Non-Insulin Therapies for Diabetes: GLP-1 Agonists, DPP4 Inhibitors and SGLT2 Inhibitors, 2016 - 2026

  • ID: 3814650
  • Report
  • Region: Global
  • 359 Pages
  • Roots Analysis
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Non-Insulin Therapies Are First Line Therapies Designed Especially for Patients Suffering From Type II Diabetes

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The “Non-Insulin Therapies for Diabetes: GLP-1 Agonists, DPP4 Inhibitors and SGLT2 Inhibitors, 2016-2026” report provides a comprehensive analysis of the current market landscape of these therapies and an informed opinion on how the market is likely to evolve over the next decade. The anti-diabetic drugs market broadly comprises of insulin and non-insulin therapies.

Non-insulin therapies are further classified under various categories based on their respective mechanisms of action. Of the different types of non-insulin therapies, GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors have been the most popular in the last few years. As mentioned earlier, these therapeutic classes have captured the attention of a number of pharmaceutical companies and drug developers worldwide.

Several companies, including pharmaceutical giants, mid-sized players and start-ups, have come up with innovative technologies and novel formulations of these drug classes. Such advances have generated and sustained significant momentum in this segment of the industry.

Specifically, GLP-1 agonists, which have been researched for several years, have a rich pipeline of clinical and preclinical molecules. DPP4 inhibitors currently have a relatively larger market share; however, they are now giving way to other relatively newer and emerging classes such as SGLT2 inhibitors.

During the course of our study, we identified over 80 molecules belonging to these three drugs classes. More than 70% of the candidates are currently under clinical / preclinical development; the efforts are actively being led by several companies. Focused primarily on these three classes of drugs, this report features:

- An overview of the market landscape highlighting important details on each molecule such as key players, current phase of product development, route of administration and dosage regime.
- Detailed profiles of drugs that have been recently approved / marketed or are in the late stages of development.
- A list of key opinion leaders (KOLs) who were involved in the discovery and development of GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors.
- An analysis of recently published clinical trial data depicting the prevalent trends and technical developments that have taken place in the industry.
- A discussion on the potential side effects and warnings issued by regulatory authorities suggesting areas of improvement / guidance for future drug development.
- A list of upcoming non-insulin novel therapies that are currently in early stages of development and likely to become a part of the anti-diabetic drugs market in the near future.

The report also provides an estimate of the likely future size of the non-insulin therapies for diabetes. Our forecast model was built based on an understanding of the existing market trends and likely future opportunities for GLP-1 agonists, DPP4 inhibitors, SGLT2 inhibitors and other non-insulin anti-diabetic drug classes. We have provided informed estimates of the expected future sales of marketed and late stage product candidates under each category, highlighting their share in the overall market over the next ten years.

The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzedfrom publicly available data. Unless otherwise specified, all financial figures are presented in USD.

Chapter Outlines

Chapter 2 is an executive summary of the insights captured in our research. The summary offers a high level view on the likely evolution of GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors during the coming decade.

Chapter 3 provides a general introduction to diabetes and discusses associated symptoms, available diagnostic methods and tests, and other complications associated with the condition. It also includes a detailed classification of the various therapeutic interventions available for the treatment of diabetes. These include both insulin based and non-insulin therapies. The chapter also provides brief descriptions of their respective mechanisms of action.

Chapter 4 provides a comprehensive overview of the market landscape of GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors. It includes information on over 100 different molecules that fall under these classes of drugs. Some of these are already approved and are available in different regions across the globe. The rest are currently in various stages of preclinical / clinical development. The chapter presents analysis of the molecules based on their current phase of development, the various routes of administration being considered for their systemic delivery, dosage frequency, type of molecule and key players involved in developing these molecules.

Chapter 5 contains detailed profiles of recently approved and late stage GLP-1 agonists. Each profile covers information on several aspects of these drugs such as their history of development, clinical trial results, dosage form and regime, recent sales of the product (for marketed drugs), the current status of development, and the collaborations and partnerships that have been inked related to that particular drug / drug candidate.

Chapter 6 contains detailed profiles of recently approved and late stage DPP4 inhibitors. Each profile covers information on several aspects of these drugs such as their history of development, clinical trial results, dosage form and regime, recent sales of the product (for marketed drugs), the current status of development, and the collaborations and partnerships that have been inked related to that particular drug / drug candidate.

Chapter 7 contains detailed profiles of recently approved and late stage SGLT2 inhibitors. Each profile covers information on several aspects of these drugs such as their history of development, clinical trial results, dosage form and regime, recent sales of the product (for marketed drugs), the current status of development, and the collaborations and partnerships that have been inked related to that particular drug / drug candidate.

Chapter 8 focusses on the various side effects reported by patients treated using these drugs. It includes detailed discussions on the potential complications that may arise upon using these drugs, and the warnings issued by the FDA and other regulatory bodies regarding the associated risks. In addition, the chapter lists the various GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors that have been terminated during development due to various reasons.

Chapter 9 provides a brief introduction to other novel interventions that are currently being investigated as potential treatment options for diabetes. The chapter also includes an analysis of these novel therapeutic options based on the type of molecule being investigated and phase of development.

Chapter 10 provides a detailed analysis on the likely future size of the non-insulin therapies market over the next decade. It presents comprehensive forecast scenarios for each individual drug class mentioned in the report, namely GLP-1 agonists, DPP4 inhibitors, SGLT2 inhibitors and other non-insulin anti-diabetic drugs.

Chapter 11 presents an analysis of the Key Opinion Leaders (KOLs) in this domain. It contains schematic representations of world maps highlighting the geographical locations of these eminent scientists / researchers. The chapter presents a detailed 2X2 analysis to assess the relative experience of certain KOLs based on the number of clinical studies they participated in and the highest phase of development they investigated.

Chapter 12 provides a detailed analysis of recently published clinical data on GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors. It identifies various aspects of the ongoing research and presents analysis highlighting the active drugs, study focus areas and clinical endpoints (safety / efficacy / tolerability / pharmacodynamics / pharmacokinetics) across the published data.

Chapter 13 is a collection of interview transcripts of the discussions we held with key stakeholders in the industry.

Chapter 14 summarizes the entire report. The chapter presents a list of key takeaways and offers our independent opinion on the current market scenario and evolutionary trends that are likely to determine the future of this segment of the industry.

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures in the report.

Chapter 16 is an appendix,which contains the list of companies and organizations that have been mentioned in the report.

