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INTRODUCTION

STUDY GOALS AND OBJECTIVES

The aim of this report is to provide detailed market, technology, and industry analyses to help readers quantify and qualify the market for drugs used in the treatment of diabetes and for devices and instruments used in the diagnosis and monitoring of diabetes. Special emphasis is given to major forces contributing to the vigorous growth of the diabetes market. Important trends are identified and sales forecasts by product categories and major country markets are provided through 2017. These forecasts are based on epidemiological data and projections, as well as on information about R&D trends and differential market potential on a country-by-country basis. Health care policies, demographics, and the wider economic environment are also taken into account.

REASONS FOR DOING THE STUDY

It is widely recognized that the prevalence of the most common type of diabetes mellitus, Type 2, is now reaching epidemic proportions all over the world. Cases of Type 1 diabetes are also on the rise, although to a less spectacular degree. These trends are of great concern, not only to the individuals affected, but also to governments and providers of health care. Indeed, the economic consequences of diabetes are vast, involving not only the direct burden of managing the disease but also the common and often catastrophic complications such as cardiovascular disease, peripheral neuropathy, and blindness.

Prompt diagnosis and effective treatment of diabetes are essential, not optional, priorities for governments and health care agencies. The already large market for diabetes monitoring and treatment will certainly grow in line with increasing incidence and with improvements in diagnosis. Thus diabetes is of great commercial significance to the suppliers of drugs used in treatment and to the suppliers of devices needed for disease monitoring.

Among the information needs of companies in this field is an accurate and up-to-date assessment of the current extent of the diabetes epidemic, its likely evolution over the next five years, and the impact of drugs and technical developments now in the pipeline.

SCOPE OF REPORT

This report discusses the implications of the above-mentioned trends in the context of the current size and growth of the diabetes market, discussed both in global terms and in terms of the most important national markets. Companies in the relevant pharmaceutical and medical industries are discussed, with profiles of the leaders and an update on merger and acquisition (M&A) activity. Five-year global sales forecasts are provided for main drug and device categories, and breakdowns are provided for several national markets.

A comprehensive refresher course on diabetes is provided as an appendix.

MARKET ANALYSES AND FORECASTS

The dimensions of the surging diabetes epidemic can be witnessed in stark outline against previous smaller estimates only a few years back. Increased awareness of this “modern plague” has led naturally to improved and more frequent testing practices. This new awareness has also led to improved treatment compliance by patients. Added to these are the more expensive therapies and increased penetration of continuous glucose monitoring (CGM) approaches, which all combine to build a public health menace of accelerating proportions.

For the purpose of market analyses in this report, the global market is defined as 13 countries which together make up over 80% of the total diabetes universe. These countries are the U.S., Canada, Brazil, Mexico, China, India, Japan, Russia, Germany, France, Italy, Spain and the U.K.

Market figures are based on revenues at the manufacturer level and are projected at 2012-dollar value without attempting to predict the effect of inflation/deflation. Therapeutic categories discussed include insulins and oral hypoglycemic agents, devices including blood glucose monitors and accessories, and software aids to self-management of diabetes by patients.

METHODOLOGY

Primary research for this report included interviews with leading individuals in relevant companies and medical associations; primary sources of published data include epidemiological and economic studies, company annual reports, SEC filings, and government publications. Secondary sources consisted of literature searches, industry journals, and other commercial publications. Data for market estimates and forecasts were pooled from a range of sources, critically assessed by BCC.

INTENDED AUDIENCE

This report is designed to satisfy the information needs of a wide variety of individuals involved in the diabetes marketplace, including company senior management executives seeking to base their strategic decisions on the best available information with regard to market forces and trends. However, it is also aimed at managers and executives in marketing, research, planning, and sales departments who need readable, comprehensive, and up-to-date background information on the marketplace in which they are operating.

INFORMATION SOURCES

Sources of information included marketing strategists, industry executives, government and professional agencies, and surveys of physicians. Company annual reports and SEC filings, journal articles, and data from health care institutions were also mined, as well as publications of relevant associations such as the International Diabetes Federation and the American and British Diabetic Associations.

