There has been a dramatic increase in the incidence of diabetes worldwide,
which has been exacerbated by the growing obesity problem across the globe.
Once thought of as primarily a childhood disease--sometimes referred to as
juvenile diabetes, now mostly Type 1 diabetes--the obesity crisis linked to
the adoption of a high-fat, high-carbohydrate, high-calorie American diet has
resulted in skyrocketing rates of diabetes among adults across the world. To
compound the global diabetes epidemic, health professionals are witnessing an
alarming increase in inflammatory diseases resulting from adult onset (i.e.,
Type 2) diabetes. This phenomenon is referred to as "metabolic syndrome" where
a confluence of inflammatory conditions occur along with the diabetes. As a
result, growing evidence appears to show that metabolic syndrome makes the
diabetic patient susceptible to degenerative health conditions such as
cardiovascular disease, stroke and, now believed, Alzheimer's disease. 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
(WHO), 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 TriMark Publications report charts the changing landscape
of the global diabetic population and explores the added health concerns
resulting from the metabolic syndrome phenomenon and one of its major risk
factors: cardiovascular disease (CVD). Furthermore, this study 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 and other inflammatory diseases in the future.
Methodology
The author of this report holds a Ph.D. in biochemistry from the University of
Minnesota, with many decades of experience in science writing and as a medical
industry analyst. He has over 30 years of experience in laboratory testing and
instrument and reagent development technology, as well as extensive experience
in senior level positions in biotech and medical service companies. The editor
of this report holds a Master's degree in immunology, and has substantial
experience in science writing and as a medical industry analyst. She also has
many years of laboratory experience investigating cancer immunotherapies, has
conducted laboratory testing, and instrument and reagent development for
biotech companies.
Company-specific information is obtained mainly from industry trade
publications, academic journals, news and research articles, press releases
and corporate websites, as well as annual reports for publicly-held firms.
Additionally, sources of information include the non-governmental
organizations (NGOs) such as the World Health Organization (WHO), governmental
entities like the U.S. Department of Health and Human Services (HHS), and U.S.
federal agencies such as National Institutes of Health (NIH), Food and Drug
Administration (FDA) and the Centers of Disease Control and Prevention (CDC).
Where possible and practicable, the most recent data available have been used.
Some of the statistical information was taken from Biotechnology Associates'
databases and from TriMark's private data stores. The information in this
study was obtained from sources that we believe to be reliable, but we do not
guarantee the accuracy, adequacy or completeness of any information or
omission or for the results obtained by the use of such information. Key
information from the business literature was used as a basis to conduct
dialogue with and obtain expert opinion from market professionals regarding
commercial potential and market sizes.
Primary Sources
TriMark collects information from hundreds of Database Tables and mans
comprehensive multi-client research projects, as well as Sector Snapshots that
it publishes annually. TiMark extracts relevant data and analytics from its
research as part of this data collection.
Secondary Sources
TriMark uses research publications, journals, magazines, newspapers,
newsletters, industry reports, investment research reports, trade and industn
association reports, government-alliliated trade releases and other published
information as part of its secondary research materials. The information is
then analyzed and translated by the Industry Research Group into a TriMark
study. The Editorial Group reviews the complete package with product and
market forecasts, critical industry trends, threats and opportunities,
competitive strategies and market share determinations.
