疫苗佐剂市场基于(关键地区、市场参与者、规模和份额)- 到 2030 年的预测

  • Report Code : TIPRE00004430
  • Category : Pharmaceuticals
  • Status : Published
  • No. of Pages : 155
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【研究报告】疫苗佐剂市场规模预计将从2022年的24.8239亿美元增长到2030年的69.3155亿美元;预计 2022 年至 2030 年市场复合年增长率将达到 13.7%。
市场洞察和分析师观点:
佐剂是添加到疫苗制剂中的成分,可在接种疫苗的人中产生更强的免疫反应。传染病暴发和大流行的增加以及兽用疫苗佐剂的监管批准是推动市场发展的关键因素。然而,产品召回和不良反应阻碍了疫苗佐剂市场的增长。
增长动力:
对佐剂研究发展的支持和产品上市的合作努力为疫苗佐剂市场创造了机会
美国国家过敏症研究所传染病 (NIAID) 在开发、发现和表征新疫苗佐剂方面发挥着重要作用。该研究所在提高现有疫苗的功效、针对现有和新出现的传染病设计新的或更好的疫苗以及开发治疗过敏、自身免疫性疾病和癌症的疫苗方面发挥着至关重要的作用。此外,NIAID的疫苗佐剂研究计划旨在开发一套佐剂,包括可以与抗原匹配以优化最终疫苗功效的候选剂。因此,为了促进 NIAID 支持的疫苗佐剂研究人员与更广泛的科学界之间的合作,NIAID 于 2020 年建立了疫苗佐剂纲要 (VAC)。这个基于网络的工具显示佐剂特征,以帮助疫苗开发人员识别适合其目标疾病的佐剂.
SK Biosciences 和 GSK 等疫苗业务公司正在通过实施合作等增长战略来大规模生产佐剂,以满足全球需求。例如,2022 年 4 月,SK Biosciences 和 GSK 在 3 期临床试验获得积极数据后宣布向韩国食品药品安全部 (KMFDS) 提交 SKYCovione 的生物许可申请。因此,各政府部门为促进疫苗佐剂研发提供的支持、顶级制造商之间的合作以及通过此类合作业务策略推出创新产品可能会在预测期内为疫苗佐剂市场的增长提供利润丰厚的机会。
战略见解
报告细分和范围:
“疫苗佐剂市场”根据佐剂类别和类型进行细分。市场按佐剂类别分为矿物盐佐剂、乳剂佐剂、脂质体佐剂等。矿物盐佐剂细分市场在 2022 年占据最大市场份额。乳剂佐剂细分市场预计 2022 年至 2023 年复合年增长率最高,达到 14.6%。疫苗佐剂市场按类型分为人用疫苗佐剂和兽用疫苗佐剂。人疫苗佐剂细分市场在 2022 年占据更大的市场份额,预计在预测期内该细分市场的复合年增长率将达到 14.0%。
细分市场分析:
人疫苗佐剂细分市场拥有更大的市场到 2022 年,该领域的复合年增长率预计将达到 14.0%。根据美国国立卫生研究院(NIH)的报告,佐剂有助于抗原诱导早期、高度、持久的免疫反应,从而节省生产成本。用于人疫苗的佐剂的例子包括氢氧化铝和磷酸铝、磷酸钙和油乳剂。此外,替代佐剂的开发、分离和化学合成也取得了很大进展,如胞壁酰二肽衍生物、单磷酰脂质A、脂质体、QS21、MF-59和免疫刺激复合物(ISCOMS)。
SEPPIC提供注射疫苗佐剂,用于配制有效的治疗性疫苗。这些即用型油基佐剂与水相中的抗原混合时可产生稳定的乳液。 SEPPIC 的 MONTANIDE ISA 51 VG 是第一种针对非小细胞肺癌的治疗性疫苗。这种人佐疫苗是采用创新技术开发的关键预防产品。
疫苗佐剂市场,按类型 - 2022 年和 2030 年
矿物盐佐剂细分市场在 2022 年佐剂类别疫苗佐剂市场中占据最大份额。预计乳剂佐剂市场在预测期内将以 14.6% 的最快复合年增长率增长。矿物盐如不溶性铝盐和磷酸钙在疫苗制剂中用作佐剂。铝盐佐剂有助于诱导早期和持久的保护性免疫力。用于人类疫苗的铝佐剂受到美国食品和药物管理局 (FDA) 的监管,添加少量的铝可以帮助人体建立比疫苗中单独抗原更高的免疫原性。炎症部位的矿物盐佐剂配方通过释放促炎细胞因子产生快速免疫反应。因此,矿物盐佐剂诱导针对抗原的快速免疫反应的能力有利于疫苗佐剂市场的增长。
表面活性剂是含有乳液的表面活性化合物。这些化合物作为免疫刺激佐剂,源自植物皂树。五种含有“皂苷”的表面活性佐剂已被批准用于人类肠胃外给药。它们是表面活性糖苷,含有三萜结构的疏水核,核上有碳水化合物链。
技术进步是疫苗佐剂市场的趋势
目前,铝盐或凝胶佐剂主要用于在美国获得许可的疫苗。单磷酰脂质 A (MPL) 佐剂和疏水性共聚物是这些成分的例子。疏水性微球在疫苗生产过程中提出了挑战,主要是由于环境废物处理和污染问题。此外,使用这些微球使得该过程耗时、成本高且效率低。因此,制造商强调开发新技术以避免使用有机溶剂。例如,Aphios的疫苗佐剂技术涵盖了纳米技术,其生产包括含有或不含乙醇等极性共溶剂的超临界、临界或近临界流体[称为超流体(SFS)]。将可生物降解的生物聚合物溶解的 SFS 与亚单位疫苗混合在水溶液中或作为纳米颗粒浆料。因此,正在开发这种新的疫苗佐剂技术,通过新颖的工艺制造可生物降解的聚合物纳米球(PNS),这使得疫苗制造商能够排除使用有机溶剂。因此,技术进步可能会在未来几年给疫苗佐剂市场带来新趋势。
区域分析:
