Diabetic Complications

Decision Resources, Inc, December 2011, Pages: 253

The rapidly rising prevalence of diabetes, an aging population, and inadequate maintenance of blood glucose control contribute directly to the growing prevalence of diabetic complications. Together, these complications are responsible for severe morbidity (e.g. blindness, leg amputations, kidney failure) and high levels of mortality. The economic burden of these complications, estimated at $58 billion in the United States in 2007, is considerable. The high unmet need for disease-modifying therapies that can reverse or stop the progression of the microvascular complications of diabetes therefore provides tremendous commercial opportunities for efficacious therapies.

Executive Summary

What are the key parameters of the diabetic retinopathy, neuropathy, and nephropathy markets?
What factors are driving the markets for diabetic retinopathy, neuropathy, and nephropathy therapies?
What factors are constraining the market for diabetic retinopathy, neuropathy, and nephropathy therapies?
Since we last reported on diabetic complications
What are the drug development activities of note in diabetic retinopathy, neuropathy, and nephropathy?
What do the experts say?
What key challenges and opportunities remain?

1 Etiology and Pathophysiology
Overview
Disease Pathophysiology
Disease Classifications
Retinopathy
Neuropathy
Nephropathy
Pathology
Retinopathy
Neuropathy
Nephropathy
Pathways and Drug Targets Associated with Multiple Diabetic Complications
Overview
Protein Kinase C
Transforming Growth Factor-Beta
Advanced-Glycation End Products
Polyol Pathway
Risk Factors
Duration of Diabetes
Other Diabetic Complications
Genetic Susceptibility
Gender
Poor Glycemic Control
Hypertension
Dyslipidemia
Smoking
Hemodynamic Factors
Drug Induction

2 Epidemiology and Patient Populations
Introduction
Diabetic Retinopathy
Overview
Disease Definition
Methods
Subpopulations
Diagnosed and Drug-Treated Populations
Percentage Diagnosed
Percentage Drug-Treated
Diabetic Neuropathy
Overview
Disease Definition
Methods
Diagnosed and Drug-Treated Populations
Percentage Diagnosed
Percentage Drug-Treated
Diabetic Nephropathy
Overview
Disease Definition
Methods
Subpopulations
Diagnosed and Drug-Treated Populations
Percentage Diagnosed
Percentage Drug-Treated

3 Current Therapies and Medical Practice
Treatment Providers
Retinopathy
Neuropathy
Nephropathy
Goals of Treatment
Retinopathy
Neuropathy
Nephropathy
Currently Marketed Products
Diabetic Retinopathy
Nonpharmacological Approaches
Laser Photocoagulation
Vitrectomy
Diabetic Neuropathy
Nonpharmacological Approaches
Diabetic Nephropathy
Nonpharmacological Approaches
Treatment Guidelines and Factors Influencing Drug Selection
Retinopathy
Neuropathy
Nephropathy
Treatment Algorithm
Retinopathy
Neuropathy
Nephropathy
Country-Specific Prescribing Practices
Retinopathy
Neuropathy
Nephropathy
Country-Specific Reimbursement Issues

4 Unmet Needs
Overview
Disease-Modifying Agents
Diabetic Retinopathy
Diabetic Neuropathy
Diabetic Nephropathy
Improved Diagnosis Rates
Therapies for Painful Diabetic Neuropathy with Fewer Side Effects than Current Drugs
More-Efficacious Therapies for Diabetic Retinopathy
Improved Delivery of Diabetic Retinopathy Therapies

5 Emerging Therapies
Overview
Future Positioning of Key Competitors
Drug Development and Regulatory Hurdles
Diabetic Retinopathy
VEGF Inhibitors
Overview
Mechanism of Action
Bevasiranib
Pegaptanib
Ranibizumab
Aflibercept
Protein Kinase C Inhibitors
Overview
Mechanism of Action
Ruboxistaurin
Angiogenesis Inhibitors
Overview
Mechanism of Action
Sirolimus
Ocular Corticosteroid Implants
Overview
Mechanism of Action
Ozurdex (Ophthalmic Dexamethasone)
Iluvien
Vitreal Detachment Therapies
Overview
Mechanism of Action
Vitreosolve
Ocriplasmin
Diabetic Neuropathy
Aldose Reductase Inhibitors
Overview
Mechanism of Action
Ranirestat
Antiepileptic Drugs
Overview
Mechanism of Action
Gabapentin GR
Gabapentin-Enacarbil
Pregabalin CR
Glutamate Receptor Antagonists
Overview
Mechanism of Action
Dextromethorphan/Quinidine
Perampanel
Na+/K+ ATPase Modulators
Overview
Mechanism of Action
Long-Acting C-Peptide (Ersatta)
Voltage-Gated Ion-Channel Inhibitors
Overview
Mechanism of Action
CNSB-001
Topical Analgesics
Overview
Mechanism of Action
Amitriptyline/Ketamine (AmiKet)
Clonidine (ARC-4558)
HGF Activators
Overview
Mechanism of Action
VM-202-DPN
Diabetic Nephropathy
Antioxidants/Anti-inflammatories
Overview
Mechanism of Action
Bardoxolone Methyl
Bindarit
Endothelin A Receptor Antagonists
Overview
Mechanism of Action
Atrasentan
Advanced Glycation End Product Modulators
Overview
Mechanism of Action
Pyridoxamine
Direct Renin Inhibitors
Overview
Mechanism of Action
Aliskiren
Direct Renin Inhibitor Fixed-Dose Combinations
Overview
Mechanism of Action
Aliskiren/Amlodipine/Hydrochlorothiazide
Angiotensin II Receptor Antagonist Fixed-Dose Combinations
Overview
Mechanism of Action
Azilsartan/Chlorthalidone

