Molecular biomarkers and diagnostics are playing increasingly important roles in the modern pharmaceutical and healthcare industries. To more efficiently discover drugs, companies now increasingly apply these technologies in order to find the right drug for the right patient. These efforts are leading to the gradual realization of personalized medicine across the globe.
One of the forces driving the development of personalized medicine is genomic and proteomic research. Genomics and proteomics directly facilitate the development of new biomarkers and diagnostic tools. Moreover, genomics and proteomics are also increasingly employed in the development of translational medicines as the technologies can lead to the discovery of antibody-based biomarkers that are able to predict not only the efficacy but also the safety of a drug candidate.
Currently, there are about 250 Chinese companies involved in genomic and proteomic research and its application in the development of biomarkers and diagnostic products. Of these companies, about 70% were founded in the last three to five years. A large portion (about 25%) of these firms were either founded by foreign companies as their wholly owned Chinese divisions or jointly founded with local Chinese partners. Among the companies founded by Chinese entrepreneurs, a majority (about 80%) were founded by “sea turtles” who possess knowledge, experience, and skills gained from working abroad.
Current Technical Capability
In the past, genomic and proteomic research in China was mainly conducted at the country's research institutions. The Chinese government realized the potential of these technologies early on and has provided financial support and favorable policies.
The current capabilities of Chinese companies pursuing genomic and proteomic research include the development of reagents for measuring molecular events such as intracellular pathways, cell signaling, and gene expression, and development of nucleic acid-based biochips that can be integrated into next-generation diagnostic products.
Some companies also provide service for DNA synthesis, pathway profiling of lead compounds, assay development, and high-content/-throughput screening. Their capabilities in proteomic research include protein expression, protein structural determination, molecular cloning for construction of monoclonal antibodies, and synthesis of gene vectors.
Using their skills and experience in genomics and proteomics, some companies also provide services for target identification and validation to help drug companies elucidate disease-causing mechanisms. A number of Chinese organizations also possess large-scale genetic databases resulting from genome/proteome sequencing. With their strong capability in bioinformatics, these organizations also provide custom service to outside companies.
At present the majority of China-based companies conducting genomic and proteomic research are focusing on the development of diagnostic products including testing reagents and kits for hospital and/or laboratory use. Most of the products are for in vitro use and were developed based on nucleic acid technologies.
A growing number of China-based companies also offer diagnostic testing services, including quantitative- and real-time PCR-based diagnostic assays.
So far we have not seen any evidence that Chinese biotech companies are capable of independently developing (including identification and validation) biomarkers to support clinical research. A number of them do, however, possess the ability to detect and analyze biomarkers.
This shortcoming is related to the industry's short service history. The majority of these Chinese biotech firms are still limited in service scope, capability, capacity, and experience compared with their counterparts in the developed countries. Currently, only a small number of them could be considered world-class players.