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市场调查报告书
商品编码
1818084
全球製药製造自动化市场:预测至 2032 年—按组件、自动化模式、应用、最终用户和地区进行分析Automation in Pharmaceutical Manufacturing Market Forecasts to 2032 - Global Analysis By Component (Hardware, Software, and Services), Mode of Automation (Semi-Automatic Systems, and Fully Automatic Systems), Application, End User and By Geography |
根据 Stratistics MRC 的数据,全球製药製造自动化市场预计在 2025 年达到 135 亿美元,到 2032 年将达到 287 亿美元,预测期内的复合年增长率为 11.3%。
製药生产自动化涉及机器人技术、製程控制系统和数据分析的集成,以简化药品、疫苗和生技药品的生产。配方、填充、包装和品管的自动化可提高准确性、一致性和法规遵循。自动化减少了人为干预,最大限度地降低了污染和操作失误的风险。它加快了生产週期,同时确保了产品的高品质。由于药品需求不断增长、监管审查日益严格以及全球健康挑战日益严峻,对可扩展且高效的生产方法的需求推动了市场的发展。
对高效药品生产的需求不断增加
製药业面临着巨大的压力,需要在管理复杂的生产流程的同时缩短新治疗方法的上市时间。自动化能够直接解决这个问题,它能够提高生产线的产量,最大限度地减少人为错误,并确保批次间的一致性。此外,自动化还能帮助製造商优化资源利用率,降低长期营运成本。在竞争和经济压力的驱动下,对效率的不懈追求是投资自动化系统(从机器人流程自动化到整合控制系统)的根本催化剂。
自动化设备投入大
进入和拓展市场的一个重大障碍是自动化基础设施所需的巨额资本支出。这不仅包括用于复杂机器人、製造执行系统 (MES) 和专用硬体的初始投入,还包括系统整合、检验和员工培训的附加成本。此外,整体拥有成本也带来了巨大的财务挑战,尤其对中小型企业 (SME) 而言。如此高的投资标准会减慢投资报酬率 (ROI) 的计算速度,并需要长期的策略规划,这限制了各级製药企业的广泛采用。
扩大生物製药生产
生物製药产业(包括生技药品、单株抗体以及细胞和基因疗法)的快速发展为自动化带来了巨大的机会。这些复杂的产品需要严格的环境控制、精确的过程参数管理以及理想情况下由自动化封闭式系统管理的无菌製程条件。自动化确保了这些精细工艺所需的高保真度和可重复性。此外,灵活的模组化自动化解决方案可以有效缓解生物生产固有的可扩展性挑战,从而为自动化供应商开闢新的高价值细分市场。
互联繫统中的网路安全威胁
随着製药製造业拥抱工业4.0,操作技术(OT) 与资讯科技 (IT) 的整合也带来了网路攻击的风险。高效互联的自动化系统虽然容易受到攻击,但可能导致智慧财产权被盗、营运中断或程式参数被严重篡改,从而危及药品的安全性和有效性。成功的攻击不仅会直接威胁患者健康,还可能导致严重的监管违规行为和声誉受损。因此,网路威胁的复杂性已成为製药业数位转型面临的重大挑战。
新冠疫情是製药自动化市场的主要催化剂,暴露了全球供应链中的关键漏洞,并凸显了对敏捷且富有韧性的製造能力的迫切需求。疫苗和治疗药物的空前需求加速了自动化的应用,以便在保持设施内社交距离的同时快速扩大生产通讯协定。这场危机凸显了自动化系统在确保业务永续营运的重要性,迫使许多製造商加快数位化和自动化策略,以确保其营运在未来能够抵御类似的中断。
预计硬体部分将成为预测期内最大的部分
预计硬体部分将在预测期内占据最大的市场份额,因为它是任何自动化装置的物理支柱。此部分包括机械臂、自动化工作单元、感测器、控制器和组装等关键组件。这些有形资产需要大量的资本支出,是工厂车间自动化流程的关键推动因素。由于这些核心组件持续需要建立初始自动化功能,再加上其高成本软体和服务,这些因素巩固了硬体在整体市场收益中的主导地位。
预计在预测期内,品管和法规遵循部分将以最高的复合年增长率成长。
预计品管和法规遵从领域将在预测期内实现最高成长率,这得益于製药业必须严格遵守美国食品药物管理局 (FDA) 和欧洲药品管理局 (EMA) 等机构制定的《药品生产品质管理规范》(GMP) 指南。在这一领域,透过机器视觉检测和自动取样系统等技术实现的自动化,可显着减少人为错误,并提供可靠且数据丰富的审核追踪。此外,药品日益复杂,人工品质检查已难以满足需求,这推动了对先进自动化合规解决方案的需求,以确保患者安全并简化监管核准。
预计北美将在预测期内占据最大的市场份额。这种主导地位得益于其成熟的製药业、主要市场参与者的集中以及早期的技术采用。此外,美国食品药物管理局 (FDA) 实施的严格法律规范也是推动製造商采用先进流程来确保品质的主要驱动因素。该地区拥有雄厚的财力,能够投资于高成本的自动化技术,并专注于复杂的生技药品研究,这些优势使其牢牢占据了市场收益的领先地位。
预计亚太地区在预测期内的复合年增长率最高。这项加速成长的动力源自于印度和中国等国家不断扩大的製药生产足迹,这些国家是国际原料药和学名药的製造地。该地区各国政府正积极透过「工业4.0」和「印度製造」等倡议推动工业自动化。此外,跨国公司寻求经济高效的生产替代方案的投资不断增加,加上国内对高品质药品的需求不断增长,正在推动全部区域製造设施的快速现代化和自动化。
