首页 » 自身免疫性疾病 » 2023年全球多发性硬化症(MS)市场将达200亿美元


来源:生物谷 2014-08-09 17:35

2014年8月9日讯 /生物谷BIOON/ --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,4种预期推出的新药(百健艾迪的Plegridy,罗氏的ocrelizumab,百健艾迪/艾伯维的daclizumab,梯瓦/Active制药的Nerventra,Receptos公司的RPC-1063)和1种预期获批的新药(赛诺菲/拜耳的Lemtrada),将在未来10年内,帮助推动美国、日本、欧盟五大主要市场(法国、德国、意大利、西班牙、英国)多发性硬化症(MS)药物销售以4%的年度复合增长率(CAGR)增长,并在2023年达到200亿美元。值得注意的是,未来仿制药及预期的生物仿制药竞争,将驱动全球主要MS市场在2018年达到220亿美元的峰值。

——Tecfidera将统治美国市场:报告预测,在美国市场,随着MS群体对注射类药物依赖性的逐渐下降,百健艾迪的口服新药Tecfidera(Dimethyl fumarate,富马酸二甲酯)预计将于2015年取代梯瓦(Teva)的注射药物Copaxone,成为MS市场的领导者。Tecfidera于2013年4月获FDA批准,用作复发缓解型多发性硬化症(RRMS,约占所有MS病例的85%)的一线口服治疗药物。与其他注射药物相比,Tecfidera针对MS复发具有更好的疗效,同时具有较少的严重安全风险或监控需求以及可接受的耐受性。


——Ocrelizumab极具临床及商业前景:接受采访的众多专家,均对罗氏单抗药物ocrelizumab治疗MS的强大疗效及相对有利的给药属性(6个月注射一次)表达了积极意见,但同时指出,ocrelizumab的安全性必须在正开展的III期临床试验中得到确认。专家们一致对ocrelizumab持有谨慎乐观的态度,认为该药将成为二三线MS治疗的首选药物。ocrelizumab是一种以CD20+ B细胞为靶点的人源化单克隆抗体,每6个月注射一次,有望显著改善患者的依从性。依从性差是MS治疗中的一个巨大挑战。因此,对MS群体而言,ocrelizumab比每日2次的口服药物或每2天注射一次的注射药物更有吸引力。



英文原文:Biogen Idec's Tecfidera is Forecast to Overtake Teva's Copaxone Franchise as the U.S. Market Leader by 2015, According to Findings from Decision Resources Group

BURLINGTON, Mass., Aug. 7, 2014 /PRNewswire/ -- Decision Resources Group finds that the forecast launch of Biogen Idec's Plegridy, Roche/Genentech's ocrelizumab, Biogen Idec/AbbVie's daclizumab, Teva/Active Biotech's Nerventra and Receptos' RPC-1063, coupled with the expected U.S. approval of Genzyme/Sanofi/Bayer HealthCare's Lemtrada, will help drive total sales across the multiple sclerosis (MS) market in the United States, France, Germany, Italy, Spain, United Kingdom and Japan to over $20 billion in 2023, reflecting 4 percent annual growth from 2013. Of note, future generics and projected biosimilar competition will cause major-market sales to contract in the latter part of our study period from a 2018 peak of over $22 billion.

——U.S. market dominance of Tecfidera: With greater cross-trial efficacy on relapses than injectable agents, few serious safety risks or monitoring requirements and acceptable tolerability, Tecfidera has experienced robust uptake in the United States. The drug is forecast to become the U.S. market leader by 2015, supported by gradually declining reliance on the platform injectable therapies.

——Success for follow-on injectables: Despite physicians' and patients' enthusiasm for oral disease-modifying therapies, injectable products remain important current treatment options and comprise a meaningful element of the MS pipeline. We forecast that both Plegridy and Teva's Copaxone 40 mg three-times weekly, two follow-on products offering improved dosing characteristics over time-tested clinical mainstays, will help sustain these companies' respective franchises and earn blockbuster sales during the forecast period.

——Ocrelizumab's clinical and commercial promise: Interviewed experts express positive opinions about ocrelizumab's potential for strong efficacy in MS as well as its relatively favorable delivery profile. Interviewed thought leaders are quick to note that the drug's safety must be established in ongoing Phase III studies, but they are cautiously optimistic that ocrelizumab may become a preferred agent in later-line MS treatment.

Comments from Decision Resources Group Analyst John Crowley, Ph.D.:

——"Continued clinical success with anti-inflammatory compounds accentuates the unmet need for bona fide neuroprotective or regenerative therapies for MS. Such an agent could be initiated early in the disease process and/or in combination with immunological agents to benefit the entire spectrum of MS patients. Development in this arena is active—notably with Biogen Idec's Phase II candidate BIIB-033—but advancement overall is constrained by the difficulty of identifying valid drug targets and the optimal design for clinical trials."

——"Interviewed experts routinely note the pressing unmet need for effective therapies to treat progressive forms of MS. Although experts generally report low expectations for ongoing clinical trials assessing drugs like Tysabri, Gilenya and ocrelizumab, the commercial potential for a successful agent is sizable—we expect a drug's approval for secondary- or primary-progressive MS could result in sales exceeding $1 billion in that population alone."

About Decision Resources Group

Decision Resources Group offers best-in-class, high-value information and insights on critical issues within the healthcare industry. Clients rely on this analysis and data to make informed decisions.

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