by Tyler Fritsch
LECOM Doctor of Pharmacy Candidate, Class of 2016
Researchers approximate that 387 million people worldwide are living with diabetes mellitus, whose prevalence will reach 10% of the world’s adult population (592 million) by 2035. Furthermore, it is estimated that only 6% of those living with diabetes mellitus are without DM-related complications such as kidney failure, myocardial infarction (MI), ischemic stroke, subarachnoid hemorrhage (SAH), blindness, and amputations.
According to Global Business Intelligence, the world market for diabetes care products summate to $41 billion, which is up 12% annually over the last decade. The expenditures related to diabetes mellitus are projected to experience perpetual growth due to the increased prevalence of DM and the yearning for more effective treatments. The global therapeutics market for diabetes care is predominantly attributed to the T2DM population, who accounts for 90% of all DM patients. The T2DM population is postulated to constitute 95% of total DM care expenditures by 2021. The level of market growth is trending in an exponential fashion, which is theorized to undergo siege and scrutiny in the near future as government-sanctioned cost-cutting mandates are expected to be implemented.
With the diabetes market being ubiquitous and well-developed, operational growth of several drug companies is being precluded. Incidentally, the high diagnostic rates of DM and the ever-growing patient need is prompting drug companies such as Novo Nordisk to take an astute approach to remain lucrative with the launch of a novel insulin in 2016, Tresiba (degludec), and its corresponding combination product, Xutolphy (Tresiba and Victoza). Dr. Klaus Henning Jensen, medical director at Novo Nordisk UK stated, “We believe that Xutolphy provides some clear benefits for a clear group of patients with type 2 diabetes mellitus who are not sufficiently well controlled on basal insulins.” Jensen goes on to explain, “But what’s probably most important to patients and doctors is that it’s available as one single pen,” This is simply one exemplification of how the current and future trends of the diabetes market is incentivizing manufacturers to make innovative advances correlating to the management of DM.
The ascending prevalence and expenditures in relation to DM has inaugurated a new market known as biosimilars. Biosimilar compounds are derived from genetically modified living cells and are structurally complex and chemically similar to already approved biologic reference medicines, but are not identical, and cannot be categorized as generics. Though, biosimilars are designed not to divert from the clinical efficacy sought out by the innovator product. According to IMS Health, the savings of using biosimilars are expected to be upwards of 20-30% in comparison to insulins and other biological drugs. Numerous pharma companies are pipelining biosimilar versions of insulin products to penetrate the established insulin market. Lilly and Boehringer Ingelheim already have a biosmiliar insulin product seeking to confront the current market, which has been predominantly controlled by Novo Nordisk and Sanofi. A spokeswoman from Lilly commented on this novel class of biosimilars stating, “The introduction of biosimilars can help expand the range of available treatment options that health care professionals can prescribe. We are aware of the expectation by over-stretched health systems, such as the NHS, for biosimilars to offer a cost-efficiency versus the original reference molecule. She further elaborated on the subject of biosimilars saying. “The first priority for healthcare companies today is to match the medicine to the specific need in a patient’s treatment journey and we believe that payer policies should allow the healthcare professional the freedom to choose either the current medicine or biosimilar product.
Merck also has begun developing an insulin biosimilar, MK-1293, and has completed a superiority Phase III trial comparing MK-1293 with Sanofi’s Lantus in people with T2DM. It is also being analyzed against Lantus and Novo Nordisk’s Novolog in a Phase I study in patients with T1DM. In response to the threat from biosimilars, Sanofi has sought to create products as the successors to Lantus. The French firm introduced Toujeo, its new insulin glargine product, in the UK, and it is already available in the US, Canada, the European Union and Japan.
A future endeavor that’s being researched in response to the prevalence and expenditures corresponding to DM are stem cells. Stem cells are undifferentiated and non-specific, thereby having the capability to develop into many different cell types. Based on this notion, stem cells are prognosticated to have significant therapeutic potential. Cells cultivated in the early embryonic stages can give rise to pluripotent cells, which possess the ability to mature into any cell type, including insulin-producing beta cells. The differentiation of embryonic stem cells and adult stem cells is monumental such that the latter under normal conditions is impeded by the number of different specialized cells they can give rise to. Currently, it has not been exemplified that parallel scientific results can be procured from using adult stem cells. Thus, drug companies are utilizing human embryonic stem cells in order to drive research into developing beta cells for potential transplantation into patients as a curative approach towards diabetes mellitus.
- The increasing prevalence and expenditures coinciding with DM have given rise to innovation and further advancement.
- Novel insulin products such as Tresiba and Xutolphy, and biosimilars such as MK-1293, are indicative of drug companies’ responses to the ever-changing outlook of diabetes care.
- Stem cell research is a prominent and promising future endeavor seeking to drastically change how we approach the treatment of diabetes mellitus.
Pharmafile. “Moving Forward in Diabetes.” Web. 10 June 2015. < http://www.pharmafile.com/news/499362/moving-forward-diabetes>.