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市場調查報告書

第一型糖尿病:全球藥物預測及市場分析

PharmaPoint: Type 1 Diabetes - Global Drug Forecast and Market Analysis to 2023

出版商 GlobalData 商品編碼 329463
出版日期 內容資訊 英文 289 Pages
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第一型糖尿病:全球藥物預測及市場分析 PharmaPoint: Type 1 Diabetes - Global Drug Forecast and Market Analysis to 2023
出版日期: 2015年03月01日 內容資訊: 英文 289 Pages
簡介

第一型糖尿病是自體免疫疾病,由於胰島的β細胞永久破壞,是在體內無法產生胰島素的病。過去90年以上胰島素治療持續進行。長有期作用型、速效型等具各種作用期胰島素類似物在過去10年上市,同時,也進行了血糖監測系統等其他的開發,胰島素給藥系統也大幅進步。第一型糖尿病市場預計今後10年從66億美元向規模,擴大到約2倍的136億美元。

本報告提供第一型糖尿病的概要與治療方法、市場收益與預測、開發平台分析、現在及未來的競爭趨勢、各國家趨勢、參與企業簡介等彙整資料。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因與病理學
  • 症狀
  • 預後
  • 生活品質

第4章 流行病學

  • 疾病的背景
  • 風險係數和共生病症
  • 全球趨勢
    • 美國
    • EU
    • 日本
    • 加拿大
  • 預測方法
  • 第一型糖尿病的流行病學預測
  • 討論

第5章 疾病管理

  • 診斷和治療概要
    • 臨床評估
    • 治療指南主要的處方藥
    • 臨床現況
  • 美國
  • 法國
  • 德國
  • 義大利
  • 西班牙
  • 英國
  • 日本
  • 加拿大

第6章 競爭評估

  • 概要
  • 目前治療方法

第7章 未滿足需求和機會

  • 概要
  • 疾病調整治療:β細胞的保存
  • 避免低血糖
  • 減重和代謝症候群的控制
  • 不穩定性糖尿病的治療
  • 對於治療的提高患者遵守度

第8章 開發平台評估

  • 概要
  • 臨床實驗製圖
  • 臨床開發的潛力藥物
  • 生技仿製藥胰島素
  • 人工胰臟
  • 早期開發階段

第9章 現在及未來加入廠商

  • 概要
  • 企業策略趨勢
  • 企業簡介
    • Novo Nordisk
    • Sanofi 207
    • Eli Lilly

第10章 市場預測

  • 全球市場
    • 預測
    • 促進要素與阻礙:全球的課題
  • 美國
  • EU
  • 日本
  • 加拿大

第11章 附錄

圖表

目錄
Product Code: GDHC105PIDR

Type 1 diabetes (T1D) is an autoimmune disease that permanently destroys beta cells of the pancreatic islet, which means that the body can no longer produce insulin. Over the last 90 years, insulin therapy has been evolving continuously, as at present, no other treatment can be offered to a patient who is newly diagnosed with T1D. A variety of insulin analogs with different times of action - long-acting as well as short or rapid-acting analogs - have been on the market for the past decade. In addition, many other developments were happening in parallel, such as glucose monitoring and significant advances in insulin delivery systems. The T1D market will approximately double over the forecast period, growing from $6.6 billiion to $13.6 billion.This growth will be fueled by the significant increase in T1D prevalence as well as the uptake of the novel ultra-long-acting insulin analogs, novel ultra-rapid formulations of insulin analogs, and the adjunct therapies for T1D. The launches of these novel products will offset the dip in sales caused by the patent expiries of seven insulin products, and the consequent emergence of biosimilars.

Highlights

Key Questions Answered

  • Insulin therapy has been the cornerstone of the T1D treatment. The advances in insulin therapies have contributed to better treatment of T1D patients; nevertheless, the overall life expectancy in T1D patients is still 10-15 years less than in the healthy population. Therefore, there are considerably high unmet needs within the indication. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the T1D market?
  • The current late-stage T1D pipeline encompasses one novel ultra-long-acting insulin analog, several novel ultra-rapid formulations of already marketed human insulins and rapid-insulin analogs, biosimilar versions of marketed insulins, and last but not least, adjunctive therapies that are focused on complementing intensive insulin therapy. Will the late-stage drugs make a significant impact on the T1D market? Which of these drugs will have the highest peak sales at the highest CAGR, and why?
  • We have seen a significant increase in T1D diagnosed prevalence over the past 10 years. How will epidemiological changes impact the growth of the future market?

