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Molecular Diagnostics in Cancer Testing

  • August 2015
  • -
  • TriMark Publications
  • -
  • 231 pages

Molecular diagnostics is a rapidly-advancing area of research and medicine, with new technologies and applications being continually added. The technologies that come under the umbrella of molecular diagnostics include first-generation amplification, DNA probes, fluorescent in-situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors and molecular labels, and gene expression profiling using microarrays. These technologies are improving the discovery of therapeutic molecules for cancer, the screening, diagnosis and classification of cancer patients, and the optimization of drug therapy. This TriMark Publications report describes the specific segment of the in vitro diagnostics (IVD) market known as molecular diagnostics (MD), with a specialization in the MD tests for cancer.

In the current medical diagnostics market, molecular diagnostics for cancer testing offers one of the brightest areas for growth and innovation. The confluence of breakthroughs in genomics, proteomics, and the development of microarray devices to measure analytes in the blood and various body tissues, has led to this revolutionary market segment offering the power of advanced analytical techniques to the diagnosis and treatment of cancer. This report analyzes the size and growth of the molecular diagnostics market in its applications for cancer detection and therapy, examining the factors that influence the various market segments and the dollar volume of sales, both in the United States and worldwide.

Table Of Contents

Molecular Diagnostics in Cancer Testing










TABLE OF CONTENTS



1. Overview 10

1.1 Statement of Report 10

1.2 About this Report 10

1.3 Scope of the Report 11

1.4 Methodology 11

1.5 Executive Summary 13



2. Introduction 17

2.1 Demographics of Diabetes 18

2.1.1 Worldwide Diabetes 18

2.1.2 U.S. Diabetes 21

2.2 Economics of Diabetes 26

2.2.1 Worldwide Costs of Diabetes 26

2.2.2 Costs of Diabetes in the U.S. 27



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

3.1 Pre-Diabetes Syndrome 33

3.2 Metabolic Syndrome 33

3.2.1 Prevalence of Metabolic Syndrome 36

3.2.2 Management of Metabolic Syndrome 37

3.2.3 The Outlook for Metabolic Syndrome 37

3.2.4 The Debate Regarding Metabolic Syndrome 37

3.3 Diabetes and Inflammation 39

3.4 Diagnosis of Diabetes Mellitus 40

3.5 Progression of Diabetes 40

3.6 Risk Factors and Diabetes 40

3.6.1 Obesity 41

3.6.2 Stress-Induced Hyperglycemia 44

3.7 Complications and Co-Morbidities in Type 2 Diabetes 45

3.7.1 Preventing Complications and Co-Morbidities in Diabetes 50

3.7.2 Hypoglycemia Resulting from Treatment 51

3.8 Cardiovascular Disease (CVD) 51

3.8.1 CVD Facts 51

3.8.2 Cardiac Care Therapeutics 58

3.8.2.1 Anti-Hypertensive Drugs 60

3.8.2.2 Cholesterol Management Drugs 61

3.8.2.3 Anticoagulants 65

3.8.3 CVD Diagnostics 65



4. Pharmaceutical Industry and the Anti-Diabetes Market 67

4.1 The Worldwide Pharmaceutical Industry 67

4.1.1 Pharmaceutical Randamp;D Spending by Type, Growth Rate and Expenditure 67

4.1.2 Global Pharmaceutical Market 69

4.2 Total Diabetes Drug Market Size and Growth 75

4.2.1 Sales Forecast for the Global Anti-diabetes Drug Market 80

4.3 Diabetic Medications Overview 81

4.3.1 Recent Trends in Diabetic Drug Usage 84

4.3.2 Market Influence Factors 86



5. Non-Insulin Anti-Diabetes Products 88

5.1 Anti-Diabetic Drug Therapy Overview 88

