China Generic Drugs Status 2018

The total number of drugs approvals in China is 189,000, and more than 95% of them are generic drugs. The domestic generic drug market has reached 500 billion-yuan, accounting for about 40% of the total drug consumption market. But the industry concentration is very low, CR8 in China is 18.82%, while CR8 in India accounts for 52.31%, and CR8 in the United States accounts for 52.96%.

Low-level imitation and vicious low-price competition are serious in China. Among 3244 chemical drug varieties, 262 varieties account for 70% of the total registered number

Due to the lack of compulsory requirements for consistency evaluation between approved drugs and original research drugs in the past, there is a big gap between the efficacy of some drugs and original research drugs, and the industry has poor profitability, with an average gross profit rate of 5-10%, which is much lower than the international average level of about 50%. By 2018, the number of Enterprises above the scale of the pharmaceutical industry in China had reached 7483, of which 1437 were loss-making enterprises, accounting for 19.2%.