ANALYST CREDENTIALS

Paul Evers has been involved in analyzing pharmaceutical and medical markets for 20 years. He is the author of previous reports on the diabetes marketplace covering both therapeutic and monitoring aspects.

Table Of Contents

Global Markets for Diabetes Therapeutics and Diagnostics -- Focus on the Americas
TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 1
STUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING THE STUDY 1
SCOPE OF REPORT 1
MARKET ANALYSES AND FORECASTS 2
METHODOLOGY 2
INTENDED AUDIENCE 2
INFORMATION SOURCES 2
ANALYST CREDENTIALS 2
RELATED REPORTS 3
BCC ONLINE SERVICES 3
DISCLAIMER 3
CHAPTER 2 SUMMARY 5
THE DIABETES MARKET 5
LEADING COMPANIES 5
SUMMARY TABLE DIABETES MARKET BREAKDOWN BY REGIONS, THROUGH 2017 ($
BILLIONS) 6
SUMMARY FIGURE DIABETES MARKET EVOLUTION BY REGION, 2011-2017 ($ BILLIONS) 6
CHAPTER 3 OVERVIEW 8
DIABETES BASICS 8
STRUCTURE OF THE DIABETES MARKET 8
DRIVERS FOR GROWTH 8
RISING PREVALENCE 8
TABLE 1 GLOBAL AND REGIONAL DIABETES PREVALENCE, 2011 AND 2017 (CASES IN
MILLIONS) 8
NEW TECHNOLOGY 9
RATE OF MARKET GROWTH 10
CURRENT TREATMENT OF DIABETES 10
INSULIN 10
Insulin Administration Devices 10
ORAL ANTIDIABETIC DRUGS 11
MONITORING DEVICES FOR DIABETES 11
TABLE 2 TOTAL DIABETES MARKET IN 2012 ($ BILLIONS) 11
REGIONAL SEGMENTATION 11
TABLE 3 ADULT DIABETES MARKET BY REGION (MILLIONS/%) 12
MARKET GROWTH 12
THE DIABETES INDUSTRY 12
PHARMACEUTICAL COMPANIES 12
MEDICAL DEVICE COMPANIES 13
CHAPTER 4 PRODUCTS AND SUPPLIERS 15
INSULIN 15
HISTORY 15
Bovine and Porcine Insulin 16
Humanized Insulin 16
COMPANIES SUPPLYING INSULIN 17
Eli Lilly 17
Sanofi 17
Novo Nordisk 17
Some Other Suppliers 17
Wockhardt Limited: India 17
BioconB: India 18
Shreya Life Sciences: India 18
Diosynth: the Netherlands 18
TABLE 4 MAJOR BRANDS OF INSULIN 18
INSULIN DELIVERY 19
SYRINGES 19
INSULIN SYRINGE MANUFACTURERS 19
Becton Dickinson 19
Owen Mumford 20
Terumo 20
B. Braun 20
PENS 20
TABLE 5 INSULIN PENS 21
MANUFACTURERS OF INSULIN PENS 21
Novo Nordisk 21
Owen Mumford 22
Other Makers 22
INJECTORS 22
INJECTOR MANUFACTURERS 23
Activa Brand Products 23
Antares Pharma 23
Bioject 23
MediCool Inc. 23
Owen Mumford 24
Palco Labs Inc. 24
Rosch AG Medizintechnik 24
INSULIN PUMPS 24
What Is an Insulin Pump? 24
The Infusion Set 25
Candidates for Pump Therapy 25
COMPANIES SUPPLYING INSULIN PUMPS 26
Animas Corp. 26
Sooil Development Co. 27
Medtronic MiniMed 27
Nipro Diabetes Systems 27
Roche Insulin Delivery Systems 27
Insulet 27
Tandem Diabetes Care 28
TABLE 6 INSULIN PUMPS 28
Problems with Pumps-or Users? 28
