1. Executive Summary
1.1 The Diabetes Market Trajectory
1.1.1 Visiongain's Prediction for Total Diabetes Sales in 2025
1.1.2 Diabetes is Spreading at an Epidemic Rate: The Need for Pharmaceuticals is Growing
1.1.3 Diabetes Care Works: The Market will Expand Significantly
1.1.4 Awareness, Advocacy and Government Spending Aimed at Diabetes are all Expanding
1.2 Aims, Scope and Format of the Report
1.3 Research and Analysis Methods
2. Introduction to Diabetes and its Treatment
2.1 What is Diabetes Mellitus?
2.1.1 Symptoms of Diabetes
2.1.2 Type 1 Diabetes
2.1.3 Type 2 Diabetes
2.1.4 Gestational Diabetes
2.1.5 Other Types of Diabetes
2.1.6 "Pre-Diabetes": Impaired Glucose Tolerance (IGT) and Metabolic Syndrome
2.2 Health Consequences: Diabetes Can Cause Heart, Kidney, Eye, and Nerve Damage
2.2.1 Heart Problems
2.2.2 Kidney Damage
2.2.3 Blindness
2.2.4 Neuropathy
2.2.5 Amputation
2.2.6 Ketoacidosis, Coma, and Death
2.3 Obesity: The Major Diabetes Risk Factor
2.4 Other Risk Factors: Age, Genetics, Race
2.4.1 Type 2 Diabetes Risk Increases with Age
2.4.2 Obesity Increases Chances of Type 2 Diabetes
2.4.3 Genetic Factors
2.4.4 Type 1 Diabetes: Genetics vs. Environment
2.4.5 Family History
2.4.6 Ethnicity
2.5 Diagnosis: Guidelines are Subject to Change
2.6 Prevalence: Diabetes Rates are Rising Epidemically
2.7 The Economic Costs of Diabetes: $58 billion in the US
2.8 Treatments
2.8.1 Insulin: a Central Therapeutic Product
2.8.2 Medications
2.8.3 More Novel Therapies? A New Discovery about how Insulin Works May Lead to New Drugs
2.9 Diabetes Treatment Noncompliance Rates 25% to 90%
3. The World Diabetes Drug Market, 2010-2025
3.1 The World Diabetes Drug Market in 2009
3.1.1 Human Insulins & Analogues had Largest Market Share in 2009
3.1.2 Top Twenty Anti-Diabetic Brands, 2009
3.2 The World Diabetes Drug Market Forecast, 2010-2025
3.3 Anti-Diabetic Pharmaceutical Therapeutic Category Sales Forecasts, 2010-2025
3.3.1 Two Therapeutic Categories will Power Growth from 2010-2016
3.3.2 Human Insulins and Analogues will Continue to Drive Growth from 2017-2025
4. Human Insulins and Analogues: Market Prospects, 2010-2025
4.1 Leading Human Insulins and Analogues
4.1.1 Lantus – Commercial Prospects
4.1.2 Novorapid – Commercial Prospects
4.1.3 Humalog – Commercial Prospects
4.1.4 Novomix – Commercial Prospects
4.1.5 Levemir – Commercial Prospects
4.1.6 Actraphane HM – Commercial Prospects
5. Other Anti-Diabetic Agents: Market Prospects, 2010-2025
5.1 Leading Oral Anti-Diabetic Products
5.1.1 Actos – Commercial Prospects
5.1.2 Avandia: How will Sales Fare After 2013?
5.1.3 Avandamet – Commercial Prospects
5.1.4 Januvia – Commercial Prospects
5.2 Byetta/Exenatide LAR: Potentially Revolutionary Non-Insulin Injection Blockbuster