Key Findings

  • The main driver of the enormous expansion of the T1D market will be the significant increase in T1D diagnosed prevalence as well as the uptake of novel ultra-long-acting insulin analogs , novel ultra-rapid-acting formulations of currently marketed rapid-acting insulin analogs and adjunct therapies such as GLP-1 RAs and SGLT-2, inhibitors.
  • The major global barrier for the T1Dmarket will be the biosimilar erosion of the leading insulin brands for T1D treatment, such as Lantus (insulin glargine), Levemir (insulin detemir), Humalog (insulin lispro), and NovoLog (insulin aspart).
  • The dynamics of the insulin market will not change drastically over the next 10 years in terms of the current and future players in the T1D market and GlobalData expects that Novo Nordisk, Sanofi, and Eli Lilly will continue ruling this space, as they are undertaking various strategies to defend their franchises from upcoming biosimilar erosion.
  • One of the largest unmet needs is a need for therapies that would interfere with the pathogenic processes involved in the eradication of the beta cells in T1D patients. Other unmet needs include hypoglycemia avoidance, weight loss and control of the associated metabolic syndrome, treatment for brittle diabetes, and increased patient compliance.

Scope

  • Overview of type 1 diabetes, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized T1D therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2013 and forecast for ten years to 2023.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the T1D therapeutics market.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global T1Dtherapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Additionally a list of acquisition targets included in the pipeline product company list.
  • Develop business strategies by understanding the trends shaping and driving the global T1D therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global T1D therapeutics market in future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Track drug sales in the global T1D therapeutics market from 2013-2023.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1. Table of Contents

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

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports
  • 2.3. Upcoming Related Reports

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
    • 3.1.3. Biomarkers for Monitoring the Islet Autoreactivity of Type 1 Diabetes
  • 3.2. Symptoms
  • 3.3. Prognosis
  • 3.4. Quality of Life

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
  • 4.3. Global Trends
    • 4.3.1. US
    • 4.3.2. 5EU
    • 4.3.3. Japan
    • 4.3.4. Canada
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Sources Not Used
    • 4.4.3. 8MM, Forecast Assumptions and Methods - Diagnosed Prevalent Cases of Type 2 Diabetes in Persons Ages ≥20 Years
    • 4.4.4. 8MM, Forecast Assumptions and Methods - Diagnosed Prevalent Cases of Type 1 Diabetes
  • 4.5. Epidemiological Forecast for Type 1 Diabetes (2013-2023)
    • 4.5.1. Diagnosed Prevalent Cases of Type 1 Diabetes
    • 4.5.2. Age-Specific Diagnosed Prevalent Cases of Type 1 Diabetes
    • 4.5.3. Sex-Specific Diagnosed Prevalent Cases of Type 1 Diabetes
    • 4.5.4. Age-Standardized Diagnosed Prevalence of Type 1 Diabetes
    • 4.5.5. Diagnosed Prevalent Cases of Type 1 Diabetes Segmented by Body Mass Index
  • 4.6. Discussion
    • 4.6.1. Epidemiological Forecast Insight
    • 4.6.2. Limitations of the Analysis
    • 4.6.3. Strengths of the Analysis

5. Disease Management

  • 5.1. Diagnosis and Treatment Overview
    • 5.1.1. Diagnosis
    • 5.1.2. Treatment Guidelines and Leading Prescribed Therapies
    • 5.1.3. Clinical Practice
  • 5.2. US
  • 5.3. France
  • 5.4. Germany
  • 5.5. Italy
  • 5.6. Spain
  • 5.7. UK
  • 5.8. Japan
  • 5.9. Canada

6. Competitive Assessment

  • 6.1. Overview
  • 6.2. Current Treatments
    • 6.2.1. Human Insulins (Injectable Formulations)
    • 6.2.2. Humalog (insulin lispro)
    • 6.2.3. NovoLog/NovoRapid (insulin aspart)
    • 6.2.4. Apidra (insulin glulisine)
    • 6.2.5. Lantus (insulin glargine)
    • 6.2.6. Levemir (insulin detemir)
    • 6.2.7. Tresiba (insulin degludec)
    • 6.2.8. Pancreas and Islet Cell Transplantation

