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Frontier Pharma: Type 2 Diabetes Mellitus - GPCRs and Protein Kinases Dominate Pipeline, with Most Promising First-in-Class Targets Demonstrating Potential Disease-Modifying Effects

Frontier Pharma: Type 2 Diabetes Mellitus - GPCRs and Protein Kinases Dominate Pipeline, with Most Promising First-in-Class Targets Demonstrating Potential Disease-Modifying Effects

Summary


Type 2 diabetes mellitus (T2DM) is a chronic, progressive and serious metabolic disorder characterized by hyperglycemia (high blood glucose levels) and associated with numerous complications and co-morbidities, including cardiovascular, renal and neurodegenerative diseases.

Global prevalence of the disease has risen rapidly in the past several decades, primarily as a result of rising obesity, a major risk factor for T2DM. This has resulted in a large and competitive market landscape, with a number of drugs competing with one another for different market segments, across multiple lines of therapy.

The emergence over the past decade of glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase 4 (DPP-4) inhibitors and sodium-glucose cotransporter 2 (SGLT-2) inhibitors has intensified competition. These new drug classes have been highly commercially successful and are now well established within the treatment algorithm.0
In spite of these developments, there are still significant unmet needs for T2DM, and the rationale for investment in first-in-class innovation remains strong. First-in-class products account for a considerable proportion of the large T2DM pipeline, with a diverse range of first-in-class targets identified.

Scope

The escalating T2DM public healthcare need has resulted in a competitive market landscape

     
  • What is the pathophysiology of T2DM?
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  • What are the common co-morbidities and complications?
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  • How has the emergence of new drug classes in the past decade impacted the treatment algorithm?
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  • What are the most significant unmet needs within the market?
The T2DM pipeline is large and innovative
     
  • Which molecule types and molecular targets are most prominent within the pipeline?
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  • Which first-in-class targets are most promising?
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  • How does the ratio of first-in-class targets to first-in-class products differ by stage of development and molecular target class?
The T2DM deals landscape is highly active
     
  • Do T2DM products attract high deal values?
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  • Which molecule types and molecular targets dominate the deals landscape?
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  • Which first-in-class pipeline products have no prior involvement in licensing or co-development deals?
Reasons to buy

This report will allow you to -
  • Appreciate the current clinical and commercial landscapes by considering disease pathogenesis, etiology, epidemiology, symptoms, co-morbidities and complications, and treatment options.
  • Identify leading products and companies within the market, as well as key unmet needs, in order to gain a competitive understanding of gaps in the current market.
  • Recognize innovative pipeline trends by analyzing therapies by stage of development, molecule type and molecular target.
  • Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, all first-in-class targets in the T2DM pipeline have been assessed and ranked according to clinical potential. Promising early-stage targets have been further reviewed in greater detail.
  • Consider first-in-class pipeline products with no prior involvement in licensing and co-development deals that may represent potential investment opportunities.


Type 2 diabetes mellitus market ripe with opportunities for potential investors, says GBI Research

The increasing demand for type 2 diabetes mellitus (T2DM) therapeutics, caused by rising prevalence of the disease, has resulted in a large and competitive market landscape. There are a number of drugs competing for different market segments, across multiple lines of therapy, according to business intelligence provider GBI Research.

The company’s latest report states that the emergence over the past decade of glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase 4 inhibitors and sodium-glucose cotransporter 2 inhibitors has intensified competition. These new drug classes have been highly commercially successful and are now well established within the T2DM treatment algorithm.

The leading products within these drug classes are Novo Nordisk’s Victoza, Merck’s Januvia, and Janssen’s Invokana, respectively. In 2015, these drugs generated $2.7 billion, $4.3 billion, and $1.6 billion, respectively.

Fiona Chisholm, Analyst for GBI Research, notes: “In spite of recent developments, there are still significant unmet needs for T2DM. Treatment regimens are often complex, and many drugs have limited long-term efficacy and side effects that are particularly undesirable for the T2DM patient population, such as increased cardiovascular risk factors or weight gain.