6 Market Outlook
Overview
Diabetic Retinopathy
Overview
Drug-Class-Specific Trends
VEGF Inhibitors
Ocular Corticosteroid Implants
Diabetic Neuropathy
Overview
Drug-Class-Specific Trends
Antiepileptic Drugs
Antidepressants
Single and Dual-Acting Opioid Analgesics
Aldose Reductase Inhibitors
HGF Activators
Diabetic Nephropathy
Overview
Drug-Class-Specific Trends
Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Receptor
Antagonists
Direct Renin Inhibitors
Fixed-Dose Combination Agents
Antioxidants
Endothelin A Receptor Antagonists
Appendix A Bibliography
Appendix B Market Forecast Methodology
Bottom-Up Market Forecasting Overview
Patient Populations
Drug-Specific Assumptions
General Sources of Data
Agents Included in Our Market Analysis
Diabetic Neuropathy
Diabetic Nephropathy
Pricing, Dosing, Days of Therapy, and Compliance Assumptions
General Statements About Pricing
Dosing, Days of Therapy, and Compliance
Diabetic Retinopathy (DME)
Diabetic Neuropathy
Diabetic Nephropathy
Generic Erosion
Emerging Therapy Prices
Diabetic Retinopathy
Diabetic Neuropathy
Diabetic Nephropathy
Appendix C Experts Interviewed—Diabetic Complications

Tables and Figures

Table 1-1 International Clinical Diabetic Retinopathy Disease Severity Scale

Table 1-2 Diabetic Neuropathy

Table 1-3 Definitions of Albumin Excretion Abnormailities

Table 1-4 US National Kidney Foundation Classification of Chronic Kidney Disease

Table 1-5 Hyperglycemia and Diabetic Retinopathy and Nephropathy: Results of Clinical Trials

Table 2-1 Number of Total Prevalent Cases of Diabetic Retinopathy Among Diagnosed Diabetics in the Major Pharmaceutical Markets by Severity, 2010-2020

Table 2-2 Number of Total Prevalent Cases of Diabetic Macular Edema Among Diagnosed Diabetics in the Major Pharmaceutical Markets, 2010-2020

Table 2-3 Number of Total, Diagnosed, and Drug-Treated Prevalent Cases of Diabetic Macular Edema Among Diagnosed Diabetics in the Major Pharmaceutical Markets, 2010-2020

Table 2-4 Key Sources for Diabetic Retinopathy Epidemiology and Model Parameters

Table 2-5 Number of Total Prevalent Cases of Diabetic Neuropathy in the Major Pharmaceutical Markets, 2010-2020

Table 2-6 Number of Total, Diagnosed, and Drug-Treated Prevalent Cases of Diabetic Neuropathy in the Major Pharmaceutical Markets, 2010-2020

Table 2-7 Key Sources for Diabetic Neuropathy Epidemiology and Model Parameters

Table 2-8 Number of Total Prevalent Cases of Albuminuria Among Diagnosed Diabetics in the Major Pharmaceutical Markets, 2010-2020

Table 2-9 Number of Total Prevalent Cases of Diabetic Nephropathy Among Diagnosed Diabetics in the Major Pharmaceutical Markets by CKD Stage, 2010-2020

Table 2-10 Number of Total, Diagnosed, and Drug-Treated Prevalent Cases of Diabetic Nephropathy Among Diagnosed Diabetics in the Major Pharmaceutical Markets, 2010-2020

Table 2-11 Key Sources for Diabetic Nephropathy Epidemiology and Model Parameters

Table 3-1 Diabetic Retinopathy Treatment Providers and Referral Patterns by Market

Table 3-2 Diabetic Neuropathy Treatment Providers and Referral Patterns, by Market

Table 3-3 Diabetic Nephropathy Treatment Providers and Referral Patterns, by Market

Table 3-4 End Points Used in Clinical Trials for Diabetic Retinopathy

Table 3-5 End Points Used in Clinical Trials for Diabetic Neuropathy

Table 3-6 End Points Used in Clinical Trials for Diabetic Nephropathy

Table 3-7 Current Therapies Used for Diabetic Retinopathy

Table 3-8 Current Classes Used for Diabetic Retinopathy—Mechanism of Action

Table 3-9 Clinical Trials of Current Therapies for Diabetic Retinopathy

Table 3-10 Comparison of Current Therapies for Diabetic Retinopathy

Table 3-11 Expert Insight: Leading Therapies in Diabetic Retinopathy

Table 3-12 Clinical Trials of Antiepileptic Drugs in Diabetic Neuropathy

Table 3-13 Clinical Trials of Antidepressants in Diabetic Neuropathy

Table 3-14 Clinical Trials of Opioid Analgesics in Diabetic Neuropathy

Table 3-15 Clinical Trials of Aldose-Reductase Inhibitors in Diabetic Neuropathy

Table 3-16 Current Classes Used for Diabetic Neuropathy—Mechanism of Action

Table 3-17 Key Current Therapies Used for Diabetic Neuropathy

Table 3-18 Comparison of Key Current Therapies for Diabetic Neuropathy

Table 3-19 Current Therapies Used for Diabetic Nephropathy

Table 3-20 Clinical Trials of ACE Inhibitors in Diabetic Nephropathy

Table 3-21 Clinical Trials of AIIRAs and Aliskiren in Diabetic Nephropathy

Table 3-22 Clinical Trials of Calcium-Channel Blockers in Diabetic Nephropathy

Table 3-23 Current Classes Used for Diabetic Nephropathy—Mechanism of Action

Table 3-24 Comparison of Current Therapies for Diabetic Nephropathy

Table 3-25 Expert Insight: Leading Therapies in Diabetic Nephropathy

Table 3-26 Diabetic Complications Treatment Guidelines, by Market

Table 3-27 Factors Influencing Drug Selection in Diabetic Retinopathy

Table 3-28 Factors Influencing Drug Selection in Diabetic Neuropathy

Table 3-29 Factors Influencing Drug Selection in Diabetic Nephropathy

Table 3-30 Reimbursement Environment for Diabetic Retinopathy, by Market

Table 3-31 Reimbursement Environment for Diabetic Neuropathy, by Market

Table 3-32 Reimbursement Environment for Diabetic Nephropathy, by Market

Table 5-1 Therapies in Development for Diabetic Retinopathy and Diabetic Macular Edema

Table 5-2 Therapies in Development for Diabetic Neuropathy

Table 5-3 Therapies in Development for Diabetic Nephropathy

Table 5-4 Estimated Launch Dates of Key Emerging Therapies for the Treatment of Diabetic Retinopathy and Diabetic Macular Edema

Table 5-5 Estimated Launch Dates of Key Emerging Therapies for the Treatment of Diabetic Neuropathy

Table 5-6 Estimated Launch Dates of Key Emerging Therapies for the Treatment of Diabetic Nephropathy

Table 5-7 Development of Aldose Reductase Inhibitors for the Treatment of Diabetic Neuropathy

Table 6-1 Timeline of Key Market Events for Diabetic Macular Edema

Table 6-2 Timeline of Key Market Events for Diabetic Neuropathy

Table 6-3 Timeline of Key Market Events for Diabetic Nephropathy

Table 6-4 Sales of Drugs to Treat Diabetic Macular Edema in the Major Pharmaceutical Markets, 2010-2020

Table 6-5 Sales of Drugs to Treat Diabetic Neuropathy in the Major Pharmaceutical Markets, 2010-2020

Table 6-6 Sales of Drugs to Treat Diabetic Nephropathy in the Major Pharmaceutical Markets, 2010-2020

Table B-1 Sources for Drug Prices

Figure 1-1 The Underlying Mechanisms of Diabetic Complications

Figure 1-2 Anatomy of the Eye

Figure 3-1 Diabetic Retinopathy Decision Tree

Figure 3-2 Diabetic Neuropathy Decision Tree

Figure 3-3 Diabetic Nephropathy Decision Tree

Figure 4-1 Unmet Needs: Attainment and Remaining Opportunity in Diabetic Complications

Customers who bought this item also bought

• Global Diabetic Retinopathy Drug Pipeline Capsule - 2012
• Type 2 Diabetes (Event Driven)
• Nitric Oxide - Therapeutics, Markets and Companies
• Neuroprotection - Drugs, Markets and Companies
• Stakeholder Opinions: Diabetic Renal Disease
• The Global Diabetes Market: Therapeutics, Diagnostics and Complications
• Chronic Pain
• Neuropathic Pain
• Hospital Insight Series: Diabetic Foot Infections, United States, 2011
• Diabetes Diagnostics - Global Strategic Business Report