ORAL HYPOGLYCEMIC DRUGS 29
SULFONYLUREAS 29
TABLE 7 SULFONYLUREAS 29
BIGUANIDES 30
ALPHA-GLUCOSIDASE INHIBITOR 30
GLITAZONES 30
PRANDIAL GLUCOSE REGULATORS 30
GLP-1 ANALOGS; ALSO KNOWN AS INCRETIN MIMETICS 31
AMYLIN MIMETIC 31
TABLE 8 ORAL HYPOGLYCEMICS 32
DIAGNOSIS AND MONITORING 32
THE ROLE OF SELF-MONITORING 32
SMBG Frequency 33
BLOOD GLUCOSE MONITORING DEVICES: SUPPLIERS AND PRODUCTS 33
Lancets 34
TABLE 9 INTERNATIONAL SUPPLIERS OF BLOOD LANCETS 34
BLOOD-SAMPLING DEVICES 34
Bayer Diagnostics 34
Becton Dickinson 35
Cell Robotics 35
LifeScan 35
Roche Diagnostics 35
BLOOD GLUCOSE MONITORS 35
77 Elektronika Kft 35
Abbott Laboratories 36
Acon Laboratories Inc. 36
AgaMatrix Inc. 36
Apex Biotechnology Corp. 37
Arkray USA 37
Aventir Biotech LLC 37
Bayer Corp. 37
Belbiosens 38
Diagnostic Devices Inc. 38
Eumed Biotechnology Co. Ltd. 38
GlucoPlus Inc. 38
HMD Bio Medical 38
Health and Life Co. 38
HemoCue AB 39
Home Diagnostics Inc. 39
Hypoguard 39
i-SENS Inc. 39
LifeScan Inc. 39
Medtronic 39
Menarini Diagnostics 40
National Diagnostic Products 40
Novabiomedical Corp. 40
Roche 40
TaiDoc Technology Corp. 41
US Diagnostics Inc. 41
GLUCOSE METER ACCURACY 41
OTHER TESTING APPROACHES 42
HEMOGLOBIN A1C 42
Hemoglobin A1c Meters 42
Hemoglobin A1c Kits 43
SOFTWARE AIDS TO DIABETES MONITORING 44
AIDA On-Line 44
Bayer Care: Blood Sugar Log 44
Body Sigma 44
Dailyrating 44
DiabetEASE 44
Diabetes Assistant 45
Diabetes Homecare Center 45
Ecivon 45
HealthEngage Diabetes 45
Lifeclinic 46
PlasmaGlucose 46
Symcare 46
CHAPTER 5 NEW DEVELOPMENTS IN DIABETES 48
APPROACHES BASED ON CURRENT TECHNOLOGY 48
NOVEL INSULIN DELIVERY TECHNOLOGY 48
Oral-Lyn 48
Oramed 48
Medingo Micro-Pump Patch 48
Inhaled Insulin 49
Transdermal Approach 49
IMPROVED ORAL ANTIDIABETIC DRUGS 50
Dutogliptin 50
Byetta LAR 50
Lixisenatide 50
NEW DEVELOPMENTS IN GLUCOSE TESTING 51
Continuous Glucose Monitoring (CGM) 51
Reimbursement 52
Noninvasive Monitoring 52
TABLE 10 SELECTED COMPANIES DEVELOPING NONINVASIVE GLUCOSE MONITORING 55
Integrated Testing 56
ARTIFICIAL PANCREAS 57
Roche 57
Abbott 58
Novo Nordisk/LifeScan 58
Animas 58
RADICAL APPROACHES 59
ALTERNATIVES TO INSULIN 59
IMMUNOTHERAPY 60
TRANSPLANTATION 60
CELL AND STEM CELL THERAPIES 61
GENE THERAPY 62
Gene Therapy Approaches for Expressing Insulin 62
Gene Therapy Approaches for Immunomodulation 62
Gene Therapy Approaches for Cell-Based Therapies 62
A NEW AGE OF MOBILITY IN DIABETES MANAGEMENT 63
THE IMPACT OF NEW DEVELOPMENTS ON THE DIABETES MARKET 64
CHAPTER 6 THE GLOBAL DIABETES MARKET 67
MARKET COMPONENTS 67
SIZE 67
TABLE 11 GLOBAL DIABETES MARKET, 2011 ($ BILLIONS) 67
