Launch Excellence in the Diabetes Market: Lessons from - IMS Health

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WHITE PAPER | DIABETES LAUNCH EXCELLENCE Growth in the market for Type II Diabetes treatments has consistently out-performed the pharmaceutical market as a whole, and IMS believes that this will continue for the next decade, driven by the obesity epidemic, an aging population, and the advent of new therapies. In fact, in IMS’s perspective, diabetes stands out as one of the elite group of major therapy areas that will continue to outperform the market as a whole to 2016. Within this out-performing group, it is also the only primary-care-driven therapy area of any size, the others being specialist areas. However, while epidemiology and unmet need mean there are multi-billion dollar opportunities for successful launches and many potential contenders for blockbuster status, success is still not a foregone conclusion. IMS has studied the launch strategies and subsequent market performance of the frontrunner products in the dipeptidyl peptidase IV (DPP-IV) therapeutic class worldwide to understand what separates clear market leaders from those with less impressive sales. From this, we’ve drawn key learnings pertinent to companies preparing to launch one of the many products currently in development for Type II Diabetes. THE NEXT DECADE: A CROWDED FIELD Over the next ten years, most of the new therapies introduced for Type II Diabetes will cluster in just a few drug classes, meaning that the market will see a small number of first-in-class launches followed by an avalanche of follower brands. These follower products will naturally face a challenging launch environment if they cannot demonstrate value propositions that are differentiated from first-in-class products in the eyes of clinical opinion leaders, prescribers, and payers. Nevertheless, experience has shown that companies whose products are not first to market can still win—in specific segments or countries. Here, we examine how various strategies have played out for companies marketing DPP-IV inhibitors and consider the implications for products in the pipeline. IMS HEALTH | LAUNCH EXCELLENCE IN THE DIABETES MARKET 2
WHITE PAPER | DIABETES LAUNCH EXCELLENCE DPP-IVs: CHANGING THE TREATMENT REGIMEN Of the two recent new product classes to treat Type II Diabetes, the oral DPP-IVs and the injectable GLP-1s, DPP-IV inhibitors stand out for their success in overall sales levels, as they are used earlier and for a broader group of patients than the GLP-1s. Although there is a range of existing oral diabetes therapies, the fact that no class provides a definitive therapeutic approach to the disease means there is always opportunity for new classes of oral agents for patients post metformin monotherapy. DPP-IVs came into a largely generic oral market where the only on-patent oral agents, the Thiazolidinediones (TZDs), were approaching loss of exclusivity, with one of the two members of the class, Avandia ® (rosiglitazone), facing a major question on safety. The first DPP-IV inhibitor on the market was Januvia ® (sitagliptin), introduced in the U.S. in 2006 by Merck & Co. (Novartis’s Galvus ® (vildagliptin) was delayed in the U.S. due to questions of side effects). Since then, further DPP-IVs, Onglyza ® (saxagliptin) and Tradjenta (linagliptin) have also entered the market, and the pipeline promises more to come. In the five years since, DPP-IVs have captured 33 percent of worldwide sales of non-insulin, anti-diabetic products. And in the mature eight markets, DPP-IVs account for 58 percent of the value growth in diabetes treatments. JANUVIA: FIRST TO MARKET TAKES ALL Januvia now dominates sales of DPP-IV products in developed markets. In 2011, the brand accounted for approximately 80 percent of worldwide sales for plain DPP-IV inhibitors. Later launches in the class—such as Onglyza and Galvus—have been unable to unseat Januvia from its leadership position. In the U.S., Januvia enjoyed three years of exclusivity in its class before AstraZeneca/BMS introduced Onglyza. During this time, Januvia used strong promotion to gain early buy-in from stakeholders and to build a positive brand image. It secured its place as “the” gliptin, an image that AstraZeneca/BMS was unable to change despite heavy U.S. promotional investment. Similar market dynamics occurred in Europe where Januvia was launched in 2007. Here, the next plain DPP-IV inhibitor to be launched was Galvus, in 2008. Since then Galvus has achieved sales of just 12 percent of those seen for Januvia in Europe. Januvia’s success is particularly meaningful because the brand has not demonstrated any clinically relevant differentiation over other products in the class 1 . This suggests that the variance in performance within the class was aided by Januvia’s position as first in class. Januvia was in the right place at the right time, and when subsequent entries came along, physicians generally did not move from their first gliptin choice. FOOTNOTE: 1 Key opinion leaders were unaware of any differentiation between products in the class, and the only head-to-head trial in the class showed Januvia’s 100mg “non-inferiority” compared to Onglyza 5 mg. Source: IMS interviews with Key Opinion Leaders as part of IMS’s Therapy Prognosis research program. IMS HEALTH | LAUNCH EXCELLENCE IN THE DIABETES MARKET 3
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Launch Excellence in the Diabetes Market: Lessons from - IMS Health

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