Research Methodology

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market may evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:

- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Industry analysts’ views

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
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1. Preface
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. Executive Summary

3. Introduction
3.1. Chapter Overview
3.2. Diabetes: Introduction
3.2.1. Diabetes: Classification
3.2.2. Diabetes: Symptoms
3.2.3. Diabetes: Diagnosis
3.2.4. Diabetes: Associated Health Risks / Complications
3.2.5. Diabetes: Therapies
3.2.5.1. Insulin Therapies
3.2.5.2. Non-Insulin Therapies
3.2.5.2.1. Alpha-glucosidase Inhibitors
3.2.5.2.2. Amylin Agonists
3.2.5.2.3. Biguanides
3.2.5.2.4. Dipeptidyl peptidase-4 (DPP4) inhibitors
3.2.5.2.5. Glinides / Meglitinides
3.2.5.2.6. GLP-1 Analogs / GLP-1 Agonists
3.2.5.2.7. Sodium-glucose cotransporter 2 (SGLT2) Inhibitors
3.2.5.2.8. Sulfonylureas
3.2.5.2.9. Thiazolidinediones (or ‘glitazones’or TZDs)

4. Market Overview
4.1. Chapter Overview
4.2. Non-Insulin Anti-Diabetic Therapies: History of Development / Evolution Timeline
4.3. GLP-1 Agonists, DPP4 Inhibitors and SGLT2 Inhibitors: Overall Market Overview
4.4. GLP-1 Agonists: Current Market Landscape
4.4.1. GLP-1 Agonists: Approved Drugs
4.4.2. GLP-1 Agonists: Pipeline Drugs
4.4.3. GLP-1 Agonists: Key Players
4.4.4. GLP-1 Agonists: Distribution by Route of Administration
4.4.5. GLP-1 Agonists: Distribution by Dosage Frequency
4.4.6. GLP-1 Agonists: Distribution by Type of Molecule

4.5. DPP4 Inhibitors: Current Market Landscape
4.5.1. DPP4 Inhibitors: Approved Drugs
4.5.2. DPP4 Inhibitors: Pipeline Drugs
4.5.3. DPP4 Inhibitors: Key Players
4.5.4. DPP4 Inhibitors: Distribution by Type of Therapy
4.5.5. DPP4 Inhibitors: Distribution by Dosage Frequency

4.6. SGLT2 Inhibitors: Current Market Landscape
4.6.1. SGLT2 Inhibitors: Approved Drugs
4.6.2. SGLT2 Inhibitors: Pipeline Drugs
4.6.3. SGLT2 Inhibitors: Key Players
4.6.4. SGLT2 Inhibitors: Distribution by Type of Therapy
4.6.5. SGLT2 Inhibitors: Distribution by Dosage Frequency
4.7. GLP-1 Agonists, DPP4 Inhibitors and SGLT2 Inhibitors: Key Players

5. GLP-1 Agonists
5.1. Chapter Overview
5.2. Albiglutide (GSK)
5.2.1. Product Overview
5.2.2. History of Development
5.2.3. Dosage Form, Regimen and Price
5.2.4. Historical Sales
5.2.5. Current Status of Development
5.2.6. Key Clinical Trial Results
5.2.6.1. Harmony 1 Study (Abstract Number: 2013-LB-5644)
5.2.6.2. Harmony 2 Study (Abstract Number: 2013-LB-5749)
5.2.6.3. Harmony 3 Study (Abstract Number: 2013-LB-5750)
5.2.6.4. Harmony 4 Study (Abstract number: 2013-LB-5751)
5.2.6.5. Harmony 5 Study (Abstract Number: 2013-LB-5752)
5.2.6.6. Harmony 6 Study
5.2.6.7. Harmony 7 Study
5.2.6.8. Harmony 8 Study
5.2.7. Recent Collaborations

5.3. Dulaglutide (Eli Lilly / Sumitomo Dainippon Pharma)
5.3.1. Product Overview
5.3.2. History of Development
5.3.3. Dosage Form, Regimen and Price
5.3.4. Historical Sales
5.3.5. Current Status of Development
5.3.6. Key Clinical Trial Results
5.3.6.1. AWARD-1
5.3.6.2. AWARD-2
5.3.6.3. AWARD-3
5.3.6.4. AWARD-4
5.3.6.5. AWARD-5
5.3.6.6. AWARD-6
5.3.6.7. AWARD-8
5.3.6.8. AWARD-9
5.3.6.9. Trulicity® versus Lantus®
5.3.6.10. Trulicity® versus Victoza®
5.3.7. Recent Collaborations

5.4. ITCA 650 (Intarcia Therapeutics / Servier)
5.4.1. Product Overview
5.4.2. History of Development
5.4.3. Intarcia’s Technology Platform
5.4.4. Current Status of Development
5.4.5. Key Clinical Trial Results
5.4.5.1. FREEDOM 1 HBL: Interim Results
5.4.5.2. FREEDOM-1 and FREEDOM-1 HBL: Top-Line Results
5.4.5.3. FREEDOM-2 Comparative Trial: Top-Line Results
5.4.5.4. FREEDOM-CVO: Top-Line Results
5.4.6. Funding
5.4.7. Recent Collaborations

5.5. Polyethylene Glycol Loxenatide / PEX 168 (Jiangsu Hansoh Pharmaceutical)
5.5.1. Product Overview
5.5.2. Current Status of Development
5.5.3. Key Clinical Trial Results

5.6. Semaglutide / NN9535 / NN9924 / OG217SC (Novo Nordisk/Emisphere)
5.6.1. Product Overview
5.6.2. History of Development
5.6.3. NN9924 and the Eligen® Technology
5.6.4. Manufacturing
5.6.5. Dosage Form and Regimen
5.6.6. Current Status of Development
5.6.6.1. PIONEER Clinical Program
5.6.6.2. SUSTAIN Clinical Program
5.6.7. Key Clinical Trial Results
5.6.7.1. NN9535: Phase III Results
5.6.7.2. NN9924/OG217SC: Phase II Results
5.6.8. Recent Collaborations

5.7. Uni-E4 (Uni-Bio Science Group)
5.7.1. Product Overview
5.7.2. Key Clinical Trial Results

6. DPP4 Inhibitors / CD26 Antigen Antagonists
6.1. Chapter Overview
6.2. Alogliptin (Takeda / Furiex Pharmaceuticals (Acquired by Forest Laboratories))
6.2.1. Product Overview
6.2.2. History of Development
6.2.3. Dosage Form, Regimen and Price
6.2.4. Historical Sales
6.2.5. Current Status of Development
6.2.6. Key Clinical Trial Results
6.2.6.1. EXAMINE Program
6.2.6.2. ENDURE Trial
6.2.7. Recent Collaborations

6.3. Trelagliptin (Takeda / 3SBio)
6.3.1. Product Overview
6.3.2. History of Development
6.3.3. Dosage Form, Regimen and Price
6.3.4. Current Status of Development
6.3.5. Key Clinical Trial Results
6.3.6. Recent Collaborations

6.4. Omarigliptin (Merck)
6.4.1. Product Overview
6.4.2. History of Development
6.4.3. Current Status of Development
6.4.4. Key Clinical Trial Results

6.5. Evogliptin (Dong-A Pharmaceutical / Luye Pharma Group / Eurofarma / Geropharm / Alkem Labs)
6.5.1. Product Overview
6.5.2. Dosage Forms, Regimen and Price
6.5.3. Current Status of Development
6.5.4. Key Clinical Trial Results
6.5.5. Recent Collaborations

6.6. Gosogliptin (SatRx / Pfizer)
6.6.1. Product Overview
6.6.2. Current Status of Development
6.6.3. Recent Collaborations

