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市場調查報告書
商品編碼
1886172
數位生物製造市場規模、佔有率、預測及趨勢分析:按產品(軟體/硬體)、功能(產品設計、分析、自動化)、應用(單株抗體、蛋白質、疫苗)和生物製程劃分-全球預測至2035年Digital Biomanufacturing Market Size, Share, Forecast, & Trends Analysis by Offering (Software Hardware), Functionality (Product Design, Analytics, Automation), Applicatison (MAB, Protein, Vaccine), and Bioprocess - Global Forecast to 2035 |
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預計2025年至2035年,數位生物製造市場將以12.6%的複合年增長率成長,到2035年達到764億美元。本報告對五大主要地區的數位生物製造市場進行了詳細分析,重點關注當前市場趨勢、市場規模、近期發展以及至2035年的預測。
基於廣泛的二級和一級研究以及對市場現狀的詳細分析,本報告對關鍵行業驅動因素、限制因素、機會和挑戰的影響進行了分析。此市場成長的驅動因素包括:對生物製藥的需求不斷增長、大型企業擴大生物製藥廠產能、對連續生物製程的日益重視、生物製造製程優化需求的不斷增長,以及對品質標準和法規遵從性的日益重視。此外,人工智慧 (AI) 和機器學習的融合、基於雲端的製造平台、數位孿生技術的應用以及向生物工藝 4.0 的轉型,預計也將支持市場成長。
然而,仍有許多挑戰,包括技術採用成本高昂、生物製藥的研發和生產流程複雜、與傳統系統整合方面的挑戰,以及對資料安全和智慧財產權保護的擔憂。
數位生物製造市場按產品(軟體和硬體)、功能(產品設計、流程優化和分析、自動化和控制、即時品質監控和合規性、供應鍊和營運管理以及其他功能)、生物製程(上游和下游生物製程)、應用(單株抗體、重組荷爾蒙/蛋白、疫苗、細胞生物製劑、基因生物製劑、生物相似藥、工業生物技術以及其他應用)、最終用戶(生物製藥公司、學術和研究機構、CDMO/CRO、食品和工業生物技術公司以及其他最終用戶)和地區進行細分。本研究也評估了產業競爭對手,並提供了國家層面的市場分析。
預計到 2025 年,軟體領域將佔最大的市場佔有率,達到 58%。該領域的主導地位主要歸功於其作為核心智慧層的基礎性作用,它驅動著所有生物製造流程的流程優化、數據分析和即時決策。這些軟體包括先進的製程分析技術 (PAT) 系統、先進的數據分析軟體、製造執行系統 (MES) 以及能夠創建生物製程操作虛擬副本的尖端數位孿生平台。此外,嵌入這些平台的人工智慧 (AI) 和機器學習功能的持續發展也推動了該領域的成長。我們看到,簡單的監控系統正在轉變為能夠進行預測分析、自主流程調整和認知決策的智慧平台。在預測期內,受雲端解決方案和高階分析技術日益普及的推動,軟體領域也預計將顯著成長。
預計到2025年,製程優化和分析領域將引領數位生物製造市場。該領域的領先地位反映了生物製造製程持續改進的重要性,即使是微小的最佳化也能顯著降低成本、提高產量和品質。製程優化和分析包括先進的統計製程控制、實驗設計 (DoE)、多元數據分析以及基於機器學習的最佳化演算法,這些技術能夠持續分析製程參數並識別改進機會。這些系統整合了來自整個生物製程工作流程中多個來源的數據,從而提供對製程性能的全面洞察。這使製造商能夠在確保合規性的同時,實現更高的產品產量、降低批次間差異並最大限度地降低生產成本。然而,在預測期內,供應鏈營運管理預計將以16.5%的複合年增長率(CAGR)實現最高成長,這主要得益於全球生物製藥企業日益認識到端到端可視性和協調的重要性。
預計到2025年,上游生物製程將佔數位生物製造市場最大的佔有率。這一主導地位源於其作為所有生物製造營運基礎的根本作用,以及其對整體工藝經濟性的顯著影響。上游製程的最佳化尤其重要,因為它們直接影響產品的產量、品質和一致性。細胞培養製程的複雜性,包括pH值、溶解氧、溫度、營養水平和代謝物濃度等眾多相互依存的變量,為數位化優化創造了巨大的機會。先進的製程分析技術、即時監控系統和人工智慧驅動的控制演算法能夠顯著提高細胞生產力、降低污染風險並優化培養基消耗,從而促進數位化解決方案在上游生物製程的廣泛應用。
