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四大疫苗厂商仅有一家成功,行业格局要变天?

四大疫苗厂商仅有一家成功,行业格局要变天?

Kat Eschner 2021年03月10日
多样化将成为疫苗行业的新特征

在2020年12月,只要卷起袖子打上一针就能够创造历史。

在全世界的关注下,英国率先施打了第一剂辉瑞-BioNTech疫苗,美国也紧随其后开始疫苗接种。在那之后的几个月,全世界有超过2.65亿人已经接种了一剂或多剂新冠疫苗。

这一结果比专家预期的时间提前了数年,也是制药行业对这场全球健康危机最有效的应对措施。然而,此次生物技术的胜利也预示着以营利为目的制药行业将迎来巨变。该行业目前正在致力于解决如何生产足够多的疫苗剂量来满足需求。

2020年1月,在疫情大规模爆发之前,疫苗行业被四家大公司主导,它们分别是:葛兰素史克、默沙东、赛诺菲和辉瑞。

一年多以后,行业局面已经发生了变化。到目前为止,在开发新冠疫苗的竞赛中,这四大公司中只有辉瑞一家获胜。辉瑞的信使核糖核酸(mRNA)疫苗分两剂施打的保护率高达95%。辉瑞预计2021年疫苗收入有望达到约150亿美元,占公司总收入的近30%。

与此同时,Moderna、阿斯利康和Novavax等曾经市场知名度不高的公司,也因疫苗变得家喻户晓。而且中国和俄罗斯也在发展本国疫苗产业,中国的一些医药公司,例如科兴和国药,也因新冠疫苗的成功上市走进了大众的视线。

新冠肺炎病毒似乎将会已人类长期共存。因此这些公司疫苗研制成功,意味着这个原本高度整合的行业将迎来巨变。

标普全球医疗保健行业的分析师帕特里克·贝尔说:“在疫情当中,辉瑞今年在全球疫苗销售方面的领先优势显而易见。”

贝尔表示,小型生物科技公司Moderna因为研发出一款与辉瑞疫苗效果相当的mRNA疫苗,迅速引起了人们的关注,它“有望成为行业第二。” Moderna预测今年的总产品销售额将达到184亿美元。

变革中的疫苗行业

疫苗研发的成本高昂,并且需要耗费时间,而且疫苗的年收入往往相对较低。

标普全球医疗保健行业的分析师戴维·卡普兰指出,疫苗属于数量大、价格低的商品。他表示:“这导致许多公司退出了疫苗市场。”

疫情爆发之前,疫苗行业的规模为330亿美元,仅占全球制药行业的3%。四大疫苗公司获得了该行业约90%的收入。

专家表示,虽然疫苗行业对整个制药行业收入的贡献较小,但与整个生物科技行业一样,疫苗行业在过去30年内经历了重要的技术变革,带动该行业实现显著增长。例如,针对人类乳突病毒(HPV)和带状疱疹的新疫苗,以及更有效的流感疫苗、麻疹疫苗等,形成了巨大的市场。

但在疫情爆发之前,疫苗行业存在创新陷入停滞的危险。从疫苗研发和临床试验,到开发一款成功的候选疫苗,再到日益严峻的疫苗生产挑战,公司在疫苗开发过程中需要投资数十亿美元。而且研发过程的大部分阶段都存在风险:耗费数年开展的初步研究,并不能够保证可以带来一款成功的疫苗,或者在疫苗获得批准之后也无法保证是否还有足够的需求,使生产疫苗依旧有利可图。

正常情况下,疫苗行业的技术变革可能需要经历数十年时间。但由于新冠疫情的紧迫性,政府和疫苗行业为了开发疫苗投入了大量资金。在行业、政府和学术界的通力合作下,有多款疫苗用史上最快的时间成功上市,在这个过程中发展了未来的疫苗技术,并培养了疫苗生产所需要的联系。

新mRNA技术的发展是最直接的例子。全世界有大批科学家和投资者从事该技术的研究超过30年。

贝尔说:“新冠疫情帮助加快了部分mRNA技术的开发进度,在正常情况下该技术的发展可能需要更长时间。”

美国政府斥资100亿美元发起的新冠疫苗开发计划“曲速行动”为Moderna和辉瑞创新疫苗的诞生创造了环境。Moderna获得了约10亿美元直接补助以及大量后勤支持,而辉瑞则得到了政府的承诺,只要其研发工作取得成功,政府将采购价值约20亿美元的疫苗。

