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四大疫苗廠商僅有一家成功,行業(yè)格局要變天?

Kat Eschner
2021-03-10

多樣化將成為疫苗行業(yè)的新特征

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在2020年12月,只要卷起袖子打上一針就能夠創(chuàng)造歷史。

在全世界的關(guān)注下,英國(guó)率先施打了第一劑輝瑞-BioNTech疫苗,美國(guó)也緊隨其后開始疫苗接種。在那之后的幾個(gè)月,全世界有超過2.65億人已經(jīng)接種了一劑或多劑新冠疫苗。

這一結(jié)果比專家預(yù)期的時(shí)間提前了數(shù)年,也是制藥行業(yè)對(duì)這場(chǎng)全球健康危機(jī)最有效的應(yīng)對(duì)措施。然而,此次生物技術(shù)的勝利也預(yù)示著以營(yíng)利為目的制藥行業(yè)將迎來巨變。該行業(yè)目前正在致力于解決如何生產(chǎn)足夠多的疫苗劑量來滿足需求。

2020年1月,在疫情大規(guī)模爆發(fā)之前,疫苗行業(yè)被四家大公司主導(dǎo),它們分別是:葛蘭素史克、默沙東、賽諾菲和輝瑞。

一年多以后,行業(yè)局面已經(jīng)發(fā)生了變化。到目前為止,在開發(fā)新冠疫苗的競(jìng)賽中,這四大公司中只有輝瑞一家獲勝。輝瑞的信使核糖核酸(mRNA)疫苗分兩劑施打的保護(hù)率高達(dá)95%。輝瑞預(yù)計(jì)2021年疫苗收入有望達(dá)到約150億美元,占公司總收入的近30%。

與此同時(shí),Moderna、阿斯利康和Novavax等曾經(jīng)市場(chǎng)知名度不高的公司,也因疫苗變得家喻戶曉。而且中國(guó)和俄羅斯也在發(fā)展本國(guó)疫苗產(chǎn)業(yè),中國(guó)的一些醫(yī)藥公司,例如科興和國(guó)藥,也因新冠疫苗的成功上市走進(jìn)了大眾的視線。

新冠肺炎病毒似乎將會(huì)已人類長(zhǎng)期共存。因此這些公司疫苗研制成功,意味著這個(gè)原本高度整合的行業(yè)將迎來巨變。

標(biāo)普全球醫(yī)療保健行業(yè)的分析師帕特里克·貝爾說:“在疫情當(dāng)中,輝瑞今年在全球疫苗銷售方面的領(lǐng)先優(yōu)勢(shì)顯而易見。”

貝爾表示,小型生物科技公司Moderna因?yàn)檠邪l(fā)出一款與輝瑞疫苗效果相當(dāng)?shù)膍RNA疫苗,迅速引起了人們的關(guān)注,它“有望成為行業(yè)第二。” Moderna預(yù)測(cè)今年的總產(chǎn)品銷售額將達(dá)到184億美元。

變革中的疫苗行業(yè)

疫苗研發(fā)的成本高昂,并且需要耗費(fèi)時(shí)間,而且疫苗的年收入往往相對(duì)較低。

標(biāo)普全球醫(yī)療保健行業(yè)的分析師戴維·卡普蘭指出,疫苗屬于數(shù)量大、價(jià)格低的商品。他表示:“這導(dǎo)致許多公司退出了疫苗市場(chǎng)。”

疫情爆發(fā)之前,疫苗行業(yè)的規(guī)模為330億美元,僅占全球制藥行業(yè)的3%。四大疫苗公司獲得了該行業(yè)約90%的收入。

專家表示,雖然疫苗行業(yè)對(duì)整個(gè)制藥行業(yè)收入的貢獻(xiàn)較小,但與整個(gè)生物科技行業(yè)一樣,疫苗行業(yè)在過去30年內(nèi)經(jīng)歷了重要的技術(shù)變革,帶動(dòng)該行業(yè)實(shí)現(xiàn)顯著增長(zhǎng)。例如,針對(duì)人類乳突病毒(HPV)和帶狀皰疹的新疫苗,以及更有效的流感疫苗、麻疹疫苗等,形成了巨大的市場(chǎng)。