5.2.1 Byetta's Strengths
5.2.2 Restraints on Byetta
6. Drivers and Restraints in the Diabetes Drug Market
6.1 Strengths: Diabetes is Increasing, and Diabetes Drugs Work
6.1.1 Diabetes is Chronic
6.1.2 Younger Patients, More-Comprehensive Diagnoses
6.1.3 Prevention is Inadequate
6.1.4 Drugs Often Used in Combination
6.2 Weaknesses
6.2.1 Diagnostic Inadequacies
6.2.2 Developing Countries Cannot Afford Many Drugs
6.2.3 Noncompliance Rates up to 65%
6.3 Opportunities
6.3.1 Increasing Prevalence of Diabetes and Unhealthy Lifestyles
6.3.2 The Greying of the World Population
6.3.3 Obesity: A Major Contributing Factor for Type 2 Diabetes
6.3.4 Expanding Markets: India and China
6.3.5 Changing Guidelines for Defining Diabetes
6.3.6 Techniques for Increasing Patient Compliance
6.3.7 Novel Drugs, Novel Delivery Methods
6.4 Threats
6.4.1 The Most-Significant Threat: Changes in Drug Approval Guidelines
6.4.2 Changing FDA Guidelines for New Drug Approvals
6.4.3 Generic Erosion of Branded Drug Sales
6.4.4 Vaccine to Prevent Type 1 Diabetes?
6.4.5 Diabetes Drugs' Side Effects
7. Antidiabetic Drugs: Leading Country Markets, 2010-2025
7.1 Leading Anti-Diabetic Pharmaceutical Country Markets, 2009
7.2 Leading Developed Country Anti-Diabetic Pharmaceutical Markets, 2010-2025
7.2.1 The US Anti-Diabetic Pharmaceutical Market
7.2.2 The Japanese Anti-Diabetic Pharmaceutical Market
7.2.3 European Diabetes Pharmaceutical Markets
7.3 Emerging Economy Anti-Diabetic Pharmaceutical Market Forecasts, 2010-2025
7.3.1 Anti-Diabetic Pharmaceuticals are Making the Leap to Developing Countries
7.3.2 The Chinese Anti-Diabetic Pharmaceutical Market
7.3.3 The Indian Anti-Diabetic Pharmaceutical Market
8. The R&D Pipeline for Diabetes Treatments
8.1 The Anti-Diabetic Drugs Pharmaceutical Pipeline
8.2 The Human Insulins and Analogues Pipeline
8.2.1 Technosphere Insulin (Mankind)
8.2.2 VIAject/VIAdel (Biodel)
8.2.3 CKD 401(Chong Kun Dang)
8.2.4 BHT 3021/RG 7426 (Bayhill Therapeutics/Genentech)
8.2.5 Nasulin/CPE-215 (CPEX Pharmaceuticals)
8.2.6 Capsulin (Diabetology)
8.2.7 ORMD 0801 (Oramed)
8.2.8 TPM 02/Insulin (Phosphagenics)
8.2.9 IN 105 (Biocon)
8.2.10 NN 1250 (Novo Nordisk)
8.2.11 NN 5401 (Novo Nordisk)
8.2.12 SBS 1000 (SemBioSys)
8.3 The Glitazone Anti-Diabetics Pipeline
8.3.1 ACTOplus met XR (Takeda)
8.3.2 Balaglitazone/DRF 2593 (Dr Reddy's/Nordic Bioscience)
8.3.3 MK 0431C (Merck & Co)
8.3.4 MSDC 0160 (Metabolic Solutions Development)
8.3.5 Lobeglitazone/CKD 501 (Chong Kun Dang)
8.4 DPP-IV Inhibitor Anti-Diabetics Pipeline
8.4.1 SYR 322 (Takeda)
8.4.2 Alogliptin (Takeda)
8.4.3 Linagliptin/BI 1356 BS (Boehringer Ingelheim)
8.4.4 Dutogliptin/PHX 1149 (Phenomix)
8.4.5 LC 15 0444 (LG Life Sciences)
8.4.6 Saxagliptin and Metformin Combination
