In 2023, the pharmaceutical market can be out of the circle without the "weight loss miracle drug" GLP-1 (glucagon-like peptide-1). As a new category that is fanatical around the world, it has attracted many domestic and foreign pharmaceutical companies to increase their layout.
On the one hand, from the perspective of drug efficacy, GLP-1RA (GLP-1 receptor agonist) has become the most ideal hypoglycemic drug due to its advantages over insulin. Musk's "planting grass" has made GLP-1 weight loss drugs successfully popular all over the world, and has become a "popular fried chicken" in the diabetes and weight loss market.
On the other hand, from the perspective of market development, it also has great potential. Debang Securities predicts that the global market size of GLP-1 in the field of type 2 diabetes and obesity will reach 90 billion US dollars in 2030. Among them, the type 2 diabetes drug market accounts for about $35 billion to $40 billion, and the weight loss drug market accounts for about $50 billion to $55 billion.
With the increase in the rate of diabetes and obesity in mainland China year by year, the market scale of hypoglycemic and weight-loss drugs is also expanding. There are 141 million diabetic patients in the mainland, the largest number in the world. The prevalence of overweight and obesity among adults is now over 50% and is expected to reach 61% by 2030.
"With the launch of more GLP-1 drugs, it is expected that the market size of GLP-1 in China will exceed 60 billion yuan in 2030. Liu Lihe, executive director of CIC Insight Consulting, pointed out in an interview with the 21st Century Business Herald reporter that at present, many domestic pharmaceutical companies have entered the GLP-1 track, and the drugs under development include GLP-1 innovative drugs and biosimilars.
Nugget Market
In terms of bariatric indications, there are currently only three GLP-1 products approved by multinational pharmaceutical companies, namely liraglutide and semaglutide from Novo Nordisk, and Eli Lilly Zepbound (Tirzepatide, tirpatide), which was approved by the FDA in November 2023.
According to the analysis of Nature, the strongest weight loss drug tirpatide has a unique activity to stimulate insulin secretion. Many people in the industry also bluntly said: tirpatide will become the biggest competitor of semaglutide.
Market recognition has also pushed the market value of these two multinational giants to climb. Debang Securities analysis pointed out that the U.S. capital market highly recognizes the explosive growth of GLP-1, Novo Nordisk semaglutide and Eli Lilly tilpatide, which are expected to exceed $20 billion and $4 billion respectively in 2023, catalyzed by sales exceeding expectations and clinical data exceeding expectations, helping Eli Lilly's market value of $500 billion and Novo Nordisk's market value of $400 billion, becoming the world's top three pharmaceutical companies by market capitalization.
In this way, Novo Nordisk and Eli Lilly have announced plans to expand production capacity in the third quarter of 2023. Novo Nordisk said it is investing more than 42 billion Danish kroner ($6 billion) to expand its production facilities in Denmark for a product portfolio of current and future serious chronic diseases. These construction projects will be progressively completed from the end of 2025 to 2029. Novo Nordisk also mentioned that the investment will improve the company's ability to meet future market demand, including GLP-1 products.
Eli Lilly chose to invest $450 million in its North Carolina facility to provide additional drug filling, equipment assembly and packaging capabilities for products, including Mounjaro. Eli Lilly will also continue to focus on other parts of the supply chain, as demand is expected to remain high and production bottlenecks may change over time.
Judging from the current market layout, drug development targeting GLP-1 receptors has become the mainstream of clinical research on weight loss drugs. On the whole, Novo Nordisk and Eli Lilly are in the leading position in the layout of GLP-1 drug indications for diabetes among multinational companies, and both have approved a number of drugs. In addition, Pfizer, Amgen, Novartis, Takeda Pharmaceuticals and Boehringer Ingelheim also have products under development. In recent years, domestic enterprises have also entered the market and continued to increase R&D investment, striving to gain a place in the market as soon as possible.
At present, two GLP-1 drugs have been approved by domestic companies. In March 2023, Huadong Medicine's liraglutide injection was approved by the NMPA for the indication of diabetes, and in July 2023, the indication for obesity or overweight was approved by the NMPA, and in July 2023, the benaglutide injection developed by Renhui Biotech was approved for marketing by the NMPA, as the first original innovative drug approved for the indication of weight loss in China, and benaglutide injection is also the third approved GLP-1 class reduction drug in the world.
In addition, the number of products under development by Hengrui Pharmaceutical, Innovent Biologics and other companies is in the forefront. According to the Insight database, more than 100 new GLP-1 drugs have entered the clinical stage in China. Domestic pharmaceutical companies have also laid out more than 20 products for weight loss indications.
In November 2023, AstraZeneca and Chengyi Biotech reached an authorization license for new drugs for cardiometabolic diseases and obesity, and obtained the global rights and interests of Chengyi Biotech's next-generation oral GLP-1 receptor agonist ECC5004 as monotherapy and combination therapy.
