Diabetes mellitus is a group of chronic endocrine disorders characterized by hyperglycemia due to insufficient levels of insulin, a hormone responsible for regulating blood sugar. Symptoms include excessive excretion of urine (polyuria), thirst (polydipsia),
constant hunger, weight loss, vision changes, and fatigue. According to the World Health Organization (WHO), approximately 8.5% of adults had diabetes in 2014. Type 1 diabetes accounts for around 5–10% of the total diabetic population. The majority of cases of type 1 diabetes may be classified as type 1a, an autoimmune disease characterized by the destruction of pancreatic beta cells, with a minority of cases making up type 1b, which is described as idiopathic diabetes mellitus.
CONTENTS
8 OVERVIEW
8 Latest key takeaways
10 DISEASE BACKGROUND
10 Disease definition
10 Patient segmentation
10 Diagnosis
12 TREATMENT
12 Daily insulin replacement therapy is required to prevent hyperglycemia
14 EPIDEMIOLOGY
14 Prevalence methodology in adults (20–85+ years)
16 Prevalence methodology in children and adolescents (0–19 years)
19 MARKETED DRUGS
24 PIPELINE DRUGS
32 KEY REGULATORY EVENTS
32 Teplizumab Speeds Toward Delay Of Type 1 Diabetes Indication
32 FDA Approves Medtronic’s Bluetooth-Enabled Insulin Pump For Children Ages 2 To 6
32 Excalibur To Test AZ Compound In Diabetics With COVID-19
33 Sanofi Has EU Insulin Aspart Biosimilar Approval
33 Lilly Lyumjev Took BLA Path To Approval
33 ADA 2020: Tandem Wins FDA Nod For T:Slim Pump Technology In Children; Positive Feedback on Studies
34 Mylan And Biocon’s Semglee Insulin Glargine Approved In US
34 Sanofi’s Insulin Aspart Biosimilar Gets European Nod
34 Provention Bio Teplizumab On Track To Complete BLA By Year-End
35 Keeping Track: US FDA Okays BMS’ Zeposia In MS, Nixes Lilly/BI’s Empagliflozin For Type 1 Diabetes
35 Empagliflozin Likely Needs Another Trial After Rebuke By US FDA Panel
35 EMA Accepts First Diabetes Drug Onto PRIME
36 PROBABILITY OF SUCCESS
37 LICENSING AND ASSET ACQUISITION DEALS
37 Medtronic Adds Smart Insulin Pen By Acquiring Companion Medical
37 Rise Of Digital Health: Teladoc Acquires Livongo In $18.5Bn Deal, Creating Virtual Care Giant
37 Medtronic/Tandem Patent Agreement Paves Way For Diabetes Product Development
38 Blackstone Invests $337M In Medtronic’s Diabetes R&D
38 Genprex Licenses Diabetes Gene Therapy From Pitt
38 With $260m Settlement From Sanofi, Lexicon Looks For New Zynquista Partner
39 CLINICAL TRIAL LANDSCAPE
40 Sponsors by status
41 Sponsors by phase
42 Recent events
44 DRUG ASSESSMENT MODEL
44 Long-acting insulins
46 Rapid-acting insulins
47 Non-insulin treatments
49 MARKET DYNAMICS
50 FUTURE TRENDS
50 Questionable clinical benefit and pricing pressure from biosimilars will slow uptake of next-generation products
50 Pricing pressure in the US diabetes market will continue to impact rebates or shift prescribing trends towards more affordable insulins
51 Teplizumab uptake will be dependent on overcoming pricing and reimbursement issues, along with the introduction of screening programs to identify at-risk patients
51 SGLT-2 inhibitors are expected to have slow uptake in the EU and Japan due to narrow target populations, DKA risk, and minor glycemic benefits
52 CONSENSUS FORECASTS
55 RECENT EVENTS AND ANALYST OPINION
55 Diamyd for Diabetes Mellitus, Type I (September 14, 2020)
56 ProTrans for Diabetes Mellitus, Type I (September 8, 2020)
58 XP-3924 for Diabetes Mellitus, Type I (June 18, 2020)
LIST OF FIGURES
59 NN9828 for Diabetes Mellitus, Type I (June 15, 2020)
61 Teplizumab for Diabetes Mellitus, Type I (June 15, 2020)
62 AT247 for Diabetes Mellitus, Type I (June 14, 2020)
64 TTP399 for Diabetes Mellitus, Type I (June 13, 2020)
66 Jardiance for Diabetes Mellitus, Type I (March 20, 2020)
67 TTP399 for Diabetes Mellitus, Type I (February 10, 2020)
68 Zynquista for Diabetes Mellitus, Type I (December 2, 2019)