Table of Contents
Table of Contents
1. Overview
1.1. Statement of Report
1.2. About This Report
1.3. Scope of the Report
1.4. Methodology
1.5. Executive Summary
2. Introduction
2.1. Demographics of Diabetes
2.1.1. Worldwide Diabetes
2.1.2. U.S. Diabetes
2.2. Economics of Diabetes
3. Understanding the Metabolic Conditions Underlying and Associated with Diabetes
3.1. Pre-Diabetes Syndrome
3.2. Metabolic Syndrome
3.3. Diabetes and Inflammation
3.4. Diagnosis of Diabetes Mellitus
3.5. Progression of Diabetes
3.6. Risk Factors and Diabetes
3.6.1. Obesity
3.6.2. Stress-Induced Hyperglycemia
3.7. Complications and Co-Morbidities in Type 2 Diabetes
3.7.1. Preventing Complications and Co-Morbidities in Diabetes
3.8. Hypoglycemia Resulting From Treatment
3.9. Cardiovascular Disease (CVD)
3.9.1. CVD Facts
3.9.2. Cardiac Care Therapeutics
3.9.2.1. Anti-Hypertensive Drugs
3.9.2.2. Cholesterol Management Drugs
3.9.2.3. Anticoagulants
3.9.3. CVD Diagnostics
4. Pharmaceutical Industry and the Anti-Diabetes Market
4.1. The Worldwide Pharmaceutical Industry
4.1.1. Pharmaceutical R&D Spending by Type, Growth Rate and Expenditure
4.1.2. Global Pharmaceutical Market
4.2. Total Diabetes Drug Market Size and Growth
4.2.1. Sales of Anti-Diabetic Drugs Continue to Rise
4.3. Diabetic Medications Overview
4.3.1. Recent Trends in Diabetic Drug Usage
4.3.2. Market Influence Factors
5. Non-Insulin Anti-Diabetes Products
5.1. Anti-Diabetic Drug Therapy Overview
5.1.1. Sulfonylureas
5.1.2. Meglitinides
5.1.3. Biguanides
5.1.4. Thiazolidinediones (TZDs)
5.1.5. α-Glucosidase Inhibitors
5.1.6. Incretin Mimetics/Glucagon-Like Peptide (GLP-1) Analogs and
Agonists
5.1.6.1. Byetta (Exenatide)
5.1.6.2. Victoza (Liraglutide)
5.1.6.3. Bydureon (exenatide LAR)
5.1.7. Amylin Analog
5.1.8. DPP-IV Inhibitors
5.1.8.1. Januvia (Sitagliptin)
5.1.8.2. Onglyza (Saxagliptin)
5.1.8.3. Tradjenta (Linagliptin)
5.1.9. Combination Therapy
5.1.9.1. Youth With Recent-Onset Type 2 Diabetes Should Be Started on
Combination Therapies
5.1.10. Comparisons of the Anti-Diabetes Drugs
5.2. Drivers and Trends
5.2.1. Market Share of Anti-Diabetic Drugs
5.2.2. Forecasts for Anti-Diabetic Drugs
5.2.3. Sales Forecast for the Global Diabetes Market
5.3. The Future
5.3.1. Practice Patterns
5.3.2. New Products in Pipeline
5.3.2.1. Novel GLP-1 Agonists and Analogs
5.3.2.2. Novel DPP-IV Inhibitors
5.3.2.3. Sodium Glucose Cotransporter 2 (SGLT-2)
5.3.2.4. Emerging Non-Insulin Anti-Diabetes Targets and Drugs in the
Pipeline
5.3.2.5. Novel Approaches to Finding New Drug Targets
5.4. Anti-Diabetic Drug Patent Expiry
