Diabetes, Metabolic Syndrome and Cardiovascular Disease. October 2005 3. Understanding the Metabolic Conditions Underlying and Associated with Diabetes …
TriMark Publications
October 2005
Volume: TMRDIA05-1003
DIABETES, METABOLIC SYNDROME AND CARDIOVASCULAR DISEASE
SAMPLE COPY, NOT FOR RESALE
Reshaping Tomorrows Diabetes Market
Diabetes, Metabolic Syndrome and Cardiovascular Disease
October 2005
TABLE OF CONTENTS 1 Overview 6 11 Statement of Report 12 About this Report 6 13 Scope of the Report 14 Methodology 8 15 Executive Summary 2 Introduction 12 21 Demographics of Diabetes 211 Worldwide Diabetes 212 US Diabetes 12 22 Economics of Diabetes
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3 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 31 Pre-Diabetes Syndrome 28 32 Metabolic Syndrome 29 33 Diabetes and Inflammation 30 34 Progression of Diabetes 30 35 Complications and Co-Morbidities in Type 2 Diabetes 30 36 Hypoglycemia and Treatment 33 37 Risk Factors and Diabetes 33 38 Cardiovascular Disease Facts 35 4 Current Treatment Paradigms 41 41 The Worldwide Pharmaceutical Industry 41 411 Total Diabetes Drug Market Size and Growth 412 Sales of Anti-diabetic Drugs Continue to Rise 413 Epidemiology/Cost of Treatment 53 42 Diabetic Medications Overview 53 421 Recent Trends in Diabetic Drug Usage 55 422 Factors that are Likely to
Influence the Market 423 Anti-Diabetic Drug Therapy Overview 57 4231 Sulfonylureas 60 4232 Meglitinides 61 4233 Biguanides 62 4234 Thiazolidinediones TZDs 63 4235 a-Glucosidase Inhibitors 64 4236 Combination Therapy 65 4237 Drivers and Trends 65 4238 Market Share of Anti-Diabetic Drugs66 424 Forecasts for Anti-Diabetic Drugs 67 4241 Sales Forecast for the Global Diabetes Market 4242 The Future 68 42421 Practice Patterns 69 42422 New Products in Pipeline 69 425 Anti-Diabetic Drug Patent Expiry 70 426 Regulatory Issues 70 43 Sulfonylureas and Meglitinides 70 431 First-generation Sulfonylurea Agents 72 432 Second-generation Sulfonylurea Agents 441 Thiazolidinediones 73 442 PPAR Agonists 74 45 a-Glucosidase Inhibitors 74 46 Insulin Markets 74 461 Major Players and Market Share 75 462 Rapid-Acting Insulin 78 463 Intermediate-Acting Insulin 80 464 Long-Acting Insulin 80 465 Ultra Long-Acting Insulin 81 466 Insulin Mixtures 81 467 Newly Approved Insulin 82 468 Pipeline Insulin 83 469 Insulin in Development 83 4691 Inhaled Insulin Overview 84 4692 Inhaled Insulin Pipeline 84 4693 Oral insulin 85 4694 Barriers for Non-Injected Insulin 86 4695 Patient Potential for Non-Injected Insulin
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Diabetes, Metabolic Syndrome and Cardiovascular Disease
October 2005
47 Other Anti-diabetic Therapy Drug Candidates 471 Lipid Abnormalities 86 472 High Blood Pressure 87 473 Anticoagulants 89 48 Biguanides 89 49 Drugs Used Off-Label 89 491 Glucagon-Like Insulinotropic Peptide GLP-1 492 Pramlintide Symlin 89 493 Niacin Derivatives 89 494 Benfluorex 90 495 D-Chiro-Inositol90 496 Exendin-4 90 410 Investigational New Agents 90 411 New Medicines in Development 90
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5 Emerging Oral Anti-diabetes Products 95 51 Novel Oral Medications 95 52 PPAR agonists 95 53 Insulin Mimetics 95 54 GLP-1 95 55 Immune Modulators 96 56 Artificial Pancreas96 561 Pancreatic Transplantation 97 5611 Pancreatic Organ Transplantation 97 5612 Allo-Islet Transplantation 97 5613 Transplantation of Encapsulated Pancreatic Cells 97 5614 Implantation of Genetically Engineered b-Cells or Embryonic Stem Cells 562 Current Status 98 57 Other Type Drugs 99 58 New Pipeline Diabetic Drug Candidates 99 59 Drug Research Overview 103 6 Projections for the Anti-diabetes Drug Market 106 61 Implantable Insulin Pumps 109
