What is cdmo
Cdmo, namely contract development and manufacturing organization (cdmo), is an organization that provides process development and preparation, process optimization, registration and validation batch production, and commercialized customized R & D and production services for pharmaceutical manufacturers and biotechnology companies, especially innovative products.
The content of cdmo services covers the process development, production and packaging services of intermediates, APIs and preparations, spanning different stages of R & D, and the order size also shows an obvious trend of enlargement with the progress of the project.
The inflection point of cdmo innovative drug orders is generally in the new drug application stage. With the patent expiration of innovative drugs and entering the end of product life cycle, the order scale of cdmo has also entered a relative decline period, and the large varieties of characteristic API are still profitable.
Core competitiveness of cdmo
The core value of cdmo is to use its own advantages of specialization and scale to help customers save costs, improve success rate and efficiency, and fully comply with regulations in different stages of R & D and production
1) Cost: according to chemical Weekly’s estimation, the production link accounts for about 30% of the total cost of new drug research and development. The production cost is mainly composed of two parts: one is the cost of purchasing production equipment and its construction and maintenance; the other is the cost of manpower.
Due to the advantages of specialization, cdmo enterprises have various types of production equipment, which can meet the production needs of different entrusted enterprises. Some of the equipment prices are relatively high. It is uneconomical for pharmaceutical enterprises to only use one drug for research and development. Moreover, due to the scale effect, the human cost of cdmo enterprises is lower.
2) Success rate and efficiency: due to the different production requirements in each stage of production, it is necessary to improve the production process at each stage. Relying on the technology accumulation of specialized production process, cdmo enterprises can better and faster complete the improvement of production process, so as to improve the success rate and production efficiency of high-tech drug research and development.
3) Compliance: cdmo enterprises help the entrusted enterprises optimize the production process level, operate and manage the production, so as to make the product quality and environmental protection indicators in the production process meet the regulatory requirements.
The main hardware barriers of cdmo are the plants and production equipment that meet the quality control / compliance requirements of customers and regulatory authorities; the main software barriers are the accumulated technical and management capabilities and word-of-mouth brands through a variety of different types of projects and customers.
The software and hardware capabilities of these cdmo have different manifestations in meeting the core demands of two main types of customers: large pharmaceutical enterprises and innovative small and medium-sized pharmaceutical enterprises.
Analysis of cdmo market scale
The main sources of cdmo demand are the outsourcing part of process development and trial drug production of large and small pharmaceutical enterprises, and the outsourcing part of commercial order production. Therefore, the core factors affecting the growth space of cdmo include:
1) Sales revenue growth and R & D investment intention of large pharmaceutical enterprises;
2) The financing situation of innovative small and medium-sized pharmaceutical enterprises (most of them invest in R & D);
3) Cdmo outsourcing penetration.
According to the statistics of global drug R & D in recent years, it is found that large pharmaceutical enterprises maintain a high number of R & D projects, while innovative small and medium-sized pharmaceutical enterprises show a faster growth; and focusing on the demand of drug R & D enterprises to improve R & D efficiency and reduce R & D costs, the penetration rate of cdmo outsourcing is increasing year by year. Our statistical analysis of the global and Chinese cdmo markets is as follows:
Market competition analysis of cdmo Market competition analysis of cdmo Market competition analysis of cdmo
From a global perspective, cdmo enterprises in Europe and the United States focus on preparations and biotechnology. Most of the core income of domestic cdmo enterprises comes from the production of API / intermediates of small molecules.
From the horizontal comparison data, compared with domestic cdmo enterprises, the global cdmo giants represented by Lonza have more comprehensive service contents, mature business covers APIs and pharmaceutical products of small and medium molecules, and has obvious advantages in production capacity and scale.
Its production bases are all over the world, covering the mainstream pharmaceutical enterprises and biotech customers in the world, and the key strategic layout is in the field of preparation or biotechnology, with small scale The income contribution of molecular raw materials has decreased year by year.
In addition to Yaoming bio, the core revenue of other cdmo companies at present comes from the production of API / intermediates of small molecules, and the related technology, capacity management system and customer relationship are more mature;
however, the business of macromolecules or preparations is mostly just in the beginning, without mature technical team and many successful project experience. Therefore, from the short-term to the medium-term (2-3 years), domestic small molecule cdmo with more comparative advantages will benefit more obviously from this round of industry demand increase and global capacity transfer trend.
In the long run, further analysis from the attributes of customer demand and outsourcing service provider’s supply capacity shows that the comparative advantage of domestic small molecule cdmo business is more obvious, and the concentration degree of a single Chinese enterprise in the global small molecule API / intermediate cdmo subdivision field is expected to reach more than 10%.
From the perspective of raw material supply chain, maturity of engineers and technical team, customer recognition and cost, domestic cdmo has more obvious comparative advantages in the field of small molecule API / intermediate. In addition, the demand share of biotechnology has increased in recent years.
In this subdivision area, it is very hopeful to create one or several leading companies with a global market share of more than 10%, with a potential revenue of more than $2 billion (combined with the data analysis of Frost & Sullivan and patheon, the global small molecule API / intermediate market should exceed $20 billion).
industrial chain: it is more commercialized than cro, and cdmo emphasizes R & D more than CMO.
Compared with cro, the amount of commercial orders of cdmo is related to the sales scale of drugs after marketing. If the sales of drugs are good, the number of orders may vary from several times to dozens of times of orders in clinical stage. CMO can be understood as general OEM production, and the future trend is to turn to cdmo. Compared with CMO, cdmo emphasizes its R & D capability in addition to production.
spatial growth rate: within three years, China’s market is nearly 10 billion US dollars, with a growth rate of nearly 30%, twice that of the world.
It is estimated that the global production outsourcing service market will reach US $51.8 billion in 2023, with an annual compound growth rate of 14.1%. The scale of China’s production outsourcing service market will further reach 8.5 billion US dollars in 2023, with an annual compound growth rate of 28.9%, twice the global growth rate.
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