6.7. Retagliptin (Jiangsu Hengrui Medicine)
6.7.1. Product Overview
6.7.2. Current Status of Development

7. SGLT2 Inhibitors
7.1. Chapter Overview
7.2. Canagliflozin (Mitsubishi Tanabe Pharma / Janssen / Daiichi Sankyo)
7.2.1. Product Overview
7.2.2. History of Development
7.2.3. Dosage Form, Regimen and Price
7.2.4. Historical Sales
7.2.5. Current Status of Development
7.2.6. Key Clinical Trial Results
7.2.6.1. Long Term Effects in Older Type II Diabetic Patients
7.2.6.2. Real-World Analysis
7.2.6.3. Comparison between INVOKANA® and Other DPP4 Inhibitors
7.2.7. Recent Collaborations

7.3. Luseogliflozin (Taisho Pharmaceutical / Taisho Toyama Pharmaceutical / Novartis)
7.3.1. Product Overview
7.3.2. History of Development
7.3.3. Dosage Form, Regimen and Price
7.3.4. Current Status of Development
7.3.5. Key Clinical Trial Results
7.3.5.1. As a Monotherapy
7.3.5.1.1. Study 1: Placebo Controlled (24 weeks)
7.3.5.1.2. Study 2: Long-Term Treatment (52 weeks)
7.3.5.2. As Combination Therapy
7.3.5.2.1. Study 1: Combination with Glimepiride
7.3.5.2.2. Study 2: Combination with Metformin, DPP4 inhibitor, Pioglitazone, Glinides or alpha-glucosidase inhibitor
7.3.6. Historical Sales
7.3.7. Recent Collaborations

7.4. Tofogliflozin (Chugai Pharmaceutical / Sanofi / Kowa)
7.4.1. Product Overview
7.4.2. History of Development
7.4.3. Current Status of Development
7.4.4. Key Clinical Trial Results
7.4.4.1. As a Monotherapy
7.4.5. Recent Collaborations

7.5. Empagliflozin (Boehringer Ingelheim / Eli Lilly)
7.5.1. Product Overview
7.5.2. History of Development
7.5.3. Dosage Form, Regimen and Price
7.5.4. Manufacturing
7.5.5. Current Status of Development
7.5.6. Key Clinical Trial Results
7.5.6.1. As a Monotherapy: Retrospective Data
7.5.6.2. As a Fixed-Dose Combination Therapy
7.5.6.2.1. Combination with Metformin
7.5.6.2.2. Combination with Linagliptin
7.5.6.3. CV Outcome Results (EMPA-REG OUTCOME®)
7.5.7. Recent Collaborations

7.6. Ipragliflozin (Astellas Pharma / Kotobuki Pharmaceutical / MSD K.K.)
7.6.1. Product Overview
7.6.2. History of Development
7.6.3. Dosage Form, Regimen and Price
7.6.4. Current Status of Development
7.6.5. Key Clinical Trial Results
7.6.5.1. As a Monotherapy
7.6.5.2. As a Combination Therapy
7.6.6. Recent Collaborations

7.7. Bexagliflozin (Theracos)
7.7.1. Product Overview
7.7.2. Current Status of Development
7.7.3. Key Clinical Trial Results

7.8. Ertugliflozin (PF-04971729, MK-8835) (Pfizer /Merck)
7.8.1. Product Overview
7.8.2. Current Status of Development
7.8.3. Key Clinical Trial Results
7.8.3.1. As a Monotherapy: VERTIS Mono
7.8.3.2. As a Combination Therapy with JANUVIA®: VERTIS Factorial
7.8.4. Recent Collaborations

7.9. Sotagliflozin (Lexicon/Sanofi)
7.9.1. Product Overview
7.9.2. History of Development
7.9.3. Current Status of Development
7.9.4. Key Clinical Trial Results
7.9.4.1. Type I Diabetes: Phase II Results
7.9.4.2. Type II Diabetes: Phase IIb Results
7.9.4.3. Type II Diabetes: Phase IIa Results
7.9.4.4. Type I Diabetes / Type II Diabetes with Renal Impairment
7.9.4.5. As a Combination Therapy
7.9.5. Recent Collaborations

8. Discontinued Molecules and Common Side Effects
8.1. Chapter Overview
8.2. DPP4 Inhibitors
8.2.1. Common Side Effects
8.2.2. Warnings Issued by Regulatory Agencies
8.3. SGLT2 Inhibitors
8.3.1. Common Side Effects
8.3.2. Warnings issued by Regulatory Agencies
8.4. GLP-1 Agonists
8.4.1. Common Side Effects
8.4.2. Warnings Issued by Regulatory Agencies
8.5. DPP4 Inhibitors, GLP-1 Agonists, SGLT2 Inhibitors: Terminated Molecules
8.5.1. Distribution by Type of Drug Class and Phase of Development
8.5.2. Distribution by Year of Termination

9. Novel Non-Insulin Therapies for Diabetes
9.1. Chapter Overview
9.2. Novel Non-Insulin Therapies for Diabetes
9.2.1. Novel Non-Insulin Therapies for Diabetes: Distribution by Type of Drug Class
9.2.2. Novel Non-Insulin Therapies for Diabetes: Distribution by Phase of Development
9.2.3. Novel Non-Insulin Therapies for Diabetes: Distribution by Type of Molecule

10. Market Forecast
10.1. Chapter Overview
10.2. Forecast Methodology
10.3. Overall Non-Insulin Therapies for Diabetes Market

10.4. Overall GLP-1 Agonists Market
10.4.1. Liraglutide (1.2mg and 1.8mg)
10.4.2. Exendin-4 / ITCA 650
10.4.3. Exenatide Extended Release
10.4.4. Dulaglutide
10.4.5. Albiglutide
10.4.6. Lixisenatide
10.4.7. Semaglutide Subcutaneous
10.4.8. Liraglutide / Insulin Degludec
10.4.9. Semaglutide Oral / OG217SC / NN9924
10.4.10. Exenatide
10.4.11. Other GLP-1 Agonists

10.5. Overall DPP4 Inhibitors Market
10.5.1. Sitagliptin
10.5.2. Vildagliptin
10.5.3. Saxagliptin
10.5.4. Linagliptin
10.5.5. Alogliptin
10.5.6. Gosogliptin
10.5.7. Other DPP4 Inhibitors
10.6. Overall SGLT2 Inhibitors Market
10.6.1. Sotagliflozin
10.6.2. Empagliflozin
10.6.3. Canagliflozin
10.6.4. Dapagliflozin
10.6.5. Tofogliflozin
10.6.6. Ertugliflozin
10.6.7. Bexagliflozin
10.6.8. Other SGLT2 Inhibitors

11. Publication Analysis
11.1. Chapter Overview
11.2. Scope and Methodology
11.3. GLP-1 Agonists: List of Publications
11.3.1. Publications on GLP-1 Agonists: Distribution by Focus Drug
11.3.2. Publications on GLP-1 Agonists: Distribution by Key Parameters

11.4. DPP4 Inhibitors: List of Publications
11.4.1. Publications on DPP4 Inhibitors: Distribution by Focus Drug
11.4.2. Publications on DPP4 Inhibitors: Distribution by Key Parameters

11.5. SGLT2 Inhibitors: List of Publications
11.5.1. Publications on SGLT2 Inhibitors: Distribution by Focus Drug
11.5.2. Publications on SGLT2 Inhibitors: Distribution by Key Parameters

