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老年性黃斑部病變 (AMD) :全球醫藥品市場預測與市場分析

Age-Related Macular Degeneration: Global Drug Forecast and Market Analysis to 2028

出版商 GlobalData 商品編碼 646067
出版日期 內容資訊 英文 204 Pages
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老年性黃斑部病變 (AMD) :全球醫藥品市場預測與市場分析 Age-Related Macular Degeneration: Global Drug Forecast and Market Analysis to 2028
出版日期: 2020年04月30日內容資訊: 英文 204 Pages
簡介

主要7個國家 (美國、法國、德國、義大利、西班牙、英國、日本) 的老年性黃斑部病變 (AMD)的治療藥市場,預計從2016年的49億美元,到2026年擴大到115億美元。

本報告提供老年性黃斑部病變 (AMD)的治療藥市場相關調查分析,疾病的概要與指南,競爭情形,主要藥物的詳細資訊 (產品說明,安全性,有效性) 、SWOT分析,銷售額預測,影響分析 (趨勢,促進因素、阻礙因素) 等相關的系統性資訊。

第1章 目錄

第2章 摘要整理

第3章 簡介

第4章 疾病概要

  • 病因與病情生理
  • 分類
  • 症狀
  • 預後

第5章 流行病學

  • 疾病的背景
  • 危險因素和合併症
  • 全球趨勢與轉變
  • 預測手法
  • 流行病學預測
  • 討論

第6章 疾病的管理

  • 診斷概要
  • 治療概要

第7章 競爭評估

  • 概要
  • Lucentis (Ranibizumab)
  • Avastin (Bevacizumab)
  • Eylea (Aflibercept)
  • Macugen (Pegaptanib Sodium)
  • Visudyne (Verteporfin)

第8章 與未滿足需求機會評估

第9章 開發平台評估

  • 概要
  • 臨床實驗製圖
  • 臨床開發中的潛力藥物
  • 開發的初期階段的有潛力的藥劑
  • 開發中的其他藥劑
  • 生物相似藥

第10章 現在、未來的主要企業

  • 概要
  • 企業策略趨勢
  • Roche/Genentech
  • Novartis/Alcon
  • Regeneron
  • Bayer
  • Valeant
  • Allergan
  • Ohr Pharmaceutical
  • Apellis
  • Ophthotech
  • Opthea

第11章 市場預測

  • 全球市場
  • 美國
  • EU5個國家
  • 日本

第12章 附錄

本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。

目錄
Product Code: GDHC194PIDR

Age-related macular degeneration (AMD) is an eye condition that is characterized by the gradual deterioration of the macula, which is the oval-shaped area of the retina that is responsible for central vision. AMD is the most common cause of significant irreversible vision loss among the elderly. Classified by disease severity, AMD can be divided into three distinct stages. These are the early, intermediate, and late types of AMD. Out of the late forms, there are two further subtypes: dry (dAMD) and wet (wAMD). Dry AMD is evidenced by atrophy of the cells lining the retina, the accumulation of debris and the death of photoreceptors near the center of the fundus.

Wet AMD is characterized by the growth of abnormal blood vessels that disrupt and misalign the layers of the retina, leading to sight loss. Another form late AMD is geographic atrophy (GA), a slowly progressing subtype characterized by cell death and extensive damage to the retinal pigment epithelium which is a layer of cells attached to blood vessels in the choroid.

There is no way to reverse the sight loss caused by AMD although the progression of the disease can be slowed through treatment with intravitreal anti-angiogenic drugs. Commonly used therapy options in the 9MM are Bayer/Regeneron's Eylea (aflibercept), Roche/Genentech's Lucentis (ranibizumab) and Roche's anti-neoplastic agent Avastin (bevacizumab), which is used as an off-label therapy for retinal diseases. These drugs inhibit vascular endothelial growth factor (VEGF) which is a protein that promotes the growth of new blood vessels, which leak contents onto the macula in the pathophysiology of wet AMD. There are no approved therapies for neither GA nor dAMD.

Geographic atrophy, dry AMD and wet AMD are treated as separate indications in this forecast model although it is possible to have dry AMD in one eye and wet AMD in the second eye. Although severe side effects from anti-VEGF drugs are rare, it is possible for patients to develop ocular inflammation and increased intraocular pressure as well as a temporary worsening of sight loss in the immediate aftermath of an intravitreal injection. Unmet needs include the desire to reduce the frequency of administration of intravitreal therapies, the need to identify and monitor at earlier stages of disease and to develop therapies for dry AMD and GA.

