CONTENTS
8 OVERVIEW
8 Latest key takeaways
11 DISEASE BACKGROUND
11 Definition
12 Patient segmentation
14 TREATMENT
14 Major treatment guidelines
14 Guideline treatment targets are individualized according to patient characteristics
15 Treatment guidelines are shifting their approach based on results from recent clinical outcomes studies
17 Cardiology societies are joining in
19 EPIDEMIOLOGY
22 MARKETED DRUGS
37 PIPELINE DRUGS
47 KEY REGULATORY EVENTS
47 FDA Grants Priority Review To Bayer’s Finerenone And AstraZeneca’s Farxiga
47 Amphastar Has First US Glucagon Rival
47 Xeris Picks Up European Nod
47 Bayer Finerenone Could Face Review Issue In Hyperkalemia Risk
48 Daewoong Readies Diabetes Contender Enavogliflozin, Aiming For ’23 Launch
48 Label Expansion For Trulicity
48 Excalibur To Test AZ Compound In Diabetics With COVID-19
49 Sanofi Has EU Insulin Aspart Biosimilar Approval
49 EC Approves Extended Invokana Indication On Renal Outcomes In DKD
49 Japan Nods Include Rybelsus For Type 2 Diabetes
50 Lilly Lyumjev Took BLA Path To Approval
50 Mylan And Biocon’s Semglee Insulin Glargine Approved In US
50 Sanofi’s Insulin Aspart Biosimilar Gets European Nod
50 Type 2 Diabetes Drugs Can Skip Cardiovascular Outcome Trials, But Phase III Must Be Longer, Broader
52 PROBABILITY OF SUCCESS
53 LICENSING AND ASSET ACQUISITION DEALS
53 Biocon And International Diabetes Federation Promote Insulin Access
53 Philips Extends Leadership In Patient Monitoring By Buying BioTelemetry For $2.8Bn
53 Abbott Becomes First Anchor Sponsor For American Diabetes Association Health Equity Now Initiative
53 Exec Chat: How Glooko Plans To Ride Digital Health Care Wave To Profitability
54 Novo Nordisk Pays $1.80bn To Buy Emisphere
54 Bayer, Hua Partner On Diabetes Candidate In China
54 Medtronic Adds Smart Insulin Pen By Acquiring Companion Medical
55 Rise Of Digital Health: Teladoc Acquires Livongo In $18.5Bn Deal, Creating Virtual Care Giant
55 Biocon Partners With Voluntis On Digital Therapeutics For Diabetics
55 Medtronic/Tandem Patent Agreement Paves Way For Diabetes Product Development
56 Boehringer, Cipla Ally For Oral Anti-Diabetic Drugs
56 Blackstone Invests $337M In Medtronic’s Diabetes R&D
56 Hanmi In Tough Spot After Sanofi Efpeglenatide U-Turn
56 Ildong To Speed Drug Development Using Evotec’s Indigo Platform
57 Genprex Licenses Diabetes Gene Therapy From Pitt
57 Deals Shaping The Medical Industry, March 2020
58 CLINICAL TRIAL LANDSCAPE
59 Sponsors by status
60 Sponsors by phase
61 Recent events
66 DRUG ASSESSMENT MODEL
67 Generically available oral drugs
68 Branded non-insulin drugs
77 Insulins
83 Other pipeline mechanisms
84 SWOT ANALYSIS
88 MARKET DYNAMICS
93 FUTURE TRENDS
94 CONSENSUS FORECASTS
102 RECENT EVENTS AND ANALYST OPINION
102 Tirzepatide for Diabetes Mellitus, Type 2 (March 4, 2021)
104 Tirzepatide for Diabetes Mellitus, Type 2 (February 17, 2021)
108 Tirzepatide for Diabetes Mellitus, Type 2 (December 9, 2020)
111 Ozempic for Diabetes Mellitus, Type 2 (November 17, 2020)
113 Zynquista for Diabetes Mellitus, Type 2 (November 16, 2020)
115 Insulin Icodec for Diabetes Mellitus, Type 2 (September 22, 2020)
120 KEY UPCOMING EVENTS
121 KEY OPINION LEADER INSIGHTS
121 Interviews with physicians at the ADA conference (2019)
125 UNMET NEEDS
126 BIBLIOGRAPHY
127 Prescription information
130 APPENDIX
LIST OF FIGURES
12 Figure 1: Guideline diagnostic criteria for type 2 diabetes
13 Figure 2: Line of therapy for primary care for type 2 diabetes, in major markets
