core points
Cell gene therapy cures diseases from the root, advanced technology just needs strong
The core of gene therapy is to precisely attack the root of the disease – abnormal DNA, which is a fundamental treatment strategy. The indications of cell gene therapy are mainly monogenic genetic diseases (rare diseases). The pathogenic genes of these diseases are clear, and at the same time, there is a lack of effective treatment methods, and they face huge unmet clinical needs. Just like small molecule drugs and antibody drugs led the first two industrial revolutions of biomedicine, gene therapy has been rated as the most influential biotechnology of the year by “Nature” for many years, and is expected to lead the third industrial revolution of biomedicine. As of the end of 2021, there are more than 1,700 CGT clinical trials under development worldwide, and dozens of clinical trials in China have been registered (according to the registration number), showing a growing trend.
Favored by policy support and capital, China’s cell gene therapy is expected to overtake in a corner
The gene therapy track is the most favored by capital. According to the financing transactions in the CGT field in China, the total financing amount in the CGT field in 2020 is about 12.6 billion US dollars, and the compound annual growth rate from 2016 to 2020 will reach 59.3%. The amount increased significantly. It is expected that capital investment in the CGT field will continue to increase in the future, and capital injection will also promote the development of the CGT industry. In terms of policies, as the country and various provinces and cities attach great importance to the innovation and development of biomedicine, a series of industrial policies have been issued under the “13th Five-Year Plan” and “14th Five-Year Plan” to support gene therapy and its CRO/CDMO industry. The domestic gene therapy market will expand rapidly and is expected to reach 17.89 billion yuan by 2025, while the cell gene therapy CDMO is expected to grow to 19.74 billion yuan by 2027, and the expected compound annual growth rate from 2022 to 2027 will be as high as 43.3%. The number of CGT clinical trials in China has grown explosively, second only to the United States, and is expected to overtake in a corner.
CGT production is quite different from small molecules and relies more on CDMO industrialization services
The biological basis and therapeutic mechanism of gene therapy are highly cutting-edge and exploratory, leading to certain differences in drug development. Compared with small-molecule and macromolecule pharmaceuticals, gene therapy is more dependent on complex technical mechanisms, high-threshold process development and large-scale production, stringent regulatory requirements, limited industrialization experience, and differentiated drug dosage for indications. Serving in CDMO; if new drug companies build their own production lines, they will face problems such as low capacity utilization and insufficient flexibility of equipment, and the transfer and verification of processes will bring high costs, so the stability and quality of CDMO business will be greatly improved objectively. Persistent. CGTCDMO can save production equipment and production team investment for CGT new drug companies, allowing them to focus on CGT drug research and development. According to JPMorgan statistics, the outsourcing penetration rate of gene therapy exceeds 65%, far exceeding the 35% of traditional biologics.
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