GlobalData estimates that drug sales for AMD in 2018 were approximately $8.6B across the nine major markets (US, France, Germany, Italy, Spain, UK, Japan, China, and Australia). Over the 10-year forecast period, the market is expected to grow to $18.4B at a CAGR of 7.9%. This growth will be driven by the launch of 11 late-stage pipeline products. The two highest selling drugs are expected to be MacuCLEAR's therapy for dry AMD, MC-1101, and Roche/Chugai's faricimab, a monoclonal antibody for wet AMD.

Key Highlights

  • The AMD market is expected to grow at a CAGR of 7.9% from 2018 to 2028, reaching a global value of $18.4 billion.
  • Anti-VEGFs dominate the AMD marketplace, although the frequency of administration of intravitreal injections is burdensome for wet AMD patients. Other unmet needs include the fact that there are no treatments available for dry AMD or GA, lack of early diagnosis, and the fact that there is no way to reverse the sight loss caused by untreated AMD.
  • KOLs were satisfied by the anti-angiogenic mechanism of action as a way to control wet AMD, although the invasive route of administration of anti-VEGF therapies is uncomfortable for many patients.
  • Clinical trial data is limited for MacuCLEAR's MC-1101 (dry AMD) and Alkeus Pharma's ALK-001 (GA), although this is unlikely to be a significant obstacle in generating sales because of the lack of approved therapies for these indications.
  • Dobecure, a Spanish biopharmaceutical company are developing ethamsylate, which is a fibroblast inhibitor. This product is being developed to treat both dry and wet AMD. This is the only pipeline product being developed for both late forms of AMD and is expected to launch in the 5EU markets. The product is marketed for hematological conditions and is genericized, limiting sales in comparison to biologics such as fusion proteins and monoclonal antibodies.
  • Despite the warning from the American Society of Retina Specialists that Novartis' Beovu (brolucizumab) was linked to retinal vasculitis in a subset of wet AMD patients, the drug is still expected to become a top-selling marketed product by the end of the forecast period because of its high annual cost of therapy and classification as a longer-acting anti-VEGF therapy.
  • Allergan's abicipar pegol is also a longer-acting anti-VEGF therapy, administered five times a year, as is Roche/Genentech's faricimab, injected four times a year. Faricimab is expected to launch in all of the 9MM, contributing to its position as the top-selling late-stage pipeline product for wet AMD.
  • Apellis Pharma's first-in-class immunosuppressive therapy APL-2 is expected to generate higher sales than Alkeus Pharma's GA therapy, ALK-001. This is because complement inhibition is a mechanism of action that has shown efficacy in clinical trials exploring the potential for immunosuppressive techniques to treat geographic atrophy. Furthermore, APL-2, will launch in the US, 5EU, and Australian markets whereas ALK-001 will only launch in the US market during the forecast window.
  • Chengdu Kanghong's Langmu (conbercept) will also become a top-selling marketed product and benefit from a significant increase in sales. This is partially because the drug is more likely to be selected in China for its less expensive annual cost of therapy compared to Eylea and Lucentis. The large Chinese patient population will be a key driver of sales and the drug is also in the pipeline in the US market, expected to launch in 2023. Another low-cost anti-VEGF, which is Roche/Genentech's Avastin, is widely available across the 9MM. Sales of Avastin will increase in sales at the beginning of the forecast window before the launch of longer-acting anti-angiogenic therapies.
  • The sales of Eylea, Lucentis, and Avastin will decline in all of the 9MM due to the emergence of longer-acting therapies and the entry of biosimilars which will erode sales of their branded counterparts.
  • A sustained release version of ranibizumab being developed by Roche is expected to become a top-selling drug because the product, administered in the form of an ocular implant is changed after several months and may be selected as a more convenient option for patients in the US and 5EU markets, where the drug is expected to launch in 2021 and 2022, respectively.

Key Questions Answered in This Report

  • What were the main drugs used to manage wet AMD in 2018?
  • When will the late stage pipeline products launch in each of the 9MM?
  • What effect will each of the late-stage pipeline agents have on drug sales in the 9MM?
  • Which unmet needs will remain unaddressed in the forecast period?
  • What opportunities remain for drug developers?

