Source | New Kangjie
In the past 30 years, the prevalence of hyperlipidemia in mainland China has increased significantly, and the demand for hypolipidemic drugs has continued to expand, and this category has gradually entered the normalization adjustment. In addition to traditional drugs such as statins, fibrates, and bile acid chelators, many biological agents have recently been added, such as drugs that inhibit VLDL apolipoprotein production, and proprotein convertase subtilisin (PCSK9) inhibitors and other regulating and adjuvant hypolipidemic drugs. So how will many lipid-lowering drugs perform in the market of grade hospitals and retail terminals in 2023?
01
The sales of lipid-lowering drugs in 2023 hospitals will be about 14.5 billion
This new lipid-lowering drug increased by 222% year-on-year
According to the Zhongkang Kaisi system, the total sales of lipid-lowering drugs in domestic hospitals and retail markets will reach 25.3 billion yuan in 2023. Among them, the sales of domestic hospitals were about 14.5 billion yuan, a year-on-year increase of 7.1%.
Sales of lipid-lowering drugs in national hospitals
Source: Zhongkang Kaisi system
In the 2023 TOP10 list of lipid-lowering drug sales in national hospitals, there are 3 lipid-lowering drugs with sales of more than 1 billion yuan. Among them, atorvastatin calcium ranked first with a fault score of 2.1 billion yuan, about 4.2 billion yuan, followed by rosuvastatin calcium and evolocumab, with sales of 2.1 billion yuan and 1.1 billion yuan.
In 2023, it will be the top 10 in the sales of lipid-lowering drugs in national hospitals
Source: Zhongkang Kaisi system, sorted out by Xinkangjie
From the perspective of sales growth, there are 3 products that have risen by more than 100%, the new PCSK9 biologics alixirumab performed well, up 221.9%, and evolocumab and hibermibe rose 134.7% and 124.9% respectively. while amlodipine, atorvastatin calcium, and ezetimibe decreased by 18% and 47.3%, respectively.
Studies in recent years have shown that the lipid-lowering effect of PCSK9 biologics drugs far exceeds that of statins, and the domestic PCSK9 inhibitor track has long gathered many players, according to incomplete statistics, there are more than 15 domestic research projects on PCSK9 targeted new drugs.
In August 2023, two new PCSK9 inhibitor drugs were approved for marketing in China, namely Tolecimab, which was independently developed by Innovent Biologics, and Inkeslan sodium injection by Novartis. Tolecimab is a monoclonal antibody, which is the first self-developed PCSK9 inhibitor in China, which is used once every 2 or 4 weeks, and Inkslane sodium injection is the world's first and only small interfering RNA (siRNA) drug for LDL-C lowering, and patients are given a booster shot three months after the first injection, and only need to be injected twice a year thereafter.
Although Innovent won the title of the first domestic drug, Amgen's evolocumab and Sanofi's alixirumab have taken the lead in the market, and both PCSK9 inhibitors have entered the medical insurance, and will further compete for more market share in the future.
At present, the three PCSK9 monoclonal antibody drugs of Junshi Biosciences, Akeso Biosciences and Hengrui Pharmaceutical have all received the "Notice of Acceptance" approved and issued by the State Drug Administration. It is reported that Junshi Biosciences' angareximab was recently accepted, and the applications of Hengrui Pharmaceutical's recarcinumab and Akeso's inucimab were accepted in June 2023.
02
In 2023, the sales of lipid-lowering drugs in retail terminals will exceed 10.8 billion
The sales volume of the statin drug market is about 8.3 billion yuan
In terms of the retail market, the market size of lipid-lowering drugs in 2023 will be 10.838 billion yuan, a year-on-year increase of 4.7%. On the whole, the retail market of lipid-lowering drugs has stabilized, maintaining sales of 10 billion+ in the past two years.
Sales of lipid-lowering drugs at retail terminals
Source: Zhongkang Kaisi system
In the 2023 national top 10 retail terminal lipid-lowering drug sales list, 2 drugs have sales of more than 2 billion yuan. Whether it is in a grade hospital or a retail terminal, the market share of atorvastatin calcium is unshakable, and it ranks first with sales of 5 billion yuan at the retail end, and rosuvastatin calcium ranks second with a difference of 2.2 billion yuan, with sales of 2.8 billion yuan.
In 2023, it will be the top 10 in the sales of lipid-lowering drugs in retail terminals in China
Source: Zhongkang Kaisi system, sorted out by Xinkangjie
From the perspective of sales growth, there were 4 products that rose by more than 10%, with total gynostemma glycosides performing well, with a year-on-year increase of 40.1%, and fenofibrate, ezetimibe, and Xuezhikang rising by 16.2%, 20.2% and 10% respectively. Simvastatin and pitavastatin calcium decreased by 25.2% and 15.7% respectively.
At present, lipid-lowering drugs mainly include: statins, fibrates, bile acid chelators and other traditional drugs. Among them, statins, as the cornerstone of lipid-lowering therapy, are facing increasingly fierce competition. According to the data of Zhongkang Kaisi system, the market sales of hypolipidemic statins in retail terminals in 2023 will be about 8.3 billion yuan.
Sales of hypolipidemic statins in the national retail market
Source: Zhongkang Kaisi system
03
After the reshuffle of centralized procurement, the market for many drugs has shrunk
It is difficult for the "first brother" to lower lipids to return to the peak of 10 billion
Since the implementation of the national centralized procurement policy, lipid-lowering drugs have become the focus of attention. In the nine batches of national centralized procurement that have been implemented, a total of 6 lipid-lowering drugs have been included. Among them, two best-selling drugs, atorvastatin calcium and rosuvastatin calcium, were the first to be included in the first batch of centralized procurement, while amlodipine, atorvastatin calcium and ezetimibe were included in the eighth and seventh batches respectively.
In 2023, the sales of lipid-lowering drugs in domestic hospitals will be TOP10 centralized procurement
Source: Zhongkang Kaisi system
Under the influence of the national centralized procurement policy, the entire lipid-lowering drug market has shrunk to a certain extent. According to the data of Zhongkang Kaisi system, the sales of ezetimibe in grade hospitals in 2023 will be less than 600 million yuan, a year-on-year decrease of 47.3%, and the impact on the retail market will be small, with sales of nearly 400 million yuan in 2023, a year-on-year increase of 20.2%.
Sales of ezetimibe in national hospitals
Source: Zhongkang Kaisi system
Atorvastatin calcium, as the "first brother" of lipid-lowering drugs, is also inevitably affected by centralized procurement. According to the Zhongkang Kaisi system, in 2020, the sales of atorvastatin calcium in national hospitals fell by 58.4% year-on-year to 4 billion yuan, and in the past four years, it will be difficult to return to the sales peak of 10.9 billion yuan in 2018.
Sales of atorvastatin calcium in national hospitals
Source: Zhongkang Kaisi system
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