“Alongside the rapidly expanding prevalence population, this ensures that sustained investment in T2DM product innovation continues to be an attractive commercial prospect. Indeed, with 591 products in development, T2DM pipeline activity is very high in comparison to other related indications within metabolic disorders such as obesity and type 1 diabetes mellitus, which have 254 and 244 active products in development, respectively.”

T2DM therapeutics can often attract high values in licensing or co-development strategic consolidations. GBI Research’s analysis of licensing and co-development deals relating to T2DM therapeutics since 2006 has identified aggregate deal values of $9.2 billion and $9.5 billion, respectively, for deals with disclosed deal values.

“Despite this, the majority of first-in-class products in development for T2DM have no disclosed involvement in previous licensing or co-development. Among these products, the range of molecular targets is relatively wide, providing ample and diverse opportunities for potential investors. Entering into a licensing or co-development deal can have significant benefits for both parties, including shared product development risks, financial and R&D resource support, and portfolio or geographical expansion, Chisholm concludes.

- Comments provided by Fiona Chisholm, Analyst for GBI Research.
- Information based on GBI Research’s report: “Frontier Pharma: Type 2 Diabetes Mellitus - GPCRs and Protein Kinases Dominate Pipeline, with Most Promising First-in-Class Targets Demonstrating Potential Disease-Modifying Effects”.
- This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research’s team of industry experts.

