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主要先進国における1型糖尿病治療薬市場 2021年:特許消滅にも関わらず革新的・多様なパイプラインが市場成長を促進

Type 1 Diabetes Mellitus Therapeutics in Major Developed Markets to 2021 - Innovative and Diversified Pipeline to Drive Market Growth Despite Patent Expirations

発行 GBI Research 商品コード 347556
出版日 ページ情報 英文 160 Pages
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主要先進国における1型糖尿病治療薬市場 2021年:特許消滅にも関わらず革新的・多様なパイプラインが市場成長を促進 Type 1 Diabetes Mellitus Therapeutics in Major Developed Markets to 2021 - Innovative and Diversified Pipeline to Drive Market Growth Despite Patent Expirations
出版日: 2015年11月01日 ページ情報: 英文 160 Pages
概要

1型糖尿病 (T1DM) は、慢性、進行性かつ重篤な疾患であり、通常は自己免疫反応の結果としてのインスリン分泌膵臓ベータ細胞の破壊または欠乏によって特徴づけられます。

当レポートでは、主要先進国における1型糖尿病治療薬市場について調査分析し、市場の概要、上市製品、パイプライン製品、市場予測、取引と戦略的統合などについて、体系的な情報を提供しています。

第1章 目次

第2章 イントロダクション

  • 疾患の概要
  • 糖尿病の分類
  • 症状
  • 病因
    • 遺伝
    • 年齢
    • 早食い
    • 病原体への暴露
    • ビタミンDの不足
  • 病態生理学
  • 疫学
  • 併存疾患と合併症
    • 急性代謝性合併症
    • 長期的血管合併症
    • その他の併存疾患・合併症
  • 診断
  • 治療法
    • インスリン療法
    • 非インスリン補助療法
    • ライフスタイル改善
    • ベータ細胞置き換え療法
  • 治療アルゴリズム
    • MDI治療法向け基礎インスリン
    • MDI治療法向けボーラス
    • CSII向けボーラス

第3章 上市済み製品

  • 概要
  • ヒトインスリン製品
    • ヒューマリン製品:Eli Lilly
    • ノボリン製品:Novo Nordisk
    • アフレッツア製品:Sanofi・MannKind Corporation
  • インスリンアナログ製品
    • Humalog (インスリンリスプロ):Eli Lilly and Company
    • Novolog (インスリンアスパルト) :Novo Nordisk
    • Apidra (インスリングルリジン):Sanofi
    • Lantus (インスリングラルギン):Sanofi
    • Levemir (インスリンデテミル):Novo Nordisk
    • Tresiba (インスリンデグルデク) ・Ryzodeg (インスリンデグルデク・インスリンアスパルト):Novo Nordisk
    • Toujeo (インスリングラルギン): Sanofi

第4章 パイプライン製品

  • 概要
  • パイプライン:開発ステージ・分子タイプ・投与経路・プログラムタイプ
  • パイプライン分布:分子標的別
    • パイプラインにおける分子標的グループ
  • 治験状況
    • 治験の失敗率
    • 治験の期間
    • 治験の規模
    • 治験メトリクスの比較分析
  • 有望なパイプライン分子
    • インスリン療法
    • 非インスリン補助療法

第5章 市場予測

  • 地域市場
  • 世界市場
  • 北米
    • 治療の利用パターン
    • 治療の年間コスト
    • 市場規模
  • 欧州の主要5か国
  • 日本
  • T1DM治療薬市場の促進因子・障壁

第6章 戦略的合併

  • ライセンシング
  • 共同開発

第7章 付録

図表リスト

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目次
Product Code: GBIHC372MR

Executive Summary

Type 1 Diabetes Mellitus (T1DM) is a chronic, progressive and serious disease characterized by a destruction or failure of insulin-secreting pancreatic beta cells, usually as a result of an autoimmune response. The resulting insulin deficiency prevents insulin-sensitive cells from carrying out essential glucose metabolism and leads to hyperglycemia (high blood glucose levels). As a result, immediate and lifelong treatment with exogenous insulin therapy is initiated upon diagnosis of T1DM. Exogenous insulin has remained the mainstay of T1DM therapy since it was used to treat the first human patient in 1922.

