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全球疫苗契约製造市场:分析 - 按产品、类型、业务规模、流程、应用、最终用户、地区和预测(截至 2030 年)Vaccine Contract Manufacturing Market Forecasts to 2030 - Global Analysis By Product, Type, Scale of Operations, Process, Application, End User and By Geography |
预计2023年全球疫苗契约製造市场规模将达35.1亿美元,预测期内复合年增长率为13.1%,2030年将达83亿美元。疫苗契约製造涉及将疫苗生产委託给第三方製造商。製药公司与受託製造厂商(CMO) 合作,利用他们的专业知识、设施和资源来高效、大规模地生产疫苗。这种方法可以实现及时且经济高效的疫苗生产,同时使公司能够专注于研究、开发和行销。合约製造商遵守严格的品质标准和监管要求,以确保安全性和有效性。这种模式允许弹性的生产能力,并加速疫苗的供应,以满足全球需求,特别是在疫情和紧急情况期间。
美国小儿科会2022年3月发布的资料显示,美国有超过100万人长期感染B型肝炎,而婴儿时期感染B型肝炎的人一生中死亡的可能性更大有90%的机会患上肝癌等严重慢性疾病。
疫苗需求增加
疫苗需求的增加是推动疫苗契约製造市场成长的关键因素。随着世界人口继续优先考虑预防性医疗保健措施,对高效疫苗生产的需求不断增加。疫苗契约製造为製药公司提供了快速扩大生产以满足不断增长的需求的弹性。此外,将製造委託给专业设施使公司能够专注于研发,加速疫苗创新。此外,与契约製造製造商合作简化了生产流程,使我们能够及时向市场提供疫苗。
品管挑战
品管挑战主要源自于严格遵守监管标准的需要、复杂的製造流程以及大量生产的要求。确保不同批次和设施的产品品质一致是一个主要障碍。此外,製造地分散在世界各地,使标准化和监控变得复杂。此外,在保持严格的品质标准的同时满足生产期限的紧迫性可能会导致错误和疏忽。原料和设备的不一致加剧了这些挑战。
全球疫苗需求
全球疫苗契约製造市场受到全球疫苗需求不断增长的推动,带来了巨大的商机。随着COVID-19大流行的出现以及人们对疫苗接种兴趣的增加,迫切需要扩大产能。该市场具有弹性、扩充性和成本效益的优势,能够快速应对新出现的感染疾病和大规模疫苗接种宣传活动。外包疫苗生产可以降低与内部生产相关的风险,例如监管合规性和资源分配。
智慧财产权问题
许多疫苗受到专利、商标和商业机密的保护,这限制了生产方法和技术的取得。这为寻求进入市场或扩大生产规模的契约製造製造商造成了障碍。此外,智慧财产权纠纷可能会导致法律诉讼、延误以及製造商成本增加。此外,智慧财产权法缺乏明确性和执行力可能会抑制新疫苗生产技术的创新和投资。透过明确的授权协议和有效的智慧财产权保护机制解决这些问题对于确保公平获得疫苗和培育竞争性製造外包市场至关重要。
COVID-19 大流行从多个方面对疫苗受託製造市场产生了重大影响。首先,疫苗生产服务需求空前激增,导致现有生产能力紧张,产生了产能扩张和产能提升的需求。其次,疫苗开发和分销的紧迫性要求製药公司和契约製造製造商之间进行合作,从而促进契约製造的成长。此外,对疫苗生产先进技术(例如 mRNA 技术)的关注为拥有专业知识的契约製造製造商创造了新的机会。
预计预测期内临床领域规模最大
疫苗契约製造市场的临床领域呈现稳定成长,疫苗开发和临床试验投资的增加带动了契约製造服务的需求。此外,感染疾病和流行病的激增正在加速疫苗研究,并导致对製造能力的需求增加。此外,生物技术和免疫学的进步正在扩大疫苗开发的范围,进一步推动该领域的成长。临床部门处理早期临床试验,其中生产的速度和弹性至关重要,这使得製造外包成为製药公司的重要合作伙伴。
生技公司领域预计在预测期内复合年增长率最高。
随着生技公司越来越多地委託製造外包给专业受託製造厂商(CMO) 以专注于研发,生物技术领域正在经历强劲成长。感染疾病爆发和持续的 COVID-19 大流行推动了对疫苗的需求,这推动了扩大生产能力的需求。生物技术的进步使得能够开发出更复杂的疫苗,并且需要专门的製造技术。此外,CMO 提供的弹性和扩充性使生物技术公司能够快速回应不断变化的市场需求和监管要求。
北美拥有先进的生物製药基础设施和专业知识,吸引企业委託疫苗製造,因此疫苗契约製造市场正在显着成长。 COVID-19大流行加速了对疫苗生产能力的需求,促使製药公司寻求受託製造服务,以快速回应全球需求。此外,监管支持和有利的政府措施正在为疫苗生产合作伙伴关係创造有利的环境。
由于其製造基础设施和熟练的劳动力,亚太地区正在经历显着的成长,使其成为外包疫苗生产的一个有吸引力的地区。有利的政府政策和激励措施正在鼓励跨国製药公司在该地区设立生产设施。此外,由于人口增长和医疗保健意识的提高,对疫苗的需求不断增加,正在刺激市场扩张。此外,COVID-19 大流行凸显了疫苗生产能力的重要性,促使各国政府和企业投资扩大亚太地区的生产能力。
According to Stratistics MRC, the Global Vaccine Contract Manufacturing Market is accounted for $3.51 billion in 2023 and is expected to reach $8.30 billion by 2030 growing at a CAGR of 13.1% during the forecast period. Vaccine contract manufacturing involves outsourcing the production of vaccines to third-party manufacturers. Pharmaceutical companies partner with contract manufacturing organizations (CMOs) to leverage their expertise, facilities, and resources for the efficient and scalable production of vaccines. This approach allows companies to focus on research, development, and marketing while ensuring timely and cost-effective manufacturing of vaccines. Contract manufacturers adhere to strict quality standards and regulatory requirements, providing assurance of safety and efficacy. This model enables flexibility in production capacity, accelerating the availability of vaccines to meet global demand, especially during pandemics or emergencies.