但在疫情爆發(fā)之前,疫苗行業(yè)存在創(chuàng)新陷入停滯的危險(xiǎn)。從疫苗研發(fā)和臨床試驗(yàn),到開發(fā)一款成功的候選疫苗,再到日益嚴(yán)峻的疫苗生產(chǎn)挑戰(zhàn),公司在疫苗開發(fā)過程中需要投資數(shù)十億美元。而且研發(fā)過程的大部分階段都存在風(fēng)險(xiǎn):耗費(fèi)數(shù)年開展的初步研究,并不能夠保證可以帶來一款成功的疫苗,或者在疫苗獲得批準(zhǔn)之后也無法保證是否還有足夠的需求,使生產(chǎn)疫苗依舊有利可圖。

正常情況下,疫苗行業(yè)的技術(shù)變革可能需要經(jīng)歷數(shù)十年時(shí)間。但由于新冠疫情的緊迫性,政府和疫苗行業(yè)為了開發(fā)疫苗投入了大量資金。在行業(yè)、政府和學(xué)術(shù)界的通力合作下,有多款疫苗用史上最快的時(shí)間成功上市,在這個(gè)過程中發(fā)展了未來的疫苗技術(shù),并培養(yǎng)了疫苗生產(chǎn)所需要的聯(lián)系。

新mRNA技術(shù)的發(fā)展是最直接的例子。全世界有大批科學(xué)家和投資者從事該技術(shù)的研究超過30年。

貝爾說:“新冠疫情幫助加快了部分mRNA技術(shù)的開發(fā)進(jìn)度,在正常情況下該技術(shù)的發(fā)展可能需要更長(zhǎng)時(shí)間。”

美國(guó)政府斥資100億美元發(fā)起的新冠疫苗開發(fā)計(jì)劃“曲速行動(dòng)”為Moderna和輝瑞創(chuàng)新疫苗的誕生創(chuàng)造了環(huán)境。Moderna獲得了約10億美元直接補(bǔ)助以及大量后勤支持,而輝瑞則得到了政府的承諾,只要其研發(fā)工作取得成功,政府將采購(gòu)價(jià)值約20億美元的疫苗。

Moderna是一家小型生物科技公司,在2018年才進(jìn)行首次公開募股。該公司有獨(dú)特的優(yōu)勢(shì)充分利用“曲速行動(dòng)”創(chuàng)造的融資環(huán)境。如果沒有“曲速行動(dòng)”提供的資金和專業(yè)技術(shù),一家小型生物科技公司不可能有實(shí)力完成數(shù)輪臨床試驗(yàn)并完善候選疫苗。

該公司以及其他有望開發(fā)疫苗的公司,與美國(guó)國(guó)立健康研究院合作生產(chǎn)了多款候選疫苗,將完成相同的試驗(yàn)過程。Moderna的疫苗最終取得成功。

候選疫苗開發(fā)競(jìng)賽

在mRNA技術(shù)發(fā)展的三十年間,整個(gè)制藥行業(yè)一直很難維持發(fā)展動(dòng)力和維護(hù)行業(yè)的聲譽(yù)。新冠疫情為該行業(yè)創(chuàng)造了兩個(gè)方面條件的改善:公司迅速?gòu)默F(xiàn)有治療藥物中尋找對(duì)抗這種疾病的辦法(幾乎所有現(xiàn)有治療方法均無效),并向醫(yī)院、護(hù)理中心等機(jī)構(gòu)捐贈(zèng)了大量稀缺的個(gè)人防護(hù)用品,希望借此改善公司的形象。