611 Market Share 110 612 Drivers of Demand for Pumps 114 62 Insulin Pills 114 63 Transdermal Insulin 115 64 Oral Spray Insulin 115 65 Inhaled Insulin 116 651 Important Players 117 66 Insulin-Producing Cells 118 67 Transplantation Procedures 119 68 Anti-Obesity Drug Xenical to Prevent or Delay Development of Type 2 Diabetes 7 Diagnosing Diabetes Using In Vitro Laboratory Tests121 71 New Diagnostic Guidelines 121 72 Diabetes Tests 121 721 Fasting Plasma Glucose FPG Test 121 722 Glucose Tolerance Test 122 723 Test for Glycosylated Hemoglobin 122 724 Fructosamine 122 73 Glucose Monitoring 123 731 Overview of Market Segment 126 732 Competitive Strategies 126 733 Analyses of the Current Market Conditions, Competition and Product Mix 7331 First-Generation Monitors 127 7332 Second-Generation Monitors 128 7333 Third-Generation SMBG Technologies 129 7334 Product Overview 129 73341 LifeScan 130 73342 Roche Diagnostics 133 7333 Bayer Diagnostics Ames Division 133 73331 Abbott Diagnostics 135 73332 Other Players 135 734 Adjacent Markets 138 735 What Are the Advantages of Using a Continuous Glucose-Monitoring Device? 8 Insulin Delivery Technologies 139 81 Lancets and Lancing Devices
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Diabetes, Metabolic Syndrome and Cardiovascular Disease
October 2005
82 Insulin Pens 141 83 Injections Aids 145 831 Automatic Injectors 145 832 Syringe Magnifiers 145 833 Insulin Infusers 145 84 Insulin Jet Injectors 146 85 External Insulin Pumps 146 86 Implantable Insulin Pumps 146 87 Artificial Pancreas146 88 Insulin Patches 146 89 Market Forecasts for Insulin Administration Technologies 891 Insulin Inhalers 147 892 Mouth Sprays 147 893 Pills 147 894 The Patch 148
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9 Market Trends, Challenges and Strategic Options 149 91 Overview 149 92 Diabetes Drug Market Trends149 921 Overview 149 922 Emergence of Therapeutics with Improved Administration Characteristics 149 923 Increasing Prevalence of Obesity 149 93 Diabetes Mellitus Market Challenges 151 931 Overview 151 932 Diabetic Pain Therapeutics 151 933 Market Prospects of Inhalable Drugs and Their Ability to Establish Safety Levels 151 934 Changing Consumer Preference Drives Product Development in Invasive Technology Segment 152 935 Non-Invasive Technology for Revenue Potential 152 936 Developing Countries Emerging as Key
Markets for Diabetes Monitoring Devices 152 937 Consumer-Driven Marketing Campaigns–Essential, though Expensive 153 938 Escalating Expenditure for RD and Marketing Triggers Consolidation 153 939 Market Size Predictions 153 9310 Major Competitors 153 94 Strategic Options 154 941 Overview 154 942 Combined Self-Testing Glucose Monitor with Insulin Delivery 154 943 Diabetes Drugs in Pipeline 155 95 FDA Therapeutic Targets 158 Appendix 1 Appendix 2 159 160
INDEX OF FIGURES Figure 1: Demographic Changes in Diabetes Populations in 2010, 2025, 2050 13 Figure 2: Annual Number of New Cases of Diagnosed Diabetes Among Adults Aged 18 to 79 Years, US, 1997-2002 14 Figure 3: Crude and Age-Adjusted Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, US, 1997-2002 14 Figure 4: Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, by Age, US, 1997-2002 15 Figure 5: Age-Adjusted Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, by Sex, US, 1997-2002 15 Figure 6: Incidence of Diagnosed Diabetes per 1000 Population Aged 18 to 79 Years, by Sex and Age, US, 1997-2002 16 Figure 7: Age-Adjusted Incidence of Diagnosed Diabetes per 1000
Population Aged 18 to 79 Years, by Race, US, 1997-2002 16 Figure 8: Distribution of Duration of Diabetes Among Adults Aged 18 to 79 Years, US, 2002 17 Figure 9: Number of Hospital Discharges with Diabetes as First-Listed Diagnosis, US, 1980-2001 17 Figure 10: Crude and Age-Standardized Hospital Discharge Rates for Diabetes as First-Listed Diagnosis per 1,000 Persons in Diabetic Population, US, 1980-2001 18 Figure 11: Distribution of Age at Diagnosis of Diabetes Adults Aged 18 to 79 Years, US, 2002 18 Figure 12: Number of Adults with Diabetes Using Diabetes Medication by Type of Medication, US, 1997-2002 19 Figure 13: Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication by Type of Medication, US, 1997-2002 19 Figure 14: Crude and Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication, US, 1997-2002 20 Figure 15: Percentage of Adults with Diabetes Using Diabetes Medication, by Age, US, 1997-2002 21 Figure 16: How Diabetes Dollars Are Spent in the US 25 Figure 17: Standardized Prevalence of Diagnosed and Undiagnosed Diabetes and Impaired Fasting Glucose in the US Adult Population 29 Figure 18: Overlap Between Individuals Diagnosed as Diabetic