Moderna是一家小型生物科技公司,在2018年才进行首次公开募股。该公司有独特的优势充分利用“曲速行动”创造的融资环境。如果没有“曲速行动”提供的资金和专业技术,一家小型生物科技公司不可能有实力完成数轮临床试验并完善候选疫苗。

该公司以及其他有望开发疫苗的公司,与美国国立健康研究院合作生产了多款候选疫苗,将完成相同的试验过程。Moderna的疫苗最终取得成功。

候选疫苗开发竞赛

在mRNA技术发展的三十年间,整个制药行业一直很难维持发展动力和维护行业的声誉。新冠疫情为该行业创造了两个方面条件的改善:公司迅速从现有治疗药物中寻找对抗这种疾病的办法(几乎所有现有治疗方法均无效),并向医院、护理中心等机构捐赠了大量稀缺的个人防护用品,希望借此改善公司的形象。

但大奖是疫苗。

在2020年,全世界有数百款新冠候选疫苗投入研发,许多疫苗都得到了政府支持。生物供应管理联盟的执行董事德文德拉·米什拉表示:“疫苗研发出现了高度分散的局面。”

米什拉所在的组织很早就开始发布有关新冠疫情的时事通讯,以帮助来自整个生物科技行业供应链的会员及时跟踪行业动态。早在去年5月,时事通讯中就开始分享与疫苗开发竞赛有关的资料。

截至2020年年底,仍然在开发当中的候选疫苗有200多种。目前已经在全世界接种的疫苗接近两位数。强生旗下的杨森制药开发的最新疫苗,在2月28日获得了美国食品与药品管理局的紧急使用授权。

到目前为止,四大疫苗公司只有一家公司在较短时间内,成功开发出一款有效的新冠疫苗,这凸显出了开发新疫苗的难度。

贝尔说:“默沙东放弃了两款候选疫苗的开发计划。葛兰素史克和赛诺菲正在合作开发一款疫苗,目前尚未成功。”他认为,虽然葛兰素史克-赛诺菲的疫苗最终肯定会上市,但这在短期内无法实现。葛兰素史克还在与德国生物制药公司CureVac合作开发下一代mRNA疫苗。

分布问题

虽然疫苗开发的分散性确实能够在短期内诞生大量新冠疫苗,但大批量生产疫苗的需求,以及高度全球化的制药行业原材料运输中断,和疫苗的物流网络遭到的前所未有的破坏,导致疫苗供应链陷入了混乱。

米什拉称:“新冠疫情暴露出生命科学供应链的缺点。它暴露出我们相关的联系是多么脆弱。”

生产疫苗所需要的技术和原材料必须获得良好生产规范标准认证。遵照这种高标准会产生高生产成本,这意味着生物科技公司会充分利用其资源。

公司为了生产数十亿剂疫苗不得不寻找额外产能,这个问题使制药行业供应链当前的动态变化加快了速度,但这种变化能否长期持续下去,我们仍然需要拭目以待。

受到生产规模等因素的影响,制药公司可能会自行建设生产设施,自行内部生产疫苗,或者租用定制研发生产组织的产能。

贝尔表示:“这给定制研发生产组织带来了福音。”贝尔和卡普兰在去年合作发布的一篇报告中指出,即使初期疫苗生产需求下降之后,定制研发生产组织获得的好处可能会持续存在。

定制研发生产组织使小型生物科技公司既可以进行产品生产,又能够节省不会频繁投入使用的内部设施的维护开支。虽然疫情让各国更加重视在国内生产疫苗和药品,但行业观察家们预测,大型制药公司可能会继续利用定制研发生产组织,应对国内的疫苗生产压力。

在疫情期间,没有成功研发出疫苗的制药公司同意与取得成功的其他公司共享其内部产能。最近,美国总统乔·拜登宣布,默沙东计划生产强生的疫苗,这将大幅增加疫苗供应。

但合作并不容易。

戴尔豪斯大学的病毒学家艾莉森·凯尔文指出:“有一个问题是,每家公司都针对各自产品的需求建设了生产设施,而且有时候这些产品并不重叠。”

疫情并不意味着对其他关键药品的需求已经消失:治疗其他疾病的药物与以往一样是必不可少的。凯尔文依旧强调,“创造性思维”使公司即使在非常规环境下,也可以展开合作,尽可能生产足够多的疫苗。