7. Unmet Need and Opportunity

  • 7.1. Overview
  • 7.2. Disease-Modifying Treatment - Preservation of Beta Cells
    • 7.2.1. Unmet Need
    • 7.2.2. Gap Analysis
    • 7.2.3. Opportunity
  • 7.3. Hypoglycemia Avoidance
    • 7.3.1. Unmet Need
    • 7.3.2. Gap Analysis
    • 7.3.3. Opportunity
  • 7.4. Weight Loss and Control of Associated Metabolic Syndrome
    • 7.4.1. Unmet Need
    • 7.4.2. Gap Analysis
    • 7.4.3. Opportunity
  • 7.5. Treatment for Brittle Diabetes
    • 7.5.1. Unmet Need
    • 7.5.2. Gap Analysis
    • 7.5.3. Opportunity
  • 7.6. Increased Patient Adherence to Therapy
    • 7.6.1. Unmet Need
    • 7.6.2. Gap Analysis
    • 7.6.3. Opportunity

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Clinical Trial Mapping
    • 8.2.1. Clinical Trials by Class/Patient Population/Biomarkers/Line of Therapy
  • 8.3. Promising Drugs in Clinical Development
    • 8.3.1. Novel Ultra-Long-Acting Insulin Analog: Insulin Peglispro
    • 8.3.2. Novel Formulation of Insulin Glargine: Toujeo
    • 8.3.3. Novel Inhalable Formulation of Human Insulin: Afrezza (Technosphere Insulin)
    • 8.3.4. Ultra-Rapid-Acting Formulations of Marketed Insulins and Insulin Analogs
    • 8.3.5. Adjunct Therapies
  • 8.4. Biosimilar Insulins
    • 8.4.1. Overview of the Regulatory Processes for Biosimilar Insulins
    • 8.4.2. Biosimilar Insulins Pipeline
    • 8.4.3. Forecast
  • 8.5. Artificial Pancreas
  • 8.6. Early-Stage Development: Disease-Modifying Therapies for T1D and Smart Insulins

9. Current and Future Players

  • 9.1. Overview
  • 9.2. Trends in Corporate Strategy
  • 9.3. Company Profiles
    • 9.3.1. Novo Nordisk
    • 9.3.2. Sanofi
    • 9.3.3. Eli Lilly

10. Market Outlook

  • 10.1. Global Markets
    • 10.1.1. Forecast
    • 10.1.2. Drivers and Barriers - Global Issues
  • 10.2. United States
    • 10.2.1. Forecast
    • 10.2.2. Key Events
    • 10.2.3. Drivers and Barriers
  • 10.3. 5EU
    • 10.3.1. Forecast
    • 10.3.2. Key Events
    • 10.3.3. Drivers and Barriers
  • 10.4. Japan
    • 10.4.1. Forecast
    • 10.4.2. Key Events
    • 10.4.3. Drivers and Barriers
  • 10.5. Canada
    • 10.5.1. Forecast
    • 10.5.2. Key Events
    • 10.5.3. Drivers and Barriers

11. Appendix

  • 11.1. Bibliography
  • 11.2. Abbreviations
  • 11.3. Methodology
  • 11.4. Forecasting Methodology
    • 11.4.1. Diagnosed Type 1 Diabetes Patients
    • 11.4.2. Percent Drug-Treated Patients
    • 11.4.3. Drugs Included in Each Therapeutic Class
    • 11.4.4. Launch and Patent Expiry Dates
    • 11.4.5. General Pricing Assumptions
    • 11.4.6. Individual Drug Assumptions
    • 11.4.7. Pricing of Pipeline Agents
  • 11.5. Physicians and Specialists Included in This Study
  • 11.6. About the Authors
    • 11.6.1. Author
    • 11.6.2. Epidemiologist
    • 11.6.3. Global Head of Healthcare
  • 11.7. About GlobalData
  • 11.8. Disclaimer

