2型糖尿病市場：規模および動向 - 疫学、疾患管理、パイプライン分析、競合企業評価、アンメットニーズ、臨床試験戦略、予測（2019年～2029年）

世界の主要9ヶ国市場の2型糖尿病市場は、2019年に450億米ドルとなりました。同市場は、今後11.5%のCAGRで拡大し、2029年には1,362億米ドルに達すると予測されています。特に、米国市場が糖尿病治療薬市場の成長に最も貢献しています。

当レポートでは、2型糖尿病（T2D）市場について調査し、疾患の概要と疫学、治療法、SWOT分析、パイプライン製品動向、アンメットニーズと機会、市場の見通しなどを提供しています。

目次

第1章 2型糖尿病（T2D）：エグゼクティブサマリー

第2章 イントロダクション

第3章 疾患の概要

• 病因
• 病態生理学
• 症状
• 予後と生活の質

第4章 疫学

• 疾患の背景
• 危険因子と合併症
• 世界的および歴史的動向
• 予測調査手法
• 2型糖尿病の疫学的予測（2018年～2028年）
• 議論

第5章 疾病管理

• 診断と治療の概要
• 米国
• EU5ヶ国
  • フランス
  • ドイツ
  • イタリア
  • スペイン
  • 英国
• 日本
• 中国
• インド

第6章 競合評価

• 概要

第7章 アンメットニーズと機会

• 概要
• 持続的な血糖コントロールを提供する疾患修飾治療
• 非血糖効果のある薬
• 副作用プロファイルが改善された薬剤
• 患者のコンプライアンスの向上
• 急性T2D小児患者向けの薬剤
• インスリン薬の価格設定の規制と適正価格の生物製剤の必要性

第8章 パイプラインの評価

• 概要
• 臨床開発中の有望な薬剤

第9章 現在および将来の参入企業

• 概要
• 企業戦略の動向

第10章 市場の見通し

• 世界
• 米国
• EU5ヶ国
• 日本
• 中国
• インド

第11章 付録

List of Tables

List of Tables

• Table 1: T2D: Key Metrics in the Nine Major Pharmaceutical Markets
• Table 2: Primary Pathophysiologic Conditions Associated with T2D
• Table 3: Symptoms of T2D presents an overview of the most frequently observed symptoms for T2D.
• Table 4: Risk Factors and Comorbidities for T2D
• Table 5: Diagnostic Tests and Typical Criteria for Diagnosing T2D
• Table 6: Country Profile, T2D Management, US
• Table 7: Country Profile, T2D Management, France
• Table 8: Country Profile, T2D Management, Germany
• Table 9: Absence of Typical T2D Symptoms, Italy
• Table 10: Individuals with Increased Risk of T2D, Italy
• Table 11: Country Profile, T2D Management, Italy
• Table 12: Country Profile, T2D Management, Spain
• Table 13: Country Profile, T2D Management, UK
• Table 14: Country Profile, T2D Management, Japan
• Table 15: Country Profile, T2D Management, China
• Table 16: Country Profile, T2D Management, India
• Table 17: Leading Branded Treatments for T2D, 2022
• Table 18: T2D Market - Drivers and Barriers, 2020
• Table 19: Key Events Impacting Sales for T2D in the US, 2019-2029
• Table 20: T2D Market - Drivers and Barriers in the US, 2020
• Table 21: Key Events Impacting Sales for T2D in the 5EU, 2019-2029
• Table 22: T2D Market - Drivers and Barriers in the 5EU, 2020
• Table 23: Key Events Impacting Sales for T2D in Japan, 2019-2029
• Table 24: T2D Market - Drivers and Barriers in Japan, 2020
• Table 25: Key Events Impacting Sales for T2D in China, 2019-2029
• Table 26: T2D Market - Drivers and Barriers in China, 2020
• Table 27: Key Events Impacting Sales for T2D in India, 2019-2029
• Table 28: T2D Market - Drivers and Barriers in India, 2020
• Table 29: Number of High-Prescribing Physicians Surveyed