12. KOL Analysis
12.1. Chapter Overview
12.2. Scope and Methodology
12.3. GLP-1 Agonists: Key Opinion Leaders
12.3.1. GLP-1 Agonists: Prominent Researchers
12.3.2. GLP-1 Agonists: Leading Key Opinion Leaders
12.4. DPP4 Inhibitors: Key Opinion Leaders
12.4.1. DPP4 Inhibitors: Prominent Researchers
12.4.2. DPP4 Inhibitors: Leading Key Opinion Leaders
12.5. SGLT2 Inhibitors: Key Opinion Leaders
12.5.1. SGLT2 Inhibitors: Prominent Researchers
12.5.2. SGLT2 Inhibitors: Leading Key Opinion Leaders

13. Interview Transcripts

14. Conclusion
14.1. The Lucrative Anti-Diabetic Drugs Market Presents Immense Opportunity to Novel Non-Insulin Therapies
14.2. GLP-1 Inhibitors and DPP4 Inhibitors Currently Dominate; SGLT2 Inhibitors Have Shown Significant Promise
14.3. Companies Targeting Certain Regional Markets are Amongst the Primary Drivers
14.4. Technological Advances and Innovative Drug Development Approaches are Key to Future Success
14.5. Development of Combination Therapies and Several Novel Drug Classes Are Expected to Promote Future Growth
14.6. Multiple Side Effects Associated with the Use of Certain Drug Classes Remain a Concern
14.7. While the Respective Shares of GLP-1 Agonists and SGLT2 Inhibitors are Projected to Increase, Sales of DPP4 Inhibitors Are Likely to Dip

15. Appendix 1: Tabulated Data

16. Appendix 2: List of Companies and Organizations

List of Figures

Figure 3.1 Diabetes: Diagnostic Limits

Figure 3.2 Non-Insulin Therapies for Diabetes

Figure 4.1 Non-Insulin Therapies: Distribution by Drug Class

Figure 4.2 GLP-1 Agonists: Distribution by Phase of Development

Figure 4.3 GLP-1 Agonists: Key Players

Figure 4.4 GLP-1 Agonists: Distribution by Route of Administration

Figure 4.5 GLP-1 Agonists: Distribution by Dosage Frequency

Figure 4.6 GLP-1 Agonists: Distribution by Type of Molecule

Figure 4.7 DPP4 Inhibitors: Distribution by Phase of Development

Figure 4.8 DPP4 Inhibitors: Key Players

Figure 4.9 DPP4 Inhibitors: Distribution by Type of Therapy

Figure 4.10 DPP4 Inhibitors: Distribution by Dosage Frequency

Figure 4.11 SGLT2 Inhibitors: Distribution by Phase of Development

Figure 4.12 SGLT2 Inhibitors: Key Players

Figure 4.13 SGLT2 Inhibitors: Distribution by Type of Therapy

Figure 4.14 SGLT2 Inhibitors: Distribution by Dosage Frequency

Figure 4.15 GLP-1 Agonists, DPP4 Inhibitors and SGLT2 Inhibitors: Key Players

Figure 5.1 Tanzeum® / Eperzan®: Historical Sales, 2014-Q12016 (GBP Million)

Figure 5.2 Trulicity®: Historical Sales, 2014-2015 (USD Million)

Figure 5.3 Trulicity® Historical Sales: Distribution by Region, 2015 (USD Million)

Figure 5.4 ITCA 650: FREEDOM-1 and FREDDOM-1 HBL Clinical Trials

Figure 6.1 Alogliptin: History of Development

Figure 6.2 Alogliptin: Historical Sales, FY2011-Q1 FY2016 (JPY Billion)

Figure 6.3 Alogliptin Historical Sales: Distribution by Region, FY2015 (JPY Billion)

Figure 7.1 Canagliflozin: History of Development

Figure 7.2 INVOKANA® / INVOKAMET®: Historical Sales, 2013-Q1 2016 (USD Million)

Figure 7.3 INVOKANA® / INVOKAMET® Historical Sales: Distribution by Region, 2015-Q1 2016 (USD Million)

Figure 7.4 Empagliflozin: History of Development

Figure 7.5 Ipragliflozin: History of Development

Figure 8.1 Terminated Molecules: Distribution by Type of Drug Class

Figure 8.2 Terminated Molecules: Distribution by Type of Drug Class and Phase of Development

Figure 8.3 Terminated Molecules: Distribution by Type of Drug Class and Year of Termination

Figure 9.1 Novel Non-Insulin Therapies for Diabetes: Distribution by Type of Drug Class

Figure 9.2 Novel Non-Insulin Therapies for Diabetes: Distribution by Phase of Development

Figure 9.3 Novel Non-Insulin Therapies for Diabetes: Distribution by Type of Molecule

Figure 10.1 Non-Insulin Therapies for Diabetes Market, 2016-2026 (USD Billion)

Figure 10.2 Non-Insulin Therapies for Diabetes Market, 2016-2026: Future Trends and Details

Figure 10.3 Non-Insulin Therapies for Diabetes Market, 2016, 2021 and 2026: Distribution by Type of Drug Class

Figure 10.4 GLP-1 Agonists Market, 2016-2026 (USD Billion)

Figure 10.5 Liraglutide (1.2mg and 1.8mg) Sales Forecast, 2016-2026 (USD Million)

Figure 10.6 Exendin-4 / ITCA 650 Sales Forecast, 2017-2026 (USD Million)

Figure 10.7 Exenatide Extended Release Sales Forecast, 2016-2026 (USD Million)

Figure 10.8 Dulaglutide Sales Forecast, 2016-2026 (USD Million)

Figure 10.9 Albiglutide Sales Forecast, 2016-2026 (USD Million)

Figure 10.10 Lixisenatide Sales Forecast, 2016-2026 (USD Million)

Figure 10.11 Semaglutide/NN9535 Sales Forecast, 2018-2026 (USD Million)

Figure 10.12 Liraglutide / Insulin Degludec Sales Forecast, 2016-2026 (USD Million)

Figure 10.13 Semaglutide Oral / OGC217SC / NN9924 Sales Forecast, 2020-2026 (USD Million)

Figure 10.14 Exenatide Sales Forecast, 2016-2026 (USD Million)

Figure 10.15 DPP4 Inhibitors Market, 2016-2026 (USD Billion)

Figure 10.16 Sitagliptin Sales Forecast, 2016-2026 (USD Million)

Figure 10.17 Vildagliptin Sales Forecast, 2016-2026 (USD Million)

Figure 10.18 Saxagliptin Sales Forecast, 2016-2026 (USD Million)

Figure 10.19 Linagliptin Sales Forecast, 2016-2026 (USD Million)

Figure 10.20 Alogliptin Sales Forecast, 2016-2026 (USD Million)

Figure 10.21 Gosogliptin Sales Forecast, 2017-2026 (USD Million)

Figure 10.22 SGLT2 Inhibitors Market, 2016-2026 (USD Billion)

Figure 10.23 Sotagliflozin Sales Forecast, 2018-2026 (USD Million)

Figure 10.24 Empagliflozin Sales Forecast, 2016-2026 (USD Million)

Figure 10.25 Canagliflozin Sales Forecast, 2016-2026 (USD Million)

Figure 10.26 Dapagliflozin Sales Forecast, 2016-2026 (USD Million)

Figure 10.27 Tofogliflozin Sales Forecast, 2016-2026 (USD Million)

