The entire market for microvascular complications of diabetes (MCD) diabetic nephropathy, retinopathy, and neuropathy is facing an extremely high level of unmet need across the 7MM (US, 5EU and Japan). Despite its enormous potential, the MCD market is facing the major global barrier in the sparsely populated pipeline. The diabetic retinopathy segment of the market has recently seen rapid uptake of novel anti-VEGF therapies and is experiencing a strong growth. On the other hand, the diabetic neuropathy and nephropathy segments face the barrier in and increasing number of generic competitors.

The uptake of drugs receiving additional approval for diabetic retinopathy/DME, such as Eylea, Iluvien and Ozurdex, will further drive sales in the MCD market. A dip in sales in the diabetic neuropathy market will happen from mid-2014 due to the patent expiry of Cymbalta. Another dip in sales in the diabetic neuropathy segment will happen around 2018, when Lyrica’s patent expires.

Scope

• Overview of MCD including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
• Detailed information on the key drugs in Italy including product description, safety and efficacy profiles as well as a SWOT analysis.
• Sales forecast for the top drugs in Italy from 2012-2022.
• Analysis of the impact of key events as well the drivers and restraints affecting the Italy MCD market.

Reasons to buy

• Understand and capitalize by identifying products that are most likely to ensure a robust return
• Stay ahead of the competition by understanding the changing competitive landscape for MCD
• Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
• Make more informed business decisions from insightful and in-depth analysis of drug performance
• Obtain sales forecast for drugs from 2012-2022 in Italy