List of Figures

List of Figures

• Figure 1: Global Sales By Region (Type 2 Diabetes) 2019 and 2029
• Figure 2: Company Portfolio Gap Analysis in T2D, 2019-2029
• Figure 3: Competitive Assessment of Late-Stage (Phase III) Pipeline Agents in T2D, 2019-2029
• Figure 4: T2D Pathophysiology
• Figure 5: 9MM, Diagnosed Prevalence of T2D (%), Men, All Ages, 2018
• Figure 6: 9MM, Diagnosed Prevalence of T2D (%), Women, All Ages, 2018
• Figure 7: 9MM, Sources Used and Not Used to Forecast Diagnosed Prevalent Cases of T2D
• Figure 8: 9MM, Sources Used to Forecast the Prevalent Cases of CKD Among the Diagnosed Prevalent Cases of T2D
• Figure 9: 9MM, Sources Used to Forecast the Prevalent Cases of CVD Among the Diagnosed Prevalent Cases of T2D
• Figure 10: 9MM, Sources Used to Forecast the Prevalent Cases of Obesity Among the Diagnosed Prevalent Cases of T2D
• Figure 11: 9MM, Sources Used to Forecast the Prevalent Cases of Hypertension Among the Diagnosed Prevalent Cases of T2D
• Figure 12: 9MM, Sources Used to Forecast the Prevalent Cases of Dyslipidemia Among the Diagnosed Prevalent Cases of T2D
• Figure 13: 9MM, Sources Used to Forecast the Prevalent Cases of Atherosclerosis Among the Diagnosed Prevalent Cases of T2D
• Figure 14: 9MM, Diagnosed Prevalent Cases of T2D, Both Sexes, All Ages, N, 2018
• Figure 15: 9MM, Age-Specific Diagnosed Prevalent Cases of T2D, Both Sexes, N, 2018
• Figure 16: 9MM, Sex-Specific Diagnosed Prevalent Cases of T2D, All Ages, N, 2018
• Figure 17: 9MM, Prevalent Cases of CKD Among the Diagnosed Prevalent Cases of T2D, Both Sexes, All Ages, N, 2018
• Figure 18: 9MM, Prevalent Cases of CVD Among the Diagnosed Prevalent Cases of T2D, Both Sexes, All Ages, N, 2018
• Figure 19: 9MM, Prevalent Cases of Obesity Among the Diagnosed Prevalent Cases of T2D, Both Sexes, All Ages, N, 2018
• Figure 20: 9MM, Prevalent Cases of Hypertension Among the Diagnosed Prevalent Cases of T2D, Both Sexes, All Ages, N, 2018
• Figure 21: 9MM, Diagnosed Prevalent Cases of Dyslipidemia Among the Diagnosed Prevalent Cases of T2D, Both Sexes, All Ages, N, 2018
• Figure 22: 9MM, Prevalent Cases of Atherosclerosis Among the Diagnosed Prevalent Cases of T2D, Both Sexes, All Ages, N, 2018
• Figure 23: ADA Treatment Algorithm for Antihyperglycemic Therapy in T2D
• Figure 24: Unmet Needs and Opportunities in T2D
• Figure 25: Pipeline Agents in Development for T2D
• Figure 26: Key Phase II/III Trials for the Promising Pipeline Agents That GlobalData Expects to be Licensed for T2D in the 9MM During the Forecast Period
• Figure 27: Company Portfolio Gap Analysis in T2D, 2019-2029
• Figure 28: Global Sales for T2D by Country/Region, 2019 and 2029
• Figure 29: Sales for T2D in the US by Drug Class, 2019 and 2029
• Figure 30: Sales for T2D in the 5EU by Drug Class, 2019 and 2029
• Figure 31: Sales for T2D in Japan by Drug Class, 2019 and 2029
• Figure 32: Sales for T2D in China by Drug Class, 2019 and 2029
• Figure 33: Sales for T2D in India by Drug Class, 2019 and 2029

Type 2 Diabetes Mellitus, or T2D for short, refers to a defect in insulin secretion and sensitivity, whereby the B-cells in the pancreas fail to secrete sufficient amounts of insulin and cells fail to uptake adequate amounts of insulin due to loss of sensitivity, commonly referred to as insulin resistance. The dysfunction of pancreatic B-cells is thought to be caused by a defect in their signaling, resulting in raised blood sugar (hypoglycemia), which over time leads to multiple comorbidities requiring continuous medical vigilance. Many of the current therapies for T2D are unable to alter the disease's natural course, with glycemic control deteriorating over time, resulting in complex treatment regimens

New therapies entering the market will be a main driver of growth, with recently launched GLP-1RA Rybelsus (oral semaglutide) is likely to obtain a large share of the non-insulin T2D drug market and biosimilar and oral insulins are likely to obtain a large market share from their costly branded originators. Other major drivers for the T2D market are the increasing prevalence of obesity and the increasing prevalence of cardiovascular and kidney disease . Based on epidemiological analysis by GlobalData, the number of diagnosed prevalent cases of T2D will grow 25.93% over the forecast period, at an AGR of 2.3%, from 171,547,536 cases in 2019 to 216,029,212 cases by 2029 across the nine major pharmaceutical markets covered in this report, the US, 5EU (France, Germany, Italy, Spain and UK), Japan, India and China.