Figure 10.28 Ertugliflozin Sales Forecast, 2018-2026 (USD Million)

Figure 10.29 Bexagliflozin Sales Forecast, 2018-2026 (USD Million)

Figure 11.1 Publications on GLP-1 Agonists: Distribution by Focus Drug

Figure 11.2 Publications on GLP-1 Agonists: Distribution by Study Focus, Publication Month and other Parameters

Figure 11.3 Publications on DPP4 Inhibitors: Distribution by Focus Drug

Figure 11.4 Publications on DPP4 Inhibitors: Distribution by Study Focus, Publication Month and other Parameters

Figure 11.5 Publications on SGLT2 Inhibitors: Distribution by Focus Drug

Figure 11.6 Publications on SGLT2 Inhibitors: Distribution by Study Focus, Publication Month and other Parameters

Figure 12.1 GLP-1 Agonists: Mapping Prominent Researchers

Figure 12.2 GLP-1 Agonists: Leading Key Opinion Leaders

Figure 12.3 DPP4 Inhibitors: Mapping Prominent Researchers

Figure 12.4 DPP4 inhibitors: Leading Key Opinion Leaders

Figure 12.5 SGLT2 Inhibitors: Mapping Prominent Researchers

Figure 12.6 SGLT2 Inhibitors: Leading Key Opinion Leaders

Figure 14.1 Overall Non-Insulin Therapies Market Forecast: Distribution by Drug Class, 2016-2026 (USD Billion)

List of Tables

Table 4.1 Anti-Diabetic Drug Classes: History of Development

Table 4.2 GLP-1 Agonists: Approved Drugs

Table 4.3 GLP-1 Agonists: Pipeline Drugs

Table 4.4 DPP4 Inhibitors: Approved Drugs

Table 4.5 DPP4 Inhibitors: Pipeline Drugs

Table 4.6 SGLT2 Inhibitors: Approved Drugs

Table 4.7 SGLT2 Inhibitors: Pipeline Drugs

Table 5.1 Albiglutide: Product Overview

Table 5.2 Albiglutide: Active / Planned Clinical Trials

Table 5.3 Albiglutide Harmony 2 Clinical Trial: Adverse Events

Table 5.4 Albiglutide Harmony 3 Clinical Trial: Adverse Events

Table 5.5 Albiglutide Harmony 4 Clinical Trial: Adverse Events

Table 5.6 Albiglutide Harmony 5 Clinical Trial: Adverse Events

Table 5.7 Albiglutide Harmony 6 Clinical Trial: Results

Table 5.8 Albiglutide Harmony 6 Clinical Trial: Adverse Events

Table 5.9 Albiglutide Harmony 7 Clinical Trial: Results

Table 5.10 Albiglutide Harmony 7 Clinical Trial: Adverse Events

Table 5.11 Dulaglutide: Product Overview

Table 5.12 Trulicity®: Active / Planned Clinical Trials

Table 5.13 Trulicity®: AWARD Clinical Program Results

Table 5.14 Trulicity®: AWARD-1 Clinical Trial Results

Table 5.15 Trulicity®: AWARD-2 Clinical Trial Results

Table 5.16 Trulicity®: AWARD-3 Clinical Trial Results

Table 5.17 Trulicity®: AWARD-4 Clinical Trial Results

Table 5.18 Trulicity®: AWARD-5 Clinical Trial Results

Table 5.19 Trulicity®: AWARD-6 Clinical Trial Results

Table 5.20 Trulicity®: AWARD-9 Clinical Trial Results

Table 5.21 Trulicity® versus Lantus®: Phase III Clinical Trial Results

Table 5.22 Trulicity® versus Lantus®: Phase III Clinical Trial Adverse Events

Table 5.23 Trulicity® versus Victoza®: Phase III Clinical Trial Results

Table 5.24 Trulicity® versus Victoza®: Phase III Clinical Trial Adverse Events

Table 5.25 ITCA 650: FREEDOM Clinical Trial Development Program

Table 5.26 ITCA 650: Active / Planned Clinical Trials

Table 5.27 ITCA 650: FREEDOM-2 Clinical Trial Results

Table 5.28 PEX 168: Active / Planned Clinical Trials

Table 5.29 PEX 168: Clinical Trial Results

Table 5.30 Semaglutide: Active / Planned Clinical Trials

Table 5.31 Semaglutide: SUSTAIN Clinical Program Key Characteristics

Table 5.32 Semaglutide: SUSTAIN 1 Clinical Trial Results

Table 5.33 Semaglutide: SUSTAIN 1 Clinical Trial Adverse Events

Table 5.34 Semaglutide: SUSTAIN 3 Clinical Trial Results

Table 5.35 Semaglutide: SUSTAIN 2 Clinical Trial Results

Table 5.36 Semaglutide: SUSTAIN 5 Clinical Trial Results

Table 5.37 Semaglutide: SUSTAIN 4 Clinical Trial Results

Table 5.38 Semaglutide: SUSTAIN 4 Clinical Trial Adverse Events

Table 5.39 Uni-E4: Phase III Clinical Trial Results

Table 6.1 Alogliptin: Product Overview

Table 6.2 Alogliptin: Dosage Form, Regimen and Price

Table 6.3 Alogliptin: Active / Planned Clinical Trials

Table 6.4 Alogliptin EXAMINE Program: Dose and % Recipient Population

Table 6.5 Alogliptin ENDURE Trial: Drug and Dosage Combinations

Table 6.6 Trelagliptin: Active / Planned Clinical Trials

Table 6.7 Omarigliptin: Phase III Clinical Trial Adverse Events

Table 6.8 Evogliptin: Active / Planned Clinical Trials

Table 6.9 Evogliptin: Phase II Clinical Trial Results

Table 6.10 Retagliptin: Active / Planned Clinical Trials

Table 7.1 Canagliflozin: Product Overview

Table 7.2 Canagliflozin: Dosage Form, Regimen and Price

Table 7.3 Canagliflozin: Active / Planned Clinical Trials

Table 7.4 Canagliflozin as Monotherapy in Older Type II Diabetic Patients: Phase III Clinical Trial Results

Table 7.5 INVOKANA®: First Real-World Analysis

Table 7.6 INVOKANA®: Second Real-World Analysis

Table 7.7 INVOKANA®: Third Real-World Analysis

Table 7.8 Luseogliflozin: Active / Planned Trials

Table 7.9 Tofogliflozin: Active / Planned Clinical Trials

Table 7.10 Empagliflozin: Product Overview

Table 7.11 Empagliflozin: Dosage Form, Regime and Price

Table 7.12 Empagliflozin: Active / Planned Clinical Trials

Table 7.13 Empagliflozin: Retrospective Data (After 12 weeks)

Table 7.14 Empagliflozin: Retrospective Data (After 24 weeks)

Table 7.15 Glyxambi®: Phase III Clinical Trial Results

Table 7.16 Glyxambi®: Phase III Clinical Trial Adverse Events

Table 7.17 Ipragliflozin: Active / Planned Clinical Trials

Table 7.18 Ipragliflozin as Combination Therapy: Phase III Clinical Trial Results

