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市場調查報告書

疾病分析:第二型糖尿病

Disease Analysis: Type 2 Diabetes

出版商 Datamonitor Healthcare 商品編碼 927051
出版日期 內容資訊 英文 116 Pages
商品交期: 最快1-2個工作天內
價格
疾病分析:第二型糖尿病 Disease Analysis: Type 2 Diabetes
出版日期: 2020年02月12日內容資訊: 英文 116 Pages
簡介

本報告提供全球第二型糖尿病治療藥臨床實驗形勢與市場趨勢預測相關分析,疾病概要和流行病學的預測,目前主要治療藥 (已上市/開發中產品) 和臨床實驗的進展,目前未滿足需求和未來的市場機會,臨床實驗/市場將來相關專家的見解等資訊彙整,為您概述為以下內容。

概要

疾病的背景情況

  • 定義
  • 患者的分類

治療方法

  • 主要的治療方法的指南
  • 指南治療的目標:配合患者特性的個體化
  • 治療指南:成果為基礎的方法的變更 (從近來臨床成果)

流行病學

成藥

開發平台藥物

法規上主要的動向

成功的可能性

授權合約/資產收購交易

臨床實驗環境

  • 臨床試驗贊助者的分類:各狀況
  • 臨床試驗贊助者的分類:各相位
  • 目前的趨勢

醫藥品的評估模式

  • 非胰島素
  • 非專利口服藥
  • 非胰島素系品牌藥
  • 胰島素
  • 其他的開發平台的機制

SWOT分析

市場動態

未來趨勢

共識的預測

近幾年的市場趨勢和分析師的見解

  • ORMD-0801:第二型糖尿病 (2019年11月18日)
  • PEX168:第二型糖尿病 (2019年9月19日)
  • Tresiba:第二型糖尿病 (2019年9月19日)
  • PEX168:第二型糖尿病 (2019年9月17日)
  • Ozempic:第二型糖尿病 (2019年9月17日)
  • ZGN-1061:第二型糖尿病 (2019年9月5日)
  • Zynquista:第二型糖尿病 (2019年6月26日)
  • Remogliflozin Etabonate:第二型糖尿病 (2019年7月11日)
  • HM12525A:第二型糖尿病 (J2019年6月3日)

今後的市場主要動向

KOL (專家)的見解

  • 醫生的採訪 (ADA conference)

未滿足需求

參考文獻

  • 處方藥的資訊

附錄

目錄
Product Code: DMKC0211587

Latest Key Takeaways:

The type 2 diabetes market is dynamic and complex. In the non-insulin segment, while older generic drugs are widely used, especially first-line metformin in the US and EU, the more novel branded drugs are used in a sizable minority of patients, generating over $24bn in sales in 2018.

The DPP-IV inhibitors have been the most commonly used of these, due to their safety and tolerability, albeit with intermediate efficacy, but GLP-1 agonists and SGLT-2 inhibitors are poised to overtake them in the important US market, with recommendations in a 2018 American Diabetes Association/European Association for the Study of Diabetes (ADA/EASD) consensus report for patients with relevant co-morbidities due to their benefits on major adverse cardiovascular events (MACE), and for the SGLT-2 inhibitors in particular, heart failure (HF) and renal impairment. This is expected to continue to grow these classes, though clinical inertia still needs to be overcome among a number of physicians, and intense pricing competition, with increasing rebates in the US, is typical across the indication. However, loss of exclusivity will start to take a toll on all of these classes over the next 10 years, particularly starting with patent expirations for the leading DPP-IV inhibitor, Januvia, in 2022. The SGLT-2 inhibitors are hoping to bolster growth with data and label additions for pivotal HF and chronic kidney disease (CKD) trials, including in non-diabetics. Jardiance has taken the lead, with a strong reduction in cardiovascular (CV) death, after Invokana faltered due to concerns about an increased risk of amputations. Side effects, including increased risk of genitourinary infections, and safety concerns have generally held the class back somewhat.