但大獎(jiǎng)是疫苗。

在2020年,全世界有數(shù)百款新冠候選疫苗投入研發(fā),許多疫苗都得到了政府支持。生物供應(yīng)管理聯(lián)盟的執(zhí)行董事德文德拉·米什拉表示:“疫苗研發(fā)出現(xiàn)了高度分散的局面。”

米什拉所在的組織很早就開始發(fā)布有關(guān)新冠疫情的時(shí)事通訊,以幫助來自整個(gè)生物科技行業(yè)供應(yīng)鏈的會(huì)員及時(shí)跟蹤行業(yè)動(dòng)態(tài)。早在去年5月,時(shí)事通訊中就開始分享與疫苗開發(fā)競(jìng)賽有關(guān)的資料。

截至2020年年底,仍然在開發(fā)當(dāng)中的候選疫苗有200多種。目前已經(jīng)在全世界接種的疫苗接近兩位數(shù)。強(qiáng)生旗下的楊森制藥開發(fā)的最新疫苗,在2月28日獲得了美國(guó)食品與藥品管理局的緊急使用授權(quán)。

到目前為止,四大疫苗公司只有一家公司在較短時(shí)間內(nèi),成功開發(fā)出一款有效的新冠疫苗,這凸顯出了開發(fā)新疫苗的難度。

貝爾說:“默沙東放棄了兩款候選疫苗的開發(fā)計(jì)劃。葛蘭素史克和賽諾菲正在合作開發(fā)一款疫苗,目前尚未成功。”他認(rèn)為,雖然葛蘭素史克-賽諾菲的疫苗最終肯定會(huì)上市,但這在短期內(nèi)無法實(shí)現(xiàn)。葛蘭素史克還在與德國(guó)生物制藥公司CureVac合作開發(fā)下一代mRNA疫苗。

分布問題

雖然疫苗開發(fā)的分散性確實(shí)能夠在短期內(nèi)誕生大量新冠疫苗,但大批量生產(chǎn)疫苗的需求,以及高度全球化的制藥行業(yè)原材料運(yùn)輸中斷,和疫苗的物流網(wǎng)絡(luò)遭到的前所未有的破壞,導(dǎo)致疫苗供應(yīng)鏈陷入了混亂。

米什拉稱:“新冠疫情暴露出生命科學(xué)供應(yīng)鏈的缺點(diǎn)。它暴露出我們相關(guān)的聯(lián)系是多么脆弱。”

生產(chǎn)疫苗所需要的技術(shù)和原材料必須獲得良好生產(chǎn)規(guī)范標(biāo)準(zhǔn)認(rèn)證。遵照這種高標(biāo)準(zhǔn)會(huì)產(chǎn)生高生產(chǎn)成本,這意味著生物科技公司會(huì)充分利用其資源。

公司為了生產(chǎn)數(shù)十億劑疫苗不得不尋找額外產(chǎn)能,這個(gè)問題使制藥行業(yè)供應(yīng)鏈當(dāng)前的動(dòng)態(tài)變化加快了速度,但這種變化能否長(zhǎng)期持續(xù)下去,我們?nèi)匀恍枰媚恳源?/p>

受到生產(chǎn)規(guī)模等因素的影響,制藥公司可能會(huì)自行建設(shè)生產(chǎn)設(shè)施,自行內(nèi)部生產(chǎn)疫苗,或者租用定制研發(fā)生產(chǎn)組織的產(chǎn)能。

貝爾表示:“這給定制研發(fā)生產(chǎn)組織帶來了福音。”貝爾和卡普蘭在去年合作發(fā)布的一篇報(bào)告中指出,即使初期疫苗生產(chǎn)需求下降之后,定制研發(fā)生產(chǎn)組織獲得的好處可能會(huì)持續(xù)存在。