Table 7.19 Bexagliflozin: Phase II Clinical Trial Results

Table 7.20 Ertugliflozin: Active/Planned Clinical Trials

Table 7.21 Ertugliflozin: Phase III Clinical Trial Results (VERTIS Mono)

Table 7.22 Ertugliflozin: Phase III Clinical Trial Adverse Events (VERTIS Mono)

Table 7.23 Ertugliflozin: Phase III Clinical Trial Results (VERTIS Factorial)

Table 7.24 Ertugliflozin: Phase III Clinical Trial Adverse Events (VERTIS Factorial)

Table 7.25 Sotagliflozin: Active/Planned Clinical Trials

Table 7.26 Sotagliflozin: Phase IIb Study Results, Reduction in HbA1c levels

Table 7.27 Sotagliflozin: Phase IIb Study Results, Reduction in Blood Pressure

Table 7.28 Sotagliflozin: Phase IIa Study Results

Table 8.1 DPP4 Inhibitors: Regulatory Agencies Warnings

Table 8.2 SGLT2 Inhibitors: Regulatory Agencies Warnings

Table 8.3 DPP4 inhibitors/SGLT2 inhibitors/GLP-1 Agonists: Terminated Molecules

Table 9.1 List of Novel Non-Insulin Therapies for Diabetes

Table 11.1 GLP-1 Agonists: List of Publications

Table 11.2 DPP4 Inhibitors: List of Publications

Table 11.3 SGLT2 Inhibitors: List of Publications

Table 12.1 GLP-1 Agonists: List of Key Opinion Leaders

Table 12.2 DPP4 Inhibitors: List of Key Opinion Leaders

Table 12.3 SGLT2 inhibitors: List of Key Opinion Leaders

Table 15.1 Non-Insulin Therapies: Distribution by Drug Class

Table 15.2 GLP-1 Agonists: Distribution by Phase of Development

Table 15.3 GLP-1 Agonists: Key Players

Table 15.4 GLP-1 Agonists: Distribution by Route of Administration

Table 15.5 GLP-1 Agonists: Distribution by Dosage Frequency

Table 15.6 GLP-1 Agonists: Distribution by Type of Molecule

Table 15.7 DPP4 Inhibitors: Distribution by Phase of Development

Table 15.8 DPP4 Inhibitors: Key Players

Table 15.9 DPP4 Inhibitors: Distribution by Type of Therapy

Table 15.10 DPP4 Inhibitors: Distribution by Dosage Frequency

Table 15.11 SGLT2 Inhibitors: Distribution by Phase of Development

Table 15.12 SGLT2 Inhibitors: Key Players

Table 15.13 SGLT2 Inhibitors: Distribution by Type of Therapy

Table 15.14 SGLT2 Inhibitors: Distribution by Dosage Frequency

Table 15.15 GLP-1 Agonists, DPP4 Inhibitors and SGLT2 Inhibitors: Key Players

Table 15.16 Tanzeum® / Eperzan®: Historical Sales, 2014-Q12016 (GBP Million)

Table 15.17 Trulicity®: Historical Sales, 2014-2015 (USD Million)

Table 15.18 Trulicity® Historical Sales: Distribution by Region, 2015 (USD Million)

Table 15.19 Alogliptin: Historical Sales, FY2011-Q1 FY2016 (JPY Billion)

Table 15.20 Alogliptin Historical Sales: Distribution by Region, FY2015 (JPY Billion)

Table 15.21 INVOKANA® / INVOKAMET®: Historical Sales, 2013-Q1 2016 (USD Million)

Table 15.22 INVOKANA® / INVOKAMET® Historical Sales: Distribution by Region, 2015-Q1 2016 (USD Million)

Table 15.23 Terminated Molecules: Distribution by Type of Drug Class

Table 15.24 Terminated Molecules: Distribution by Type of Drug Class and Phase of Development

Table 15.25 Terminated Molecules: Distribution by Type of Drug Class and Year of Termination

Table 15.26 Novel Non-Insulin Therapies for Diabetes: Distribution by Type of Drug Class

Table 15.27 Novel Non-Insulin Therapies for Diabetes: Distribution by Phase of Development

Table 15.28 Novel Non-Insulin Therapies for Diabetes: Distribution by Type of Molecule

Table 15.29 Non-Insulin Therapies for Diabetes Market, 2016-2026 (USD Billion)

Table 15.30 Non-Insulin Therapies for Diabetes Market, 2016, 2021 and 2026: Distribution by Type of Drug Class

Table 15.31 GLP-1 Agonists Market, 2016-2026 (USD Billion)

Table 15.32 Liraglutide (1.2mg and 1.8mg) Sales Forecast, 2016-2026 (USD Million)

Table 15.33 Exendin-4 / ITCA 650 Sales Forecast, 2017-2026 (USD Million)

Table 15.34 Exenatide Extended Release Sales Forecast, 2016-2026 (USD Million)

Table 15.35 Dulaglutide Sales Forecast, 2016-2026 (USD Million)

Table 15.36 Albiglutide Sales Forecast, 2016-2026 (USD Million)

Table 15.37 Lixisenatide Sales Forecast, 2016-2026 (USD Million)

Table 15.38 Semaglutide/NN9535 Sales Forecast, 2018-2026 (USD Million)

Table 15.39 Liraglutide / Insulin Degludec Sales Forecast, 2016-2026 (USD Million)

Table 15.40 Semaglutide Oral / OGC217SC / NN9924 Sales Forecast, 2020-2026 (USD Million)

Table 15.41 Exenatide Sales Forecast, 2016-2026 (USD Million)

Table 15.42 DPP4 Inhibitors Market, 2016-2026 (USD Billion)

Table 15.43 Sitagliptin Sales Forecast, 2016-2026 (USD Million)

Table 15.44 Vildagliptin Sales Forecast, 2016-2026 (USD Million)

Table 15.45 Saxagliptin Sales Forecast, 2016-2026 (USD Million)

Table 15.46 Linagliptin Sales Forecast, 2016-2026 (USD Million)

Table 15.47 Alogliptin Sales Forecast, 2016-2026 (USD Million)

Table 15.48 Gosogliptin Sales Forecast, 2017-2026 (USD Million)

Table 15.49 SGLT2 Inhibitors Market, 2016-2026 (USD Billion)

Table 15.50 Sotagliflozin Sales Forecast, 2018-2026 (USD Million)

Table 15.51 Empagliflozin Sales Forecast, 2016-2026 (USD Million)

Table 15.52 Canagliflozin Sales Forecast, 2016-2026 (USD Million)

Table 15.53 Dapagliflozin Sales Forecast, 2016-2026 (USD Million)

Table 15.54 Tofogliflozin Sales Forecast, 2016-2026 (USD Million)

Table 15.55 Ertugliflozin Sales Forecast, 2018-2026 (USD Million)

Table 15.56 Bexagliflozin Sales Forecast, 2018-2026 (USD Million)

Table 15.57 Publications on GLP-1 Agonists: Distribution by Focus Drug

Table 15.58 Publications on DPP4 Inhibitors: Distribution by Focus Drug

Table 15.59 Publications on SGLT2 Inhibitors: Distribution by Focus Drug

Table 15.60 Overall Non-Insulin Therapies Market Forecast: Distribution by Drug Class, 2016-2026 (USD Billion)

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Diabetes, considered to be the most common metabolic disorder in humans, is ranked among the top ten fatal diseases in the US. The increasing incidence, growing prevalence and the progressive nature of the disease has spurred several pharmaceutical companies to develop novel approaches / therapies to provide better treatment options for diabetic patients worldwide. While insulin supplements and insulin based therapies represent a major portion of the anti-diabetic drugs market, non-insulin therapies are first line therapies designed especially for patients suffering from type II diabetes.