疫苗供应链关键的最后一英里,也是制药公司考虑的问题之一。

滑铁卢大学的管理学教授侯赛因·阿博依·莫里兹表示,政府需要稳定的疫苗供应来推动大规模接种,但在当前这种前所未有的环境下,公司很难保证疫苗供应的可预测性。

但他相信目前出现的供应问题只是“成长的烦恼”。他说:“我确信,疫苗公司会扩大生产规模,未来我们的疫苗供应量会大幅增加。”

应对新冠疫情开启了疫苗行业的新时代,多样化将成为疫苗行业的新特征。

卡普拉称:“我不认为疫情结束之后的疫苗市场会变得比疫情之前更加分散。”

过去,Moderna这种小公司最常见的结果是,在产品大有可为的阶段,被大型制药公司收购。但现在,当需求出现的时候,Moderna恰逢其时,能够利用其创新能力,维持公司的独立性。

从长远来看,当前的局面对Moderna等公司以及Novavax和Inovio等小型创新公司的意义仍然有待观察,但它们的创新有望帮助它们绕过收购阶段,以更强有力的姿态进入市场。

主要的不确定因素依旧是新冠疫苗能够在多长时间内维持盈利。

但随着病毒变异和感染人数的持续增加,有一种可能性变得越来越高:人们可能都需要接种疫苗,或者变异病毒株要求人们重新接种疫苗,因此在今后很长一段时间里,新冠疫苗将必不可少。

莫里兹说:“问题在于,新冠肺炎是仍会在全球范围内传播流行,还是会变成一种地方性流行病。目前看来,新冠疫情似乎不会像我最初想象的那样很快结束。”(财富中文网)

翻译:刘进龙

审校:汪皓

在2020年12月,只要卷起袖子打上一针就能够创造历史。

在全世界的关注下,英国率先施打了第一剂辉瑞-BioNTech疫苗,美国也紧随其后开始疫苗接种。在那之后的几个月,全世界有超过2.65亿人已经接种了一剂或多剂新冠疫苗。

这一结果比专家预期的时间提前了数年,也是制药行业对这场全球健康危机最有效的应对措施。然而,此次生物技术的胜利也预示着以营利为目的制药行业将迎来巨变。该行业目前正在致力于解决如何生产足够多的疫苗剂量来满足需求。

2020年1月,在疫情大规模爆发之前,疫苗行业被四家大公司主导,它们分别是:葛兰素史克、默沙东、赛诺菲和辉瑞。

一年多以后,行业局面已经发生了变化。到目前为止,在开发新冠疫苗的竞赛中,这四大公司中只有辉瑞一家获胜。辉瑞的信使核糖核酸(mRNA)疫苗分两剂施打的保护率高达95%。辉瑞预计2021年疫苗收入有望达到约150亿美元,占公司总收入的近30%。

与此同时,Moderna、阿斯利康和Novavax等曾经市场知名度不高的公司,也因疫苗变得家喻户晓。而且中国和俄罗斯也在发展本国疫苗产业,中国的一些医药公司,例如科兴和国药,也因新冠疫苗的成功上市走进了大众的视线。

新冠肺炎病毒似乎将会已人类长期共存。因此这些公司疫苗研制成功,意味着这个原本高度整合的行业将迎来巨变。

标普全球医疗保健行业的分析师帕特里克·贝尔说:“在疫情当中,辉瑞今年在全球疫苗销售方面的领先优势显而易见。”

贝尔表示,小型生物科技公司Moderna因为研发出一款与辉瑞疫苗效果相当的mRNA疫苗,迅速引起了人们的关注,它“有望成为行业第二。” Moderna预测今年的总产品销售额将达到184亿美元。

变革中的疫苗行业

疫苗研发的成本高昂,并且需要耗费时间,而且疫苗的年收入往往相对较低。

标普全球医疗保健行业的分析师戴维·卡普兰指出,疫苗属于数量大、价格低的商品。他表示:“这导致许多公司退出了疫苗市场。”

