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市場調查報告書
商品編碼
1641382
全球生物製藥合約製造市場:特色見解(2024-2029)Global Biopharmaceutical Contract Manufacturing Market - Focused Insights 2024-2029 |
預計2023年至2029年期間全球生物製藥合約製造市場規模的年複合成長率為 16.51%。
2024年,領先的CMO 之一Sanofi在法國生物製造領域投資超過 10億美元,以加強其在法國的藥品生產能力。2023年,GTP Bioways 在法國開設了兩家新的生物製藥製造工廠。2024年,Lonza宣布同意以 12億美元從Roche收購Genentech的美國製造部門。
2024年,Thermo Fischer Scientific收購了 Olink Holding AB。 Olink 是開發下一代蛋白質體學解決方案的先驅。2023年,Wuxi Biologics宣布將增加其德國工廠的生產能力。自2020年起,該公司已在德國投資建造和改造兩家新工廠。2023年,Merck在德國開設了兩家新的製造工廠,開拓 mRNA 服務。此外,該公司宣布推出基因穩定性平台,可降低43%的成本,縮短66%的生物安全測試時間。
2023年,全球領先的CDMO ACG Biologics 完成了位於米蘭細胞與基因卓越中心製造基地的製造工廠的擴建。
合約製造組織(CMO)轉向創新和更先進的製造技術,包括機器人、自動化和連續製造。 The Manufacturing Dive(2024年)的一篇文章 報導,合約製造商尋求最佳化其製造流程,以滿足創紀錄的藥品短缺和對複雜新藥的需求。連續生產技術在 CMO 中越來越受歡迎。在這個技術中,輸入材料不斷被引進生產、轉化,而加工後的輸出材料則不斷被移除。自動化是 CMO 中快速發展的趨勢,它可以提高一致性和準確性,同時最大限度地減少人為錯誤。自動化、製程控制系統和先進的機器人技術現已盛行,能夠持續監測和最佳化生物製程,以提高產品品質並實現更高的產量。
在生物製藥行業,研發、臨床試驗、產品審批和將新產品推向市場變得越來越複雜,因此生物製藥公司尋找更加多樣化和經驗豐富的成熟合約製造商。然而,最近隨著對更小眾和敏感的治療領域的關注度增加,生物製藥公司開始向 CMO 尋求更專業的服務和能力。由於生物製藥行業面臨激烈的競爭和監管挑戰,生物製藥公司尋求在特定或單一領域具有專業知識的CMO。這一因素為規模較小、新興的專業 CMO 創造了機會,它們可以提供客製化的解決方案和服務,滿足生物製藥公司的獨特需求。
本報告研究了全球生物製藥合約製造市場,並概述了市場以及依產品、生物製藥、表達系統、業務規模、公司規模和地區劃分的趨勢,以及參與市場的公司概況。
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