GROWTH 68
MARKET ANALYSIS BY PRODUCT CATEGORY 68
INSULINS AND INSULIN DELIVERY DEVICES 68
Major Suppliers 69
TABLE 12 GLOBAL SALES OF LEADING INSULIN PRODUCTS, 2011 ($ MILLIONS) 69
OTHER ANTIDIABETIC DRUGS 69
Major Suppliers 69
TABLE 13 SALES OF OTHER ANTIDIABETIC DRUGS, 2011 ($ MILLIONS) 70
INSULIN PUMPS 70
TABLE 14 DIABETES MARKET BREAKDOWN BY REGION, THROUGH 2017 ($ BILLIONS) 71
MONITORING PRODUCTS 71
Major Suppliers 71
TABLE 15 LEADING SUPPLIERS OF GLUCOSE MONITORING PRODUCTS, 2011 (MILLIONS/%) 71
TRENDS 71
REGIONAL SEGMENTATION 72
TABLE 16 RISING PREVALENCE OF DIABETES BY REGION, THROUGH 2017 (CASES IN
MILLIONS) 72
NATIONAL MARKETS 72
North America 73
TABLE 17 TOTAL DIABETES MARKET FOR CANADA AND THE U.S., THROUGH 2017 ($
BILLIONS) 73
South and Central America 74
TABLE 18 TOTAL DIABETES MARKET FOR MEXICO AND BRAZIL, THROUGH 2017 ($
BILLIONS) 74
Europe 74
TABLE 19 MAJOR EUROPEAN ECONOMIES: TOTAL DIABETES MARKET, THROUGH 2017 ($
BILLIONS) 75
Asia 75
TABLE 20 MAJOR ASIAN COUNTRIES: TOTAL DIABETES MARKET, THROUGH 2017 ($
BILLIONS) 75
CHAPTER 7 THE AMERICAN MARKET 77
NORTH AMERICA 77
THE U.S. 77
Vital Statistics 77
Health and Health Care 77
THE U.S. PHARMACEUTICAL MARKET 79
The Diabetes Market 79
TABLE 21 PREVALENCE OF DIABETES IN THE U.S., THROUGH 2017 (CASES IN MILLIONS) 79
TABLE 22 U.S.: DIABETES MEDICATIONS MARKET, THROUGH 2017 ($ BILLIONS) 80
TABLE 23 U.S.: DIABETES DEVICES MARKET, THROUGH 2017 ($ BILLIONS) 80
CANADA 80
Vital Statistics 80
Health and Health Care 80
CANADA'S PHARMACEUTICAL MARKET 81
The Diabetes Market 81
TABLE 24 PREVALENCE OF DIABETES IN CANADA, THROUGH 2017 (CASES IN MILLIONS) 82
TABLE 25 CANADA: DIABETES MEDICATIONS MARKET, THROUGH 2017 ($ BILLIONS) 82
TABLE 26 CANADA: DIABETES DEVICES MARKET, THROUGH 2017 ($ BILLIONS) 82
LATIN AMERICA 83
BRAZIL 83
Vital Statistics 83
Health and Health Care 83
BRAZIL'S PHARMACEUTICAL MARKET 84
The Diabetes Market 85
TABLE 27 PREVALENCE OF DIABETES IN BRAZIL, THROUGH 2017 (CASES IN MILLIONS) 85
TABLE 28 BRAZIL: DIABETES MEDICATIONS MARKET, THROUGH 2017 ($ BILLIONS) 85
TABLE 29 BRAZIL: DIABETES DEVICES MARKET, THROUGH 2017 ($ BILLIONS) 85
MEXICO 86
Vital Statistics 86
Health and Health Care 86
MEXICO'S PHARMACEUTICAL MARKET 86
Market Resistors 87
The Diabetes Market 87
TABLE 30 PREVALENCE OF DIABETES IN MEXICO, THROUGH 2017 (CASES IN MILLIONS) 87
TABLE 31 MEXICO: DIABETES MEDICATIONS MARKET, THROUGH 2017 ($ BILLIONS) 88
TABLE 32 MEXICO: DIABETES DEVICES MARKET, THROUGH 2017 ($ BILLIONS) 88
CHAPTER 8 COMPANY PROFILES 90
LEADING COMPANIES 90
ABBOTT LABORATORIES 90