疫情爆发之前,疫苗行业的规模为330亿美元,仅占全球制药行业的3%。四大疫苗公司获得了该行业约90%的收入。

专家表示,虽然疫苗行业对整个制药行业收入的贡献较小,但与整个生物科技行业一样,疫苗行业在过去30年内经历了重要的技术变革,带动该行业实现显著增长。例如,针对人类乳突病毒(HPV)和带状疱疹的新疫苗,以及更有效的流感疫苗、麻疹疫苗等,形成了巨大的市场。

但在疫情爆发之前,疫苗行业存在创新陷入停滞的危险。从疫苗研发和临床试验,到开发一款成功的候选疫苗,再到日益严峻的疫苗生产挑战,公司在疫苗开发过程中需要投资数十亿美元。而且研发过程的大部分阶段都存在风险:耗费数年开展的初步研究,并不能够保证可以带来一款成功的疫苗,或者在疫苗获得批准之后也无法保证是否还有足够的需求,使生产疫苗依旧有利可图。

正常情况下,疫苗行业的技术变革可能需要经历数十年时间。但由于新冠疫情的紧迫性,政府和疫苗行业为了开发疫苗投入了大量资金。在行业、政府和学术界的通力合作下,有多款疫苗用史上最快的时间成功上市,在这个过程中发展了未来的疫苗技术,并培养了疫苗生产所需要的联系。

新mRNA技术的发展是最直接的例子。全世界有大批科学家和投资者从事该技术的研究超过30年。

贝尔说:“新冠疫情帮助加快了部分mRNA技术的开发进度,在正常情况下该技术的发展可能需要更长时间。”

美国政府斥资100亿美元发起的新冠疫苗开发计划“曲速行动”为Moderna和辉瑞创新疫苗的诞生创造了环境。Moderna获得了约10亿美元直接补助以及大量后勤支持,而辉瑞则得到了政府的承诺,只要其研发工作取得成功,政府将采购价值约20亿美元的疫苗。

Moderna是一家小型生物科技公司,在2018年才进行首次公开募股。该公司有独特的优势充分利用“曲速行动”创造的融资环境。如果没有“曲速行动”提供的资金和专业技术,一家小型生物科技公司不可能有实力完成数轮临床试验并完善候选疫苗。

该公司以及其他有望开发疫苗的公司,与美国国立健康研究院合作生产了多款候选疫苗,将完成相同的试验过程。Moderna的疫苗最终取得成功。

候选疫苗开发竞赛

在mRNA技术发展的三十年间,整个制药行业一直很难维持发展动力和维护行业的声誉。新冠疫情为该行业创造了两个方面条件的改善:公司迅速从现有治疗药物中寻找对抗这种疾病的办法(几乎所有现有治疗方法均无效),并向医院、护理中心等机构捐赠了大量稀缺的个人防护用品,希望借此改善公司的形象。

但大奖是疫苗。

在2020年,全世界有数百款新冠候选疫苗投入研发,许多疫苗都得到了政府支持。生物供应管理联盟的执行董事德文德拉·米什拉表示:“疫苗研发出现了高度分散的局面。”

米什拉所在的组织很早就开始发布有关新冠疫情的时事通讯,以帮助来自整个生物科技行业供应链的会员及时跟踪行业动态。早在去年5月,时事通讯中就开始分享与疫苗开发竞赛有关的资料。

截至2020年年底,仍然在开发当中的候选疫苗有200多种。目前已经在全世界接种的疫苗接近两位数。强生旗下的杨森制药开发的最新疫苗,在2月28日获得了美国食品与药品管理局的紧急使用授权。

到目前为止,四大疫苗公司只有一家公司在较短时间内,成功开发出一款有效的新冠疫苗,这凸显出了开发新疫苗的难度。

贝尔说:“默沙东放弃了两款候选疫苗的开发计划。葛兰素史克和赛诺菲正在合作开发一款疫苗,目前尚未成功。”他认为,虽然葛兰素史克-赛诺菲的疫苗最终肯定会上市,但这在短期内无法实现。葛兰素史克还在与德国生物制药公司CureVac合作开发下一代mRNA疫苗。

分布问题

虽然疫苗开发的分散性确实能够在短期内诞生大量新冠疫苗,但大批量生产疫苗的需求,以及高度全球化的制药行业原材料运输中断,和疫苗的物流网络遭到的前所未有的破坏,导致疫苗供应链陷入了混乱。

米什拉称:“新冠疫情暴露出生命科学供应链的缺点。它暴露出我们相关的联系是多么脆弱。”