According to Fasting Plasma Glucose Concentration ADA criteria or the Two Hour Glucose Value WHO Criteria 34 Figure 19: Sales Forecast for the Global Diabetes Market 68 Figure 20: Utilization: Compliance by Class 77 Figure 21: Analysis of Diabetes Pipeline by Company, 2000 93 Figure 22: Relative Risk of Diabetes Complications by Mean HbA1c 110 Figure 23: Worldwide Diabetes Market, 2000, 2001, 2002 and 2007 111
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Diabetes, Metabolic Syndrome and Cardiovascular Disease
October 2005
INDEX OF TABLES Table 1: Total of People with Diabetes in the World and in Selected Nations, 2000 and 2030 12 Table 2: Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication by Type of Medication US, 1997-2002 Table 3: Crude and Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication, US, 1997-2002 21 Table 4: Percentages of Adults with Diabetes Using Diabetes Medication by Age, US, 1997-2002 22 Table 5: Annual Estimated Cost of Diabetes Care, US 22 Table 6: Impacts of Diabetes on Americans 23 Table 7: Leading Ten Diagnoses by Total US Patient Visits, 2001 23 Table 8: US Incidence of
Diabetes by Age, 2005 23 Table 9: Prevalence, Cost and Medicines for Major Diseases in the US, 2005 24 Table 10: Top Ten Causes of Death in the US, 2003 24 Table 11: Per-Event Costs of Diabetes Complications Estimated 26 Table 12: Percentage of Persons with Type 1 Diabetes Experiencing Various Complications 31 Table 13: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease In Type 2 Diabetes Mellitus Table 14: Average Years Gained Free of Diabetes-Related Disease with Intensive Management 33 Table 15: Worldwide Market for Cardiac Care Therapeutics 37 Table 16: Major Causes of End Stage Renal Disease 40 Table 17: Worldwide Clinical Development Costs for Drugs, 2003 41 Table 18: Pharmaceutical RD Expenditures by World Region, 1990-2003 42 Table 19: US Listed Pharmaceutical Companies Ranked by 2001 RD Expenditures 42 Table 20: Global Pharmaceutical Sales 43 Table 21: World Pharmaceutical Sales Share by Region 2003 43 Table 22: The Worlds Top-Selling Drugs 2003 44 Table 23: Pharmaceutical Product Sales by Country Market 44 Table 24: Top Pharmaceutical Companies by Market Capitalization 45 Table 25: Leading Therapy Classes Global Pharmaceutical Sales
2000 and 2003 45 Table 26: Leading Ten Therapeutic Classes by US Sales, 2002 46 Table 27: Top Ten Drug Classes by Retail Dollars 46 Table 28: Top Ten Drugs by Retail Dollars 46 Table 29: Top Ten Pharmaceutical Firms by Retail Dollars 47 Table 30: Worldwide Anti-Diabetes Drug Market 48 Table 31: Oral Anti-Diabetic Therapy Major World Markets, 2003 48 Table 32: Worldwide Market Share of Anti-Diabetic Drugs by Type, 2003 and 2007 49 Table 33: The Leading Five Oral Anti-diabetics For 2004 50 Table 34: Oral Hypoglycemic Drugs Used to Treat Type 2 Diabetes 51 Table 35: Worldwide Sales of Avandia 51 Table 36: Worldwide Sales of Actos 52 Table 37: Worldwide Sales of Glucophage 52 Table 38: Worldwide Sales of Starlix 53 Table 39: World Diabetes Pharmaceutical Market 54 Table 40: Trends In Prescription Drug Use Among Patients with Type 2 Diabetes, 1997-2002 56 Table 41: Classes of Oral Hypoglycemic Agents 58 Table 42: Clinical Efficacy of Oral Hypoglycemic Agents 58 Table 43: Average Dose and Cost Comparison of Hypoglycemic Agents 59 Table 44: Average Dose and Cost Comparison of Hypoglycemic Agents 60 Table 45: Relative Efficacy of Oral Agents for Diabetes 60 Table 46: Thiazolidinediones