Overview 90
ABBOTT DIABETES CARE, INC. 91
BAYER AG 91
Overview 91
Diabetes Products 92
BECTON DICKINSON 92
Overview 92
Diabetes Products 93
BRISTOL-MYERS SQUIBB 93
Overview 93
Problems with Generics 93
Diabetes Products 93
Pipeline 94
ELI LILLY AND CO. 94
Overview 94
Diabetes Products 94
Pipeline 95
GLAXO SMITHKLINE 95
Overview 95
Diabetes Products 95
Pipeline 96
JOHNSON and JOHNSON 96
Overview 96
Diabetes Products 96
Pipeline 97
MEDTRONIC 97
Overview 97
Diabetes Products 98
Pipeline 98
MERCK and CO. LTD. 98
Diabetes 99
SmartCells 99
MERCK KGAA 100
Overview 100
Diabetes Products 100
NOVARTIS INTERNATIONAL AG 101
Overview 101
Diabetes Products 101
Research 101
NOVO NORDISK A/S 102
Overview 102
Diabetes Products 102
Pipeline 103
TABLE 33 NOVO NORDISK DIABETES PRODUCT PIPELINE 104
ROCHE 104
Overview 104
Diabetes Products 105
Blood Glucose Monitoring Systems 105
Diabetes Data Management 106
Insulin Pump Systems 106
Lancet Devices 106
Other 107
Pipeline 107
SANOFI 107
Overview 107
Diabetes Products 108
TAKEDA 108
Overview 108
Pipeline 109
TABLE 34 DIABETES PRODUCTS IN DEVELOPMENT BY TAKEDA 109
OTHER COMPANIES 110
77 ELEKTRONIKA CO., LTD. 110
AGAMATRIX, INC. 110
ANIMAS CORP. 111
BIO-IMPEDANCE GENERAL LTD. 111
DEBIOTECH S.A. 112
INLIGHT SOLUTIONS, INC. 112
LIFESCAN, INC. 113
MANNKIND CORP. 113
A. MENARINI DIAGNOSTICS S.R.L. 114
NIPRO CORP. 3-9-3, 114
OWEN MUMFORD LTD. 115
PALCO LABS, INC. 116
PRODIGY DIABETES CARE LLC 116
TERUMO CORP. 117
TRANSITION THERAPEUTICS INC. 117
CHAPTER 9 APPENDIX I: ABOUT DIABETES 119
BLOOD SUGAR REGULATION 119
INSULIN 119
TYPE 1 DIABETES 120
TYPE 2 DIABETES 120
GESTATIONAL DIABETES 121
OBESITY-RELATED TYPE 2 DIABETES IN CHILDREN 121
MATURE-ONSET DIABETES OF THE YOUNG (MODY) 122
OTHER DIABETIC STATES 122
LATENT AUTOIMMUNE DIABETES (LADA) 122
PREDIABETES 122
DIAGNOSIS 123
GLUCOSE TESTS 123
OFFICIAL CRITERIA 123
DIFFERENTIAL DIAGNOSIS 123
TYPE 1 DIABETES 123
TYPE 2 DIABETES 124
CURRENT TREATMENT 124
TYPE 1 DIABETES 124
TYPE 2 DIABETES 124
Sulfonylureas 125
Biguanides 125
Alpha-Glucosidase Inhibitors 125
Glitazones (Thiazolidinediones) 126
Prandial Glucose Regulators 126
Incretin Mimetics 126
Dipeptidyl Peptidase 4 (DPP-4) Inhibitors 126
DIET 126
MONITORING DIABETES 126
BLOOD SUGAR CONTROL 126
THE DIABETES CONTROL AND COMPLICATIONS TRIAL (DCTT) 127
GLYCATED HEMOGLOBIN (HBA1C) 128
FRUCTOSAMINE 129
PREVALENCE OF DIABETES 129
TYPE 1 130
TYPE 2 130
DIABETIC COMPLICATIONS 130
RETINOPATHY 131
NEUROPATHY 131
NEPHROPATHY 132
INCREASED MORTALITY RISK 132
METABOLIC SYNDROME 132
CHAPTER 10 APPENDIX 2: GLOSSARY 135
TABLE 35 GLOSSARY 135

