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Frontier Pharma:2型糖尿病

Frontier Pharma: Type 2 Diabetes Mellitus - Therapies Targeting GPCRs and Protein Kinases Dominate Pipeline, with Strong Repositioning Opportunities into Associated Areas, Including Obesity and Cardiovascular Disease

発行 GBI Research 商品コード 630781
出版日 ページ情報 英文 77 Pages
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Frontier Pharma:2型糖尿病 Frontier Pharma: Type 2 Diabetes Mellitus - Therapies Targeting GPCRs and Protein Kinases Dominate Pipeline, with Strong Repositioning Opportunities into Associated Areas, Including Obesity and Cardiovascular Disease
出版日: 2018年04月01日 ページ情報: 英文 77 Pages
概要

当レポートでは、2型糖尿病について調査分析し、イノベーション事例、概要、パイプライン製品の評価、プログラムの評価、戦略的統合など、体系的な情報を提供しています。

第1章 目次

第2章 エグゼクティブサマリー

第3章 イノベーション事例

  • 生物製剤の機会が拡大
  • 分子標的の多様化
  • 革新的なファーストインクラス製品 (画期的医薬品) の開発が今も魅力的
  • 規制・償還政策が、ファーストインクラス製品のイノベーションに有利に
  • 2型糖尿病における持続的イノベーション

第4章 臨床・商業情勢

  • 2型糖尿病の概要
  • 疾病の分類
  • 症状
  • 診断
  • 病因
  • 病態生理
  • 併存疾患・合併症
  • 疫学
  • 治療
  • 上市製品の概要
  • T2DM (2型糖尿病) におけるアンメットニーズおよび商業的な機会

第5章 パイプライン製品イノベーションの評価

  • 概要
  • パイプライン:開発段階別、分子タイプ別
  • パイプライン:分子標的別
  • 市場とパイプライン間のプログラムの比較分布:分子標的クラス別
  • ファーストインクラスと非ファーストインクラスパイプラインプログラムの比較分布:分子標的クラス別
  • パイプライン内のファーストインクラスプログラムとファーストインクラス分子標的の比率
  • すべてのパイプライン製品のリスト

第6章 シグナリング (シグナル伝達) ネットワーク、因果関係、イノベーションの調整

  • 2型糖尿病におけるシグナル伝達ネットワークの複雑さ
  • シグナリング経路、病因性突然変異、およびファーストインクラス分子標的の統合
  • ファーストインクラス分子標的マトリクスの評価

第7章 ファーストインクラス分子標的の評価

第8章 戦略的統合

  • 産業別のファーストインクラス契約
  • ライセンシング契約
  • 共同開発契約
  • 事前ライセンシングあり/なしのファーストインクラスプログラムまたは共同開発契約への関与

第9章 付録

目次
Product Code: GBIHC471MR

Abstract

  • Frontier Pharma: Type 2 Diabetes Mellitus - Therapies Targeting GPCRs and Protein Kinases Dominate Pipeline, with Strong Repositioning Opportunities into Associated Areas, Including Obesity and Cardiovascular Disease

