Diabetes Drug Market Re-shuffles: Blockbuster Semaglutide Surges by 35,678%, Huahai Pursues First-to-File Generics, Shijiazhuang Siyao and Fuyuan Tap into a $70B+ Market

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Recently, the diabetes medication market has seen renewed activity. Shandong Shengdi Pharmaceutical's HR20031 Tablets (Ⅱ) and HR20031 Tablets (Ⅰ), Huahai Pharmaceutical Co., Ltd.'s Dapagliflozin Metformin Hydrochloride Sustained-Release Tablets (I), and other products have been accepted by the CDE for production applications. JIANGSU CHENPAI PHARMACEUTICAL CO., LTD.'s Voglibose Tablets, Shijiazhuang No.4 Pharmaceutical Co., Ltd.'s Epalrestat Tablets, and Beijing Front Pharmaceutical Co., Ltd.'s Sitagliptin Phosphate Tablets have been approved for marketing. Data from Menet shows that in recent years, the market size of chemical drugs (including biologics) for diabetes treatment in China’s public medical institutions has exceeded 50 billion yuan annually, with sales declining slightly in 2022 compared to the previous year. Breaking it down by category, insulin sales plummeted by over 20%, while GLP-1 receptor agonists gained significant traction. The top 10 rankings saw major changes, with Acarbose Tablets reversing their decline, and the exclusive blockbuster drug Semaglutide Injection experiencing a staggering 35,678% increase in sales. Among domestic brands, only Tonghua Dongbao Pharmaceutical Co., Ltd. made it onto the list.

Huahai Makes a Strong Push for the First Generic Diabetes Drug, Shijiazhuang No.4 Pharmaceutical, Front Pharma, and Others Follow Suit

On November 8, the CDE official website showed that Huahai Pharmaceutical Co., Ltd.'s Dapagliflozin and Metformin Hydrochloride Sustained-Release Tablets (I), Dapagliflozin and Metformin Hydrochloride Sustained-Release Tablets (III), and Dapagliflozin and Metformin Hydrochloride Sustained-Release Tablets (IV) were all accepted for production on the same day as Category 4 generics. Currently, only AstraZeneca holds the production approval for these three products, and no domestic pharmaceutical companies have been approved yet. Among them, Beijing Front Pharmaceutical Co., Ltd. has submitted applications for Dapagliflozin and Metformin Hydrochloride Sustained-Release Tablets (I) and (III), both received in October this year; there are currently no companies with pending applications for Dapagliflozin and Metformin Hydrochloride Sustained-Release Tablets (IV).

On November 10, the marketing applications for HR20031 Tablets (Ⅱ) and HR20031 Tablets (Ⅰ) from Shandong Shengdi Pharmaceutical, Dapagliflozin Tablets from Huisen Biopharmaceutical, and Pioglitazone Metformin Tablets from Jiangsu Ambition Pharmaceutical were accepted by the CDE.

Recently, the official website of the National Medical Products Administration showed that the Voglibose Tablets produced by JIANGSU CHENPAI PHARMACEUTICAL CO.,LTD. have been approved for production as a Category 4 generic drug, which is considered to have passed the evaluation. Voglibose Tablets are included in the ninth batch of national procurement. Data from Menet shows that in 2022, the terminal sales of Voglibose Tablets in Chinese public medical institutions, including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions), exceeded 400 million yuan, with a year-on-year increase of 13.33%. Prior to this, Epalrestat Tablets from Shijiazhuang No.4 Pharmaceutical Co.,Ltd., Epalrestat Tablets from Zhejiang Hengyan Pharmaceutical Technology, Sitagliptin Phosphate Tablets from Beijing Front Pharmaceutical Co., Ltd., Saxagliptin Metformin Hydrochloride Extended-Release Tablets (Ⅰ) and Saxagliptin Metformin Hydrochloride Extended-Release Tablets (Ⅲ) from Hefei Heyuan Pharmaceutical were all approved for production under the new classification.

So far this year, 26 products (83 specifications) of chemical drugs for diabetes treatment (including biologics) have been approved for marketing in China, with 51 products (175 application numbers) under review for production. Market competition is extremely fierce.

Centralized Procurement Impacts a Market Exceeding 50 Billion! Insulin Plummets, GLP-1 Receptor Agonists Gain Popularity

In recent years, the market size of diabetes drugs (including biologics) in China's public medical institutions has exceeded 50 billion yuan. In 2022, sales declined year-on-year. From the perspective of manufacturers, foreign pharmaceutical companies occupy the leading position, with Novo Nordisk, AstraZeneca, and Sanofi ranking in the top three. Among the TOP10, there are four domestic pharmaceutical companies: Tonghua Dongbao Pharmaceutical Co., Ltd., Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., Gan&Lee Pharmaceuticals, and Yangtze River Nanjing Hailing Pharmaceutical Co., Ltd.