定制研發(fā)生產(chǎn)組織使小型生物科技公司既可以進(jìn)行產(chǎn)品生產(chǎn),又能夠節(jié)省不會(huì)頻繁投入使用的內(nèi)部設(shè)施的維護(hù)開支。雖然疫情讓各國(guó)更加重視在國(guó)內(nèi)生產(chǎn)疫苗和藥品,但行業(yè)觀察家們預(yù)測(cè),大型制藥公司可能會(huì)繼續(xù)利用定制研發(fā)生產(chǎn)組織,應(yīng)對(duì)國(guó)內(nèi)的疫苗生產(chǎn)壓力。

在疫情期間,沒有成功研發(fā)出疫苗的制藥公司同意與取得成功的其他公司共享其內(nèi)部產(chǎn)能。最近,美國(guó)總統(tǒng)喬·拜登宣布,默沙東計(jì)劃生產(chǎn)強(qiáng)生的疫苗,這將大幅增加疫苗供應(yīng)。

但合作并不容易。

戴爾豪斯大學(xué)的病毒學(xué)家艾莉森·凱爾文指出:“有一個(gè)問題是,每家公司都針對(duì)各自產(chǎn)品的需求建設(shè)了生產(chǎn)設(shè)施,而且有時(shí)候這些產(chǎn)品并不重疊。”

疫情并不意味著對(duì)其他關(guān)鍵藥品的需求已經(jīng)消失:治療其他疾病的藥物與以往一樣是必不可少的。凱爾文依舊強(qiáng)調(diào),“創(chuàng)造性思維”使公司即使在非常規(guī)環(huán)境下,也可以展開合作,盡可能生產(chǎn)足夠多的疫苗。

疫苗供應(yīng)鏈關(guān)鍵的最后一英里,也是制藥公司考慮的問題之一。

滑鐵盧大學(xué)的管理學(xué)教授侯賽因·阿博依·莫里茲表示,政府需要穩(wěn)定的疫苗供應(yīng)來推動(dòng)大規(guī)模接種,但在當(dāng)前這種前所未有的環(huán)境下,公司很難保證疫苗供應(yīng)的可預(yù)測(cè)性。

但他相信目前出現(xiàn)的供應(yīng)問題只是“成長(zhǎng)的煩惱”。他說:“我確信,疫苗公司會(huì)擴(kuò)大生產(chǎn)規(guī)模,未來我們的疫苗供應(yīng)量會(huì)大幅增加。”

應(yīng)對(duì)新冠疫情開啟了疫苗行業(yè)的新時(shí)代,多樣化將成為疫苗行業(yè)的新特征。

卡普拉稱:“我不認(rèn)為疫情結(jié)束之后的疫苗市場(chǎng)會(huì)變得比疫情之前更加分散。”

過去,Moderna這種小公司最常見的結(jié)果是,在產(chǎn)品大有可為的階段,被大型制藥公司收購(gòu)。但現(xiàn)在,當(dāng)需求出現(xiàn)的時(shí)候,Moderna恰逢其時(shí),能夠利用其創(chuàng)新能力,維持公司的獨(dú)立性。

從長(zhǎng)遠(yuǎn)來看,當(dāng)前的局面對(duì)Moderna等公司以及Novavax和Inovio等小型創(chuàng)新公司的意義仍然有待觀察,但它們的創(chuàng)新有望幫助它們繞過收購(gòu)階段,以更強(qiáng)有力的姿態(tài)進(jìn)入市場(chǎng)。

主要的不確定因素依舊是新冠疫苗能夠在多長(zhǎng)時(shí)間內(nèi)維持盈利。

但隨著病毒變異和感染人數(shù)的持續(xù)增加,有一種可能性變得越來越高:人們可能都需要接種疫苗,或者變異病毒株要求人們重新接種疫苗,因此在今后很長(zhǎng)一段時(shí)間里,新冠疫苗將必不可少。

莫里茲說:“問題在于,新冠肺炎是仍會(huì)在全球范圍內(nèi)傳播流行,還是會(huì)變成一種地方性流行病。目前看來,新冠疫情似乎不會(huì)像我最初想象的那樣很快結(jié)束。”(財(cái)富中文網(wǎng))