GlobalData projects that the marketplace for T2D within the 9MM will grow from $45bn in 2019 at a compound annual growth rate (CAGR) of 11.5% to $136.2B by 2029. In particular, GlobalData expects US market will contribute the most to the antidiabetic market's growth, contributing sales in $24.7B sales in 2019 (54% of the global antidiabetic market) and $66B in 2029 (48.5% of the global antidiabetic market).

In terms of the current treatment landscape, the consensus among interviewed physicians was that although they have a number of efficacious treatment options at their disposal, there are still patients that remain unable to achieve optimal glycemic control, address insulin resistance and reverse or slow the decline in B-cell function. Additionally, KOLs interviewed by GlobalData highlighted the lack of treatment options for patients with T2D and complex comorbidities such as cardiorenal disease, an extremely important unmet need. Another major issue mentioned is the cost of insulin treatment, with a strong need for controls on insulin drug pricing and a fair price for biosimilar/interchangeable insulins.

In addition, drug classes across the T2D marketplace often have poor side-effect profiles and there is an urgent need to broaden the drugs available to T2D patients to allow for safer and more tailored therapies. Despite a number of drugs currently in development, GlobalData's research suggests that the future level of attainment of these unmet needs will be modest, and a relatively high level of opportunity exists for drug developers to enter the T2D market.

Key Highlights

• The proportion of people at risk of developing T2D is expected to increase over the 10-year forecast period due to an increased life expectancy coupled with rapid socioeconomic change, increased prevalence of obesity and the increased prevalence of cardiovascular (CV) disease
• The potential launch of 10 late-stage pipeline agents will increase the number of patients who can be offered pharmacological treatment options. In addition, five of these drugs in late-stage development are expected to have a high annual cost of therapy (ACOT), a factor that will contribute to notable profitability.
• Cardiorenal disease is being increasingly recognized in clinical practice and there has been a renewed interest among the medical community to understand the pathophysiological mechanisms underpinning its pathogenesis.
• Despite the plethora of therapies currently available to T2D patients, there is still room for improvement within the treatment space. The most recognizable is the need for novel treatment options for patients unable to achieve optimal glycemic control.

KEY QUESTIONS ANSWERED

Despite the existence of numerous well-established treatment options in the T2D space, a few-yet significant-unmet needs remain.

• Which unmet needs are the most pressing in the 9MM?
• Where should pharmaceutical companies focus drug development efforts in order to become a significant player in the space?

The T2D market has been overcrowded by drug developers launching 'Me-Too' therapies for many years, though more recently, clinical development activity has resulted in more innovative treatments

• What are the most promising late-stage candidates and how much in sales are they expected to generate over the forecast period?
• What do KOLs say about their clinical and commercial positioning?

T2D remains a highly prevalent condition, and there are many new and emerging players entering the space, as well as more established companies developing novel therapies

• Which companies have been leading the way, historically?
• What new companies are emerging in the space?

Scope

• Overview of T2D: including epidemiology, disease etiology and management.
• Topline T2D drugs market revenue, annual cost of therapy, and anticipated sales for major late-stage pipeline drugs.
• Key topics covered include assessment of current and pipeline therapies, unmet needs, current and future players and market outlook for the US, 5EU, Japan, India and China over the 10-year forecast period.
• Pipeline analysis: Emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
• Analysis of the current and future market competition in the global T2D therapeutics market. Insightful review of the key industry drivers, restraints and challenges.

