Specific differences of CRO, CMO and CDMO

2022-03-28

In recent years, the competition in the global pharmaceutical industry is becoming increasingly fierce, and the division of labor in the pharmaceutical industry chain is becoming increasingly refined. The specialized outsourcing in the pharmaceutical industry has become an important strategic choice for pharmaceutical enterprises.

With the continuous improvement of the degree of specialization of pharmaceutical outsourcing service institutions, the content of pharmaceutical outsourcing service gradually covers every link from disease target research, drug compound screening, clinical trial service, process research and development, large-scale production and market sales.

According to the content of services provided, pharmaceutical outsourcing services mainly include CRO, CMO and CDMO enterprises.


The difference between CRO, CMO and CDMO

CRO enterprises (contract customization R&D institutions) refer to the institutions that provide professional services for pharmaceutical enterprises and R&D institutions in the process of drug research and development through contracts. CRO enterprise services in drug research and development of the whole stage, in charge of all or part of the activities involved in the drug development process, its fundamental purpose is to help companies to carry on the scientific or medical research, mainly provides services including safety evaluation of new drug discovery, research services, pharmacokinetic, pharmacology and toxicology, preclinical study and clinical data management, for new drug registration, etc.

Unlike CRO enterprises, CMO/CDMO enterprises mainly focus on pharmaceutical manufacturing services. Among them, CMO (contract customized production organization) refers to the enterprises that provide pharmaceutical enterprises with the production and packaging services of intermediates, apis and preparations in the form of contract customization. Traditional CMO enterprises only provide OEM services based on the technical route provided by the entrusted enterprises. With the increasing requirements of pharmaceutical companies for cost control and efficiency improvement, pharmaceutical enterprises hope that CMO enterprises can undertake more innovative service functions of process research and development and improvement, and CDMO enterprises came into being.

CDMO enterprise (contract custom R&D and production organization) in addition to providing traditional CMO production services, more emphasis on the development and innovation of production process. CDMO companies often engage in in-depth cooperation with customers early in the clinical phase of new drugs, providing development, design and optimization services for pharmaceutical process, and on this basis, providing customized manufacturing services from kilogram to ton. CDMO enterprises take advantage of their own technological advantages and production capacity to undertake the process development and production functions of pharmaceutical enterprises, so that pharmaceutical enterprises can focus more on drug research and development.