Summary

  • Type 2 diabetes mellitus (T2DM) is a major metabolic disease and one of the leading causes of death worldwide. The prevalence is on the rise, alongside increases in obesity due to lifestyle changes in the 21st century. Type 2 diabetes is characterized by insulin resistance leading to dysregulation of glucose control and chronic hyperglycemia.
  • This leads to several co-morbidities and complications, some of which are associated with damage to blood vessels as a result of elevated blood glucose levels. The disease is progressive: patients' standard of living deteriorate over time and the symptoms worsen, meaning more complex treatment regimens are required over time. The complexity of the treatment means there is a high diversity of marketed products. In recent years new drug types have been great commercial successes and reached blockbuster status. This alongside the financial cost of type 2 diabetes to healthcare providers has led to significant investment in R&D on therapeutics in this area.
  • The demand for T2DM therapeutics 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. Since the mid-2000s a number of new drug classes have entered the market including glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase 4 (DPP-4) inhibitors and sodium-glucose linked transporter-2 (SGLT-2) inhibitors. These drug classes have proved to be highly commercially successful.
  • The T2DM pipeline is large with more than 560 products in active development, which accounts for almost a third of the metabolic disorders pipeline. This pipeline is dominated by products acting on G protein coupled receptors (GPCR) and protein kinases.
  • First-in-class products have the greatest potential in terms of development and commercial prospects. Among the pipeline products, 152 are first-in-class, which act on 95 distinct first-in-class targets. In line with the overall pipeline, first-in-class innovation is dominated by products acting on GPCRS and protein kinases. Additionally, there is a strong representation of first-in-class products at the Preclinical development stage.
  • The report "Frontier Pharma: Type 2 Diabetes Mellitus - Therapies Targeting GPCRs and Protein Kinases Dominate Pipeline, with Strong Repositioning Opportunities into Associated Areas, Including Obesity and Cardiovascular Disease" enables you to -
  • Appreciate the current clinical and commercial landscapes by considering disease pathogenesis, etiology, epidemiology, symptoms, and diagnosis and treatment options.
  • Identify leading products and key unmet needs within the 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 proprietary matrix assessments, first-in-class targets in the pipeline have been assessed and ranked according to clinical potential. Individual matrix assessments are provided for targets identified in the pipeline for T2DM. Promising early-stage first-in-class targets are 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.

Scope

  • Requirement for new types of therapeutics to add to already complex treatment algorithms for severe T2DM
  • What are the most important etiological risk factors and pathophysiological processes implicated in T2DM?
  • What is the current treatment algorithm?
  • How effective are current therapies for these indications, and how does this impact prognosis? What are the side effects associated with these treatments?
  • The T2DM pipeline is dominated by G-protein-coupled receptors (GPCRs) and protein kinases
  • Which molecule types and molecular targets are most prominent in the T2DM pipeline?
  • Which first-in-class targets are most promising?
  • How does the level of first-in-class innovation change within different target classes?
  • How does first-in-class target diversity differ by stage of development and molecular target class?
  • The deals landscape is active and dominated by products that target GPCRS and protein kinases
  • Which molecular types/molecular target groups attract the highest deal values?
  • How has deal activity fluctuated over the past decade?
  • Which first-in-class pipeline products have no prior involvement in licensing or co-development deals?

Reasons to buy

  • Appreciate the current clinical and commercial landscapes by considering disease pathogenesis, etiology, epidemiology, symptoms, and diagnosis and treatment options.
  • Identify leading products and key unmet needs within the 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 proprietary matrix assessments, first-in-class targets in the pipeline have been assessed and ranked according to clinical potential. Individual matrix assessments are provided for targets identified in the pipeline for T2DM. Promising early-stage first-in-class targets are 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.

1 Table of Contents

1 Table of Contents 2

  • 1.1 List of Tables 4
  • 1.2 List of Figures 4

2 Executive Summary 6

  • 2.1 Competitive Market Landscape Driven by Rising Prevalence 6
  • 2.2 Large and Diverse Pipeline Dominated by Products Acting on G Protein Coupled Receptors (GPCR) and Protein Kinases 6
  • 2.3 Strong Opportunities for Investment in First-in-Class Products 6

3 The Case for Innovation 7

  • 3.1 Growing Opportunities for Biologic Products 7
  • 3.2 Diversification of Molecular Targets 8
  • 3.3 Innovative First-in-Class Product Developments Remain Attractive 8
  • 3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Innovation 9
  • 3.5 Sustained Innovation in Type 2 Diabetes Mellitus 9

4 Clinical and Commercial Landscape 10

  • 4.1 Overview of Type 2 Diabetes Mellitus 10
  • 4.2 Disease Classification 10
    • 4.2.1 Type 1 Diabetes Mellitus 10
    • 4.2.2 Type 2 Diabetes Mellitus 11
    • 4.2.3 Type 3 Diabetes Mellitus 11
    • 4.2.4 LADA 11
    • 4.2.5 MODY 11
    • 4.2.6 Gestational 11
    • 4.2.7 Pancreatic diabetes 11
    • 4.2.8 Prediabetes 11
  • 4.3 Symptoms 11
  • 4.4 Diagnosis 12
  • 4.5 Etiology 12
  • 4.6 Pathophysiology 13
  • 4.7 Comorbidities and Complications 14
  • 4.8 Epidemiology 15
  • 4.9 Treatment 16
    • 4.9.1 Non-Insulin T2DM Therapies 17
    • 4.9.2 Insulin-Based T2DM Therapies 19
  • 4.10 Overview of Marketed Products 20
  • 4.11 Unmet Need and Commercial Opportunities in T2DM 22

