The large number of outsourcing firms in China has increased the options available to pharma/biotech companies, however, at present none of these service providers address the entire drug discovery, development, and manufacturing process. The entire Chinese pharma service industry, as a whole, can provide a full scope of services though. Table 1 lists the distribution of service providers in each technical sector of the drug R&D and manufacturing process.
Early-Stage Drug Discovery: China is a hot spot for pharma/biotech companies looking for large compound libraries that possess the structural features of drug-like molecules. This is mainly because the country has a huge pool of skilled synthetic organic chemists. Companies specializing in the synthesis of specialty chemicals, scaffolds and building blocks, as well as isolation and purification of natural products from traditional Chinese medicines, are spread all over the country.
Many rare chemicals that are hard to source are also available in China. In addition, many chemicals that are not profitable to make in other places are available in China at reasonable prices. Currently, more than 30 service providers possess focused compound libraries of various sizes.
Chinese service providers don’t just provide focused compound libraries. Their service capabilities cover all areas of early-stage drug discovery. There are more than 15 companies providing services related to target identification and validation such as DNA sequencing, elucidation of protein structures, and reconstruction of proteins. In addition, there are more than 25 CROs performing medicinal chemistry-related research such as lead discovery and optimization, assay and assay method development, and pharmacological property study such as determination of PK and PD.
Many of these firms boast advanced techniques and experience such as high- throughput screening, computer-aided drug discovery, and structure-activity relationship expertise.
ADME/Tox Studies and Preclinical Research: There is a large group of China-based companies providing preclinical research including: in vivo efficacy testing, in vivo/in vitro ADME screening, plasma protein binding studies, metabolite profiling, and toxicity studies. The rapid proliferation of services in this segment is largely the result of the appearance of multinational CROs, lured by a favorable regulatory environment as well as readily available manpower resources at low cost.
Several CROs currently offering services in China are actually the service divisions, branches, or subsidiaries of Western-based CROs, e.g., CrimsonPharma, Bridge Laboratories, and Crown Biosciences.
Clinical Research: Contract clinical research has been conducted in China for more than a decade. In addition to a vast patient pool, China also has many specialized hospitals that have concentrated medical facilities, specialists, and knowledge in specific disease areas.
Pharma companies have also realized that China has a wealth of well-trained hospital physicians, thanks in large part to training providing by Western firms. The majority of these medical resources are located in major Chinese cities.
So far, most of clinical trials conducted in China are performed by major pharma companies or multinational CROs. Quintiles, PPD, and Covance have clinical trial centers in China, as do AstraZeneca, Pfizer, GlaxoSmithKline, and Sanofi-Aventis. In recent years, however, an increasing number of Chinese-founded CROs have started to emerge. At present there are a total of 14 CROs offering services in this sector.
Contract Manufacturing: Among all the sectors in the Chinese outsourcing industry, contract manufacturing is the most active. Service capability in this sector has greatly improved in recent years as evidenced by the shift of focus from the manufacturing of pharma intermediates to the manufacturing of APIs.
Many Chinese pharma companies also provide contract manufacturing services, typically on a seasonal basis when spare production capacity is available. At present there are about 60 contract manufacturing providers in China. The majority of them have expertise in chemical process research and development as well as advanced pilot plants for step-by-step process scale up.
API production facilities in Chinese CMOs are also generally supported by a QC/QA laboratory equipped with advanced analytical instruments. Many of them have production capacities that range from multikilograms to low-end metric tons (with reactor volumes ranging from 50 L to 3,000 L), and are able to handle a variety of chemical transformations. Technologies for some special chemistry tasks such as large-scale chiral resolution are also available.