Reasons to Buy

The report will enable you to -

• Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
• Develop business strategies by understanding the trends shaping and driving the global type 2 diabetes therapeutics market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global type 2 diabetes market in the future.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing 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 type 2 diabetes therapeutics market from 2019-2029.
• 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

Table of Contents

1 Type 2 Diabetes (T2D): Executive Summary - Updated Dec 2022, based on events up to Dec 5, 2022

• 1.1 Continued, Significant Growth in the T2D Market, With Drug Sales Expected to Almost Double Across the 9MM by the End of the Forecast Period
• 1.2 T2D Developers Battle for Share in an Increasingly Crowded Market
• 1.3 Decrease in Sales Among Branded T2D Drugs Across the 9MM
• 1.4 Glucagon-Like Peptide -1 Receptor Agonist Class Faces Intense Internal Competition, Largely Revolving Around Drugs' Ability to Improve Patient Compliance/Ease of Administration and Reduced Risk of Major Adverse Cardiovascular Events
• 1.5 Label Expansions for SGLT-2 Inhibitors
• 1.6 What Do Physicians Think?

2 Introduction - Updated Dec 2022, based on events up to Dec 5, 2022

• 2.1 Catalyst
• 2.2 Related Reports

3 Disease Overview

• 3.1 Etiology
• 3.2 Pathophysiology
• 3.3 Symptoms
• 3.4 Prognosis and Quality of Life

4 Epidemiology

• 4.1 Disease Background
• 4.2 Risk Factors and Comorbidities
• 4.3 Global and Historical Trends
• 4.4 Forecast Methodology
  • 4.4.1 Sources
  • 4.4.2 Forecast Assumptions and Methods: Diagnosed Prevalent Cases of T2D
  • 4.4.3 Forecast Assumptions and Methods: Prevalent Cases of CKD Among the Diagnosed Prevalent Cases of T2D
  • 4.4.4 Forecast Assumptions and Methods: Prevalent Cases of CVD Among the Diagnosed Prevalent Cases of T2D
  • 4.4.5 Forecast Assumptions and Methods: Prevalent Cases of Obesity Among the Diagnosed Prevalent Cases of T2D
  • 4.4.6 Forecast Assumptions and Methods: Prevalent Cases of Hypertension Among the Diagnosed Prevalent Cases of T2D
  • 4.4.7 Forecast Assumptions and Methods: Prevalent Cases of Dyslipidemia Among the Diagnosed Prevalent Cases of T2D
  • 4.4.8 Forecast Assumptions and Methods: Prevalent Cases of Atherosclerosis Among the Diagnosed Prevalent Cases of T2D
• 4.5 Epidemiological Forecast for Type 2 Diabetes (2018-2028)
  • 4.5.1 Diagnosed Prevalent Cases of T2D
  • 4.5.2 Age-Specific Diagnosed Prevalent Cases of T2D
  • 4.5.3 Sex-Specific Diagnosed Prevalent Cases of T2D
  • 4.5.4 Comorbidities Among the Diagnosed Prevalent Cases of T2D
• 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
• 5.2 US
• 5.3 5EU
  • 5.3.1 France
  • 5.3.2 Germany
  • 5.3.3 Italy
  • 5.3.4 Spain
  • 5.3.5 UK
• 5.4 Japan
• 5.5 China
• 5.6 India

6 Competitive Assessment - Updated Dec 2022, based on events up to Dec 5, 2022

• 6.1 Overview

7 Unmet Needs and Opportunities

• 7.1 Overview
• 7.2 Disease-Modifying Treatments Providing Sustained Glycemic Control
• 7.3 Drugs with Non-glycemic Benefits
• 7.4 Drugs with Improved Side-Effect Profiles
• 7.5 Increased Patient Compliance
• 7.6 Drugs for the Emergent T2D Pediatric Population
• 7.7 Controls on Insulin Drug Pricing and the Need for Fairly Priced Biologics

8 Pipeline Assessment - Updated Dec 2022, based on events up to Dec 5, 2022

• 8.1 Overview
• 8.2 Promising Drugs in Clinical Development

9 Current and Future Players - Updated Dec 2022, based on events up to Dec 5, 2022

• 9.1 Overview
• 9.2 Trends in Corporate Strategy

10 Market Outlook - Updated Dec 2022, based on events up to Dec 5, 2022

• 10.1 Global Markets
  • 10.1.1 Forecast
  • 10.1.2 Drivers and Barriers - Global Issues
• 10.2 US
  • 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 China
  • 10.5.1 Forecast
  • 10.5.2 Key Events
  • 10.5.3 Drivers and Barriers
• 10.6 India
  • 10.6.1 Forecast
  • 10.6.2 Key Events
  • 10.6.3 Drivers and Barriers

11 Appendix

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