Available for Type 2 Diabetes Mellitus 63 Table 47: Therapeutic Comparison of the Available Thiazolidinediones 63 Table 48: Oralin Sales Forecast Through 2008 66 Table 49: AERx Sales Forecast Through 2008 66 Table 50: HIM 2 Sales Forecast Through 2008 66 Table 51: Oral Anti-diabetic Agents and Their Approved Indications and Uses72 Table 52: Brand and Generic Names for the Sulfonylureas Sold in the US 72 Table 53: Preparations of Sulfonylurea Tablets 73 Table 54: Worldwide Insulin Sales 75 Table 55: Worldwide Insulin Sales and Market Share by World Region 2003 75 Table 56: Worldwide Insulin Sales and Market Share by Company, 2003 76 Table 57: US Insulin Sales and Market Share by Company, 2003 76 Table 58: US Insulin Sales, 2000-2009 76 Table 59: Worldwide Recombinant Human Insulin Sales and Market Share by Company, 2005 78 Table 60: Pharmacokinetics of Available Insulins 78 Table 61: Action Times for Each Insulin 81 Table 62: Key Drivers of the Type 2 Diabetes Insulin Market to 2012 86 Table 63: Lipoprotein Risk Levels and Treatment Goals in Adult Patients with Diabetes 87 Table 64: Agents for Lowering Lipid Levels in Patients with Dyslipidemia 87 Table 65: Suggested Pharmacological
Treatment Agents for Hypertension in Patients with Diabetes 88 Table 66: New Drugs in Human Clinical Trials by Disease Type 94
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Diabetes, Metabolic Syndrome and Cardiovascular Disease
October 2005
Table 67: GLP-1 Pipeline: Selected Drugs in Development that Target GLP-1 96 Table 68: Cells of the Pancreas 98 Table 69: Selected Mid-2004 Press Releases on Emerging Anti-diabetes Agents Table 70: Diabetes Agents in the Pipeline 100 Table 71: Control Averages by Treatment 110 Table 72: Reduced Risk for Various Diseases When Blood Glucose is Near Normal Table 73: Worldwide Diabetes Market, through 2007 Millions 111 Table 74: Types of Insulin Pumps on the Market 111 Table 75: Laboratory Assessment of Diabetic Vascular Disease 123 Table 76: The Global Population of Persons with Diabetes 124 Table 77: The Glucose Market for OTC Testing in the US, 1996-2007 125 Table 78: The Glucose Market for OTC Testing Worldwide, 2000-2007 125 Table 79: OTC Glucose Meter US Market Share for Blood Glucose Measurements Table 80: Lancet Characteristics 141 Table 81: Lancing Device Characteristics 141 Table 82:
Worldwide Insulin Injector Pen Dollar Volume, 1998-2006 143 Table 83: Insulin Delivery Systems Percent Retail Market Share 144 Table 84: Insulin Delivery Systems Percent Retail Market Share by Company, 2003 Table 85: Summary of Inhaled Insulin Products 148 Table 86: Worldwide Diabetes Drugs in Pipeline, 2004 155 Table 87: Top Therapeutic Drug Categories Worldwide, 2004 156 Table 88: Top Therapeutic Categories in US Development, 2003 156 Table 89: Pharmaceutical Companies Number of Products in Development 156 Table 90: Pharmaceutical Companies Number of Diabetes Products in Development Table 91: Drugs in Preclinical Testing, 2004 157 Table 92: New Diabetes Drugs in Pipeline without Major Pharma Alliances 158
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Diabetes, Metabolic Syndrome and Cardiovascular Disease
October 2005
1 Overview 11 Statement of Report This report describes the specific market segment of the pharmaceutical market for diabetes and two of its related diseases, metabolic syndrome and cardiovascular disease It begins with a textbook explanation of the biology underlying diabetes, and then it reviews and