According to Stratistics MRC, the Global Automation in Pharmaceutical Manufacturing Market is accounted for $13.5 billion in 2025 and is expected to reach $28.7 billion by 2032 growing at a CAGR of 11.3% during the forecast period. Automation in pharmaceutical manufacturing involves integrating robotics, process control systems, and data analytics to streamline production of medicines, vaccines, and biologics. It enhances precision, consistency, and regulatory compliance by automating formulation, filling, packaging, and quality control. Automation reduces human intervention, minimizing contamination risks and operational errors. It accelerates production cycles while ensuring high product quality. The market grows due to increasing demand for pharmaceuticals, regulatory scrutiny, and the need for scalable, efficient production methods amid rising global health challenges.
Increasing demand for efficient drug production
The industry faces immense pressure to reduce time-to-market for new therapies while managing complex production workflows. Automation directly addresses this by enhancing production line throughput, minimizing human error, and ensuring batch-to-batch consistency. Furthermore, it enables manufacturers to optimize resource utilization and lower long-term operational costs. This relentless pursuit of efficiency, driven by competitive and economic pressures, is a fundamental catalyst for investing in automated systems, from robotic process automation to integrated control systems.
High investment in automation equipment
A significant barrier to market entry and expansion is the substantial capital expenditure required for automation infrastructure. This includes not only the initial outlay for sophisticated robotics, manufacturing execution systems (MES), and specialized hardware but also the ancillary costs for system integration, validation, and employee training. Moreover, the total cost of ownership presents a considerable financial challenge, particularly for small and mid-sized enterprises (SMEs). This high investment threshold can delay ROI calculations and necessitates long-term strategic planning, thereby restraining widespread adoption across all tiers of pharmaceutical manufacturers.
Expansion of biopharmaceutical production
The rapid growth of the biopharmaceutical sector, encompassing biologics, monoclonal antibodies, and cell and gene therapies, presents a substantial opportunity for automation. These complex products require stringent environmental controls, precise process parameter management, and aseptic processing conditions that are ideally managed by automated and closed systems. Automation ensures the high fidelity and reproducibility necessary for these sensitive processes. Additionally, the scalability challenges inherent in bioproduction can be effectively mitigated through flexible and modular automation solutions, opening a new and high-value market segment for automation vendors.