8.4.7 MK 0431C (Merck & Co)
8.4.8 SK 0403 (Sanwa Kagaku/ Kowa/ Choongwae)
8.4.9 Teneligliptin/MP 513 (Mitsubishi Tanabe Pharma)
8.4.10 ALS 20426/AMG 222 (Amgen)
8.4.11 Carmegliptin/R 1579 (Roche)
8.4.12 KRP 104 (Kyorin)
8.4.13 Melogliptin/GRC 8200 (Glenmark)
8.4.14 SYR 472 (Takeda)
8.4.15 TA 6666 (Mitsubishi Tanabe Pharma)
8.5 Sulphonylurea and Biguanide Anti-Diabetics Pipeline
8.5.1 NCT00660907/Dapagliflozin + Metformin Combination (AstraZeneca)
8.5.2 Metformin XL (Flamel Technologies)
8.5.3 Metcontrol (Generex Biotechnology)
8.6 Alpha-glucosidase Inhibitor Anti-Diabetics Pipeline
8.6.1 KMV 0207 (Kissei/Takeda)
8.6.2 PharmaLinks Compounds (University of Strathclyde)
8.7 Miscellaneous Class of Anti-Diabetic Drugs in the R&D Pipeline
8.7.1 Byetta LAR/AC 2993 LAR (Amylin/Alkermes/Eli Lilly)
8.7.2 Albiglutide/GSK 716155 (GlaxoSmithKline)
8.7.3 Lixisenatide/ZP 10/AVE 0010 (sanofi-aventis)
8.7.4 LY 2189265 (Eli Lilly)
8.7.5 Taspoglutide/ BIM 51077 (Roche)
8.7.6 ITCA 650 (Intarcia)
8.7.7 Gosogliptin/PF 734200 (Pfizer)
8 7.8 Semaglutide/NN 9535 (Novo Nordisk)
8.7.9 Bromocriptine/Cycloset (VeroScience/ S2 Therapeutics)
8.7.10 SF 1019/R-1818 (Argyll Biotechnologies)
8.7.11 Arhalofenate/MBX 102 (Metabolex and Ortho-McNeil)
8.7.12 Canagliflozin/TA 7284 (Mitsubishi Tanabe Pharma/ Johnson & Johnson)
8.7.13 Dapagliflozin (Bristol-Myers Squibb)
8.7.14 DiaPep277 (Andromeda/ DeveloGen)
8.7.15 Mirabegron/YM 178 (Astellas)
8.7.16 Otelixizumab/TRX 4/ChAglyCD3 (GlaxoSmithKline/Tolerx/BTG)
8.7.17 Teplizumab/MGA 031 (MacroGenics/Eli Lilly)
8.7.18 DIAMYD/GAD65 (Diamyd Medical)
9. Expert Views from Key Opinion Leaders
9.1 Prof. R. Keith Campbell, Pharm.B., MBA, CDE Distinguished Professor in Diabetes Care, Department of Pharmacotherapy, College of Pharmacy, Washington State University, WA, US
9.1.1 Key Unmet Needs
9.1.2 About Research and Development
9.1.3 Problems with the Current Use of Anti-Diabetic Treatments
9.1.4 Challenges in the Development of Anti-Diabetic Drugs
9.1.5 Complexities Involved in Developing New Anti-Diabetic Drugs
9.1.6 Technologies and Strategies for Discovery of New Anti-Diabetic Agents
9.1.7 Growth Opportunities in Diabetes Market
9.1.8 Challenges Facing the Diabetes Pharmaceutical Industry
9.1.9 Main Regions Offering Growth Potential Worldwide
9.1.10 Pipeline Developments from a Physician's Perspective
9.1.11 Prospects of Replacing Current Drugs and Treatments
9.2 Interview with Dr Fred Levine, M.D., Ph.D. Professor, Burnham Institute for Medical Research; Director, Sanford Children's Health Research Center, La Jolla, California, US
9.2.1 On Alternative Delivery Methods
9.2.2 On Cardiovascular Problems Associated with Oral Anti-Diabetics
9.2.3 On Obesity and Diabetes
9.2.4 On Byetta
