Organoids refer to the use of adult stem cells or pluripotent stem cells in vitro, through three-dimensional culture to form tissue analogues
with a certain spatial structure and function.
At present, in the process of new drug research and development, organoid technology has been widely used
.
As of September 2020, the FDA has officially filed 63 clinical trials
using organoid technology.
In China, since 2017, there have been about 20 organoid clinical trial studies registered in China and approved by the ethics committee, covering 8 cancer types
.
Because organoids have a place in the field of drug research and development, they can partially replace traditional methods such as animal experiments, and have a wide range of application prospects
in organ development, precision medicine, regenerative medicine, gene editing, disease modeling and other fields.
At present, many domestic and foreign pharmaceutical companies are competing to deploy this innovative technology
.
In foreign countries, including Johnson & Johnson, Sanofi, Merck, AstraZeneca, Pfizer, Sanofi, etc.
, have introduced organoid technology
in the research and development of new drugs through cooperation, purchase and investment.
In addition, more than 20 large multinational pharmaceutical companies such as AbbVie, Merck, and Novartis have jointly established the non-profit organization IQ Consortium (Innovation and Quality Alliance), which is committed to promoting the standardized application of organoid chips and accelerating the drug research and development process
.
At present, a series of industry standards for liver, kidney, lung and other models have been released
.
In terms of progress, in 2021, Sanofi's first FDA-approved new drug based entirely on organoid model research to obtain preclinical data entered clinical trials
in 2021.
It marks the first time that organoid experiments have replaced traditional animal experiments and are officially recognized
by the United States.
In China, although local pharmaceutical companies applied late, with the release of favorable policies, the research and application of organoid technology has gradually increased
.
At the end of January 2021, the Ministry of Science and Technology issued a notice on the "Guidelines for the Application of Six Key Special Projects of the "14th National Key R&D Plan in 2021" to solicit opinions, and the "organic-based malignant tumor disease model" was included in the "14" national key research and development plan, and the first batch of key special projects
will be launched.
Subsequently, China's CDE included organoids in the non-clinical pharmacological research
of gene therapy products for the first time in the "Gene Therapy and Cell Therapy Validation Guidelines".
At present, domestic organoid technology is deployed and used in the field of new drug research and development, including WuXi AppTec, Hengrui Pharmaceutical, BeiGene and other local pharmaceutical companies
.
Among them, BeiGene announced in December 2021 that it would "join hands" with Chuangxin International, a domestic organoid company, to jointly establish a new organoid drug research and development technology platform
.
For another example, the Department of Translational Medicine of Hengrui Pharmaceutical has established an in vitro organoid culture technology platform, which can conduct drug research
in the simulated human organ and tumor microenvironment.
At the same time, capital has also increased this track
.
Under FDA Modernization Act 2.
0 (S.
5002), animal testing for new drug development was adjusted to "non-clinical testing and trials," which also ignited the enthusiasm
of investors in organoids.
It is understood that some emerging companies are intensively obtaining capital attention and obtaining large amounts of financing, among which in 2021, there are many investment institutions in this field such as CDH VGC, SDIC Innovation, Kai Venture Capital, Delian Capital, etc
.
With the entry of pharmaceutical companies and the increase in capital, the scale of the organoid market is expected to continue to expand
.
Data show that in 2020, the global organoid market size is about 500 million US dollars, with the advancement of medical technology, the market size will further expand, it is expected that from 2021 to 2026, the global organoid market size will maintain a compound annual growth rate
of 18.
2%.
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