Sales of the injectable GLP-1 agonists have grown substantially with the addition of a more convenient weekly formulation, Eli Lilly's Trulicity, which expanded usage of the segment rather than displacing Novo Nordisk's daily Victoza, which was the first in the class to show a CV benefit. However, Novo Nordisk's weekly Ozempic, introduced in 2018, is more effective, and has helped the franchise stay ahead in sales. The battle is continuing with trials of higher doses of both drugs, new CV indications, and development of Eli Lilly's GIP co-agonist, tirzepatide. Another fairly effective weekly GLP-1 agonist in development, efpeglenatide, was dropped by Sanofi in late 2019 as the company did not have confidence it could be differentiated enough. Pipeline ITCA-650 is implanted under the skin every six months, which could be attractive to a segment of patients, though it did not show a clear CV benefit in its modest-sized cardiovascular outcomes trial (CVOT). While the GLP-1 agonists cause weight loss, their main side effect is nausea, and as injectables they tend to be used after oral drugs have failed. However, an oral formulation of Ozempic, Rybelsus, approved in 2019, appears to be the most effective branded oral drug and is poised to disrupt the segment, as well as expand usage earlier on in competition with other oral classes.

In Japan, DPP-IV inhibitors are used more commonly at first line, and guidelines are somewhat equivocal about the implications of the CV findings of the other classes for Japanese patients.

In the insulin segment, the popular analogs are coming under increasing pricing pressure with the advent of biosimilars. The latter have had only limited sales so far, but are still ramping, and additional biosimilars are poised to soon enter the US market. For basal insulin analogs, Toujeo and Tresiba are Sanofi and Novo Nordisk's longer-acting replacements for segment leader Lantus and for Levemir, respectively. Toujeo has not been able to stem losses for Sanofi's basal analog portfolio in the US, with only a quarter of the sales of Lantus, but has had more success in doing so outside the US. For Novo Nordisk, Levemir's profile was not as strong as Lantus's to start with and lagged in sales, so Tresiba is more of an advance, and has helped to increase usage in the US and stabilize overall sales in other areas.

Weekly basal insulins are in development, and while there are questions about their utility, they could be especially useful in fixed-ratio combinations (FRCs) with weekly GLP-1 agonists. For mealtime insulins, the more recent ultra-rapid-acting formulations have relatively marginal benefits over their predecessors, and Novo Nordisk's Fiasp only has modest sales, though it is still early in its ramp. It is also still early in the ramp of mealtime biosimilars, which in the US face the challenge of more exclusive payer contracts. For the insulins space in general, while companies are looking into glucose-sensitive insulins with a lower risk of hypoglycemia, it is still uncertain how promising these will be.

Improving insulin sensitivity is a mechanistic unmet need, but pipeline candidates so far have not appeared very compelling, though imeglimin has shown intermediate efficacy in Japanese patients.

Given limited budgets for many patients, there could be indirect competition with novel dyslipidemia drugs.

The overall likelihood of approval of a Phase I type 2 diabetes asset is 7.5%, and the average probability a drug advances from Phase III is 68.4%. Type 2 diabetes drugs, on average, take 8.7 years from Phase I to approval, compared to 9.2 years in the overall endocrine space.

TABLE OF CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Patient segmentation

TREATMENT

  • Major treatment guidelines
  • Guideline treatment targets are individualized according to patient characteristics
  • Treatment guidelines are shifting their approach based on results from recent clinical outcomes studies

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • As Sanofi Exits Diabetes R&D, Meaning of Diabetes R&D Blurs

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Hanmi Says Sanofi Made 'Optimal' Efpeglenatide Decision, Still Eyes 2021 Approval
  • Novo Nordisk Enters Its First Strategic RNAi Pact

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

  • Non-insulins
  • Generically available oral drugs
  • Branded non-insulin drugs
  • Insulins
  • Other pipeline mechanisms

SWOT ANALYSIS

MARKET DYNAMICS

FUTURE TRENDS

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • ORMD-0801 for Diabetes Mellitus, Type 2 (November 18, 2019)
  • PEX168 for Diabetes Mellitus, Type 2 (September 19, 2019)
  • Tresiba for Diabetes Mellitus, Type 2 (September 19, 2019)
  • PEX168 for Diabetes Mellitus, Type 2 (September 17, 2019)
  • Ozempic for Diabetes Mellitus, Type 2 (September 17, 2019)
  • ZGN-1061 for Diabetes Mellitus, Type 2 (September 5, 2019)
  • Zynquista for Diabetes Mellitus, Type 2 (July 26, 2019)
  • Remogliflozin Etabonate for Diabetes Mellitus, Type 2 (July 11, 2019)
  • HM12525A for Diabetes Mellitus, Type 2 (July 3, 2019)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