evaluates widely accepted pharmaceutical approaches to diabetes that are currently in use Finally, market forecasts and an analysis of products in the worldwide prescriptions market will help the reader understand the significance of past developments and speculate on future possibilities about the market of diabetes therapies as an area of research and investment 12 About this Report The principal objectives of this report are to: Identify viable technology drivers through a comprehensive look at various platform technologies for diabetes, metabolic syndrome and cardiovascular disease Provide a complete understanding of the leading diabetes tests that are used for disease prediction, screening, prognosis and monitoring, encompassing their basic principles and applications Discover feasible market opportunities via an identification of high-growth applications in different therapeutic areas, with a focus on the largest and most rapidly expanding markets for diabetes, metabolic syndrome and cardiovascular disease Focus on global industry development through an in-depth analysis of the major world markets for molecular diagnostics, including forecasts for growth Summarize the
blood glucose testing market, including definitions, processes and trends
Market figures regarding the current value of the diabetes drug market are taken from the most recently available data of the global pharmaceutical industry The following categories of diabetes drugs will be covered herein: Rapid-acting insulin Short-activity insulin Intermediate-acting insulin Long-acting insulin Ultra-long-acting insulin Insulin mixtures Sulfonylureas Meglitinides Biguanides Thiazolidinediones -Glucosidase inhibitors
This market analysis includes the use of charts and graphs to show product growth and marketplace trends In addition, a discussion of the biology underlying diabetes provides the reader with a more comprehensive understanding of the possibilities for future treatment as well as avenues for possible research and development budgets Company-specific information, including sales figures, drug pipeline status and research and development trends, is provided throughout the report
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Diabetes, Metabolic Syndrome and Cardiovascular Disease
October 2005
In addition to its principal
objectives, this report will: Assess the diabetes, metabolic disease and cardiovascular disease market drivers and bottlenecks, from the perspective of the medical and scientific research communities Discuss the potential benefits of the diabetes, obesity and metabolic disease market for various sectors of the medical and scientific community Establish the current total market size and future growth of the diabetes, obesity and metabolic disease market and analyze the current size and growth of therapeutic segments Provide current and forecasted market shares for each company Discuss profit and business opportunities for each therapeutic segment Provide strategic recommendations for near-term business opportunities Assess current commercial applications used by the diabetes, obesity and metabolic disease market Assess the blood glucose-testing business mode
The following questions will be answered: What are the business models currently used by companies in the diabetes, obesity and metabolic disease market? How will drug manufacturers, researchers, physicians, patients and payers influence the diabetes, obesity and metabolic disease market? What are the
technologies used in diabetes, obesity and metabolic disease therapies? Who holds the proprietary rights to diabetes, obesity and metabolic disease market therapeutic technology? What regulatory processes must diabetes, obesity and metabolic disease therapeutics undergo in the US, Japan and Europe? How will new diabetes, obesity and metabolic disease therapies change treatment and payment paradigms? How will litigation concerns increase physician use of diabetes, obesity and metabolic disease therapies? How will diabetes, obesity and metabolic disease therapies reduce adverse drug reactions and decrease total patient care cost? How will diabetes, obesity and metabolic disease therapies reduce healthcare expenditures? How will drug development cost and time decrease with diabetes, obesity and metabolic disease therapy use?