Consequently, insulin products comprise the vast majority of the T1DM market, which is largely monopolized by three big pharma players: Eli Lilly, Novo Nordisk and Sanofi. However, insulin treatment regimens are often inconvenient and are associated with undesirable side effects such as hypoglycemia (low blood glucose levels) and weight gain. In addition, there is a significant unmet need for more diversified treatment options including therapies capable of altering the clinical course of the pathological beta cell destruction and adjuvant therapies capable of improving glycemic control and reducing insulin requirements.

Scope

The report assesses the current T1DM market and forecasts market trends to 2021. Areas covered include -

  • An introduction to T1DM, which includes classification, symptoms, etiology, pathophysiology, co-morbidities and complications, diagnosis and treatment
  • An analysis of the leading insulin therapies in the current T1DM marketed products landscape.
  • An analysis of the pipeline for T1DM. This includes a breakdown of pipeline molecules by stage of development, molecule type, route of administration, molecular target and novelty. Trends in T1DM clinical trial size, duration and failure rates, by molecule type and molecular target are discussed. A comparative analysis of the most promising pipeline molecules is also provided.
  • Forecast projections for the T1DM market to 2021. An analysis is provided for the global market and each of the eight major markets. The forecast incorporates projected, low and high variance scenarios based on treatment usage patterns and annual therapy costs in each of the major markets.
  • An analysis of strategic consolidations, including co-development and licensing deals, within the T1DM indication.

Reasons to buy

  • The report will provide clients with a strong understanding of the T1DM indication and an appreciation of the evolving landscape of the T1DM therapeutics market. The report will enable clients to -
  • Appreciate the current T1DM marketed products landscape, including the dominant therapeutic strategies, products, and companies, and recognize gaps within the market and areas of unmet need
  • Identify trends and developments within the T1DM pipeline and consider how the future competitive environment will be impacted.
  • Consider market opportunities and potential risks by examining trends in T1DM clinical trial duration and size, as well as clinical trial failure rates, amongst clinical phases and molecule types
  • Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the T1DM therapeutics market
  • Understand how strategic consolidations have shaped the current T1DM pipeline and marketed products landscapes

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Disease Overview
  • 2.2. Classification of Diabetes Mellitus
  • 2.3. Symptoms
  • 2.4. Etiology
    • 2.4.1. Genetics
    • 2.4.2. Age
    • 2.4.3. Early Diet
    • 2.4.4. Exposure to Infectious Agents
    • 2.4.5. Vitamin D Deficiency
  • 2.5. Pathophysiology
  • 2.6. Epidemiology
  • 2.7. Co-morbidities and Complications
    • 2.7.1. Acute Metabolic Complications
    • 2.7.2. Long-term Vascular Complications
    • 2.7.3. Other Co-morbidities and Complications
  • 2.8. Diagnosis
  • 2.9. Treatment
    • 2.9.1. Insulin Therapy
    • 2.9.2. Non-insulin Adjunctive Therapy
    • 2.9.3. Lifestyle Modifications
    • 2.9.4. Beta Cell Replacement Therapy
  • 2.10. Treatment Algorithm
    • 2.10.1. Basal Insulin for MDI Therapy
    • 2.10.2. Bolus Insulin for MDI Therapy
    • 2.10.3. Bolus Insulin for CSII

3. Marketed Products

  • 3.1. Overview
  • 3.2. Human Insulin Products
    • 3.2.1. Humulin Products - Eli Lilly
    • 3.2.2. Novolin Products - Novo Nordisk
    • 3.2.3. Afrezza (insulin human) - Sanofi and MannKind Corporation
  • 3.3. Insulin Analog Products
    • 3.3.1. Humalog (insulin lispro) - Eli Lilly and Company
    • 3.3.2. Novolog (insulin aspart) Products - Novo Nordisk
    • 3.3.3. Apidra (insulin glulisine) - Sanofi
    • 3.3.4. Lantus (insulin glargine) - Sanofi
    • 3.3.5. Levemir (insulin detemir) - Novo Nordisk
    • 3.3.6. Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart) - Novo Nordisk
    • 3.3.7. Toujeo (insulin glargine) - Sanofi