根据地理位置,全球疫苗佐剂市场分为北美、欧洲、亚太地区、南美和南美地区。中美洲、中东和非洲。 2022年,北美贡献了全球最大的疫苗佐剂市场份额。亚太地区预计 2022 年至 2030 年复合年增长率最高。疫苗佐剂产品审批的加速促进了亚太市场的增长。此外,生产佐剂的顶级制造商的存在进一步促进了整体市场增长。
快速的产品审批流程有利于美国的疫苗佐剂市场。 2023年5月,葛兰素史克(GSK)的Arexvy(呼吸道合胞病毒疫苗,佐剂)获得美国食品和药物管理局(FDA)批准,旨在预防呼吸道合胞病毒(RSV)引起的下呼吸道疾病(LRTD) 。因此,Arexvy 成为世界上第一个 FDA 批准的针对老年人的 RSV 疫苗。 2022 年 10 月,Novavax, Inc. 的 COVID-19 佐剂疫苗获得了 FDA 的紧急使用授权 (EUA),该疫苗可作为成年患者的加强疫苗。
佐剂开发 BAA 计划、佐剂模拟物生产计划、和推进结核病 (TB) 疫苗佐剂研究 (AVAR-T) 是美国的一些佐剂开发计划,旨在确保为传染病和免疫介导疾病的临床前疫苗研究提供新型疫苗。美国FDA许可用于传染病疫苗的主要佐剂包括铝佐剂(氢氧化物/磷酸盐); AS04,即4'-单磷酰脂质A(MPL); AS01B,MPL 和 QS-21 的脂质体制剂; MF59,水包油乳液;和CpG 1018,一种CpG寡核苷酸。因此,快速且明确的疫苗佐剂产品审批流程以及政府开发疫苗佐剂的举措推动了美国对疫苗佐剂的需求。
加拿大卫生部批准的疫苗和佐剂清单如下。
佐剂授权在加拿大使用的疫苗
品牌名称
佐剂
ADACEL
AlPO4
ADACEL-POLIO
AlPO4
AREXVY
AS01E
AVAXIM
Al( OH)3
BEXSERO
Al(OH)3
CERVARIX
AS04
BOOSTRIX-POLIO
Al(OH)3, AlPO4
FLUAD
MF59
GARDASIL 9
AAHS
SHINGRIX
AS01B
来源:加拿大公共卫生局
加拿大卫生部的产品批准推动了疫苗佐剂市场的增长。 2022 年 2 月,Medicago 和 GSK 宣布批准针对 COVID-19 的 COVIFENZ 疫苗。因此,重组佐剂疫苗含有植物病毒样颗粒(VLP)。加拿大卫生部已批准将其用于主动免疫以预防 COVID-19。据加拿大公共卫生局报告,每年有超过20万人受到各种感染,其中8000名患者因感染通过医护人员、患者和访客传播而死亡。在加拿大,人类艰难梭菌相关感染死亡率增加了两倍。因此,加拿大制造商专注于生产用于治疗应用的疫苗中的免疫调节剂(充当佐剂)。例如,Inimex Pharmaceuticals(加拿大伯纳比)正在致力于疫苗佐剂免疫调节剂的开发。其 IMX942 是一种 IDR-1 衍生物,可作为治疗人类的抗菌剂。
2022 年 4 月,Ocugen 和 Bharat Biotech 签署了一项协议,将在墨西哥共同开发、供应和商业化 Covaxin (BBV152)。 COVAXIN 包含灭活的 SARS-CoV-2 抗原和佐剂。墨西哥卫生当局授予 COVAXIN 用于成人的紧急使用授权 (EUA)。开发、供应和生产佐剂疫苗的快速批准有利于墨西哥的疫苗佐剂市场。
行业发展和未来机遇:
疫苗佐剂市场领先企业的各种战略发展如下:
2022 年 4 月,GSK plc 和 SK Bioscience 提交了 SKYCovione 的生物制品许可申请,SKYCovione 是一种基于重组蛋白的佐剂 COVID-19 候选疫苗。它含有葛兰素史克的大流行佐剂。继在 III 期临床试验中获得积极数据后,两家公司已向韩国食品药品安全部提交了生物制剂许可申请。 2021 年 11 月,Seppic 推出了 MONTANIDE GEL P PR,这是一种基于专有聚合物技术的水性佐剂禽注射疫苗,满足禽疫苗市场无害化的需求。此外,MONTANIDE GEL P PR 特别稳定,可以抵抗禽类疫苗中常用的不稳定抗原介质。 2023 年 10 月,SPI Pharma Inc. 和 Q-Vant Biosciences Inc. 宣布建立合作伙伴关系,结合 Q-Vant 在可持续皂苷提取领域的领先地位技术与 SPI 在制药行业的全球影响力和服务专业知识相结合。该安排包括投资扩展 Q-Vant 专有的 100% 可持续 Q-SAP 技术,以及一项独家商业协议,以加速其皂苷佐剂在全球兽医和人类疫苗配方中的采用。 2023 年 1 月,韩国食品和农业部药品安全 (KMFDS) 授予 SK Bioscience 增强 NuvaxovidTM 的生产和营销授权,用于 18 岁及以上成年人的给药,作为增强剂。竞争格局和主要公司:
SPI Pharma Inc、GSK Plc、CSL Ltd、Seppic SA、 Hawaii Biotech Inc.、Dynavax Technologies Corp、InvivoGen SAS、Croda International Plc、Novavax Inc. 和 Phibro Animal Health Corp 是疫苗佐剂市场的知名公司。这些公司专注于新技术、升级现有产品和地域扩张,以满足全球不断增长的消费者需求。
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

