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市場調查報告書
商品編碼
1503313
到 2030 年生技藥品合約開發和製造組織 (CDMO) 市場預測:按產品、服務、類型、最終用戶和地區進行的全球分析Biologics Contract Development and Manufacturing Organization Market Forecasts to 2030 - Global Analysis By Product, Service (Contract Manufacturing Organization and Contract Research Organization ), Type, End User and By Geography |
根據 Stratistics MRC 預測,2024 年全球生技藥品合約開發和製造組織(CDMO)市場規模將達到 145.4 億美元,預測期內複合年成長率為 14.9%,到 2030 年將達到 334.5 億美元。
單株抗體、疫苗、細胞和基因療法以及重組蛋白等生物產品是在稱為合約生技藥品開發和製造組織 (CDMO) 的專業服務提供者的協助下開發和製造的。 CDMO 在細胞株開發、製程最佳化、分析測試和大規模生產等領域擁有豐富的經驗,這使得這些組織對於生物製藥產業至關重要。此外,透過與 CDMO 合作,生物製藥公司可以降低成本、加快產品開發並更好地應對複雜的法規環境。
根據國際製藥工程學會 (ISPE) 的說法,合約生技藥品開發和受託製造廠商(CDMO) 對製藥業至關重要,它們提供必要的服務,促進複雜生物製藥。
人們對生技藥品的興趣日益濃厚
世界各地糖尿病、癌症和自體免疫疾病等慢性疾病的增加需要更有效和強化的治療。生技藥品因其高特異性和有效性而成為首選治療選擇。對生物製藥日益成長的需求促使製藥公司尋求 CDMO,因為它們擁有高效能滿足其生產需求的專業知識。此外,人口老化和生物技術的發展正在刺激CDMO市場的穩定成長。
營運成本過高
生產生技藥品的高營運成本是生技藥品合約開發和製造組織(CDMO)市場面臨的主要障礙之一。製造生技藥品涉及複雜且成本高昂的步驟,包括先進的細胞培養技術、精製技術和嚴格的品管措施。對專業設施、高素質工人和最尖端科技的需求進一步增加了成本。此外,為了遵守法規和行業標準,CDMO 必須在設備和基礎設施方面進行大量資本投資,這可能非常昂貴。
利用尖端製造技術
自動化、連續生物加工和一次性系統等現代製造技術為 CDMO 提供了提高產品品質和業務效率的重要機會。透過降低生產成本和提高擴充性,這些技術還可以降低污染風險。此外,透過利用這些創新,CDMO 可以增強其競爭優勢並應對不斷成長的優質生技藥品市場。
熟練勞動力不足;
生技藥品產業需要高技能的專業人員,包括細胞生物學、生物製程工程和監管事務方面的專家。然而,全球範圍內缺乏具備必要知識和經驗的專家來支持生技藥品的發現和生產。 CDMO 無法吸引和留住熟練員工可能會抑制其擴展和更有效營運的能力。此外,為了吸引和留住頂尖人才,CDMO 必須提供有競爭力的薪資、培訓計畫和職涯發展機會。這是因為對技術工人的競爭非常激烈。
由於 COVID-19 大流行,生技藥品合約開發和製造組織 (CDMO) 市場經歷了巨大的成長和變化。對疫苗、治療方法和診斷工具的迫切需求催生了對 CDMO 服務的前所未有的需求,從而加快了生產進度並提高了製造能力。此外,COVID-19 疫苗和治療方法的快速開發和廣泛生產在很大程度上是透過 CDMO 實現的,這凸顯了它們在生物製藥供應鏈中的重要性。
生技藥品產業預計將在預測期內成為最大的產業
生技藥品產業在生技藥品合約開發和製造組織(CDMO)市場中佔據最大的市場佔有率。生技藥品包括多種複雜藥物,包括重組蛋白、細胞和基因療法、疫苗和單株抗體。由於慢性病盛行率的上升以及對個人化和標靶治療的需求不斷成長,生物製藥市場正在擴大。此外,製藥公司正在大力投資生技藥品的開發和商業化,因為它們比傳統小分子藥物具有顯著的治療益處。
契約製造組織(CMO)產業預計在預測期內複合年成長率最高
在生技藥品合約開發和製造組織(CDMO)市場中,受託製造廠商(CMO)細分市場通常表現出最高的複合年成長率。 CMO 是為生物製藥提供端到端製造服務的專家,包括製程開發、放大和商業製造。此外,由於對生技藥品的需求不斷增加、製造流程複雜以及對專業知識的需求,製藥公司正在將製造委託給 CMO。
北美通常佔據生技藥品合約開發和製造組織(CDMO)市場的最大佔有率。許多因素促成了該地區的優勢,包括蓬勃發展的生物製藥產業、最先進的醫療設施、強大的法規環境以及高素質的勞動力。此外,北美擁有大量生物技術和製藥公司以及著名的學術和研究機構,為生技藥品的開發和製造創造了一個充滿活力的生態系統。
亞太地區的生技藥品合約開發和製造組織 (CDO) 市場的複合年成長率通常最高。生物製藥公司外包的增加、醫療保健基礎設施投資的增加以及中國、印度和韓國等國家生物製藥製造能力的增加是推動這一成長的因素。此外,有利的政府政策、監管改革和支持生物技術創新的舉措進一步增強了該地區對 CDMO 的吸引力。
According to Stratistics MRC, the Global Biologics Contract Development and Manufacturing Organization (CDMO) Market is accounted for $14.54 billion in 2024 and is expected to reach $33.45 billion by 2030 growing at a CAGR of 14.9% during the forecast period. Biological products, such as monoclonal antibodies, vaccines, cell and gene therapies, and recombinant proteins, are developed and manufactured with the assistance of specialized service providers known as biologics contract development and manufacturing organizations, or CDMOs. Because they offer experience in fields like cell line development, process optimization, analytical testing, and large-scale production, these organizations are vital to the biopharmaceutical sector. Moreover, biopharma companies can cut costs, expedite product development, and more skillfully navigate complex regulatory environments by collaborating with CDMOs.
