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市场调查报告书
商品编码
1641382
全球生物製药合约製造市场:特色见解(2024-2029)Global Biopharmaceutical Contract Manufacturing Market - Focused Insights 2024-2029 |
预计2023年至2029年期间全球生物製药合约製造市场规模的年复合成长率为 16.51%。
2024年,领先的CMO 之一Sanofi在法国生物製造领域投资超过 10亿美元,以加强其在法国的药品生产能力。2023年,GTP Bioways 在法国开设了两家新的生物製药製造工厂。2024年,Lonza宣布同意以 12亿美元从Roche收购Genentech的美国製造部门。
2024年,Thermo Fischer Scientific收购了 Olink Holding AB。 Olink 是开发下一代蛋白质体学解决方案的先驱。2023年,Wuxi Biologics宣布将增加其德国工厂的生产能力。自2020年起,该公司已在德国投资建造和改造两家新工厂。2023年,Merck在德国开设了两家新的製造工厂,开拓 mRNA 服务。此外,该公司宣布推出基因稳定性平台,可降低43%的成本,缩短66%的生物安全测试时间。
2023年,全球领先的CDMO ACG Biologics 完成了位于米兰细胞与基因卓越中心製造基地的製造工厂的扩建。
合约製造组织(CMO)转向创新和更先进的製造技术,包括机器人、自动化和连续製造。 The Manufacturing Dive(2024年)的一篇文章 报导,合约製造商寻求最佳化其製造流程,以满足创纪录的药品短缺和对复杂新药的需求。连续生产技术在 CMO 中越来越受欢迎。在这个技术中,输入材料不断被引进生产、转化,而加工后的输出材料则不断被移除。自动化是 CMO 中快速发展的趋势,它可以提高一致性和准确性,同时最大限度地减少人为错误。自动化、製程控制系统和先进的机器人技术现已盛行,能够持续监测和最佳化生物製程,以提高产品品质并实现更高的产量。
在生物製药行业,研发、临床试验、产品审批和将新产品推向市场变得越来越复杂,因此生物製药公司寻找更加多样化和经验丰富的成熟合约製造商。然而,最近随着对更小众和敏感的治疗领域的关注度增加,生物製药公司开始向 CMO 寻求更专业的服务和能力。由于生物製药行业面临激烈的竞争和监管挑战,生物製药公司寻求在特定或单一领域具有专业知识的CMO。这一因素为规模较小、新兴的专业 CMO 创造了机会,它们可以提供客製化的解决方案和服务,满足生物製药公司的独特需求。
本报告研究了全球生物製药合约製造市场,并概述了市场以及依产品、生物製药、表达系统、业务规模、公司规模和地区划分的趋势,以及参与市场的公司概况。
The global biopharmaceutical contract manufacturing market is expected to grow at a CAGR of 16.51% from 2023 to 2029.
RECENT VENDORS ACTIVITIES
KEY TAKEAWAYS
MARKET TRENDS & DRIVERS
Attention Towards Technology Adoption
Contract Manufacturing Organizations (CMOs) are shifting towards innovative and more advanced manufacturing technologies, such as robotics, automation, and continuous manufacturing. The Manufacturing Dive article (2024) reported that contract manufacturers seek to optimize manufacturing processes to meet demand for combat record-high drug shortages and new and complex drugs. Where Continuous Manufacturing technology become more popular among CMOs. In this technology, input materials are continuously fed into production and transformed, and processed output materials are continuously removed. Automation is a rapidly growing trend among CMOs that delivers more consistency, and precision and minimizes human error. Currently, automation, process control systems, and advanced robotics, that becoming popular to enable continued monitoring and optimization of bioprocesses, to improve product quality and lead to higher yield.
Attention Towards Specialized Capabilities and Services
In the biopharmaceutical industry, research and development, clinical trials, product approvals, and new products in the market have become more and more complex, the biopharma companies seeking more diverse, experienced, and well-established contract manufacturers. However, in recent days, with the growing attention toward more niche and care-demanding therapeutic areas, now biopharma companies looking for more specialized services and capabilities in CMOs. As the biopharmaceutical industry experiences huge competition and challenges from regulatory bodies, biopharma companies looking for CMOs who are experts in specific or single areas. This factor creates opportunities for small and emerging specialized CMOs that can offer tailored solutions and services to meet the unique requirements of biopharma companies.