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to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

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to country scope.

Frequently Asked Questions


Which region is expected to witness significant demand for vaccine adjuvants market in the coming years?

Global vaccine adjuvants market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa and South & Central America. North America held the largest market share of the vaccine adjuvants market in 2022.

Which type held the largest share in the vaccine adjuvants market?

The human vaccine segment dominated the global vaccine adjuvants market and held the largest market share in 2022.

What is vaccine adjuvants?

A vaccine adjuvant is an agent that increases a specific immune response to an antigen. Aluminum salts are the only approved vaccine adjuvants currently licensed by the Food and Drug Administration (FDA). All other adjuvants are considered experimental and must undergo special preclinical testing.

Who are the key players in the vaccine adjuvants market?

The vaccine adjuvants market majorly consists of the players such SPI Pharma Inc, GSK Plc, CSL Ltd, Seppic SA, Hawaii Biotech Inc, Dynavax Technologies Corp, InvivoGen SAS, Croda International Plc, Novavax Inc, Phibro Animal Health Corp, and amongst others.

Which are the top companies that hold the market share in vaccine adjuvants market?

GSK and Novovax are the top two companies that hold huge market shares in the vaccine adjuvants market.

What are the driving factors for the vaccine adjuvants market across the globe?

Key factors that are driving the growth of this market are rising infectious diseases and pandemic and product approvals of veterinary vaccine adjuvants are expected to boost the market growth for the vaccine adjuvants over the years.

Which adjuvant class leads the vaccine adjuvants market?

The mineral salts segment held the largest share of the market in the global vaccine adjuvants market and held the largest market share in 2022.

What is the market CAGR value of vaccine adjuvants market during forecast period?

The CAGR value of the vaccine adjuvants market during the forecasted period of 2022-2030 is 13.7%.

The List of Companies - Vaccine Adjuvant Market

  1. SPI Pharma Inc    
  2. GSK Plc   
  3. CSL Ltd    
  4. Seppic SA               
  5. Hawaii Biotech Inc             
  6. Dynavax Technologies Corp           
  7. InvivoGen SAS     
  8. Croda International Plc    
  9. Novavax Inc          
  10. Phibro Animal Health Corp

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