翻譯:劉進(jìn)龍

審校:汪皓

在2020年12月,只要卷起袖子打上一針就能夠創(chuàng)造歷史。

在全世界的關(guān)注下,英國(guó)率先施打了第一劑輝瑞-BioNTech疫苗,美國(guó)也緊隨其后開始疫苗接種。在那之后的幾個(gè)月,全世界有超過2.65億人已經(jīng)接種了一劑或多劑新冠疫苗。

這一結(jié)果比專家預(yù)期的時(shí)間提前了數(shù)年,也是制藥行業(yè)對(duì)這場(chǎng)全球健康危機(jī)最有效的應(yīng)對(duì)措施。然而,此次生物技術(shù)的勝利也預(yù)示著以營(yíng)利為目的制藥行業(yè)將迎來巨變。該行業(yè)目前正在致力于解決如何生產(chǎn)足夠多的疫苗劑量來滿足需求。

2020年1月,在疫情大規(guī)模爆發(fā)之前,疫苗行業(yè)被四家大公司主導(dǎo),它們分別是:葛蘭素史克、默沙東、賽諾菲和輝瑞。

一年多以后,行業(yè)局面已經(jīng)發(fā)生了變化。到目前為止,在開發(fā)新冠疫苗的競(jìng)賽中,這四大公司中只有輝瑞一家獲勝。輝瑞的信使核糖核酸(mRNA)疫苗分兩劑施打的保護(hù)率高達(dá)95%。輝瑞預(yù)計(jì)2021年疫苗收入有望達(dá)到約150億美元,占公司總收入的近30%。

與此同時(shí),Moderna、阿斯利康和Novavax等曾經(jīng)市場(chǎng)知名度不高的公司,也因疫苗變得家喻戶曉。而且中國(guó)和俄羅斯也在發(fā)展本國(guó)疫苗產(chǎn)業(yè),中國(guó)的一些醫(yī)藥公司,例如科興和國(guó)藥,也因新冠疫苗的成功上市走進(jìn)了大眾的視線。

新冠肺炎病毒似乎將會(huì)已人類長(zhǎng)期共存。因此這些公司疫苗研制成功,意味著這個(gè)原本高度整合的行業(yè)將迎來巨變。

標(biāo)普全球醫(yī)療保健行業(yè)的分析師帕特里克·貝爾說:“在疫情當(dāng)中,輝瑞今年在全球疫苗銷售方面的領(lǐng)先優(yōu)勢(shì)顯而易見。”

貝爾表示,小型生物科技公司Moderna因?yàn)檠邪l(fā)出一款與輝瑞疫苗效果相當(dāng)?shù)膍RNA疫苗,迅速引起了人們的關(guān)注,它“有望成為行業(yè)第二。” Moderna預(yù)測(cè)今年的總產(chǎn)品銷售額將達(dá)到184億美元。

變革中的疫苗行業(yè)

疫苗研發(fā)的成本高昂,并且需要耗費(fèi)時(shí)間,而且疫苗的年收入往往相對(duì)較低。

標(biāo)普全球醫(yī)療保健行業(yè)的分析師戴維·卡普蘭指出,疫苗屬于數(shù)量大、價(jià)格低的商品。他表示:“這導(dǎo)致許多公司退出了疫苗市場(chǎng)。”

疫情爆發(fā)之前,疫苗行業(yè)的規(guī)模為330億美元,僅占全球制藥行業(yè)的3%。四大疫苗公司獲得了該行業(yè)約90%的收入。

專家表示,雖然疫苗行業(yè)對(duì)整個(gè)制藥行業(yè)收入的貢獻(xiàn)較小,但與整個(gè)生物科技行業(yè)一樣,疫苗行業(yè)在過去30年內(nèi)經(jīng)歷了重要的技術(shù)變革,帶動(dòng)該行業(yè)實(shí)現(xiàn)顯著增長(zhǎng)。例如,針對(duì)人類乳突病毒(HPV)和帶狀皰疹的新疫苗,以及更有效的流感疫苗、麻疹疫苗等,形成了巨大的市場(chǎng)。

