Global Human Recombinant Insulin Market – Industry Insights
Discovery of insulin is considered to be one of the most important events in the history of the diabetes treatment. Furthermore, major advances in human insulin technology is the synthesis of human insulin analogue by recombinant technology. Currently, human insulin delivery system available for the administration of insulin include insulin syringes, insulin pumps, jet injections, and pens. Key players are focused on developing recombinant human insulin instead of animal-based insulin, owing to increasing demand for human insulin in the treatment of diabetes. Human recombinant insulin has a faster onset of action and lower immunogenicity than pork or beef insulin. Currently human recombinant insulin is gaining significant traction with the development of biosimilar analogue of human insulin.
According to the Addressing the Challenge and Constraints of Insulin Sources and Supply (ACCISS): 2016 report, the insulin market including human recombinant insulin largely contributes around 40 local manufacturers, with largely local markets apart from three largest global insulin manufactures: Novo Nordisk A/S, Sanofi S.A. and Eli Lilly and Company. Furthermore, various manufacturers offer a recombinant analog of human insulin-like growth factor that has been specifically engineered for the research and industrial cell culture market, providing a consistent, compliant, and reliable alternative to recombinant insulin. Such manufacturers include: Merck KGaA, Thermo Fisher Scientific, Inc., among others. These manufacturers offers recombinant human insulin analogue products as a raw material or blended with custom media formulations for small scale process development and commercial biomanufacturing applications. Launch of biosimilar and other insulin products and research for recombinant insulin products is expected to drive growth of the market during the forecast period.
Moreover, rising diabetes population, worldwide combined with increasing research and development (R&D) activities by various government and private organizations in human insulin development is expected to boost growth of the human recombinant insulin market in the near future.
The global human recombinant insulin market was valued at US$ 27.4 billion in 2018, and is expected to witness a CAGR of 7.2% over the forecast period (2018 – 2026).
Figure 1: Global Human Recombinant Insulin Market Share, By Product Type:
Increasing Investment in Diabetes Research Activities is expected to Boost the Growth of Human Recombinant Insulin Market
Various government and private research organizations are engaged research and development activities for developing advanced treatment in diabetes care to increase the effectiveness of human insulin, reduce diabetes burden, and minimize the risk of diabetes associated disorders such as diabetes-associated blindness, kidney disease, heart attacks, strokes or limb loss. For instance, American Diabetes Association (ADA) invested US$ 807.4 million in more than 4,700 research projects in diabetes research since 1952 till 2017. According to ADA, 2017 review, ADA invested more than US$ 37.4 million for diabetes research in 2017, and supported 371 diabetes related research projects. The European Foundation for the Study of Diabetes (EFSD): a division of European Association for the Study of Diabetes (EASD), provides funding initiatives in all areas of diabetes research. EFSD aims to accelerates and support research in the field of diabetes to introduce innovative diabetic management portfolio.
In September 2017, Biocon Limited: an India-based biopharmaceutical firm received funding from Juvenile Diabetes Research Foundation (JDRF) to study oral insulin drug candidate: Tregopil, to evaluate the safety and tolerability in people suffering with type 1 diabetes. The collaboration between Biocon and JDRF is a part of JDRF's Industry Discovery and Development Partnership (IDDP) programme, through which JDRF provides financial support to Biocon to accelerate research in type 1 diabetes management.
Increasing Incidence of Diabetes Worldwide is expected to Drive Growth of the Human Recombinant Insulin Market
Insulin plays a vital role in diabetes management by controlling blood sugar level. Both type 1 and type 2 diabetes people are benefited by maintaining blood sugar levels. Increasing incidence of diabetes is expected to be major factor driving growth of the market in the near future. For instance, according to the World Health Organization (WHO), 2016, an estimated 422 million adults are suffering from diabetes. The major spike in incidence of type 2 diabetes over the last decade is mainly attributed to increasing prevalence of obesity. According to the International Diabetes Federation (IDF) Atlas 2017, global burden of diabetes is affecting more than 425 million people, among which one-third are older than 65 years of age. Moreover, the number of people with diabetes may rise to 629 million in 2045. Furthermore, 352 million with impaired glucose tolerance are at high risk of developing diabetes. Furthermore, continuous increase in incidence rate of diabetes, owing to unhealthy lifestyle, binge eating, obesity, overweight, physical inactivity, and insulin resistivity among global population is expected to further boost growth of the human recombinant insulin market over the forecast period.
However, high cost of insulin may restrain growth of the market, as patients from low and middle countries are unable to afford it. According to the Pharmaceutical Care Management Association (PCMA) May 2018 report, prices of insulin have increased over 10-fold since 1985 and prices have exhibited significant rise during the last past 10 years (2008 to 2018). According to PCMA, prices for Humulin/Novolin have increased from around US$ 25 per prescription in 1985 to nearly US$ 300 in 2016. Furthermore, prices for long-acting insulins have increased from around US$ 100 per prescription in 2007 to nearly US$ 400 in 2016.
Key players operating in human recombinant insulin market include Novo Nordisk A/S, Eli Lilly and Company, Sanofi S.A., Julphar Gulf Pharmaceutical Industries, Biocon Limited, Bioton S.A., Gan & Lee Pharmaceuticals, Ltd., Zhuhai United Laboratories Co., Ltd., Wanbang Biopharmaceuticals Co., Ltd., and Dongbao Enterprise Group Co., Ltd.
Recombinant human insulin is the synthetic insulin, developed using recombinant DNA technology by growing insulin proteins within Escherichia coli. Recombinant human insulin has a faster onset of action and lower immunogenicity than other types of insulin such as pork or beef insulin. Human insulin is available primarily in two forms: a short acting (regular) form and an intermediate acting (NPH) form. Moreover, the premixed human insulin is formed by combining two types of insulin, among which one is controls blood sugar level throughout the day, while second type of insulin helps to control blood sugar at meal times. Human recombinant insulin market is gaining traction due to development of biosimilar analogue of insulin, worldwide.
Sedentary and unhealthy lifestyle, binge eating, obesity, impaired glucose tolerance, diabetes family history, and increased insulin resistance are some of the risk factors for developing diabetes among the global population. Moreover, increasing number of diabetic population, and growing research and development (R&D) studies in human recombinant insulin to introduce improved version of insulin in the market is expected to boost the growth of human recombinant insulin market in near future. Key manufactures are launching innovative and improved human recombinant insulin in the market to fulfill the increasing demand for insulin. According to the Addressing the Challenge and Constraints of Insulin Sources and Supply (ACCISS): 2016 report, global insulin market is largely dominated by three pharmaceutical companies: Novo Nordisk A/S, Sanofi S.A. and Eli Lilly and Company. Furthermore, Southeast Asia and Latin America accounts with higher number of smaller human recombinant insulin manufactures, than other regions.
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