表紙
市場調查報告書

糖尿病性黃斑水腫的前景:現狀和未來展望

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

出版商 MP Advisors 商品編碼 948143
出版日期 內容資訊 英文 81 Pages
商品交期: 最快1-2個工作天內
價格
糖尿病性黃斑水腫的前景:現狀和未來展望 Outlook of Diabetic Macular Edema - Current Landscape and the Way Forward"
出版日期: 2020年07月03日內容資訊: 英文 81 Pages
簡介

2019年,全球糖尿病性黃斑水腫(DME)市場估計約為37億美元。發達國家的糖尿病發病率很高,美國占DME整體市場的51%。在2018年,估計美國大約有240萬人患有二甲醚,但估計有70%的人得到診斷和治療。

本報告調查了糖尿病性黃斑水腫(DME)的全球市場,並分析了DME的病理生理和流行病學,當前的治療範例,批准的藥物,非標籤藥物的臨床開發結果以及批准的藥物的臨床數據。比較,未滿足的需求,抗VEGF藥物和類固醇的前景,生物仿製藥的進入和影響,開發渠道趨勢等。

第1章執行摘要

第2章DME:不僅影響VEGF疾病-炎症級聯/血管生成,而且影響最大的是什麼?

  • DME的多元性更加清晰:炎症是DME的最初症狀
  • VEGF以外的靶向途徑,例如炎症和氧化途徑:未來成功治療的關鍵

第3章DME:增加經濟負擔和生活質量

  • DME發病率上升:由於糖尿病和人口老齡化
  • 與DME相關的治療負擔中當前的地區差異:由於治療範例的標準化,將來在縮小

第4章DME治療範例轉變

  • 抗VEGF治療:已證明行之有效,取代激光成為一線藥物
  • 類固醇:在治療範例中的重要作用
  • 大量未滿足的需求:一半的DME患者對目前的治療反應不佳
  • 當前治療藥物的臨床數據比較:建議初始治療的次數和最佳給藥頻率以獲得更好的結果
  • DME治療的地區差異:改變治療範例的新型治療劑的可用性

第5章滿足未滿足需求並轉變治療範式的候選藥物

  • 正在開發的下一代抗VEGF藥物:關注可持續性
  • 正在臨床開發中的藥物,有可能與現有標準療法抗VEGF-A聯合治療
  • 作用於上游的非VEGF靶標
  • 改變DME治療環境的基因治療藥物的可能性
  • 新型口服和局部用藥:通過非侵入性治療和預防性治療改變標準治療的可能性
  • 緩釋藥物輸送

第6章影響市場增長的因素:持久性,非侵入性,基因治療藥物,生物仿製藥

  • 抗VEGF藥物引領當前的DME市場:其功效優於類固醇
  • Avastin和Triamcinolone Acetonide的不合格使用:顯示價格敏感性對處方和保險範圍的影響
  • 抗VEGF藥物,類固醇和潛在的管道化合物的當前市場狀況:推動DME部門的增長
  • 生物仿製藥對當前形勢的影響
目錄

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