但在疫情爆發(fā)之前,疫苗行業(yè)存在創(chuàng)新陷入停滯的危險(xiǎn)。從疫苗研發(fā)和臨床試驗(yàn),到開發(fā)一款成功的候選疫苗,再到日益嚴(yán)峻的疫苗生產(chǎn)挑戰(zhàn),公司在疫苗開發(fā)過程中需要投資數(shù)十億美元。而且研發(fā)過程的大部分階段都存在風(fēng)險(xiǎn):耗費(fèi)數(shù)年開展的初步研究,并不能夠保證可以帶來一款成功的疫苗,或者在疫苗獲得批準(zhǔn)之后也無法保證是否還有足夠的需求,使生產(chǎn)疫苗依舊有利可圖。

正常情況下,疫苗行業(yè)的技術(shù)變革可能需要經(jīng)歷數(shù)十年時(shí)間。但由于新冠疫情的緊迫性,政府和疫苗行業(yè)為了開發(fā)疫苗投入了大量資金。在行業(yè)、政府和學(xué)術(shù)界的通力合作下,有多款疫苗用史上最快的時(shí)間成功上市,在這個(gè)過程中發(fā)展了未來的疫苗技術(shù),并培養(yǎng)了疫苗生產(chǎn)所需要的聯(lián)系。

新mRNA技術(shù)的發(fā)展是最直接的例子。全世界有大批科學(xué)家和投資者從事該技術(shù)的研究超過30年。

貝爾說:“新冠疫情幫助加快了部分mRNA技術(shù)的開發(fā)進(jìn)度,在正常情況下該技術(shù)的發(fā)展可能需要更長(zhǎng)時(shí)間。”

美國(guó)政府斥資100億美元發(fā)起的新冠疫苗開發(fā)計(jì)劃“曲速行動(dòng)”為Moderna和輝瑞創(chuàng)新疫苗的誕生創(chuàng)造了環(huán)境。Moderna獲得了約10億美元直接補(bǔ)助以及大量后勤支持,而輝瑞則得到了政府的承諾,只要其研發(fā)工作取得成功,政府將采購(gòu)價(jià)值約20億美元的疫苗。

Moderna是一家小型生物科技公司,在2018年才進(jìn)行首次公開募股。該公司有獨(dú)特的優(yōu)勢(shì)充分利用“曲速行動(dòng)”創(chuàng)造的融資環(huán)境。如果沒有“曲速行動(dòng)”提供的資金和專業(yè)技術(shù),一家小型生物科技公司不可能有實(shí)力完成數(shù)輪臨床試驗(yàn)并完善候選疫苗。

該公司以及其他有望開發(fā)疫苗的公司,與美國(guó)國(guó)立健康研究院合作生產(chǎn)了多款候選疫苗,將完成相同的試驗(yàn)過程。Moderna的疫苗最終取得成功。

候選疫苗開發(fā)競(jìng)賽

在mRNA技術(shù)發(fā)展的三十年間,整個(gè)制藥行業(yè)一直很難維持發(fā)展動(dòng)力和維護(hù)行業(yè)的聲譽(yù)。新冠疫情為該行業(yè)創(chuàng)造了兩個(gè)方面條件的改善:公司迅速?gòu)默F(xiàn)有治療藥物中尋找對(duì)抗這種疾病的辦法(幾乎所有現(xiàn)有治療方法均無效),并向醫(yī)院、護(hù)理中心等機(jī)構(gòu)捐贈(zèng)了大量稀缺的個(gè)人防護(hù)用品,希望借此改善公司的形象。

但大獎(jiǎng)是疫苗。

在2020年,全世界有數(shù)百款新冠候選疫苗投入研發(fā),許多疫苗都得到了政府支持。生物供應(yīng)管理聯(lián)盟的執(zhí)行董事德文德拉·米什拉表示:“疫苗研發(fā)出現(xiàn)了高度分散的局面。”

