NEW YORK, Sept. 8, 2015 /PRNewswire/ -- 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
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 R&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 & 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 & Development 251
10.35 Johnson & 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 & 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
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