Lipisense has its greatest market potential and is expected to have the most significant medical impact in preventing cardiovascular disease (CVD)—including myocardial infarction and stroke—in high-risk patients with moderately elevated plasma triglyceride levels. Cardiovascular disease is the leading cause of death both in Sweden and globally. In 2019, nearly 18 million people worldwide died from CVD, corresponding to almost one third of all deaths [1].

One of the most important risk factors for CVD is dyslipidemia, an umbrella term for elevated plasma levels of total cholesterol, LDL cholesterol, or triglycerides, or reduced levels of the protective lipoprotein HDL. For the past ~30 years, statins have been the standard treatment for dyslipidemia. The statin Lipitor was for many years the world’s best-selling drug, reaching peak annual sales of nearly USD 13 billion in 2006 [2]. Despite the success of statins in reducing CVD risk, there remains a substantial residual risk of disease, partly attributable to elevated levels of triglyceride-rich remnant particles—a lipid fraction uniquely targeted by Lipisense, but against which statins have limited effect. According to GlobalData, the number of individuals with elevated triglyceride levels was estimated at ~151 million across the seven major markets (7MM: US, Japan, UK, Germany, France, Italy, and Spain) in 2022, with an expected increase to 158 million by 2032, driven by rising obesity, metabolic syndrome, and type 2 diabetes [3].

The dyslipidemia market is projected to grow faster in value than in patient numbers, expanding from ~USD 6 billion in 2022 to ~USD 16 billion in 2032 across the 7MM, corresponding to a compound annual growth rate (CAGR) of 10.8% [3]. This growth is primarily driven by the expected uptake of newer, more effective therapies in addition to the increasing patient base. Given Lipisense’s unique profile compared with other novel agents anticipated to launch by 2032, it is reasonable to expect that Lipisense, once approved, could further accelerate market expansion.

In addition to risk reduction for cardiovascular disease, Lipisense also holds significant potential for the treatment of severe hypertriglyceridemia (SHTG), defined as triglyceride levels ≥500 mg/dL. The main therapeutic goal in these patients is to prevent episodes of potentially life-threatening acute pancreatitis. Currently, ~5 million patients suffer from SHTG across the 7MM, and this number is expected to increase [3]. Among those treated with available triglyceride-lowering drugs, only about half achieve treatment targets.

On a conservative basis—considering only SHTG—Lipisense is estimated to have a sales potential of approximately USD 1.5 billion, assuming an annual price of USD 6,000 (comparable to the lipid-lowering PCSK9 inhibitors Repatha and Praluent [4,5]) and a market share of 5% among patients with very high triglyceride levels. The commercial potential rises sharply if the much larger group of patients with elevated triglycerides overall is included, where each additional 1% market share in the 7MM corresponds to annual sales of ~USD 9 billion.

References

[1] World Health Organization. Cardiovascular diseases (CVDs). https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds) (accessed 25 Aug 2025).

[2] Pfizer. 2006 Financial Report, p.16.

[3] GlobalData. Dyslipidemia: Seven-Market Drug Forecast and Market Analysis. Report Code: GDHC275PIDR-7M. Published July 2023.

[4] https://www.repatha.com/repatha-cost (price as of Jan 2025, accessed 25 Aug 2025).

[5] https://www.regeneron.com/downloads/codrugcosteducation_praluent.pdf (updated 15 Jan 2025, accessed 25 Aug 2025)