Launch excellence for diabetes medicines

The market for non-insulin diabetes treatments has experienced strong growth over the past decade, averaging 9.5 per cent over the past five years. Epidemiology and unmet need have combined to generate demand for new product classes. The first of these, the DPP-IV class, is dominated by Merck & Co’s Januvia®, but further launches are lining up in another major new class, the SGLT-2s. Given the similarities in the competitive characteristics of this new class compared to the DPP-IVs, IMS believes there may be significant learning opportunities from the successes and failures of recent oral diabetes agent launches.


DPP-IVs offered a new alternative in the treatment pathway, post metformin alone and prior to the later stages of treatment with insulins, or, latterly, GLP-1s pre-insulin. These diabetes medicines have been the primary success story over the past five years, capturing 33 percent of worldwide value sales of non-insulin, anti-diabetic products.

The first DPP-IV inhibitor was Januvia (sitagliptin), introduced in 2006 in the U.S. by Merck. Today, Januvia dominates sales of DPP-IV products in developed markets, with the brand accounting for about 80 percent of worldwide sales for single compound products. Januvia’s success can be attributed to both an excellent commercialization plan from Merck and a strong element of serendipity. 
Pharmerging markets account for the vast majority of the volume potential of the diabetes market, driven by growing and aging populations acquiring Western habits. In Brazil, Russia and India, Merck’s Januvia was launched before Novartis’s Galvus.  Nonetheless, Novartis’ family of products accounted for more than 50 percent of the DPP-IV market in 2011. Most of this success is attributable to Eucreas, which has outperformed Janumet® (sitagliptin/metformin) considerably.  Meanwhile, Galvus has held its own against Januvia.
IMS’s research program of interviews with key opinion leaders (KOLs), providers and payers suggests that recent DPP-IV launches have lacked clear points of differentiation in these stakeholders’ eyes. Boehringer Ingelheim targeted a niche patient population – those with renal impairment – with Tradjenta® (linagliptin), because the product is not excreted via the kidneys.  The product is experiencing slow uptake in Europe due to differentiation not being achieved.  For example, the German Institute for Quality and Efficiency in Health Care (IQWiG) failed to find that Tradjenta provided an added benefit, resulting in Boehringer Ingelheim choosing not to launch in Germany.
The next major class of drugs – SGLT-2s – are likely to experience market dynamics that mirror those of the DPP-IV inhibitors. A large number of these molecules are in late-stage development and are expected to launch around the same time.  Like the DPP-IV inhibitors, IMS KOL interviews suggest the SGLT-2s may not be clearly differentiated from one another in the eyes of prescribers in terms of safety, efficacy or convenience. The first-to-market product will therefore have a significant advantage.  
This summary was taken from the report by Sarah Rickwood and Carolyn Gauntlett from the European Thought Leadership Group IMS Health

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