India Lipid Disorder Therapeutics Market Analysis

India Lipid Disorder Therapeutics Market Executive Summary

India Lipid Disorder Therapeutics Market is at around $151.5 Mn in 2023 and is projected to reach $353.8 Mn in 2030, exhibiting a CAGR of 12.88% during the forecast period.

Lipids refer to the major components of the body made up of hydrocarbons which play an important role in the formation and functioning of living cells. They are recognized as fat-type substances that are found inside the body as vitamins, oils, and waxes. They are often referred to as cholesterol and are necessary for the body's operation, particularly the heart. If not in balance, they could be harmful. Serious health problems may arise from having too much triglycerides and low-density lipoprotein (LDL) in the blood. Lipid disorders are among the health issues that are spreading the quickest in the globe. Lipid disorders can be treated with a variety of methods, such as lifestyle modifications, fibrates, cholesterol absorption inhibitors, statins, and bile acid sequestrants. Statins are drugs that stop a molecule from secreting that causes cholesterol to be produced. After that, the liver purges our blood of any cholesterol that was already there. Pravastatin, Simvastatin (Zocor), Rosuvastatin (Crestor), Fluvastatin (Lescol), and Atorvastatin (Lipitor). The amount of dietary cholesterol that is absorbed by our bodies is decreased by cholesterol absorption inhibitors, which are occasionally used in conjunction with statins.

The prevalence of dyslipidemia is very high in India, which calls for urgent lifestyle intervention strategies to prevent and manage this important cardiovascular risk factor. Dyslipidemia has been closely linked to the pathophysiology of CVD and is a key independent modifiable risk factor for cardiovascular disease. While Asian Indians are known to have a unique pattern of dyslipidemia with lower HDL cholesterol, increased triglyceride levels, and a higher proportion of small dense LDL cholesterol, there have been no large-scale representative studies on dyslipidemia to assess the magnitude of the problem in India. The estimation of the prevalence of dyslipidemia will ensure proper planning of health care resources for both primary and secondary prevention of CVDs. The market therefore is driven by significant factors like the prevalence of cardiovascular diseases, consumer preference for over-the-counter (OTC) drugs, advancements in therapeutics, growing healthcare expenditure, and infrastructure. However, regulatory hurdles, adverse effects, and high cost of treatment restrict the growth and potential of the market.

Evolocumab and Alirocumab are monoclonal antibodies that target PCSK9 protein, leading to significant reductions in LDL cholesterol levels.

Market Dynamics

Market Growth Drivers

Prevalence of cardiovascular diseases: The growing prevalence of cardiovascular diseases (CVDs) in India, with an estimated 64 Mn cases in 2023, is a major driver for the cholesterol lowering drugs market. This rise in CVDs is fueled by various factors such as increased obesity, changing food habits, higher alcohol consumption, and smoking.  Additionally, growing awareness about bad cholesterol and its link to heart disease is further triggering the market's expansion.

Consumer preference for over-the-counter (OTC) drugs: In comparison to brand name drugs, OTC variants are usually more affordable. Additionally, the growing adoption of combination therapies that use statin with other cholesterol diminishing compounds, such as ezetimibe, is acting as another growth-inducing factor. Research has found statin-ezetimibe combination therapy to be capable of achieving near-normal lipid profiles in familial hypercholesterolemia patients reducing the risk of CVDs occurrence.

Advancements in Therapeutics: Recent advancements in lipid-lowering therapeutics, including the development of highly potent statins like Rosuvastatin and novel agents like PCSK9 inhibitors, have significantly improved treatment outcomes. These medications offer better efficacy and safety profiles, making them attractive options for managing lipid disorders. Ongoing research and development in this field continue to introduce new and improved treatments, enhancing the ability of healthcare providers to tailor therapies to individual patient needs, thus driving market growth​

Market Restraints

Regulatory Hurdles: Although India's strict medication approval regulations guarantee patient safety, they also make market entry difficult. The market dynamics may be impacted by the protracted and intricate approval procedure, which may postpone the launch of new lipid-lowering treatments. Post-approval surveillance regulations also increase the expenses and complexity of doing business for pharmaceutical businesses.​

Adverse effects: Statins are examples of lipid-lowering drugs that frequently have adverse effects that include muscle soreness, liver damage, and elevated blood sugar levels that might result in diabetes. These negative effects may discourage patients from following recommended treatment plans, which would restrict the market's potential for expansion. For pharmaceutical companies and healthcare providers, managing these adverse effects and ensuring patient safety are crucial problems.

High cost of treatment: Biologics and gene therapies, two advanced treatments for lipid problems, are expensive and hence not available to a large enough patient population. For example, the average cost of biologic therapies can exceed $20,000 per year. There may be inequities in treatment access due to the financial strain on individuals and healthcare systems. This financial barrier prevents the market from growing, which primarily affects individuals who are underinsured or without insurance.

Regulatory Landscape and Reimbursement Scenario

The Central Drugs Standard Control Organization (CDSCO) is the primary regulatory body for medical devices in India. It is responsible for overseeing the import, manufacture, sale, and distribution of medical devices in the country. The CDSCO ensures that medical devices comply with safety, quality, and efficacy standards. Upon approval of a manufacturer’s MD-14 application, the CDSCO will issue an MD-15 Import License according to the manufacturing site with the approved products listed on it. Therefore, if manufacturers use multiple manufacturing sites, an MD-15 for each site will be needed.

Central Government Health Scheme operates pan-India to provide free or subsidised medical care to Government employees, pensioners, and their dependents. The scheme covers diagnosis, treatment, medical procedures, and even reimbursements for cost of medicines and hospitalization. Before the launch of the Ayushman Bharat Mission, the CGHS was the most expansive healthcare plan in the country. It continues to be the only Government-backed policy providing for reimbursement of medicines and/or procedures in India. Under the scheme, a beneficiary can procure free/subsidized treatment from impanelled hospitals and obtain medicines from the CGHS dispensaries only. Reimbursements are valid only in the case of treatment from Government hospitals, or private medical centers in case of emergencies. The costs of selected medical devices are also reimbursed under the Scheme.

Competitive Landscape

Here are some of the major key players in the India Lipid Disorder Therapeutics Market:

Key Players

• Sun Pharmaceutical Industries Ltd
• Lupin
• Cipla
• Pfizer, Inc.
• GlaxoSmithKline plc
• Novartis AG
• Merck & Co., Inc.
• Amgen Inc.
• Takeda Pharmaceutical Company Limited
• AbbVie, Inc.
• Viatris
• AstraZeneca PLC
• Dr. Reddy’s Laboratories Ltd.