Scope

  • Overview of AMD, including the epidemiology, etiology, pathophysiology, symptoms, diagnosis, and the management of wet AMD.
  • Annualized AMD therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in patient segments including dry AMD, GA, and wet AMD in a dynamic market forecast from 2018 to 2028.
  • Topics covered include a competitive assessment of key players in the market, characterization of marketed and pipeline drugs, an examination of unmet needs, and clinical trials in the 9MM.
  • Pipeline analysis: Provides a comprehensive analysis of pipeline products including their mechanism of action, route of administration, the patient population(s) for which the product is being developed, and performance of each drug candidate in clinical trials. Candidates in Phase III have been profiled and innovative therapeutic approaches in the early-stage pipeline are also discussed within the report.
  • Analysis of the current and future market competition in the global AMD market, with a particular focus on the new drugs being developed for dry AMD and geographic atrophy.
  • The report provides an insightful review of industry drivers, barriers and challenges across the 9MM. Each industry trend in relation to AMD is independently researched to provide an extensive qualitative review of its implications.

Reasons to Buy

The report will enable you to -

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global AMD pharmacotherapy market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global AMD market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

1 Table of Contents

  • 1.1 List of Tables
  • 1.2 List of Figures

2 Age-Related Macular Degeneration: Executive Summary

  • 2.1 AMD Market Will More than Double in Size, Reaching Sales of $18.7B in 2028
  • 2.2 Fast Track Designation for Anti-GA and Anti-dAMD Agents Will Expand Treatment Options for Underserved Patient Populations
  • 2.3 Longer-Acting Anti-VEGF Therapies Are Needed to Improve Patient Compliance Rates
  • 2.4 Six Late-Stage Pipeline Agents Are Set to Generate More than $1B in Annual Sales by 2028
  • 2.5 What Do Physicians Think?

3 Introduction

  • 3.1 Catalyst
  • 3.2 Related Reports
  • 3.3 Upcoming Related Reports

4 Disease Overview

  • 4.1 Etiology and Pathophysiology
    • 4.1.1 Overview
    • 4.1.2 Etiology
    • 4.1.3 Pathophysiology
  • 4.2 Classification or Staging Systems

5 Epidemiology

  • 5.1 Disease Background
  • 5.2 Risk Factors and Comorbidities
  • 5.3 Global and Historical Trends
  • 5.4 Forecast Methodology
    • 5.4.1 Sources
    • 5.4.2 Forecast Assumptions and Methods
    • 5.4.3 Total Prevalent Cases of AMD, Early AMD, Late AMD, Late Dry AMD, and Late Wet AMD
    • 5.4.4 Total Prevalent Cases of AMD by Laterality
    • 5.4.5 Total Prevalent Cases of Total Prevalent Cases of Geographic Atrophy Secondary to Late Dry AMD
    • 5.4.6 Diagnosed Prevalent Cases of AMD, Early AMD, Late AMD, Late Dry AMD, and Late Wet AMD
  • 5.5 Epidemiological Forecast for AMD, 2018-2028
    • 5.5.1 Total Prevalent Cases of AMD
    • 5.5.2 Age-Specific Total Prevalent Cases of AMD
    • 5.5.3 Sex-Specific Total Prevalent Cases of AMD
    • 5.5.4 Total Prevalent Cases of AMD by Laterality
    • 5.5.5 Total Prevalent Cases of Early AMD
    • 5.5.6 Total Prevalent Cases of Late AMD
    • 5.5.7 Total Prevalent Cases of Late Dry AMD
    • 5.5.8 Total Prevalent Cases of Late Wet AMD
    • 5.5.9 Total Prevalent Cases of Geographic Atrophy Secondary to Late Dry AMD
    • 5.5.10 Diagnosed Prevalent Cases of AMD
    • 5.5.11 Age-Specific Diagnosed Prevalent Cases of AMD
    • 5.5.12 Sex-Specific Diagnosed Prevalent Cases of AMD
    • 5.5.13 Diagnosed Prevalent Cases of Early AMD
    • 5.5.14 Diagnosed Prevalent Cases of Late AMD
    • 5.5.15 Diagnosed Prevalent Cases of Late Dry AMD
    • 5.5.16 Diagnosed Prevalent Cases of Late Wet AMD
    • 5.5.17 Diagnosed Prevalent Cases of Geographic Atrophy Secondary to Late Dry AMD
  • 5.6 Discussion
    • 5.6.1 Epidemiological Forecast Insight
    • 5.6.2 Limitations of the Analysis
    • 5.6.3 Strengths of the Analysis

6 Disease Management

  • 6.1 Diagnosis and Treatment Overview
  • 6.2 Treatment Overview
    • 6.2.1 Treatment Guidelines
    • 6.2.2 Treating Late AMD
  • 6.3 US
  • 6.4 5EU
  • 6.5 Asia-Pacific

