With the prevalence of Type 2 Diabetes rising globally, anti-diabetics will continue to outperform the pharmaceutical market as a whole until 2016. The treatment pathway holds opportunity for any number of new agents, and the pipeline for anti-diabetics is extraordinarily rich.

The diabetes market is a complex creature and dominated by a well-entrenched therapy—Merck’s Januvia (sitagliptin phosphate)—so competing in this environment is not a piece of sugar-free cake for competitors. All other players operate within the shadow of this once-a-day Oral Anti-Diabetic (OAD) that accounts for 80% of the worldwide sales for dipeptidyl peptidase IV inhibitors (DPP-IVs). Competitors in the after-metformin market must either carve out their market share by competing directly against Januvia in the DPP-IV class, or by circumventing the class—and Januvia—altogether. This is challenging since treatment guidelines leave much to physician and patient discretion.

Undaunted, many pharmaceutical companies have been and continue to attempt to replicate the success of Merck’s blockbuster. Some companies might pull it off, but it won’t be as simple as following Januvia’s blueprint. Here is a description of some of the strategies pharma companies are using to make their mark in the diabetes drug market.

Strategy 1: Co-Exist In Januvia’s Market

Since it was introduced in 2006, Januvia has consistently achieved at least 20% yearly growth. Subsequent products in the DPP-IV class—namely Galvus from Novartis (outside of the U.S.), Onglyza from Bristol-Myers Squibb/AstraZeneca (BMS/AZ), and Tradjenta from the Boehringer Ingelheim (BI)/Lilly diabetes alliance—have not met with the same commercial success. It’s worth asking why given that all were studied in signiἀcantly larger populations prior to launch and all are ideal selections after metformin failure.

Strategy 2: Challenge Traditional Thinking With A Clear Brand Position

Novo Nordisk, faced with the challenge of introducing an injectable therapy into an oral world, has succeeded with Victoza, its once-daily, injectable GLP-1 receptor agonist. Rather than simply bridging the gap between OADs and insulin, Novo challenged the presumption that GLP-1s aren’t frontline therapy. Through head-to-head efficacy trials, the company has demonstrated Victoza’s superiority over Januvia in lowering and controlling A1c, and this is reflected on its label and in its promotional material. With this push, Novo Nordisk continues to challenge the contemporary practice of adding DPP-IV inhibitors (i.e., Januvia) for patients who have failed on metformin.

Strategy 3: Go For Something Completely Different

Several companies are planning to enter the market with a new class of drugs: sodium glucose co-transporter 2 (SGLT-2) inhibitors. BMS/AZ and Johnson & Johnson (J&J) have SGLT-2 inhibitors under review with the FDA (dapagliflozin and canagliflozin, respectively), and BI has empagliflozin in Phase III trials. This class of drugs is truly innovative and differentiated from other OADs, if not from each other. With this differentiation comes the strong potential to achieve success akin to Januvia’s and Victoza’s as frontline therapy. And BMS/AZ, J&J, BI/Lilly, and the ultimate victor in the Lexicon bidding are sure to make these drugs a portfolio priority.

Strategy 4: Take A New Approach To The Insulin Market

Meanwhile, challengers to Sanofi’s Lantus are preparing to enter the market. Lantus is the world’s dominant brand of insulin and has helped Sanofi achieve approximately one-third of the overall global market value. Novo Nordisk is introducing Tresiba (insulin degludec), an ultra long-acting, once-daily basal insulin that received its first global approval in Japan on September 28, 2012. And through an alliance, BI and Lilly are in the late stages of developing the first biosimilar insulin analog for the Western market, its own insulin glargine. The two are also working on a novel, long-acting basal insulin, PEGylated lispro.

Portfolio-Wide Challenges Abound

With so many competing options, strategies must be developed not for individual products, but for portfolios. For example:

• Novo Nordisk will be launching Tresiba in the face of heavy competition from Lantus while it continues to promote Victoza against Januvia and Bydureon, Amylin’s once-a-week injectable exenatide.

• With BMS/AZ’s acquisition of Amylin, the company has a broad diabetes portfolio in which Onglyza competes head to head with Januvia; Bydureon aims to earn a place alongside Januvia in after-metformin therapy; and SGLT-2s will ideally be positioned as the alternative, or the perfect complement, to Januvia. At the same time that the partners will be re-launching Bydureon, Onglyza will continue to drive growth against Januvia.

• When Sanofi introduces Lyxumia to compete with Victoza, its challenge will be to position GLP-1 therapy as more complementary to basal insulin than Novo Nordisk has positioned Victoza. Meanwhile, Lantus will be faced with competition from Novo Nordisk’s new entry, Tresiba.

• The BI/Lilly alliance has several “irons in the fire.” Tradjenta, which competes directly against Januvia, is the alliance’s first marketed product. Other late-stage pipeline assets include an oral anti-diabetic (an SGLT-2, empagliflozin) in a separate class from Januvia; its biosimilar to Lantus; and its novel, long-acting basal insulin. How should these be positioned in the treatment pathway?

• If Janssen’s SGLT-2 inhibitor, canagliflozin, is approved J&J’s diabetes portfolio will span devices and therapeutics. Will it then change its decentralized management style to develop a comprehensive strategy incorporating blood glucose meters (from Lifescan) and insulin pumps (from Animas) and a pharmacotherapy?

• As GlaxoSmithKline prepares to launch albiglutide, a potential best-in-class GLP1 receptor agonist taken once weekly, it will need to assess the degree to which its global image remains affected by the 2007 controversy surrounding cardiovascular complications with Avandia.

While all of this competitive jockeying is swirling around Januvia, it remains to be seen if Merck will broaden its diabetes portfolio in order to avoid an almost certain future patent cliff.

The diabetes market is a hotbed of competitive battles—the outcome of which may be determined by whether it is better to have a breadth of treatment options with a wide portfolio or to dominate one position in the treatment pathway. While time will give us the answer, it is already clear that developing strategies at the product level will not suffice. The market demands that companies approach competitive positioning and resource allocation at the portfolio level.

  • Senior Principal in the IMS Consulting Group. He has over 15 years of experience in the pharma and biotechnology sectors and is considered to be a global thought leader in the diabetes market.

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