5.5. Regulatory Issues
6. Insulin
6.1. Insulin Markets
6.1.1. Major Players and Market Share
6.1.2. Patent Expirations
6.1.3. Innovation Strategies
6.2. Insulin Therapeutics
6.2.1. Recommendations for Insulin Initiation and Administration
6.2.2. Short-Acting Insulin
6.2.3. Rapid-Acting Insulin
6.2.4. Intermediate-Acting Insulin
6.2.5. Long-Acting Insulin
6.2.6. Long-Acting Insulins in Development
6.2.7. Insulin Mixtures
6.3. Pipeline Insulin
6.4. Non-Invasive Insulin Delivery
6.4.1. Inhaled Insulin
6.4.1.1. A Chronicle of Inhaled Insulins
6.4.2. Oral Insulin
6.4.3. Transdermal Insulin
6.5. Barriers for Non-Injected Insulin
6.6. Patient Potential for Non-Injected Insulin
6.7. Insulin Delivery Devices
6.7.1. Insulin Pens
6.7.2. Injections Aids
6.7.2.1. Automatic Injectors
6.7.2.2. Syringe Magnifiers
6.7.2.3. Injection Ports
6.7.3. Insulin Jet Injectors
6.7.4. Insulin Pumps
6.7.4.1. External Insulin Pumps
6.7.4.2. Insulin Patch Pumps in Development
6.7.4.3. Implantable Insulin Pumps
6.7.4.4. Insulin Pump Market Share
6.7.4.5. Drivers of Demand for Pumps
6.8. Market Forecasts for Insulin Administration Technologies
7. Emerging Anti-Diabetes Technologies and Products
7.1. Projections for the Anti-Diabetes Drug Market
7.2. Artificial Pancreas
7.3. Insulin-Producing Cells
7.3.1. Cell Therapy Companies for Diabetes
7.4. Transplantation Procedures
7.4.1. Pancreatic Transplantation
7.4.1.1. Pancreatic Organ Transplantation
7.4.1.2. Allo-Islet Transplantation
7.4.1.3. Transplantation of Encapsulated Pancreatic Cells
7.4.1.4. Implantation of Genetically Engineered ?-Cells or Embryonic
Stem Cells
7.4.2. Current Status
7.5. Gastric Bypass Surgery to Treat Type 2 Diabetes
7.6. Immune Modulators
7.7. Anti-Obesity Drugs to Prevent or Delay Development of Type 2 Diabetes
7.8. Other Anti-Diabetic Therapy Drug Candidates
7.8.1. Lipid Abnormalities
7.8.2. High Blood Pressure
7.8.3. Anticoagulants
7.9. Drugs Used “Off-label”
7.9.1. Warfarin Sodium
8. Diagnosing Diabetes Using In Vitro Laboratory Tests
8.1. New Diagnostic Guidelines
8.2. Diabetes Tests
8.2.1. Fasting Plasma Glucose (FPG) Test
8.2.2. Glucose Tolerance Test
8.2.3. Test for Glycosylated Hemoglobin
8.2.4. Fructosamine
8.3. Glucose Monitoring
8.3.1. Overview of Market Segment
8.3.2. Competitive Strategies
8.3.3. Analyses of the Current Market Conditions, Competition and
Product Mix
8.3.3.1. First-Generation Monitors
8.3.3.2. Second-Generation Monitors
8.3.3.3. Third-Generation SMBG Technologies
8.3.3.4. Product Overview
8.3.4. What Are the Advantages of Using a Continuous Glucose-Monitoring
Device?