7 Competitive Assessment

  • 7.1 Overview

8 Unmet Needs and Opportunity Assessment

  • 8.1 Overview
  • 8.2 Lack of Therapies for GA and dAMD
  • 8.3 Longer-Acting Anti-VEGF Therapies
  • 8.4 Timely Diagnosis of Patients with Early and Intermediate AMD
  • 8.5 Less Invasive Drug Formulations

9 Pipeline Assessment

  • 9.1 Overview
  • 9.2 Late-Stage Pipeline Products
  • 9.3 Innovative Early Stage Approaches

10 Current and Future Players

11 Market Outlook

12 Appendix

List of Tables

  • Table 1: AMD: Key Metrics in the 9MM
  • Table 2: Biological Pathways Associated with AMD Risk Genes
  • Table 3: The Four-Stage AREDS Classification of AMD
  • Table 4: Symptoms of AMD
  • Table 5: Risk Factors and Comorbidities for AMD
  • Table 6: Treatment Guidelines for AMD
  • Table 7: AMD Disease Management - US
  • Table 8: AMD Disease Management - 5EU
  • Table 9: AMD Disease Management - Asia-Pacific Region
  • Table 10: Marketed Drugs for AMD in the 9MM, 2020
  • Table 11: Comparison of Therapeutic Classes in Development for AMD, 2018-2028
  • Table 12: Innovative Early-Stage Approaches for AMD
  • Table 13: Roche/Genentech's AMD Portfolio Assessment, 2020
  • Table 14: Novartis' AMD Disease Portfolio Assessment, 2020
  • Table 15: Regeneron's AMD Portfolio Assessment, 2020
  • Table 16: Bayer's AMD Portfolio Assessment, 2020
  • Table 17: Chengdu Kanghong AMD Portfolio Assessment, 2020
  • Table 18: Allergan's AMD Disease Portfolio Assessment, 2018
  • Table 19: Apellis' AMD Portfolio Assessment, 2018
  • Table 20: Alkeus Pharma's AMD Portfolio Assessment, 2020
  • Table 21: Dobecure's AMD Portfolio Assessment, 2020
  • Table 22: Gene Techno Science's AMD Portfolio Assessment, 2020
  • Table 23: Outlook Therapeutics' AMD Portfolio Assessment, 2020
  • Table 24: MacuCLEAR's AMD Portfolio Assessment, 2020
  • Table 25: AMD Market - Global Drivers and Barriers, 2018-2028
  • Table 26: Key Events Impacting Sales for AMD in the US, 2018-2028
  • Table 27: AMD Market - Drivers and Barriers in the US, 2018-2028
  • Table 28: Key Events Impacting Sales for AMD in the 5EU, 2018-2028
  • Table 29: AMD Market - Drivers and Barriers in the 5EU, 2018-2028
  • Table 30: Key Events Impacting Sales for AMD in Japan, 2018-2028
  • Table 31: AMD Market - Drivers and Barriers in Japan, 2018-2028
  • Table 32: Key Events Impacting Sales for AMD in China, 2018-2028
  • Table 33: AMD Market - Global Drivers and Barriers in China, 2018-2028
  • Table 34: Key Events Impacting Sales for AMD in Australia, 2018-2028
  • Table 35: AMD Market - Global Drivers and Barriers in Australia, 2018-2028
  • Table 36: Key Historical and Projected Launch Dates for AMD
  • Table 37: Key Historical and Projected Patent Expiry Dates for AMD
  • Table 38: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1: Global (9MM) Sales Forecast, by Country, for AMD in 2018 and 2028
  • Figure 2: Analysis of the Company Portfolio Gap in AMD During the Forecast Period
  • Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of AMD During the Forecast Period
  • Figure 4: Anatomy of the Eye and Macula: Healthy Eyes, dAMD, and wAMD
  • Figure 5: 9MM, Total Prevalence of AMD, Men and Women, Ages ≥50 Years, %, 2018
  • Figure 6: 9MM, Diagnosed Prevalence of AMD, Men and Women, Ages ≥50 Years, 2018
  • Figure 7: 9MM, Sources Used and Not Used to Forecast the Total Prevalent Cases of AMD, Early AMD, Late AMD, Late Dry AMD, and Late Wet AMD
