Diabetes Drugs Industry Analysis 2012-2019 with Leading Company Profiles
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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