8.3.5. Minimally-Invasive Continuous Glucose Monitors in Development
8.3.6. Future of Non-Invasive Glucose Technology
8.3.7. Lancets and Lancing Devices
9. Market Trends, Challenges and Strategic Options
9.1. Overview
9.2. Diabetes Drug Market Trends
9.2.1. Overview
9.2.2. Emergence of Therapeutics With Improved Administration
Characteristics
9.2.3. Increasing Prevalence of Obesity
9.3. Diabetes Mellitus Market Challenges
9.3.1. Overview
9.3.2. Diabetic Pain Therapeutics
9.3.3. Market Prospects of Inhalable Drugs and Their Ability to
Establish Safety Levels
9.3.4. Changing Consumer Preference Drives Product Development in
Invasive Technology Segment
9.3.5. Non-Invasive Technology for Revenue Potential
9.3.6. Developing Countries Emerging as Key Markets for Diabetes
Monitoring Devices
9.3.7. Consumer-Driven Marketing Campaigns - Essential, Though Expensive
9.3.8. Escalating Expenditure for R&D and Marketing Triggers
Consolidation
9.4. Strategic Options
9.4.1. Overview
9.4.2. Combined Self-Testing Glucose Monitor with Insulin Delivery
9.4.3. Diabetes Drugs in Pipeline
9.5. FDA Therapeutic Targets
9.5.1. FDA Targets Cardiotoxicity
9.5.2. Avandia FDA Warning
9.6. Outlook to Anti-Diabetes Drugs
9.7. Outlook for Cardiovascular Drugs
9.8. Recent Industry Activity
10. Company Profiles
10.1. A. Menarini
10.2. Abbott Laboratories
10.3. Amgen
10.4. AstraZeneca
10.5. Bayer
10.6. BodyMedia
10.7. Cybermedical
10.8. Debiotech
10.9. DexCom
10.10. Echo Therapeutics
10.11. Eli Lilly
10.12. Elixir Pharmaceuticals
10.13. Eksigent
10.14. Flamel Technologies
10.15. GlaxoSmithKline
10.16. Insulet
10.17. iSense Corporation
10.18. Isis Pharmaceuticals, Inc.
10.19. Johnson & Johnson
10.20. KYORIN
10.21. M-Biotech
10.22. Medtronic
10.23. Merck & Co.
10.24. Merck KGaA
10.25. MicroIslet
10.26. Mitsubishi Tanabe Pharma Corporation
10.27. Nipro Diabetes Systems
10.28. Novartis
10.29. Novo Nordisk
10.30. Novocell
10.31. ONO Pharmaceutical
10.32. Orexigen Therapeutics
10.33. Pfizer
10.34. Roche Diagnostics
10.35. Sanofi-Aventis
10.36. Sensors for Medicine and Science
10.37. Siemens
10.38. Smiths Medical
10.39. SOOIL Development
10.40. Takeda
10.41. TheraFuse
10.42. U.S. Diagnostics
10.43. VeraLight
10.44. Vivus
10.45. Ypsomed Holding
Appendix 1: The History of Insulin
INDEX OF FIGURES
Figure 2.1: Worldwide Rates of Diabetes Cases, 2011, 2020 and 2030
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years),
2011
Figure 2.3: Prevalence of Diabetes by Age in the U.S, 2010
Figure 2.4: New Adult Cases of Diabetes Diagnosed in the U.S., 2010
Figure 2.5: Mean Diabetes Healthcare-Related Expenditures Per Adult (20-79
Years) with Diabetes (USD), 2011
Figure 2.6: How Diabetes Dollars Are Spent in the U.S., 2007
Figure 3.1: Maintenance of Normal Blood Sugar Levels
Figure 3.2: Obesity (BMI 3 30) Prevalence in U.S. Adults, 2010
Figure 3.3: Percentage of Obese Adults in the U.S., 2009-2010
Figure 3.4: Percentage of Obese Children and Adolescents in the U.S.,
2009-2010
Figure 3.5: Trends in Obesity Among Children and Adolescents in the U.S.,
1963-2008
Figure 3.6: Annual Death Rate of U.S. Population From Heart Disease,
1950-2008
Figure 3.7: Heart Disease Death Rate by Race and Sex in the U.S., 1979-2008
Figure 3.8: Annual Death Rate of U.S. Population From Strokes, 1950-2008
Figure 3.9: U.S. Male and Female Population Death Rates from Strokes, 2008
Figure 3.10: Percentage of U.S. Population that Smokes, 1965-2010
Figure 3.11: Percentage of Obese Adults in the U.S., 1960-2008
Figure 3.12: Percentage of Obese Children and Adolescents in the U.S.,
1971-2008
Figure 3.13: Number of Annual Prescriptions for Popular Cholesterol Drugs,
2006-2010
Figure 4.1: Top Therapeutic Classes Contributing to Growth in Drug
Spending, 2010-2011
Figure 4.2: Top Ten Diabetes Medications, by Number of Prescriptions
Figure 4.3: U.S. Non-Insulin Anti-Diabetic Drug Prescriptions, 2010
Figure 5.1: Comparison of the Effects of the Pioglitazone and
Rosiglitazone on Lipids
Figure 5.2: Overview of GLP-1 and Blood Glucose
Figure 5.3: Global Non-Insulin Anti-Diabetes Sales by Drug Class, 2010
Figure 5.4: Global Non-Insulin Anti-Diabetes Prescriptions by Drug Class,
2010
Figure 5.5: Sales Forecast for the Global Diabetes Drug Market, 2008-2016
Figure 5.6: Sales Forecast for the U.S. Diabetes Drug Market, 2008-2016
Figure 6.1: Global Sales of Lantus (in Euro), 2005-2010
Figure 6.2: Insulin Pump Market Share, 2011
Figure 9.1: Relationship Between Diabetes Therapy and the Proposed Timeline
Figure A1.1: Novo Nordisk's Rising Market Share in the U.S. Insulin
Market, 1982-2008
INDEX OF TABLES
Table 2.1: Top Ten Countries With the Largest Estimated Number of
Diabetics (20 to 79 Years Age Group) 2011 and 2030
Table 2.2: U.S. Population of Diabetics (Diagnosed and Undiagnosed) Aged
20 Years or Older, 2010
Table 2.3: Cost of Diagnosed Diabetes in the U.S., 2007
Table 2.4: Medical Care Costs Attributable to Diabetes in the U.S., 2010
Table 2.5: Healthcare Utilization by Diabetic Patients, 2008
Table 2.6: Annual Cost of Care of UnitedHealthcare Adult Members with
Diabetes, 2009
Table 2.7: Per-Event Costs of Diabetes Complications
Table 3.1: International Diabetes Federation (IDF) Diagnostic Criteria for
Metabolic Syndrome
Table 3.2: American Heart Association and National Heart, Lung and Blood
Institute (AHA/NHLBI) Diagnostic Criteria for Metabolic Syndrome
Table 3.3: Additional Metabolic Criteria for Research
Table 3.4: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S.