13 Scope of the Report This report concentrates on the diabetes, metabolic syndrome and cardiovascular disease therapies market segment in major worldwide markets such as the US, Japan and Europe It will discuss the market size, growth rates and market components for instruments and reagents, controls and consumables used in blood glucose testing Business trends,
technology trends and developing areas of pharmaceutical therapies for diabetes, metabolic syndrome and cardiovascular disease will also be addressed The market for such therapies in clinical use is presented here in detail In addition, the dollar volume of sales, both worldwide and in the US, are reported, and the factors that influence the size and growth of individual market segments are discussed The market sizes and growth rates for the US and world markets are described in detail Emphasis is on those companies that are actively developing and marketing therapies for diabetes, metabolic syndrome and cardiovascular disease Leading companies are discussed in depth with a section on the history of the company, the product line, business and marketing analysis, and a subjective commentary of the position of the company in its market Certain topics are discussed only briefly when they are peripherally related to the major elements of this report However, these topics may constitute an entirely different field or market One such example is the category of instruments used in clinical chemistry testing Although they form the foundation for molecular diagnostic testing of blood
glucose levels, in the interest of brevity, these were not analyzed in depth in this report The reader is encouraged to consult other TriMark Publications reports at http://wwwtrimarkpublicationscom for a detailed discussion of important individual market segments related to diabetes, metabolic syndrome and cardiovascular disease, such as clinical chemistry testing, high-growth diagnostic test markets, blood gas and electrolytes over-the-counter diagnostic testing markets and point-of-care testing
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Diabetes, Metabolic Syndrome and Cardiovascular Disease
October 2005
14 Methodology The information in this report is based upon interviews with sales and marketing professionals of companies in the point of care market People from virtually every company mentioned in this report were queried, some several times, about their companies products and marketing strategies, as well as their opinions about their industry segment Information was also obtained from interviews with founders, CEOs and vice presidents of some of the companies discussed in the report were also interviewed Information regarding the
structure of the hospital laboratories and patient facilities was derived from interviews with laboratory directors and medical technologists working in these areas Other sources of information included trade association publications and meetings, product brochures and catalogs and company literature Annual reports, 10k filings and financial reports were referred to when discussing publicly-held companies Some of the information obtained for the report was taken from proprietary databases belonging to Biotechnology Associates and TriMark Publications The information set forth in this study was obtained from sources that are believed to be reliable, however TriMark does not guarantee the accuracy, adequacy or completeness of these sources, or for the analysis based on such information 15 Executive Summary Diabetes mellitus is a disease characterized by dysregulated levels of insulin, a central hormone that regulates blood glucose levels There are two main forms of diabetes: type 1 and type 2 Type 1 diabetes, also known as juvenile diabetes, is an autoimmune disease that is typically manifested in early childhood and results from the rapid and complete obliteration of the pancreatic
beta cells that produce insulin Delivery of insulin into the bloodstream is required, or else death will ensue Type 2 diabetes, otherwise known as adult onset diabetes, is heralded by a slow but progressive loss of pancreatic beta cell function and characterized by decreased responsiveness to insulin of many tissues responsible for central metabolism Type 2 diabetes is commonly treated with oral anti-diabetes drugs that supplement endogenous uptake of glucose by peripheral tissues in order to clear the glucose from circulation as rapidly as possible In addition, nearly 40 of people with type 2 diabetes are treated with insulin injections Compared to other disease markets, diabetes patients constitute an especially large market, comprised of 16 million patients in the US and 150 million patients worldwide with type 2 diabetes Type 1 diabetes is much less common than type 2 diabetes and typically affects younger individuals Type 1 diabetes usually begins before age 40, although this is not without exception In the US, the peak age at diagnosis is around age 14 Type 1 diabetes is associated with deficiency or complete lack of insulin It is not known why, but the pancreatic islet cells
fail to produce insulin in the quantities needed to maintain a normal blood glucose level Without sufficient insulin, the blood glucose rises to levels that can cause symptoms associated with hyperglycemia which also occur in type 2 diabetes It has been estimated that the yearly incidence of type 1 diabetes is 37 to 20 per 100,000 Although more than 700,000 Americans suffer from this form of diabetes, this figure amounts to fewer than 10 of all Americans diagnosed with diabetes Far more prevalent is type 2 diabetes, which plagues the other 90 of the diabetic population in the US Because the prevalence of type 2 diabetes has recently been described as epidemic, the impact of this disease in the near future will exceed current influence In 2003, the global retail sales of diabetes drugs totaled 133 billion, which was an increase of 18 from only the previous year Oral anti-diabetics were the leading category of drugs, which constituted 84 billion of worldwide retail sales The remaining 37 of the sales were accounted by insulin delivery technologies Modern diabetes drugs can successfully treat the symptoms of diabetes but fail to suppress the progression of diabetes and diabetic
