Pipeline potential of mini lab-grown organs

Chronic diseases have become the leading global health challenge, accounting for over 70 percent of deaths worldwide, a burden that continues to grow with aging populations and shifting lifestyles. Their impact extends beyond health, imposing profound economic and social costs. The limitation of current tools used in disease treatment is becoming increasingly apparent. Traditional research models often fail to accurately unravel the complex mechanisms of diseases or effectively facilitate drug discovery. As China advances the Healthy China Initiative and enters the 15th Five-Year Plan (2026-30) period, the need for more precise and efficient biomedical solutions has become urgent.

Organoid technology, a revolutionary breakthrough in the biomedical field, offers a novel platform for investigating the mechanisms underlying occurrence and development of diseases and accelerating clinical translation. Organoids are miniature, self-organizing three-dimensional structures grown in vitro that closely resemble key features of normal or pathological human tissues. Their high-throughput capability and physiological fidelity have led to their widespread recognition as a breakthrough technology.

By recapitulating the structures and functions of normal and pathological human organs, organoids provide a transformative platform for drug effectiveness and safety testing and disease modeling. They enhance predictive reliability in drug development, toxicity screening, and personalized medicine, accelerating timelines, reducing costs, and mitigating risks. Moreover, organoids empower the development of targeted therapies for rare diseases and advance diagnostic and treatment strategies for major diseases, positioning them as a cornerstone of precision medicine.

At the same time, organoid technology converges multiple scientific disciplines, including biomaterials, microfluidics, and artificial intelligence-driven drug discovery, to drive innovation and industrial growth in biomedicine, while also fostering the development of globally competitive new industries.

With tightening global regulations on animal experimentation, organoids provide a compelling alternative: highly biomimetic human models that minimize animal use while advancing ethical science. This dual advantage underpins their rising international importance.

Organoid technology has also emerged as a strategic focal point in the global biopharmaceutical landscape. The United States, European nations and Japan have strategically secured their footholds, prioritizing organoid applications in drug development, animal welfare and regenerative medicine. This positions them at the forefront of this transformative field.

For China, this means a strengthened position in the global biopharmaceutical sector and enhanced protection of public health. Beyond medicine, this technology holds transformative potential for public health emergencies, environmental toxicity testing and bio-defense applications.

China has made rapid progress in organoid research, ranking second worldwide in publication output and leading in patent filings. Domestic companies have achieved notable success in developing diverse organoid models, with related outcomes already integrated into the research and development pipelines of both Chinese and global pharmaceutical companies, demonstrating strong industrial applicability.

In recent years, organoid technology has drawn growing attention from China's regulatory and funding agencies. A series of government policies have been introduced to advance the frontiers of organoid technology.

In January 2024, China's National Medical Products Administration explicitly recognized organoids as supportive tools for evaluating stem cell products. By June 2025, organoids were officially designated as non-clinical models for rare disease drug development. In October 2025, new regulations on emerging biomedical technologies marked a pivotal shift, propelling China's organoid technology into a phase of formal legal and systematic advancement.

As a transformative life science technology, organoids are strategically aligned with China's national priorities of the 15th Five-Year Plan. Integrating organoid technology into key national initiatives through systematic planning and large-scale implementation will strengthen China's competitive edge and leadership in this critical field.

Currently, the standardization and industrialization of organoid technology are advancing worldwide. The US National Institutes of Health established its first national-level standardized organoid modeling center in September 2025. The following November, the United Kingdom government committed ￡75.9 million ($101.67 million) to replace animal tests with organoid models and to accelerate the development of a global resource network.

In this context, establishing a human-relevant and autonomously controlled organoid biobank has become a strategic priority for China. While progress has been made including the Ministry of Education's approval of the Organoid Resource Bank at Nanchang University, systematic national planning and coordinated promotion are still needed.

The establishment and effective utilization of organoid resources are essential not only for safeguarding China's core biological assets and scientific data sovereignty, but also for avoiding strategic passivity in the coming biopharmaceutical competition. As foundational infrastructure for translating cutting-edge medical technologies into scalable applications, organoid platforms demand systematic and forward-looking development.

To this end, several key actions are recommended. First, a national-level, high-standard organoid repository and sharing platform should be established to ensure autonomous and controllable management of strategic biological resources.

Second, a technical standard and ethical governance system with Chinese characteristics should be developed in parallel, thereby strengthening China's voice in international rule-setting.

Third, deeper integration should be promoted between organoid biobanks and related fields such as bio-materials, smart devices, multimodal data, AI and new drug development, to build an integrated innovation ecosystem that connects resources, tools, data, and applications.

The deep integration of organoid data systems with AI is propelling the technology toward greater intelligence and standardization. By converging multimodal data with advanced analysis, researchers can deepen mechanistic insights, enhance the predictive accuracy of drug responses, and refine personalized treatment strategies. This lays the groundwork for more efficient R&D platforms, thereby accelerating innovation.

With systematic planning and coordinated advancement, organoid technology promises to drive high-quality transformation in the biopharmaceutical industry, ushering in a new chapter for global healthcare.

The author is a deputy to the 14th National People's Congress, and an academician of the Chinese Academy of Sciences and the president of Nanchang University.

The views don't necessarily represent those of China Daily.

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