From Lab to Market: Recent Advances and Commercialisation of Organoid Technologies

By Sophie Reay

Organoids are three-dimensional (3D) tissue cultures derived from stem cells that self-organise into structures that closely resemble the structure and function of native organs[1]. Unlike traditional 2D cell cultures and animal models, organoids better replicate physiological conditions, thereby enabling more accurate studies in drug development, personalised medicine, disease modelling and regenerative medicine[2]. This mini review provides an overview of the latest advances in organoid technology and explores the growing presence of organoids within the commercial market. 

The absence or insufficient development of vascular networks in organoids leads to hypoxic conditions, nutrient deprivation and inefficient waste removal, ultimately resulting in necrosis and impaired functionality[3]. Recent advances in 3D bioprinting have driven the development of the template method of organoid vascularisation, which involves precise deposition of cells, biomaterials, and sacrificial inks that enable the formation of pre-defined, intricate vascular channels[4]. While templating allows for highly controlled vessel morphology, the static nature of vessel structure may result in vascular networks that lack functional adaptability[5]. To overcome this limitation, 4D bioprinting introduces the dimension of time, whereby printed biological structures evolve in response to relevant stimuli[6]. Notably, in June 2025, researchers in Japan produced liver organoids capable of developing fully perfused human vessels with functional sinusoid-like features[7], marking a significant advancement toward increasingly sophisticated and functional liver organoids. 

Organ-on-a-chip (OOC) technology utilises perfused microfluidic channels lined with living cells to replicate organ-level pathophysiology by controlling fluid flow, biochemical factors and cell-cell or cell-matrix interactions[8]. Integration of organoids and OOC technology has led to the emergence of state-of-the-art organoids-on-a-chip (OrgOC), which generate more comprehensive and physiologically relevant models. A further advancement is the development of multi-organ-on-chip systems (MOC), which integrate multiple OrgOCs to simulate interactions between different organs[9]. The first MOC, created in 2010, combined liver and intestinal tissues within a single microfluidic device[10]. Since then, researchers have pursued increasingly complex systems, including an eight-organ MOC comprising intestine, liver, kidney, heart, lung, skin, blood–brain barrier, and brain[11]. 

The regulatory landscape has also shifted, paving the way for organoid technology. Following the passage of the Food and Drug Administration (FDA) Modernisation Act 2.0 in 2022, the FDA no longer requires animal testing data for preclinical drug testing[12], [13]. In the same year, a landmark study by Rumsey and colleagues demonstrated the efficacy of TNT005, a monoclonal antibody inhibitor targeting the classical complement pathway, using MOC technology. Based solely on these non-animal preclinical data, TNT005 was granted FDA approval to proceed to clinical trials[14]. Since then, other drugs tested with organoid-based models, such as Petosemtamab and HRS-1893, have similarly gained regulatory clearance to enter clinical trials without supporting animal data[15]. These developments signal a potential paradigm shift in drug development, moving away from traditional animal models toward more human-relevant organoid-based systems. 

Recent technological advances are being integrated with organoid platforms to produce cutting-edge organoids. For example, CRISPR/Cas is a revolutionary technology that enables precise gene editing, and when combined with organoids, provides a powerful platform for modelling human diseases[16].  Advancements in 3D imaging techniques, such as confocal microscopy, two-photon microscopy, and light sheet-based microscopy, provide high-resolution images that reveal the spatial organisations of different cell types, tissue layers, and intricate cell-cell interactions, ultimately allowing researchers to better visualise organoid structure[17]. Additionally, integration of artificial intelligence with organoid research facilitates the comprehensive analysis of complex, large-scale, biological datasets, thereby accelerating the drug development process[15]. 

The global organoids market is projected to grow significantly, increasing from $502.92 million in 2019 to an estimated $2794.79 million in 2027, reflecting growing commercial interest in organoid technologies (Table 1). The top three companies are Thermo Fisher Scientific, Merck, and Corning, which account for approximately 75% of the market share[18]. Thermo Fisher Scientific and Corning offer comprehensive product portfolios supporting 3D organoid culture, while Merck provides whole organoid models, including an expanding range of 3dGRO® products. Details and links to launched organoid products are provided in Table 1. 

Despite this rapid growth, organoid commercialisation faces several challenges including a lack of standardisation, ethical concerns and high manufacturing costs. To address financial concerns, standardised bioprocessing and analytical procedures are under development by organisations such as ISO/TC 276 (Biotechnology) and the Organisation for Economic Co-operation and Development (OECD)[19]. In response to the issue of poor standardisation, Roche has integrated organoid datasets to generate detailed organoid atlases that will allow researchers to standardise and compare organoids[20]. 

Organoid technology holds transformative potential for the drug development landscape. With recent regulatory endorsements of New Approach Methodologies, investment in organoid technology is accelerating rapidly. Continued research focused on advancing state-of-the-art organoid models, alongside the expansion of robust, commercially available systems, will be essential to unlocking their full translational potential and enabling widespread adoption in both industry and clinical settings. 

