市場調查報告書
商品編碼
1476400
全球疫苗契約製造市場:分析 - 按產品、類型、業務規模、流程、應用、最終用戶、地區和預測(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 |
預計2023年全球疫苗契約製造市場規模將達35.1億美元,預測期內複合年成長率為13.1%,2030年將達83億美元。疫苗契約製造涉及將疫苗生產委託給第三方製造商。製藥公司與受託製造廠商(CMO) 合作,利用他們的專業知識、設施和資源來高效、大規模地生產疫苗。這種方法可以實現及時且經濟高效的疫苗生產,同時使公司能夠專注於研究、開發和行銷。合約製造商遵守嚴格的品質標準和監管要求,以確保安全性和有效性。這種模式允許彈性的生產能力,並加速疫苗的供應,以滿足全球需求,特別是在疫情和緊急情況期間。
美國小兒科會2022年3月發布的資料顯示,美國有超過100萬人長期感染B型肝炎,而嬰兒時期感染B型肝炎的人一生中死亡的可能性更大有90%的機會患上肝癌等嚴重慢性疾病。
疫苗需求增加
疫苗需求的增加是推動疫苗契約製造市場成長的關鍵因素。隨著世界人口繼續優先考慮預防性醫療保健措施,對高效疫苗生產的需求不斷增加。疫苗契約製造為製藥公司提供了快速擴大生產以滿足不斷成長的需求的彈性。此外,將製造委託給專業設施使公司能夠專注於研發,加速疫苗創新。此外,與契約製造製造商合作簡化了生產流程,使我們能夠及時向市場提供疫苗。
品管挑戰
品管挑戰主要源自於嚴格遵守監管標準的需要、複雜的製造流程以及大量生產的要求。確保不同批次和設施的產品品質一致是一個主要障礙。此外,製造地分散在世界各地,使標準化和監控變得複雜。此外,在保持嚴格的品質標準的同時滿足生產期限的緊迫性可能會導致錯誤和疏忽。原料和設備的不一致加劇了這些挑戰。
全球疫苗需求
全球疫苗契約製造市場受到全球疫苗需求不斷成長的推動,帶來了巨大的商機。隨著COVID-19大流行的出現以及人們對疫苗接種興趣的增加,迫切需要擴大產能。該市場具有彈性、擴充性和成本效益的優勢,能夠快速應對新出現的感染疾病和大規模疫苗接種宣傳活動。外包疫苗生產可以降低與內部生產相關的風險,例如監管合規性和資源分配。
智慧財產權問題
許多疫苗受到專利、商標和商業機密的保護,這限制了生產方法和技術的取得。這為尋求進入市場或擴大生產規模的契約製造製造商造成了障礙。此外,智慧財產權糾紛可能會導致法律訴訟、延誤以及製造商成本增加。此外,智慧財產權法缺乏明確性和執行力可能會抑制新疫苗生產技術的創新和投資。透過明確的授權協議和有效的智慧財產權保護機制解決這些問題對於確保公平獲得疫苗和培育競爭性製造外包市場至關重要。
COVID-19 大流行從多個方面對疫苗受託製造市場產生了重大影響。首先,疫苗生產服務需求空前激增,導致現有生產能力緊張,產生了產能擴張和產能提升的需求。其次,疫苗開發和分銷的緊迫性要求製藥公司和契約製造製造商之間進行合作,從而促進契約製造的成長。此外,對疫苗生產先進技術(例如 mRNA 技術)的關注為擁有專業知識的契約製造製造商創造了新的機會。
預計預測期內臨床領域規模最大
疫苗契約製造市場的臨床領域呈現穩定成長,疫苗開發和臨床試驗投資的增加帶動了契約製造服務的需求。此外,感染疾病和流行病的激增正在加速疫苗研究,並導致對製造能力的需求增加。此外,生物技術和免疫學的進步正在擴大疫苗開發的範圍,進一步推動該領域的成長。臨床部門處理早期臨床試驗,其中生產的速度和彈性至關重要,這使得製造外包成為製藥公司的重要合作夥伴。
生技公司領域預計在預測期內複合年成長率最高。
隨著生技公司擴大委託製造外包給專業受託製造廠商(CMO) 以專注於研發,生物技術領域正在經歷強勁成長。感染疾病爆發和持續的 COVID-19 大流行推動了對疫苗的需求,這推動了擴大生產能力的需求。生物技術的進步使得能夠開發出更複雜的疫苗,並且需要專門的製造技術。此外,CMO 提供的彈性和擴充性使生物技術公司能夠快速回應不斷變化的市場需求和監管要求。
北美擁有先進的生物製藥基礎設施和專業知識,吸引企業委託疫苗製造,因此疫苗契約製造市場正在顯著成長。 COVID-19大流行加速了對疫苗生產能力的需求,促使製藥公司尋求受託製造服務,以快速回應全球需求。此外,監管支持和有利的政府措施正在為疫苗生產合作夥伴關係創造有利的環境。
由於其製造基礎設施和熟練的勞動力,亞太地區正在經歷顯著的成長,使其成為外包疫苗生產的一個有吸引力的地區。有利的政府政策和激勵措施正在鼓勵跨國製藥公司在該地區設立生產設施。此外,由於人口成長和醫療保健意識的提高,對疫苗的需求不斷增加,正在刺激市場擴張。此外,COVID-19 大流行凸顯了疫苗生產能力的重要性,促使各國政府和企業投資擴大亞太地區的生產能力。
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.