米什拉所在的組織很早就開始發(fā)布有關(guān)新冠疫情的時(shí)事通訊,以幫助來自整個(gè)生物科技行業(yè)供應(yīng)鏈的會(huì)員及時(shí)跟蹤行業(yè)動(dòng)態(tài)。早在去年5月,時(shí)事通訊中就開始分享與疫苗開發(fā)競(jìng)賽有關(guān)的資料。

截至2020年年底,仍然在開發(fā)當(dāng)中的候選疫苗有200多種。目前已經(jīng)在全世界接種的疫苗接近兩位數(shù)。強(qiáng)生旗下的楊森制藥開發(fā)的最新疫苗,在2月28日獲得了美國(guó)食品與藥品管理局的緊急使用授權(quán)。

到目前為止,四大疫苗公司只有一家公司在較短時(shí)間內(nèi),成功開發(fā)出一款有效的新冠疫苗,這凸顯出了開發(fā)新疫苗的難度。

貝爾說:“默沙東放棄了兩款候選疫苗的開發(fā)計(jì)劃。葛蘭素史克和賽諾菲正在合作開發(fā)一款疫苗,目前尚未成功。”他認(rèn)為,雖然葛蘭素史克-賽諾菲的疫苗最終肯定會(huì)上市,但這在短期內(nèi)無法實(shí)現(xiàn)。葛蘭素史克還在與德國(guó)生物制藥公司CureVac合作開發(fā)下一代mRNA疫苗。

分布問題

雖然疫苗開發(fā)的分散性確實(shí)能夠在短期內(nèi)誕生大量新冠疫苗,但大批量生產(chǎn)疫苗的需求,以及高度全球化的制藥行業(yè)原材料運(yùn)輸中斷,和疫苗的物流網(wǎng)絡(luò)遭到的前所未有的破壞,導(dǎo)致疫苗供應(yīng)鏈陷入了混亂。

米什拉稱:“新冠疫情暴露出生命科學(xué)供應(yīng)鏈的缺點(diǎn)。它暴露出我們相關(guān)的聯(lián)系是多么脆弱。”

生產(chǎn)疫苗所需要的技術(shù)和原材料必須獲得良好生產(chǎn)規(guī)范標(biāo)準(zhǔn)認(rèn)證。遵照這種高標(biāo)準(zhǔn)會(huì)產(chǎn)生高生產(chǎn)成本,這意味著生物科技公司會(huì)充分利用其資源。

公司為了生產(chǎn)數(shù)十億劑疫苗不得不尋找額外產(chǎn)能,這個(gè)問題使制藥行業(yè)供應(yīng)鏈當(dāng)前的動(dòng)態(tài)變化加快了速度,但這種變化能否長(zhǎng)期持續(xù)下去,我們?nèi)匀恍枰媚恳源?/p>

受到生產(chǎn)規(guī)模等因素的影響,制藥公司可能會(huì)自行建設(shè)生產(chǎn)設(shè)施,自行內(nèi)部生產(chǎn)疫苗,或者租用定制研發(fā)生產(chǎn)組織的產(chǎn)能。

貝爾表示:“這給定制研發(fā)生產(chǎn)組織帶來了福音。”貝爾和卡普蘭在去年合作發(fā)布的一篇報(bào)告中指出,即使初期疫苗生產(chǎn)需求下降之后,定制研發(fā)生產(chǎn)組織獲得的好處可能會(huì)持續(xù)存在。

定制研發(fā)生產(chǎn)組織使小型生物科技公司既可以進(jìn)行產(chǎn)品生產(chǎn),又能夠節(jié)省不會(huì)頻繁投入使用的內(nèi)部設(shè)施的維護(hù)開支。雖然疫情讓各國(guó)更加重視在國(guó)內(nèi)生產(chǎn)疫苗和藥品,但行業(yè)觀察家們預(yù)測(cè),大型制藥公司可能會(huì)繼續(xù)利用定制研發(fā)生產(chǎn)組織,應(yīng)對(duì)國(guó)內(nèi)的疫苗生產(chǎn)壓力。