9.2.5 On Stem Cell Therapy/Cure
9.3 Interview with Björn Tyrberg, PhD., Associate Professor, Metabolic Signaling & Disease, Diabetes and Obesity Research Center, Burnham Institute for Medical Research, La Jolla, CA, US
9.3.1 On Diet and Diabetes
9.3.2 On The Link Between Obesity and Diabetes
9.3.3 On Byetta and Liraglutide
10. Conclusions: Diabetes is a Growth Market with Significant Opportunities
10.1 Diabetes Increasing Worldwide: 2-14% Prevalence Rate
10.2 World Diabetes Market: A Growing Opportunity
10.3 Oral Anti-Diabetics Sales vs. Insulins Sales
List of Tables
Table 2.1 Diabetes Numbers (in Millions), by WHO Region, 2000 & 2030
Table 2.2 Secondary Costs of Diabetes in the US, 2007
Table 2.3 Total Costs of Diabetes to Africa: $4.2 Billion, 2007
Table 2.4 Diabetes World Market Sales, 2009
Table 2.5 Insulin Types by Onset Rate, 2010
Table 2.6 Alternative Delivery Methods in the R&D Pipeline by Type and Development Stage, 2010
Table 2.7 Anti-Diabetic Drugs by Class, 2010
Table 3.1 Diabetes Pharmaceutical Therapeutic Category Market Shares, 2009
Table 3.2 Top Twenty Diabetes Pharmaceutical Brands, 2009
Table 3.3 World Diabetes Pharmaceutical Market Sales Forecast, 2010-2016
Table 3.4 World Diabetes Pharmaceutical Market Sales Forecast, 2017-2025
Table 3.5 Diabetes Pharmaceutical Therapeutic Category Sales Forecasts, 2010-2016
Table 3.6 Diabetes Pharmaceutical Therapeutic Category Sales Forecasts, 2017-2025
Table 4.1 Lantus Sales Forecast, 2010-2016
Table 4.2 Lantus Sales Forecast, 2017-2025
Table 4.3 Novorapid Sales Forecast, 2010-2016
Table 4.4 Novorapid Sales Forecast, 2017-2025
Table 4.5 Humalog Sales Forecast, 2010-2016
Table 4.6 Humalog Sales Forecast, 2017-2025
Table 4.7 Novomix Sales Forecast, 2010-2016
Table 4.8 Novomix Sales Forecast, 2017-2025
Table 4.9 Levemir Sales Forecast, 2010-2016
Table 4.10 Levemir Sales Forecast, 2017-2025
Table 4.11 Actraphane HM Sales Forecast, 2010-2016
Table 4.12 Actraphane HM Sales Forecast, 2017-2025
Table 5.1 Actos Sales Forecast, 2010-2016
Table 5.2 Actos Sales Forecast, 2017-2025
Table 5.3 Avandia Sales Forecast, 2010-2016
Table 5.4 Avandia Sales Forecast, 2017-2025
Table 5.5 Avandamet Sales Forecast, 2010-2016
Table 5.6 Avandamet Sales Forecast, 2017-2025
Table 5.7 Junuvia Sales Forecast, 2010-2016
Table 5.8 Junuvia Sales Forecast, 2017-2025
Table 5.9 Byetta Sales Forecast, 2010-2016
Table 5.10 Byetta Sales Forecast, 2017-2025
Table 6.1 SWOT Analysis for World Diabetes Market: Strengths & Weaknesses, 2010-2025
Table 6.2 SWOT Analysis for World Diabetes Market: Opportunities & Threats, 2010-2025
Table 6.3 Recent FDA Guidance on the Cardiovascular Risk of Diabetes Drugs
Table 7.1 Leading Diabetes Drugs: Country Markets, 2009
