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市场调查报告书

糖尿病性黄斑水肿的前景:现状和未来展望

Outlook of Diabetic Macular Edema - Current Landscape and the Way Forward"

出版商 MP Advisors 商品编码 948143
出版日期 内容资讯 英文 81 Pages
商品交期: 最快1-2个工作天内
价格
糖尿病性黄斑水肿的前景:现状和未来展望 Outlook of Diabetic Macular Edema - Current Landscape and the Way Forward"
出版日期: 2020年07月03日内容资讯: 英文 81 Pages
简介

2019年,全球糖尿病性黄斑水肿(DME)市场估计约为37亿美元。发达国家的糖尿病发病率很高,美国占DME整体市场的51%。在2018年,估计美国大约有240万人患有二甲醚,但估计有70%的人得到诊断和治疗。

本报告调查了糖尿病性黄斑水肿(DME)的全球市场,并分析了DME的病理生理和流行病学,当前的治疗范例,批准的药物,非标签药物的临床开发结果以及批准的药物的临床数据。比较,未满足的需求,抗VEGF药物和类固醇的前景,生物仿制药的进入和影响,开发渠道趋势等。

第1章执行摘要

第2章DME:不仅影响VEGF疾病-炎症级联/血管生成,而且影响最大的是什么?

  • DME的多元性更加清晰:炎症是DME的最初症状
  • VEGF以外的靶向途径,例如炎症和氧化途径:未来成功治疗的关键

第3章DME:增加经济负担和生活质量

  • DME发病率上升:由于糖尿病和人口老龄化
  • 与DME相关的治疗负担中当前的地区差异:由于治疗范例的标准化,将来在缩小

第4章DME治疗范例转变

  • 抗VEGF治疗:已证明行之有效,取代激光成为一线药物
  • 类固醇:在治疗范例中的重要作用
  • 大量未满足的需求:一半的DME患者对目前的治疗反应不佳
  • 当前治疗药物的临床数据比较:建议初始治疗的次数和最佳给药频率以获得更好的结果
  • DME治疗的地区差异:改变治疗范例的新型治疗剂的可用性

第5章满足未满足需求并转变治疗范式的候选药物

  • 正在开发的下一代抗VEGF药物:关注可持续性
  • 正在临床开发中的药物,有可能与现有标准疗法抗VEGF-A联合治疗
  • 作用于上游的非VEGF靶标
  • 改变DME治疗环境的基因治疗药物的可能性
  • 新型口服和局部用药:通过非侵入性治疗和预防性治疗改变标准治疗的可能性
  • 缓释药物输送

第6章影响市场增长的因素:持久性,非侵入性,基因治疗药物,生物仿制药

  • 抗VEGF药物引领当前的DME市场:其功效优于类固醇
  • Avastin和Triamcinolone Acetonide的不合格使用:显示价格敏感性对处方和保险范围的影响
  • 抗VEGF药物,类固醇和潜在的管道化合物的当前市场状况:推动DME部门的增长
  • 生物仿制药对当前形势的影响
目录

Global market for DME was ~$3.7 billion in 2019 with US alone contributing to 51% market share, owing to the higher incidence rates of diabetes amongst the developed nations. In 2018, ~2.4m people in the US had DME, of that only ~70% got diagnosed and treated. Following is the current treatment paradigm for DME - the first line includes Eylea (Regeneron), Lucentis (Roche/Genentech) and the second line treatment includes short term steroids implants such as dexamethasone (Ozurdex, Allergen; once every six months) or longer lasting fluocinolone acetonide (Iluvien, Alimera; once every three years). Anti-VEGFs lead the DME market due to its proven efficacy as compared to steroids, making it a premium priced segment. As a result of high cost, approved anti-VEGFs, the market witnesses extensive use of off-label us of Avastin (Roche/Genentech) and Triamcinolone acetonide - Kenalog (BMS). Despite being the last entrant in the anti-VEGF segment, Eylea has emerged as a leader owing to its superior efficacy with US market share ~69% by value ($4.6 billion) in 2019.