According to the International Society for Pharmaceutical Engineering (ISPE), Biologics Contract Development and Manufacturing Organizations (CDMOs) are vital to the pharmaceutical industry, providing essential services that enable the development, scale-up, and commercialization of complex biological products.
Growing interest in biologics
The need for more efficient and focused treatments is being driven by the rising global burden of chronic diseases like diabetes, cancer, and autoimmune disorders. Biologics are a preferred option for treatment because of their high specificity and efficacy. The increasing demand for biologics has led pharmaceutical companies to turn to CDMOs for their expertise in meeting production needs in an efficient manner. Additionally, this demand is further fueled by the aging population and biotechnology developments, which are driving the CDMO market's steady growth.
Excessive costs of operations
The high operating costs of producing biologics are one of the main obstacles facing the biologics Contract Development and Manufacturing Organization (CDMO) market. Complex and costly procedures, such as advanced cell culture techniques, purification techniques, and strict quality control measures, are involved in the manufacturing of biologics. Costs are further increased by the requirement for specialized facilities, highly qualified workers, and cutting-edge technologies. Furthermore, to comply with regulations and industry standards, CDMOs have to make large capital expenditures on equipment and infrastructure, which can be very expensive.
Utilizing cutting-edge manufacturing technologies
Modern manufacturing techniques like automation, continuous bioprocessing, and single-use systems offer CDMOs great chances to improve both the quality of their output and operational efficiency. By lowering production costs and increasing scalability, these technologies can also lower the risk of contamination. Moreover, CDMOs can reinforce their competitive advantage and satisfy the increasing market for superior biologics by putting these innovations to use.
Insufficiently skilled workforce
A highly skilled and specialized workforce is needed in the biologics industry, including experts in cell biology, bioprocess engineering, and regulatory affairs. Nonetheless, there is a dearth of professionals with the knowledge and experience needed to assist in the creation and production of biologics throughout the world. The inability of CDMOs to attract and retain skilled staff may impede their ability to expand and operate more efficiently. Additionally, in order to attract and retain top talent, CDMOs must provide competitive salaries, training programs, and opportunities for career development. This is because there is fierce competition for skilled workers.
