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 growth will be fueled mainly by the uptake of new branded drugs, such as atrasentan, Optina and ranirestat. The uptake of Eylea, which will receive additional approval for diabetic retinopathy/DME, will further drive sales in the MCD market.

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

Table of Contents

1 Table of Contents 6

1.1 List of Tables 10

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 Japan 34

4.2.1 Diagnosis 34

4.2.2 Clinical Practice 36

5 Competitive Assessment 38

5.1 Overview 38

5.2 Strategic Competitor Assessment 39

5.3 Diabetic Nephropathy: Product Profiles - Major Classes and Brands 43

5.3.1 Angiotensin-Converting Enzyme (ACE) Inhibitors 43

5.3.2 Angiotensin Receptor Blockers 46

5.4 Diabetic Retinopathy: Product Profiles - Major Classes and Brands 49

5.4.1 Lucentis (ranibizumab) 49

5.4.2 Avastin (bevacizumab) 53

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

7.2.4 Ranirestat 104

8 Market Outlook 108

8.1 Japan 108

8.1.1 Forecast 108

8.1.2 Key Events 113

8.1.3 Drivers and Barriers 113

9 Appendix 116

9.1 Bibliography 116

9.2 Abbreviations 128

9.3 Methodology 133

9.4 Forecasting Methodology 133

9.4.1 Diagnosed Patients 133

9.4.2 Percent Drug-Treated Patients 134

9.4.3 Drugs Included in Each Therapeutic Class 134

9.4.4 Launch and Patent Expiry Dates 134

9.4.5 General Pricing Assumptions 135

9.4.6 Individual Drug Assumptions 136

9.4.7 Generic Erosion 139

9.4.8 Pricing of Pipeline Agents 139

9.5 Physicians and Specialists Included in this Study 140

9.6 About the Authors 142

9.6.1 Analyst II - CVMD 142

9.6.2 Therapy Director - CVMD and Infectious Disease 142

9.6.3 Global Head of Healthcare 143

9.7 About GlobalData 144

9.8 Disclaimer 144

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 41

Table 7: ACE Inhibitors SWOT Analysis, 2013 45

Table 8: ARBs SWOT Analysis, 2013 48

Table 9: Product Profile - Lucentis 50

Table 10: Lucentis SWOT Analysis, 2013 53

Table 11: Product Profile - Avastin 55

Table 12: Avastin SWOT Analysis, 2013 57

Table 13: TCAs SWOT Analysis , 2013 60

Table 14: Product Profile - Cymbalta 62

Table 15: Product Profile - Effexor 62

Table 16: Cymbalta SWOT Analysis, 2013 64

Table 17: Product Profile - Neurontin (gabapentin) 67

Table 18: Product Profile - Lyrica (pregabalin) 67

Table 19: Lyrica SWOT Analysis, 2013 69

Table 20: Opioids SWOT Analysis, 2013 72

Table 21: Overall Unmet Needs - Current Level of Attainment 73

Table 22: Clinical Unmet Needs in MCD - Gap Analysis, 2012 81

Table 23: MCD - Clinical Trials by Phase and Status, 2013 87

Table 24: MCD - Phase Pipeline, 2013 88

Table 25: Comparison of Drugs in Development for MCD, 2013 89

Table 26: Product Profile - Eylea 91

Table 27: Eylea SWOT Analysis, 2013 95

Table 28: Product Profile - Optina 97

Table 29: Optina SWOT Analysis, 2013 99

Table 30: Product Profile - Atrasentan 101

Table 31: Atrasentan SWOT Analysis, 2013 103

Table 32: Product Profile - Ranirestat 105

Table 33: Ranirestat SWOT Analysis, 2013 107

Table 34: Japan Sales Forecasts ($) for MCD, 2012-2022 109

Table 35: Key Events Impacting Sales for MCD in Japan, 2012-2022 113

Table 36: MCD Market - Drivers and Barriers in Japan, 2013 113

Table 37: Key Launch Dates 134

Table 38: Key Patent Expiries 135

Table 39: Number of High-Prescribing Physicians Surveyed 141

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 89

Figure 4: Sales for Diabetic Nephropathy in Japan, 2012-2022 110

Figure 5: Sales for Diabetic Retinopathy in Japan, 2012-2022 111

Figure 6: Sales for Diabetic Neuropathy in Japan, 2012-2022 112