Blockbuster obesity drugs like Ozempic and Wegovy have become a global sensation. Now the Indian pharmaceutical companies also want to be part of this billion dollar obesity treatment market.
A recent report by Reuters revealed that India is planning to offer incentives to promote local manufacturing of GLP-1 drugs used to treat diabetes and obesity in 2026 citing a top government official.
Originally, these GLP-1 drugs were approved to treat diabetes but they are widely being used to treat obesity. Interestingly, as the Danish Pharma major Novo Nordisk‘s patent on semaglutide – a GLP-1 agonist and the key ingredient in its wildly popular obesity drug is set to expire in India in 2026, several Indian drugmakers have already applied for the government’s production-linked incentive (PLI) scheme.
According to the Reuters report, once the companies start manufacturing the GLP-1 drugs in 2026 after the patent expires, the government will begin giving them the incentives.
Last week, the American drugmaker said that it is yet to get the nod from India’s drug regulator for selling its blockbuster drug Tirzepatide in the country for weight loss. According to a report by ET, the Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) has so far given a go-ahead for its import and marketing for diabetes and not for weight loss and the apex body is reviewing the “obesity” indication.
Marketed under the brand name Mounjaro, the drug is indicated for type 2 diabetes treatment and as Zepbound for weight loss in the United States. Mounjaro has been available in the United States since 2022 while Zepbound was approved by the US FDA in November 2023. The company said it has yet to firm up the schedule for launching the drug in India. Reportedly, the company is planning to launch Mounjaro in India next year.
Last month, CDSCO an SEC under the CDSCO recommended the regulatory approval for two formulations of Tirzepatide – pre-filled pens and single-dose vials.
Surging market for anti-obesity drugs
A study published in the Lancet journal in March this year revealed that there were 70 million adults living with obesity in India in 2022, with almost twice the number of women than men, at 44 million and 26 million, respectively. In children aged 19 and under, 5.2 million girls and 7.3 million boys were obese. The rising incidences of obesity has become a key growth factor for the anti-obesity market. Interestingly, with the launch of Semaglutide by Novo Nordisk in January 2022, the market saw phenomenal growth.
The anti-obesity market is estimated to be around Rs 500 crore now. It has clocked a five-year compound annual growth rate (CAGR) of 32 per cent, a Business Standard report revealed. It is noteworthy that semaglutide, liraglutide, dulaglutide and orlistat are key molecules in this space. Novo Nordisk is the innovator of the first two peptides, while Eli Lilly is the innovator of dulaglutide. Orlistat was developed by Roche.
As per the latest Indian Council of Medical Research–India Diabetes (ICMR-INDIAB) study, the prevalence of diabetes and other metabolic non-communicable diseases (NCDs) in India is considerably higher than previously estimated – over 100 million people presently live with diabetes.
Moreover, India has 254 million people living with generalised obesity making it the world’s third-largest population.
“The prevalence of obesity is acute in urban centres and we are observing an upward trend in its prevalence in both adults as well as children. With the majority of India’s urban population living with obesity, and rapidly increasing, innovative treatment options with proven results for sustained weight loss are the need of the hour. This is important because obesity directly increases the risk of diabetes, cardiovascular diseases, and even certain cancers among others,” Vikrant Shrotriya, Managing Director, Novo Nordisk India told Financial Express.com.
Shrotriya also explained that obesity is often misunderstood to be the outcome of one’s lifestyle choices.
“However, underlining factors including genetics, physiology, psychology, co-morbidities and environment significantly contribute to an individual’s weight gain and/or their efforts to lose weight. As part of ‘Driving change in obesity’, Novo Nordisk has made a long-term commitment to improve the lives of people living with obesity and change how the world sees, prevents and treats obesity,” he told Financial Express.com.
What is the status of India’s anti-obesity market?
The anti-obesity drugs have taken the world by storm and their popularity is also increasing in India. Reportedly, there is a surge in popularity of Novo Nordisk’s oral semaglutide tablet, known as Rybelsus, approved for treating diabetes and weight reduction.
According to data from market researcher Pharmarack, sales of Rybelsus have more than doubled in the past year, reaching Rs 363 crore in April as compared to Rs 147 crore a year earlier.
