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. Even though the drug is still 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; however, it might meet some reimbursement opposition in Germany and apply a more aggressive pricing strategy.

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

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 Germany 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 47

5.4.1 Lucentis (ranibizumab) 47

5.4.2 Avastin (bevacizumab) 51

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 Germany 105

8.1.1 Forecast 105

8.1.2 Key Events 110

8.1.3 Drivers and Barriers 110

9 Appendix 114

9.1 Bibliography 114

9.2 Abbreviations 127

9.3 Methodology 132

9.4 Forecasting Methodology 132

9.4.1 Diagnosed Patients 132

9.4.2 Percent Drug-Treated Patients 133

9.4.3 Drugs Included in Each Therapeutic Class 133

9.4.4 Launch and Patent Expiry Dates 133

9.4.5 General Pricing Assumptions 134

9.4.6 Generic Erosion 138

9.4.7 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 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 51

Table 11: Product Profile - Avastin 53

Table 12: Avastin SWOT Analysis, 2013 55

Table 13: Corticosteroid Intravitreal Implants SWOT Analysis, 2013 59

Table 14: TCAs SWOT Analysis , 2013 62

Table 15: Product Profile - Cymbalta 63

Table 16: Product Profile - Effexor 64

Table 17: Cymbalta SWOT Analysis, 2013 66

Table 18: Product Profile - Neurontin (gabapentin) 68

Table 19: Product Profile - Lyrica (pregabalin) 69

Table 20: Lyrica SWOT Analysis, 2013 71

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: Germany Sales Forecasts ($) for MCD, 2012-2022 106

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

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

Table 36: Key Launch Dates 133

Table 37: Key Patent Expiries 134

Table 38: Number of High-Prescribing Physicians Surveyed 140

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 90

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

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

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