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市場調查報告書
商品編碼
1818084
全球製藥製造自動化市場:預測至 2032 年—按組件、自動化模式、應用、最終用戶和地區進行分析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 |
根據 Stratistics MRC 的數據,全球製藥製造自動化市場預計在 2025 年達到 135 億美元,到 2032 年將達到 287 億美元,預測期內的複合年成長率為 11.3%。
製藥生產自動化涉及機器人技術、製程控制系統和數據分析的整合,以簡化藥品、疫苗和生技藥品的生產。配方、填充、包裝和品管的自動化可提高準確性、一致性和法規遵循。自動化減少了人為干預,最大限度地降低了污染和操作失誤的風險。它加快了生產週期,同時確保了產品的高品質。由於藥品需求不斷成長、監管審查日益嚴格以及全球健康挑戰日益嚴峻,對可擴展且高效的生產方法的需求推動了市場的發展。
對高效藥品生產的需求不斷增加
製藥業面臨著巨大的壓力,需要在管理複雜的生產流程的同時縮短新治療方法的上市時間。自動化能夠直接解決這個問題,它能夠提高生產線的產量,最大限度地減少人為錯誤,並確保批次間的一致性。此外,自動化還能幫助製造商最佳化資源利用率,降低長期營運成本。在競爭和經濟壓力的驅動下,對效率的不懈追求是投資自動化系統(從機器人流程自動化到整合控制系統)的根本催化劑。
自動化設備投入大
進入和拓展市場的一個重大障礙是自動化基礎設施所需的巨額資本支出。這不僅包括用於複雜機器人、製造執行系統 (MES) 和專用硬體的初始投入,還包括系統整合、檢驗和員工培訓的附加成本。此外,整體擁有成本也帶來了巨大的財務挑戰,尤其對中小型企業 (SME) 而言。如此高的投資標準會減慢投資報酬率 (ROI) 的計算速度,並需要長期的策略規劃,這限制了各級製藥企業的廣泛採用。
擴大生物製藥生產
生物製藥產業(包括生技藥品、單株抗體以及細胞和基因療法)的快速發展為自動化帶來了巨大的機會。這些複雜的產品需要嚴格的環境控制、精確的過程參數管理以及理想情況下由自動化封閉式系統管理的無菌製程條件。自動化確保了這些精細工藝所需的高保真度和可重複性。此外,靈活的模組化自動化解決方案可以有效緩解生物生產固有的可擴展性挑戰,從而為自動化供應商開闢新的高價值細分市場。
互聯系統中的網路安全威脅
隨著製藥製造業擁抱工業4.0,操作技術(OT) 與資訊科技 (IT) 的整合也帶來了網路攻擊的風險。高效互聯的自動化系統雖然容易受到攻擊,但可能導致智慧財產權被盜、營運中斷或程式參數被嚴重篡改,從而危及藥品的安全性和有效性。成功的攻擊不僅會直接威脅患者健康,還可能導致嚴重的監管違規行為和聲譽受損。因此,網路威脅的複雜性已成為製藥業數位轉型面臨的重大挑戰。
新冠疫情是製藥自動化市場的主要催化劑,暴露了全球供應鏈中的關鍵漏洞,並凸顯了對敏捷且富有韌性的製造能力的迫切需求。疫苗和治療藥物的空前需求加速了自動化的應用,以便在保持設施內社交距離的同時快速擴大生產通訊協定。這場危機凸顯了自動化系統在確保業務永續營運的重要性,迫使許多製造商加快數位化和自動化策略,以確保其營運在未來能夠抵禦類似的中斷。
預計硬體部分將成為預測期內最大的部分
預計硬體部分將在預測期內佔據最大的市場佔有率,因為它是任何自動化裝置的物理支柱。此部分包括機械臂、自動化工作單元、感測器、控制器和組裝等關鍵組件。這些有形資產需要大量的資本支出,是工廠車間自動化流程的關鍵推動因素。由於這些核心組件持續需要建立初始自動化功能,再加上其高成本軟體和服務,這些因素鞏固了硬體在整體市場收益中的主導地位。
預計在預測期內,品管和法規遵循部分將以最高的複合年成長率成長。
預計品管和法規遵從領域將在預測期內實現最高成長率,這得益於製藥業必須嚴格遵守美國食品藥物管理局 (FDA) 和歐洲藥品管理局 (EMA) 等機構制定的《藥品生產品質管理規範》(GMP) 指南。在這一領域,透過機器視覺檢測和自動取樣系統等技術實現的自動化,可顯著減少人為錯誤,並提供可靠且數據豐富的審核追蹤。此外,藥品日益複雜,人工品質檢查已難以滿足需求,這推動了對先進自動化合規解決方案的需求,以確保患者安全並簡化監管核准。
預計北美將在預測期內佔據最大的市場佔有率。這種主導地位得益於其成熟的製藥業、主要市場參與者的集中以及早期的技術採用。此外,美國食品藥物管理局 (FDA) 實施的嚴格法律規範也是推動製造商採用先進流程來確保品質的主要促進因素。該地區擁有雄厚的財力,能夠投資於高成本的自動化技術,並專注於複雜的生技藥品研究,這些優勢使其牢牢佔據了市場收益的領先地位。
預計亞太地區在預測期內的複合年成長率最高。這項加速成長的動力源自於印度和中國等國家不斷擴大的製藥生產足跡,這些國家是國際原料藥和學名藥的製造地。該地區各國政府正積極透過「工業4.0」和「印度製造」等舉措推動工業自動化。此外,跨國公司尋求經濟高效的生產替代方案的投資不斷增加,加上國內對高品質藥品的需求不斷成長,正在推動全部區域製造設施的快速現代化和自動化。
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.