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당뇨병성 황반부종 전망 : 현재 상황과 향후 전망

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

리서치사 MP Advisors
발행일 2020년 07월 상품 코드 948143
페이지 정보 영문 81 Pages
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당뇨병성 황반부종 전망 : 현재 상황과 향후 전망 Outlook of Diabetic Macular Edema - Current Landscape and the Way Forward"
발행일 : 2020년 07월 페이지 정보 : 영문 81 Pages

2019년 세계의 당뇨병성 황반부종(DME) 시장은 약 37억 달러로 추산되고 있습니다. 선진국에서 당뇨병의 발생률이 높고, 미국이 DME 시장 전체의 51%의 점유율을 차지하고 있습니다. 2018년 미국의 약 240만 명이 DME로 추산되고 있으나, 진단 및 치료를 받고 있는 것은 70%로 추계되고 있습니다

세계의 당뇨병성 황반부종(DME) 시장을 조사했으며, DME의 병태생리·역학, 현재의 치료 패러다임, 승인 의약품, 적응외 의약품의 임상 개발 성과, 승인약의 임상 데이터 비교, 미충족 요구, 항VEGF제 및 스테로이드의 전망, 바이오시밀러의 참여와 영향, 개발 파이프라인의 동향 등을 정리하여 전해드립니다.

제1장 개요

제2장 DME : 단순한 VEGF 질환이 아니다. - 염증 캐스케이드·혈관신생, 가장 큰 영향을 미치는 것은?

  • DME의 다원적 성질이 보다 명확화 : 염증은 DME의 초기 증상
  • 염증 경로 및 산화 경로 등 VEGF를 초월한 경로의 표적화 : 향후 치료 성공의 열쇠

제3장 DME : 경제와 QOL에 대한 부담의 확대

  • DME의 발생률 증가 : 당뇨병의 증가·인구 고령화에 기인
  • 현재 DME 관련 치료 부담의 지역 격차 : 치료 패러다임의 표준화에 의해 향후 축소

제4장 DME의 치료 패러다임 이동

  • 항VEGF 치료 : 유효성이 증명된 제일 선택약으로서 레이저를 대신한다.
  • 스테로이드 : 치료 패러다임에서 중요한 역할
  • 큰 미충족 요구 : DME 환자의 반수가 현재의 치료법에 대해 좋은 반응을 보이지 않는다.
  • 현재 치료제의 임상 데이터 비교 : 더 나은 결과를 얻기 위한 초기 치료와 최적의 투여 빈도 수를 시사
  • DME 치료의 지역 차이 : 치료 패러다임에 변화를 초래하는 새로운 치료제의 가용성

제5장 미충족 요구를 충족하고 치료 패러다임을 변혁하는 파이프라인 후보의약품

  • 개발중인 차세대 항VEGF제 : 지속성에 초점
  • 기존 표준 치료인 항VEGF-A와의 병용요법으로서의 가능성을 가진 임상 개발중인 약제
  • 업스트림에서 작용하는 비VEGF 표적
  • DME 치료 환경에 변화를 초래하는 유전자 치료제의 가능성
  • 새로운 경구제·국소제 : 비침습적 치료 및 예방적 치료에 의해 표준 치료를 바꿀 가능성
  • 서방적 약물전달

제6장 시장 성장에 대한 영향요인 : 지속성·비침습성·유전자 치료제·바이오시밀러

  • 항VEGF제가 현재의 DME 시장을 선도 : 스테로이드와 비교하여 유효성이 우위이기 때문이다.
  • Avastin 및 Triamcinolone acetonide의 적응외 사용 : 처방 및 보험 적용에 대한 가격 민감도의 영향을 나타낸다.
  • 항VEGF제·스테로이드·잠재적 파이프라인 화합물의 현재 시장 구도 : DME 부문의 성장을 촉진
  • 현재 상황에서 바이오시밀러의 영향
KSA 20.07.29

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
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