By force cdmo gradually become the pharmaceutical enterprises research and development production activities of the optimal solution

The CDMO industry chain is deeply involved in the development and production of innovative drugs.CDMO, or Cont r act Devel opment and Manuf actur ing Or ganization (contract development and production organization), provides customized research and development and production services such as process development and preparation, process optimization, amplification, registration and validation batch production, and commercialization, especially for products of pharmaceutical and biotechnology companies, especially innovative products. Its services cover intermediates, API, preparation process development, production and packaging services. CDMO services span different stages of drug development, and order sizes show a significant amplification trend as the project progresses: Preclinical/Clinical Phase I.I. (kg/$100,000) →C.C. PHASE II (0.1 to 3 ton/million U.S. dollars) →Clinical PHASE III. 1 ton to 10 tons / 10 million yuan - RMB billion→ new drug application (3 tons to 100 tons / billion yuan class) → new drug after the market (3 tons to 100 tons / heavy drug more than 1 billion yuan).CDMO innovative drug orders are generally placed at an inflection point in the new drug application stage. With the expiration of patents for innovative drugs and the end of the product life cycle, CDMO's order size has entered a period of relative decline, but the large varieties of specialty API are still profitable.

cdMO core values stand outCDMO's core value is to leverage its specialization and scale to help customers save costs, increase success and efficiency, and achieve full compliance at different stages of product development and production.Cost Chemical Weekl y estimates that production costs account for about 30% of the total cost of developing new drugs. Production costs are mainly composed of two parts: first, the purchase and construction of production equipment, maintenance costs; CDMO enterprises have professional advantages, with many types of production equipment, can meet the production needs of different entrusted enterprises, some of which are more expensive, pharmaceutical companies if only for the development of one drug is not economical, and because of the scale effect, CDMO enterprises lower labor costs than pharmaceutical enterprises.Success rate and efficiency Because the requirements of each stage of new drug research and development are different, so each stage needs to improve the relevant process, relying on the technical accumulation of specialized production process, CDMO enterprises can better and faster to complete process improvement work, thereby improving the success rate of new drug research and development and production efficiency.Compliance CDMO enterprises help entrust enterprises to optimize the level of production technology, operation and management of production, so that product quality and environmental protection in the production process and other indicators to meet regulatory requirements.

can meet the diversified needs of pharmaceutical companiesCDMO's main hardware barrier is the need for plant and production equipment that meets customer and regulatory quality control/compliance requirements, and the main software barrier is through exposure to a wide range of different types of projects and the technology, management capabilities, and reputational brands accumulated by customers. CDMO's hardware and software capabilities are reflected differently in meeting the core requirements of the two main types of customers of large pharmaceutical companies and innovative small and medium-sized pharmaceutical enterprises.The core concern of start-ups is the speed and success rate of drug launches. Start-ups themselves have limited financial capacity, poor risk tolerance, and need to devote limited resources to the core processes of new drug development, so they often focus more on costs and the speed and success rate of drug launches. The advantages of CDMO specialization and scale are precisely what these needs are.The core concern of large pharmaceutical companies is research and development efficiency and capacity flexibility. From past data, the difficulty of research and development of innovative drugs increased, the success rate of research and development decreased, patent protection period was compressed by too long research and development cycle, resulting in the emergence of patent challenges earlier, the rate of return of new drugs seriously shrunk, new drug sales less than expected, overcapacity, so large pharmaceutical companies have a higher demand for research and development efficiency and capacity flexibility, and CDMO can meet their needs.While the global generic and innovative drug markets are currently growing steadily overall, Eval uat e Pharma predicts that between 2019 and 2024, global sales of innovative pharmaceutical products at risk from the patent cliff could reach $198 billion.Taken together, the average cost to market for innovative drugs is rising, while sales of innovative drugs are on the decline, and the return on investment of innovative drugs is declining significantly. According to Deloitte, the average cost of listing innovative drugs has risen from $1,183 million in 2010 to $1,981 million in 2019, while peak sales have fallen from $816 million in 2010 to $376 million in 2019;Therefore, whether it is large pharmaceutical companies or innovative small and medium-sized pharmaceutical enterprises, in the trend of declining return on investment of innovative drugs, are looking for their own research and development and production activities of the best solution, different CDMO business models are also born of demand. In Europe and the United States, the birthplace of the CDMO model, CDMO is more as a large pharmaceutical companies commercial production of flexible capacity, relying on the production line capacity competitive advantage, resulting in economies of scale effect, Lonza, Cat al ent, DSM and other international large-scale production capacity giants are such representatives; Type of services, hoping to improve the efficiency of research and development production convergence, reduce management costs, the whole pharmaceutical industry, pharmaceutical industry is the representative of such an integrated platform service providers, and to Jiuzhou Pharmaceuticals, Kailaiying, Pro Pharmaceuticals as the representative of another type of CDMO, is in the sub-sector for several years, has the ability to provide pharmaceutical customers with more effective solutions in the field of technological advantages, so as to achieve from D (process development) to M (production) deep binding, become the leader in the sub-sector.
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China Medical Journal)
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