5 Assessment of Pipeline Product Innovation 23

  • 5.1 Overview 23
  • 5.2 Pipeline by Stage of Development and Molecule Type 23
  • 5.3 Pipeline by Molecular Target 24
  • 5.4 Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class 26
  • 5.5 Comparative Distribution of First-in-Class and Non-First-in-Class Pipeline Programs by Molecular Target Class 27
  • 5.6 Ratio of First-in-Class Programs to First-in-Class Molecular Targets within the Pipeline 28
  • 5.7 List of All First-in-Class Pipeline Programs 30

6 Signaling Network, Disease Causation and Innovation Alignment 39

  • 6.1 Complexity of Signaling Networks in Type 2 Diabetes Mellitus 39
  • 6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 39
  • 6.3 First-in-Class Molecular Target Matrix Assessment 39

7 First-in-Class Molecular Target Evaluation 44

  • 7.1 Pipeline Programs Targeting G Protein Coupled Receptor Kinase 5 (GRK5) 44
  • 7.2 Pipeline Programs Targeting Gastric Inhibitory Polypeptide Receptors (GIPR) 45
  • 7.3 Pipeline Programs Targeting Bone Morphogenetic Protein Receptor Type 1A (BMPR1A), Bone Morphogenetic Protein Receptor Type 1B (BMPR1B) and Bone Morphogenetic Protein Receptor Type 2 (BMPR2) 46
  • 7.4 Pipeline Programs Targeting Solute Carrier Family 13 Member 5 (SLC13A5) 48
  • 7.5 Pipeline Programs Targeting N Formyl Peptide Receptor 3 (FPR3) and N Formyl Peptide Receptor 2 (FPR2) 49
  • 7.6 Pipeline Programs Targeting Neuromedin U receptor 2 (NMUR2) and Neuromedin U receptor 1 (NMUR1) 50
  • 7.7 Pipeline Programs Targeting Peptide YY (PYY) 51
  • 7.8 Pipeline Programs Targeting Apelin Receptor (APLNR) 52
  • 7.9 Pipeline Programs Targeting Insulin Receptor Substrate (IRS1) and Insulin Receptor Substrate (IRS2) 53
  • 7.10 Conclusion 56

8 Strategic Consolidations 57

  • 8.1 Industry-Wide First-in-Class Deals 57
  • 8.2 Licensing Deals 58
    • 8.2.1 Deals by Region, Value and Year 58
    • 8.2.2 Deals by Stage of Development and Value 59
    • 8.2.3 Deals by Molecule Type and Molecular Target 59
    • 8.2.4 List of Deals with Disclosed Deal Values 60
  • 8.3 Co-development Deals 62
    • 8.3.1 Deals by Region, Value and Year 62
    • 8.3.2 Deals by Stage of Development and Value 62
    • 8.3.3 Deals by Molecule Type and Molecular Target 63
    • 8.3.4 List of Deals with Disclosed Deal Values 64
  • 8.4 First-in-Class Programs with and without Prior Licensing or Co-development Deal Involvement 65

9 Appendix 69

  • 9.1 References 69
  • 9.2 Abbreviations 74
  • 9.3 Methodology 75
    • 9.3.1 Data Integrity 75
    • 9.3.2 Innovative and Meaningful Analytical Techniques and Frameworks 75
    • 9.3.3 Evidence Based Analysis and Insight 75
  • 9.4 Secondary Research 75
    • 9.4.1 Market Analysis 76
    • 9.4.2 Pipeline Analysis 76
    • 9.4.3 Licensing and Co-development Deals 77
  • 9.5 Contact Us 77
  • 9.6 Disclaimer 77