16 Figure 3: ADA treatment algorithm (updated from the ADA/EASD original)
17 Figure 4: AACE treatment algorithm
21 Figure 5: Trends in prevalent cases of type 2 diabetes in adults (20–85+ years), 2018–27
37 Figure 6: Overview of pipeline drugs for type 2 diabetes in the US
37 Figure 7: Pipeline drugs for type 2 diabetes, by company
38 Figure 8: Pipeline drugs for type 2 diabetes, by drug type
38 Figure 9: Pipeline drugs for type 2 diabetes, by classification
52 Figure 10: Probability of success in the type 2 diabetes pipeline
58 Figure 11: Clinical trials in type 2 diabetes
58 Figure 12: Top 10 drugs for clinical trials in type 2 diabetes
59 Figure 13: Top 10 companies for clinical trials in type 2 diabetes
59 Figure 14: Trial locations in type 2 diabetes
60 Figure 15: Type 2 diabetes trials status
61 Figure 16: Type 2 diabetes trials sponsors, by phase
66 Figure 17: Datamonitor Healthcare’s drug assessment summary for non-insulins for type 2 diabetes
67 Figure 18: Datamonitor Healthcare’s drug assessment summary for insulins for type 2 diabetes
84 Figure 19: DPP-IV inhibitors SWOT analysis
85 Figure 20: SGLT-2 inhibitors SWOT analysis
86 Figure 21: GLP-1 receptor agonists SWOT analysis
87 Figure 22: Insulins SWOT analysis
88 Figure 23: Generically available older drugs market dynamics
89 Figure 24: DPP-IV inhibitors market dynamics
90 Figure 25: SGLT-2 inhibitors market dynamics
91 Figure 26: GLP-1 receptor agonists market dynamics
92 Figure 27: Insulins market dynamics
93 Figure 28: Future trends in type 2 diabetes
104 Figure 29: Tirzepatide for Diabetes Mellitus, Type 2 (March 4, 2021): Phase III – SURPASS-2 (vs. Semaglutide)
107 Figure 30: Tirzepatide for Diabetes Mellitus, Type 2 (February 17, 2021): Phase III – SURPASS-3 (vs. Degludec)
108 Figure 31: Tirzepatide for Diabetes Mellitus, Type 2 (February 17, 2021): Phase III – SURPASS-5 (w/Basal Insulin)
111 Figure 32: Tirzepatide for Diabetes Mellitus, Type 2 (December 9, 2020): Phase III – SURPASS-1 (Monotherapy)
113 Figure 33: Ozempic for Diabetes Mellitus, Type 2 (November 17, 2020): Phase III – SUSTAIN FORTE (1.0mg, 2.0mg doses)
115 Figure 34: Zynquista for Diabetes Mellitus, Type 2 (November 16, 2020): Phase III – SCORED
118 Figure 35: Insulin Icodec for Diabetes Mellitus, Type 2 (September 22, 2020): Phase II – vs. Insulin Glargine U100 (basal insulin switching)
118 Figure 36: Insulin Icodec for Diabetes Mellitus, Type 2 (September 22, 2020): Phase II – 3 titration regimens vs. Insulin Glargine U100 (Insulin-naïve Subjects)
119 Figure 37: Insulin Icodec for Diabetes Mellitus, Type 2 (September 22, 2020): Phase II – w/Metformin +/- DPP-4 Inhibitors (Insulin naïve)
120 Figure 38: Key upcoming events in type 2 diabetes
LIST OF TABLES
20 Table 1: Prevalent cases of type 2 diabetes in adults (20–85+ years), 2018–27
23 Table 2: Marketed drugs for type 2 diabetes
39 Table 3: Pipeline drugs for type 2 diabetes in the US
95 Table 4: Historical global sales, by drug ($m), 2015–19
99 Table 5: Forecasted global sales, by drug ($m), 2021–25
102 Table 6: Tirzepatide for Diabetes Mellitus, Type 2 (March 4, 2021)
105 Table 7: Tirzepatide for Diabetes Mellitus, Type 2 (February 17, 2021)
109 Table 8: Tirzepatide for Diabetes Mellitus, Type 2 (December 9, 2020)
112 Table 9: Ozempic for Diabetes Mellitus, Type 2 (November 17, 2020)
113 Table 10: Zynquista for Diabetes Mellitus, Type 2 (November 16, 2020)
116 Table 11: Insulin Icodec for Diabetes Mellitus, Type 2 (September 22, 2020)
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