Rybelsus was launched in India as an oral drug in 2022 and it is being touted as a breakthrough in Type 2 diabetes treatment. It is available in three strengths (3, 7, and 14 mg), and the monthly cost comes to approximately Rs 10,000, as per a Business Standard report.
According to Pharmarack, India has witnessed a surge in sales of anti-obesity medications, with the market tripling in two years, bouncing back from previous sluggish growth till 2021.
Currently, Indians have limited prescription medication options that address obesity, Shrotriya revealed.
“Anti-Obesity Medications (AOMs) that are safe and provide sustained weight loss results need to be accompanied with evidence-based care approaches, support from relevant stakeholders and coordinated action to make obesity a healthcare priority for India. Novo Nordisk has a pipeline of innovative anti-obesity medications. We are working to make semaglutide injection 2.4 mg available as soon as possible,” he told Financial Express.com.
Pharmarack data revealed that Semaglutide holds approximately 66 per cent of the value market share in the anti-obesity segment, followed by Dapagliflozin, another medication for Type 2 diabetes. Sapale anticipates sustained sales growth for Semaglutide in India, given the high prevalence of obesity.
Meanwhile, Indian drugmakers are also racing to manufacture weight loss drugs. Ozempic is expected to witness 23% growth in sales, reaching $12.5 billion in 2023, according to the data analytics firm GlobalData. Taking advantage of the limited availability of the anti-obesity drugs, some of the pharma firms like Cipla Dr. Reddy’s, Lupin, Zydus, and Sun Pharma are actively engaged in the development of anti-obesity medications for the Indian market.
“The anti-obesity is a category that is important for us not only for India but globally. When the opportunity arises for us to bring these products into the respective markets, we will do so. Opportunity would be based on Loss of Exclusivity/patent expiry. For 40 years, we have stood for access, affordability and innovation largely by bringing in best-in-class generics into the market. We will continue this effort that help or enhance current standard of care, and add innovations to it,” a spokesperson of Dr. Reddy’s Laboratories told Financial Express.com.
Companies such as Sun Pharmaceutical Industries Ltd, Lupin, Torrent, and Zydus Cadila have obesity drug candidates advancing through various stages of development. Although Cipla is working working on an obesity drug, the pharma major is also open to market Eli Lilly’s weight loss drugs in India.
On June 21, Sun Pharma announced the findings for its drug Utreglutide, coded GL0034, in obese adults. When administered once weekly, the company said GL0034 confirmed clinically meaningful weight loss and improved glucometabolic parameters over a four-week treatment period in individuals with obesity, even in the lowest dosing regimen.
According to the company, the drug demonstrated glucometabolic activity and reductions in lipid levels, including triglycerides, total cholesterol, and non-HDL cholesterol, suggesting novel and beneficial effects on lipid metabolism. In a press statement, Dilip Shanghvi, Founder and Managing director, Sun Pharma said: “The promising data from our GL0034 study highlights our commitment to addressing the growing global health challenge of obesity.”
Utreglutide (a subcutaneous injection) is a novel differentiated incretin analogue with potent, long-acting agonist activity at the GLP-1 receptor. The company claims that that drug can cut down hunger pangs in the stomach. Sun Pharma presented the clinical data at the annual American Diabetes Association.
Although the early findings are interesting, it might be to celebrate as the drug still needs to undergo crucial phases of the trial.
In April this year, Bengaluru-based Biocon Ltd. scored an early win with the UK approval for the first generic version of liraglutide injectible, whose patent ends in November. According to a Bloomberg report, the weight loss drug, sold under the brand name Saxenda by patent holder Novo Nordisk A/S, is among the first of the groundbreaking medications in this category to lose patent protection. Biocon has also filed applications before the US and European regulators for liraglutide.
In May this year, Biocon signed an exclusive licensing and supply agreement with Handok, a specialty pharmaceutical company in South Korea, for the commercialization of synthetic Liraglutide. The company has not yet filed for liraglutide approval in India.
How do these anti-obesity drugs work?
