Foreign Giants Dominate Insulin Market as Seven Domestic New Products Await Launch

Medicine Network, June 4 – Recently, the National Medical Products Administration (NMPA) approved the marketing application in China for insulin degludec/insulin aspart injection, developed and manufactured by Novo Nordisk, for the treatment of type 2 diabetes in adults. Reportedly, this product is the first soluble dual-insulin formulation, composed of 70% insulin degludec and 30% insulin aspart, effectively addressing both fasting and postprandial blood glucose control. In September 2018, the import application for this product was successfully included in the priority review pathway due to its status as an innovative drug with significant therapeutic advantages. Data from the Menet MED Drug Review Database 2.0 show that the two application numbers were approved after a review period of 381 days.

 

　　Insulin and Its Analogs Surpassed 2.5 Billion in 2018, with Foreign Brands Occupying 7 of the Top 10 Spots

 

Diabetes mellitus is a chronic, multifactorial disease characterized primarily by disorders of glucose metabolism, resulting from an absolute or relative deficiency of insulin or reduced sensitivity of target cells to insulin. Insulin is one of the most effective therapeutic agents, and insulin preparations rank first in global usage among diabetes medications. Studies have shown that insulin is the sole treatment option for patients with type 1 diabetes; furthermore, approximately 30%–40% of patients with type 2 diabetes will eventually require insulin therapy.

 

According to statistics from the International Diabetes Federation, the global number of people with diabetes reached 370 million in 2011, and it is estimated that by 2030, there will be nearly 550 million people with diabetes worldwide, while China has become the country with the largest number of diabetes patients. According to the latest epidemiological survey, the incidence rate of diabetes in China is 11.6%, with type 2 diabetes accounting for approximately 90%.

 

Figure 1: Public hospitals in key provinces and municipalitiesHospitalAnnual Sales Trends of Chemical Drugs for Diabetes by Subcategory (Unit: 10,000 Yuan)

　(Source: Competitive Landscape of Key Provincial and Municipal Public Hospital Terminals on Menet)

 

With the growing number of diabetes patients, the market size of diabetes medications in China has been increasing year by year. Data from Menet shows that since 2016, the market size of chemical drugs for diabetes in key provincial and municipal public hospitals has exceeded the 6 billion yuan mark, rising to 6.77 billion yuan in 2018. Insulin and its analogs, as the main therapeutic drugs, hold a market share of over 37%, with sales exceeding 2.5 billion yuan at the terminal level in key provincial and municipal public hospitals in 2018.

 

Table 1: Market Share of the Top 10 Brands of Chemical Insulin and Its Analogs in Public Hospitals in Key Provinces and Cities

(Source: Competitive Landscape of Key Provincial and Municipal Public Hospital Terminals on Menet)

 

In recent years, the combined market share of the top 10 brands of chemical insulin and its analogs in public hospitals across key provinces and municipalities has remained at approximately 95%. Among these top 10 brands, seven are from foreign pharmaceutical companies. Novo Nordisk holds four positions with its products: Insulin Aspart 30 Injection, Insulin Aspart Injection, Insulin Detemir Injection, and Protamine Biosynthetic Human Insulin Injection, which collectively account for over 44% of the market share. Eli Lilly has two products on the list—Insulin Lispro Injection and Protamine Zinc Recombinant Human Insulin Injection—with a combined market share exceeding 12%. Sanofi’s Insulin Glargine Injection ranks first, with its market share steadily increasing in recent years, reaching 26.72% in 2018.

 

 

　　Table 2: Overview of Insulin Products Approved for Market Launch from 2018 to Present

(Source: Menet MED China Drug Review Database 2.0)

 

Hefei Tianmai Biotechnology’s Recombinant Human Insulin Injection is classified under Category 15 of therapeutic biological products, as an existing national drug.Standardbiological products, which were submitted under the new drug application procedure. The product was accepted for review in September 2015 and, after a period of 967 days, was approved for production on May 8, 2018.

 

It is reported that the gene for Hefei Tianmai Biotechnology’s recombinant human insulin injection originates from the world-leading BTG Biological Research Institute in Israel. This institute is recognized as one of the “Big Four” mastering core insulin technologies, alongside Novo Nordisk, Eli Lilly, and Sanofi. The recombinant DNA technology employed in this product yields insulin that is structurally identical to endogenous human insulin, thereby avoiding immune responses. Compared with animal-derived insulin, this product offers superior efficacy and safety.

 

Novo Nordisk’s insulin degludec/insulin aspart injection is the first soluble dual-insulin formulation, comprising 70% insulin degludec and 30% insulin aspart. It effectively addresses both fasting and postprandial glucose control, with low rates of confirmed hypoglycemia and nocturnal confirmed hypoglycemia. The product was first approved globally in December 2012 and is currently marketed in 26 countries and regions worldwide.

