What Does the Future Hold for the Anti-Obesity Drug Market in 2024?

The year 2023 witnessed the rise in popularity of anti-obesity drugs in the pharmaceutical industry, and the trend is expected to continue in 2024. One of the key developments to watch out for is the expiration of the patent for Liraglutide (Victoza), a GLP-1 peptide drug manufactured by Novo Nordisk. This event is likely to have significant implications for the industry as a whole.

1. India: Glenmark Initiates the Competition
Glenmark Pharmaceuticals Limited, an Indian company, has launched its first generic version of Liraglutide called Lirafit, setting the stage for a fierce competition in the anti-obesity drug market in 2024. Lirafit is priced significantly lower than Victoza, with a standard dosage costing around 100 Indian rupees ($1.20), reducing treatment costs by approximately 70%. Clinical trials conducted by Glenmark have demonstrated the efficacy, safety, and good tolerability of Lirafit in adult type 2 diabetes patients in India.

Several Indian companies, including Sun Pharmaceutical, Biocon Ltd., and Virchow Biotech, have joined the competition for Victoza. Sun Pharmaceutical, for instance, showcased promising results of its novel long-acting GLP-1 receptor agonist, GL0034, in Phase 1 studies involving non-obese and obese non-diabetic adults.

Apart from Victoza, many Indian companies are also developing plans for semaglutide, another GLP-1 drug. Cipla Limited has expressed interest in developing an oral formulation of semaglutide, while Dr. Reddy's Laboratories Ltd. is working on the development of injectable semaglutide.

2. China: Continued Expansion of GLP-1 Market
Generic versions of Victoza have already obtained approval in China. In 2023, Huadong Medicine received approval for its liraglutide injection for the treatment of type 2 diabetes, followed by its approval for obesity treatment. Similarly, Tonghua Dongbao's generic version of Victoza has been approved for diabetes treatment in China.

Huadong Medicine not only entered the anti-obesity drug market with its generic liraglutide but also possesses a robust GLP-1 pipeline, including generic semaglutide and licensed products such as HDM1002 (GLP-1R), SCO-094 (GLP-1R/GIPR), and the in-house developed DR10624 (GLP-1R, GCGR, FGF21R). Clinical trials for the generic semaglutide are currently underway in China, with an expected market launch in 2026.

The semaglutide patent is set to expire in 2026, and it has already faced invalidation in China. Novo Nordisk has appealed this decision to the Beijing Intellectual Property Court, awaiting the final outcome. Novo Nordisk asserts that the tablet formulation and once-daily dosing regimen are protected by other patents, which are valid until 2031-2034.

According to Frost & Sullivan, the revenue of China's anti-obesity drug market is projected to reach 25.9 billion Chinese yuan (CNY) by 2030, with a compound annual growth rate of 35.1% from 2021 to 2030.

While Novo Nordisk and Eli Lilly strive to obtain approvals for their GLP-1 flagship products in China, domestic development of beinaglutide has already been approved. Beinaglutide, like semaglutide, is a GLP-1 receptor agonist (Eli Lilly's tirzepatide is a GLP-1/GIP dual receptor agonist). Beinaglutide's chemical structure, with its "straightforward" sequence of natural amino acids and the absence of fatty side chains that bind to albumin, necessitates three daily injections in terms of pharmacokinetics, unlike Wegovy, which requires only one weekly injection.

Beinaglutide, however, is just a stepping stone for Chinese biotech companies in the development of next-generation anti-obesity drugs. Leading the pipeline of promising GLP-1 products is mazdutide, a collaborative effort between China's Xinda Biopharmaceuticals and Eli Lilly. Mazdutide is a GLP-1/glucagon dual receptor agonist that achieves a delicate balance between blood glucose control and weight reduction. Its mechanism closely resembles Boehringer Ingelheim's anti-obesity drug pipeline product, Survodutide.

Xinda Biopharmaceuticals reported impressive results from a mid-stage clinical trial at the end of last year, showing an approximately 18.6% weight reduction in patients. Jefferies analysts found these results to be "impressive" and ranked mazdutide above semaglutide. Xinda Biopharmaceuticals plans to initiate Phase III trials for mazdutide in 2024.

3. United States: Focus on Novel Mechanisms and Combination Therapies
In the United States, the anti-obesity drug market is also expected to see advancements in 2024. While GLP-1 receptor agonists like semaglutide and liraglutide have gained popularity, there is growing interest in novel mechanisms of action.

One notable drug in development is setmelanotide, a melanocortin-4 receptor (MC4R) agonist. Setmelanotide has shown promising results in clinical trials, especially in patients with rare genetic disorders of obesity. The drug is being developed by Rhythm Pharmaceuticals and is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity.

Combination therapies are also being explored. For instance, Novo Nordisk is conducting Phase II trials for a combination therapy of semaglutide and bupropion, an antidepressant that has been associated with weight loss. The combination aims to provide enhanced weight loss benefits by targeting multiple pathways simultaneously.

4. Regulatory Environment and Challenges
Despite the advancements and opportunities in the anti-obesity drug market, there are regulatory and market challenges to consider. The FDA has set high standards for weight-loss drugs due to safety concerns and the need for long-term efficacy data. This poses a challenge for drug manufacturers seeking approval for new anti-obesity drugs.

Additionally, the societal perception and stigma surrounding obesity can impact the adoption and commercial success of anti-obesity drugs. Public education and awareness campaigns are crucial to address the underlying biases and promote understanding of obesity as a complex medical condition.

The anti-obesity drug market in 2024 is poised for significant developments. The entry of generic versions of Liraglutide in India, the expansion of the GLP-1 market in China, and the exploration of novel mechanisms and combination therapies in the United States are key trends to watch. However, regulatory challenges and societal perceptions remain important factors that will shape the future of the anti-obesity drug market.