List of Tables

  • Table 1: Symptoms of T1D
  • Table 2: Risk Factors and Comorbidities for T1D
  • Table 3: 8MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of T1D
  • Table 4: 8MM, Sources of Epidemiological Data Used for the Prevalent Cases of T1D Segmented by BMI
  • Table 5: 8MM, Sources Not Used in the Epidemiological Analysis of T1D
  • Table 6: 8MM, Diagnosed Prevalent Cases of T1D, All Ages, Both Sexes, N, 2013-2023
  • Table 7: 8MM, Diagnosed Prevalent Cases of T1D, by Age, Both Sexes, N (Row %), 2013
  • Table 8: 8MM, Diagnosed Prevalent Cases of T1D, by Sex, All Ages, N (Row %), 2013
  • Table 9: Diagnostic Tests and Typical Criteria for Diagnosing T1D
  • Table 10: Treatment Guidelines for T1D
  • Table 11: Most Prescribed Drugs for T1D in the 8MM, 2014
  • Table 12: Percent of Patients on Different Insulin Regimens in the 8MM, 2013
  • Table 13: Country Profile, T1D Management - US
  • Table 14: Country Profile, T1D Management - France
  • Table 15: Country Profile, T1D Management - Germany
  • Table 16: Country Profile, T1D Management - Italy
  • Table 17: Country Profile, T1D Management - Spain
  • Table 18: Country Profile, T1D Management - United Kingdom
  • Table 19: Country Profile, T1D Management - Japan
  • Table 20: Country Profile, T1D Management - Canada
  • Table 21: Insulins - Overview and Comparison
  • Table 22: Leading Treatments for Type 1 Diabetes, 2014
  • Table 23: Efficacy - Novolin R versus NovoLog
  • Table 24: Human Insulins SWOT Analysis, 2014
  • Table 25: Global Sales Forecasts ($m) for Human Insulins (Regular, NPH, and Mix), 2013-2023
  • Table 26: Product Profile - Humalog
  • Table 27: Efficacy - Humalog versus Regular Human Insulin (Humulin R)
  • Table 28: Adverse Events - Humalog versus Regular Human Insulin (Humulin R)
  • Table 29: Humalog SWOT Analysis, 2014
  • Table 30: Global Sales Forecasts ($m) for Humalog, 2013-2023
  • Table 31: Product Profile - NovoLog/NovoRapid
  • Table 32: Efficacy - NovoLog versus Regular Human Insulin (Novolin R)
  • Table 33: Adverse Events - NovoLog versus Regular Human Insulin (Novolin R)
  • Table 34: NovoLog SWOT Analysis, 2014
  • Table 35: Global Sales Forecasts ($m) for NovoLog, 2013-2023
  • Table 36: Product Profile - Apidra
  • Table 37: Efficacy - Apidra versus Humalog
  • Table 38: Adverse Events from Pooled Studies - Humalog versus Comparators
  • Table 39: Apidra SWOT Analysis, 2014
  • Table 40: Global Sales Forecasts ($m) for Apidra, 2013-2023
  • Table 41: Product Profile - Lantus
  • Table 42: Efficacy - Lantus versus NPH Insulin
  • Table 43: Adverse Events from Pooled Studies in Adults - Lantus versus NPH insulin
  • Table 44: Lantus SWOT Analysis, 2014
  • Table 45: Global Sales Forecasts ($m) for Lantus, 2013-2023
  • Table 46: Product Profile - Levemir
  • Table 47: Efficacy - Levemir versus Lantus in Adult T1D Patients
  • Table 48: Adverse Events from Two Pooled Studies in Adults - Levemir versus Lantus
  • Table 49: Levemir SWOT Analysis, 2014
  • Table 50: Global Sales Forecasts ($m) for Levemir, 2013-2023
  • Table 51: Product Profile - Tresiba
  • Table 52: Efficacy - Tresiba versus Lantus in Adult T1D Patients (52-Week Trial)
  • Table 53: Rate of Hypoglycemia - Levemir versus Lantus
  • Table 54: Tresiba SWOT Analysis, 2014
  • Table 55: Global Sales Forecasts ($m) for Tresiba, 2013-2023
  • Table 56: Unmet Need and Opportunity in T1D
  • Table 57: T1D - Late-Stage Pipeline Excluding Biosimilars, 2014
  • Table 58: Product Profile - Insulin Peglispro
  • Table 59: Insulin Peglispro SWOT Analysis, 2014
  • Table 60: Global Sales Forecasts ($m) for Insulin Peglispro, 2013-2023
  • Table 61: Product Profile - Toujeo
  • Table 62: Toujeo SWOT Analysis, 2014
  • Table 63: Global Sales Forecasts ($m) for Toujeo, 2013-2023
  • Table 64: Product Profile - Afrezza
  • Table 65: Efficacy - Afrezza versus NovoLog
  • Table 66: Adverse Events - Afrezza versus Subcutaneous Insulin
  • Table 67: Afrezza SWOT Analysis, 2014
  • Table 68: Global Sales Forecasts ($m) for Afrezza, 2013-2023
  • Table 69: Overview of Ultra-Rapid-Acting Insulin Formulations in Later-Stage Development, 2014
  • Table 70: Ultra-Rapid Insulin Formulations SWOT Analysis, 2014
  • Table 71: Global Sales Forecasts ($m) for Ultra-Rapid-Acting Insulin Formulations, 2013-2023
  • Table 72: Product Profile - Victoza
  • Table 73: Victoza SWOT Analysis, 2014
  • Table 74: Global Sales Forecasts ($m) GLP-1 Receptor Agonists, 2013-2023
  • Table 75: Product Profile - Jardiance
  • Table 76: Jardiance SWOT Analysis, 2014
  • Table 77: Global Sales Forecasts ($m) for SGLT-2 inhibitors, 2013-2023
  • Table 78: Drugs in Phase I and Phase II Development for T1D,* 2014
  • Table 79: Key Companies in the T1D Market in the 8MM, 2014
  • Table 80: Novo Nordisk's T1D Portfolio Assessment, 2014
  • Table 81: Novo Nordisk SWOT Analysis, 2014
  • Table 82: Sanofi's T1D Portfolio Assessment, 2014
  • Table 83: Sanofi SWOT Analysis, 2014
  • Table 84: Eli Lilly's T1D Portfolio Assessment, 2014
  • Table 85: Eli Lilly SWOT Analysis, 2014
  • Table 86: Global Sales Forecasts ($m) for Type 1 Diabetes, 2013-2023
  • Table 87: Type 1 Diabetes Market - Drivers and Barriers, 2014
  • Table 88: Sales Forecasts ($m) for Type 1 Diabetes in the United States, 2013-2023
  • Table 89: Key Events Impacting Sales for T1D in the US, 2013-2023
  • Table 90: Type 1 Diabetes Market - Drivers and Barriers in the US, 2014
  • Table 91: Sales Forecasts ($m) for Type 1 Diabetes in the 5EU, 2013-2023
  • Table 92: Key Events Impacting Sales for T1D in the 5EU, 2013-2023
  • Table 93: Type 1 Diabetes Market - Drivers and Barriers in the 5EU, 2014
  • Table 94: Sales Forecasts ($m) for Type 1 Diabetes in Japan, 2013-2023
  • Table 95: Key Events Impacting Sales for T1D in Japan, 2013-2023
  • Table 96: Type 1 Diabetes Market - Drivers and Barriers in Japan, 2014
  • Table 97: Sales Forecasts ($m) for Type 1 Diabetes in Canada, 2013-2023
  • Table 98: Key Events Impacting Sales for T1D in Canada, 2013-2023
  • Table 99: Type 1 Diabetes Market - Drivers and Barriers in Canada, 2014
  • Table 100: Key Launch Dates
  • Table 101: Key Patent Expiries
  • Table 102: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country