生产疫苗所需要的技术和原材料必须获得良好生产规范标准认证。遵照这种高标准会产生高生产成本,这意味着生物科技公司会充分利用其资源。

公司为了生产数十亿剂疫苗不得不寻找额外产能,这个问题使制药行业供应链当前的动态变化加快了速度,但这种变化能否长期持续下去,我们仍然需要拭目以待。

受到生产规模等因素的影响,制药公司可能会自行建设生产设施,自行内部生产疫苗,或者租用定制研发生产组织的产能。

贝尔表示:“这给定制研发生产组织带来了福音。”贝尔和卡普兰在去年合作发布的一篇报告中指出,即使初期疫苗生产需求下降之后,定制研发生产组织获得的好处可能会持续存在。

定制研发生产组织使小型生物科技公司既可以进行产品生产,又能够节省不会频繁投入使用的内部设施的维护开支。虽然疫情让各国更加重视在国内生产疫苗和药品,但行业观察家们预测,大型制药公司可能会继续利用定制研发生产组织,应对国内的疫苗生产压力。

在疫情期间,没有成功研发出疫苗的制药公司同意与取得成功的其他公司共享其内部产能。最近,美国总统乔·拜登宣布,默沙东计划生产强生的疫苗,这将大幅增加疫苗供应。

但合作并不容易。

戴尔豪斯大学的病毒学家艾莉森·凯尔文指出:“有一个问题是,每家公司都针对各自产品的需求建设了生产设施,而且有时候这些产品并不重叠。”

疫情并不意味着对其他关键药品的需求已经消失:治疗其他疾病的药物与以往一样是必不可少的。凯尔文依旧强调,“创造性思维”使公司即使在非常规环境下,也可以展开合作,尽可能生产足够多的疫苗。

疫苗供应链关键的最后一英里,也是制药公司考虑的问题之一。

滑铁卢大学的管理学教授侯赛因·阿博依·莫里兹表示,政府需要稳定的疫苗供应来推动大规模接种,但在当前这种前所未有的环境下,公司很难保证疫苗供应的可预测性。

但他相信目前出现的供应问题只是“成长的烦恼”。他说:“我确信,疫苗公司会扩大生产规模,未来我们的疫苗供应量会大幅增加。”

应对新冠疫情开启了疫苗行业的新时代,多样化将成为疫苗行业的新特征。

卡普拉称:“我不认为疫情结束之后的疫苗市场会变得比疫情之前更加分散。”

过去,Moderna这种小公司最常见的结果是,在产品大有可为的阶段,被大型制药公司收购。但现在,当需求出现的时候,Moderna恰逢其时,能够利用其创新能力,维持公司的独立性。

从长远来看,当前的局面对Moderna等公司以及Novavax和Inovio等小型创新公司的意义仍然有待观察,但它们的创新有望帮助它们绕过收购阶段,以更强有力的姿态进入市场。

主要的不确定因素依旧是新冠疫苗能够在多长时间内维持盈利。

但随着病毒变异和感染人数的持续增加,有一种可能性变得越来越高:人们可能都需要接种疫苗,或者变异病毒株要求人们重新接种疫苗,因此在今后很长一段时间里,新冠疫苗将必不可少。

莫里兹说:“问题在于,新冠肺炎是仍会在全球范围内传播流行,还是会变成一种地方性流行病。目前看来,新冠疫情似乎不会像我最初想象的那样很快结束。”(财富中文网)

翻译:刘进龙

审校:汪皓

A rolled-up sleeve and a brief jab: That’s all it took to make history in December 2020. The world watched as the first doses of the Pfizer-BioNTech vaccine were administered, first in the U.K. and then followed quickly by the United States. In the months since, more than 265 million people around the world have received one or more doses of a COVID-19 vaccine.

These outcomes, literally years ahead of what experts expected, represent the most potent pharmaceutical response to a global health crisis ever mustered. But this triumph of biotechnology also signals a huge change for the for-profit industry currently engaged in figuring out the problem of how to produce enough vaccine doses to keep up with demand.

In January 2020, as the pandemic was brewing, the vaccine industry was dominated by four big companies: GlaxoSmithKline, Merck, Sanofi, and Pfizer. More than a year later, the picture has changed. Only one of these four companies has so far won the race to develop a COVID-19 vaccine: Pfizer, whose messenger RNA (mRNA) vaccine was found to provide 95% protection when used in a two-dose regimen. The company anticipates approximately $15 billion in revenue from its vaccine in 2021, which will represent nearly 30% of company revenue overall.

