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 currently marketed product with the highest growth rate over the forecast period will be Regeneron/Bayer’s Eylea. Despite the drug still being in the pipeline for DME, it is being used off-label already. Its usage will drastically increase upon its approval for the DME indication in 2014.

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 the UK including product description, safety and efficacy profiles as well as a SWOT analysis.
• Sales forecast for the top drugs in the UK from 2012-2022.
• Analysis of the impact of key events as well the drivers and restraints affecting the UK 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 the UK

Table of Contents

1 Table of Contents 5

1.1 List of Tables 9

1.2 List of Figures 10

2 Introduction 11

2.1 Catalyst 11

2.2 Related Reports 12

3 Disease Overview 14

3.1 Etiology and Pathophysiology 16

3.1.1 Diabetic Nephropathy 16

3.1.2 Diabetic Retinopathy 18

3.1.3 Diabetic Neuropathy 19

3.2 Prognosis 20

3.3 Quality of Life 21

3.4 Symptoms 22

4 Disease Management 23

4.1 Treatment Overview 23

4.1.1 Diagnosis and Referrals 23

4.1.2 Screening 25

4.1.3 Treatment Guidelines 26

4.2 Japan 33

4.2.1 Diagnosis 33

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 48

5.4.1 Lucentis (ranibizumab) 48

5.4.2 Avastin (bevacizumab) 52

5.5 Diabetic Neuropathy: Product Profiles - Major Classes and Brands 57

5.5.1 Tricyclic Antidepressants 57

5.5.2 Serotonin-Norepinephrine Reuptake Inhibitors - Cymbalta (duloxetine) and Effexor (venlafaxine) 60

5.5.3 Anticonvulsants - Neurontin (gabapentin) and Lyrica (pregabalin) 64

5.5.4 Opioids 69

6 Opportunity and Unmet Need 72

6.1 Overview 72

6.2 Unmet Needs 73

6.2.1 Unified Treatment for the Microvascular Complications of Diabetes 73

6.2.2 Optimization of Personalized Therapy in the Microvascular Complications of Diabetes 73

6.2.3 Treatment for Diabetic Nephropathy that Would Prevent ESRD 75

6.2.4 Cardio- and Renoprotective Therapy for Diabetic Nephropathy 76

6.2.5 Efficient Therapy for Retinopathy 77

6.2.6 Convenient Administration in Diabetic Retinopathy Treatment 77

6.2.7 Treatment for Diabetic Neuropathy 78

6.3 Unmet Needs Gap Analysis 79

6.4 Opportunity: Therapy for the Underlying Cause of the Microvascular Complications of Diabetes 81

6.5 Opportunity: Patient-Tailored Therapy for the Microvascular Complications of Diabetes 81

6.6 Opportunity: Efficacious Therapy for Diabetic Nephropathy 82

6.7 Opportunity: Topical Treatment for Diabetic Retinopathy 82

6.8 Opportunity: Treatment for Diabetic Neuropathy 83

7 Pipeline Assessment 84

7.1 Overview 84

7.2 Promising Drugs in Clinical Development 87

7.2.1 Eylea (aflibercept) 89

7.2.2 Optina (danazol) 94

7.2.3 Atrasentan Hydrochloride 99

8 Market Outlook 103

8.1 UK 103

8.1.1 Forecast 103

8.1.2 Key Events 108

8.1.3 Drivers and Barriers 108

9 Appendix 112

9.1 Bibliography 112

9.2 Abbreviations 125

9.3 Methodology 130

9.4 Forecasting Methodology 130

9.4.1 Diagnosed Patients 130

9.4.2 Percent Drug-Treated Patients 131

9.4.3 Drugs Included in Each Therapeutic Class 131

9.4.4 Launch and Patent Expiry Dates 131

9.4.5 General Pricing Assumptions 132

9.4.6 Individual Drug Assumptions 133

9.4.7 Generic Erosion 137

9.4.8 Pricing of Pipeline Agents 137

9.5 Physicians and Specialists Included in this Study 138

9.6 About the Authors 140

9.6.1 Analyst II - CVMD 140

9.6.2 Therapy Director - CVMD and Infectious Disease 140

9.6.3 Global Head of Healthcare 141

9.7 About GlobalData 142

9.8 Disclaimer 142

List of Tables

Table 1: Risk Factors for MCD 16

Table 2: Symptoms of MCD 22

Table 3: Diagnostic Tests and Typical Criteria for MCD 24

Table 4: Treatment Guidelines for MCD 27

Table 5: Most Prescribed Drugs for MCD by Class in the 7MM, 2012 30

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 52

Table 11: Product Profile - Avastin 54

Table 12: Avastin SWOT Analysis, 2013 56

Table 13: TCAs SWOT Analysis , 2013 59

Table 14: Product Profile - Cymbalta 61

Table 15: Product Profile - Effexor 61

Table 16: Cymbalta SWOT Analysis, 2013 63

Table 17: Product Profile - Neurontin (gabapentin) 66

Table 18: Product Profile - Lyrica (pregabalin) 66

Table 19: Lyrica SWOT Analysis, 2013 68

Table 20: Opioids SWOT Analysis, 2013 71

Table 21: Overall Unmet Needs - Current Level of Attainment 72

Table 22: Clinical Unmet Needs in MCD - Gap Analysis, 2012 80

Table 23: MCD - Clinical Trials by Phase and Status, 2013 86

Table 24: MCD - Phase Pipeline, 2013 87

Table 25: Comparison of Drugs in Development for MCD, 2013 88

Table 26: Product Profile - Eylea 90

Table 27: Eylea SWOT Analysis, 2013 94

Table 28: Product Profile - Optina 96

Table 29: Optina SWOT Analysis, 2013 98

Table 30: Product Profile - Atrasentan 100

Table 31: Atrasentan SWOT Analysis, 2013 102

Table 32: UK Sales Forecasts ($) for MCD, 2012-2022 104

Table 33: Key Events Impacting Sales for MCD in the UK, 2012-2022 108

Table 34: MCD Market - Drivers and Barriers in the UK, 2013 108

Table 35: Key Launch Dates 131

Table 36: Key Patent Expiries 132

Table 37: Number of High-Prescribing Physicians Surveyed 139

List of Figures

Figure 1: Potential Mechanisms of Diabetes-Induced Microvascular Complications 15

Figure 2: General Treatment Algorithms for MCD 28

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in MCD, 2012-2022 88

Figure 4: Sales for Diabetic Nephropathy in the UK, 2012-2022 105

Figure 5: Sales for Diabetic Retinopathy in the UK, 2012-2022 106

Figure 6: Sales for Diabetic Neuropathy in the UK, 2012-2022 107