4. Pipeline

  • 4.1. Overview
  • 4.2. Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type
  • 4.3. Pipeline Distribution by Molecular Target
    • 4.3.1. Molecular Target Groups in the Pipeline
  • 4.4. Clinical Trial Landscape
    • 4.4.1. Clinical Trial Failure Rates
    • 4.4.2. Clinical Trial Duration
    • 4.4.3. Clinical Trial Size
    • 4.4.4. Comparative Clinical Trial Metrics Analysis
  • 4.5. Promising Pipeline Molecules
    • 4.5.1. Insulin Therapies
    • 4.5.2. Non-insulin Adjuvant Therapies

5. Market Forecast to 2021

  • 5.1. Geographical Markets
  • 5.2. Global Markets
  • 5.3. North America
    • 5.3.1. Treatment Usage Patterns
    • 5.3.2. Annual Cost of Therapy
    • 5.3.3. Market Size
  • 5.4. Top Five European Markets
    • 5.4.1. Treatment Usage Patterns
    • 5.4.2. Annual Cost of Therapy
    • 5.4.3. Market Size
  • 5.5. Japan
    • 5.5.1. Treatment Usage Patterns
    • 5.5.2. Annual Cost of Therapy
    • 5.5.3. Market Size
  • 5.6. Drivers and Barriers for the T1DM Therapeutics Market
    • 5.6.1. Drivers
    • 5.6.2. Barriers

6. Strategic Consolidations

  • 6.1. Licensing Deals
    • 6.1.1. ViaCyte Enters into Option for Licensing Agreement with Janssen Research & Development
    • 6.1.2. Eli Lilly Enters into Licensing Agreement with MacroGenics
    • 6.1.3. Bayhill Therapeutics Enters into Licensing Agreement with Genentech
    • 6.1.4. King's College Enters into Licensing Agreement with UCB
    • 6.1.5. Nuvilex Enters into Licensing Agreement with University of Technology Sydney
    • 6.1.6. Sanofi Enters into Licensing Agreement with MannKind for Afrezza
    • 6.1.7. Eli Lilly Enters into Licensing Agreement with Adocia
  • 6.2. Co-development Deals
    • 6.2.1. GlaxoSmithKline Signs Partnership Agreement with Tolerx
    • 6.2.2. Diamyd Medical Enters into Co-Development Agreement with Ortho-McNeil-Janssen
    • 6.2.3. Osiris Therapeutics Enters into an Agreement with Juvenile Diabetes Research Foundation International
    • 6.2.4. Transition Therapeutics Enters into Co-Development Agreement with Juvenile Diabetes Research Foundation
    • 6.2.5. BioLineRx Enters into Co-Development Agreement with JHL Biotech

7. Appendix

  • 7.1. All Pipeline Drugs by Phase of Development
    • 7.1.1. Discovery
    • 7.1.2. Preclinical
    • 7.1.3. IND/CTA-filed
    • 7.1.4. Phase I
    • 7.1.5. Phase II
    • 7.1.6. Phase III
    • 7.1.7. Pre-registration
  • 7.2. Market Forecasts to 2021
    • 7.2.1. Global
    • 7.2.2. US
    • 7.2.3. Canada
    • 7.2.4. UK
    • 7.2.5. France
    • 7.2.6. Germany
    • 7.2.7. Italy
    • 7.2.8. Spain
    • 7.2.9. Japan
  • 7.3. References
  • 7.4. Heat Map References
  • 7.5. Abbreviations
  • 7.6. Research Methodology
  • 7.7. Secondary Research
  • 7.8. Marketed Product Profiles
  • 7.9. Late-Stage Pipeline Candidates
  • 7.10. Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products
  • 7.11. Product Competitiveness Framework
  • 7.12. Pipeline Analysis
    • 7.12.1. Overall Pipeline
    • 7.12.2. Clinical Trials
    • 7.12.3. Failure Rate
    • 7.12.4. Clinical Trial Size
    • 7.12.5. Clinical Trial Duration
    • 7.12.6. Clinical Trial Endpoint Analysis
  • 7.13. Forecasting Model
  • 7.14. Deals Data Analysis
  • 7.15. Expert Panel Validation
  • 7.16. Contact Us
  • 7.17. Disclaimer