Although the multifactorial nature of DME has become clearer with involvement of several pathways, approved therapies target only one pathway and half of the patients continue to lose vision even after the treatments. In addition, high cost, adverse effects associated with intra-vitreal injections and limited patient convenience highlights the high unmet need. As a result, a few dozen initiatives are being undertaking to develop improved therapies for DME by a range of pharma companies globally. The late stage pipeline comprises of long-lasting VEGF blockers and compounds with VEGF-independent mechanisms such as Tie-2/Angiopoietin pathway modulators and integrin inhibitors. In the long run, non-invasive therapies (oral and topical), prophylactic treatment and gene therapy is likely to transform DME's treatment paradigm. Current major players in the DME market, including Regeneron and Roche, are focusing on maintaining the market share with formulations improvements reducing the frequency of administration, as their products heads for patent cliff. Despite biosimilars entry, the DME drug market in the US is estimated to grow rapidly (~ $2 billion - 2020) to reach $3.3 billion by 2025 (CAGR 10%), with over 90% contribution from anti-VEGF. In the coming decade, DME treatment is likely witness a paradigm shift from invasive injectable treatments to non-invasive options. The future therapies will empower ophthalmologists with better options to manage the debilitating condition without compromising the patient's vision and safety.

This report provides insights into:

  • Epidemiology, multifactorial pathophysiology of DME, and significant role of inflammatory cascade in the progression of DME
  • Current treatment paradigm, clinical development outcomes of approved and off-label drugs, real-world data comparison of the approved therapies and limitations of the current therapies
  • Current and future market landscape of DME drugs (anti-VEGFs and steroids), along with the potential impact of biosimilars entry on the Innovator molecules
  • In depth analyses of development pipeline (Pre-clinical -PhIII), while identifying the novel therapies with the potential to change the treatment paradigm

TABLE OF CONTENTS

CHAPTER 1: EXECUTIVE SUMMARY

CHAPTER 2: DME IS JUST NOT A VEGF DISEASE - INFLAMMATORY CASCADE AND ANGIOGENESIS, WHAT IMPACTS THE MOST?

  • Multifactorial nature of DME has become clearer, inflammation is a very early event in the development of DME
  • Targeting pathways beyond VEGF such as inflammatory and oxidative pathways holds the key for future treatment success

CHAPTER 3: DME - AN INCREASING ECONOMIC AND QUALITY OF LIFE BURDEN GLOBALLY

  • Increasing incidences of DME driven by the rising rates of diabetes and ageing population globally
  • Geographic differences with current DME related treatment burden will be diminished in the future as the treatment paradigm standardizes

CHAPTER 4: SHIFTING TREATMENT PARADIGMS OF DME

  • Anti-VEGF treatments have replaced laser as first line therapy with proven efficacy
  • A definite role of steroids in the treatment paradigm, as inflammatory pathway has a major role to play
  • Large unmet need remains as half of the DME patients have sub-optimal responses to the current therapies; greater personalization is still in need
  • Clinical data comparison of current treatments with real world data are indicative of early stage treatment and optimal number of dosage frequencies for better outcome
  • Geography specific difference in the treatment of DME - availability of new treatments to change the treatment paradigm

CHAPTER 5: NOVEL PIPELINE CANDIDATES TO TRANSFORM THE TREATMENT PARADIGM BY ADDRESSING THE KEY UNMET NEEDS - LONGER DURABILITY AND IMPROVED DELIVERY PROFILES

  • Next generation anti-VEGF agents in development focus on durability with less frequent dosing than the current treatments
  • Drugs in clinical development with potential as a combination therapy with existing standard of care anti-VEGF-A therapies to address DME patients who respond sub-optimally or become refractory to existing therapies
  • Non-VEGF targets to act upstream to address all oxidative pathways with potential to reduce treatment burden, improve visual outcomes - A solution to the sub-optimal efficacy of current treatment
  • Potential of gene therapy to transform the DME treatment landscape - One-time treatment for the patients who have demonstrated a strong dependence on frequent anti-VEGF treatments
  • Novel oral and topical therapies could transform the standard of care with non-invasive and prophylactic treatment
  • Sustained drug delivery treatment to address the current need for frequent intravitreal injections

CHAPTER 6: EVEN AMIDST BIOSIMILARS ENTRY, THE HIGH-COST DME DRUG MARKET IN THE US IS ESTIMATED TO GROW RAPIDLY DUE TO THE ENTRY OF DRUGS WITH MORE DURABILITY, NON-INVASIVE TREATMENT OPTIONS AND EVENTUALLY WITH THE ENTRY OF GENE THERAPY

  • Anti-VEGFs leads the current DME market due to its proven efficacy compared to steroids
  • Off-label use of Avastin and Triamcinolone acetonide are indicative of price sensitivity influence on prescription and insurance coverage
  • Current market landscape of anti-VEGFs, steroids and potential pipeline compounds to drive market growth in the DME sector
  • Impact of biosimilars in the current landscape