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市场调查报告书
商品编码
1841984
北美活性药物成分市场规模、份额和趋势分析报告:按合成类型、製造商、类型、应用、国家和细分市场预测,2025 年至 2033 年North America Active Pharmaceutical Ingredients Market Size, Share & Trends Analysis Report By Type Of Synthesis, By Type Of Manufacturer, By Type, By Application, By Country, And Segment Forecasts, 2025 - 2033 |
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北美活性药物成分市场规模预计在 2024 年达到 9,664 万美元,预计到 2033 年将达到 1.4734 亿美元,2025 年至 2033 年的复合年增长率为 4.76%。
学名药需求的不断增长、生物技术的进步、人口老化以及有利的监管支持正在推动这一增长。
拥有强大製造能力的老牌製药公司的存在进一步支持了市场扩张。北美 API 市场正在经历重大变革时期,推动这项转型的因素包括监管措施、技术进步和旨在加强国内製造能力的策略投资。该市场中最引人注目的新兴市场发展之一是美国政府为确保更具弹性的医药供应链所做的努力。 2025 年 8 月,唐纳德·川普总统签署了一项行政命令,设立战略活性药物成分储备库 (SAPIR),以储存国家健康和安全所需的关键药物成分。这项由美国卫生与公众服务部支持的策略性倡议凸显了全球 API 供应链日益增长的脆弱性,尤其是在 COVID-19 大流行造成中断之后。此举旨在减少对海外供应商的依赖,并确保在紧急情况和中断期间随时获得基本药物。
同时,各大製药公司纷纷宣布对国内原料药製造进行大规模投资。 2025 年 2 月,北美最大的製药公司之一礼来公司宣布计划投资 270 亿美元在美国新建四家製造工厂。此次扩建旨在实现两个目的:减少对海外原料药来源的依赖,并减轻潜在药品进口关税的影响。这一策略转变反映了製药业的一个大趋势,由于贸易不确定性和海外生产成本上升等因素,越来越多的公司将生产转移回北美。作为这项倡议的一部分,礼来公司还在 2025 年 8 月确认将出售其新泽西工厂,并专注于根据以美国为中心的生产策略整合製造业务。预计此类大规模投资将对市场产生重大影响,提高本地生产能力并增强供应链弹性。
同时,监管变化正在塑造北美原料药生产的格局。 2024 年 6 月,美国食品药物管理局(FDA) 修订了 21 CFR 第 211 部分,以加强药品(包括原料药)的现行良好生产规范 (CGMP)。这些修订旨在改善整个产业的品质保证和生产流程,确保原料药符合最高的安全性和有效性标准。这些监管更新鼓励製药商采用尖端技术和品管措施。此外,2024 年 1 月,FDA 发布了新的指导草案,澄清人用药物 CGMP 指南 (ICH Q7) 也适用于原料药的生产。此举反映了 FDA 致力于加强监管和协调製药业各个环节实践的承诺。透过将法律规范扩大到原料药,FDA 确保用于人类和动物健康的原料药符合同样严格的标准,从而提高药品的整体安全性和有效性。
除了监管和投资主导的变化之外,技术进步对于塑造原料药製造业也至关重要。一个关键趋势是向连续製造转变,这使得原料药生产更有效率、可扩展且具有成本效益。 2023 年 5 月, 原料药製造商 Cambrex 完成了其位于马萨诸塞州的原料药製造工厂的大规模扩建,提高了生产能力,以满足对高品质、高效价原料药日益增长的需求。此次扩建是该公司更广泛策略的一部分,该策略旨在投资先进的製造技术,以提高生产效率并更快地响应不断变化的市场需求。连续製造与自动化即时监控系统相结合,可帮助公司缩短生产前置作业时间、降低营运成本并最大限度地降低人为错误的风险。这些技术进步有望成为维持市场成长的关键因素,因为它们提高了灵活性和对医药需求变化的应对力。
这些发展标誌着北美正在齐心协力加强其国内原料药)製造业。透过投资製造设施、法规更新和最尖端科技,该地区正致力于在全球市场动盪的背景下,增强自力更生和韧性。随着学名药和创新药需求的不断增长,北美原料药市场预计将继续发展,这些因素将有助于打造更稳健、更具前瞻性的医药供应链。该行业专注于增强製造能力、提高法规遵从性并采用先进技术,这将有助于北美在全球原料药市场保持领先地位。
The North America active pharmaceutical ingredients market was estimated at USD 96.64 million in 2024 and is projected to reach USD 147.34 million by 2033, growing at a CAGR of 4.76% from 2025 to 2033. The increasing demand for generic drugs, advancements in biotechnology, a rising aging population, and favorable regulatory support drive this growth.