5.1.1 Sulfonylureas 91

5.1.2 Meglitinides 92

5.1.3 Biguanides 93

5.1.4 Thiazolidinediones (TZDs) 94

5.1.5 a-Glucosidase Inhibitors 96

5.1.6 Amylin Analog 97

5.1.7 Glucagon-like Peptide (GLP-1) Analogs and Agonists/Incretin Mimetics 97

5.1.7.1 Byetta (Exenatide) 98

5.1.7.2 Bydureon (Exenatide LAR) 99

5.1.7.3 Victoza (Liraglutide) 99

5.1.7.4 Tanzeum (Albiglutide) 99

5.1.7.5 Trulicity (Dulaglutide) 100

5.1.8 DPP-IV Inhibitors 100

5.1.8.1 Januvia (Sitagliptin) 101

5.1.8.2 Onglyza (Saxagliptin) 102

5.1.8.3 Tradjenta (Linagliptin) 102

5.1.8.4 Galvus (Vildagliptin) 102

5.1.8.5 Nesina (Alogliptin) 102

5.1.9 SGLT-2 Inhibitors 103

5.1.9.1 Invokana (Canagliflozin) 104

5.1.9.2 Farxiga (Dapagliflozin) 104

5.1.9.3 Jardiance (Empagliflozin) 105

5.1.9.4 Suglat (Ipragliflozin) 105

5.1.9.5 Lusefi (Luseogliflozin) 105

5.1.10 Fixed Dose Combination Therapies on the Market 106

5.1.10.1 Antidiabetic Drug Options for Youth with Recent-Onset Type 2 Diabetes
Scarce 108

5.1.11 Comparisons of the Anti-Diabetes Drugs 108

5.2 Market Drivers and Trends 108

5.2.1 Market Share and Forecast of Non-Insulin Anti-Diabetic Drugs 108

5.2.2 Latest Additions to the U.S. Non-Insulin Diabetes Drug Market 111

5.3 Non-Insulin Anti-Diabetes Products in the Pipeline 111

5.3.1 Novel GLP-1 Agonists and Analogs 111

5.3.2 Novel DPP-IV Inhibitors 114

5.3.3 Sodium Glucose Cotransporter 2 (SGLT-2) Inhibitors 116

5.3.4 Emerging Anti-Diabetes Targets and Drugs in the Pipeline 117

5.3.4.1 Novel Approaches to Finding New Drug Targets 121



6. Insulin 122

6.1 Insulin Markets 122

6.1.1 Major Players and Market Share 124

6.1.2 Patent Expirations 126

6.1.3 Pathway for Insulin Biosimilars 126

6.1.3.1 Regulatory Avenues for Biosimilar Approval 126

6.1.3.2 Lantus Biosimilars 127

6.1.3.2.1 Abasaglar (formerly Abasria) and Basaglar 127

6.1.3.2.2 Other Biosimilars 127

6.1.3.3 Key Issues for Insulin Biosimilars 127

6.1.4 Innovation Strategies 128

6.2 Insulin Therapeutics 128

6.2.1 Recommendations for Insulin Initiation and Administration 130

6.2.2 Short-Acting Insulin 132

6.2.3 Rapid-Acting Insulin 133

6.2.3.1 Ultra Fast-Acting Insulins in Development 134

6.2.4 Intermediate-Acting Insulin 135

6.2.5 Long-Acting Insulin 136

6.2.6 Insulin Mixtures 137

6.3 Pipeline Insulins in Development 138

6.3.1 Tresiba (Novo Nordisk) 138

6.3.2 Ryzodeg (Novo Nordisk) 138

6.3.3 BIOD-531 (Biodel) 138

6.3.4 Xultophy (Novo Nordisk) 138

6.3.5 LixiLan (Sanofi) 139

6.3.6 rHUPH20 and Insulin (Halozyme) 139

6.3.7 FIAsp (Novo Nordisk) 139

6.3.8 BIOD-238, BIOD-250, and BIOD-351 (Biodel) 139

6.3.9 InsuPatch and InsuPad (Insuline Medical) 139

6.3.10 Smart Insulins 140

6.4 Non-Invasive Insulin Delivery 141

6.4.1 Inhaled Insulin 142

6.4.1.1 Afrezza 142

6.4.1.2 Dance Pharmaceuticals and Aerogen (Dance-501) 143

6.4.1.3 A Chronicle of Inhaled Insulins 144

6.4.2 Oral Insulin 145

6.4.3 Transdermal Insulin 148

6.5 Barriers for Non-Injected Insulin 150

6.6 Patient Potential for Non-Injected Insulin 150

6.7 Insulin Delivery Devices 150

6.7.1 Insulin Pens 152

6.7.2 Injections Aids 155

6.7.2.1 Automatic Injectors 156

6.7.2.2 Syringe Magnifiers 157

6.7.2.3 Injection Ports 157

6.7.3 Insulin Jet Injectors 158

6.7.4 Insulin Pumps 158

6.7.4.1 External Insulin Pumps 159

6.7.4.2 Animas OneTouch Ping 162

6.7.4.3 Animas Vibe 162

6.7.4.4 Accu-Chek® Combo Insulin Pump System (Roche) 163

6.7.4.5 MiniMed Paradigm Real-Time Revel (Medtronic) 163

6.7.4.6 MiniMed 530G with Enlite (Medtronic) 164

6.7.4.7 Insulet Omnipod 164

