Human Organoids Market

The global Human Organoids Market is valued at USD 2.83 Billion in 2024 and is projected to reach a value of USD 19 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 18.95% between 2025 and 2035.

Premium Insights

The global human organoid market has been experiencing significant growth in recent years and is set to continue expanding in the future. Organoid technology has been used extensively in cancer research between 2009 and 2021, particularly for therapeutic screening and precision medicine. Patient-derived organoids (PDOs) can be successfully produced from patient specimens in 3D organoid culture methods, which can more accurately imitate the elements of tumor tissue. The driving factor behind the extensive use of organoid technology in cancer research is the need for improved healthcare outcomes. By utilizing organoids, researchers can gain a deeper understanding of tumor tissue elements, leading to advancements in therapeutic screening and precision medicine.

Advancements in 3D cancer organoids is further fuelling the market growth. The development of 3D cancer organoids has been made possible due to advancements in technology, which have allowed researchers to reproduce the genotype, phenotypic, and cellular characteristics of parent tissues. There had been 2086 publications on both general and cancer organoids by 2020, with 907 (around 43%) of the publications being in the area of cancer organoids. The 3D cancer organoids may be a crucial tool for discovering the undiscovered causes of cancer. They can be utilized to research several kinds of tumors, including breast, liver, lung, and pancreatic cancers, due to their capacity to reproduce the genotype, phenotypic, and cellular characteristics of their parent tissues.

The market is expanding due to the potential use of liver organoids in regenerative medicine. Around 1,000,000 individuals are affected by liver disease each year, which is a significant burden on world health. Hepatitis, fibrosis, cirrhosis, cancer, metabolic, and autoimmune illnesses can all be caused by an imbalance in the livers function, which can be attributed to genetic or environmental factors. The only effective treatment for chronic liver disease (CLS), which is linked to a poor long-term clinical prognosis, is liver transplantation. However, the availability of donor organs only meets 10% of the worlds needs, leading to a high death rate.

The global human organoid market is witnessing substantial growth with kidney disease studies. The scarcity of donor organs for kidney transplants creates a pressing need for alternative solutions. Human organoids offer a promising solution by providing researchers and medical professionals with an innovative method to study kidney diseases and develop potential therapies. By the end of 2030, the human organoids market is expected to be dominated by the kidney segment due to an increase in kidney transplantations. According to National Kidney Foundation figures, there are around 100,000 people waiting for a kidney transplant.

Key Highlights

• North America generated more than 42.90% of revenue share in 2022.
• Asia Pacific is likely to expand at the fastest CAGR from 2023 to 2030.
• By product, the liver segment contributed largest revenue share in 2022.
• By application, the development biology segment registered most of the revenue share in 2022.
• By usability, the ready to use products segment recorded over 58.9% market share in 2022.
• By end users, the pharmaceutical & biotechnology companies segment recorded the most significant market share in 2022.

Economic Insights

In many nations, the regulations governing the use and commercialization of organoid research are not very well established and require updating. The scientific, ethical, and legal issues surrounding organoid research are highly regulated, partly governed by federal and state regulations in the U.S., and, in the case of foreign collaborations, by international laws. Regulations from the Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) are applied in organoid research. Institutional Review Board (IRB) approvals are necessary for organoid research.

According to the regulations established by the European Medicines Agency (EMA), organoids research in Europe requires approval by the Research Ethics Committee (REC). Additionally, many regulatory bodies are present in various European nations. The Institutional Committee for Stem Cell Research (IC-SCR) is the governing body in India. The Ethical Review of Biomedical Research Involving Human Subjects and the Ethical Guidelines for Human Embryonic Stem Cell Research are used as guidelines in China. Following good manufacturing practices (GMP), the production of organoids for commercial use must adhere to the same standards as the production of pharmaceutical drugs. Future organoid-based biotechnology developments are anticipated to require updated worldwide regulatory standards and control.

Top Market Trends

1. Increasing Demand for Personalized Medicine: Human organoids have emerged as a valuable tool for personalized medicine, as they can mimic the structure and function of specific organs. This has created a rising demand for human organoids in drug discovery and development processes, as they can help researchers test the efficacy and safety of potential drugs in a more accurate and personalized manner.
2. Growing Applications in Disease Modeling: Human organoids have found applications in disease modeling, as they can be used to study the development and progression of various diseases. Organoids derived from patient cells can provide valuable insights into the mechanisms of disease, leading to the development of new therapies and treatments.
3. Advancements in 3D Bioprinting Technology: The field of 3D bioprinting has seen significant advancements, enabling the generation of complex and functional human organoids. This has opened up new possibilities in the human organoids market, allowing for the creation of more accurate models for drug testing and disease research.
4. Rising Adoption in Toxicity Testing: Human organoids have shown promise in toxicity testing, allowing researchers to assess the potential toxic effects of drugs and chemicals on human organs without the need for animal testing. This has led to increased adoption of human organoids in the pharmaceutical and chemical industries, as they offer a more ethical and reliable alternative to traditional toxicity testing methods.

Market Segmentation

The global Human Organoids market can be categorized on the following: Product, Application, Usability, End Users, and Region. By Product, the market is categorized into Liver, Kidney, Pancreas, Colorectal, Heart, and Others. By Application, the market can be classified as Development Biology, Drug Toxicity & Efficacy Testing, Disease Pathology, Personalized Medicine, Regenerative Medicine, and Other Application. Based on Usability, the market can be segmented into Ready to use Products and Customizable Products. Based on End Users, the market can further be divided into Pharmaceutical & Biotechnology Companies, Contract Research Organizations (CROs), Academic & Research Institutes, and Others. Based on Region, the market is further separated into North America, Europe, Latin America, Asia Pacific, and Middle East & Africa.

