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This issue of Vital Signs, released on September 30, 2013, provides a market overview and drug pipeline analysis of Type 2 diabetes therapeutics. Additionally, a company spotlight is provided for Trovagene in San Diego, CA. The company has a proprietary transrenal nucleic acid platform with the potential to deliver superior molecular diagnostics in urine.
Type 2 diabetes is one of the most significant global health concerns of modern times. According to the International Diabetes Federation, more than 317 million people have been diagnosed with diabetes and an additional 187 million are living with undiagnosed diabetes. Type 2 diabetes is no longer a disease exclusive to developed countries; it is rapidly overwhelming developing countries such as China and India as more and more countries adopt the westernized lifestyle that contributes to disease prevalence. The global revenue earned from sales of drugs to treat type 2 diabetes was approximately $36.89 billion in 2012. The rapidly growing incidence and prevalence globally will help drive this figure to approximately $68.42 billion by 2017. The market for type 2 diabetes therapeutics in China is growing rapidly and is expected to outpace Europe to become the second-largest market by 2017. South Korea and Vietnam are also forecast to experience rapid growth.
The market for diabetes drugs has many barriers to entry, particularly for the insulin segment, which requires a great deal of specialization. Due to the chronic nature of the disease and the numerous co-morbidities that make this patient population particularly sensitive to long-term drug safety, the clinical and regulatory hurdles are considerable and the inherent risks involved, such as failure to receive marketing approval after a relatively large investment of time and money, limit this market to those organizations with the necessary expertise and capital. Despite the risk, the immense potential market has stimulated a vast and growing pipeline of new therapies aimed at more precise glucose control, improved safety profiles, and greater convenience to patients. This article will summarize some of the key findings from a recent analysis of the type 2 diabetes therapeutics market, which examines, in detail, the insulin and non-insulin segments of this market on a global level.
Non-insulin Therapeutics Segment
Non-insulin anti-diabetic drugs are mostly oral therapies and are typically prescribed as first-line therapy when diet and exercise alone are insufficient to control elevated blood glucose. Non-insulin therapeutics can be sub-segmented into Standard of Care (SOC) therapies and add-on to SOC. The main drug classes prescribed as SOC are all available as low-cost generics and are comprised of biguanides (metformin), sulfonylureas (glipizide, glyburide, gliclazide, glimepiride), and alpha glucosidase inhibitors (acarbose, voglibose, miglitol). In the United States and most of the world, metformin is the gold standard for first-line therapy. Add-on therapies, which are comprised of newer novel drug classes, are typically prescribed in combination with SOC when those treatments eventually fail to control elevated blood glucose on their own. Add-on therapies can also generally be prescribed as first-line or monotherapy when SOC therapies are contraindicated or not well tolerated.
The main drug classes used as add-on therapies are metiglinides, glitazones, incretin-based therapies comprised of glucagon-like peptide-1 (GLP-1) analogues or receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, and the newest class, sodium-glucose co-transporter 2 (SGLT2) inhibitors. The metiglinides, of which there are two marketed drugs, Novartis’ Starlix (nateglinide) and Novo Nordisk’s Prandin (repaglinide), are post-meal glucose-lowering therapies and are a relatively minor portion of the market. Santarus’ new diabetes product Cycloset (bromocriptine) launched in 2010 is a novel first-in-class oral antidiabetic (OAD) based on the circadian rhythm of dopamine activity. Cycloset also has a minor share of the market, but is gaining ground as physicians become more familiar with its unique mechanism. The glitazones (also known as thiazoladinediones (TZDs) or PPAR gamma agonists), represented by Takeda’s Actos (pioglitazone) and GlaxoSmithKline’s Avandia (rosiglitazone), were former blockbusters until the recent emergence of serious safety issues and have since seen significant declines in sales, thereby restraining overall revenue growth for the segment. However, the segment was soon revived, stimulated by strong uptake of Novo Nordisk’s Victoza (liraglutide, a GLP-1 analogue) and the continued strong sales of Januvia along with the introduction of additional members of the DPP-4 class and the initial launches of a new class, the SGLT2 inhibitors. In 2012, the majority of global revenue generated for the non-insulin therapeutics segment was from sales of Januvia as well as metformin, the most widely prescribed diabetes therapeutic worldwide.
The recent implication of the incretin-based therapies such as Januvia and Victoza in increased risk of pancreatic cancer has drawn considerable media attention, but is not expected to have a significant impact on the market overall in light of the lack of compelling data in support of the theory. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) each initiated an investigation of the matter in March 2013 and both agencies have recently announced in July 2013 that they have found no confirmed link between incretin therapies and increased risk for pancreatic cancer. This is good news for the manufacturers of the numerous GLP-1 therapies coming to market. While this class has been long dominated by Byetta (exenatide) and Victoza (liraglutide), several rivals are beginning to arrive to the market, the most advanced being Sanofi’s Lyxumia (lixisenatide), currently under review by the FDA with a decision expected in December 2013 or early 2014. Lyxumia, developed by Zealand Pharma and commercialized by Sanofi, is already approved in Mexico, Australia, Europe, and most recently Japan. GlaxoSmithKline is also awaiting FDA approval for its once-weekly GLP-1 albiglutide, with a decision expected in April 2014. Most anticipated, however, is Eli Lilly’s dulaglutide, a once-weekly GLP-1 with strong positive data that is poised to be a formidable competitor to all of the GLP-1s, including Victoza. Dulaglutide could launch as early as late 2014 or 2015.
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