In the meantime, others—Moderna, AstraZeneca, Novavax—once on the periphery of market awareness, have become household names, and countries like China and Russia are developing homegrown vaccine industries. As COVID-19 starts to look like it’s here to stay, their success signals a sea change in the highly consolidated industry.

“For the pandemic, Pfizer is clearly going to be the leader in vax sales globally this year,” says Patrick Bell, a health care analyst at S&P Global. Moderna, a small biotech company catapulted into the limelight after producing an mRNA vaccine whose effectiveness is on par with Pfizer’s, is “going to enter as potentially No. 2,” Bell says. The company anticipates $18.4 billion in total product sales this year.

A changing industry

Making vaccines is costly and time-consuming, and vaccine revenues in any given year tend to be relatively small. Vaccines are a high-volume, low-price commodity, says David Kaplan, a health care analyst at S&P Global. “That has led to a lot of companies exiting the market,” he says. Before the pandemic, vaccines were a $33 billion industry, representing only 3% of the global pharmaceutical industry. The Big Four produced about 90% of the revenue in this sector.

Despite its small contribution to pharma industry revenues, the vaccines segment—like biotech more generally—has seen significant technological change in the past 30 years, which has driven remarkable growth, experts say. New vaccines for human papillomavirus (HPV) and shingles, for example, as well as improved vaccines for everything from influenza to measles, created a significant market.

But prior to the pandemic, the industry was in danger of getting stuck in a plateau between innovations. From the research and clinical trials needed to develop a successful vaccine candidate to the scale-up challenges of producing vaccines, companies need to invest billions of dollars. And there’s risk at most stages of the process: There’s no guarantee that primary research, which can take years, will lead to a successful vaccine or that demand once the vaccine is approved will be sufficient enough to make the vaccine worth producing.

Under normal circumstances, technological change in this environment can take decades. But because of the urgency of the COVID-19 pandemic, governments and industry poured funding into the search for a vaccine. A high level of collaboration between industry, governments, and academia has produced multiple successful vaccines in record time, in the process catapulting vaccine technology, and the connections required to produce it, into the future.

The development of nascent mRNA technology, which an international cohort of scientists and investors had been working on for more than 30 years, is the main example of this phenomena. “COVID has helped to accelerate some of the mRNA technology which was under development but would otherwise have proceeded at a slower pace,” says Bell.

Operation Warp Speed, the U.S. government’s $10-billion COVID-19 vaccine development initiative, created the environment that produced Moderna and Pfizer’s innovative vaccines. Moderna received about $1 billion in direct support as well as significant logistical support, while Pfizer received the government’s commitment that it would buy approximately $2 billion worth of its vaccine if successful.

Moderna, a small biotech company whose IPO was only in 2018, was in a unique position to leverage the funding environment created by Operation Warp Speed. Without the funding and expertise provided by Operation Warp Speed, it’s unlikely that a small biotech company could have mustered the funding for rounds of clinical trials and refinement of its drug candidate.

The company, together with other vaccine hopefuls, partnered with the National Institutes of Health to produce multiple vaccine candidates that would progress along the same trial lines. Its vaccine came out on top.

The race to develop vaccine candidates

The broader pharmaceutical industry has struggled to maintain momentum and preserve reputation over the past three decades during which mRNA technology was being developed. The COVID-19 pandemic offered the conditions to improve on both fronts: Companies immediately turned to their available stock of treatments to see if anything worked against the disease (nearly all available treatments weren’t useful) and dipped into stores of PPE for image-boosting opportunities to donate the scarce protective equipment to hospitals, care homes, and others in desperate need.

The big prize, though, was a vaccine. Literally hundreds of COVID-19 vaccine candidates went into development around the world in the course of 2020, many with the support of governments. “A very distributed development of the vaccine took place,” says Devendra Mishra, executive director of Bio Supply Management Alliance.

Mishra’s organization, which brings together members of the entire biotech supply chain, started producing a newsletter early on in the pandemic to help its members keep track of what was going on. As early as May, that newsletter started sharing material about the burgeoning race to develop a vaccine.