Increasing Drug Approvals by Emerging, Small & Medium-Sized Biopharma Companies
Small & Medium pharma biotech companies are the most potential clients for CMOs/CDMOs as these entities face several issues in the development and manufacturing of their drugs. New and often small-sized to mid-sized biotech companies are seeking contract manufacturing companies to introduce their products due to a lack of resources and associated capabilities to invest in manufacturing facilities of their own. In the past few years, small-sized biopharma companies have accelerated their R&D and launched around 30% to 40% of new drugs. There are more than 5,500 total small and mid-sized biopharma companies present across the world revealed by Contract Pharma news in 2023, and it is expected that in upcoming years (by 2026-2027) they will contribute more than 55% of new drugs launched.
Rapid Developments in Biopharma Contract Production Services with AI
With the growing competition across the biopharmaceutical contract manufacturing industry, vendors are advancing them with new approaches that drive their efficiency in contract manufacturing. The partnership with the right contract manufacturer is an emerging trend that led to rising advancements among the vendors to stay competitive in the market. The majority of CMOs/CDMOs are developing and expanding their services to keep pace with rapidly evolving the global market. These factors attract more and more biopharma companies towards contract manufacturing and drive market growth. CMOs are advancing their performance with artificial intelligence (AI) and electronic platforms to become more cost-effective and speed up production time.
INDUSTRY RESTRAINTS
High Cost of Biologics Contract Manufacturing
Biopharmaceuticals are medicines made from living cells that treat common and serious diseases, such as cancer, diabetes, rheumatoid arthritis, and other inflammatory diseases. These are highly targeted and effective, and they are increasingly important in the fight against these diseases. They are relatively complex molecules and are usually composed of proteins for transplantation, carbohydrates, nucleic acids, cells or tissues, or complex complexes of these substances. Their examples include hormones, vaccines, blood products, allergens, mAbs, recombinant therapeutic proteins, C>, growth factors, cytokines, and insulin. Unfortunately, most patients cannot afford biologics. Medical costs divide consumers into rich and poor categories. Both categories are stressed due to high biological costs, but the poor stress much more. Expensive biological products are not easily accessible to poor patients. This is more pronounced in low- and middle-income countries.
SEGMENTATION INSIGHTS
INSIGHTS BY PRODUCT
The global biopharmaceutical contract manufacturing market by product is segmented into finished dosage form (FDF) and active pharmaceutical ingredients (API). The finished dosage form (FDF) accounted for the largest market share in 2023. An FDF (Finished Dosage Form) is a drug product that has undergone all stages of production, including manufacturing, testing, and regulatory approval before being made available to the public. The FDF contains both active pharmaceutical ingredients (APIs), which are responsible for the therapeutic effects experienced by the user, and inactive ingredients (excipients), which serve as carriers to facilitate the function of the active ingredients. Producing finished dosage forms requires specialized equipment, advanced technologies, and expertise. As the biopharmaceutical industry continues to expand, many companies are partnering with contract manufacturers to meet global FDF demand and ensure compliance with regulatory standards.
By Product
INSIGHTS BY BIOLOGICS
The global biopharmaceutical contract manufacturing market by biologics is categorized into monoclonal antibodies, vaccines, and other biologics. The monoclonal antibodies segment holds the largest market share of over 46% in 2023. Monoclonal antibodies (mAbs) currently dominate the biopharmaceutical product category, primarily driven by the rising prevalence of complex and severe health conditions, such as cancer, and the increasing sophistication of treatment approaches. Furthermore, 53 Biologics, a leading CDMO (Contract Development and Manufacturing Organization), reported a significant rise in research and development activities for monoclonal antibodies following the COVID-19 pandemic. As the demand for highly specific and immune-supportive biopharmaceutical products grows, the need for monoclonal antibody contract manufacturing is rapidly increasing worldwide.
