Insulin Industry: Boundless Opportunities in the Chinese Market
——“Recombinant Human Insulin” Series Product Training Sidelights
Zhongshan Branch Liang Faxiong
On August 10, 9:00 AM, all seats in the conference room of Zhongshan Preparation Factory were occupied. Xiao Yongjun, chief inspector of Institute of Biology, and Wen Jiandong, product manager of Market Department is delivering a special training concerning diabetes and insulin products. “Our company organized a team with more than 200 members in 2002 dedicated to the research and development of biological pharmacy, over the past 8 years, we have got the production approval for four recombinant human insulins, USLIN N, USLIN R, USLIN 30R and USLIN 50R, which had been launched on January 22, 2012”, Xiao said, “and we have realized the integrated production from raw material to preparation.” At present, our company is accelerating the research and development of insulin analogues like the insulin aspart (quick-acting) and glargine (long-acting), producing new brands.
Unique production process, high product quality standard
The traditional way to produce inslulin is mainly to reproduce insulin gene that shears off with Escherichia coli, then cultivate Escherichia coli in large-scale to generate insulin.
United Laboratories USLIN is notable for the application of the most advanced pichia pastoris DNA recombinant and extracellular expression, strong secretion and post processing ability. USLIN, cultured in synthetic media, features quicker growth speed and low costs. It has the posttranslational modification to heterologous protein, which prokaryote does not have, for instance, the glycosylation. Since insulin expresses by secretion, it is able to extract insulin without cell disruption, thus reducing impurities like the heterologous protein and DNA in the insulin, achieving high product purity, stable quality and higher safety; the product quality standard is higher than the existing Chinese Pharmacopoeia, USP (United States Pharmacopeia) and European Pharmacopeias standards.
Higher clinical application value
During the research and development of recombinant human insulin, compare the safety and effectiveness in curing diabetics of USLIN and Novolin through multicenter, random, open and referenced clinical research. Clinical analysis were carried out respectively in 16 hospitals like Beijing Military Region General Hospital, Capital Medical University Beijing Tongren Hospital and Bethune International Peace Hospital, etc., result showed that, compared with Novolin, indexes of USLIN series products produced by United Laboratories, such as the major therapeutic effect index (glycosylated hemoglobin), minor therapeutic effect index (2h postprandial hyperglycemia and fasting blood glucose in vein), incidence of hypoglycemia and the adverse reaction ratio, showed no evident difference, indicating the higher safety, tolerance and compliance, therefore, it has higher clinical application value.
Huge development potential of Chinese insulin market
Throughout the development history of insulin, the animal insulin in the past is of low purity and prone to be allergic; recombinant human insulin in nowadays is higher purity and widely used; the insulin analogue in future will be fast-acting and long-acting.
According to latest data, there are 175 million diabetics around the world, of which 920, 000 in China, China has “eclipsed” India as the country with most diabetics in Asia. The average growth rate per annum of insulin market is 14.09%, market value in 2008 was 11 billion USD, and reached 14.5 billion USD in 2010.
According to Medical Economics, the growth rate of global insulin market in future will maintain at 10%, far higher than 3%-6%, the expansion rate of global pharmaceutical market. In China, only 2% of diabetics use insulin products to control blood sugar, while 30% in USA. In the coming years, Chinese insulin market will expand with the rate of 20%-30%. Low utilization rate of insular is the major feature of Chinese insular market. With the expansion of insular market and transformation of product structure, the second-generation (recombinant human insulin) and third-generation (insulin analogue) insulin products have huge market potential in China.
n the training session, Manager Wen said, global insulin market will maintain a stable growth. In the coming decade, global diabetic drug markets will main a compound growth of approximately 10% under following key driving forces: the multiple obesity, longer life expectancy, higher per capita income, and the release of new diabetic drugs. Insulin, the most important diabetic treatment drug, has maintained a compound growth in global sales of 14% in the past five years.
Insulin products presently widely used in China include the pig insulin, recombinant human insulin and insulin analogue, the insulin market in China is potential since they are mainly supplied by foreign plants, while by little domestic ones. Insulin industry has huge potential as Chinese insulin market has still far from fully developed. The aged tendency of population China faces will inevitably push up the incidence of diabetics, and promote the expansion of Chinese insulin market.
Tailor for customer, provide first-rate service
In order to better serve customers, United Laboratories Market Department has tailored a series of product introduction materials like the Diabetics Education Manual and abdomen /thigh injection site rotation, graphically introducing the operation of United Laboratories Pen, injection of insulin and notice to the initial insulin treatment.
Diabetics at home and abroad has have been at pains to save insulin safely and effectively in daily life and during travel. Our company is accelerating the design and development of insulin cooler bag to provide diabetics the safe and convenient way to save and carry insulin. In the near future, diabetics will have access to the humanistic care and unveil a new page in your daily life and travel.