complications The primary area of pharmaceutical development for the treatment of type 1 diabetes, an autoimmune disease, is insulin-delivery technologies There are many consequences of this dramatic increase in the number of patients of diabetes Foremost, diabetes is a disease for which long-term pharmacological maintenance is a necessity in virtually all cases Moreover, this condition inexorably worsens over time and must be remedied by increased medication, including combination therapy Secondly, diabetes is typically associated with a host of co-morbidities, including: Cardiovascular disease CVD Renal function
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Diabetes, Metabolic Syndrome and Cardiovascular Disease
October 2005
Deterioration of vision Neuropathy
These co-morbidities require vigilant surveillance and management, and in most cases, require pharmacological intervention that can incur high medical care costs Key opinion leaders recognize these precipitating or interrelated conditions as a new disease state called metabolic syndrome These efforts are intended to assist in early recognition and pharmacological intervention of
patients at risk for diabetes Of particular interest is the strong correlation between diabetes and cardiovascular disease CVD, a component of metabolic syndrome As a result, diabetes experts are increasingly urging diabetes screening by cardiologists, and conversely, that endocrinologists prescribe CVD agents when diagnosing type 2 diabetes The net outcome of this trend will be an increased number of prescriptions written for both disease states Among the growing number of patients with diabetes are new patient subpopulations Specifically, the indoctrination of a western lifestyle in many growing economies is resulting in increased prevalence of diabetes, even in developing nations In addition, whereas diabetes was previously a health concern of the elderly, epidemiological data have shown that record numbers of middle-aged adults and children are now at risk or patients of this condition Not only are the needs of these groups somewhat unique, their predominance also means that the average patient will require medical attention for decades longer than the typical diabetes patient in the past This can have grave ramifications for the prevalence of co-morbidities such as:
Dyslipidemia Hypertension Kidney failurePsychological outcomes such as depression
The societal burden for uncontrolled diabetes and/or debilitating diabetes-related complications extend beyond medical care: workers disability, unemployment and disturbance to family structure are just a few As such, there has been mounting concern among policy-makers In fact, the US government has declared war on obesity, since it is a major health risk precipitating type 2 diabetes Quality of life and the monetary ramifications for governmentsupported healthcare are two key reasons for the governments commitment to this issue It is widely accepted that type 2 diabetes is a largely preventable disorder, and research clearly confirms that the co-morbidities of diabetes can be forestalled or prevented with early and aggressive management of elevated glucose levels, the primary contributor to the co-morbid conditions of diabetes The anti-diabetes market is divided into two primary pharmacological interventions: oral anti-hyperglycemic agents and insulin delivery technologies Excessively high levels of circulating glucose is toxic to many organ systems, hence the diabetes-related complications can
arise when blood glucose levels go unchecked To date, oral antidiabetes agents address elevated glucose levels through a number of different mechanisms of action that are expanding rapidly as improved therapies enter the marketplace In the category of insulin delivery, modifications are being developed to improve the rate of onset and duration of effect Additionally, entirely novel types of delivery systems are also being introduced These non-injectable formulations are intended to provide alternatives to the pain, inconvenience and social stigma associated with the traditional method of needle-injections Currently, the key players in the diabetes market and their principal products in this market are GlaxoSmithKline Avandia, Eli Lilly Humulin, Humalog, Merck Glucophage, Novo Nordisk broad range of insulin products and Takeda Actos Bristol-Myers Squibb BMS and AstraZeneca, both of whom have strong presence in the CVD market, are also actively developing anti-diabetes drugs A number of manufacturers also benefit from the wide use of anti-diabetes drugs that are already produced as generic medications eg, metformin and most sulfonylureas Metformin maintains the largest slice of the
oral anti-diabetes market, comprising approximately one-quarter of all sales It is a drug trusted by doctors and patients alike The recent introduction of generic derivatives and its inclusion in combination therapies also increase its widespread use Thiazolidinediones TZDs have also been favored, although patients with lower insurance benefits are more likely to receive generic sulfonylureas instead of TZDs as a component of their total pharmacological regimen
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