In terms of sales channels, the market shares of urban public hospitals and urban community centers in China have increased, while those of county-level public hospitals and township health centers have declined.

Top 5 Subcategories of Diabetes Medications (Including Biologics) in Chinese Public Medical Institutions in 2022

Source: MiNei Network's Competitive Landscape of Drug Terminals in China's Public Medical Institutions

In terms of subcategories, insulin and its analogs, GLP-1 receptor agonists, alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, and SGLT2 inhibitors are the five top-selling subcategories. Among them, the sales of insulin and its analogs declined by more than 20% year-on-year due to the impact of centralized procurement; GLP-1 receptor agonists experienced the fastest growth rate of 117.90%, entering the TOP5 subcategories for the first time.

TOP10 Shakeup! Exclusive Star Drug Surges 35678%, Only One Chinese Brand Remains

Top 10 Chemical Drugs (Including Biologics) for Diabetes Treatment in Chinese Public Medical Institutions in 2022

Source: Terminal Competition Pattern of Pharmaceutical Products in China's Public Medical Institutions (MiNe Network)

The sales revenue of the top 10 products all exceeded 1 billion yuan. Insulin glargine injection and insulin aspart 30 injection are blockbuster products at the 4-billion-yuan level. Semaglutide injection, with an astonishing growth rate of 35,678%, entered the top 10 for the first time, and only Novo Nordisk holds the production approval.

Notably, among the TOP10, except for Dapagliflozin Tablets, Sitagliptin Phosphate Tablets, and Semaglutide Injection, the remaining seven products have been included in the national procurement program. Among them, six products have experienced varying degrees of decline. Acarbose Tablets, one of the earliest diabetes medications incorporated into the national procurement program, rebounded in 2022 after two consecutive years of significant drops, with a year-on-year increase of over 20%.

Top 10 Diabetes Medication Brands (Including Biologics) in Chinese Public Medical Institutions, 2022

Source: Terminal Competition Pattern of Pharmaceutical Products in Chinese Public Medical Institutions (MiNe Network)

Among the top 10 brands, foreign pharmaceutical companies occupy 9 positions, and the only Chinese brand is Tonghua Dongbao Pharmaceutical Co., Ltd.'s 30/70 Mixed Recombinant Human Insulin Injection. In terms of growth rate, three brands showed positive growth: AstraZeneca's Dapagliflozin Tablets, MSD's Sitagliptin Phosphate Tablets, and Novo Nordisk's Semaglutide Injection.

In terms of quantity, Novo Nordisk has the most, with five products: Insulin Aspart 30 Injection, Human Insulin Isophane Mixed Injection (30R), Semaglutide Injection, Insulin Aspart Injection, and Liraglutide Injection.

Quarterly Sales of Semaglutide Injection in Chinese Public Medical Institutions, 2022 (Unit: Billion Yuan)

Source: Terminal Competition Pattern of Pharmaceutical Products in Chinese Public Medical Institutions (MiNe Network)

Semaglutide Injection, developed by Novo Nordisk, is a new type of long-acting glucagon-like peptide-1 (GLP-1) analog. It is used for blood glucose control in adult patients with type 2 diabetes whose blood sugar levels are not adequately controlled by metformin and/or sulfonylureas despite dietary control and exercise. It also reduces the risk of major cardiovascular adverse events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adult patients with type 2 diabetes who have cardiovascular disease. The product was approved in China in April 2021 and included in the medical insurance system in the same year. Data from MiNe Network shows that the market size of Semaglutide Injection in Chinese public medical institutions has surged, with sales increasing by 35,678% year-on-year in 2022. Currently, no domestic pharmaceutical companies have reported production under review for Semaglutide Injection. Ten domestic pharmaceutical companies, including Zhengda Tianqing Pharmaceutical Group, Livzon Group Xinpjiang Pharmaceutical, and Huadong Medicine, have been approved for clinical trials. Recently, Huadong Medicine stated on its investor interaction platform that the diabetes indication for its Semaglutide Injection is currently in the Phase III clinical trial enrollment stage, with the number of enrolled subjects gradually increasing. According to Novo Nordisk's latest financial report, in the first three quarters of this year, the company’s star product, Semaglutide, achieved significant growth.

Source: MiNeiNet Database, Company Announcements

Note: The terminal competitive landscape of pharmaceuticals in Chinese public medical institutions by Menet, covers the statistical scope of urban public hospitals, county-level public hospitals, urban community health centers, and township health centers, excluding private hospitals, private clinics, and village health rooms. The sales mentioned above are calculated based on the average retail price of products at the point of sale. Any corrections or omissions are welcome!