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Pharmas sprint to launch type 2 diabetes drugs as competition heats up

By Mia Burns (

The global pre-diabetes population is three times the size of the current diabetes patient population, according to Frost & Sullivan. The company has released new research titled Analysis of the Global Type 2 Diabetes Therapeutics Market indicating that 15 new drugs for type 2 diabetes are in late-stage development. In addition, the analysis outlines opportunities in the market and the industry’s future through an international evaluation of current drugs and those in the pipeline.

Frost & Sullivan executives say that a tremendous increase in the pandemic’s prevalence is in store, and the industry is in dire need of better tools to prevent disease progression. The identification of the precursors to fully developed diabetes through prophylactic therapy is vital, as an unexplored market segment driven by an ever-growing customer base. Meeting patients’ needs through the inclusive therapeutics approach allows practitioners to prevent and manage disease progression. This is crucial in the shift to prevention over treatment in the healthcare market and aligns with the new paradigm of physician quality over quantity.

“The unexplored market segment is referring to new therapies targeting genetic or pathological precursors to developing diabetes, and yes, pre-diabetes would be considered a precursor,” says Frost & Sullivan Life Sciences Senior Industry Analyst Debbie Toscano. “In a sense, medical prophylaxis for patients at particularly high risk of developing diabetes regardless of lifestyle, similar to preventative treatment of certain patients at high risk for breast cancer if they carry a mutated BRAC gene. While there are many studies evaluating prophylactic treatment of pre-diabetics, identification, and validation of other strongly linked precursors and drug discovery around targeting these precursors is largely unexplored.”

Presently, studies of the market are limited in their approach. “Current market research approaches tend to focus on the broader trends of the diabetes market to address multi-client needs,” says Frost & Sullivan Life Sciences Global Program Director Jennifer Lazar Brice. “This includes drivers, restraints, trends, challenges, opportunities, market sizing and forecasting. Often times, the information provided is too broad and does not dig deep enough into competitor and product strategies. In addition, these reports are typically regional in nature, or simply a global overview. ‘Analysis of the Type 2 Diabetes Therapeutics Market’ is one of the first true global market research studies which provides detailed analysis on the products on the market and in development across the globe in this 339 page study. In addition to addressing industry trends, unmet needs, and a market outlook, pipeline products are analyzed to show estimated product launch timelines, efficacy analyses, differentiating factors, among others. These are commonly asked questions and needs required by competitive intelligence executives.”

Brice also told Med Ad News Daily, “Our goal is to create content that is customized and actionable for our clients. While Frost & Sullivan does provide a subscription portal with market research reports, we do not view ourselves as a report warehouse. We want to make sure the information provided in our deliverables can answer our client's specific questions that they have about the marketplace and provide insights on what their current and future competition is doing. We engage our clients with our analysts and consultants across the globe. If their exact answers are not addressed in our studies, we provide interactive and customized services to address their specific needs as part of our service offerings.”

The company claims that a steady stream of products is expected to launch during the next six years. “There are a few drugs and companies that stand out from the pack,” Toscano told Med Ad News Daily. “Novo Nordisk is still the leader in the insulin market and looks to keep that position with their strong portfolio and pipeline combination product IDegLira, which is liraglutide (Victoza) and insulin degludec (Tresiba) in one convenient shot. Although a component of this product (insulin degludec) has suffered a regulatory setback in the United States (requirement of a cardiovascular outcomes trial), it has been approved in the European Union and Japan. Tresiba is an ultra-long-acting insulin with a duration of action beyond that of Lantus, the most popular once-daily insulin from Sanofi. The combination of this next-gen insulin with liraglutide has shown clinical data superior to any diabetes product, and stands an excellent chance of reaching blockbuster status, leveraging the well-known highly effective therapeutic approach of insulin and GLP-1 therapy.

Another pipeline product that looks very promising is NewMet, currently in Phase II. This product is being developed by a small company called Elcelyx, run by diabetes pharma veteran Alain Baron, formerly of Amylin Pharmaceuticals. This product is a new proprietary formulation of metformin, the gold standard oral diabetes therapeutic. Metformin is very effective, but can have tolerability issues with many patients, and also requires large doses. Elcelyx is developing their gut-targeted formulation of metformin based on their discovery of metformin's mechanism of action in the gut. This new formulation promises to exert comparable efficacy with a much smaller dose and greatly improved tolerability since it stays in the gut and does not get absorbed systemically. Since this is a well-known drug that has been used and trusted for decades, it is highly likely to see strong uptake, but this will probably be highly dependent on a strong marketing campaign and we are anticipating a partnership with a large pharma to see it through. Additional new products in the late-stage pipeline include SGLT2 inhibitors, next generation GLP-1 receptor agonists with less frequent dosing, and next-gen insulins with improved safety and efficacy profiles, as well as some new fixed combination products such as SGLT2 combinations with metformin or DPP-4 inhibitors. The SGLT2 inhibitors are anticipated to achieve blockbuster status with their convenient once-daily oral regimens and added benefits such as weight loss and blood pressure lowering.”

Toscano says that physicians are in desperate need of patient-friendly tools that enable aggressive yet safe management of the disease to prevent complications that are costly to both the patients’ quality of life and the healthcare system. “Diabetes therapy can be very challenging for patients, especially in the later stages of the disease when multiple therapies are incorporated,” she told Med Ad News Daily. “Insulin therapy can be particularly challenging since patients must consider the effects of their diet and activity on insulin dosage on a daily basis. Simple once-daily oral regimens with greater durability are needed, especially for elderly patients and others who may have more difficulty with injections and dosage titration. Therapies with strong efficacy without the burden of risk of hypoglycemia would also increase the patient-friendly aspect.”

Posted: September 2013