FirstWord Lists – Diabetes launches to continue unabated: what is in the late-stage pipeline?

The diabetes market will be shaped by the entrance of a succession of new products over the next few years, many of which will compete with each other.

Driven by ageing populations and the increasing incidence of diabetes, the market is expected to enjoy steady volume growth over the next few years. However, an increasing level of competitiveness, coupled with a lack of differentiation across products within certain diabetes drug classes, is likely to see pricing power reduced versus historical precedents (see ViewPoints: Talk of diabetes JV split illustrates divergent paths of AstraZeneca, Bristol-Myers Squibb and ViewPoints: As Novo Nordisk finds to its loss, price is now king in the US diabetes market).

Nevertheless, analysts at Goldman Sachs recently suggested that by 2017 diabetes would become established as the second largest disease area (in revenue) across the developed markets. Thus, the launch and subsequent performance of late-stage pipeline products will be watched closely.

One notable observation stemming from the forthcoming launches listed below is that the diabetes market remains something of a 'closed shop' to outsiders. GlaxoSmithKline will look to re-enter the market via its GLP-1 albiglutide, but has a legacy in diabetes via its Avandia franchise (effectively withdrawn from the US and EU markets in 2007), while Pfizer is looking to enter the fray but will do so via collaboration with its US rival Merck & Co. Such high barriers to entry are testament to the success of Johnson & Johnson and its first-in-class SGLT-2 inhibitor Invokana, which was launched in the US last year.

This year is expected to witness a glut of new diabetes approvals. From a corporate perspective it is Eli Lilly that has most to gain; the company is relying heavily on the launches of dulaglutide and empagliflozin to not only reverse a poor run of form with the regulatory authorities, but help drive revenue growth - ViewPoints: Eli Lilly's gap year.

An established player in the insulin market and in the DPP-4 class via its Tradjenta franchise, Eli Lilly's expansion into the GLP-1 and SGLT-2 segments should be recognised as providing the company the broadest portfolio of diabetes products. A key catalyst – with data expected to read out in the first half of 2014 – is a non-inferiority study for dulaglutide versus Novo Nordisk's market-leading Victoza franchise.

Another likely entrant to the GLP-1 market in 2014 is GlaxoSmithKline's albiglutide. Failure to demonstrate non-inferiority to Victoza in Phase III studies has blunted the commercial outlook for the drug. Nevertheless, GlaxoSmithKline appeared to confirm on its Q4 earnings call last week that the company is no longer seeking a marketing partner for albiglutide.

Beyond 2014, the focus of competitor dynamics switches to the insulin market, where Sanofi hopes to launch its Lantus successor U300 and Novo Nordisk's Tresiba is expected to make a later-than-expected entrance to the US market (see In Focus: FDA rejection of Tresiba – unexpected, unnecessary and avoidable? – How a delayed US launch for Novo Nordisk's blockbuster in waiting continues to shape the diabetes market).

Eli Lilly also is looking to bolster its credentials, but was dealt a setback last week when Sanofi confirmed the use of legal action to potentially delay launch of Eli Lilly's biosimilar Lantus product - ViewPoints: Delay to biosimilar Lantus – let the pricing party continue.

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