Table 3.5: Odds Ratio of Progression to Complications Associated with Type
2 Diabetes
Table 3.6: Prevalence of Complications Among Patients with Diabetes
Table 3.7: Novel Risk Factors and Possible Mechanisms of the Excess Risk
of Coronary Heart Disease in Type 2 Diabetes Mellitus
Table 3.8: Major Causes of End-Stage Renal Disease
Table 3.9: Clinical Recommendations for Adults with Diabetes
Table 3.10: Laboratory Assessment of Diabetic Vascular Disease
Table 3.11: Average Years Gained Free of Diabetes-Related Disease with
Intensive Management
Table 3.12: Medical Care Costs Attributable to Diabetes in the U.S., 2010
Table 3.13: Summary of Cardiovascular Diseases (CVDs)
Table 3.14: Death Rate From Cardiovascular Diseases by Country, 2008
Table 3.15: Percentage of Adults Smokers by Country, 2008
Table 3.16: Selected Potential Patent Expirations of Cardiac Care Drugs,
2012-2013
Table 3.17: Worldwide Market for Cardiac Care Therapeutics, 2007-2014
Table 4.1: Global R&D Spending in the Pharmaceutical Industry, 2008-2012
Table 4.2: Pharmaceutical Companies Ranked by Total R&D Expenditures, 2011
Table 4.3: Leading Therapy Classes for R&D, 2010
Table 4.4: Global Pharmaceutical Sales by Region and Country, 2010 and 2015
Table 4.5: World Pharmaceutical Sales Share by Region, 2010
Table 4.6: Top Ten Global Pharmaceutical Companies by Global Sales, 2011
Table 4.7: Leading Ten Therapeutic Classes by U.S. Sales, 2006-2011
Table 4.8: Top Ten Therapeutic Classes by U.S. Dispensed Prescriptions,
2006-2011
Table 4.9: Leading Therapy Classes by Global Pharmaceutical Sales, 2015
Table 4.10: Top Selling Drugs in the U.S., 2010
Table 4.11: Worldwide Anti-Diabetes Drug Market, 2008-2016
Table 4.12: Oral Anti-Diabetic Therapy Major World Markets, 2010
Table 4.13: The Leading Five Anti-Diabetics by Sales, 2011
Table 4.14: American College of Physicians 2012 Practical Guideline for
the Use of Anti-Diabetes Drugs for Type 2 Diabetes
Table 4.15: Summary of Glucose-Lowering Interventions as Monotherapy
Table 5.1: Classes of Non-Insulin Hypoglycemic Agents
Table 5.2: Non-Insulin Hypoglycemic Drugs Used to Treat Type 2 Diabetes,
2012
Table 5.3: Relative Efficacy of Diabetes Drugs
Table 5.4: Average Dose and Cost Comparison of Oral Hypoglycemic Agents
Table 5.5: Fixed-Dose Oral Anti-Diabetes Drug Combinations
Table 5.6: Delivery Method of Non-Insulin Anti-Diabetes Drugs in the
Pipeline, 2011
Table 5.7: GLP-1 Agonist Pipeline: Selected Drugs in Development That
Target GLP-1
Table 5.8: DPP-IV Inhibitor Pipeline
Table 5.9: Summary of Emerging Non-Insulin Anti-Diabetes Drug Categories
Table 6.1: Market Shares of Animal, Human and Modern Insulin, 1995-2010 (%
of Total Insulin Market)
Table 6.2: Worldwide Insulin Sales, 2008-2016
Table 6.3: Worldwide Insulin Sales and Market Share by World Region, 2011
Table 6.4: Estimated U.S. Retail Insulin Sales, 2011-2015
Table 6.5: Worldwide Insulin Sales and Market Share by Company, 2011
Table 6.6: U.S. Insulin Sales and Market Share by Company, 2011
Table 6.7: Therapeutic Insulins on the Market
Table 6.8: Pharmacokinetics of Therapeutic Insulins on the Market
Table 6.9: Pharmacokinetics of Short-Acting Insulins
Table 6.10: Pharmacokinetics of Rapid-Acting Insulins
Table 6.11: Pharmacokinetics of Intermediate-Acting Insuslins
Table 6.12: Pharmacokinetics of Long-Acting Insulins
Table 6.13: Pharmacokinetics of Insulin Mixtures
Table 6.14: Status of Inhaled Insulin Products, 2011
Table 6.15: Key Drivers of the Type 2 Diabetes Insulin Market, 2012
Table 6.16: A Comparison of Existing Insulin Delivery Devices
Table 6.17: Insulin Pens
Table 6.18: Estimated Worldwide Demand for Insulin Injector Pens by
Volume, 2012-2016
Table 6.19: Injection Aids
Table 6.20: Jet Injectors
Table 6.21: Control Averages by Treatment
Table 6.22: Reduced Risk for Various Diseases When Blood Glucose is Near
Normal
Table 6.23: Leading Insulin Pump Manufacturers
Table 6.24: Comparison of Current External Insulin Pumps on the Market
Diabetes, Metabolic Syndrome and Cardiovascular Disease published by Trimark Publications in December 1, 2012. This report consists of 219 pages and the price starts from US $ 3400.
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