Cybersecurity threats in connected systems
As pharmaceutical manufacturing embraces Industry 4.0, the convergence of operational technology (OT) with information technology (IT) creates vulnerabilities to cyber-attacks. Connected automation systems, while efficient, are potential targets for breaches that could lead to intellectual property theft, operational shutdown, or catastrophic manipulation of process parameters compromising drug safety and efficacy. A successful attack not only poses a direct threat to patient health but also risks severe regulatory non-compliance and reputational damage. Consequently, the evolving sophistication of cyber threats remains a critical concern for the industry's digital transformation.
The COVID-19 pandemic acted as a profound catalyst for the pharmaceutical automation market. It exposed critical vulnerabilities in global supply chains and highlighted the urgent need for agile and resilient manufacturing capabilities. The unprecedented demand for vaccines and therapeutics accelerated the adoption of automation to rapidly scale up production while maintaining social distancing protocols in facilities. This crisis underscored the value of automated systems in ensuring business continuity, thereby compelling many manufacturers to fast-track their digitalization and automation strategies to future-proof their operations against similar disruptions.
The hardware segment is expected to be the largest during the forecast period
The hardware segment is expected to account for the largest market share during the forecast period due to its fundamental role as the physical backbone of any automation setup. This segment includes essential components such as robotics arms, automated workcells, sensors, controllers, and assembly lines. These tangible assets require significant capital investment and are the primary enablers of automated processes on the factory floor. The continued necessity for these core components to establish initial automation capabilities, coupled with their high cost relative to software and services, solidifies hardware's dominant position in the overall market revenue.
The quality control and regulatory compliance segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the quality control and regulatory compliance segment is predicted to witness the highest growth rate. This is driven by the pharmaceutical industry's non-negotiable requirement to adhere to stringent Good Manufacturing Practice (GMP) guidelines set by agencies like the FDA and EMA. Automation in this segment, through technologies like machine vision for inspection and automated sampling systems, drastically reduces human error and provides robust, data-rich audit trails. Moreover, the increasing complexity of drug products makes manual quality checks insufficient, thereby fueling the demand for advanced, automated compliance solutions to ensure patient safety and streamline regulatory approvals.
During the forecast period, the North America region is expected to hold the largest market share. This dominance is attributed to the presence of a well-established pharmaceutical industry, a high concentration of leading market players, and early technological adoption. Furthermore, the stringent regulatory framework enforced by the U.S. FDA compelling manufacturers to implement advanced processes for quality assurance acts as a key driver. The region's robust financial capacity to invest in high-cost automation technologies and a strong focus on researching complex biologics solidify its position as the revenue leader in this market.
Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR. This accelerated growth is fueled by the expanding pharmaceutical manufacturing footprint in countries like India and China, which are major global hubs for API and generic drug production. Governments in the region are actively promoting industrial automation through initiatives like "Industry 4.0" and "Make in India." Additionally, increasing investments from multinational corporations seeking cost-effective production alternatives, coupled with rising domestic demand for high-quality medicines, are driving the rapid modernization and automation of manufacturing facilities across the region.
Key players in the market
Some of the key players in Automation in Pharmaceutical Manufacturing Market include Siemens, Rockwell Automation, KUKA, Becton Dickinson and Company, Capsa Healthcare, Omnicell, Baxter International, Yuyama, ScriptPro, Swisslog Healthcare, SYNTEGON, IMA Group, GEA Group, FANUC, Themis Automation, Turck, Bausch+Strobel, and Sartorius.
In July 2025, Capsa Healthcare acquired BlueBin, integrating predictive analytics and Kanban-based supply chain systems to enhance clinical supply management.
In June 2025, Pharbaco achieved GMP-EU compliance by implementing advanced automation and energy-efficient cleanroom solutions, utilizing FactoryTalk(R) Historian for environmental data analysis.
In February 2025, Siemens announced its Xcelerator Smart Lab Ecosystem, which revolutionizes lab and cleanroom design with modular, plug-and-play infrastructure. This solution can accelerate lab design by up to 80% while ensuring compliance with pharmaceutical standards.
In January 2025, BD and Biosero announced a collaboration to integrate robotic arms with BD's flow cytometry instruments, aiming to accelerate drug discovery and development.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.