According to data published by the American Academy of Pediatrics in March 2022, more than 1 million people in the United States have long-term hepatitis B infections, and people who are infected with hepatitis B as a baby have a 90% chance of developing serious, chronic conditions like liver cancer in their lifetime.
Increasing demand for vaccines
The increasing demand for vaccines serves as a pivotal driver propelling the growth of the vaccine contract manufacturing market. As the global population continues to prioritize preventive healthcare measures, the need for efficient vaccine production escalates. Vaccine Contract Manufacturing offers pharmaceutical companies the flexibility to scale up production swiftly to meet this rising demand. Additionally, outsourcing manufacturing to specialized facilities enables companies to focus on research and development, accelerating vaccine innovation. Furthermore, partnerships with contract manufacturers streamline the production process, ensuring timely delivery of vaccines to the market.
Quality control challenges
Quality control challenges primarily stem from the need for strict adherence to regulatory standards, complex manufacturing processes, and the demand for high-volume production. Ensuring consistent product quality across various batches and facilities presents a significant hurdle. Additionally, the global distribution of manufacturing sites complicates standardization and oversight. Moreover, the urgency to meet production deadlines while maintaining stringent quality standards can lead to errors or oversights. Variability in raw materials and equipment further exacerbates these challenges.
Global vaccine demand
The global vaccine contract manufacturing market presents a significant opportunity driven by the escalating demand for vaccines worldwide. With the advent of the COVID-19 pandemic and increased focus on vaccination, there's a pressing need for expanded production capacity. This market offers advantages such as flexibility, scalability, and cost-effectiveness, enabling swift responses to emerging infectious diseases and large-scale immunization campaigns. Outsourcing vaccine production mitigates the risks associated with in-house manufacturing, including regulatory compliance and resource allocation.
Intellectual property issues
Many vaccines are protected by patents, trademarks, and trade secrets, limiting access to their production methods and technologies. This creates barriers for contract manufacturers seeking to enter the market or scale up production. Additionally, disputes over IP rights can lead to legal battles, delays, and increased costs for manufacturers. Lack of clarity or enforcement of IP laws can also discourage innovation and investment in new vaccine manufacturing technologies. Addressing these issues through clear licensing agreements and effective IP protection mechanisms is crucial for ensuring equitable access to vaccines and fostering a competitive contract manufacturing market.