1.1 List of Tables

  • Table 1: Type 2 Diabetes Mellitus, Global, Related Indications of T2DM First-in-Class Products, 2018 40
  • Table 2: Type 2 Diabetes Mellitus, Global, Key Features of G Protein Coupled Receptor Kinase 5 (GRK5), 2018 44
  • Table 3: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting G Protein Coupled Receptor Kinase 5 (GRK5), 2018 44
  • Table 4: Type 2 Diabetes Mellitus, Global, Key Features of Gastric Inhibitory Polypeptide Receptor (GIPR), 2018 45
  • Table 5: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Gastric Inhibitory Polypeptide Receptor (GIPR), 2018 46
  • Table 6: Type 2 Diabetes Mellitus, Global, Key Features of Bone Morphogenetic Protein Receptor Type 1A (BMPR1A), 2018 47
  • Table 7: Type 2 Diabetes Mellitus, Global, Key Features of Bone Morphogenetic Protein Receptor Type 1B (BMPR1B), 2018 47
  • Table 8: Type 2 Diabetes Mellitus, Global, Key Features of Bone Morphogenetic Protein Receptor Type 2 (BMPR2), 2018 47
  • Table 9: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Bone Morphogenetic Protein Receptor Type 1A (BMPR1A), Bone Morphogenetic Protein Receptor Type 1B (BMPR1B) and Bone Morphogenetic Protein Receptor Type 2 (BMPR2), 2018 48
  • Table 10: Type 2 Diabetes Mellitus, Global, Key Features of Solute Carrier Family 13 Member 5 (SLC13A5), 2018 48
  • Table 11: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Solute Carrier Family 13 Member 5 (SLC13A5), 2018 49
  • Table 12: Type 2 Diabetes Mellitus Drugs Market, Global, Pipeline Programs Targeting N-Formyl Peptide Receptor 2 (FPR2) and N-Formyl Peptide Receptor 3 (FPR3), 2018 49
  • Table 13: Type 2 Diabetes Mellitus Drugs Market, Global, Pipeline Programs Targeting N-Formyl Peptide Receptor 2 (FPR2) and N-Formyl Peptide Receptor 3 (FPR3) , 2018 50
  • Table 14: Type 2 Diabetes Mellitus, Global, Key Features of Neuromedin U Receptor 1 (NMUR1), 2018 51
  • Table 15: Type 2 Diabetes Mellitus, Global, Key Features of Neuromedin U Receptor 2 (NMUR2), 2018 51
  • Table 16: Type 2 Diabetes Mellitus, Global, Global, Pipeline Programs Targeting Neuromedin U Receptor 2 (NMUR2), 2018 51
  • Table 17: Type 2 Diabetes Mellitus Drugs Market, Global, Key Features of Targeting Peptide YY (PYY), 2018 52
  • Table 18: Type 2 Diabetes Mellitus Drugs Market, Global, Pipeline Programs Targeting Peptide YY (PYY), 2018 52
  • Table 19: Type 2 Diabetes Mellitus, Global, Key Features of Apelin Receptor (APLNR), 2018 53
  • Table 20: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Apelin Receptor (APLNR), 2018 53
  • Table 21: Type 2 Diabetes Mellitus, Global, Key Features of Insulin Receptor Substrate 1 (IRS1), 2018 54
  • Table 22: Type 2 Diabetes Mellitus, Global, Key Features of Insulin Receptor Substrate 2 (IRS2), 2018 55
  • Table 23: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Insulin Receptor Substrate 1 (IRS1), 2018 55
  • Table 24: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Insulin Receptor Substrate 2 (IRS2), 2018 55