In this regard, Zhou Jingye, founder and CEO of Chengyi Biotech, said in an interview with the 21st Century Business Herald reporter that if the cooperation with a large-scale multinational pharmaceutical company is started in the clinical development stage, it can accelerate the development process of the product, accelerate the listing of the product to a greater extent, and secondly, expand the trend of combining different products with different products in the future and expand the market prospects. For local GLP-1 layout enterprises, it is more advantageous to carry out cross-border cooperation in the early stage, and if they rely entirely on their own capabilities, the benefits will be smaller.
Multi-dimensional layout
For the weight loss market, GLP-1 is undoubtedly a definite and shining "pearl" at present.
A brokerage analyst told the 21st Century Business Herald that with the successive listing of liraglutide, semaglutide and tirpatide, as well as the expansion of GLP-1 drugs from type 2 diabetes to weight loss indications, the global GLP-1 market size is expected to exceed 100 billion US dollars in 2030. From the perspective of the domestic market, semaglutide will occupy more than 40% of the market share of China's GLP-1 market in 2022. At present, many domestic pharmaceutical companies have entered the GLP-1 track, and the drugs under development include GLP-1 innovative drugs and biosimilars.
Zhou Jingye believes that from the perspective of the competition pattern on the GLP-1 track, there will be two categories of more competitive products in the short term, one is oral small molecule GLP-1 receptor agonists, which have more promising future potential due to convenience, lower cost or better patient compliance, and the other is multi-target, that is, two-target or three-target peptide injection drugs, represented by Eli Lilly's tirpatide.
In the case that many layouters accelerate the layout and homogenization is very serious, there will be "involution". "In the field of small molecule GLP-1, we can see that there are two major products at the forefront, one is Pfizer's Lotiglipron and Danuglipron, and the other is Eli Lilly's Orforglipron. And in mid-2023, Pfizer stopped the development of its product Lotiglipron because of liver toxicity. This also means that the development of such products is very challenging, and it is difficult to develop them. Zhou Jingye said that if there is a first-mover advantage in this category, and there is a volume advantage, the competitive advantage will be reflected. In order to achieve this goal, it is necessary to lay out the track in advance, and the R&D ideas must be significantly better than other competitors under research.
According to relevant statistics, there are currently more than 19 GLP-1RA small molecules under clinical development worldwide, including Eli Lilly's Orforglipron (Phase III clinical trial) and Chengyi Bio's ECC5004 (Phase I clinical trial), as well as Xianweida's XW014 (Phase I clinical trial) and Derui's MDR-001 (Phase I clinical trial).
In addition, multi-target agonists have become the focus of future R&D of major companies. Eli Lilly's tirpatide is the world's first and only approved glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic peptide (GIP) receptor dual agonist, opening the era of GLP-1R/GIPR dual targets for hypoglycemic and weight loss drugs. AstraZeneca, Merck & Co., Ltd. and other companies have layouts in dual/multi-target agonists.
At present, a number of dual/multi-target agonist pipelines have entered clinical trials around the world, focusing on GLP-1R/GIPR, GLP-1R/GCGR and other combinations. However, major companies are also actively carrying out GLP-1R/GIPR/GCGR three-target research, among which Eli Lilly's Retatrutide has entered phase III clinical trials.
Domestic companies are also actively deploying and developing multi-target agonists. Among them, Innovent Biologics' GLP-1R/GCGR dual agonist IBI362 from Eli Lilly has entered Phase III clinical trials, and Huadong Pharma's three-target innovative drug DR10624 has completed the first cohort of the Phase I Single Dose Escalation (SAD) clinical trial for bariatric indications in China, and is currently conducting simultaneous SAD and MAD trials in New Zealand.
In the GLP-1 track, domestic and foreign companies will also gradually expand to a variety of indications. For example, in addition to diabetes and obesity indications, semaglutide has indications in cardiovascular diseases, non-alcoholic steatohepatitis, chronic kidney disease, Alzheimer's disease, heart failure and other fields, all of which are clinical fields with huge potential space.
The long-acting GLP-1 drug Efpeglenatide under development by Sanofi/Hanmi Pharma is a long-acting bio-improved preparation of exenatide, which is expected to be injected once a month and become an ultra-long-acting hypoglycemic drug, which has entered phase III clinical trials.
In the face of an increasingly competitive landscape, companies are likely to need to assess the risk-benefit ratio. From the perspective of the market, in the past two years, local innovative pharmaceutical companies with the layout of the GLP-1 track in China have signed cooperation projects with multinational pharmaceutical companies, which actually means that the trend of "going overseas" is accelerating. This is also due to the fact that China has a large advantage in the layout of the GLP-1 track, and now the number of domestic GLP-1 projects as a whole has even exceeded the number of American research and development.
It can be predicted that expanding overseas markets in the future will be an important direction for pharmaceutical companies to expand their market scale and avoid "involution". At present, many companies, including Hanyu Pharmaceutical and Tonghua Dongbao, are speeding up the pace of "going overseas".
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