 

Figure 2: Review Timeline for Novo Nordisk’s Insulin Degludec/Insulin Aspart Injection (Acceptance No.: JXSS1800012)

(Source: Menet MED China Drug Review Database 2.0)

 

Menet MED ChinaMedicinesData from the Review Database 2.0 shows that Novo Nordisk’s insulin degludec/insulin aspart injection (application numbers JXSS1800011 and JXSS1800012) was accepted for review on May 7, 2018, included in the priority review pathway in September of the same year, and successfully approved after 381 days.

 

 

Figure 3: Competitive Landscape of Chemical Insulin and Its Analogs in Public Hospitals in Key Provinces and Cities, 2018

(Source: Competitive Landscape of Key Provincial and Municipal Public Hospital Terminals from Menet Network)

 

From the perspective of the competitive landscape, foreign pharmaceutical companies such as Novo Nordisk, Sanofi, and Eli Lilly currently hold over 85% of the market share, leaving limited room for domestic pharmaceutical enterprises. Nevertheless, Chinese companies such as Gan & Lee Pharmaceuticals, Tonghua Dongbao Pharmaceutical, and The United Laboratories remain confident in China’s insulin and insulin analog market and continue to strive in new product development.

 

Table 3: Status of Insulin Products Currently Under Review and Approval for Market Authorization

(Source: Menet MED China Drug Evaluation Database 2.0)

 

Currently, there are seven insulin products under application for market approval and undergoing review and approval. All are classified as Class 15 new therapeutic biological products, involving domestic companies Gan & Lee Pharmaceuticals, Hefei Tianmai Biotechnology, Tonghua Dongbao Pharmaceutical, and Zhuhai United Laboratories.

 

Figure 4: Market Share Trends of Chemical Insulin and Its Analogs in Public Hospitals Across Key Provinces and Cities for Three Domestic Companies

(Source: Competitive Landscape of Key Provincial and Municipal Public Hospital Terminals on Menet)

 

As a leading domestic insulin manufacturer, Gan & Lee Pharmaceuticals has seen its sales revenue in the market for chemical insulin and its analogs in public hospitals across key provinces and cities rise year by year in recent years. Its market share increased from 4.95% in 2013 to 8.01% in 2018, achieving remarkable results despite significant pressure from foreign enterprises. The company’s recombinant insulin glargine injection ranked seventh among the top 20 brands of chemical insulin and its analogs in public hospitals in key provinces and cities in 2018, with its market share rising to approximately 8%. According to the draft prospectus submitted by Gan & Lee Pharmaceuticals, the company currently possesses three recombinant insulin analog products, covering the long-acting, rapid-acting, and intermediate-acting segments of the insulin market. Currently, the marketing application for its insulin aspart injection is under review and approval. In the future, the company’s product portfolio will be further enriched, positioning it as a manufacturer with a full range of recombinant insulin analog products.

 

In recent years, Tonghua Dongbao’s market share has been increasing year by year. In 2018, its NPH recombinant human insulin injection ranked tenth among the top 20 brands of chemical insulin and its analogs in key provincial and municipal public hospitals. In its annual report, Tonghua Dongbao stated that the company began research on four types of insulin analogs in 2011, including insulin glargine, insulin aspart and its premixed formulations, insulin detemir, and insulin lispro and its premixed formulations. Currently, the company’s insulin aspart injection and insulin glargine injection are under review and approval.

 

Federal Pharmaceutical’s products currently under regulatory review include Insulin Aspart 30 Injection and Insulin Aspart Injection. According to the company’s annual report, it has initiated preclinical research on products such as Insulin Degludec Injection and Insulin Degludec/Insulin Aspart Combination Injection.

 

Hefei Tianmai Biotechnology’s recombinant human insulin injection was approved for market launch in 2018. Products currently under review and approval include protamine recombinant human insulin injection (premixed 30/70) and protamine recombinant human insulin injection. According to the company’s official website, Tianmai Biotechnology and its partners jointly launched the oral insulin capsule project in 2015, developing and applying novel oral delivery technology for protein-based drugs to fill an international gap. The oral insulin capsule has completed Phase IIb clinical trials in the United States and is poised to commence international multicenter Phase III clinical trials in China.

 

 

Currently, most domestic biologicalPharmaceuticalsEnterpriseThe market is relatively small, and the insulin production industry has high technical barriers, making it difficult for companies lacking competitive advantages to enter the market and secure a certain share. In recent years, multinational pharmaceutical companies have increased their investments in the Chinese pharmaceutical market, which will further intensify competition in the biopharmaceutical sector. The recent approval of Novo Nordisk’s insulin degludec/insulin aspart injection for import will undoubtedly create a new impact on the domestic market, leveraging the company's leadership position in China and the inherent advantages of its product. Domestic companies are continuously catching up in product research and development. Will the insulin market witness a new landscape in the future? Only time will tell.

 

Source: Menet Database, Annual Reports of Listed Companies

 

Data statistics as of June 3, 2019