![]() |
市场调查报告书
商品编码
1886172
数位生物製造市场规模、占有率、预测及趋势分析:按产品(软体/硬体)、功能(产品设计、分析、自动化)、应用(单株抗体、蛋白质、疫苗)和生物製程划分-全球预测至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 |
||||||
预计2025年至2035年,数位生物製造市场将以12.6%的复合年增长率成长,到2035年达到764亿美元。本报告对五大主要地区的数位生物製造市场进行了详细分析,重点关注当前市场趋势、市场规模、近期发展以及至2035年的预测。
基于广泛的二级和一级研究以及对市场现状的详细分析,本报告对关键行业驱动因素、限制因素、机会和挑战的影响进行了分析。此市场成长的驱动因素包括:对生物製药的需求不断增长、大型企业扩大生物製药厂产能、对连续生物製程的日益重视、生物製造製程优化需求的不断增长,以及对品质标准和法规遵从性的日益重视。此外,人工智慧 (AI) 和机器学习的融合、基于云端的製造平台、数位孪生技术的应用以及向生物工艺 4.0 的转型,预计也将支持市场成长。
然而,仍有许多挑战,包括技术采用成本高昂、生物製药的研发和生产流程复杂、与传统系统整合方面的挑战,以及对资料安全和智慧财产权保护的担忧。
数位生物製造市场按产品(软体和硬体)、功能(产品设计、流程优化和分析、自动化和控制、即时品质监控和合规性、供应炼和营运管理以及其他功能)、生物製程(上游和下游生物製程)、应用(单株抗体、重组荷尔蒙/蛋白、疫苗、细胞生物製剂、基因生物製剂、生物相似药、工业生物技术以及其他应用)、最终用户(生物製药公司、学术和研究机构、CDMO/CRO、食品和工业生物技术公司以及其他最终用户)和地区进行细分。本研究也评估了产业竞争对手,并提供了国家层面的市场分析。
预计到 2025 年,软体领域将占最大的市场占有率,达到 58%。该领域的主导地位主要归功于其作为核心智慧层的基础性作用,它驱动着所有生物製造流程的流程优化、数据分析和即时决策。这些软体包括先进的製程分析技术 (PAT) 系统、先进的数据分析软体、製造执行系统 (MES) 以及能够创建生物製程操作虚拟副本的尖端数位孪生平台。此外,嵌入这些平台的人工智慧 (AI) 和机器学习功能的持续发展也推动了该领域的成长。我们看到,简单的监控系统正在转变为能够进行预测分析、自主流程调整和认知决策的智慧平台。在预测期内,受云端解决方案和高阶分析技术日益普及的推动,软体领域也预计将显着成长。
预计到2025年,製程优化和分析领域将引领数位生物製造市场。该领域的领先地位反映了生物製造製程持续改进的重要性,即使是微小的最佳化也能显着降低成本、提高产量和品质。製程优化和分析包括先进的统计製程控制、实验设计 (DoE)、多元数据分析以及基于机器学习的最佳化演算法,这些技术能够持续分析製程参数并识别改进机会。这些系统整合了来自整个生物製程工作流程中多个来源的数据,从而提供对製程性能的全面洞察。这使製造商能够在确保合规性的同时,实现更高的产品产量、降低批次间差异并最大限度地降低生产成本。然而,在预测期内,供应链营运管理预计将以16.5%的复合年增长率(CAGR)实现最高成长,这主要得益于全球生物製药企业日益认识到端到端可视性和协调的重要性。
预计到2025年,上游生物製程将占数位生物製造市场最大的占有率。这一主导地位源于其作为所有生物製造营运基础的根本作用,以及其对整体工艺经济性的显着影响。上游製程的最佳化尤其重要,因为它们直接影响产品的产量、品质和一致性。细胞培养製程的复杂性,包括pH值、溶解氧、温度、营养水平和代谢物浓度等众多相互依存的变量,为数位化优化创造了巨大的机会。先进的製程分析技术、即时监控系统和人工智慧驱动的控制演算法能够显着提高细胞生产力、降低污染风险并优化培养基消耗,从而促进数位化解决方案在上游生物製程的广泛应用。
预计2025年,单株抗体领域将占数位生物製造市场最大的占有率,达到33%。该领域占有率占比高主要归功于其完善的生产基础设施、成熟的生产流程以及产品本身巨大的商业价值。单株抗体复杂的多步骤生产流程(包括细胞系开发、上游细胞培养、下游纯化、製剂配製以及灌装包装等製程)为数位化优化提供了许多机会。单株抗体的高价值和大规模生产特性,促使企业对先进的数位技术进行大量投资,以提高产量、降低生产成本并确保产品品质的稳定性。然而,基因工程生物製剂领域预计将实现最快成长,在预测期内复合年增长率将达到17.9%。随着这些新兴疗法获得监管部门批准并取得商业成功,FDA预计到2025年每年将批准10至20种细胞和基因治疗产品。
预计到2025年,生物製药公司将占数位生物製造市场最大的占有率。对生物製药日益增长的偏好、个人化医疗研究的不断深入以及支持生物製药应用的政策,正在推动该领域占最大的市场占有率。由于生物製药通常较为复杂,且生产成本高于传统药物,生物製造业正扩大采用数位化解决方案来减少错误并扩大生产规模。生物製药公司数量的不断增长及其对数位技术的逐步采用,推动了该领域的领先地位,约55%的公司已在其工作流程中实施了数位技术。
本产业区域分析提供了对五大主要区域(北美、欧洲、亚太、拉丁美洲以及中东和非洲)及其各区域内主要国家的详细定性和定量见解。
预计到2025年,北美将占数位生物製造市场最大的占有率(38%)。该地区占有率庞大,得益于其拥有众多大型生物製药公司、先进的技术基础设施、大量的研发投资以及有利的监管环境。特别是美国,拥有众多生物技术中心,并在生物製剂的开发和生产方面保持领先地位。北美成熟的生物製药生态系统汇聚了许多拥有广泛生产网路、高度发展的供应链以及充足技术实施资金的大型公司。该地区的监管框架,以美国食品药物管理局 (FDA) 为首,一直积极推动先进製造技术的应用,并为生物製造领域的数位化技术提供指导。
然而,预计亚太地区在预测期内将实现最高的数位化生物製造市场复合年增长率 (CAGR),达到 16.0%。这一成长主要得益于中国、印度、日本和韩国等国家生物製药产业的快速发展。该地区的成长动力来自政府对生物技术领域投资的增加、国内对生物製药需求的增长、生产能力的提升以及高性价比的合约研发生产机构 (CDMO) 的存在。此外,政府加大数位投入、对高性价比自动化解决方案的需求不断增长、生物製药生产基础设施的扩建以及人口稠密国家对营运效率的日益重视,都在推动市场扩张。该地区蓬勃发展的生物技术产业、不断扩大的研发活动、日益增长的熟练劳动力、生命科学领域不断增加的外国直接投资,以及支持数位技术的监管框架,正在为市场成长创造有利环境。
按产品/服务划分的数位生物製造市场评估
按功能划分的数位生物製造市场评估
按生物製程划分的数位生物製造市场评估
数位生物製造市场评估:按应用领域划分
数位生物製造市场评估:按最终用户划分
数位生物製造市场评估:按地区划分
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