In recent weeks, the diabetes landscape has been impacted by a number of news, chiefly the decision by the FDA not to approve Novo Nordisk's long-acting basal insulin product Tresiba until a cardiovascular outcomes study has been completed.
Consensus among analysts suggests that Tresiba could conceivably reach the US market in 3-5 years, although a worst case scenario of non-launch in the world's largest pharmaceutical market remains a possibility.
Regardless, its delay will have a notable impact on Novo Nordisk's revenue line; had the FDA approved Tresiba, it would most likely have acted as the leading sales growth driver within the diabetes space over the next five years – as it is, approval in the EU and Japan will drive anticipated revenues of around $1 billion by 2017, according to analyst consensus figures compiled by FirstWord, thereby positioning it as the 8th largest sales growth driver within the diabetes market over this period.
That Tresiba is still expected to become a blockbuster therapy within the next five years is testament to the growth credentials of the broader diabetes market; combined absolute annual sales growth across the 15 fastest growing therapies is forecast to exceed $17 billion over 2012-17, with nine franchises expected to see annual sales increase by $1 billion over the same period. Furthermore, sales of Novartis' Galvus – which is not marketed in the US – are forecast to increase from $910 million in 2012 to around $1.6 billion in 2017.
Merck & Co.'s Januvia franchise (incorporating the Janumet combination therapy) is forecast to deliver the strongest revenue expansion through to 2017, with annual sales expected to increase by around $2.7 billion. Analysts at Citi recently noted that despite growing competition in the DPP-IV inhibitor space, Januvia has the credentials to retain an approximate 65 percent share of the market. Tradjenta and Nesina represent the key competitive threats, they add. The significant opportunity for DPP-IVs as a class is any benefit in terms of cardiovascular outcomes; SAVOR (Onglyza) should be the first to read out later this year.
Despite the recent setback to Tresiba, Novo Nordisk's credentials in the diabetes space are reflected by consensus revenue forecasts for Victoza, its GLP-1 agonist, which is expected to remain the dominant class member despite its once-daily administration. AstraZeneca and Bristol-Myers Squibb's once-weekly competitor Bydureon is expected to deliver considerable growth over the next five years, while Novo Nordisk's own once-weekly product – semaglutide – is forecast to deliver sales of just below $600 million by 2017.
The key beneficiary of the Tresiba setback is Sanofi, which will retain its US-dominance of the long-acting basal insulin market via the Lantus franchise, and could find its ability to defend market share in ex-US territories boosted by the FDA's caution towards Novo Nordisk's product.
Within the insulin market in particular, biosimilar competition is another element to consider; however, with both Eli Lilly and Sanofi now committed to developing biosimilar insulins as a means to 'gap fill' and create comprehensive portfolios, there is an increased likelihood that the few dominant players in this space continue to cast the most meaningful influence. Current consensus forecasts for Eli Lilly's biosimilar Lantus stand at approximately $380 million by 2017; Eli Lilly believes biosimilars can eventually account for around a third of global sales.
The reality – noted analysts at Barclays last week – is that the US delay to Tresiba may have a profound impact on regulatory momentum for future insulin submissions, biosimilars included. The key assessment, note analysts, is whether biosimilar Lantus is deemed different enough from the branded product to potentially require pre-approval cardiovascular safety adjudication.
The delay to Tresiba demonstrates that the FDA has "applied its pre-approval safety guidelines for diabetes in general to insulin for the first time" (recent approval of Takeda's DPP-IV inhibitor Nesina comes five years after initial regulatory submission).
Regulatory hurdles may have been raised – particularly in the US – however, as demonstrated by the above list, growth opportunity for diabetes treatments remains significant.