  • Figure 8: 9MM, Sources Used to Forecast the Total Prevalent Cases of AMD by Laterality
  • Figure 9: 9MM, Sources Used to Forecast the Total Prevalent Cases of Geographic Atrophy Secondary to Late Dry AMD and Diagnosed Prevalent Cases of AMD, Early AMD, Late AMD, Late Dry AMD, and Late Wet AMD
  • Figure 10: 9MM, Total Prevalent Cases of AMD, Both Sexes, Ages ≥50 Years, N, 2018
  • Figure 11: 9MM, Total Prevalent Cases of AMDby Age, Both Sexes, N, 2018
  • Figure 12: 9MM, Total Prevalent Cases of AMD, by Sex, Ages ≥50 Years, N, 2018
  • Figure 13: 9MM, Total Prevalent Cases of AMD by Laterality, Ages ≥50 Years, Both Sexes, N, 2018
  • Figure 14: 9MM, Total Prevalent Cases of Early AMD, Both Sexes, Ages ≥50 Years, N, 2018
  • Figure 15: 9MM, Total Prevalent Cases of Late AMD, Both Sexes, Ages ≥50 Years, N, 2018
  • Figure 16: 9MM, Total Prevalent Cases of Late Dry AMD, Both Sexes, Ages ≥50 Years, N, 2018
  • Figure 17: 9MM, Total Prevalent Cases of Late Wet AMD, Both Sexes, Ages ≥50 Years, N, 2018
  • Figure 18: 9MM, Total Prevalent Cases of Geographic Atrophy Secondary to Late Dry AMD, Both Sexes, Ages ≥50 Years, N, 2018
  • Figure 19: 9MM, Diagnosed Prevalent Cases of AMD, Both Sexes, Ages ≥50 Years, N, 2018
  • Figure 20: 9MM, Diagnosed Prevalent Cases of AMD by Age, Both Sexes, N, 2018
  • Figure 21: 9MM, Diagnosed Prevalent Cases of AMD, by Sex, Ages ≥50 Years, N, 2018
  • Figure 22: 9MM, Diagnosed Prevalent Cases of Early AMD, Both Sexes, Ages ≥50 Years, N, 2018
  • Figure 23: 9MM, Diagnosed Prevalent Cases of Late AMD, Both Sexes, Ages ≥50 Years, N, 2018
  • Figure 24: 9MM, Diagnosed Prevalent Cases of Late Dry AMD, Both Sexes, Ages ≥50 Years, N, 2018
  • Figure 25: 9MM, Diagnosed Prevalent Cases of Late Wet AMD, Both Sexes, Ages ≥50 Years, N, 2018
  • Figure 26: 9MM, Diagnosed Prevalent Cases of Geographic Atrophy Secondary to Late Dry AMD, Both Sexes, Ages ≥50 Years, N, 2018
  • Figure 27: Amsler Grid, as Viewed by Patients with Normal Vision and with wAMD
  • Figure 28: Unmet Needs and Opportunities in AMD
  • Figure 29: ETDRS Chart Used to Measure Visual Acuity
  • Figure 30: Overview of the Development Pipeline in AMD
  • Figure 31: Ongoing Phase II/III Trials for Anti-VEGF Pipeline Agents in Development for AMD in the 9MM
  • Figure 32: Ongoing Phase II/III Trials for Pipeline Agents in Development for AMD in the 9MM
  • Figure 33: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of AMD During the Forecast Period
  • Figure 34: Company Portfolio Gap Analysis in AMD, 2018-2028
  • Figure 35: Clinical Trials for AMD in the 9MM by Trial Status
  • Figure 36: Global (9MM) Sales Forecast by Country for AMD in 2018 and 2028
  • Figure 37: Global (9MM) Sales Forecast by Disease Subtype in 2028
  • Figure 38: Global (9MM) Sales Forecast for GA in 2028
  • Figure 39: Global (9MM) Sales Forecast for dAMD in 2028
  • Figure 40: Global (9MM) Drug Sales for wAMD in 2018 and 2028
  • Figure 41: US Sales Forecast by Disease Subtype in 2028
  • Figure 42: US Sales Forecast for GA in 2028
  • Figure 43: wAMD Sales in the US by Drug, 2018 and 2028
  • Figure 44: 5EU Sales Forecast by Disease Subtype in 2028
  • Figure 45: wAMD Sales in the 5EU by Drug, 2018 and 2028
  • Figure 46: wAMD Sales in Japan by Drug, 2018 and 2028
  • Figure 47: wAMD Sales in China by Drug, 2018 and 2028
  • Figure 48: Sales Forecast by Disease Subtype in Australia in 2028
  • Figure 49: wAMD Sales in Australia by Drug, 2018 and 2028