Type 2 Diabetes (T2D) is an incurable disease that affects millions of people worldwide, requiring lifelong treatment. One major hurdle in managing the disease is the decreasing ability of T2D drugs to effectively treat hyperglycemia over time. Big Pharma continues to address this issue, having developed drugs across multiple drug classes to help patients achieve their target blood glucose levels.

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) represent a T2D injectable drug class that is increasingly prescribed to patients on oral anti-diabetic treatments who are struggling to get their blood glucose levels under control. On average, GLP-1RAs lower Hemoglobin A1c counts by approximately 1–1.5 percent, and also provide the non-glycemic advantage of weight loss. With the GLP-1RA space becoming increasingly crowded, it is difficult to predict which agents will hold the majority of market share within the drug class over the next decade.

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After speaking with key opinion leaders (KOLs) across the US, Europe, and Japan, GlobalData believes that growth in the GLP-1RA space will be heavily driven by agents that confer increased patient compliance and cardiovascular (CV) benefits. Specifically, Novo Nordisk’s NN9924, an oral GLP-1RA that is currently in Phase III clinical trials, may best fulfill the criteria outlined by KOLs, potentially resulting in NN9924 becoming the new market leader within the GLP-1RA space.

GLP-1RAs employ a mechanism of action involving the activation of glucagon receptors on pancreatic beta cells, causing a cascade of biochemical events that leads to insulin secretion in a glucose-dependent manner. At the same time, glucose-dependent glucagon secretion from pancreatic α cells is suppressed. The class continues to undergo major diversification, primarily regarding mode of administration.

Historically, the class was made up of agents that were delivered via once or twice daily injections, but in the past few years, novel marketed GLP-1RAs have begun to offer once weekly administration, and pipeline GLP-1RA agents offer the possibility of biannual maintenance doses via either an osmotic pump that continuously releases exenatide, or an oral administration, Intarcia Theraputics’ ITCA 650 or Novo Nordisk’s NN9924, respectively.

Additionally, in 2016, Novo Nordisk’s Victoza (liraglutide) and injectable semaglutide were shown to provide significant reductions in the risk of major adverse CV events in T2D patients. Collectively, improvements in mode of administration and positive CV outcomes are two vital factors that KOLs have identified as positively impacting GLP-1RA performance on the market. As such, the majority of KOLs interviewed by GlobalData have agreed that any GLP-1RA agent that can boast both convenient administration and positive CV data will likely gain substantial market share.

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The current GLP-1RA market leader, Victoza, which generated global sales of almost $3B in 2016, is expected to continue its dominance for the next few years, given the positive data from the LEADER trial, which revealed Victoza’s ability to significantly reduce heart attacks, strokes, and CV-related death. Unfortunately for Novo Nordisk, once-weekly GLP-1RA competitors, Eli Lilly’s Trulicity (dulaglutide) and GlaxoSmithKline’s (GSK’s) Tanzeum (albiglutide) continue to steal market share from Victoza. In anticipation of GLP-1RA market trends, Novo Nordisk developed a follow-up once-weekly GLP-1RA, semaglutide, which is a variant of Victoza and was shown to significantly reduce CV risk in T2D patients in the SUSTAIN-6 trial.

In addition, Novo Nordisk is developing NN9924, an oral version of semaglutide, which KOLs anticipate will display similar beneficial CV effects as its injectable counterpart. If approved and priced conservatively, KOLs believe that NN9924 can become the new market leader in the GLP-1 RA space within the next decade, despite stiff competition with existing GLP-1RAs and ITCA 650 (pending FDA approval). In respect to ITCA 650, KOLs have given NN9924 a slight edge over the technology platform, as the subcutaneously placed pump that is used in Intarcia’s ITCA-650 might face hurdles, including physicians not being equipped or trained to perform the pump placement procedure. Collectively, Novo Nordisk’s GLP-1RAs have huge clinical and commercial advantages within this class, with NN9924 standing out from the crowd.

Jesus Cuaron, PhD, PPM

Senior Analyst

GlobalData