By the end of 2020, more than 200 vaccine candidates were still in development. The number of vaccines currently being used around the world is nearing double digits. The newest, developed by Johnson & Johnson’s pharmaceutical arm, Janssen, received an emergency use authorization (EUA) from the U.S. Food and Drug Administration on February 28.

The difficulty of developing new vaccines is illustrated by the fact that only one of the Big Four has so far succeeded in producing a working vaccine against COVID-19 on the abridged timeline. “Merck has abandoned plans on two of their vaccine candidates,” says Bell. “GlaxoSmithKline and Sanofi were working together on one, and they still are.” While the GSK-Sanofi vaccine could hit the market eventually, it’s not arriving soon, he says. GSK has also partnered with CureVac, a German biopharma company, to work on a next-generation mRNA vaccine.

Distribution challenges

While the distributed nature of vaccine development definitely contributed to the number of vaccines developed against COVID-19 in a short time, the demands of vaccine production on a mass scale—combined with unprecedented disruptions in the logistics network that transports raw materials and vaccines around the highly globalized pharmaceutical industry—have thrown the supply chain into disarray.

“The COVID-19 pandemic exposed the vulnerabilities of the supply chain of life sciences. It showed where our links are weak,” says Mishra.

The technology and raw materials needed to produce vaccines must be certified to good manufacturing practice (GMP) standards. The expense of production at this high standard means that the resources of biotech companies tend to be fully leveraged. The problem of finding additional capacity to manufacture literally billions of doses of vaccines has accelerated an ongoing shift in the dynamics of the pharmaceutical supply chain, although it remains to be seen if this shift will endure in the long term.

Depending on considerations like production scale, pharmaceutical companies either construct the facilities to make their products in house or they rent capacity from contract development and manufacturing organizations (CDMOs). “It has been very good for the CDMOs,” says Bell. He and Kaplan coauthored a report last year in which they noted that CDMO gains may endure even after initial vaccine production demand has subsided. The organizations allow small biotech companies to manufacture their products without the overhead of maintaining an in-house facility that will frequently not be in use. The pandemic has led to more focus on producing vaccines and medicines domestically, however, and industry-watchers anticipate that Big Pharma may continue to leverage CDMO capacity in response to pressure to produce vaccines in-country.

During the pandemic, pharma companies that haven’t produced a successful vaccine have agreed to share their in-house capacity with those who have. Most recently, President Joe Biden announced Merck’s intent to produce the Johnson & Johnson vaccine, radically increasing supply.

But collaborating isn’t always simple. “One of the problems is that each company has built their manufacturing facilities to what they need for their product, and sometimes there isn’t overlap,” says Alyson Kelvin, a virologist at Dalhousie University. And the pandemic doesn’t mean the need for other critical medications has stopped: Drugs for other conditions are just as necessary as ever. Still, Kelvin emphasizes that “out of the box thinking” has allowed companies to collaborate and make as many doses of the vaccine as possible, even in unconventional circumstances.

The critical last mile of the supply chain figures into pharmaceutical companies’ considerations as well. Governments need stable supply with good forecasting to initiate mass vaccination campaigns—something that companies have struggled to provide in this new context, says University of Waterloo management sciences professor Hossein Abouee Mehrizi. But he’s optimistic that the supply issues already encountered are just growing pains. “I am pretty sure companies are going to scale up, and we’ll get much more supply than we have now,” he says.

The COVID-19 pandemic response has kick-started a new era in the vaccine industry, one that will likely be shaped by diversification.

“I do think it’s true that we’ll probably see a more fragmented market coming out of COVID than going into COVID,” says Kaplan.

In the past, it was most common for small companies like Moderna to be purchased by Big Pharma once their product was at a promising stage. But, in this case, demand occurred just as Moderna was in the right place to exploit its innovation and keep its name. What that means in the longer term for companies like Moderna and other small innovators like Novavax and Inovio has yet to be seen, but their innovations may allow them to bypass the acquisition stage and enter the market as more significant players in their own right.

Major uncertainty remains regarding how long COVID-19 vaccines themselves will remain profitable. But as the virus continues to mutate and infections continue to occur, it’s appearing more and more likely that vaccines for COVID-19 will be necessary for some time to come, whether because people will need booster shots or because mutated strains will necessitate revaccination. “The question is, is it going to be pandemic or is it going to be endemic,” says Mehrizi. “At this point, it seems like it’s not going to end as fast as I thought in the beginning.”

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