and vascularization without complex tubing. By mimicking natural blood circulation, the technology enhanced the physiological relevance of lung tissue models used for large-scale drug discovery and toxicity testing.
• In November 2024, AlveoliX achieved a major scientific milestone with the publication of a breakthrough study in Bioengineering & Translational Medicine, validating the efficacy of its advanced Lung-on-Chip technology. Conducted in collaboration with Vitrocell Systems, the University of Bern, and the Helmholtz Institute for Pharmaceutical Research Saarland, the research demonstrated a stretchable human lung model capable of mimicking alveolar inflammation and respiratory dynamics. This development provided the Global In Vitro Lung Model Market with a highly predictive tool for studying complex respiratory diseases like COPD and asthma, offering a superior alternative to traditional preclinical models for anti-inflammatory drug screening.
• In September 2024, MatTek Life Sciences, a pioneering biotech entity, entered into a strategic licensing agreement with CellEx, a prominent laboratory based in China. This collaboration marked a significant expansion within the Global In Vitro Lung Model Market, enabling the local production of MatTek’s advanced organotypic human tissues, which include their industry-leading respiratory models such as EpiAirway and EpiAlveolar. By leveraging this partnership, the company aimed to enhance the accessibility of reliable, human-relevant testing platforms for pharmaceutical development and safety assessment across the Asian market, thereby supporting the reduction of animal testing in respiratory research.

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

By Type	By Application	By Region
2D 3D	Drug Screening Toxicology 3D Model Development Basic Research Physiologic Research Stem Cell Research Regenerative Medicine	North America Europe Asia Pacific South America Middle East & Africa

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