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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。

——后续注射产品将继续成功:尽管医生和患者对口服疾病修饰疗法表现出了高涨的热情,注射型产品仍然是当前重要的治疗方案,同时也是目前MS管线的重要组成部分。报告预测,百健艾迪的Plegridy(聚乙二醇化干扰素β-1a)和梯瓦的长效版Copaxone(40mg,每周注射3次)这2种后续注射产品,将帮助维持2家公司各自的MS专营权,并在预测期内实现重磅销售额。

——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。

——抗炎化合物机遇与挑战并存:该类化合物的持续临床成功,突显了MS治疗中对切实有效的神经保护或再生疗法的远未满足的巨大医疗需求。这类药物可能作用于疾病的早期过程,并且/或联合免疫疗法可能使所有MS患者群体受益。目前这一领域的研发相当活跃,尤其是百健艾迪的II期候选药物BIIB-033,但该类药物研发面临的困境是难以确定有效的药物靶标及临床试验的优化设计。

——渐进性MS存重磅商业潜力:受访的专家常常提及,迫切需要有效的疗法来治疗渐进性MS。尽管专家对正在开展的临床试验(如评估Tysabri,Gilenya,ocrelizumab等)普遍表现出较低的预期,但如果获得成功,药物的商业潜力将相当可观。报告预计,若一种药物获批用于继发渐进性多发性硬化症(SPMS)或原发渐进性多发性硬化症(PPMS),单单在该患者群体中的销售额将突破10亿美元。(生物谷Bioon.com)

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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