在疫情期間,沒有成功研發(fā)出疫苗的制藥公司同意與取得成功的其他公司共享其內(nèi)部產(chǎn)能。最近,美國(guó)總統(tǒng)喬·拜登宣布,默沙東計(jì)劃生產(chǎn)強(qiáng)生的疫苗,這將大幅增加疫苗供應(yīng)。

但合作并不容易。

戴爾豪斯大學(xué)的病毒學(xué)家艾莉森·凱爾文指出:“有一個(gè)問題是,每家公司都針對(duì)各自產(chǎn)品的需求建設(shè)了生產(chǎn)設(shè)施,而且有時(shí)候這些產(chǎn)品并不重疊。”

疫情并不意味著對(duì)其他關(guān)鍵藥品的需求已經(jīng)消失:治療其他疾病的藥物與以往一樣是必不可少的。凱爾文依舊強(qiáng)調(diào),“創(chuàng)造性思維”使公司即使在非常規(guī)環(huán)境下,也可以展開合作,盡可能生產(chǎn)足夠多的疫苗。

疫苗供應(yīng)鏈關(guān)鍵的最后一英里,也是制藥公司考慮的問題之一。

滑鐵盧大學(xué)的管理學(xué)教授侯賽因·阿博依·莫里茲表示,政府需要穩(wěn)定的疫苗供應(yīng)來推動(dòng)大規(guī)模接種,但在當(dāng)前這種前所未有的環(huán)境下,公司很難保證疫苗供應(yīng)的可預(yù)測(cè)性。

但他相信目前出現(xiàn)的供應(yīng)問題只是“成長(zhǎng)的煩惱”。他說:“我確信,疫苗公司會(huì)擴(kuò)大生產(chǎn)規(guī)模,未來我們的疫苗供應(yīng)量會(huì)大幅增加。”

應(yīng)對(duì)新冠疫情開啟了疫苗行業(yè)的新時(shí)代,多樣化將成為疫苗行業(yè)的新特征。

卡普拉稱:“我不認(rèn)為疫情結(jié)束之后的疫苗市場(chǎng)會(huì)變得比疫情之前更加分散。”

過去,Moderna這種小公司最常見的結(jié)果是,在產(chǎn)品大有可為的階段,被大型制藥公司收購(gòu)。但現(xiàn)在,當(dāng)需求出現(xiàn)的時(shí)候,Moderna恰逢其時(shí),能夠利用其創(chuàng)新能力,維持公司的獨(dú)立性。

從長(zhǎng)遠(yuǎn)來看,當(dāng)前的局面對(duì)Moderna等公司以及Novavax和Inovio等小型創(chuàng)新公司的意義仍然有待觀察,但它們的創(chuàng)新有望幫助它們繞過收購(gòu)階段,以更強(qiáng)有力的姿態(tài)進(jìn)入市場(chǎng)。

主要的不確定因素依舊是新冠疫苗能夠在多長(zhǎng)時(shí)間內(nèi)維持盈利。

但隨著病毒變異和感染人數(shù)的持續(xù)增加,有一種可能性變得越來越高:人們可能都需要接種疫苗,或者變異病毒株要求人們重新接種疫苗,因此在今后很長(zhǎng)一段時(shí)間里,新冠疫苗將必不可少。

莫里茲說:“問題在于,新冠肺炎是仍會(huì)在全球范圍內(nèi)傳播流行,還是會(huì)變成一種地方性流行病。目前看來,新冠疫情似乎不會(huì)像我最初想象的那樣很快結(jié)束。”(財(cái)富中文網(wǎng))

翻譯:劉進(jìn)龍

審校: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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