List of Tables

  • Table 1: T1DM Therapeutics Market, Common Endpoints in T1DM Trials
  • Table 2: T1DM Therapeutics Market, Global, Breakdown of Multiple Molecular Targets, 2015
  • Table 3: T1DM Therapeutics Market, Global, Breakdown of 'Other' Molecular Targets, 2015
  • Table 4: T1DM Therapeutics Market, Global, All Pipeline Products, Discovery Phase, 2015
  • Table 5: T1DM Therapeutics Market, Global, All Pipeline Products, Preclinical Phase, 2015
  • Table 6: T1DM Therapeutics Market, Global, All Pipeline Products, IND/CTA-filed Phase, 2015
  • Table 7: T1DM Therapeutics Market, Global, All Pipeline Products, Phase I, 2015
  • Table 8: T1DM Therapeutics Market, Global, All Pipeline Products, Phase II, 2015
  • Table 9: T1DM Therapeutics Market, Global, All Pipeline Products, Phase III, 2015
  • Table 10: T1DM Therapeutics Market, Global, All Pipeline Products, Pre-registration Phase, 2015
  • Table 11: T1DM Therapeutics Market, Global, Market Forecast, 2014-2021
  • Table 12: T1DM Therapeutics Market, US, Market Forecast, 2014-2021
  • Table 13: T1DM Therapeutics Market, Canada, Market Forecast, 2014-2021
  • Table 14: T1DM Therapeutics Market, UK, Market Forecast, 2014-2021
  • Table 15: T1DM Therapeutics Market, France, Market Forecast, 2014-2021
  • Table 16: T1DM Therapeutics Market, Germany, Market Forecast, 2014-2021
  • Table 17: T1DM Therapeutics Market, Italy, Market Forecast, 2014-2021
  • Table 18: T1DM Therapeutics Market, Spain, Market Forecast, 2014-2021
  • Table 19: T1DM Therapeutics Market, Japan, Market Forecast, 2014-2021

