Before 1996, there were few CDMO/CMO companies. APIs and intermediates were mainly produced by pharmaceutical factories or supplied by chemical enterprises, mainly distributed in Europe.
From 1996 to 2007, the CDMO industry emerged: Patheon entered the field of drug CDMO and distributed the markets in Europe and North America; Catalent entered into the production of oral preparations and became independent from its parent company; Lonza, the leader of CDMO, formally intervened in the field of biopharmaceuticals and began to expand its distribution.
From 2007 to 2016, the number of innovative drugs approved increased, heavy drugs came out frequently. Pharmaceutical enterprises adjusted their production capacity one after another. The increase of outsourcing proportion helped the industry to develop rapidly again. Since 2013, the CDMO industry has grown at a rate of 10-15%, especially the small molecular API business.
Upstream and Downstream of CMO/CDMO Industry Chain
The upstream is the chemical industry. For biopharmaceuticals, mainly Bio-culture raw materials industry, CMO enterprises usually cooperate with multiple suppliers to optimize the industrial chain, control the cost of raw materials, and select suppliers to control the quality of raw materials.
In order to ensure the timely supply of products and the quality of products, pharmaceutical manufacturers will inspect and audit the technical capability, quality management system and EHS system of CMO enterprises, and establish long-term strategic cooperative relations with a few core suppliers.
Driving Force of CMO/CDMO Development: Continuous Growth of New Drug Research and Development
According to statistics, since 2001, the global innovation drug R&D pipeline has maintained a sustained growth, and has accelerated in recent years. At the same time, the global innovation drug R&D expenditure has also maintained a growth rate of 2-3% in recent years. Pharmaceutical enterprises can not fully cover all R&D projects, so it is necessary to outsource some projects or businesses.