Table 1. Leading companies in the global organoid market, their geographical location, and application areas[18], [21]. 

References 

1 Jiang X, Oyang L, Peng Q, Liu Q, Xu X, Wu N, et al. Organoids: opportunities and challenges of cancer therapy. Front Cell Dev Biol. 2023;11:1232528. 

2 Yao Q, Cheng S, Pan Q, Yu J, Cao G, Li L, Cao H. Organoids: development and applications in disease models, drug discovery, precision medicine, and regenerative medicine. MedComm (2020). 2024 Oct;5(10):e735. 

3 Zhou R, Brislinger D, Fuchs J, Lyons A, Langthaler S, Hauser CAE, Baumgartner C. Vascularised organoids: Recent advances and applications in cancer research. Clin Transl Med. 2025 Mar;15(3):e70258. 

4 Nwokoye PN, Abilez OJ. Bioengineering methods for vascularizing organoids. Cell Rep Methods. 2024 Jun 17;4(6):100779. 

5 Zhao X, Xu Z, Xiao L, Shi T, Xiao H, Wang Y, et al. Review on the Vascularization of Organoids and Organoids-on-a-Chip. Front Bioeng Biotechnol. 2021;9:637048. 

6 Werschler N, Quintard C, Nguyen S, Penninger J. Engineering next generation vascularized organoids. Atherosclerosis. 2024 Nov;398:118529. 

7 Saiki N, Nio Y, Yoneyama Y, Kawamura S, Iwasawa K, Kawakami E, et al. Self-organization of sinusoidal vessels in pluripotent stem cell-derived human liver bud organoids. Nat Biomed Eng. 2025 Jun 25. 

8 Liu K, Chen X, Fan Z, Ren F, Liu J, Hu B. From organoids to organoids-on-a-chip: Current applications and challenges in biomedical research. Chin Med J (Engl). 2025 Apr 5;138(7):792-807. 

9 Srivastava SK, Foo GW, Aggarwal N, Chang MW. Organ-on-chip technology: Opportunities and challenges. Biotechnol Notes. 2024;5:8-12. 

10 van Midwoud PM, Merema MT, Verpoorte E, Groothuis GMM. A microfluidic approach for  assessment of interorgan interactions in drug metabolism using intestinal and liver slices. Lab Chip. 2010;10(20):2778-86. 

11 Novak R, Ingram M, Marquez S, Das D, Delahanty A, Herland A, et al. Robotic fluidic coupling and interrogation of multiple vascularized organ chips. Nat Biomed Eng. 2020 Jan 27. 

12 FDA. FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs.  2025. 

13 Han JJ. FDA Modernization Act 2.0 allows for alternatives to animal testing. Artif Organs. 2023 Mar;47(3):449-50. 

14 Rumsey JW, Lorance C, Jackson M, Sasserath T, McAleer CW, Long CJ, et al. Classical Complement Pathway Inhibition in a "Human-On-A-Chip" Model of Autoimmune Demyelinating Neuropathies. Adv Ther (Weinh). 2022 Jun;5(6). 

15 Liangbin Zhou SC, Jun Liu, Zhilong Zhou, Zhenyu Yan, Chenzhong Li, Xiangxiang Zeng, Rocky S. Tuan, and Zhong Alan Li. When artificial intelligence (AI) meets organoids and organs-on-chips (OoCs): Game-changer for drug discovery and development? The Innovation Life. 2025;3(1). 

16 Driehuis E, Clevers H. CRISPR/Cas 9 genome editing and its applications in organoids. Am J Physiol Gastrointest Liver Physiol. 2017 Mar 1;312(3):G257-G65. 

17 Maharjan S, Ma C, Singh B, Kang H, Orive G, Yao J, Shrike Zhang Y. Advanced 3D imaging and organoid bioprinting for biomedical research and therapeutic applications. Adv Drug Deliv Rev. 2024 May;208:115237. 

18 Anubhab Mukherjee AS, Maheshree Maibam, Bharti Bisht and Manash K. Paul. Organoids and Commercialization.  Organoid Bioengineering - Advances, Applications and Challenges: IntechOpen 2022. 

19 Aprajita Sinha MM, Ronit Jain, Kalash Aggarwal, Asish Kumar Sahu, Pawan Gupta, Sayan Paul, Bharti Bisht, Manash K. Paul. Organoid: Biomedical application, biobanking, and pathways to translation. Heliyon. 2025;11(10). 

20 Roche. Mapping the future of organoids.  2025  [cited 20/08/2025]; Available from: https://www.roche.com/stories/mapping-the-future-of-organoids 

21 Hanbyeol Lee JSI, Da Bin Choi, Dong-Hun Woo. Trends in the global organoid technology and industry: from organogenesis in a dish to the commercialization of organoids. Organoid.1.