預計2025年,單株抗體領域將佔數位生物製造市場最大的佔有率,達到33%。該領域佔有率佔比高主要歸功於其完善的生產基礎設施、成熟的生產流程以及產品本身巨大的商業價值。單株抗體複雜的多步驟生產流程(包括細胞系開發、上游細胞培養、下游純化、製劑配製以及灌裝包裝等製程)為數位化優化提供了許多機會。單株抗體的高價值和大規模生產特性,促使企業對先進的數位技術進行大量投資,以提高產量、降低生產成本並確保產品品質的穩定性。然而,基因工程生物製劑領域預計將實現最快成長,在預測期內複合年增長率將達到17.9%。隨著這些新興療法獲得監管部門批准並取得商業成功,FDA預計到2025年每年將批准10至20種細胞和基因治療產品。
預計到2025年,生物製藥公司將佔數位生物製造市場最大的佔有率。對生物製藥日益增長的偏好、個人化醫療研究的不斷深入以及支持生物製藥應用的政策,正在推動該領域佔最大的市場佔有率。由於生物製藥通常較為複雜,且生產成本高於傳統藥物,生物製造業正擴大採用數位化解決方案來減少錯誤並擴大生產規模。生物製藥公司數量的不斷增長及其對數位技術的逐步採用,推動了該領域的領先地位,約55%的公司已在其工作流程中實施了數位技術。
本產業區域分析提供了對五大主要區域(北美、歐洲、亞太、拉丁美洲以及中東和非洲)及其各區域內主要國家的詳細定性和定量見解。
預計到2025年,北美將佔數位生物製造市場最大的佔有率(38%)。該地區佔有率龐大,得益於其擁有眾多大型生物製藥公司、先進的技術基礎設施、大量的研發投資以及有利的監管環境。特別是美國,擁有眾多生物技術中心,並在生物製劑的開發和生產方面保持領先地位。北美成熟的生物製藥生態系統匯聚了許多擁有廣泛生產網路、高度發展的供應鏈以及充足技術實施資金的大型公司。該地區的監管框架,以美國食品藥物管理局 (FDA) 為首,一直積極推動先進製造技術的應用,並為生物製造領域的數位化技術提供指導。
然而,預計亞太地區在預測期內將實現最高的數位化生物製造市場複合年增長率 (CAGR),達到 16.0%。這一成長主要得益於中國、印度、日本和韓國等國家生物製藥產業的快速發展。該地區的成長動力來自政府對生物技術領域投資的增加、國內對生物製藥需求的增長、生產能力的提升以及高性價比的合約研發生產機構 (CDMO) 的存在。此外,政府加大數位投入、對高性價比自動化解決方案的需求不斷增長、生物製藥生產基礎設施的擴建以及人口稠密國家對營運效率的日益重視,都在推動市場擴張。該地區蓬勃發展的生物技術產業、不斷擴大的研發活動、日益增長的熟練勞動力、生命科學領域不斷增加的外國直接投資,以及支持數位技術的監管框架,正在為市場成長創造有利環境。
按產品/服務劃分的數位生物製造市場評估
按功能劃分的數位生物製造市場評估
按生物製程劃分的數位生物製造市場評估
數位生物製造市場評估:按應用領域劃分
數位生物製造市場評估:按最終用戶劃分
數位生物製造市場評估:按地區劃分
Digital Biomanufacturing Market Size, Share, Forecast, & Trends Analysis by Offering (Software [PAT, MES, Digital Twin] Hardware), Functionality (Product Design, Analytics, Automation), Application (MAB, Protein, Vaccine), and Bioprocess - Global Forecast to 2035
According to the research report titled, 'Digital Biomanufacturing Market Size, Share, Forecast, & Trends Analysis by Offering (Software [PAT, MES, Digital Twin], Hardware), Functionality (Product Design, Analytics, Automation), Application (MAB, Protein, Vaccine), and Bioprocess-Global Forecast to 2035,' the digital biomanufacturing market is projected to reach $76.4 billion by 2035, at a CAGR of 12.6% during the forecast period 2025-2035. The report provides an in-depth analysis of the global digital biomanufacturing market across five major regions, emphasizing the current market trends, market sizes, recent developments, and forecasts till 2035.