Table of Contents

1 Table of Contents 6

1.1 List of Tables 9

1.2 List of Figures 11

2 Introduction 12

2.1 Catalyst 12

2.2 Related Reports 13

3 Disease Overview 15

3.1 Etiology and Pathophysiology 17

3.1.1 Diabetic Nephropathy 17

3.1.2 Diabetic Retinopathy 19

3.1.3 Diabetic Neuropathy 20

3.2 Prognosis 21

3.3 Quality of Life 22

3.4 Symptoms 23

4 Disease Management 24

4.1 Treatment Overview 24

4.1.1 Diagnosis and Referrals 24

4.1.2 Screening 26

4.1.3 Treatment Guidelines 27

4.2 Italy 34

4.2.1 Diagnosis 34

4.2.2 Clinical Practice 35

5 Competitive Assessment 37

5.1 Overview 37

5.2 Strategic Competitor Assessment 38

5.3 Diabetic Nephropathy: Product Profiles - Major Classes and Brands 42

5.3.1 Angiotensin-Converting Enzyme (ACE) Inhibitors 42

5.3.2 Angiotensin Receptor Blockers 45

5.4 Diabetic Retinopathy: Product Profiles - Major Classes and Brands 47

5.4.1 Lucentis (ranibizumab) 47

5.4.2 Avastin (bevacizumab) 52

5.4.3 Corticosteroid Intravitreal Implants 56

5.5 Diabetic Neuropathy: Product Profiles - Major Classes and Brands 59

5.5.1 Tricyclic Antidepressants 59

5.5.2 Serotonin-Norepinephrine Reuptake Inhibitors - Cymbalta (duloxetine) and Effexor (venlafaxine) 62

5.5.3 Anticonvulsants - Neurontin (gabapentin) and Lyrica (pregabalin) 66

5.5.4 Opioids 71

6 Opportunity and Unmet Need 74

6.1 Overview 74

6.2 Unmet Needs 75

6.2.1 Unified Treatment for the Microvascular Complications of Diabetes 75

6.2.2 Optimization of Personalized Therapy in the Microvascular Complications of Diabetes 75

6.2.3 Treatment for Diabetic Nephropathy that Would Prevent ESRD 77

6.2.4 Cardio- and Renoprotective Therapy for Diabetic Nephropathy 78

6.2.5 Efficient Therapy for Retinopathy 79

6.2.6 Convenient Administration in Diabetic Retinopathy Treatment 79

6.2.7 Treatment for Diabetic Neuropathy 80

6.3 Unmet Needs Gap Analysis 81

6.4 Opportunity: Therapy for the Underlying Cause of the Microvascular Complications of Diabetes 83

6.5 Opportunity: Patient-Tailored Therapy for the Microvascular Complications of Diabetes 83

6.6 Opportunity: Efficacious Therapy for Diabetic Nephropathy 84

6.7 Opportunity: Topical Treatment for Diabetic Retinopathy 84

6.8 Opportunity: Treatment for Diabetic Neuropathy 85

7 Pipeline Assessment 86

7.1 Overview 86

7.2 Promising Drugs in Clinical Development 89

7.2.1 Eylea (aflibercept) 91

7.2.2 Optina (danazol) 96

7.2.3 Atrasentan Hydrochloride 101

8 Market Outlook 105

8.1 Italy 105

8.1.1 Forecast 105

8.1.2 Key Events 110

8.1.3 Drivers and Barriers 110

9 Appendix 113

9.1 Bibliography 113

9.2 Abbreviations 126

9.3 Methodology 131

9.4 Forecasting Methodology 131

9.4.1 Diagnosed Patients 131

9.4.2 Percent Drug-Treated Patients 132

9.4.3 Drugs Included in Each Therapeutic Class 132

9.4.4 Launch and Patent Expiry Dates 132

9.4.5 General Pricing Assumptions 133

9.4.6 Individual Drug Assumptions 134

9.4.7 Generic Erosion 138

9.4.8 Pricing of Pipeline Agents 138

9.5 Physicians and Specialists Included in this Study 139

9.6 About the Authors 141

9.6.1 Analyst II - CVMD 141

9.6.2 Therapy Director - CVMD and Infectious Disease 141

9.6.3 Global Head of Healthcare 142

9.7 About GlobalData 143

9.8 Disclaimer 143

List of Tables

Table 1: Risk Factors for MCD 17

Table 2: Symptoms of MCD 23

Table 3: Diagnostic Tests and Typical Criteria for MCD 25

Table 4: Treatment Guidelines for MCD 28

Table 5: Most Prescribed Drugs for MCD by Class in the 7MM, 2012 31

Table 6: Leading Drug Treatments for MCD, 2013 40

Table 7: ACE Inhibitors SWOT Analysis, 2013 44

Table 8: ARBs SWOT Analysis, 2013 47

Table 9: Product Profile - Lucentis 49

Table 10: Lucentis SWOT Analysis, 2013 51

Table 11: Product Profile - Avastin 53

Table 12: Avastin SWOT Analysis, 2013 55

Table 13: Corticosteroid Intravitreal Implants SWOT Analysis, 2013 58

Table 14: TCAs SWOT Analysis , 2013 61

Table 15: Product Profile - Cymbalta 63

Table 16: Product Profile - Effexor 63

Table 17: Cymbalta SWOT Analysis, 2013 65

Table 18: Product Profile - Neurontin (gabapentin) 68

Table 19: Product Profile - Lyrica (pregabalin) 68

Table 20: Lyrica SWOT Analysis, 2013 70

Table 21: Opioids SWOT Analysis, 2013 73

Table 22: Overall Unmet Needs - Current Level of Attainment 74

Table 23: Clinical Unmet Needs in MCD - Gap Analysis, 2012 82

Table 24: MCD - Clinical Trials by Phase and Status, 2013 88

Table 25: MCD - Phase Pipeline, 2013 89

Table 26: Comparison of Drugs in Development for MCD, 2013 90

Table 27: Product Profile - Eylea 92

Table 28: Eylea SWOT Analysis, 2013 96

Table 29: Product Profile - Optina 98

Table 30: Optina SWOT Analysis, 2013 100

Table 31: Product Profile - Atrasentan 102

Table 32: Atrasentan SWOT Analysis, 2013 104

Table 33: Italy Sales Forecasts ($) forMCD, 2012-2022 106

Table 34: Key Events Impacting Sales for MCD in Italy, 2012-2022 110

Table 35: MCD Market - Drivers and Barriers in Italy, 2013 110

Table 36: Key Launch Dates 132

Table 37: Key Patent Expiries 133

Table 38: Number of High-Prescribing Physicians Surveyed 140

List of Figures

Figure 1: Potential Mechanisms of Diabetes-Induced Microvascular Complications 16

Figure 2: General Treatment Algorithms for MCD 29

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in MCD, 2012-2022 90

Figure 4: Sales for Diabetic Nephropathy in Italy, 2012-2022 107

Figure 5: Sales for Diabetic Retinopathy in Italy, 2012-2022 108

Figure 6: Sales for Diabetic Neuropathy in Italy, 2012-2022 109