Currently, the pharma market is highly fragmented, comprising of approximately 5,000 manufacturers, a majority of which are small and medium-size companies. This fragmentation keeps the research and development spending to as low as five percent of sales on average. The companies are mostly engaged in production of generics, therapeutic medicines, active pharmaceutical ingredients and traditional Chinese medicine. More than 90 percent of drugs registered in China are generic ones.
However, this fragmented Chinese pharmaceutical industry is about to witness some degree of consolidation and increased competition in the next few years. In 2017, major medical reforms had started in the country which include stringent drug quality regulations, medicine innovation incentives, reduction in layers of pharma distribution intermediaries, etc. China Food and Drugs Administration (CFDA) adjusted test requirements on the quality of off-patent generic drugs to lift industry standards. Generic drugs approved for production before 2008 are quite prone to being low quality. In 2019, the newly revised Drug Administration Law came into effective to make the drug rules more in line with the international standards. It implemented a number of new systems regarding the traceability and approval of drugs, online drug sales, as well as quality management of drug franchise business. These reforms will most probably promote merges and acquisitions as well as R&D spendings in the industry. Recently, an increasing number of Chinese pharmaceutical and investment companies engaged in mergers and acquisitions abroad speeding up the internationalization progress in the pharmaceutical market. 166 biotechnology or pharmaceutical company takeovers with Chinese involvement were registered in the third quarter of 2021.
On the other hand, overseas investment into China’s pharma industry as well as the numbers of international companies bringing products into the Chinese market are growing. On June 1, 2017, CFDA officially became a member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. This initiated the true integration of China’s drug regulatory system into the international community and facilitated foreign drugs review and listing processes. The foreign drug applications in China increased from 13 in 2016 to 123 in 2021.
Within the next decade, the country’s pharmaceutical industry will undoubtedly go through some drastic structural changes. Its position in the global market is likely to shift from a pharma manufacturing base to a strategic and R&D hub.