2014年10月24日讯 /生物谷BIOON/ --年龄相关性黄斑变性（AMD）是导致老年人不可逆视力障碍的主要原因。其中，湿性AMD主要是黄斑区新生血管异常所致，在AMD中是最具破坏性的类型。而干性AMD是视网膜色素上皮细胞（RPE）和感光细胞萎缩（也称为地图样萎缩）的晚期类型，占所有AMD的90%，目前市场上还没有特异性治疗药物。
根据全球领先的制药与医疗保健顾问公司Decision Resources日前发布的一份新报告，未来10年（2013-2023），美国、日本、欧洲5大主要市场（法国、德国、意大利、西班牙、英国）中，年龄相关性黄斑变性（AMD）药物市场将以6%的年度复合增长率（CAGR）增长，到2023年达到近90亿美元。推动AMD市场增长的因素包括：人口老龄化导致AMD患病率增加，多重用药（polypharmacy）率的上升，针对地图样萎缩（GA，干性AMD的晚期类型）的首批制剂的预期上市及市场的快速吸纳。
——罗氏单抗lampalizumab将成为首个干性AMD治疗药物：该药预计将在2013-2023预测期的后5年上市，该药的临床和商业里程碑将导致这一细分市场快速扩张。报告预测，lampalizumab在2023年之后的年销售峰值将突破10亿美元。Acucela/大冢的另一种地图样萎缩（GA）药物emixustat预计将在lampalizumab上市后不久紧跟着上市。
——辅助药物Fovista上市推动湿性AMD多重用药率提高：目前引领单抗药物的单药疗法将继续主导湿性AMD的治疗，包括Lucentis（罗氏/诺华）、Eylea（拜耳/Regeneron）、Avastin（罗氏/中外制药，标签外用药）。目前，诺华和Ophthotech公司正在合作开发一种辅助治疗药物Fovista，该药预计将于2018年在美国上市，届时将正式并大幅扩张AMD的联合治疗，到2023年将使AMD市场增加超过5亿美元。
——生物仿制药将制约AMD市场增长：湿性AMD主流单抗药物的生物仿制药预计将在2013-2023预测期的后5年上市，将部分侵蚀品牌药的市场份额。在较近期，一些欧洲国家政府正式批准Avastin标签外用药，用于湿性AMD的治疗，将部分侵蚀已批准的VEGF抑制剂（Lucentis，Eylea）的患者份额。
——地图样萎缩（GA）细分市场强劲增长：随着强有效的治疗药物的上市，地图样萎缩（GA）患者的预后将有望大幅改善，该病诊断和药物处方率的提高、新兴制剂的预期溢价，七国集团（G7）GA药物市场预计将在首批新药上市后的3年内，迅速突破10亿美元大关。
——多种因素助推Fovista商业成功：作为一种辅助药物，Fovista将避免与现有湿性AMD药物的直接竞争。然而，该药的商业成功，将取决于定价和报销是否在主要市场中有利，而这将基于Fovista作为一种辅助药物其价值的成本/效益分析以及愿意将Fovista纳入湿性AMD临床治疗现有方案的医生的广泛程度。II期临床试验中，Fovista对其他亚组患者的关注，如具有视网膜下纤维化风险的患者群体，或对当前VEGF抑制剂疗法难治的患者群体，将帮助推动视网膜专家和纳税人对该药的一致认同。
英文原文：The Age-Related Macular Degeneration Drug Market Will Grow to Nearly $9 Billion in 2023, Fueled in Part by the Anticipated Launch of the First Therapies for Geographic Atrophy
The Age-Related Macular Degeneration Drug Market Will Grow to Nearly $9 Billion in 2023, Fueled in Part by the Anticipated Launch of the First Therapies for Geographic Atrophy
October 20, 2014 – Burlington, Mass. – Decision Resources Group finds that the market for age-related macular degeneration (AMD) pharmacotherapies will expand 6 percent annually to reach nearly $9 billion in 2023 in the G7 pharmaceutical markets (United States, France, Germany, Italy, Spain, the United Kingdom and Japan). Forces combining to drive forecasted market growth include increasing AMD prevalence due to population aging, rising rates of polypharmacy, and the anticipated launch and rapid uptake of the first agents for the treatment of geographic atrophy—the advanced dry form of AMD.
Other key findings from the Pharmacor report entitled Age-Related Macular Degeneration:
First drug approved for geographic atrophy: Following a projected launch in the second half of the 2013-2023 forecast period, Roche/Genentech’s lampalizumab will become the first agent ever approved for the treatment of geographic atrophy, a clinical and commercial milestone leading to the advent and rapid expansion of this market segment. Decision Resources Group forecasts that lampalizumab will achieve blockbuster sales peaking beyond 2023, despite early competition from Acucela/Otsuka’s emixustat hydrochloride for the treatment of geographic atrophy, which is expected to launch shortly after lampalizumab.
Increasing polypharmacy in wet AMD: Monotherapy with current mainstays Lucentis (Roche/Genentech/Novartis), Eylea (Regeneron/Bayer HealthCare), and off-label Avastin (Roche/Genentech/Chugai) will continue to dominate wet AMD treatment. The 2018 U.S. launch of Fovista (Ophthotech/Novartis), which is being developed as an adjunct therapy, will formalize and substantially expand combination treatment for the disease, adding more than $500 million to the AMD market in 2023
Factors constraining growth of AMD market: Biosimilar versions of wet AMD mainstays expected to launch in the second half of the forecast period will lead to moderate brand share erosion. In the nearer term, the efforts of some European governments to formally permit the off-label use of Avastin for wet AMD will temper the patient share of approved VEGF inhibitors.
Comments from Decision Resources Group Analyst Nadja Rozovsky, Ph.D.:
“The prognosis of geographic atrophy patients is expected to improve substantially with the advent of effective treatments for the disease. With a forecasted growth in diagnosis and prescription drug-treatment rates and the assumption of premium pricing for emerging agents, the G7 market for geographic atrophy therapies is expected to rapidly cross the billion dollar threshold within three years of the first launch.”
“As an adjunctive treatment, Fovista will avoid direct competition with established wet AMD agents. Its commercial success, however, will depend on whether pricing and reimbursement terms will be favorable in the major markets, based on a cost/benefit analysis of its value as an additive treatment, and how widely physicians would incorporate this regimen-based approach in wet AMD. The focus of the Fovista Phase II trials in additional patient subgroups, such as those at risk for subretinal fibrosis or who are refractory to currently available VEGF inhibitors therapies, likely will drive endorsement among retinal specialists and payers alike.”