6.7.4.8 DANA IIS (Sooil) 165

6.7.4.9 t:flex (Tandem Diabetes Care) 165

6.7.4.10 t:slim (Tandem Diabetes Care) 165

6.7.4.11 Snap (Asante) 165

6.7.5 Insulin Infusion Sets 166

6.7.6 Insulin Patch Pumps in Development or Only Available Outside the U.S. 167

6.7.7 Implantable Insulin Pumps 169

6.7.8 Insulin Pump Market Share 170

6.7.9 Drivers of Demand for Pumps 171

6.8 Market Forecasts for Insulin Administration Technologies 171



7. Emerging Anti-Diabetes Technologies and Products 172

7.1 Projections for the Anti-Diabetes Drug Market 172

7.2 Artificial Pancreas 176

7.2.1 MiniMed 530G System 177

7.2.2 Animas® Vibe™ System 177

7.2.3 Next generation Medtronic Artificial Pancreas Systems (MiniMed 640G) 177

7.2.4 FDA's Artificial Pancreas Guidance Document 178

7.3 Insulin-Producing Cells 178

7.3.1 Gene Therapy 179

7.3.2 Cell Therapy Companies for Diabetes 180

7.3.2.1 ViaCyte (formerly Novocell, Inc.) 180

7.3.2.2 Sernova 180

7.4 Pancreatic Transplantation 181

7.4.1 Candidates for Pancreatic Transplantation 181

7.4.1.1 Pancreatic Organ Transplantation 182

7.4.1.2 Allo-Islet Transplantation 182

7.4.1.3 Implantation of Genetically Engineered -Cells or Embryonic Stem Cells
183

7.4.2 ADA Position on Pancreatic Transplantation 183

7.5 Immune Modulators 184

7.6 Gastric Bypass Surgery to Treat Type 2 Diabetes 184

7.7 Anti-Obesity Drugs to Prevent or Delay Development of Type 2 Diabetes 185

7.7.1 Xenical (Roche) 185

7.7.2 Qsymia (Vivus) 185

7.7.3 Belviq (Arena Pharmaceuticals) 185

7.7.4 Contrave (Orexigen Therapeutics) 185

7.7.5 Anti-Obesity Drugs in Development 186

7.8 Other Anti-Diabetic Therapy Drug Candidates 186

7.8.1 Lipid Abnormalities 186

7.8.1.1 New Cholesterol Guidelines 186

7.8.2 High Blood Pressure 189

7.8.3 Aspirin Therapy 191

7.8.4 Pre-Mixed Glucagon for Self-Treating Hypoglycemia 191

7.9 Drugs Used “Off-Label” 191

7.9.1 Warfarin Sodium 191

7.10 Insulin and Anti-diabetes Drug Combinations 191

7.10.1 Xultophy (Novo Nordisk) 191

7.10.2 LixiLan (Sanofi) 192



8. Diagnosing Diabetes Using In Vitro Laboratory Tests 193

8.1 Diagnostic Guidelines 193

8.2 Diagnosis of Diabetes 193

8.2.1 Fasting Plasma Glucose (FPG) Test 196

8.2.2 Glucose Tolerance Test 197

8.2.3 Test for Glycosylated Hemoglobin (HbA1c or A1c) 197

8.2.4 Fructosamine 198

8.2.5 Screening Tests for Diabetes-Related Complications 199

8.3 Glucose Monitoring 200

8.3.1 Overview of Market Segment 202

8.3.2 Competitive Strategies 202

8.3.3 Analyses of the Current Market Conditions, Competition and Product Mix 204

8.3.3.1 First-Generation Monitors 205

8.3.3.2 Second-Generation Monitors 205

8.3.3.3 Third-Generation SMBG Technologies 206

8.3.3.4 Product Overview 206

8.3.3.4.1 LifeScan 206

8.3.3.4.2 Roche Diagnostics 209

8.3.3.4.3 Bayer HealthCare 210

8.3.3.4.4 Abbott Diabetes Care 212

8.3.3.4.5 Other Players 214

8.3.4 What are the Advantages of Using a Continuous Glucose-Monitoring Device?
215

8.3.5 Minimally-Invasive Continuous Glucose Monitors in Development 216

8.3.6 Future of Non-Invasive Glucose Technology 216

8.3.7 Lancets and Lancing Devices 216



9. Market Trends, Challenges and Strategic Options 220

9.1 Overview 220

9.2 Diabetes Drug Market Trends 220

9.2.1 Overview 220

9.2.2 Emergence of Therapeutics with Improved Administration Characteristics 220

9.2.2.1 Barriers to the Initiation of Insulin Therapy in Type 2 Diabetics 222

9.2.3 Increasing Prevalence of Obesity 222

9.2.4 Consumer Preference Drives Product Development in Invasive Technology
Segment 223