These new-class of anti-obesity drugs have rose to fame because of their ability to “mimic the hormones”. These drugs mimicking a naturally occurring hormone called glucagon-like peptide 1 (GLP-1). According to Nature report, GLP-1 not only regulates blood sugar levels, but also binds to receptors in the brain that control appetite and receptors in the gut that slow digestion and contribute to a feeling of being full.
In 2014, the US Food and Drug Administration (FDA) approved the first class of GLP-1 drugs for weight loss. Liraglutide, marketed as Saxenda by Novo Nordisk, based in Bagsværd, Denmark, is a daily injection that can trigger an average body-weight loss of 8% after a year. The drugs that afterwards turned out to be more effective in the ways they triggered weight-loss.
In 2021, the FDA approved semaglutide, sold as Wegovy by Novo Nordisk, as a weight-loss treatment, and in 2023 it approved tirzepatide, marketed as Zepbound by Eli Lilly, based in Indianapolis, Indiana. Tirzepatide mimics GLP-1 as well as another hormone that stimulates insulin secretion, known as glucose-dependent insulinotropic polypeptide (GIP).
As the drugs are expensive, Indian and Chinese pharmaceutical companies plan to slash that price is by developing biosimilars, cheaper versions of expensive brand-name drugs. According to the Nature report, Companies are preparing to release biosimilar versions of GLP-1 drugs when patent protections lift in different markets. In China, the patent for liraglutide has already expired, and the one for semaglutide will expire in 2026 in India and China.
No weight-loss biosimilars have yet been approved in India. However, Glenmark Pharmaceuticals has launched Lirafit, a liraglutide biosimilar, in January for treating type 2 diabetes.
What doctors say?
Anti-obesity medication or weight loss medications are pharmacological agents that reduce or control excess body fat, Dr. Sanjay Verma – Director, Minimal Access, GI & Bariatric Surgery. Fortis Escorts, Okhla Road, New Delhi told Financial Express.com.
“These medications reduce appetite and consequently energy intake, increasing energy expenditure, redirecting nutrients from adipose to lean tissue, or interfering with the absorption of calories. The medications liraglutide, naltrexone/bupropion, orlistat, semaglutide and tirzepatide are approved by the US Food and Drug Administration (FDA) for weight management in combination with a reduced-calorie diet and increased physical activity,” Dr. Verma said.
As of 2024, no medication has been shown to be as effective at long-term weight reduction as bariatric surgery, he said.
Meanwhile, Dr Vivek Bindal, Director & Head of Department, Institute of Minimal Access, Bariatric & Robotic Surgery, Max Super Speciality Hospitals told Financial Express.com that weight-loss drugs offer potential benefits such as appetite suppression and increased metabolism, aiding in weight reduction.
“However, they can also have adverse effects like gastrointestinal issues, increased heart rate, and dependency. Long-term efficacy and safety require thorough consideration. The effectiveness of weight-loss drugs in India varies based on factors like individual response, adherence to treatment, and lifestyle changes. While they may provide initial weight loss, sustainable results often require comprehensive lifestyle modifications including diet and exercise,” Dr. Bindal informed.
It’s important to consider options beyond weight-loss drugs, such as bariatric surgery, he emphasised.
“While surgery can offer significant weight loss benefits, it’s most effective when combined with lifestyle changes including diet and exercise. Seeking guidance from healthcare professionals ensures a comprehensive strategy tailored to individual needs, promoting long-term success and overall well-being,” he told Financial Express.com.
While highlighting the worrisome popularity of these drugs, Dr Parveen Bhatia, Senior Consultant, Institute of Minimal Access, Metabolic & Bariatric Surgery, Sir Ganga Ram Hospital, New Delhi revealed that potential side effects like nausea, vomiting, and increased risk of pancreatitis should be monitored.
“In India, these drugs can be effective in reducing weight and associated health risks, especially when combined with lifestyle modifications and professional guidance. Effectiveness varies depending on individual patient factors, medication adherence, and appropriate patient selection. It’s crucial to note that these drugs are not a quick fix and should be used under medical supervision. Additionally, addressing the root causes of obesity, including promoting healthy eating habits, regular physical activity, and stress management, is essential for sustainable weight management and improved overall health,” Dr. Bhatia told Financial Express.com.
