PharmaSourcesMay 10, 2023
Tag: Hyperlipidemia , hypolipidemic drug , Statins
Clinical data shows that hyperlipidemia is an important risk factor for causing other serious diseases, such as coronary heart disease, myocardial infarction, and stroke, and therefore anti-hyperlipidemia is of great significance in the prevention and treatment of cardiovascular and cerebrovascular diseases.
In 2021, the market size of the hypolipidemic drug industry in China was about RMB40.23 billion, and the average annual compound growth rate over the past five years was 10.0%. As the population aging in China is intensifying and drugs made in China are gradually replacing imported drugs, the market for hypolipidemic drugs in China is expected to grow continuously.
Hypolipidemic drugs reduce plasma triglyceride or cholesterol content by preventing the absorption of cholic acid or cholesterol from the intestine, promoting the excretion of cholic acid or cholesterol with feces, activating lipoprotein metabolism, and promoting the hydrolysis of triglycerides.
According to the mechanism of action, the chemical hypolipidemic drugs currently in clinical use can be classified into several categories, including statins, fibrates, nicotinic acids, bile chelators, and PCSK9 inhibitors, in which statins and fibrates are clinically preferred.
Statins reduce cholesterol synthesis in patients mainly by binding to HMG-CoA reductase through competitive inhibition. Among them, third-generation statins have greatly improved the experience of patients with hyperlipidemia by virtue of significant lipid-lowering effects, higher safety, and long-acting mechanism of action, thus occupying a major market share. They are represented by drugs such as atorvastatin and rosuvastatin, of which the latter is also known as the 'super statin'.
Fibrates can activate PPAR, induce lipoprotein esterase expression, and promote triglyceride hydrolysis in triglyceride-rich lipoprotein particles, leading to a reduction of very low-density lipoprotein in plasma. The representing drugs are fenofibrate, gemfibrozil, etc.
In general, the hypolipidemic drug industry in China is more concentrated due to the restriction of technology and funding barriers.
Currently, imported drugs are occupying the market for hypolipidemic drugs in China, represented by Pfizer Pharmaceuticals and AstraZeneca. Their hypolipidemic drugs, atorvastatin calcium tablets and rosuvastatin calcium tablets, which are innovative third-generation statins, were successively approved for marketing in China in December 2000 and January 2007. With multifaceted competitive advantages, these two innovator drugs have rapidly achieved very high market occupancy after entering the Chinese market.
In 2018, the National Healthcare Security Administration launched the pilot work of volume-based purchasing, reconstructing the hypolipidemic drug market patterns in China. However, it is noteworthy that many years after the centralized procurement, Pfizer's atorvastatin calcium tablets and AstraZeneca's rosuvastatin calcium tablets are still taking up the top two sales of hypolipidemic drugs in China.
Among the Chinese hypolipidemic drug manufacturing enterprises, Jingxin Pharmaceutical, Jialin Pharmaceutical, LunanBETTER Pharmaceutical, Topfond Pharma, and Hisun Pharmaceutical are in the first echelon of drugs made in China. Their hypolipidemic drugs are mainly statins. The products owned by these enterprises have successively passed the consistency assessment of generic drugs, gradually improving their brand competitiveness. In addition, influenced by China's policies such as volume-based purchasing, the market share of domestic products is gradually expanding, showing the trend of replacing products made in China with imported products.
It is deduced that the overall market size of hypolipidemic drugs made in China is expected to reach RMB50 billion in 2024, and the compound growth rate can reach 13.5% in the next five years.
In terms of age, the elderly over 60 years old is a high incidence group of dyslipidemia. Statistics show that the overall prevalence rate of dyslipidemia in the elderly in China is as high as 47.0%. At present, the number of people aged 65 years and older in China has already surpassed 200 million, and the proportion will gradually increase in the future. In light of this, the prominent aging problem in China will allow the demand for hypolipidemic drugs to grow concomitantly, which is the main driving force for market growth.
Moreover, the Chinese government places increasing emphasis on the prevention and treatment of chronic diseases, guaranteeing the prevention and treatment for potential patients with chronic diseases, including hyperlipidemia, and improving the proportion of diagnosed patients. Therefore, the market application of hypolipidemic drugs will be expanded.
Taking multiple factors together, the size of the hypolipidemic drug market in China is expected to continue to expand in the future, making it one of the fastest growing drug market segments worldwide.
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