List of Figures

  • Figure 1: Etiology of T1D
  • Figure 2: 8MM, Diagnosed Prevalent Cases of T1D, All Ages, Both Sexes, N, 2013-2023
  • Figure 3: 8MM, Diagnosed Prevalent Cases of T1D, by Age, Both Sexes, N, 2013-2023
  • Figure 4: 8MM, Diagnosed Prevalent Cases of T1D, by Sex, All Ages, N, 2013
  • Figure 5: 8MM, Age-Standardized Diagnosed Prevalence (%) of T1D, All Ages, by Sex, 2013
  • Figure 6: 8MM, Diagnosed Prevalent Cases of T1D, All Ages, by BMI (kg/m2), 2013
  • Figure 7: T1D - Disease Management Flowchart
  • Figure 8: Percent of Patients on Different Insulin Regimens in 2013 and 2018 (Average across the 8MM)
  • Figure 9: T1D Therapeutics - Clinical Trials by Country and by General Class, 2014
  • Figure 10: Competitive Assessment of Late-Stage Pipeline Agents in Type 1 Diabetes, 2013-2023
  • Figure 11: Estimated Sales of Biosimilars versus Their Branded Counterparts in T1D, 2013-2023
  • Figure 12: Company Portfolio Gap Analysis in Type 1 Diabetes, 2013-2023
  • Figure 13: Global Sales for Type 1 Diabetes by Region, 2013-2023
  • Figure 14: Sales for Type 1 Diabetes in the United States by Drug Class, 2013-2023
  • Figure 15: Sales for Type 1 Diabetes in the 5EU by Drug Class, 2013-2023
  • Figure 16: Sales for Type 1 Diabetes in the 5EU by Country, 2013-2023
  • Figure 17: Sales for Type 1 Diabetes in Japan by Drug Class, 2013-2023
  • Figure 18: Sales for Type 1 Diabetes in Canada by Drug Class, 2013-2023
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