The market for biologics contract development and manufacturing organizations (or CDMOs) has seen tremendous growth and change as a result of the COVID-19 pandemic. An unprecedented demand for CDMO services resulted from the pressing need for vaccines, treatments, and diagnostic tools, which sped up production schedules and increased manufacturing capacity. Furthermore, the rapid development and widespread manufacturing of COVID-19 vaccines and treatments were made possible in large part by CDMOs, underscoring the significance of these organizations in the biopharmaceutical supply chain.
The Biologics segment is expected to be the largest during the forecast period
In the biologics contract development and manufacturing organization (CDMO) market, the biologics segment has the largest market share. Biologics comprise a broad spectrum of intricate medicinal items, such as recombinant proteins, cell and gene therapies, vaccines, and monoclonal antibodies. The market for biologics has expanded due to the rising incidence of chronic illnesses and the rising need for individualized and targeted treatments. Moreover, pharmaceutical companies have made significant investments in the development and commercialization of biologics due to their significant therapeutic advantages over traditional small-molecule drugs.
The Contract Manufacturing Organization (CMO) segment is expected to have the highest CAGR during the forecast period
In the biologics contract development and manufacturing organization (CDMO) market, the contract manufacturing organization (CMO) segment usually shows the highest CAGR. CMOs are experts in offering biopharmaceutical products end-to-end manufacturing services, encompassing process development, scaling up, and commercial production. Additionally, pharmaceutical companies outsource manufacturing to CMOs due to the growing demand for biologics, complex manufacturing processes, and the requirement for specialized expertise.
In the biologics contract development and manufacturing organization (CDMO) market, North America typically holds the largest share. Numerous elements contribute to the region's dominance, such as a thriving biopharmaceutical sector, state-of0-the-art healthcare facilities, a solid regulatory environment, and a highly qualified labour force. Furthermore, a thriving ecosystem for the development and production of biologics is fostered by the large number of biotech and pharmaceutical companies, as well as eminent academic and research institutions located in North America.
In the market for biologics contract development and manufacturing organizations (CDOs), the Asia-Pacific region usually shows the highest CAGR. Increasing outsourcing among biopharmaceutical companies, growing investments in healthcare infrastructure and growing biopharmaceutical manufacturing capabilities in nations like China, India, and South Korea are some of the factors driving this growth. Moreover, the region's appeal to CDMOs is further enhanced by advantageous government policies, regulatory reforms, and initiatives to support biotech innovation.
Key players in the market
Some of the key players in Biologics Contract Development and Manufacturing Organization (CDMO) market include Samsung Biologics, Boehringer Ingelheim Group, Sandoz Biopharmaceuticals (Novartis AG), Parexel International Corporation, Fujifilm Diosynth Biotechnologies USA Inc., AbbVie Contract Manufacturing, Lonza Group, Binex Co. Limited, Rentschler Biotechnologies, Toyobo Co. Limited, AGC Biologics, PRA Health Sciences, Catalent Inc, Wuxi Biologics and JRS Pharma.
In May 2024, AbbVie and Gilgamesh Pharmaceuticals have announced a collaboration and option-to-license agreement to develop next-generation therapies for psychiatric disorders. This collaboration will leverage AbbVie's expertise in psychiatry and Gilgamesh's innovative research platform to discover novel neuroplastogens.
In April 2024, FUJIFILM Diosynth Biotechnologies, a global leading contract development and manufacturing organization (CDMO), announced that it will expand its large-scale cell culture manufacturing facility currently under construction with a $1.2 billion investment from FUJIFILM Corporation.
In February 2024, Samsung Biologics, a global contract development and manufacturing organization (CDMO), has signed a partnership agreement with LegoChem Biosciences, a biotech company pioneering the research and development of antibody-drug conjugate (ADC) programs.