The presence of established pharmaceutical companies with strong manufacturing capabilities further supports the market's expansion. The North America API market is undergoing a significant transformation, driven by various dynamic factors, including regulatory initiatives, technological advancements, and strategic investments to bolster domestic manufacturing capabilities. One of the most prominent developments in this market is the U.S. government's efforts to ensure a more resilient pharmaceutical supply chain. In August 2025, President Donald Trump signed an executive order to establish the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) to stockpile critical drug components necessary for national health and security. This strategic initiative, supported by the U.S. Department of Health and Human Services, highlights the growing recognition of the vulnerabilities in the global API supply chain, especially following the disruptions caused by the COVID-19 pandemic. This move is intended to reduce dependence on foreign suppliers, ensuring that essential medicines are readily available during emergencies and disruptions.
Simultaneously, major pharmaceutical companies have announced significant investments in domestic API manufacturing. In February 2025, Eli Lilly, one of the largest pharmaceutical companies in North America, revealed plans to invest USD 27 billion to construct four new manufacturing facilities in the United States, with three of these facilities dedicated to API production. The purpose of this expansion is twofold: to reduce reliance on foreign sources of APIs and to mitigate the impact of potential pharmaceutical import tariffs. This strategic shift reflects broader trends in the pharmaceutical industry, where companies are increasingly bringing production back to North America, driven by factors such as trade uncertainties and rising costs of overseas manufacturing. As part of this initiative, Eli Lilly also confirmed in August 2025 that it would sell a New Jersey plant, focusing on consolidating its manufacturing operations to align with its U.S.-centric production strategy. Such large-scale investments are expected to impact the market significantly, increasing local production capacity and enhancing supply chain resilience.
Alongside these developments, regulatory changes are shaping the landscape of API manufacturing in North America. In June 2024, the U.S. Food and Drug Administration (FDA) amended 21 CFR Part 211, enhancing Current Good Manufacturing Practices (CGMP) for drug products, including APIs. These revisions aim to improve quality assurance and manufacturing processes across the industry, ensuring that APIs meet the highest safety and efficacy standards. Such regulatory updates push pharmaceutical manufacturers to adopt state-of-the-art technologies and quality control measures. Furthermore, in January 2024, the FDA released new draft guidance clarifying that the human drug CGMP guidelines (ICH Q7) now apply to manufacturing veterinary APIs. This move reflects the FDA's commitment to enhancing oversight and aligning practices across various pharmaceutical industry segments. By expanding regulatory oversight to include veterinary APIs, the FDA ensures that APIs used in human and animal health meet the same rigorous standards, thereby improving the overall safety and effectiveness of medications.
In addition to regulatory and investment-driven changes, technological advancements are pivotal in shaping the API manufacturing sector. A significant trend is the shift toward continuous manufacturing, which allows for more efficient, scalable, and cost-effective production of APIs. In May 2023, Cambrex, an API manufacturer, completed a large-scale expansion of its API production plant in Massachusetts, increasing its capacity to meet the growing demand for high-quality, high-potency APIs. This expansion is part of a broader strategy by companies to invest in advanced manufacturing technologies that enhance production efficiency and enable faster response times to changing market demands. Continuous manufacturing, which involves automated, real-time monitoring systems, helps companies reduce production lead times, lower operational costs, and minimize the risk of human error. These technological innovations are expected to be a key factor in sustaining market growth, as they offer greater flexibility and responsiveness to shifts in the demand for pharmaceutical products.
These developments indicate a concerted effort to strengthen North America's domestic API manufacturing sector. By leveraging investments in manufacturing facilities, regulatory updates, and cutting-edge technologies, the region is positioning itself to become more self-reliant and resilient in the face of global disruptions. With increasing demand for generic and innovative drugs, the North American API market is set to continue evolving, driven by these factors contributing to a more robust and future-proof pharmaceutical supply chain. The industry's focus on enhancing manufacturing capacity, improving regulatory compliance, and adopting advanced technologies will help ensure North America remains at the forefront of the global API market.
North America Active Pharmaceutical Ingredients Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the North America active pharmaceutical ingredients market report based on type of synthesis, type of manufacturer, type, application, and country: