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Diabetes Drugs Industry Analysis 2012-2019 with Leading Company Profiles

Friday, September 23, 2016 2:43
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(Before It's News)

As the diabetes epidemic escalates, a new sense of urgency has taken hold. Proactive strategies for prevention of the disease are being put in place by international health organizations such as the World Health Organization, as well as by the health departments of industrialized and developing countries, and even at the local level where food ingredients regulations are being passed. This report evaluates widely-accepted therapeutic approaches to diabetes that are currently in use, while providing an in-depth analysis of emerging technologies that will be used to treat diabetes in the future.

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Major Points From Table of Contents

1. Overview 10

2. Introduction 17

3. Understanding the Metabolic Conditions Underlying and Associated with Diabetes 32

4. Pharmaceutical Industry and the Anti-Diabetes Market 67

5. Non-Insulin Anti-Diabetes Products 88

6. Insulin 122

7. Emerging Anti-Diabetes Technologies and Products 172

8. Diagnosing Diabetes Using In Vitro Laboratory Tests 193

9. Market Trends, Challenges and Strategic Options 220

10. Company Profiles 232

 

List of Tables

Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in Millions, 2013 and 2035 19

Table 2.2: Top Ten Countries with the Largest Estimated Number of Diabetics (20 to 79 Years Age Group),

2013 and 2035 20

Table 2.3: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group, 2013 20

Table 2.4: Countries with the Largest Number of Deaths Attributable to Diabetes, 2013 21

Table 2.5: U.S. Population of Diagnosed Diabetics Aged 20-79 Years, 2013 23

Table 2.6: Percentage of U.S. Adults with Diagnosed Diabetes by State, 2010 24

Table 2.7: Cost of Diagnosed Diabetes in the U.S., 2012 28

Table 2.8: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009 29

Table 2.9: Healthcare Utilization by Diabetic Patients, 2012 30

Table 3.1: International Diabetes Federation (IDF) Diagnostic Criteria for Metabolic Syndrome 34

Table 3.2: Ethnic Specific Values for Waist Circumference in IDF’s Metabolic Syndrome Criteria 34

Table 3.3: American Heart Association and National Heart, Lung, and Blood Institute (AHA/NHLBI) Diagnostic Criteria for Metabolic Syndrome 34

Table 3.4: Additional Metabolic Criteria for Research 36

Table 3.5: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S. 45

Table 3.6: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes 47

Table 3.7: Prevalence of Complications Among Patients with Diabetes 48

Table 3.8: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 48

Table 3.9: Major Causes of End-Stage Renal Disease 48

Table 3.10: Clinical Recommendations for Adults with Diabetes 50

Table 3.11: Laboratory Assessment of Diabetic Vascular Disease 50

Table 3.12: Average Years Gained Free of Diabetes-Related Disease with Intensive Management 51

Table 3.13: Summary of Cardiovascular Diseases (CVDs) 51

Table 3.14: Death Rate from Cardiovascular Diseases by Country, 2008 53

Table 3.15: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S.,

2010 57

Table 3.16: Selected Patent Expirations of Cardiac Care Drugs, 2012-2016 59

Table 3.17: Worldwide Market for Cardiac Care Therapeutics, 2010-2017 60

Table 4.1: Global R&D Spending in the Pharmaceutical Industry, 2010-2014 67

Table 4.2: Pharmaceutical Companies Ranked by Total R&D Expenditures, 2014 67

Table 4.3: Leading Therapy Classes for R&D, 2014 68

Table 4.4: Leading Disease Indications for R&D, 2014 69

Table 4.5: Cost of Clinical Trial Protocol Procedure by Endpoint Type, 2012 69

Table 4.6: Global Pharmaceutical Sales by Region and Country, 2012 and 2017, and CAGR 2008-2012 and

2013-2017 70

Table 4.7: World Pharmaceutical Sales Share by Region, 2013 71

Table 4.8: Leading Ten Therapeutic Classes by Global Sales, 2010-2014 72

Table 4.9: Estimated Leading Therapy Classes by Global Sales in the Developed Market, 2018 72

Table 4.10: Estimated Leading Therapy Classes by Global Sales in the Pharmerging Market, 2018 73

Table 4.11: Leading Ten Therapeutic Classes by U.S. Sales, 2009-2013 73

Table 4.12: Top Ten Therapeutic Classes by U.S. Dispensed Prescriptions, 2009-2013 73

Table 4.13: Top Selling Drugs Worldwide by Sales, 2014 74

Table 4.14: Top Selling Drugs in the U.S. by Sales, 2014 74

Table 4.15: Top Ten Global Pharmaceutical Companies by Global Sales, 2014 75

Table 4.16: Worldwide Anti-Diabetes (Insulin and Non-Insulin) Drug Market, 2012-2019 76

Table 4.17: U.S. Anti-Diabetes (Insulin and Non-Insulin) Drug Market, 2012-2019 76

Table 4.18: Anti-Diabetic Therapy Markets, 2014 76

Table 4.19: Top Ten Branded Anti-Diabetics by Sales Worldwide, 2014 79

Table 4.20: Top Ten Branded Anti-Diabetics by Monthly Prescriptions Worldwide, 2014 80

Table 4.21: American College of Physicians 2012 Practical Guideline for the Use of Anti-Diabetes Drugs for Type 2 Diabetes 82

Table 4.22: Summary of Glucose-Lowering Interventions as Monotherapy 83

Table 5.1: Classes of Non-Insulin Hypoglycemic Agents 89

Table 5.2: Branded Non-Insulin Hypoglycemic Drugs Used to Treat Type 2 Diabetes in the U.S., 2014 90

Table 5.3: Relative Efficacy of Diabetes Drugs 91

Table 5.4: Fixed-Dose Oral Anti-Diabetes Drug Combinations 106

Table 5.5: Worldwide Non-Insulin Anti-Diabetes Drug Market, 2012-2019 110

Table 5.6: U.S. Non-Insulin Anti-Diabetes Drug Market, 2012-2019 110

Table 5.7: Diabetes Drugs Approved for U.S. Market, 2014 and 2015 111

Table 5.8: GLP-1 Agonist Pipeline: Selected Drugs in Development 112

Table 5.9: DPP-IV Inhibitor Pipeline: Selected Drugs in Development 115

Table 5.10: SGLT-2 Inhibitor Pipeline: Selected Drugs in Development 116

Table 5.11: Fixed-Dose Combination Drugs with SGLT-2 Inhibitor: Selected Drugs in Development 116

Table 5.12: Summary of Emerging Non-Insulin Anti-Diabetes Drug Categories 118

Table 6.1: Value Market Shares of Animal, Human and Modern Insulin, 1995-2014 122

Table 6.2: Worldwide Insulin Market, 2012-2019 123

Table 6.3: Worldwide Insulin Sales and Market Share by World Region, 2014 123

Table 6.4: U.S. Insulin Market, 2012-2019 123

Table 6.5: Key Drivers of the Type 2 Diabetes Insulin Market, 2014 124

Table 6.6: Worldwide Insulin Sales and Value Market Share by Company, 2014 124

Table 6.7: U.S. Insulin Sales and Value Market Share by Company, 2014 125

Table 6.8: Insulins on the U.S. Market 128

Table 6.9: Pharmacokinetics of Therapeutic Insulins on the U.S. Market 129

Table 6.10: Comparison of Recommendations from Existing Guidelines 132

Table 6.11: Pharmacokinetics of Short-Acting Insulins 132

Table 6.12: Pharmacokinetics of Rapid-Acting Insulins 133

Table 6.13: Pharmacokinetics of Intermediate-Acting Insulins 135

Table 6.14: Pharmacokinetics of Long-Acting Insulins 136

Table 6.15: Pharmacokinetics of Insulin Mixtures 137

Table 6.16: A Comparison of Existing Insulin Delivery Devices 151

Table 6.17: Insulin Pens 152

Table 6.18: Estimated Worldwide Demand for Insulin Pens by Volume, 2013-2018 155

Table 6.19: Injection Aids 156

Table 6.20: Jet Injectors 158

Table 6.21: Control Averages by Treatment 159

Table 6.22: Reduced Risk for Various Diseases When Blood Glucose is Near Normal 159

Table 6.23: Leading Insulin Pump Manufacturers 160

Table 6.24: Comparison of Current External Insulin Pumps on the Market 160

Table 6.25: Insulin Infusion Sets 166

Table 6.26: Worldwide Insulin Pump Market, 2013-2019 170

Table 7.1: Advantages and Disadvantages of Newer Type 2 Diabetes Therapies 173

Table 7.2: Cells of the Pancreas 179

Table 7.3: Statin Recommendations for Designated Treatment Groups 187

Table 7.4: Statins Currently Available in the U.S. 187

Table 7.5: Statin Intensity Chart 188

Table 7.6: Summary of Non-Statin Cholesterol Lowering Drugs 188

Table 7.7: Suggested Pharmacological Treatment Agents for Hypertension 190

Table 8.1: Criteria for the Diagnosis of Diabetes 194

Table 8.2: Categories of Increased Risk for Diabetes (Pre-Diabetes) 194

Table 8.3: Normal Glucose Values?Fasting State 194

Table 8.4: Criteria for Testing for Diabetes in Asymptomatic Adults 195

Table 8.5: Criteria for Type 2 Diabetes in Asymptomatic Children 195

Table 8.6: Screening for and Diagnosis of Gestational Diabetes Mellitus (GDM) 196

Table 8.7: Laboratory Assessment of Diabetic Vascular Disease 200

Table 8.8: Worldwide Glucose Self-Testing Market Sales (Meters, Strips and Lancets), 2012-2018 201

Table 8.9: Market for Glucose Self-Testing in the U.S. (includes Meters, Strips and Lancets), 2012-2018 201

Table 8.10: Market Share of U.S. Blood Glucose Self-Testing, 2013 202

Table 8.11: Lancet Characteristics 219

Table 9.1: BRIC Countries, Percentage of GDP Spent on Healthcare, 2013 226

Table A1.1: Select Archived Press Release Excerpts 270

List of Figures

Figure 2.1: Worldwide Diabetes Cases, 2013 and 2035 18

Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2013 19

Figure 2.3: Annual Number of New Cases of Diagnosed Diabetes Among U.S. Adults Aged 18-79 Years,

1980-2012 22

Figure 2.4: New Adult Cases of Diabetes Diagnosed in the U.S., 2012 23

Figure 2.5: Diagnosed and Undiagnosed Diabetes by Age in the U.S., 2013 23

Figure 2.6: Number of Deaths from Diabetes by Age in the U.S., 2010 25

Figure 2.7: Number of Diabetes Deaths by Race and Sex in the U.S., 2010 26

Figure 2.8: Mean Diabetes Healthcare-Related Expenditures Per Adult (20-79 Years) with Diabetes (USD),

2013 27

Figure 2.9: How Diabetes Dollars are Spent in the U.S., 2012 29

Figure 3.1: Maintenance of Normal Blood Sugar Levels 32

Figure 3.2: Prevalence of Self-Reported Obesity (BMI 30) Among U.S. Adults, 2012 42

Figure 3.3: Prevalence of Obesity Among Adults in the U.S., 2009-2010 43

Figure 3.4: Percentage of Obese Children and Adolescents in the U.S., 2009-2010 43

Figure 3.5: Trends in Obesity Among Children and Adolescents in the U.S., 1988-2010 44

Figure 3.6: Age-Adjusted Percentage of People with Diabetes Aged 35 Years or Older Reporting Heart Disease or Stroke, by Sex in the U.S., 1997-2011 45

Figure 3.7: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation, by Age in the U.S., 1997-2011 49

Figure 3.8: Number (in Millions) of Adults Aged 18 Years or Older with Diagnosed Diabetes Reporting Visual Impairment in the U.S., 1997-2011 49

Figure 3.9: Annual Death Rate of U.S. Population from Heart Disease, 1950-2009 53

Figure 3.10: Annual Death Rate of U.S. Population from Strokes, 1950-2009 54

Figure 3.11: Percentage Breakdown of Deaths Attributable to Cardiovascular Disease in the U.S., 2010 54

Figure 3.12: Death Rates from Cardiovascular Disease by State, 2010 55

Figure 3.13: Percentage of Obese Adults in the U.S., 1960-2010 56

Figure 3.14: Percentage of Obese Children and Adolescents in the U.S., 1971-2010 57

Figure 3.15: Number of Annual Prescriptions for Popular Cholesterol Drugs, 2007-2012 62

Figure 4.1: Sales Forecast for the Global Diabetes Drug Market, 2012-2019 81

Figure 4.2: Sales Forecast for the U.S. Diabetes Drug Market, 2012-2019 81

Figure 4.3: Percentage of U.S. Diabetics Taking Medications, 2010-2012 82

Figure 4.4: U.S. Non-Insulin Anti-Diabetic Drug Prescriptions, 2014 85

Figure 5.1: Overview of GLP-1 and Blood Glucose 97

Figure 5.2: Overview of DPP-4 Inhibitors and Blood Glucose 101

Figure 5.3: SGLT-2 Inhibitor Mechanism of Action 103

Figure 5.4: Global Non-Insulin Anti-Diabetes Sales by Drug Class, 2014 109

Figure 5.5: Global Non-Insulin Anti-Diabetes Prescriptions by Drug Class, 2014 109

Figure 6.1: Global Sales of Lantus, 2005-2014 125

Figure 6.2: Insulin Pump Market Share, 2014 170

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