Table of Contents
The marketed and development product landscape for diabetes therapeutics is becoming crowded with multiple products with little differentiation. However, there is still ample room for growth through the introduction of novel therapies that fill therapeutic gaps left by available products. Comprehensive information on market background and global overview and analysis of drug development, detailed product and pipeline analysis by market segment, drug class, and stage of development, and detailed product profiles for key marketed and late-stage products is included in the study. Also included are time-sensitive details such as new product launch timelines, cardiovascular outcomes trials timelines, and patent expirations.
Drug development activity for diabetes shows no signs of slowing despite the many
challenges associated with entry into this crowded and demanding market. The enormity
of the growing patient population coupled with substantial gaps left by available therapies
continues to motivate numerous global participants.
Regulatory hurdles are significant, with cardiovascular safety at the forefront of the
ideal product profile.
Product differentiation and prescribing decisions are becoming increasingly difficult
with the availability of multiple competing drug classes.
Drug developers are responding with several pipeline advancements and new targets.
Overall, the pipeline of non-insulin drug candidates from Phase 1 through pre-registration
has grown from approximately x to x since Q1 2013.
The availability of orally administered antidiabetic biopharmaceuticals is getting closer to
a reality, with x oral insulin analogs and x oral glucagon-like peptide-1 (GLP-1)
analogs/agonists in various stages of development, along with an inhalable insulin
(Mannkind’s Afrezza) currently under US Food and Drug Administration (FDA) review.
Other noteworthy developments in the insulin market include the imminent arrival of
several concentrated insulins to meet the needs of very obese or highly insulin-resistant
patients and the clinical advancement of several ultra-rapid-acting insulin analogs with
improved efficacy and convenience.
The non-insulin segment of the market is also undergoing some dynamic changes,
notably the advancement of x GLP-1/insulin combination products (Sanofi/Zealand’s
LixiLan and Novo Nordisk’s IDegLira) to late-stage development. There also seems to be
a resurgence of interest in the glucokinase activator (GKA) target, with x candidates in
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