Sulfonylureas, biguanides, glinides, TZDs and alpha- glucosidase inhibitors were the first classes of non-insulin therapies to hit the market. Subsequently, incretin based therapies, such as GLP-1 agonists and DPP4 inhibitors, emerged as the standard of care for the treatment of type II diabetes. More recently, SGLT2 inhibitors have also been identified as an effective treatment solution for the same patient population. These three classes have captured a significant portion of the overall anti-diabetes market in a relatively short time span.

GLP-1 agonists and DPP4 inhibitors were introduced in the market over a decade ago while the first SGLT2 inhibitor was approved only in 2012. A number of drugs have emerged as blockbusters; examples include VICTOZA® (GLP-1 agonist), JANUVIA® / JANUMET® (DPP4 inhibitor) and INVOKANA® / INVOKAMET® (SGLT2 inhibitor).

Several companies, including both big pharmaceutical players and small to mid-sized companies, are active in this area. Companies engaged in developing anti-diabetic drug classes have actively entered into collaborations with other stakeholders to either acquire / develop / commercialize candidate therapies or for technology licensing. For instance, Tobira acquired the exclusive rights to develop and commercialize evogliptin from Dong-A ST in April 2016; Eli Lilly and Sumitomo Dainippon Pharma entered into a sales collaboration agreement for Trulicity® in July 2015; Novo Nordisk in-licensed Zosano’s technology to develop a transdermal patch formulation of Novo’s GLP-1 analogs, including semaglutide in February 2014; Takeda and Sanofi signed a co-promotion agreement for alogliptin in China in April 2013.

Recently issued FDA warnings specifically for DPP4 and SGLT2 inhibitors are likely to impact their adoption. However, new advances in drug development and the introduction of novel technologies are expected to help stakeholders operate within a proper framework and work towards eliminating the current gaps.

Example Highlights

- With a current total / combined share of more than 70% in the overall non-insulin market, GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors represent the three most prominent anti-diabetic drug classes. In terms of size, currently, the market of GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors is worth over USD 4 billion, USD 10 billion and USD 2 billion respectively. Overall, the market is highly fragmented and well distributed across different regions.

- Combined, the three drug classes have over 20 approved drugs (accounting around 40 different formulations / fixed-dose combinations) for the treatment of type II diabetes. In addition, the clinical / preclinical pipeline is rich and has over 70 molecules in different stages of development. Of the three classes, DPP4 inhibitors currently has the maximum number of marketed drugs (over 10, excluding fixed-dose combinations). On the other hand, GLP-1 agonists represent the most active class of drugs with over 40 molecules under development. SGLT2 inhibitors are also emerging at a rapid pace and already have six marketed drugs across different regions. Semaglutide (Novo Nordisk), ITCA 650 (Intarcia Therapeutics), sotagliflozin (Sanofi / Lexicon Pharmaceuticals), ertugliflozin (Merck / Pfizer), retagliptin (Jiangsu Hengrui Medicine) and gosogliptin (SatRx / Pfizer) are examples of late stage drugs that are likely to receive approval in the near future.

- Overall we came across over 80 pharmaceutical companies actively engaged in the discovery, development and commercialization of non-insulin therapies. Established pharmaceutical players have captured a major share of the non-insulin anti-diabetic drugs market. In fact, AstraZeneca, BMS, Eli Lilly and Sanofi are developing non-insulin therapies across all the three drug classes. Several other companies such as Daiichi Sankyo, Janssen, Merck, Mitsubishi Tanabe Pharma, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda and Zealand Pharma have invested heavily in the development of multiple molecules belonging to these drug classes. A number of start-ups / small companies such as (in alphabetical order) Alteogen, Amunix, ArisGen, C4XD, Diartis Pharmaceuticals, Oramed Pharmaceutical, PegBio, Poxel, Rani Therapeutics, Receptos, SatRx, Sirona Biochem and Spitfire Pharma have entered this space and are also competing to gain a significant share in the overall non-insulin therapies market.

- In addition to increased competition of such therapies in the major geographies such as the US and EU, some stakeholders have focused on tapping a localized opportunity. Drugs such as teneligliptin (Mitsubishi Tanabe Pharma), trelagliptin (Takeda), ipragliflozin (Astellas Pharma/ Kotobuki Pharmaceutical) and luseogliflozin (Taisho Pharmaceutical) have been approved only in Japan. Similarly, retagliptin (Jiangsu Hengrui Medicine) and Uni-E4 (Uni-Bio Science Group) are in Phase III clinical development in China only.

- With a vision to increase patient compliance, several pharmaceutical companies have introduced fixed-dose formulations of different drugs. Prominent examples include Eucreas® / Galvumet® / Galvus Met® / Icandra® / Zomarist® (vildagliptin + metformin) (Novartis), INVOKAMET® / VOKANAMET® (canagliflozin + metformin) (Janssen Pharmaceutical Companies / Mitsubishi Tanabe Pharma / Daiichi Sankyo), JANUMET® / Velmetia® (sitagliptin + metformin) (Merck), Xigdua® (dapagliflozin + metformin) (Astra Zeneca / BMS) and Xultophy® / IDegLira (liraglutide + insulin degludec) (Novo Nordisk).

- Technological advancements are amongst the key future growth drivers. Drug developers are investigating new routes of administration using several innovative technology platforms, such as Axcess™ (Diabetology), Eligen® (Emisphere Technologies), PharmFilm® Technology (MonoSol Rx) and the Protein Oral Delivery (POD™) technology (Oramed Pharmaceuticals), to facilitate the oral administration of GLP-1 agonists. Other innovative technologies such as the Intravail® drug delivery platform are attempting to facilitate nasal administration.Companies such as ScinoPharm and Panacea Biotech are developing oral capsule formulations of DPP4 inhibitors. Their molecules, DBPR108 and PBL 1427, respectively, are still in the early stages of clinical development.SGLT2 inhibitors, primarily used to treat type II diabetes, are also being developed for the treatment of type I diabetes. Examples include sotagliflozin (Theracos) and remogliflozin (BHV Pharma).

- Dual agonist drugs are also being developed to provide more effective treatment options. Examples of molecules that target both the GLP-1 receptor and glucagon receptor include MK-8521 (Merck), TTP401 / LY2944876 (Transition Therapeutics / Eli Lilly), MEDI0382 (AstraZeneca), SAR425899 (Sanofi) and MOD-6030 / MOD-6031 (OPKO Biologics). On the other hand, NN9709 (Novo Nordisk) and SAR438335 (Sanofi) are being developed to act on both GLP-1 and GIP receptors.

- Several research institutes, companies and organization have made significant contribution to the discovery and overall development of these therapies. During the study, we identified over 400 key opinion leaders who have played critical role in the development of GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors. In addition, we identified over 50 articles, published during the 12 months beginning January 2015, which focused on these three drug classes. The design of these studies primarily focussed on evaluating the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of the drugs.