1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Executive Summary
2.1 Large and Competitive Market Landscape Driven by Rising Prevalence
2.2 Investment in First-in-Class Innovation Remains Strong
2.3 Opportunities for Investment in First-in-Class Product Development are Considerable
3 The Case for Innovation
3.1 Growing Opportunities for Biologic Products
3.2 Diversification of Molecular Targets
3.3 Innovative First-in-Class Product Development Remains Attractive
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation
3.5 Sustained Innovation
3.6 GBI Research Report Guidance
4 Clinical and Commercial Landscape
4.1 Disease Overview
4.2 Classification of Diabetes Mellitus
4.3 Symptoms
4.4 Epidemiology
4.5 Etiology
4.6 Pathophysiology
4.7 Co-morbidities and Complications
4.8 Management and Treatment of Type 2 Diabetes Mellitus
4.8.1 Non-insulin T2DM Therapies
4.9 Insulin-Based T2DM Therapies
4.10 Overview of Marketed Products in Type 2 Diabetes
4.11 Unmet Need and Commercial Opportunities in T2DM
5 Assessment of Pipeline Product Innovation
5.1 Pipeline by Stage of Development, Molecule Type and Molecular Target
5.2 Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class
5.3 First-in-Class Programs by Molecular Target Category
6 Type 2 Diabetes Mellitus Signaling Network, Disease Causation and Innovation Alignment
6.1 Complexity of Signaling Networks
6.2 Signaling Pathways and First-in-Class Molecular Target Integration
6.3 First-in-Class Matrix Assessment
7 First-in-Class Target and Pipeline Program Evaluation
7.1 Pipeline Programs Targeting Insulin Receptor Substrate 1 and Insulin Receptor Substrate 2
7.2 Pipeline Programs Targeting G-Protein Coupled Receptor Kinase 5 (GRK5)
7.3 Pipeline Programs Targeting Type 2 Angiotensin II Receptor
7.4 Pipeline Programs Targeting Islet Amyloid Polypeptide (IAPP)
7.5 Pipeline Programs Targeting Nacht LRR and PYD Domains Containing Protein 3
7.6 Pipeline Programs Targeting Peroxisome Proliferator Activated Receptor Gamma Coactivator 1 Alpha (PPARGC1A)
7.7 Pipeline Programs Targeting Glucagon
7.8 Pipeline Programs Targeting Alpha Synuclein
7.9 Pipeline Programs Targeting Microtubule Associated Protein Tau
8 Strategic Consolidations
8.1 Industry-Wide First-in-Class Deals
8.2 Licensing Deals
8.3 Co-development Deals
8.4 First-in-Class Programs Not Involved in Licensing or Co-development Deals
9 Appendix
9.1 References
9.2 Abbreviations
9.3 Research Methodology
9.4 Secondary Research
9.4.1 Market Analysis
9.4.2 Pipeline Analysis
9.4.3 First-in-Class Matrix Assessment
9.4.4 First-in-Class Target Profiles
9.4.5 Licensing and Co-development Deals
9.5 Contact Us
9.6 Disclaimer
1.1 List of Tables
Table 1: Type 2 Diabetes Mellitus, Global, Related Indications of T2DM First-in-Class Products, 2016
Table 2: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Insulin Receptor Substrate 1, 2016
Table 3: Type 2 Diabetes Mellitus, Global, Key Features of Insulin Receptor Substrate 1, 2016
Table 4: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Insulin Receptor Substrate 2, 2016
Table 5: Type 2 Diabetes Mellitus, Global, Key Features of Insulin Receptor Substrate 2, 2016
Table 6: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting G-Protein Coupled Receptor Kinase 5, 2016
Table 7: Type 2 Diabetes Mellitus, Global, Key Features of G-Protein Coupled Receptor Kinase 5, 2016
Table 8: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Type 2 Angiotensin II Receptor, 2016
Table 9: Type 2 Diabetes Mellitus, Global, Key Features of Type 2 Angiotensin II Receptor, 2016
Table 10: Type 2 Diabetes Mellitus, Global Pipeline Programs Targeting Islet Amyloid Polypeptide, 2016
Table 11: Type 2 Diabetes Mellitus, Global, Key Features of Islet Amyloid Polypeptide, 2016
Table 12: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Nacht LRR and PYD Domains Containing Protein 3, 2016
Table 13: Type 2 Diabetes Mellitus, Global, Key Features of Nacht LRR and PYD Domains Containing Protein 3, 2016
Table 14: Type 2 Diabetes Mellitus, Global Pipeline Programs Targeting Peroxisome Proliferator Activated Receptor Gamma Coactivator 1 Alpha, 2016
Table 15: Type 2 Diabetes Mellitus, Global, Key Features of Peroxisome Proliferator Activated Receptor Gamma Coactivator 1 Alpha, 2016
Table 16: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Glucagon, 2016
Table 17: Type 2 Diabetes Mellitus, Global, Key Features of Glucagon, 2016
Table 18: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Alpha Synuclein, 2016
Table 19: Type 2 Diabetes Mellitus Market, Global, Key Features of Alpha Synuclein, 2016
Table 20: Type 2 Diabetes Market, Global, Pipeline Programs Targeting Microtubule Associated Protein Tau, 2016
Table 21: Type 2 Diabetes Mellitus Market, Global, Key Features of Microtubule Associated Protein Tau,
