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

Table of Contents

1 Table of Contents 5

1.1 List of Tables 8

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 Spain 33

4.2.1 Diagnosis 33

4.2.2 Clinical Practice 34

5 Competitive Assessment 36

5.1 Overview 36

5.2 Strategic Competitor Assessment 37

5.3 Diabetic Nephropathy: Product Profiles - Major Classes and Brands 41

5.3.1 Angiotensin-Converting Enzyme (ACE) Inhibitors 41

5.3.2 Angiotensin Receptor Blockers 44

5.4 Diabetic Retinopathy: Product Profiles - Major Classes and Brands 46

5.4.1 Lucentis (ranibizumab) 46

5.4.2 Avastin (bevacizumab) 51

5.4.3 Corticosteroid Intravitreal Implants 55

5.5 Diabetic Neuropathy: Product Profiles - Major Classes and Brands 58

5.5.1 Tricyclic Antidepressants 58

5.5.2 Serotonin-Norepinephrine Reuptake Inhibitors - Cymbalta (duloxetine) and Effexor (venlafaxine) 61

5.5.3 Anticonvulsants - Neurontin (gabapentin) and Lyrica (pregabalin) 65

5.5.4 Opioids 70

6 Opportunity and Unmet Need 73

6.1 Overview 73

6.2 Unmet Needs 74

6.2.1 Unified Treatment for the Microvascular Complications of Diabetes 74

6.2.2 Optimization of Personalized Therapy in the Microvascular Complications of Diabetes 74

6.2.3 Treatment for Diabetic Nephropathy that Would Prevent ESRD 76

6.2.4 Cardio- and Renoprotective Therapy for Diabetic Nephropathy 77

6.2.5 Efficient Therapy for Retinopathy 78

6.2.6 Convenient Administration in Diabetic Retinopathy Treatment 78

6.2.7 Treatment for Diabetic Neuropathy 79

6.3 Unmet Needs Gap Analysis 80

6.4 Opportunity: Therapy for the Underlying Cause of the Microvascular Complications of Diabetes 82

6.5 Opportunity: Patient-Tailored Therapy for the Microvascular Complications of Diabetes 82

6.6 Opportunity: Efficacious Therapy for Diabetic Nephropathy 83

6.7 Opportunity: Topical Treatment for Diabetic Retinopathy 83

6.8 Opportunity: Treatment for Diabetic Neuropathy 84

7 Pipeline Assessment 85

7.1 Overview 85

7.2 Promising Drugs in Clinical Development 88

7.2.1 Eylea (aflibercept) 90

7.2.2 Optina (danazol) 95

7.2.3 Atrasentan Hydrochloride 100

8 Market Outlook 104

8.1 Spain 104

8.1.1 Forecast 104

8.1.2 Key Events 109

8.1.3 Drivers and Barriers 109

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 39

Table 7: ACE Inhibitors SWOT Analysis, 2013 43

Table 8: ARBs SWOT Analysis, 2013 46

Table 9: Product Profile - Lucentis 48

Table 10: Lucentis SWOT Analysis, 2013 50

Table 11: Product Profile - Avastin 52

Table 12: Avastin SWOT Analysis, 2013 54

Table 13: Corticosteroid Intravitreal Implants SWOT Analysis, 2013 57

Table 14: TCAs SWOT Analysis , 2013 60

Table 15: Product Profile - Cymbalta 62

Table 16: Product Profile - Effexor 62

Table 17: Cymbalta SWOT Analysis, 2013 64

Table 18: Product Profile - Neurontin (gabapentin) 67

Table 19: Product Profile - Lyrica (pregabalin) 67

Table 20: Lyrica SWOT Analysis, 2013 69

Table 21: Opioids SWOT Analysis, 2013 72

Table 22: Overall Unmet Needs - Current Level of Attainment 73

Table 23: Clinical Unmet Needs in MCD - Gap Analysis, 2012 81

Table 24: MCD - Clinical Trials by Phase and Status, 2013 87

Table 25: MCD - Phase Pipeline, 2013 88

Table 26: Comparison of Drugs in Development for MCD, 2013 89

Table 27: Product Profile - Eylea 91

Table 28: Eylea SWOT Analysis, 2013 95

Table 29: Product Profile - Optina 97

Table 30: Optina SWOT Analysis, 2013 99

Table 31: Product Profile - Atrasentan 101

Table 32: Atrasentan SWOT Analysis, 2013 103

Table 33: Spain Sales Forecasts ($) for MCD, 2012-2022 105

Table 34: Key Events Impacting Sales for MCD in Spain, 2012-2022 109

Table 35: MCD Market - Drivers and Barriers in Spain, 2013 109

Table 36: Key Launch Dates 131

Table 37: Key Patent Expiries 132

Table 38: 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 89

Figure 4: Sales for Diabetic Nephropathy in Spain, 2012-2022 106

Figure 5: Sales for Diabetic Retinopathy in Spain, 2012-2022 107

Figure 6: Sales for Diabetic Neuropathy in Spain, 2012-2022 108