9.3 Diabetes Mellitus Market Challenges 223

9.3.1 Overview 223

9.3.2 Patent Expirations 224

9.3.3 Market Prospects of Inhalable Insulin 224

9.4 Strategic Options 225

9.4.1 Developing Countries are Key Markets for Growth 226

9.4.2 Consumer-Driven Marketing Campaigns 227

9.4.3 Strategies for Successful New Product Launches 227

9.4.4 Collaborations and Strategic Alliances 228

9.5 FDA Guidelines for Developing Anti-Diabetic Drugs 229

9.6 Recent Industry Activity 229



10. Company Profiles 232

10.1 A. Menarini 232

10.2 Abbott Laboratories 232

10.3 Abbvie 236

10.4 Amgen 236

10.5 Amylin Pharmaceuticals (bought by Bristol-Myers Squibb) 237

10.6 Animas (part of Johnson andamp; Johnson) 237

10.7 Asante 237

10.8 Astellas Pharma, Inc. 237

10.9 AstraZeneca PLC 238

10.10 Bayer 239

10.11 Becton, Dickinson and Company 241

10.12 Biocon 242

10.13 Biodel 243

10.14 BodyMedia 243

10.15 Boehringer Ingelheim 243

10.16 Bristol Myers Squibb 244

10.17 Cellnovo 244

10.18 CeQur 244

10.19 ConjuChem 244

10.20 Daiichi Sankyo 245

10.21 Dance Biopharm 245

10.22 Debiotech 245

10.23 DexCom 245

10.24 Echo Therapeutics, Inc. 247

10.25 Eli Lilly 248

10.26 FIFTY50 Medical, Inc. 249

10.27 Flamel Technologies 249

10.28 Generex Biotechnology Corporation 249

10.29 GlaxoSmithKline PLC 250

10.30 Halozyme Therapeutics 250

10.31 Insulet 250

10.32 Insuline Medical Ltd. 251

10.33 Intarcia Therapeutics, Inc. 251

10.34 Janssen Research andamp; Development 251

10.35 Johnson andamp; Johnson 252

10.36 Kowa Pharmaceuticals 253

10.37 Lexicon Pharmaceuticals 253

10.38 MannKind Corporation 254

10.39 Medipacs 254

10.40 Medtronic 254

10.41 Merck andamp; Company, Inc. 255

10.42 Mitsubishi Tanabe Pharma Corporation 256

10.43 Novartis 256

10.44 Novo Nordisk 256

10.45 Oramed Pharmaceuticals 257

10.46 Orexigen Therapeutics, Inc. 257

10.47 Owen Mumford 258

10.48 PhaseBio Pharmaceuticals 258

10.49 Pfizer 258

10.50 Prometheon Pharma 259

10.51 Roche Diagnostics 259

10.52 Sanofi 261

10.53 Sernova 262

10.54 Smiths Medical 262

10.55 SOOIL Development 263

10.56 Taisho Pharmaceuticals 263

10.57 Takeda 263

10.58 Tandem Diabetes Care, Inc. 263

10.59 Theracos, Inc. 264

10.60 Transdermal Specialties, Inc. 264

10.61 Valeritas 264

10.62 ViaCyte, Inc. (formerly Novocell) 264

10.63 Vivus, Inc. 265

10.64 vTv Therapeutics (formerly TransTech Pharma) 265

10.65 Ypsomed Holding 265

10.66 Zealand Pharma 265



Appendix 1: The History of Insulin 267





INDEX 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





INDEX 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 Randamp;D Spending in the Pharmaceutical Industry, 2010-2014 67

Table 4.2: Pharmaceutical Companies Ranked by Total Randamp;D Expenditures, 2014 67

Table 4.3: Leading Therapy Classes for Randamp;D, 2014 68

Table 4.4: Leading Disease Indications for Randamp;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






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Frontier Pharma: Versatile Innovation in Oncology - Identifying and Commercializing Versatile First-in-Class Innovation

Frontier Pharma: Versatile Innovation in Oncology - Identifying and Commercializing Versatile First-in-Class Innovation

  • $ 6 995
  • Industry report
  • July 2015
  • by GBI Research

Frontier Pharma: Versatile Innovation in Oncology - Identifying and Commercializing Versatile First-in-Class Innovation Summary The oncology therapy area comprises a large and diverse range of indications, ...


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