The COVID-19 pandemic significantly impacted the vaccine contract manufacturing market in several ways. Firstly, there was an unprecedented surge in demand for vaccine manufacturing services, leading to a strain on existing capacities and prompting the need for expansion and ramping up of production capabilities. Secondly, the urgency of vaccine development and distribution necessitated collaborations between pharmaceutical companies and contract manufacturers, driving growth in the contract manufacturing sector. Additionally, the focus on advanced technologies for vaccine production, such as mRNA technology, created new opportunities for contract manufacturers with specialized expertise.
The clinical segment is expected to be the largest during the forecast period
The clinical segment in the vaccine contract manufacturing market is witnessing robust growth due to increasing investments in vaccine development and clinical trials are driving demand for contract manufacturing services. Additionally, the surge in infectious diseases and pandemics has accelerated vaccine research, leading to a higher demand for manufacturing capacity. Moreover, advancements in biotechnology and immunology have widened the scope of vaccine development, further fueling growth in this segment. The clinical segment caters to early-stage trials, where speed and flexibility in manufacturing are crucial, making contract manufacturers' indispensable partners for pharmaceutical companies.
The biotech companies segment is expected to have the highest CAGR during the forecast period
The Biotech Companies segment is experiencing robust growth because biotech firms are increasingly outsourcing manufacturing to specialized contract manufacturing organizations (CMOs) to focus on research and development. The demand for vaccines, driven by infectious disease outbreaks and the ongoing COVID-19 pandemic, is driving the need for expanded manufacturing capacity. Advancements in biotechnology are enabling the development of more complex vaccines, necessitating specialized manufacturing expertise. Additionally, the flexibility and scalability offered by CMOs allow biotech companies to respond quickly to changing market demands and regulatory requirements.
North America has witnessed significant growth in the vaccine contract manufacturing market due to the region's boasting advanced biopharmaceutical infrastructure and expertise, attracting companies to outsource vaccine production. The COVID-19 pandemic has accelerated demand for vaccine manufacturing capabilities, prompting pharmaceutical firms to seek contract manufacturing services to meet global needs swiftly. Additionally, regulatory support and favourable government initiatives have fostered a conducive environment for vaccine manufacturing partnerships.
The Asia-Pacific region has experienced significant growth due to the region manufacturing infrastructure coupled with a skilled workforce, making it an attractive destination for vaccine production outsourcing. Favourable government policies and incentives have encouraged multinational pharmaceutical companies to establish manufacturing facilities in the region. Moreover, the increasing demand for vaccines, driven by population growth and rising healthcare awareness, has further fueled market expansion. Furthermore, the COVID-19 pandemic has highlighted the importance of vaccine manufacturing capacity, prompting governments and companies to invest in expanding production capabilities in the Asia Pacific.
Key players in the market
Some of the key players in Vaccine Contract Manufacturing market include AGC Biologics, Ajinomoto Bio-Pharma Services, Catalent, Charles River Laboratories International Inc., CJ CheilJedang Corporation, CSL Seqirus, Curia Global, Emergent BioSolutions Inc., Fujifilm Holdings Corporation , Gedeon Richter (Richter-Helm BioLogics) , ICON PLC, IDT Biologika GmbH, KBI Biopharma, Lonza Group AG, Merck KGaA, Recipharm AB, Samsung Biologics and WuXi Biologics.
In April 2024, Invenra Inc., an innovative leader in bispecific antibody technology, has announced a strategic collaboration with Catalent, a global Contract Development and Manufacturing Organization (CDMO) specializing in innovative drug development solutions. The collaboration will harness the combined expertise and proprietary technologies of Invenra and Catalent to co-discover novel bispecific antibody-drug conjugates.
In April 2024, Merck has launched the Aptegra CHO Genetic Stability Assay, which leverages whole-genome sequencing and bioinformatics to significantly accelerate customers' biopharmaceutical safety testing, thereby helping to accelerate customers' entry into commercial production.
Bacterial
Viral
Other Types
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.