Genetics can spike Indians’ cholesterol, but relief may be at hand

The world's top pharmaceutical companies are developing drugs to lower a type of cholesterol common among Indians due to genetic factors, which may be launched in the country in the coming years.

Companies like Novartis and Eli Lilly are working on drugs to treat high levels of lipoprotein(a), also called Lp(a), a type of cholesterol that has no therapy yet and cannot be reduced by diet or exercise. High levels of cholesterol are a leading cause of heart attacks and strokes, with South Asians genetically more vulnerable to high levels of Lp(a).

“One of the biggest healthcare burdens in India is on the cardiovascular side,” said Amitabh Dube, country president and managing director, Novartis India. “We’re (trying) to focus ourselves on the cardiovascular segment where we believe we can make the biggest change in India. What we are seeing today is that the cardiac burden is impacting a younger lot of population (more) than the older lot,” said Dube, whose company is strengthening its cardiovascular portfolio in India.

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The likely debut of such drugs could help reduce the burden of cardiovascular diseases (CVDs) that cause one in every four non-natural deaths in India, aggravated by lifestyle issues. While higher Lp(a) levels are not the leading cause of CVDs, they increase the risk of developing it, especially among people with other risk factors like high blood pressure, smoking, diabetes and obesity.

While the drugs are still in the trial phase, drugmakers have expressed plans for potential India launches in the coming years.

The pipeline

Novartis’ drug Pelacarsen, used to lower Lp(a), is currently in global phase 3 trials. It is also working on a next-generation Lp(a)-lowering therapy, building upon the foundation established by Pelacarsen, along with partner Ionis Pharmaceuticals.

“We are continuing our research here [on] Lp(a)…and we potentially will launch a newer product in 2027 for addressing lipoprotein-a. We have clinical trials happening in India for this product. And once the global approval is coming with a positive result, we [will] be in a position to launch this product,” Dube said.

Last year, the Swiss drugmaker launched another cholesterol-lowering drug in India. Inclisiran, sold under brand name Sybrava in India, is an injectable to be taken twice a year. It targets high levels of low-density lipoprotein cholesterol (LDL-C), often called bad cholesterol. The drug is a PCSK9 inhibitor, which works by blocking a protein called PCSK9 in the liver. Unlike Lp(a), LDL-C levels are influenced by genetics as well as lifestyle factors.

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US-based Eli Lilly is also working on a drug to target Lp(a), called Lepodisiran. The company published promising phase 2 results on 30 March, showing that the drug reduced Lp(a) levels by an average of 94% over the 60 to 180-day period after treatment with the highest tested dose.

In an interview with The Economic Times last month, Eli Lilly’s CEO David Ricks said that with this, the company is pursuing an “important target for Indians”.

Amgen is also conducting phase 3 trials for its drug candidate Olpasiran, which too aims to lower Lp(a).

India’s cardiac burden

Cardiovascular diseases account for a quarter of all deaths in India. There is an increasing incidence of heart attacks among people under 40.

According to a 2023 Lancet report, “the CVD epidemic in Indians is characterized by a higher relative risk burden, an earlier age of onset, higher case fatality and higher premature deaths.”

A study published in the Indian Heart Journal in 2019 stated that Indians, in general, develop acute myocardial infarction (AMI) about 10 years earlier, and AMI rates are three to fivefold higher in young Indians than in other populations.

There are several reasons driving the high incidence, including lifestyle factors, elevated levels of LDL-C, as well as higher Lp(a) levels which could increase risk.

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Lp(a) levels are genetically-predetermined, and cannot be significantly changed through lifestyle changes such as diet or exercise.

While elevated Lp(a) levels are not uncommon (1 in 5 people globally have it), studies have linked South Asians with a higher predisposition towards elevated Lp(a)s. Approximately 25% of South Asians have elevated Lp(a) levels (over 50 mg/dl).

Doctors pointed out that while higher Lp(a) levels may increase the risk of developing CVD, stress, eating habits and smoking are the leading causes of cardiac issues among young Indians.

“We are forgetting the fact that our lifestyles have completely changed…the amount of stress that people go through, the amount of smoking and substance issues that are there, the amount of sleepless nights… All these add to your high incidence of heart diseases in the youngsters,” Dr. Ajit Menon, director of cardiac sciences at Mumbai's Sir HN Reliance Foundation Hospital said.

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“If you go across all ages of heart disease patients, Lp(a) is found to be high in some people …but in the younger population, it may play a bigger role,” said Dr Akshay Mehta, Mumbai-based interventional cardiologist.

“It is a more dangerous risk factor than simple cholesterol or LDL-C because the Lp(a) particle not only causes fat deposits but can also cause thrombosis and inflammation,” he said, adding that for patients with very high levels (over 100 mg/dl), risks of younger heart attacks, strokes and narrowing of the aortic valve are much higher.

“Lipoprotein-a is a risk factor…what we have been doing until now is we do not have any treatment for Lp(a), so we try to keep the total cholesterol down, and keep the LDL-C cholesterol as low as possible,” Dr. Menon said.

Market size

According to Pharmarack, a pharmaceutical B2B commerce and market research firm, India's cardiac drug market has tripled in value in the last decade to more than ₹30,000 crore, of which the lipid-lowering drug market is worth ₹6,785 crore. The market for Inclisiran in India is ₹7.30 crore.

Within the cardiac segment, the market for dyslipidemia (abnormal levels of lipids like cholesterol and triglycerides) is estimated to be around ₹7,000 crore in India, according to Vishal Manchanda, senior vice-president of institutional research at Systematix Group. “Most patients are treated with statins…[but] about 5-10 % of patients would be eligible for treatment with these novel agents,” he said.

Affordability and accessibility

Drugs targeting Lp(a) levels will not be for everyone, doctors said. “Lp(a) just indicates that you are at high risk, it doesn't tell you anything else,” Dr. Akshay Nakrani, a Mumbai-based cardiologist said. “Even if they come out with these drugs, how much impact Lp(a) will have on reducing (cardiac) events is still uncertain,” he said. 

“It will still be a secondary drug…not a primary drug for all people with cholesterol, Dr. Menon said.

Doctors also raised concerns over the affordability of the drugs when they are launched. Being innovator drugs, these are expected to be expensive, and may not be accessible for everyone.

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For instance, Novartis’ cholesterol drug launched last year is priced at approximately ₹1.2 lakh per injection, or around ₹2.4 lakh annually.

Dube of Novartis India addressed the challenge around accessibility for innovator companies. “Access is not just one stakeholder's challenge…It is a multifaceted challenge,” he said.

“It cannot be that the pharmaceutical industry takes the entire burden of access, or the government takes the entire burden of access, or patient groups and patient stakeholders take the entire burden…if all of us come together…we will be in a position to have a better solution for access to patients,” he added.

As of March 2025, the moving annual total (MAT) value of the cardiac segment was ₹30,203 crore, according to a report from Pharmarack, a pharmaceuticals database. MAT refers to the total sales value or volume of a specific drug or a portfolio of drugs over the preceding 12 months.

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