- Extensive efforts are being made by pharmaceutical companies to explore new and innovative therapeutic strategies and agents that are safer and more effective than the already available options. Many novel non-insulin therapies are under clinical development. Examples of these new anti-diabetic drug classes include glucokinase activators, GPR119 agonists, GCGR antagonists, 11-beta hydroxysteroid dehydrogenase type 1 inhibitors, glycogen phosphorylase inhibitors and PTP-1B antagonists.

- It is important to highlight that nearing patent expiries of currently available drugs and the potential health hazards associated with the use of some of these inhibitors are going to negatively impact the market growth. However, our overall outlook is highly promising. We believe that SGLT2 inhibitors are likely to grow at an annualized growth rate of ~17%, followed by GLP-1 agonists (expected growth rate of ~13.4%).
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- Oramed Pharmaceuticals
- Örebro University
- Oregon Health and Science University
- Osaka University Graduate
- Oslo University Hospital Ullevaal
- Otsuka Pharmaceutical
- Panacea Biotec
- PAREXEL International
- Park Nicollet International Diabetes Center
- PegBio
- Peking Union Medical College Hospital
- Pennington Biomedical Research Center
- People's Hospital, Peking Universty
- Peptron
- Pfizer
- Pharmaceutical Product Development
- PharmaIN
- Pharmsynthez
- PhaseBio Pharmaceuticals
- Phenomix
- Phoenix VA Healthcare System
- Phoundry Pharmaceuticals
- Pitié-Salpêtrière Hospital
- Palatin Technologies
- Pontificia Universidad Catolica de Chile
- Population Health Research Institute
- Post Graduate Institute of Medical Education and Research
- Poxel
- Prism Research
- Probiodrug
- Profil Institut für Stoffwechselforschung
- Profil Institute for Metabolic Research
- Prosidion
- Pusan National University Hospital
- Pusat Perubatan Universiti Kebangsaan
- Qianfoshan Hospital
- Quilvest
- Quintiles
- Quotient Bioresearch Clinical Services
- RA Capital
- Radboud University
- Rani Therapeutics
- Receptos
- Rigshospitalet
- Rikshospitalet Medical Center
- Roche
- Royal Adelaide Hospital
- Royal Bournemouth Hospital
- Royal Devon & Exeter NHS Trust
- Royal Surrey County Hospital
- Royalty Pharma
- Ruhr-University Bochum
- Saint Luke's Mid America Heart Institute
- Samsung Medical Center
- Sana Klinikum Offenbach
- Sanofi
- Sanwa Kagaku Kenkyusho
- Sao Paulo General Hospital
- SatRx
- Scientisic Research Institute of Cardiology and Internal Diseases
- ScinoPharm
- Seattle Children's Hospital
- Second University of Naples
- Second Xiangya Hospital of Central South University
- Seoul National University Bundang Hospital
- Seoul St. Mary's Hospital
- Serometrix
- Services Hospital
- Servier
- Severance Hospital
- Shandong Provincial Hospital
- Shanghai Jiao Tong University School of Medicine
- Shanghai Mental Health Center
- Shanghai Sixth People's Hospital
- Sheba Medical Center
- Sirona Biochem
- Slotervaart Hospital
- Spitfire Pharma
- St Michael's Hospital
- St. Josef Hospital
- St. Joseph's Health Care, London
- Stanford University
- Stendhal
- Steno Diabetes Center
- Sumitomo Dainippon Pharma
- Sun Pharma Advanced Research
- Sun Yat-Sen University
- Sydney Diabetes Centre
- Taichung Veterans General Hospital
- Taipei Medical University WanFang Hospital
- Taisho Pharmaceutical
- Takeda
- Tampere University Hospital
- Tarix Pharmaceuticals
- Teijin Pharma
- Teva Active Pharmaceutical Ingredients
- The Baupost Group
- The Catholic University of Korea
- The First Affiliated Hospital of Xi’an Jiaotong University
- The First Affiliated Hospital of Xiamen University
- The First Affiliated Hospital of Zhejiang University
- The George Institute for Global Health
- The George Washington University Medical Faculty Associates
- The National Center for Scientific Research
- The Third Xiangya Hospital of Center South University
- Theracos
- Therapix Biosciences
- Theratechnologies
- Third Military Medical University, China
- Thomas Jefferson University
- TIMI Study Group
- Tobira Therapeutics
- Tolerx
- Toronto Western Hospital
- Transition Therapeutics
- TransTech Pharma
- Tulane University
- Turku PET Centre
- Turku University Hospital
- UCL Institute of Neurology
- UKMMC
- UMass Medical School
- Uni-Bio Science Group
- Universität zu Lübeck
- Université de Lorraine
- Université de Montréal
- University at Buffalo
- University College Dublin
- University Health Network
- University Hospital Center of Toulouse
- University Hospital of Basel
- University Hospital of Caen
- University Hospital of Palermo
- University Medical Center Groningen
- University Medical Center Hamburg-Eppendorf
- University Medical Center Ljubljana,Slovenia
- University Nijmegen Medical Center
- University of Aarhus
- University of Adelaide
- University of Alabama at Birmingham
- University of Alberta
- University of Amsterdam
- University of Birmingham
- University of Bordeaux
- University of British Columbia
- University of California
- University of California, Davis
- University of California, Los Angeles
- University of Chicago
- University of Cincinnati
- University of Colorado
- University of Copenhagen
- University of Dundee
- University of Exeter
- University of Geneva
- University of Guadalajara
- University of Illinois at Chicago
- University of Leicester
- University of Manchester
- University of Maryland
- University of Miami
- University of Michigan
- University of Minnesota
- University of Munich
- University of Nebraska-Lincoln
- University of Nevada School of Medicine
- University of North Carolina, Chapel Hill
- University of Nottingham
- University of Oulu
- University of Padova Medical School
- University of Palermo
- University of Pennsylvania
- University of Pittsburgh
- University of São Paulo General Hospital
- University of Southern California
- University of Surrey
- University of Tartu
- University of Texas
- University of Texas Health Science Center
- University of Texas Medical Branch
- University of the Ryukyus
- University of Tokyo
- University of Toronto
- University of Washington
- University of Western Ontario
- Uppsala University
- UT Southwestern Medical Center
- VA Puget Sound Health Care System
- Vall d'Hebron Research Institute
- Vanderbilt University School of Medicine
- Velocity Pharmaceutical Development
- Venrock
- Viking Therapeutics
- Vitae Pharmaceuticals
- VIVUS
- vTv Therapeutics
- VU University Medical Center
- Wake Forest University / Wake Forest University Health Sciences
- Walter Reed Army Medical Center- Diabetes Institute
- Wan Fang Hospital
- Wanbang Biopharmaceuticals (subsidiary of Shanghai Pharmaceutical Group)
- Washington University CRS
- Washington University School of Medicine
- Woman's Hospital
- World Health Organization
- Wuhan General Hospital of Guangzhou Command
- Xenetic Biosciences
- Yale University
- Yeshiva University
- Yokohama City University School of Medicine
- Yuhan
- Zealand Pharma
- Zosano Pharma
- Zydus Cadila
- ZymoGenetics
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