1.2 List of Figures
Figure 1: Type 2 Diabetes Mellitus, Global, Innovation Trends in Product Approvals Across the Pharmaceutical Market, 1987-2014
Figure 2: Type 2 Diabetes Mellitus, Global, Post-Marketing-Approval Sales Performance of First-in-Class and Non-First-in-Class Products Across Pharmaceutical Industry ($m), 2006-2013
Figure 3: Type 2 Diabetes Mellitus, Global, Marketed Products by Molecule Type, 2016
Figure 4: Type 2 Diabetes Mellitus, Global, Marketed Products by Molecular Target, 2016
Figure 5: Type 2 Diabetes Mellitus, Global, Pipeline Size by Therapy Area, 2016
Figure 6: Type 2 Diabetes Mellitus, Global, Pipeline by Stage of Development and Molecule Type, 2016
Figure 7: Type 2 Diabetes Mellitus, Global, Pipeline by Molecular Target and Stage of Development, 2016
Figure 8: Type 2 Diabetes Mellitus, Global, Pipeline Breakdown of GPCR and Protein Kinase Molecular Target, 2016
Figure 9: Type 2 Diabetes Mellitus, Global, Distribution of Pipeline and Marketed Products by Molecular Target Class, 2016
Figure 10: Type 2 Diabetes Mellitus, Global, Distribution of Pipeline Products by First-in-Class Status and Molecular Target Class, 2016
Figure 11: Type 2 Diabetes Mellitus, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Stage of Development, 2016
Figure 12: Type 2 Diabetes Mellitus, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Molecular Target Class, 2016
Figure 13: Type 2 Diabetes Mellitus, Global, Ratio of First-in-Class Targets to First-in-Class Products by Stage of Development, 2016
Figure 14: Type 2 Diabetes Mellitus, Global, Ratio of First-in-Class Targets to First-in-Class Products by Molecular Target, 2016
Figure 15: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 1)
Figure 16: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 2)
Figure 17: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 3)
Figure 18: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 4)
Figure 19: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 5)
Figure 20: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 6)
Figure 21: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 7)
Figure 22: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 8)
Figure 23: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 9)
Figure 24: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 10)
Figure 25: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 11)
Figure 26: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 12)
Figure 27: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 13)
Figure 28: Type 2 Diabetes Mellitus, Global, All Pipeline Products, 2016 (part 14)
Figure 29: Type 2 Diabetes Mellitus, Global, First-in-Class Molecular Target Analysis Matrix Part 1, 2016
Figure 30: Type 2 Diabetes Mellitus, Global, First-in-Class Molecular Target Analysis Matrix Part 2, 2016
Figure 31: Type 2 Diabetes Mellitus, Global, First-in-Class Molecular Target Analysis Matrix Part 3, 2016
Figure 32: Type 2 Diabetes Mellitus, Global, First-in-Class Molecular Target Analysis Matrix Part 4, 2016
Figure 33: Type 2 Diabetes Mellitus, Global, Industry-Wide Licensing Deals by Stage of Development, 2006-2016
Figure 34: Type 2 Diabetes Mellitus, Global, Industry-Wide Licensing Deals by Deal Value, Upfront Payment Value, Stage of Development and First-in-Class Status ($m), 2006-2014
Figure 35: Type 2 Diabetes Mellitus, Global, Licensing Deals by Region, Value and Year, 2006-2016
Figure 36: Type 2 Diabetes Mellitus, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016
Figure 37: Type 2 Diabetes Mellitus, Global, Number and Aggregate Deal Value of Licensing Deals by Molecule Type, 2006-2016
Figure 38: Type 2 Diabetes Mellitus, Global, Frequency and Aggregate Deal Value of Licensing Deals by Molecular Target, 2006-2016
Figure 39: Type 2 Diabetes Mellitus, Global, Co-development Deals by Region and Deal Value and Year, 2006-2016
Figure 40: Type 2 Diabetes Mellitus, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016
Figure 41: Type 2 Diabetes Mellitus, Global, Number and Aggregate Deal Value of Co-development Deals by Molecule Type, 2006-2016
Figure 42: Type 2 Diabetes Mellitus, Global, Frequency and Aggregate Deal Value of Co-development Deals by Molecular Target, 2006-2016
Figure 43: Type 2 Diabetes Mellitus, Global, Deal Involvement of First-in-Class Programs, 2016 (part 1)
Figure 44: Type 2 Diabetes Mellitus, Global, Deal Involvement of First-in-Class Programs, 2016 (part 2)
Figure 45: Type 2 Diabetes Mellitus, Global, Deal Involvement of First-in-Class Programs, 2016 (part 3)
Figure 46: Type 2 Diabetes Mellitus, Global, Deal Involvement of First-in-Class Programs, 2016 (part 4)
Figure 47: Type 2 Diabetes Mellitus, Global, Deal Involvement of First-in-Class Programs, 2016 (part 5)

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