Following extensive secondary and primary research and an in-depth analysis of the market scenario, the report conducts the impact analysis of the key industry drivers, restraints, opportunities, and challenges. The growth of this market is driven by the escalating demand for biologics, capacity expansions of biopharmaceutical plants by key players, increased focus on continuous bioprocessing, rising need for process optimization in biomanufacturing, and the growing emphasis on quality standards and regulatory compliance. Moreover, the integration of artificial intelligence and machine learning, cloud-based manufacturing platforms, digital twin technology adoption, and the shift towards Bioprocessing 4.0 are expected to support the market's growth.
However, the market's growth faces notable challenges including the high cost of technology deployment, complex development and manufacturing processes of biopharmaceuticals, integration challenges with legacy systems, and concerns about data security and intellectual property protection.
The key players operating in the digital biomanufacturing market are GE Healthcare Technologies Inc. (U.S.), Siemens Xcelerator (subsidiary of Siemens) (Germany), Cytiva (subsidiary of Danaher Corporation) (U.S.), ABB Ltd. (Switzerland), Sanofi S.A. (France), Emerson Electric Co. (U.S.), Honeywell International, Inc. (U.S.), SAP SE (Germany), OVO Biomanufacturing Inc. (U.S.), Schneider Electric SE (France), Dassault Systemes (France), Oracle Corporation (U.S.), and 3M (U.S.).
The digital biomanufacturing market is segmented by offering (software and hardware), functionality (product design, process optimization & analytics, automation & control, real-time quality monitoring and compliance, supply chain and operations management, and other functionalities), bioprocess (upstream bioprocess and downstream bioprocess), application (monoclonal antibodies, recombinant hormones/proteins, vaccines, cellular-based biologics, gene-based biologics, biosimilars, industrial biotech, and other applications), end user (biopharmaceutical companies, academic and research institutes, CDMOs & CROs, food and industrial biotech companies, and other end users), and geography. The study also evaluates industry competitors and analyzes the market at the country level.
The software segment is projected to account for the largest market share of 58% in 2025. The dominance of this segment is primarily attributed to its fundamental role as the core intelligence layer driving process optimization, data analytics, and real-time decision-making across all biomanufacturing processes. This includes sophisticated process analytical technology (PAT) systems, advanced data analysis software, manufacturing execution systems (MES), and cutting-edge digital twin platforms that create virtual replicas of bioprocessing operations. The segment's growth is further accelerated by the continuous evolution of artificial intelligence and machine learning capabilities embedded within these platforms, transitioning from simple monitoring systems to intelligent platforms capable of predictive analytics, autonomous process adjustments, and cognitive decision-making. The software segment is also expected to register significant growth during the forecast period, driven by increasing adoption of cloud-based solutions and advanced analytics capabilities.
The process optimization & analytics segment is expected to dominate the digital biomanufacturing market in 2025. This segment's leadership reflects the critical need for continuous improvement in biomanufacturing processes, where even minor optimizations can result in significant cost savings, yield improvements, and quality enhancements. Process optimization & analytics encompasses advanced statistical process control, design of experiments (DoE), multivariate data analysis, and machine learning-powered optimization algorithms that continuously analyze process parameters to identify opportunities for improvement. These systems integrate data from multiple sources across the bioprocessing workflow to provide comprehensive insights into process performance, enabling manufacturers to achieve higher product yields, reduce batch-to-batch variability, and minimize production costs while maintaining regulatory compliance. However, the supply chain & operations management segment is projected to register the highest CAGR of 16.5% during the forecast period, driven by the increasing recognition of the importance of end-to-end visibility and coordination across global biopharmaceutical operations.
