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  4. > A Product and Pipeline Analysis of the Global Diabetes Therapeutics Market

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.


Executive Summary

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
the pipeline.

Table Of Contents

A Product and Pipeline Analysis of the Global Diabetes Therapeutics Market
Table of Contents


Executive Summary 6
Executive Summary 7
Recent Market Developments 9
New Market Opportunities 11
Companies to Watch 12
Methodology and Scope 13
Introduction 15
Market Background 17
Disease Classification and Diagnostics—Type 2 Diabetes 18
Disease Classification and Diagnostics—Type 1 Diabetes 19
Diagnostic Criteria 20
Market Segmentation 21
Competitive Landscape 26
Timeline of New Product Launches 27
Competitive Landscape—Insulin Segment, Count of Marketed and Pipeline
Products 28
Competitive Landscape—Insulin Segment, Marketed and Pipeline Products 29
Marketed Product Analysis—Insulin Segment 30
Pipeline Analysis—Insulin Segment, Products in Late-stage Clinical Development 32
Pipeline Analysis—Insulin Segment, Products in Mid-stage Clinical Development 34
Pipeline Analysis—Insulin Segment, Products in Early-stage Clinical Development 35
Competitive Landscape—Non-insulin Segment, Count of Marketed and Pipeline
Products 37
Competitive Landscape—Non-insulin Segment, Late-stage and Marketed
Products 38
Competitive Landscape—Non-insulin Segment, Early- and Mid-stage Pipeline
Products 39
Marketed Product Analysis—Non-insulin Segment 40
Pipeline Analysis—Non-insulin Segment, Products in Late-stage Clinical
Development 45
Pipeline Analysis—Non-insulin Segment, Products in Mid-stage Clinical
Development 48
Pipeline Analysis—Non-insulin Segment, Products in Early-stage Clinical
Development 53
Patent Expirations 59
Cardiovascular Outcomes Trials Timeline 61
Comparative Product Profiles of Promising Late-stage Candidates 62
Comparative Efficacy Analysis 63
Comparative Efficacy Analysis Discussion 65
Product Profiles 66
Marketed Product Profiles—Rapid-acting Insulin 67
Marketed Product Profiles—Intermediate-acting/Premix Insulin 68
Marketed Product Profiles—Basal Insulin 69
Marketed Product Profiles—DPP-4 Inhibitors 70
Marketed Product Profiles—GLP-1 Agonists/Analogs 72
Marketed Product Profiles—SGLT2 Inhibitors 74
Conclusions and Recommendations 75
Conclusions and Recommendations 76
The Last Word—3 Big Predictions 77
The Last Word—Discussion 78
Legal Disclaimer 81
The Frost and Sullivan Story 82

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