Orient: The market prospect of lipid-lowering drugs is vast. New targets and new technological routes are constantly being validated.
12/02/2025
GMT Eight
Orient released a research report stating that the prevalence of abnormal blood lipids is constantly increasing and becoming younger, leading to a vast prospect for the lipid-lowering drug market. At the same time, new targets and new technological routes are constantly being validated, and the approval of innovative drugs can also drive rapid market expansion. Domestic innovative drug companies have layout in popular targets such as PCSK9, ANGPTL3, and Lp(a). In terms of the PCSK9 target, four domestic monoclonal antibodies from Xinda, Kangfang, Junshi, and Hengrui have been approved for marketing, with several other products in late clinical stages; in addition, Shiye and Yuekang are actively developing siRNA drugs targeting PCSK9. In other target areas, Hengrui and Junshi are developing siRNA drugs targeted at ANGPTL3, with Hengrui's product entering Phase III clinical trials, leading in progress.
Orient's main points are as follows:
The global prevalence of cardiovascular diseases is increasing, driving steady growth in the lipid-lowering drug market.
From a global perspective, the lipid-lowering drug market is expected to reach $33.12 billion in 2023, projected to reach $46.58 billion ten years later with a CAGR of 3.45% during the period. In the domestic market, the prevalence of abnormal blood lipids and the mortality rate of cardiovascular diseases are increasing year by year and becoming younger. The prevalence of abnormal blood lipids in the population aged 18 and above in China has risen to 40.4%. In 2023, the sales of lipid-lowering drugs in hospitals and retail terminals in China have exceeded $25 billion, with prospects for steady growth in the future.
The trend of replacing imported traditional lipid-lowering drugs and combination therapy is gaining momentum.
Domestic drugs are gradually occupying a major market position in traditional statins, cholesterol inhibitors, and fibrates. In the statin class, Qilu Pharmaceutical's market share of atorvastatin has rapidly increased in recent years, surpassing the original Pfizer. Similarly, the market share of domestic drugs in the cholesterol inhibitors and fibrate classes is also increasing. In addition, in order to improve the rate of blood lipid control and reduce the incidence of adverse reactions, the combination therapy of lipid-lowering drugs has become an important trend, with single compound formulations providing a new option for combination treatment.
PCSK9 new drugs are coming in strong, with domestic drugs catching up.
The global sales momentum of PCSK9 inhibitors is strong, with representative drugs on the market including evolocumab and alirocumab, with global sales in 2023 reaching $1.64 billion (+26.2%) and $1.09 billion (+26.4%) respectively. Inclisiran as the first long-acting siRNA drug reached global sales of $360 million in 2023, showing rapid growth (+217%). On the domestic drug front, the first PCSK9 inhibitor, INNOVENT BIO's tocilizumab, was launched in August 2023, and drugs targeting the same target from Kangfang, Junshi, and Hengrui were recently approved for marketing, leading to intense competition.
Innovative targets are emerging, and global research and development of lipid-lowering drugs is accelerating.
The main four targets are as follows: 1) ANGPTL3: mainly targeting high triglyceride levels and familial combined hyperlipidemia that are ineffective with statin drugs, it is expected to provide hope for rare genetic disease patients; 2) ApoC-III inhibitors: mainly targeting high triglyceride levels and familial chylomicronemia syndrome with RNA interference therapy; 3) LP(a): traditional lipid-lowering drugs have limited effect due to the genetic factors determining Lp(a) levels, with many MNCs actively targeting this area and entering Phase III trials; 4) CETP: This target has yet to be fully validated, with Pfizer, Roche, Gilead, and Merck all actively involved, but research has been terminated due to safety issues or poor efficacy. Recently, NewAmsterdam Pharmaceuticals announced positive results from the Phase III BROADWAY trial, potentially becoming a game-changer.
Recommended stocks to watch are Jiangsu Hengrui Pharmaceuticals (600276.SH), INNOVENT BIO (01801), AKESO (09926), JUNSHI BIO-U (688180.SH), Shenzhen Salubris Pharmaceuticals (002294.SZ), CSPC PHARMA (01093).
Risk warning: risks of regulatory policy changes, intensified market competition, and research and development progress or clinical trial results falling short of expectations.