69 Jardiance for Diabetes Mellitus, Type I (November 13, 2019)
72 Jardiance for Diabetes Mellitus, Type I (November 11, 2019)
74 Toujeo for Diabetes Mellitus, Type I (October 31, 2019)
76 KEY UPCOMING EVENTS
77 KEY OPINION LEADER INSIGHTS
78 UNMET NEEDS
78 Smart insulins or other novel therapies that reduce the risk of hypoglycemia
78 Better options for insulin administration and automated blood glucose control
78 Prevention of type 1 diabetes
80 BIBLIOGRAPHY
80 Prescription information
82 APPENDIX
LIST OF FIGURES
11 Figure 1: Guideline diagnostic criteria for type 1 diabetes
13 Figure 2: Recommended steps following type 1 diabetes treatment initiation
16 Figure 3: Trends in prevalent cases of type 1 diabetes in adults (20–85+ years), 2018–27
18 Figure 4: Trends in prevalent cases of type 1 diabetes in children and adolescents (0–19 years), 2018–27
24 Figure 5: Overview of pipeline drugs for type 1 diabetes in the US
24 Figure 6: Pipeline drugs for type 1 diabetes, by company
25 Figure 7: Pipeline drugs for type 1 diabetes, by drug type
25 Figure 8: Pipeline drugs for type 1 diabetes, by classification
36 Figure 9: Probability of success in the type 1 diabetes pipeline
39 Figure 10: Clinical trials in type 1 diabetes
39 Figure 11: Top 10 drugs for clinical trials in type 1 diabetes
40 Figure 12: Top 10 companies for clinical trials in type 1 diabetes
40 Figure 13: Trial locations in type 1 diabetes
41 Figure 14: Type 1 diabetes trials status
42 Figure 15: Type 1 diabetes trials sponsors, by phase
44 Figure 16: Datamonitor Healthcare’s drug assessment summary for type 1 diabetes
49 Figure 17: Market dynamics in type 1 diabetes
50 Figure 18: Future trends in type 1 diabetes
56 Figure 19: Diamyd for Diabetes Mellitus, Type I (September 14, 2020): Phase IIb – DIAGNODE-2
58 Figure 20: ProTrans for Diabetes Mellitus, Type I (September 8, 2020): Phase I/II – ProTrans- 1/2 (Dose Escalation)
59 Figure 21: XP-3924 for Diabetes Mellitus, Type I (June 18, 2020): Phase II – PK/PD Study
61 Figure 22: NN9828 for Diabetes Mellitus, Type I (June 15, 2020): Phase II – Proof-of-Principle
62 Figure 23: Teplizumab for Diabetes Mellitus, Type I (June 15, 2020): Phase II – At-Risk (NIDDK)
64 Figure 24: AT247 for Diabetes Mellitus, Type I (June 14, 2020): Phase I – ARE-247-101 (Austria)
66 Figure 25: TTP399 for Diabetes Mellitus, Type I (June 13, 2020): Phase Ib/II – Simplici-T1
75 Figure 26: Toujeo for Diabetes Mellitus, Type I (October 31, 2019): Phase III – EDITION JUNIOR
76 Figure 27: Key upcoming events in type 1 diabetes
LIST OF TABLES
15 Table 1: Prevalent cases of type 1 diabetes in adults (20–85+ years), 2018–27
17 Table 2: Prevalent cases of type 1 diabetes in children and adolescents (0–19 years), 2018–27
20 Table 3: Marketed drugs for type 1 diabetes
26 Table 4: Pipeline drugs for type 1 diabetes in the US
53 Table 5: Historical global sales, by drug ($m), 2015–19
54 Table 6: Forecasted global sales, by drug ($m), 2020–24
55 Table 7: Diamyd for Diabetes Mellitus, Type I (September 14, 2020)
57 Table 8: ProTrans for Diabetes Mellitus, Type I (September 8, 2020)
58 Table 9: XP-3924 for Diabetes Mellitus, Type I (June 18, 2020)
60 Table 10: NN9828 for Diabetes Mellitus, Type I (June 15, 2020)
61 Table 11: Teplizumab for Diabetes Mellitus, Type I (June 15, 2020)
63 Table 12: AT247 for Diabetes Mellitus, Type I (June 14, 2020)
65 Table 13: TTP399 for Diabetes Mellitus, Type I (June 13, 2020)
67 Table 14: Jardiance for Diabetes Mellitus, Type I (March 20, 2020)
68 Table 15: TTP399 for Diabetes Mellitus, Type I (February 10, 2020)
69 Table 16: Zynquista for Diabetes Mellitus, Type I (December 2, 2019)
70 Table 17: Jardiance for Diabetes Mellitus, Type I (November 13, 2019)
73 Table 18: Jardiance for Diabetes Mellitus, Type I (November 11, 2019)
74 Table 19: Toujeo for Diabetes Mellitus, Type I (October 31, 2019)
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