LIST OF TABLES
SUMMARY TABLE DIABETES MARKET BREAKDOWN BY REGIONS, THROUGH 2017 ($
BILLIONS) 6
TABLE 1 GLOBAL AND REGIONAL DIABETES PREVALENCE, 2011 AND 2017 (CASES IN
MILLIONS) 8
TABLE 2 TOTAL DIABETES MARKET IN 2012 ($ BILLIONS) 11
TABLE 3 ADULT DIABETES MARKET BY REGION (MILLIONS/%) 12
TABLE 4 MAJOR BRANDS OF INSULIN 18
TABLE 5 INSULIN PENS 21
TABLE 6 INSULIN PUMPS 28
TABLE 7 SULFONYLUREAS 29
TABLE 8 ORAL HYPOGLYCEMICS 32
TABLE 9 INTERNATIONAL SUPPLIERS OF BLOOD LANCETS 34
TABLE 10 SELECTED COMPANIES DEVELOPING NONINVASIVE GLUCOSE MONITORING 55
TABLE 11 GLOBAL DIABETES MARKET, 2011 ($ BILLIONS) 67
TABLE 12 GLOBAL SALES OF LEADING INSULIN PRODUCTS, 2011 ($ MILLIONS) 69
TABLE 13 SALES OF OTHER ANTIDIABETIC DRUGS, 2011 ($ MILLIONS) 70
TABLE 14 DIABETES MARKET BREAKDOWN BY REGION, THROUGH 2017 ($ BILLIONS) 71
TABLE 15 LEADING SUPPLIERS OF GLUCOSE MONITORING PRODUCTS, 2011 (MILLIONS/%) 71
TABLE 16 RISING PREVALENCE OF DIABETES BY REGION, THROUGH 2017 (CASES IN
MILLIONS) 72
TABLE 17 TOTAL DIABETES MARKET FOR CANADA AND THE U.S., THROUGH 2017 ($
BILLIONS) 73
TABLE 18 TOTAL DIABETES MARKET FOR MEXICO AND BRAZIL, THROUGH 2017 ($ BILLIONS) 74
TABLE 19 MAJOR EUROPEAN ECONOMIES: TOTAL DIABETES MARKET, THROUGH 2017 ($
BILLIONS) 75
TABLE 20 MAJOR ASIAN COUNTRIES: TOTAL DIABETES MARKET, THROUGH 2017 ($
BILLIONS) 75
TABLE 21 PREVALENCE OF DIABETES IN THE U.S., THROUGH 2017 (CASES IN MILLIONS) 79
TABLE 22 U.S.: DIABETES MEDICATIONS MARKET, THROUGH 2017 ($ BILLIONS) 80
TABLE 23 U.S.: DIABETES DEVICES MARKET, THROUGH 2017 ($ BILLIONS) 80
TABLE 24 PREVALENCE OF DIABETES IN CANADA, THROUGH 2017 (CASES IN MILLIONS) 82
TABLE 25 CANADA: DIABETES MEDICATIONS MARKET, THROUGH 2017 ($ BILLIONS) 82
TABLE 26 CANADA: DIABETES DEVICES MARKET, THROUGH 2017 ($ BILLIONS) 82
TABLE 27 PREVALENCE OF DIABETES IN BRAZIL, THROUGH 2017 (CASES IN MILLIONS) 85
TABLE 28 BRAZIL: DIABETES MEDICATIONS MARKET, THROUGH 2017 ($ BILLIONS) 85
TABLE 29 BRAZIL: DIABETES DEVICES MARKET, THROUGH 2017 ($ BILLIONS) 85
TABLE 30 PREVALENCE OF DIABETES IN MEXICO, THROUGH 2017 (CASES IN MILLIONS) 87
TABLE 31 MEXICO: DIABETES MEDICATIONS MARKET, THROUGH 2017 ($ BILLIONS) 88
TABLE 32 MEXICO: DIABETES DEVICES MARKET, THROUGH 2017 ($ BILLIONS) 88
TABLE 33 NOVO NORDISK DIABETES PRODUCT PIPELINE 104
TABLE 34 DIABETES PRODUCTS IN DEVELOPMENT BY TAKEDA 109
TABLE 35 GLOSSARY 135

LIST OF FIGURES
SUMMARY FIGURE DIABETES MARKET EVOLUTION BY REGION, 2011-2017 ($ BILLIONS) 6

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