Table 7.2 Leading Anti-Diabetic Drugs: Country Market Sales Forecasts, 2010-2016
Table 7.3 Leading Anti-Diabetic Drugs: Country Market Sales Forecasts, 2017-2025
Table 8.1 Key Drugs in the Human Insulins and Analogues R&D Pipeline, 2009
Table 8.2 Key Drugs in the Glitazone Anti-Diabetics R&D Pipeline, 2009
Table 8.3 Key Drugs in the DPP-IV Inhibitor Anti-Diabetics R&D Pipeline, 2009
Table 8.4 Key Drugs in the Sulphonylurea and Biguanide Anti-Diabetics R&D Pipeline, 2009
Table 8.5 Key Drugs in the Alpha-Glucosidase Inhibitor Anti-Diabetics R&D Pipeline, 2009
Table 8.6 Key Drugs in the Miscellaneous Class R&D Pipeline, 2009
List of Figures
Figure 2.1 Rise in Diabetes Cases (in Millions), by WHO Region, 2000 & 2030
Figure 2.2 Secondary (Non-Medical) Costs of Diabetes in the US, 2007
Figure 2.3 Secondary Costs of Diabetes in Africa, 2007
Figure 3.1 Diabetes Pharmaceutical Therapeutic Category Market Shares, 2009
Figure 3.2 World Diabetes Pharmaceutical Market Sales Forecasts, 2010-2016
Figure 3.3 World Diabetes Pharmaceutical Market Sales Forecasts, 2017-2025
Figure 3.4 Diabetes Pharmaceutical Therapeutic Category Market Shares, 2009
Figure 3.5 Diabetes Pharmaceutical Therapeutic Category Market Shares, 2015
Figure 3.6 Diabetes Pharmaceutical Therapeutic Category Market Shares, 2020
Figure 3.7 Diabetes Pharmaceutical Therapeutic Category Market Shares, 2025
Figure 3.8 Diabetes Pharmaceutical Therapeutic Category Sales Forecasts, 2010-2025
Figure 4.1 Lantus Sales Forecast, 2010-2025
Figure 4.2 Novorapid Sales Forecast, 2010-2025
Figure 4.3 Humalog Sales Forecast, 2010-2025
Figure 4.4 Novomix Sales Forecast, 2010-2025
Figure 4.5 Levemir Sales Forecast, 2010-2025
Figure 4.6 Actraphane HM Sales Forecast, 2010-2025
Figure 5.1 Actos HM Sales Forecast, 2010-2025
Figure 5.2 Avandia Sales Forecast, 2010-2025
Figure 5.3 Avandamet Sales Forecast, 2010-2025
Figure 5.4 Junuvia Sales Forecast, 2010-2025
Figure 5.5 Byetta Sales Forecast, 2010-2025
Figure 6.1 Global Population Aged Over 65 Years, 2010-2025
Figure 6.2 Population Aged 65 Years or Over in Major Anti-Diabetic Pharmaceutical Country Markets, 2009 and 2025
Figure 6.3 Prevalence of Diabetes Worldwide in Major Anti-Diabetic Pharmaceutical Country Markets, 2000 and 2030
Figure 6.4 Global Prevalence of Diabetes and Diabetic Retinopathy, 2007 and 2030
Figure 7.1 Leading Anti-Diabetic Drugs: Country Market Shares, 2009
Figure 7.2 Leading Anti-Diabetic Drugs: Country Market Shares, 2015
Figure 7.3 Leading Anti-Diabetic Drugs: Country Market Shares, 2020
Figure 7.4 Leading Anti-Diabetic Drugs: Country Market Shares, 2025
Figure 7.5 US and Japanese Anti-Diabetic Drugs: Market Sales Forecasts, 2010-2025
Figure 7.6 European, Chinese, Indian and Brazilian Anti-Diabetic Drugs: Market Sales Forecasts, 2010-2025