By Biologics
INSIGHTS BY EXPRESSION SYSTEMS
The global biopharmaceutical contract manufacturing market by expression systems is segmented into mammalian and non-mammalian. The mammalian segment shows significant growth, with the fastest-growing CAGR of 16.78% during the forecast period. The development of biopharmaceuticals using transgenic mammalian cell lines remains a cornerstone of the biotechnology and pharmaceutical industries, with the market experiencing exponential growth since the introduction of human tissue plasminogen activator in 1987 and erythropoietin in 1988. Mammalian cells are widely considered for expression systems in biologics manufacturing, particularly for producing monoclonal antibodies. Chinese Hamster Ovary (CHO) cells, for instance, are responsible for over 70% of recombinant pharmaceutical protein production. Their unique ability to perform post-translational modifications, which are critical for drug safety and efficacy, makes mammalian expression systems essential for producing therapeutic proteins, complex proteins, and monoclonal antibodies, further driving their widespread application in the industry.
By Expression Systems
INSIGHT BY SCALE OF OPERATION
Based on the scale of operation, the commercial segment dominates and holds the largest share of the global biopharmaceutical contract manufacturing market. The commercial-scale operation in biopharma, driven by the outsourcing of biologics production, is significantly contributing to the growth of the commercial segment. By leveraging contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), biopharma companies can achieve large-scale production efficiently, reducing costs and time-to-market for essential biologics like vaccines, monoclonal antibodies, and cell and gene therapies. This scalability allows companies to meet the rising global demand driven by infectious diseases, chronic illnesses, cancers, and autoimmune disorders. Moreover, outsourcing enables biopharma companies to focus on research and innovation while relying on expert manufacturers to handle production complexities. This model also facilitates faster regulatory compliance and access to advanced manufacturing technologies, enhancing productivity. As a result, the commercial segment benefits from expanded market reach, improved profitability, and the ability to address global health challenges effectively, further fueling its growth.
By Scale of Operation
INSIGHT BY COMPANY SIZE
Based on the company size, the large companies segment accounted for the largest global biopharmaceutical contract manufacturing market share. Following the COVID-19 pandemic, budget constraints have become a common issue for large biopharma companies, primarily due to the substantial financial burden of investments in vaccine and therapeutic development. As a result, many companies are shifting from in-house manufacturing to outsourcing, allowing them to focus on core competencies like innovation while taking advantage of cost-effective contract manufacturing services. This trend is driven by the need to reduce manufacturing costs while ensuring high-quality production. CMOs in developing countries, such as India, South Korea, and Switzerland, are emerging as key players in this shift, offering advanced manufacturing facilities, a familiar regulatory environment, and significant cost savings. This movement toward outsourcing to developing countries is helping large biopharma companies optimize production and remain competitive in the global market.
By Company Size
GEOGRAPHICAL ANALYSIS
North America dominates and holds the largest share of the global biopharmaceutical contract manufacturing market. The market dominance of these regions can be attributed to the high concentration of biopharma companies, the growing trend of outsourcing biopharma contract manufacturing due to cost and regulatory compliance considerations, and the presence of several leading market players. In North America, numerous biopharma companies are actively involved in developing novel biologics. Significant investments in research and development aimed at strengthening pipelines for chronic autoimmune diseases are expected to drive the launch of new therapeutics in the region. The increasing number of approvals for novel therapeutics is creating valuable opportunities for market growth in North America.
By Geography
COMPETITIVE LANDSCAPE
The global biopharmaceutical contract manufacturing market report consists of exclusive data on 45 vendors. The market is highly competitive. There are several leading, growing, and emerging market players are present across the global market. Some emerging players compete against large and small medium-sized market players. Boehringer Ingelheim, Lonza, Samsung Biologics, AbbVie, Catalent, Emergent BioSolution, FUJIFILM, Merck KGaA, Pfizer, and Wuxi Biologics are leading companies that accounted for major market share in the global biopharmaceutical contract manufacturing market. These vendors are continuously focusing on expanding their biopharmaceutical contract manufacturing services that meet clients' requirements, international regulations, and increase the efficiency of their product, strengthen their market position.
Key Vendors
Other Prominent Vendors
KEY QUESTIONS ANSWERED:
CHAPTER - 1: Competitive Landscape of Biopharmaceutical Contract Manufacturing Market Overview
CHAPTER - 2: Competitive Landscape of Biopharmaceutical Contract Manufacturing Market
CHAPTER - 3: Biopharmaceutical Contract Manufacturing Market Prospects & Opportunities
CHAPTER - 4: Biopharmaceutical Contract Manufacturing Market Segmentation Data
CHAPTER - 5: Key Regions Overview
CHAPTER - 6: Biopharmaceutical Contract Manufacturing Market Industry Overview
CHAPTER - 7: Appendix