List of Figures

  • Figure 1: T1DM Therapeutics Market, Global, Marketed Basal Insulin Products for MDI Regimens, 2015
  • Figure 2: T1DM Therapeutics Market, Global, Marketed Basal Insulin Products for MDI Regimens (continued), 2015
  • Figure 3: T1DM Therapeutics Market, Global, Marketed Basal Insulin Products for MDI Regimens (continued), 2015
  • Figure 4: T1DM Therapeutics Market, Global, Marketed Basal Insulin Products for MDI Regimens (continued), 2015
  • Figure 5: T1DM Therapeutics Market, Global, Marketed Bolus Insulin Products for MDI Regimens, 2015
  • Figure 6: T1DM Therapeutics Market, Global, Marketed Bolus Insulin Products for CSII, 2015
  • Figure 7: T1DM Therapeutics Market, Global, Pipeline, 2015
  • Figure 8: T1DM Therapeutics Market, Global, Pipeline by Molecular Target, 2015
  • Figure 9: T1DM Therapeutics Market, Global, Breakdown of Molecular Target Groups, 2015
  • Figure 10: T1DM Therapeutics Market, Global, Clinical Trial Failure Rates and Reasons for Failure, 2006-2015
  • Figure 11: T1DM Therapeutics Market, Global, Clinical Trial Failure Rate by Molecule Type, 2006-2015
  • Figure 12: T1DM Therapeutics Market, Global, Clinical Trial Failure Rate by Molecular Target, 2006-2015
  • Figure 13: T1DM Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2015
  • Figure 14: T1DM Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2015
  • Figure 15: T1DM Therapeutics Market, Global, Clinical Trial Recruitment Size by Stage of Development and Molecule Type (participants), 2006-2015
  • Figure 16: T1DM Therapeutics Market, Global, Clinical Trial Recruitment Size by Stage of Development and Molecular Target (participants), 2006-2015
  • Figure 17: T1DM Therapeutics Market, Global, Average Failure Rate (%), Average Clinical Trial Duration (months), Average Clinical Trial Recruitment Size (participants) and Average Cumulative Clinical Trial Recruitment Size (participants) by Stage of Development and Molecule Type, 2006-2015
  • Figure 18: T1DM Therapeutics Market, Global, Average Failure Rate (%), Average Clinical Trial Duration (months), Average Clinical Trial Recruitment Size (participants) and Average Cumulative Clinical Trial Recruitment Size (participants) by Stage of Development and Molecular Target, 2006-2015
  • Figure 19: T1DM Therapeutics Market, Global, NN-1218 Forecast ($m), 2017-2021
  • Figure 20: T1DM Therapeutics Market, Global, Insulin Peglispro Forecast ($m), 2018-2021
  • Figure 21: T1DM Therapeutics Market, Global, Jardiance Forecast ($m), 2018-2021
  • Figure 22: T1DM Therapeutics Market, Global, Farxiga Forecast ($m), 2018-2021
  • Figure 23: T1DM Therapeutics Market, Global, Sotagliflozin Forecast ($m), 2018-2021
  • Figure 24: T1DM Therapeutics Market, Global, Glassia Forecast ($m), 2018-2021
  • Figure 25: T1DM Therapeutics Market, Global, Adjuvant Therapy Pipeline Products, 2015
  • Figure 26: T1DM Therapeutics Market, Global, Treatment Usage Patterns (million), 2014-2021
  • Figure 27: T1DM Therapeutics Market, Global, Market Size ($bn), 2014-2021
  • Figure 28: T1DM Therapeutics Market, North America, Treatment Patterns, 2014-2021
  • Figure 29: T1DM Therapeutics Market, North America, Annual Cost of Therapy ($), 2014-2021
  • Figure 30: T1DM Therapeutics Market, North America, Market Size, 2014-2021
  • Figure 31: T1DM Therapeutics Market, Top Five European Countries, Treatment Usage Patterns ('000), 2014-2021
  • Figure 32: T1DM Therapeutics Market, Top Five Countries of Europe, Annual Cost of Therapy ($), 2014-2021
  • Figure 33: T1DM Therapeutics Market, Top Five Countries of Europe, Market Size ($m), 2014-2021
  • Figure 34: T1DM Therapeutics Market, Japan, Treatment Usage Patterns ('000), 2014-2021
  • Figure 35: T1DM Therapeutics Market, Japan, Annual Cost of Therapy ($), 2014-2021
  • Figure 36: T1DM Therapeutics Market, Japan, Market Size ($m), 2014-2021
  • Figure 37: T1DM Therapeutics Market, Global, Licensing Deals by Region and Deal Value ($m), 2006-2015
  • Figure 38: T1DM Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, 2006-2014
  • Figure 39: T1DM Therapeutics Market, Global, Licensing Deals by Deal Value ($m), Upfront Payment Value ($m) and Stage of Development, 2006-2015
  • Figure 40: T1DM Therapeutics Market, Global, Licensing Deals by Stage of Development, Molecule Type and Aggregate Deal Value ($m), 2006-2015
  • Figure 41: T1DM Therapeutics Market, Global, Co-development Deals by Region and Deal Value ($m), 2006-2015
  • Figure 42: T1DM Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, 2006-2014
  • Figure 43: T1DM Therapeutics Market, Global, Co-development Deals by Deal Value ($m), Upfront Payment Value ($m) and Stage of Development, 2006-2015
  • Figure 44: T1DM Therapeutics Market, Global, Co-development Deals by Stage of Development, Molecule Type and Aggregate Deal Value ($m), 2006-2015
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