1.2 List of Figures

  • Figure 1: Type 2 Diabetes Mellitus, Global, Innovation Trends in Product Approvals Across the Pharmaceutical Market, 1987-2014 7
  • 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 8
  • Figure 3: Type 2 Diabetes Mellitus, Global, Market by Molecule Type and Molecular Target, 2018 21
  • Figure 4: Type 2 Diabetes Mellitus, Global, Pipeline Size by Therapy Area, 2018 23
  • Figure 5: Type 2 Diabetes Mellitus, Global, Pipeline by Stage of Development and Molecule Type, 2018 24
  • Figure 6: Type 2 Diabetes Mellitus, Global Pipeline by Molecular Target and Stage of Development, 2018 25
  • Figure 7: Type 2 Diabetes Mellitus, Global, Pipeline Breakdown of GPCR and Protein Kinase Molecular Target Class, 2018 25
  • Figure 8: Type 2 Diabetes Mellitus, Global, Distribution of Pipeline and Marketed Products by Molecular Target Class, 2018 26
  • Figure 9: Type 2 Diabetes Mellitus, Global, Distribution of Pipeline Products by First-in-Class Status and Molecular Target Class, 2018 27
  • Figure 10: Type 2 Diabetes Mellitus, Global, Percentage Distribution of First-in-Class and Non-First-in-class Pipeline Programs by Stage of Development and Molecular Target Class, 2018 28
  • Figure 11: Type 2 Diabetes Mellitus, Global, Ratio of First-in-Class Products to First-in-Class Targets by Stage of Development and Molecular Target Class, 2018 29
  • Figure 12: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 1) 30
  • Figure 13: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 2) 31
  • Figure 14: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 3) 32
  • Figure 15: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 4) 33
  • Figure 16: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 5) 34
  • Figure 17: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 6) 34
  • Figure 18: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 7) 35
  • Figure 19: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 8) 35
  • Figure 20: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 9) 36
  • Figure 21: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 10) 36
  • Figure 22: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 11) 37
  • Figure 23: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 12) 38
  • Figure 24: Type 2 Diabetes Mellitus, Global, First-in-Class Molecular Target Matrix Assessment for Type 2 Diabetes Mellitus, 2018 (part 1) 41
  • Figure 25: Type 2 Diabetes Mellitus, Global, First-in-Class Molecular Target Matrix Assessment for Type 2 Diabetes Mellitus, 2018 (part 2) 42
  • Figure 26: Type 2 Diabetes Mellitus, Global, First-in-Class Molecular Target Matrix Assessment for Type 2 Diabetes Mellitus, 2018 (part 2) 43
  • Figure 27: Type 2 Diabetes Mellitus, Global, Industry-Wide Licensing Deals by First-in-Class Status and Stage of Development, 2006-2015 57
  • Figure 28: Type 2 Diabetes Mellitus, Global, Industry-Wide Licensing Deals by First-in-Class Status, Deal Value, Upfront Payment Value and Stage of Development, 2006-2014 58
  • Figure 29: Type 2 Diabetes Mellitus, Global Licensing Deals by Region, Value and Year 2006-2018 59
  • Figure 30: Type 2 Diabetes Mellitus, Global, Licensing Deals by Deal Value, Upfront Payment Value and Stage of Development, 2006-2018 59
  • Figure 31: Type 2 Diabetes Mellitus, Global, Number and Aggregate Deal Value of Licensing Deals by Molecule Type and Molecular Target Class, 2006-2018 60
  • Figure 32: Type 2 Diabetes Mellitus, Global, Licensing Deals with Disclosed Deal Values, 2006-2018 61
  • Figure 33: Type 2 Diabetes Mellitus, Global, Co-development Deals by Region, Value and Year 2006-2018 62
  • Figure 34: Type 2 Diabetes Mellitus, Global, Number and Aggregate Deal Value of Co-development Deals By Stage of Development and Year, 2006-2018 63
  • Figure 35: Type 2 Diabetes Mellitus, Global, Co-development Deals by Deal Value, Upfront Payment Value and Stage of Development, 2006-2018 64
  • Figure 36: Type 2 Diabetes Mellitus, Global, Co-development Deals with Disclosed Deal Values, 2006-2018 65
  • Figure 37: Type 2 Diabetes Mellitus, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2006-2018 (part 1) 66
  • Figure 38: Type 2 Diabetes Mellitus, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2006-2018 (part 2) 67
  • Figure 39: Type 2 Diabetes Mellitus, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2006-2018 (part 3) 68
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