The upstream bioprocess segment is expected to account for the largest share of the digital biomanufacturing market in 2025. The upstream segment's dominance is due to its fundamental role as the foundation of all biomanufacturing operations and its significant impact on overall process economics. Upstream processes directly influence product yield, quality, and consistency, making optimization in this area particularly valuable. The complexity of cell culture processes, with their numerous interdependent variables including pH, dissolved oxygen, temperature, nutrient levels, and metabolite concentrations, creates substantial opportunities for digital optimization. Advanced process analytical technology, real-time monitoring systems, and AI-powered control algorithms can significantly improve cell productivity, reduce contamination risks, and optimize media consumption, driving the widespread adoption of digital solutions in upstream bioprocessing.
The monoclonal antibodies segment is expected to account for the largest share of 33% of the digital biomanufacturing market in 2025. The large share of this segment is attributed to the established manufacturing infrastructure, well-understood production processes, and significant commercial value of these products. The complex multi-step production process of monoclonal antibodies, involving cell line development, upstream cell culture, downstream purification, formulation, and fill-finish operations, creates numerous opportunities for digital optimization. The high value and large production volumes of monoclonal antibodies justify substantial investments in advanced digital technologies that can improve yields, reduce production costs, and ensure consistent product quality. However, the gene-based biologics segment is experiencing the fastest growth at a CAGR of 17.9% during the forecast period, as this emerging therapeutic modality gains regulatory approval and commercial traction, with the FDA anticipating approval of 10 to 20 cell and gene therapy products per year by 2025.
The biopharmaceutical companies segment is expected to account for the largest share of the digital biomanufacturing market in 2025. The increasing preference for biopharmaceuticals, growing research in personalized medicines, and supportive initiatives for the adoption of biopharmaceuticals are supporting the segment's largest market share. Biopharmaceuticals are typically complex and costlier than conventional drugs to manufacture, leading biomanufacturing industries to deploy digital solutions to reduce errors and scale up production processes. The increasing number of biopharmaceutical companies along with the gradually increasing adoption of digital technologies in these companies contributes to the segment's dominance, with approximately 55% of companies having incorporated digital technologies in their workflows.
An in-depth geographic analysis of the industry provides detailed qualitative and quantitative insights into the five major regions (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa) and the coverage of major countries in each region.
North America is expected to account for the largest share of 38% of the digital biomanufacturing market in 2025. The large share of this region is attributed to the presence of leading biopharmaceutical companies, advanced technological infrastructure, substantial R&D investments, and a supportive regulatory environment. The United States, in particular, hosts numerous biotechnology hubs and maintains a leadership position in biologics development and manufacturing. North America's established biopharmaceutical ecosystem includes major companies with extensive manufacturing networks, well-developed supply chains, and significant financial resources for technology adoption. The region's regulatory framework, led by the FDA, has been progressive in encouraging the adoption of advanced manufacturing technologies and providing guidance on digital technologies in biomanufacturing.
However, Asia-Pacific is projected to register the highest CAGR of 16.0% during the forecast period across the overall digital biomanufacturing market. This growth is fueled by the rapidly expanding biopharmaceutical sectors in countries such as China, India, Japan, and South Korea. The region's growth is driven by increasing government investments in biotechnology, growing domestic demand for biologics, expanding manufacturing capacity, and the presence of cost-effective contract development and manufacturing organizations (CDMOs). Rising government initiatives aimed at digitization, growing demand for cost-effective automation solutions, expanding biopharmaceutical manufacturing infrastructure, and increasing focus on operational efficiency in densely populated countries are driving market expansion. The region's booming biotechnology sector, expanding research and development activities, growing skilled workforce, increasing foreign direct investments in the life sciences sector, and supportive regulatory frameworks for digital technology adoption are creating a conducive environment for market growth.
Key Questions Answered in the Report
Digital Biomanufacturing Market Assessment-by Offering
Digital Biomanufacturing Market Assessment-by Functionality
Digital Biomanufacturing Market Assessment-by Bioprocess
Digital Biomanufacturing Market Assessment-by Application
Digital Biomanufacturing Market Assessment-by End User
Digital Biomanufacturing Market Assessment-by Geography