  • Interviews with physicians at the ADA conference

UNMET NEEDS

BIBLIOGRAPHY

  • Prescription Information

APPENDIX

LIST OF FIGURES

  • Figure 1: Guideline diagnostic criteria for type 2 diabetes
  • Figure 2: Line of therapy for primary care for type 2 diabetes, in major markets
  • Figure 3: ADA/EASD treatment algorithm
  • Figure 4: AACE treatment algorithm
  • Figure 5: Trends in prevalent cases of type 2 diabetes in adults (20-85+ years), 2018-27
  • Figure 6: Overview of pipeline drugs for type 2 diabetes in the US
  • Figure 7: Pipeline drugs for type 2 diabetes, by company
  • Figure 8: Pipeline drugs for type 2 diabetes, by drug type
  • Figure 9: Pipeline drugs for type 2 diabetes, by classification
  • Figure 10: Probability of success in the type 2 diabetes pipeline
  • Figure 11: Clinical trials in type 2 diabetes
  • Figure 12: Top 10 drugs for clinical trials in type 2 diabetes
  • Figure 13: Top 10 companies for clinical trials in type 2 diabetes
  • Figure 14: Trial locations in type 2 diabetes
  • Figure 15: Type 2 diabetes trials status
  • Figure 16: Type 2 diabetes trials sponsors, by phase
  • Figure 17: Datamonitor Healthcare's drug assessment summary for non-insulins for type 2 diabetes
  • Figure 18: Datamonitor Healthcare's drug assessment summary for insulins for type 2 diabetes
  • Figure 19: DPP-IV inhibitors SWOT analysis
  • Figure 20: SGLT-2 inhibitors SWOT analysis
  • Figure 21: GLP-1 agonists SWOT analysis
  • Figure 22: Insulins SWOT analysis
  • Figure 23: Generically available older drugs market dynamics
  • Figure 24: DPP-IV inhibitors market dynamics
  • Figure 25: SGLT-2 inhibitors market dynamics
  • Figure 26: GLP-1 agonists market dynamics
  • Figure 27: Insulins market dynamics
  • Figure 28: Future trends
  • Figure 29: ORMD-0801 for Diabetic Mellitus, Type 2 (November 18, 2019)
  • Figure 30: PEX168 for Diabetes Mellitus, Type 2 (September 19, 2019)
  • Figure 31: Tresiba for Diabetes Mellitus, Type 2 (September 19, 2019)
  • Figure 32: PEX168 for Diabetes Mellitus, Type 2 (September 17, 2019)
  • Figure 33: Ozempic for Diabetes Mellitus, Type 2 (September 17, 2019)
  • Figure 34: Key upcoming events in type 2 diabetes (one of two)
  • Figure 35: Key upcoming events in type 2 diabetes (two of two)

LIST OF TABLES

  • Table 1: Prevalent cases of type 2 diabetes in adults (20-85+ years), 2018-27
  • Table 2: Marketed drugs for type 2 diabetes
  • Table 3: Pipeline drugs for type 2 diabetes in the US
  • Table 4: Historical global sales, by drug ($m), 2014-18
  • Table 5: Forecasted global sales, by drug ($m), 2020-24
  • Table 6: ORMD-0801 for Diabetes Mellitus, Type 2 (November 18, 2019)
  • Table 7: PEX168 for Diabetes Mellitus, Type 2 (September 19, 2019)
  • Table 8: Tresiba for Diabetes Mellitus, Type 2 (September 19, 2019)
  • Table 9: PEX168 for Diabetes Mellitus, Type 2 (September 17, 2019)
  • Table 10: Ozempic for Diabetes Mellitus, Type 2 (September 17, 2019)
  • Table 11: ZGN-1061 for Diabetes Mellitus, Type 2 (September 5, 2019)
  • Table 12: Zynquista for Diabetes Mellitus, Type 2 (July 26, 2019)
  • Table 13: Remogliflozin Etabonate for Diabetes Mellitus, Type 2 (July 11, 2019)
  • Table 14: HM12525A for Diabetes Mellitus, Type 2 (July 3, 2019)