Based on Product

Liver Segment to Dominate the Market Share

The liver segment is expected to dominate the market share. Liver organoids are three-dimensional structures that mimic the key features of the human liver, including its cellular composition and functionality. They are primarily used for drug screening and toxicity testing purposes. Liver organoids have gained significant attention in the healthcare industry due to their potential in replacing animal models for drug testing. They offer a more accurate representation of human liver functionality, which is essential for assessing the safety and efficacy of new drugs. The demand for liver organoids is expected to grow in the coming years, driven by the rising need for personalized medicine and the increasing focus on precision drug development. Additionally, the advancements in tissue engineering techniques and the discovery of new methods for culturing liver progenitor cells have also contributed to the growth of the liver segment in the global human organoids market.

Based on Application

Development Biology Category to Hold the Maximum Market Share

The development biology segment in the global human organoids market is a rapidly growing field of research and represents a promising opportunity for various applications in medicine. Developmental biology involves the study of how cells and tissues develop and differentiate in the human body. Human organoids, which are miniaturized versions of organs grown in the laboratory, provide an excellent platform for studying developmental processes in a controlled environment. Researchers can use human organoids to study organ formation, tissue patterning, and cell differentiation, which can lead to a better understanding of human development and disease. Moreover, the development biology segment in the global human organoids market can also contribute to the development of regenerative medicine, drug discovery, toxicology testing, and personalized medicine.

Based on Usability

Ready to use Products Segment to Hold Major Market Revenue

The ready to use products segment in the global human organoids market is witnessing significant growth due to its convenience and time-saving benefits. Ready to use organoids provide researchers with a convenient alternative, as they are derived from stem cells and are pre-grown to mimic specific organs or tissues. These organoids can be readily incorporated into research experiments, allowing researchers to focus on their specific study objectives without worrying about the complexities of organoid production. Moreover, the ready to use products segment in the global human organoids market offers standardized and reproducible organoid models, ensuring consistency and reliability in experiments. This is particularly important for drug discovery and development, as reliable organoid models can help to predict drug response more accurately and reduce the need for animal testing.

Based on End Users

Pharmaceutical & Biotechnology Companies to Lead the Market Share

The pharmaceutical and biotechnology companies segment in the global human organoids market is contributing for major market share due to advancements in technology and increasing demand for personalized medicine. Pharmaceutical and biotechnology companies are utilizing human organoids to develop new drugs, screen for potential toxicities, and study diseases at a cellular level. These organoids allow researchers to better understand disease mechanisms, test drug efficacy, and personalize treatment strategies. The market is witnessing a surge in investments and collaborations between pharmaceutical and biotechnology companies and research institutions. Major players are incorporating human organoids into their drug discovery and development pipelines, which is driving the growth of the segment.

Based on Region

North America to Maintain Dominant Position

North America held the largest market share contributing 42.90% in the human organoid market. Factors such as the increasing prevalence of chronic diseases, rising investments in regenerative medicine research, and advancements in 3D cell culture technology are driving the growth of the market. Additionally, the growing demand for personalized medicine and the need for alternatives to animal testing in drug development are further fueling market growth. Moreover, the presence of several leading pharmaceutical and biotechnology companies in North America, coupled with the availability of funding for research and development, is expected to contribute to the rapid expansion of the market in the region. Furthermore, the supportive regulatory environment and the increasing adoption of organoid-based models by academic institutions and research organizations are also boosting market growth.

Asia Pacific is estimated to generate the highest CAGR during the forecast period due to the increasing use of organoid-based models in disease modeling and drug discovery. Countries like Japan, China, and India are at the forefront of organoid research and are investing heavily in biotechnology and regenerative medicine. Additionally, the region boasts a large population base, making it an attractive market for healthcare providers and pharmaceutical companies. However, there are challenges faced in the Asia Pacific region such as regulatory issues, lack of awareness among patients, and ethical concerns surrounding the use of human tissue. Nonetheless, the Asia Pacific Human Organoids Market is expected to experience robust growth in the coming years, offering immense potential for healthcare advancements and improved patient outcomes.

Competitive Landscape

The key players in the human organoid market are focusing on product launches, partnerships, and collaborations to expand their market presence and to remain competitive. For instance, in December 2022, Molecular Devices is making major investments in organoid technologies observing as the future of drug discovery & development. These investments involve an acquisition of Cellesce, a producer and developer of patient-derived organoids (PDOs). Also, this acquisition enhances the present work being done in the industry by Molecular Devices. Moreover, companies are investing heavily in research and development to develop new and innovative products that offer better efficacy and safety.

The key players in the global Human Organoids market include - Thermo Fisher Scientific (U.S.) among others.

Recent Market Developments

• February 2023: A strategic partnership between HUB Organoids (HUB), the industry leader in adult stem cell-derived organoids, and Molecular Devices, LLC, the top provider of high-performance life science solutions, has been announced. This partnership will enable the continuous development of next-generation 3D biology technologies that will significantly lower the attrition rate of drugs from pre-clinical to clinical testing.
• December 2022: A renowned science and technology company, Merck, announced a three-year partnership with Tsinghua University Shenzhen International Graduate School (SIGS) to create a novel organoid 3D bioprinting system that will facilitate high-throughput drug discovery across a range of disease areas.

Segmentation of the Global Human Organoids Market